Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes physical brachytherapy applicators and their compatibility with existing afterloaders. There is no mention of AI/ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is indicated for the treatment of cancer using brachytherapy, which is a therapeutic intervention.

Diagnostic

No

This device is for cancer treatment using brachytherapy, which is a therapeutic rather than diagnostic application.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "applicator set" designed to be inserted into a body cavity and used with afterloaders, indicating it is a physical medical device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the treatment of cancer using brachytherapy. IVDs are used for the diagnosis or monitoring of diseases or conditions.
Device Description: The device is an applicator designed to deliver radiation into the body for therapeutic purposes. IVDs are typically used to analyze samples outside the body (in vitro).
Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect biomarkers, or provide diagnostic information.

The device is clearly a therapeutic device used in a clinical setting for cancer treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Universal Segmented Cylinder Set and Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump and rectum using HDR or PDR brachytherapy.

The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.

Product codes (comma separated list FDA assigned to the subject device)

JAQ

Device Description

The applicator sets in this submission are designed to be used with the GammaMed Plus afterloader series, Varisource 200 and IX afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectal applications. The intracavitary applicators will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Vaginal, vaginal stump, rectum, endometrium, cervix, 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 devices function correctly with the specified afterloaders;
the devices can withstand the number of cycles of use they will experience in its lifetime;
the devices enable the radioactive source to be located to the accuracy required,
the devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
the devices may be sterilized effectively
the devices can be used and sterilized for the specified number of times
the positional accuracy of the source within the devices is adequate.
the devices are biocompatible as per ISO10933 standards
the devices can be used safely and effectively in CT environments
testing of the Universal Cylinder Applicator Family in MRI environments has demonstrated they are safe to use under the conditions specified in the labelling.

Usability has been 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. Varian considers to be safe and effective and to perform as well or better than the predicate

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.

K141490

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Auqust 10, 2016

Varian Medical Systems, Inc % Mr. Peter J. Coronado Director, Regulatory Affairs 911 Hansen Wav PALO ALTO CA 94304

Re: K160516

Trade/Device Name: Universal Cylinder Applicator Family Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 20, 2016 Received: June 27, 2016

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 D.'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K160516 Device Name

Universal Cylinder Applicator Family

Indications for Use (Describe)

The Universal Segmented Cylinder Set and Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump and rectum using HDR or PDR brachytherapy.

The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump, cervix, uterus and endometrium 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

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PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

3

PREMARKET NOTIFICATION

510(k) Summary

Universal Cylinder Applicator Family

As required by 21 CFR 807.92

| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E110
Palo Alto CA94304 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado
Phone: 650/424.6320
Fax: 650/646.9200
Date: 5th February 2016 |
| Proprietary Name: | Universal Cylinder Applicator Family |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700
Class II |
| Common/Usual Name: | Universal Segmented Cylinder Applicator Set
Universal Stump Applicator Set
Universal Cervix Probe Sets |
| Predicate Devices: | K141490 Universal Cylinder Set. |
| Device Description: | The applicator sets in this submission are designed to be used with
the GammaMed Plus afterloader series, Varisource 200 and IX
afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate
(PDR) brachytherapy treatment for gynecological and rectal
applications. The intracavitary applicators will be used for the
treatment of cancerous tumors, and are designed to be inserted
into a body cavity. |
| Indications for Use: | The Universal Segmented Cylinder Applicator Set and Universal
Stump Applicator Set are indicated for use for cancer treatment of
the vagina, vaginal stump and rectum using HDR or PDR
brachytherapy. |
| | The Universal Cervix Probe Sets in combination with the Universal
Segmented Cylinder Applicator Set and the Universal Stump
Applicator Set are indicated for use for cancer treatment of the
vagina, vaginal stump, cervix, uterus and endometrium using HDR
or PDR brachytherapy. |

4

Technological Characteristics:

| FEATURE AND/OR
SPECIFICATION OF
NEW/MODIFIED DEVICE | DEVICE FEATURE/SPECIFICATION
510(K) ID #
K141490 UNIVERSAL SEGMENTED
CYLINDER APPLICATOR SET AND | NAME AND VERSION
UNIVERSAL SEGMENTED CYLINDER
APPLICATOR SET AND UNIVERSAL STUMP
APPLICATOR SET AND IN COMBINATION WITH |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | UNIVERSAL STUMP APPLICATOR SET | UNIVERSAL CERVIX PROBE SETS |
| Compatible Afterloader | GammaMed Plus afterloader series
VariSource 200 and iX afterloader | GammaMed Plus afterloader series
VariSource 200 and iX afterloader |
| Intended use | The Universal Segmented Cylinder
Applicator Set and the Universal Stump
Applicator Set are indicated for use for
cancer treatment of the vagina, vaginal
stump and rectum using HDR or PDR
Brachytherapy | The Universal Segmented Cylinder
Applicator Set and the Universal Stump
Applicator Set are intended for use for
cancer treatment of the vagina, vaginal
stump and rectum using HDR or PDR
Brachytherapy |
| | | The Universal Cervix Probe Sets in
combination with the Universal
Segmented Cylinder Applicator Set and
the Universal Stump Applicator Set are
intended for use for cancer treatment of
the vagina, vaginal stump, cervix, uterus
and endometrium using HDR or PDR
Brachytherapy |
| Indications for use | The Universal Segmented Cylinder
Applicator Set and the Universal Stump
Applicator Set are indicated for use for
cancer treatment of the vagina, vaginal
stump and rectum using HDR or PDR
Brachytherapy | The Universal Segmented Cylinder
Applicator Set and the Universal Stump
Applicator Set are indicated for use for
cancer treatment of the vagina, vaginal
stump and rectum using HDR or PDR
Brachytherapy |
| | | The Universal Cervix Probe Sets in
combination with the Universal
Segmented Cylinder Applicator Set and
the Universal Stump Applicator Set are
indicated for use for cancer treatment of
the vagina, vaginal stump, cervix, uterus
and endometrium using HDR or PDR
Brachytherapy |
| Design | Segmented Cylinder:
Cylinder segment dimension: diameters
20, 25, 30, 35, 40 mm; length 30 mm
Front segment: 1 front segment for
vaginal wall and vaginal stump
treatment
Front segment dimension: diameter 20,
25, 30, 35, 40 mm; length 50 – 60 mm
Guiding tube & applicator probe: straight
rigid ø 3.2 mm; length 200 and 250 mm | Segmented Cylinder.
Cylinder segment dimension: diameters
20, 25, 30, 35, 40 mm; length 30 mm
Front segment: 1 front segment for
vaginal wall and vaginal stump treatment
Front segment dimension: diameter 20,
25, 30, 35, 40 mm; length 50 – 60 mm
Guiding tube & applicator probe: straight
rigid ø 3.2 mm; length 200 and 250 mm |
| | | Universal Cervix Probe Sets:
6.3 mm diameter; inner length 320 mm;
cervix length 30, 40, 50, 60, 70, 80 mm;
straight, curved with 15° or 30°. |
| | | |
| Stump Applicator: | Stump Applicator: | |
| | Cylinder dimension: diameters 20, 25, 30, 35 mm; length 140 mm | |
| | Cylinder dimension: diameters 20, 25, 30, 35 mm; length 140 mm | |
| | Applicator probe dimension: Ø 3.2 mm; inner length 200 and 250 mm | |
| | Applicator probe dimension: Ø 3.2 mm; inner length 200 and 250 mm | |
| | Universal Cervix Probe Sets: | |
| | 6.3 mm diameter; inner length 320 mm; | |
| | cervix length 30, 40, 50, 60, 70, 80 mm; | |
| | straight, curved with 15° or 30°. | |
| Materials | Segmented Cylinder: | |
| | Cylinder: PPSU plastic white | |
| | Guiding tube & applicator probe: PEEK plastic natural, Titanium | |
| | Universal Cervix Probe Sets: | |
| | PEEK plastic natural, Titanium, FEP | |
| | Stump Applicator: | |
| | Cylinder: PPSU plastic white | |
| | Applicator probe: PEEK plastic natural, Titanium | |
| | Universal Cervix Probe Sets: | |
| | PEEK plastic natural, Titanium, FEP | |
| Packing | Individual | |
| Sterility | Provided non-sterile | |
| Sterilization method | Steam sterilization | |
| | 132 °C for 4 min | |
| | 134 °C for 3 min | |
| | 134 °C for 5 min | |
| Biocompatibility | Full biocompatibility | |
| Anatomical sites | Segmented Cylinder & Cervix Probe Sets: | |
| | Vaginal, vaginal stump, rectum, endometrium, cervix, uterus | |
| | Stump Applicator / Cervix Probe Sets: | |
| | Vaginal, rectum, vaginal stump, endometrium, cervix, uterus | |
| Compatibility with the environment and other devices | Segmented Cylinder & Cervix Probe Sets: | |
| | CT compatible | |
| | MR conditional | |
| | Stump Applicator & Cervix Probe Sets: | |
| | CT compatible | |
| | MR conditional | |
| Where used | Brachytherapy treatment room | |

5

6

Non Clinical Tests Bench Testing has been performed to demonstrate that

o the devices function correctly with the specified afterloaders;
the devices can withstand the number of cycles of use they will experience in its lifetime;
. the devices enable the radioactive source to be located to the accuracy required,
o the devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
. the devices may be sterilized effectively
. the devices can be used and sterilized for the specified number of times
the positional accuracy of the source within the devices is adequate.
the devices are biocompatible as per ISO10933 standards
the devices can be used safely and effectively in CT environments
testing of the Universal Cylinder Applicator Family in MRI environments has demonstrated they are safe to use under the conditions specified in the labelling.

Usability has been 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. Varian considers to be safe and effective and to perform as well or better than the predicate