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.

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.

AI/ML Overview

This FDA 510(k) summary describes a new medical device, the Varian Medical Systems 3D Interstitial Ring Applicator Sets and Ring Applicator Sets, and claims substantial equivalence to a predicate device, the Mick Radio Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator With Rectal Ring Retractor.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Specification	Predicate Device Performance (K030110)	New Device Reported Performance	Acceptance Criteria Met (Yes/No)
Compatible Afterloader	GammaMed plus, GammaMed 12i(t), VariSource	GammaMedplus iX, GammaMedplus	Yes (compatible with listed afterloaders)
Intended Use	High dose rate Brachytherapy treatment of the uterus and cervix	Cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy	Yes (expanded but similar)
Indications for Use	High Dose Rate irradiation of the uterus and cervix	Cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy	Yes (expanded but similar)
Design	Ring applicators 30°, 45°, 60°; 32mm diameter. Intrauterine tandems 30°, 45°, 60°; 20mm, 40mm, 60mm, 80mm lengths	3D interstitial ring applicators Sets (60° and 90°), 30mm diameter. Intrauterine tandems 60° and 90°; 30mm, 40mm, 50mm, 60mm, 70mm, 80mm lengths. Holes for needle application. Ring applicators Sets (45°, 60°, 90°); 26mm, 30mm diameter. Intrauterine tandems 45°, 60°, 90°; 30mm, 40mm, 50mm, 60mm, 70mm, 80mm lengths	Yes (design variations are for expanded utility)
Materials	Stainless Steel, PPSU, PEEK, Titanium	PEEK, Titanium	Yes (different materials but assessed for biocompatibility)
Packing	Individual	Individual	Yes
Sterility	Provided non sterile	Provided non sterile	Yes
Sterilization Method	Steam sterilization (15 min @ 121°C, 5 min @ 134°C, 18 min @ 134°C)	Steam sterilization (4 min @ 132°C, 3 min @ 134°C, 5 min @ 134°C)	Yes (different parameters but assessed for effectiveness)
Biocompatibility	Full biocompatibility	Full biocompatibility	Yes
Anatomical Sites	Uterus, cervix	Uterus, cervix, vagina	Yes (expanded but similar)
Compatibility with environment/other devices	CT compatible	CT compatible, MR conditional for 1.5 and 3 Tesla	Yes (adds MR compatibility)
Where Used	Brachytherapy treatment room	Brachytherapy treatment room	Yes
Device Functions Correctly	Implicit for predicate	Demonstrated through bench testing	Yes
Withstands Cycles of Use	Implicit for predicate	Demonstrated through bench testing	Yes
Radioactive Source Positional Accuracy	Implicit for predicate	Demonstrated through bench testing (accuracy required)	Yes
Material unaffected by radiation	Implicit for predicate	Demonstrated through bench testing	Yes
Sterilization Effectiveness	Implicit for predicate	Demonstrated through bench testing	Yes
Usability (IEC 62366:2007)	Implicit for predicate	Conformance to applicable requirements and specifications demonstrated through bench testing	Yes

2. Sample Size Used for the Test Set and Data Provenance

The submission form does not explicitly detail a "test set" in the context of clinical data for performance evaluation. Instead, it relies on bench testing for technical performance.

Sample Size for Bench Testing: Not specified in terms of number of devices or iterations, but implies sufficient testing to demonstrate functionality, durability, accuracy, and material integrity.
Data Provenance: The bench testing would inherently be prospective in nature, conducted by the manufacturer (Varian Medical Systems, Inc.) in Palo Alto, CA, USA, for the purpose of this submission. Since it's bench testing, country of origin is the manufacturing/testing location.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission relies on bench testing against engineering specifications and industry standards (like IEC 62366:2007) rather than clinical performance based on expert-determined ground truth. Therefore, no experts were used to establish a clinical ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. Since no clinical "test set" requiring expert judgment for ground truth establishment was conducted, there was no adjudication method. Bench testing results would typically be assessed against predefined pass/fail criteria by engineering and quality personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a physical medical instrument (an applicator for brachytherapy), not an AI/software-based diagnostic tool that would involve human readers or AI assistance. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Its function is to physically guide a radioactive source.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" used was engineering specifications, design requirements, and applicable international standards (e.g., for afterloader compatibility, material properties, sterilization effectiveness, positional accuracy, usability to IEC 62366:2007 requirements). There was no clinical ground truth (like pathology, expert consensus on disease, or outcomes data) established for the performance evaluation in this submission.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as above.

Summary

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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.

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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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PREMARKET NOTIFICATION

510(k) Summary

Remote Controlled Radionuclide applicator System

As required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E-110Palo Alto CA94304Contact Name: Peter J. CoronadoPhone: 650/424.6230Fax: 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 system21CFR892.5700Class II
Common/Usual Name:	Remote controlled radionuclide applicator system
Predicate Devices:	The Mick Radio Nuclear Instruments, Inc. CT HDR Tandem/RingApplicator With Rectal Ring Retractor (K030110)
Device Description:	The 3D Interstitial Ring Applicator Sets (60° and 90°), areapplicators for intracavitary or intracavitary/interstitialbrachytherapy. Brachytherapy is a form of radiotherapy usingGamma rays from a radioactive source placed at locations close toor within a tumor or other treatment area to a predefinedtreatment plan. The treatment plan defines the positions andtimes for the source to ensure the correct dose for the treatmentarea. The applicator acts to guide the radioactive source to thecorrect location or locations for treatment.The Ring Applicator Sets (45°, 60° and 90°), are applicators forintracavitary brachytherapy. Brachytherapy is a form ofradiotherapy using Gamma rays from a radioactive source placedat locations close to or within a tumor or other treatment area to

a predefined treatment plan. The treatment plan defines the

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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 SPECIFICATIONOF NEW/MODIFIED DEVICE	510(k) ID K030110CT HDR Tandem/Ring ApplicatorWITH RECTAL RETRACTOR	3D INTERSTITIAL RING APPLICATOR SETS (60° AND 90° )ANDRING APPLICATOR SETS (45°, 60° AND 90°)
Compatible Afterloader	GammaMed plusGammaMed 12i(t)VariSource	GammaMedplus iXGammaMedplus
Intended use	High dose rate Brachytherapytreatment of the uterus andcervix	The 3D Interstitial Ring Applicator Sets 60° and 90°)and the Ring Applicator Sets (45°, 60° and 90°) areintended for use for cancer treatment of the vagina,cervix, and uterus using HDR or PDR brachytherapy.
Indications for Use	The Mick Radio-NuclearInstruments, Inc. CT HDRTandem/Ring Applicator withRectal Retractor is indicated forHigh Dose Rate irradiation of theuterus and cervix	The 3D Interstitial Ring Applicator Sets (60° and 90°)and the Ring Applicator Sets (45°, 60° and 90°) areintended for use for cancer treatment of the vagina,cervix, and uterus using HDR or PDR brachytherapy.
Design	Ring applicators 30°, 45°, and 60°;32mm diameterIntrauterine 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 80mmlengths3D interstitial ring applicators and intrauterinetandems in sets possess holes to allow for needleapplication.Ring applicators Sets (45°,60°and 90°)(same as predicate, angle measured from differentposition); 26mm, and 30mm diameterIntrauterine 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 sterilization15 minutes @ 121°C5 minutes @ 134°C18 minutes @ 134°C	Steam sterilization4 minutes @ 132°C3 minutes @ 134°C5 minutes @ 134°C
Biocompatibility	Full biocompatibility	Full biocompatibility
Anatomical sites	Uterus, cervix	Uterus, cervix, vagina
Compatibility with theenvironment and otherdevices	CT compatible	CT compatibleMR 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

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. 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.

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.