(84 days)
Not Found
No
The 510(k) summary describes a physical medical device (applicator sets and needles) used for brachytherapy. There is no mention of software, algorithms, image processing, AI, DNN, or ML in the description, intended use, or performance studies.
Yes
The device is described as being intended to "treat cancer", which is a therapeutic purpose. It utilizes radiotherapy treatments for various anatomical sites.
No
The device is described as an applicator set and needles for brachytherapy treatments, which is a form of radiation therapy to treat cancer, not diagnose it.
No
The device description clearly details physical components like applicators, probes, and needles, indicating it is a hardware device used in brachytherapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to treat cancer of various anatomical sites (uterus, cervix, endometrium, vagina, head and neck, breast, prostate). This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical applicator set used for radiotherapy treatments. This involves delivering radiation to a patient, which is a treatment modality.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease. IVDs are designed to perform tests on these types of samples.
- Performance Studies: The performance studies focus on non-clinical tests related to the device's physical properties, functionality, and safety (biocompatibility, sterilization, etc.). There are no studies related to diagnostic accuracy or performance metrics like sensitivity, specificity, etc., which are typical for IVDs.
In summary, the device is a therapeutic medical device used for delivering radiation treatment, not a diagnostic device used for analyzing samples to aid in diagnosis.
N/A
Intended Use / Indications for Use
The Fletcher Style Applicator Sets (defined geometry) are intended to treat cancer of the uterus, cervix, endometrium and vagina.
The Interstitial Plastic Needles are designed for interstitial brachytherapy treatments in areas such as the head and neck, gynecological, breast and prostate.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus, cervix, endometrium, vagina
head and neck, gynecological, breast and prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical Tests: Biocompatibility tests referenced ISO 10933-1:2009 and 510(k) Memorandum - #G95-1. Materials released no leachable cytotoxic materials, caused no reactions identified as sensitization, showed no irritant/corrosive effect. Requirements of BS EN ISO 10993-1:2003 and FDA#G95-1 have been met.
Sterilization and Shelf Life tests were undertaken on components representative of the Titanium Fletcher-style Applicator to verify cleaning, disinfection, and sterilization cycle effectiveness, and suitability of design and material for the proposed number of cycles.
Other Bench Testing was performed to demonstrate that the device functions correctly with VariSource and GammaMedplus afterloaders, can withstand the number of cycles expected in its lifetime, that materials are not significantly affected by radiation, and that positional accuracy is adequate. The effects of Magnetic Resonance Imaging on the device when in patent contact were assessed. Usability was assessed to the requirements of IEC 62366:2007. All tests met applied pass criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
KI20341
PREMARKET NOTIFICATION
510(k) Summary
Titanium Fletcher-Style Applicator Set
As required by 21 CFR 807.92
Submitter's Name: (Paragraph (a) (1))
Varian Medical Systems 3100 Hansen Way, m/s E110 Palo Alto CA94304
Contact Name: Vy Tran Phone: 650/424.5731 Fax:650/842.5040 Date: 07 October 2011
Proprietary Name: (Paragraph (a) (2))
Classification Name: (Paragraph (a) (2))
Common/Usual Name: (Paragraph (a) (2))
Predicate Devices: (Paragraph (a) (3))
Device Description: (Paragraph (a) (4))
Intended Use: (Paragraph (a) (5)) GM11006200 Titanium Fletcher-Style Applicator Set-Defined Geometry
Remote controlled radionuclide applicator system 21CFR892.5700 Class II
GM11006200 Titanium Fletcher-Style Applicator Set
K980590Henschke Type GYN Applicator Set
The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
The Fletcher Style Applicator Sets (defined geometry) are intended to treat cancer of the uterus, cervix, endometrium and vagina
1
Technological Characteristics of the device compared with the predicate device: (Paragraph (a) (6))
| FEATURE AND/OR
SPECIFICATION OF
NEW/MODIFIED DEVICE | CLEARED DEVICE
FEATURE/SPECIFICATION | NEW DEVICE |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device
Clearance Number: | Henschke Type GYN Applicator
Set K980590 | N/A |
| Compatible Afterloader | VarlSource | GammaMedplus
GammaMed 12i(t)
VariSource |
| Intended use | The Varian VariSource Remote
High Dose Rate Afterloader
(system including applicators
and accessories) is a device
intended to be used by trained
and licensed medical personnel
to provide radiation
brachytherapy. The VariSource
Henschke Type GYN applicator
which is the subject of this
510(k) is a component of the
VariSource system. | The GammaMed Titanium
Fletcher-style Applicator Set
with defined geometry was
developed to treat cancer of the
uterus, cervix, endometrium
and vagina. |
| Indications for Use | The Henschke Type Applicator
is indicated for use in any case
where High Dose Rate (HDR)
radiation treatment of the
cervix and uterus Is accepted
clinical practice. | The GammaMed Titanium
Fletcher-style Applicator Set
with defined geometry was
developed to treat cancer of the
uterus, cervix, endometrium
and vagina. |
| Design | Rigid intra-uterine tandem and
a pair of interlocking colpostats
with Henschke type ovoids. The
hemispsherical ovoids are
segemented and will accept
either tungsten or plastic
inserts so that shielding is
optional. Distance between
ovoids is adjustable. Three
tandems are provided: one
straight and two with a
minimum and maximum
curvature of the distal end to
accommodate intrauterine tilt. | Intrauterine Probe with stopper
30 °, length: 40mm, 60mm,
80mm (optional 30mm, 50mm,
70mm
Colpostats: 20mm, 25mm,
30mm spread |
| Materials | Stainless Steel, Polysulphone,
Tungsten | PEEK Titanium, stainless steel,
PPSU. |
| Packing | individual | individual |
| Sterility | Provided Non sterile | Provided Non sterile |
| Sterilization method | EtO Gas sterilization or Steam
sterilization | Steam sterilization |
| Sterilization conditions | 30minutes ±2 minutes at
250°F±5°F (121°C±1°C). | 15minutes @121°C
5 minutes @134°C
18 minutes @134°C |
| Biocompatibility | Biocompatibility not
mentioned. | Full biocompatibility |
| Anatomical sites | uterus, cervix, | uterus, cervix, endometrium,
vagina |
| Compatibility with the
environment and other
devices | Not stated to be CT compatible
or MR Conditional for 3 Tesla | CT compatible
MR Conditional for 3 Tesla |
| Rectal Retractor | Rectal Retractor not included as
optional accessory | Rectal Retractor included as
optional accessory |
.
.
2
Non Clinical Tests (Paragraph (b) (1))
Biocompatibility tests were selected by reference to ISO 10933-1:2009, Biologicol Evaluation of Medical Devices Part 1: Evoluation & Testing and 510(k) Memorandum - #G95-1 Initial Evaluation Tests for Consideration. The over- all results for the materials were as follows:
- 1.Released no leachable cytotoxic materials
- Caused no reactions identified as sensitization
-
- Showed no irritant/corrosive effect
- Requirements of BS EN ISO 10993-1:2003 Biological evaluation of Medical Devices Part 1 and FDA#G95-1 have been met
Sterilization and Shelf Life tests have been undertaken on components that are representative of the Titanium Fletcher-style Applicator. The first group of tests was to verify that the proposed cleaning, disinfection and sterilization cycles were effective. The second was to verify the suitability of the design and material of the applicator components by inspecting for damage that might affect safety or effectiveness caused by the proposed number of cycles. In both types of test, components from other applicators that were representative of the components in the GM11006200 were used.
Other Bench Testing was performed to demonstrate that the device, functions correctly with both VariSource and GammaMedplus afterloaders; that the device can withstand the number of cycles of use that it will endure in its lifetime; that materials used are not significantly affected by the radiation they meet in the lifetime of the product; that the positional accuracy is adequate. The effects of Magnetic Resonance Imaging on the device when in patent contact were assessed. Usability was assessed to the requirements of IEC 62366:2007.
| Clinical Tests |
|---|
| (Paragraph (b) (2)) |
Conclusions (Paragraph (b) (2)) No Clinical Tests have been included in this pre-market submission
All the tests that were performed met the applied pass criteria. Varian considers the device to be safe and effective and to perform as well or better than the predicate.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304
APR 2 7 2012
Re: K120341
Trade/Device Name: Interstitial Plastic Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 20, 2012 Received: February 3, 2012
Dear Ms. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K12034
Device Name: Interstitial Plastic Needles
Indications for Use:
The Interstitial Plastic Needles are designed for interstitial brachytherapy treatments in areas such as the head and neck, gynecological, breast and prostate.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
´ AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Marlon D. Odom
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and 510(k)
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