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Appendix A
File No. 29/Misc/03/2020-DC (153) – Part 1
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA, Bhawan, New Delhi-110002
Notice
Classification of Medical Devices Pertaining to Oncology
S. Risk
Medical Device Name Intended Use
No. class
The FerriScan R2-MRI Analysis System is intended to measure liver
FerriScan R2-MRI iron concentration to aid in the identification and monitoring of non-
1 C
Analysis System transfusion dependent thalassemia patients receiving therapy with
deferasirox.
Alternating electric field
antimitotic cancer Alternating electric fields therapy is a novel anticancer treatment that
2 C
treatment system disrupts tumor cell mitosis.
generator
Alternating electric field
antimitotic cancer Alternating electric fields therapy is a novel anticancer treatment that
3 C
treatment system disrupts tumor cell mitosis.
transducer array
A sterile buffer solution intended to be used exclusively for bladder
Bladder instillation instillation to help create an optimal environment necessary for the
4 B
buffer solution effective treatment of superficial bladder cancer with a chemotherapy
agent.
An assembly of mains electricity (AC-powered) devices intended for
Breast 3-D infrared
three-dimensional (3-D) breast imaging and breast vascular analysis,
5 imaging/vascular C
typically used with mammography screening to perform a breast
analysis system
cancer risk examination.
A collection of non-sterile devices intended to collect exfoliated
Colonic cytology
6 colonic cells (colonocytes) from the surface of human rectal mucosa B
sampling set
for colorectal cancer investigation and/or patient screening.
A sterile collection of disposable devices used in conjunction with a
cryosurgical unit as well as monitoring and other devices to perform a
7 Cryosurgical set C
surgical technique that involves freezing a targeted area of tissue to
damage and destroy cancer cells in the unwanted portions.
A circular band intended to be used to enhance the mechanical
8 Capsular tension ring stability of a subluxated crystalline lens capsule in the presence of C
weak or absent supporting zonules.
An assembly of devices designed for the treatment of tumours and the
Electro cancer therapy destruction of their cancerous cells using low-voltage direct current of
9 C
system small intensity delivered via electrodes placed across the affected
body area.
Page 1 of 6A portable assembly of devices designed to electronically measure,
Electronic clinical breast map, document and store information about breast lesions/masses
10 B
examination system with regard to shape, size, location, consistency/relative hardness
during a clinical breast examination (CBE)
A collection of devices designed to remove superficial tissue from the
11 Endocervical aspirator mucous membrane lining the cervical canal (endometrium) through C
manually-powered suction.
An assembly of portable devices designed to apply low-intensity,
Alternating electric field
intermediate-frequency (100-300 kHz) alternating electric fields to
12 antimitotic cancer D
treat certain forms of recurrent or newly-diagnosed cancer; typically
treatment system
glioblastoma multiforme (GBM) [malignant brain tumour].
A collection of sterile surgical instruments and devices used for the
reduction of a vertebral compression fractures (VCFs) caused by
13 Balloon kyphoplasty kit C
trauma, cancer, or osteoporosis during a minimally invasive
procedure commonly known as balloon kyphoplasty.
A seat, typically with legs, that is a component of a therapeutic
accelerator system, and used to support and position a seated patient
14 Accelerator system chair C
during radiation therapy treatments involving the use of either a
medical linear accelerator or non-linear accelerator.
An instrument specifically designed to be used to check the
Accelerator system calibration and performance of linear and non-linear medical
15 C
quality assurance device accelerator systems used for radiation therapy applications, for
quality assurance (QA) purposes
A device designed to be worn on the wrist(s) for the application of
16 Acupressure wristband pressure to the Nei-kuan (P6) acupressure point, the area identified to B
help relieve the sensation of nausea.
Anorectal brachytherapy
A manual brachytherapy applicator specifically designed to be used
17 system applicator, C
in radiation therapy treatments of the rectum and/or anus.
manual
Anorectal brachytherapy
A remote afterloading brachytherapy applicator specifically designed
18 system applicator, C
for use in radiation therapy treatments of the rectum and/or anus.
remote-afterloading
A woman's undergarment which includes antimicrobial properties
Antimicrobial designed to support and/or contour the breast(s) or hold a dressing in
19 A
postsurgical brassiere place after surgical intervention (e.g. thoracic surgery, mastectomy,
lumpectomy)
It is intended for use during medical treatment (e.g., chemotherapy)
Antimicrobial or be used to protect the skin following treatment with a medication
20 postsurgical female (e.g. ointment, cream). It is specifically designed for patient A
underpants support/comfort in the home or healthcare facility. This is a reusable
device.
A sterile photochemical agent (psoralen) intended to be used in
Blood photochemical conjunction with ultraviolet A (UVA) irradiation to eliminate
21 C
treatment agent nucleated cells from blood or blood components (e.g. plasma,
leukocyte-enriched blood fraction).
Brachytherapy A non-tissue configured model designed to mimic the
22 radionuclide phantom, functional/physical characteristics of normal or diseased human A
test object organs during performance evaluations of brachytherapy system
Page 2 of 6components or radiation therapy treatment planning devices.
A sterile, bioabsorbable device designed to separate radioactive
Brachytherapy source sources of the seed type that are permanently implanted in close
23 C
spacer proximity to a selected localized tumour, to increase the distribution
of radioactivity to the tumour.
A mains electricity (AC-powered) component of a remote-
afterloading brachytherapy system intended to function as the primary
control panel for the remote afterloader. It typically includes
Brachytherapy system
hardware and software that allows for information display and/or
24 remote-afterloading C
transfer, data processing, analysis, and information archiving
operator console
functions; it may also be intended to interface with other devices
(e.g., radiation therapy treatment planning computer) as part of a
picture archiving and communication system (PACS).
A strip or roll of fabric or plastic material applied to the breast or
25 Breast binder A
breasts for soft tissue support. This is a single-use device.
A sterile, remote-afterloading brachytherapy applicator specifically
designed for use in radiation therapy treatments of the breast. It is typically
Breast brachytherapy designed for temporary implantation within the breast and serves as a guide
26 system applicator, for computer-controlled placement and removal of single or multiple C
remote-afterloading radioactive sources. Included are various types of applicators such as hollow
needles, tubes, or catheters, and their associated components. This is a
single-use device.
A mains electricity (AC-powered) transilluminating device with a
built-in light source using low intensity emissions of visible light and
near-infrared radiation (700 to 1050 nm) that is transmitted through
27 Breast transilluminator A
the female breast to visualize translucent tissue for the diagnosis of
cancer, or other conditions, diseases or abnormalities. This device
may also be known as a diaphanoscope.
An assembly of mains electricity (AC-powered) devices designed for
intracorporeal (endosonography or endoscopic) ultrasound imaging
28- Breast ultrasound
procedures involving the breast. It typically includes special imaging C
a imaging system
tables used to optimize the ability to give reproducible images of the
breast.
An assembly of mains electricity (AC-powered) devices designed for
28- Breast ultrasound extracorporeal ultrasound imaging procedures involving the breast. It
B
b imaging system typically includes special imaging tables used to optimize the ability
to give reproducible images of the breast
A surgical, manually-operated, instrument that is inserted into the
29 Cervical cone knife vagina and designed for excising a sample of abnormal tissue, e.g., C
indicated by the presence of precancerous changes, from the cervix.
blunt surgical instrument used to scrape and retrieve cytological
Cervical cytology material from the surface of the cervix (neck of the uterus) or vaginal
30 A
scraper, reusable area for pathological examination and diagnosis, often for the
detection of cervical cancer. This is a reusable device.
A hand-held, manual, blunt surgical instrument designed to scrape
and retrieve cytological material from the surface of the cervix (neck
Cervical cytology
31 of the uterus) or vaginal area for pathological examination and B
scraper, single-use
diagnosis, often for the detection of cervical cancer. This is a single-
use device.
Page 3 of 6A sterile flexible tube intended to deliver/remove radiation therapy
sources into a coronary artery, typically into the lumen of an
Coronary artery implanted stent, as part of a manual-afterloading brachytherapy
brachytherapy system system. It is introduced into the patient and subsequently connected to
32 D
applicator, manual- the brachytherapy system source transfer device; it includes
afterloading radiopaque markers to monitor the position of the radiation source.
Disposable devices associated with the procedure may be included
(e.g., syringe, connectors). This is a single-use device.
A device designed as a container to allow the safe deposit, collection
Cytotoxic waste
33 and storage of cytotoxic materials (e.g., chemotherapy/antineoplastic A
receptacle
drugs).
A mobile assembly of devices designed to apply electrical impulses to
the tissue to enable electroporation, a phenomenon that induces
Electroporation therapy alteration in the structure of cell membranes to increase their
34 C
system permeability and allow molecules that usually cannot enter the cell
membrane, such as drugs [electrochemotherapy (ECT)] and genetic
materials [electrogenetherapy (EGT)], to reach the cytoplasm.
A sterile, patient-contact component of an electroporation therapy
system intended to fit onto the distal tip of an endoscope and connect
to an electroporation therapy system generator to deliver electrical
Electroporation therapy
impulses to tissues during endoscopy as part of electroporation, a
35 system endoscopic C
phenomenon that induces alteration in the structure of cell
applicator
membranes to increase their permeability and allow molecules that
usually cannot enter the cell membrane, such as drugs
[electrochemotherapy (ECT)], to reach the cytoplasm.
A non-sterile endoscope with a highly flexible sleeve and distal tip intended
Externally-propelled for the visual examination of the entire adult colon [lower gastrointestinal
36 B
flexible video colonoscope (GI) tract].It is used for the screening of colorectal cancer and the detection
of other diseases of the lower GI tract. This is a single-use device.
An assembly of devices designed to produce and control heated fluids
circulated within a vessel applied to the body (e.g., vest, mattress,
Extravascular-circulation
37 jacket, band, pad, body wrap, catheter, probe) for systemic or B
hyperthermia system
localized heating to treat malignant tumours, benign growths, or other
disease-related conditions.
A vessel applied to the outside of the body (e.g., in the form of a
jacket, vest, body wrap, cushion, blanket, or mattress) that
incorporates tubing through which heated fluids are circulated for
Extravascular-circulation systemic or localized heating to treat malignant tumours, benign
hyperthermia system growths, or other disease-related conditions. he applicator typically
38 A
applicator, includes a thermometry component that monitors the temperature of
extracorporeal the applicator during operation. The applicator includes tubing,
cables, and connectors that interface with the hyperthermia system's
control unit during treatments. It is typically used in an oncology
department. This is a reusable device.
A component of a hyperthermia system that typically consists of
Extravascular-circulation catheter-enclosed tubing which is introduced into the body either
39 hyperthermia system manually or endoscopically. Heated fluid is circulated through the C
applicator, intracorporeal applicator's tubing for localized heating to treat malignant tumours,
benign growths, or other disease-related conditions. The applicator
Page 4 of 6(also called an interstitial applicator or probe) typically includes a
thermometry component that monitors the temperature of the
applicator during operation; it also includes tubing, cables, and
connectors that interface with the hyperthermia system's control unit
during treatments. It is typically used in an oncology department. This
is a single-use device.
An externally-applied device intended to be used as an artificial
40 Facial prosthesis substitute for parts or sections of the face [e.g., nose, eye(s), eye B
brows, upper lip] to help restore facial appearance.
A non-automated, x-ray beam-limiting device that is a component of
a therapeutic x-ray system and whose opening size/length/shutter
Fixed-aperture assembly is fixed. It is used in radiation therapy applications to limit
41 therapeutic x-ray system the effects of scattered radiation and to protect the patient by limiting C
collimator or eliminating exposure to non-target body areas during treatment.
This device is specifically designed for use with an x-ray simulation
or therapeutic x-ray system.
An endoscope with a flexible inserted portion intended for the visual
examination and treatment of the trachea, bronchi, and lungs. It is
inserted through the mouth or nose during bronchoscopy. Anatomical
Flexible fibre optic images are transmitted to the user by the device through a fibre optic
42 B
bronchoscope bundle. This device is commonly used to diagnose lung infections,
pneumonia, or lung cancer, and allows physicians to view the insides
of the lungs and take biopsies and samples of secretions. This is a
reusable device.
An endoscope with a flexible inserted portion intended for the visual
examination and treatment of the mediastinum (the intrapleural space
located behind the sternum). It is inserted into the body through an
artificial orifice created by an incision made during mediastinoscopy.
Flexible fibre optic
43 Anatomical images are transmitted to the user by the device through a C
mediastinoscope
fibre optic bundle. This device is commonly used to examine
structures such as lymph nodes during a staging evaluation of lung
cancer, or to establish the diagnosis of a tumour that is localized to
the mediastinum. This is a reusable device.
A portable, non-electric, mechanically-powered device designed to be
operated by healthcare professionals for dispensing a single dose of
fluid medication (e.g., for antibiotic therapy, chemotherapy,
analgesia). It consists of an empty reservoir intended to be filled with
General-purpose infusion
medication, a flow-rate regulator and a non-sterile (sterilizable)
44 pump, mechanical, C
administration line intended to be connected to an infusion catheter
single-use
(not included) for intravenous (IV), subcutaneous, intramuscular, or
epidural administration. It may include flow and fluid level
mechanical indicators and may be worn by the patient in and outside
of healthcare settings. This is a single-use device.
An endoscope with a flexible inserted portion intended for the visual
examination and treatment of the trachea, bronchi, and lungs. It is
Flexible ultrasound inserted through the mouth or nose during bronchoscopy. Anatomical
45 B
bronchoscope images are transmitted to the user by the device typically through a
fibre optic bundle or a video system, and an ultrasound probe. The
probe may be built-in or inserted through a dedicated lumen so that its
Page 5 of 6distal tip is positioned adjacent to that of the endoscope. It is
commonly used to diagnose lung infections, pneumonia, or lung
cancer, and allows physicians to view the insides of the lungs and
take biopsies and samples of secretions. This is a reusable device.
A non-electric, mechanically-powered (e.g., a spring mechanism)
device designed for the continuous or intermittent infusion of
medication, typically for antibiotic therapy, chemotherapy, or pain
General-purpose infusion
management by intravenous (IV), subcutaneous, intramuscular, or
46 pump, mechanical, C
epidural routes. It is primarily designed to be worn by the patient
reusable
during ambulation in the home. It may be used for patient-controlled
analgesia (PCA), and may include mechanical indicators for flow and
fluid level status. This is a reusable device.
An endoscope with a flexible inserted portion for endoscopic
procedures of the airways and tracheobronchial tree (i.e.,
bronchoscopy). It is inserted through the mouth or nose during
bronchoscopy. Anatomical images are transmitted to the user by a
Flexible video
47 video system with a charge-coupled device (CCD) chip at the distal B
bronchoscope, reusable
end and the images showing on a monitor. It is commonly used to
diagnose lung infections, pneumonia, or lung cancer, and allows
physicians to view the insides of the lungs and take biopsies and
samples of secretions. This is a reusable device.
The Medical Device is an accessory to an imaging system (CT, CT-
PET) intended for the spatial positioning and orientation of an
Robotic Guidance instrument guide. A surgeon then manually advances one or more
48 system for image Guided instruments for percutaneous image guided interventional procedures B
procedures through the instrument guide.
The device is not intended to make any contact with the patient.
Page 6 of 6