(109 days)
Not Found
No
The description focuses on the physical applicator device used to guide a radioactive source for brachytherapy, and the performance studies are bench tests related to the device's physical properties and functionality. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as being "intended for use for cancer treatment" using brachytherapy, which is a form of radiotherapy to treat tumors. This directly indicates a therapeutic purpose.
No
This device is intended for cancer treatment using brachytherapy, guiding a radioactive source to the treatment area. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the device is an "applicator" which is a physical device used to guide a radioactive source. The performance studies also describe bench testing of the physical device's function, durability, and sterilization. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an applicator used in brachytherapy. Its purpose is to guide a radioactive source within the patient's body for cancer treatment. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "cancer treatment," not for diagnosis or analysis of biological samples.
This device is a therapeutic medical device used for delivering radiation therapy.
N/A
Intended Use / Indications for Use
The 3D Interstitial Ring Applicator Sets (60° and the Ring Applicator Sets (45°, 60° and 90°) are intended for use for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy.
Product codes
JAQ
Device Description
The 3D Interstitial Ring Applicator Sets (60° and 90°), are applicators for intracavitary or intracavitary/interstitial brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
The Ring Applicator Sets (45°, 60° and 90°), are applicators for intracavitary brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, cervix, and uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Brachytherapy treatment room
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 Bench Testing has been performed to demonstrate that
- the device functions correctly with the specified afterloaders; .
- the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the device may be sterilized effectively
- . the device can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate.
Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications
Clinical Tests No clinical tests have been included in this pre-market submission.
Conclusions All the tests that were performed met the applied pass criteria. Body of testing provides evidence that the devices are safe and effective to perform as well or better than the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of three human profiles facing right, stacked vertically. The profiles are rendered in a thick, stylized line. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2015
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K150839
Trade/Device Name: 3D Interstitial Ring Applicator Sets (60° and 90°) and the Ring Applicator Sets (45°, 60° and 90°) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 18, 2015 Received: June 19, 2015
Dear Mr. Coronado:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150839
Device Name
3D Interstitial Ring Applicator Sets (60° and 90°) and the Ring Applicator Sets (45°, 60° and 90°)
Indications for Use (Describe)
The 3D Interstitial Ring Applicator Sets (60° and the Ring Applicator Sets (45°, 60° and 90°) are intended for use for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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PREMARKET NOTIFICATION
510(k) Summary
Remote Controlled Radionuclide applicator System
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E-110
Palo Alto CA94304
Contact Name: Peter J. Coronado
Phone: 650/424.6230
Fax: 650/646.9200 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | March 27th 2015 |
| Proprietary Name: | 3D Interstitial Ring Applicator Set 60°
3D Interstitial Ring Applicator Set 90°
Ring Applicator Set 45°
Ring Applicator Set 60°
Ring Applicator Set 90° |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700
Class II |
| Common/Usual Name: | Remote controlled radionuclide applicator system |
| Predicate Devices: | The Mick Radio Nuclear Instruments, Inc. CT HDR Tandem/Ring
Applicator With Rectal Ring Retractor (K030110) |
| Device Description: | The 3D Interstitial Ring Applicator Sets (60° and 90°), are
applicators for intracavitary or intracavitary/interstitial
brachytherapy. Brachytherapy is a form of radiotherapy using
Gamma rays from a radioactive source placed at locations close to
or within a tumor or other treatment area to a predefined
treatment plan. The treatment plan defines the positions and
times for the source to ensure the correct dose for the treatment
area. The applicator acts to guide the radioactive source to the
correct location or locations for treatment.
The Ring Applicator Sets (45°, 60° and 90°), are applicators for
intracavitary brachytherapy. Brachytherapy is a form of
radiotherapy using Gamma rays from a radioactive source placed
at locations close to or within a tumor or other treatment area to |
a predefined treatment plan. The treatment plan defines the
4
positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
Indications for Use: The 3D Interstitial Ring Applicator Sets (60° and 90°) and the Ring Applicator Sets (45°, 60° and 90°) are intended for use for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy.
Technological Characteristics:
| FEATURE AND/OR SPECIFICATION
OF NEW/MODIFIED DEVICE | 510(k) ID K030110
CT HDR Tandem/Ring Applicator
WITH RECTAL RETRACTOR | 3D INTERSTITIAL RING APPLICATOR SETS (60° AND 90° )
AND
RING APPLICATOR SETS (45°, 60° AND 90°) |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible Afterloader | GammaMed plus
GammaMed 12i(t)
VariSource | GammaMedplus iX
GammaMedplus |
| Intended use | High dose rate Brachytherapy
treatment of the uterus and
cervix | The 3D Interstitial Ring Applicator Sets 60° and 90°)
and the Ring Applicator Sets (45°, 60° and 90°) are
intended for use for cancer treatment of the vagina,
cervix, and uterus using HDR or PDR brachytherapy. |
| Indications for Use | The Mick Radio-Nuclear
Instruments, Inc. CT HDR
Tandem/Ring Applicator with
Rectal Retractor is indicated for
High Dose Rate irradiation of the
uterus and cervix | The 3D Interstitial Ring Applicator Sets (60° and 90°)
and the Ring Applicator Sets (45°, 60° and 90°) are
intended for use for cancer treatment of the vagina,
cervix, and uterus using HDR or PDR brachytherapy. |
| Design | Ring applicators 30°, 45°, and 60°;
32mm diameter
Intrauterine tandems 30°, 45°,
and 60°; 20mm, 40mm, 60mm,
and 80mm lengths | 3D interstitial ring applicators Sets (60° and 90°)
30mm diameter Intrauterine tandems 60°and, 90°;
30mm, 40mm, 50mm, 60mm, 70mm, and 80mm
lengths
3D interstitial ring applicators and intrauterine
tandems in sets possess holes to allow for needle
application.
Ring applicators Sets (45°,60°and 90°)
(same as predicate, angle measured from different
position); 26mm, and 30mm diameter
Intrauterine tandems 45°,60°, and 90°; 30mm,
40mm, 50mm, 60mm, 70mm, and 80mm lengths |
| Materials | Stainless Steel, PPSU, PEEK,
Titanium | PEEK, Titanium |
| Packing | Individual | Individual |
| Sterility | Provided non sterile | Provided non sterile |
| Sterilization method | Steam sterilization
15 minutes @ 121°C
5 minutes @ 134°C
18 minutes @ 134°C | Steam sterilization
4 minutes @ 132°C
3 minutes @ 134°C
5 minutes @ 134°C |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Uterus, cervix | Uterus, cervix, vagina |
| Compatibility with the
environment and other
devices | CT compatible | CT compatible
MR conditional for 1.5 and 3 Tesla |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |
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Non Clinical Tests Bench Testing has been performed to demonstrate that
- the device functions correctly with the specified afterloaders; .
- the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the device may be sterilized effectively
6
- . the device can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate.
Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications
Clinical Tests No clinical tests have been included in this pre-market submission.
Conclusions All the tests that were performed met the applied pass criteria. Body of testing provides evidence that the devices are safe and effective to perform as well or better than the predicate.