Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (applicator sets) used in brachytherapy. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies focus on physical characteristics and functionality, not algorithmic performance.

Therapeutic

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

Diagnostic

No

This device is used for cancer treatment via brachytherapy, delivering radiation to cancerous tumors. It is a therapy delivery device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly 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 cancer treatment using brachytherapy, which is a therapeutic procedure involving the delivery of radiation directly to a tumor. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The device is an applicator set designed to be inserted into a body cavity to deliver radiation from an afterloader. This is a delivery mechanism for therapy, not a diagnostic tool.
Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect biomarkers, or provide any information for diagnosis.
Performance Studies: The performance studies focus on the mechanical and functional aspects of the device for delivering radiation accurately and safely, not on diagnostic accuracy or performance metrics like sensitivity or specificity.

In summary, the device is a therapeutic delivery system for brachytherapy, not a diagnostic device used to analyze samples for medical information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump and rectum 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, rectum

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. 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.

K033371

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

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

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right.

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

September 26, 2014

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K141490

Trade/Device Name: Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 15, 2014 Received: August 18, 2014

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

Janine M. Morris 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) K141490

Device Name

GM11011100 - Universal Segmented Cylinder Applicator Set GM11011160 - Universal Stump Applicator Set

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com

Premarket Notification [510(k)] Summary

GM11011100 Universal Segmented Cylinder Applicator Set GM11011160 Universal Stump Applicator Set

The following information is provided following the format of 21 CFR 807.92(c).

| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way E-110
Palo Alto, CA 94304 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200 |
| | Date: 04 June 2014 |
| Proprietary Name: | Universal Segmented Cylinder Applicator Set
Universal Stump Applicator Set |
| Classification Name: | Remote controlled radionuclide applicator system
21 CFR 892.5700, Class II
Product Code: JAQ |
| Common/Usual
Name: | Remote controlled radionuclide applicator system |
| Predicate Devices: | K033371 Intracavitary Brachytherapy Applicators
(11-00415 Segmented Cylinder Set, 11-00416 Stump Applicator 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. |
| Intended Use
Statement | 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. |
| Indications for Use
Statement | 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. |

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Technological Characteristics:

| | Segmented Applicator Cylinder Set and
Stump Applicator Set (K033371) | Universal Segmented Cylinder Applicator
Set and Universal Stump Applicator Set |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible Afterloader | Varian Afterloader (GammaMed and
VariSource) | GammaMed Plus afterloader series
Varisource 200 and IX afterloader |
| Intended use | 11-00415 Segmented Cylinder Set
Segmented Cylinder Set is developed to
treat cancer of the vagina and the vaginal
stump. It is also suitable to treat rectal
cancer. The applicator set is MR and CT
compatible. The maximum implantation
time for this applicator is 2 days. | 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. |
| | 11-00416 Stump Applicator Set
Stump Applicator Set is developed for
post-operative irradiation of the vaginal
stump. The flexible applicator probe has a
connector made of titanium, so that
position checks can be made using CT or
MRI. The maximum implantation time for
this applicator is 30 days. | |
| Indications for Use | The applicators will be used with the
VariSource High Dose Rate Afterloaders to
deliver brachytherapy treatment for
gynecological and rectal applications. The
applicators will be used in medical
intracavitary for treatment of cancerous
tumors. | 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. |
| Design | Segmented Cylinder:
Cylinder segment dimension: diameters
20, 25, 30, 35 mm; length 30 mm
Front segment: 2 front segments for
vaginal wall and vaginal stump treatment
Front segment dimension: diameters 20,
25, 30, 35 mm; length 20 – 27.5 mm
Guiding tube: straight ø 6.4 mm; length
228 mm
Applicator probe: ø 3.2 mm; inner length
320 mm; flexible with blocking washer | 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 |
| | Stump Applicator:
Cylinder dimension: diameters 20, 23, 26,
30, 35 mm; length 140 mm
Applicator probe dimension:
ø 3.2 mm;
inner length 320 mm | Stump Applicator:
Cylinder dimension: diameters 20, 25, 30,
35 mm; length 140 mm
Applicator probe dimension: ø 3.2 mm;
inner length 200 and 250 mm |

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| Materials | Segmented Cylinder:
Cylinder: PPSU plastic white
Guiding tube: PEEK plastic natural
Applicator probe: FEP, Titanium | Segmented Cylinder:
Cylinder: PPSU plastic white
Guiding tube & applicator probe: PEEK
plastic natural, Titanium |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | Stump Applicator:
Cylinder: PPSU plastic white
Applicator probe: PVDF, Titanium | Stump Applicator: Cylinder: PPSU plastic
white
Applicator probe: PEEK plastic natural,
Titanium |
| Packing | Individual | Individual |
| Sterility | Provided non-sterile | Provided non-sterile |
| Sterilization method | Steam sterilization
134 °C for 5 minutes
121 °C for 15 minutes | Steam sterilization
132 °C for 4 min
134 °C for 3 min
134 °C for 5 min |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Segmented Cylinder:
Vaginal, rectum | Segmented Cylinder:
Vaginal, rectum |
| | Stump Applicator: Vaginal | Stump Applicator: Vaginal, rectum |
| Compatibility with the
environment and other
devices | Segmented Cylinder:
CT compatible
MR conditional | Segmented Cylinder:
CT compatible
MR conditional |
| | Stump Applicator:
CT compatible
MR conditional | Stump Applicator:
CT compatible
MR conditional |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

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