The Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are intended 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 cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.

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

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 gynaecological 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Universal Cylinder Applicator Family (K172611). This is a medical device, not a diagnostic AI/ML algorithm. Therefore, the information requested regarding acceptance criteria and studies that prove a device meets those criteria (especially sections related to AI/ML such as test set sample size, data provenance, ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this document.

Instead, this document describes a traditional medical device (brachytherapy applicators) and its substantial equivalence to a predicate device based on technological characteristics and functional testing.

Here's an analysis based on the document's content, focusing on what is provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of formal acceptance criteria with numerical performance targets alongside reported device performance in the way one might expect for an AI/ML algorithm (e.g., sensitivity, specificity, AUC). Instead, it describes various bench tests conducted to demonstrate conformance to applicable requirements and specifications. The "reported device performance" is a general statement of compliance.

Acceptance Criteria (Implied from Bench Tests)	Reported Device Performance
Correct functioning with specified afterloaders	Conformance to requirements
Withstanding specified number of use cycles	Conformance to requirements
Accurate radioactive source localization	Conformance to requirements
Material resistance to radiation exposure	Conformance to requirements
Effective sterilization	Conformance to requirements
Usability and sterilizability for cycle limits	Conformance to requirements
Adequate positional accuracy of the source	Conformance to requirements
Biocompatibility (per ISO 10933)	Conformance to requirements
Safe and effective use in CT environments	Conformance to requirements

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a hardware medical device; testing was primarily bench testing, not involving clinical data sets in the AI/ML sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the context of expert consensus for AI/ML, is not relevant here. Device functionality was assessed against design specifications and relevant standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication method was described as this is not an AI/ML diagnostic device requiring clinical image interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an applicator for brachytherapy, not an AI system. No MRMC study was conducted or is relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for AI/ML ground truth. The "ground truth" for this device's performance is its ability to meet engineering specifications, functional requirements, material properties, and safety standards verified through bench testing.

8. The sample size for the training set

Not applicable. This is a hardware medical device; it does not utilize a training set in the AI/ML context.

9. How the ground truth for the training set was established

Not applicable. As above, there is no AI/ML training set.

Summary regarding the device and its studies:

The document states:

Non-Clinical Tests: "Bench Testing has been performed to demonstrate that... [list of functional and safety attributes]."
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 the devices to be safe and effective and to perform as well or better than the predicate."

This 510(k) submission relies on a comparison to a predicate device (K160516 - Universal Cylinder Applicator Family) and extensive bench testing to demonstrate substantial equivalence, rather than clinical studies or AI/ML performance evaluation.

Summary

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March 21, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K172611

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: JAO Dated: March 6, 2018 Received: March 7, 2018

Dear Mr. Coronado:

We have reviewed vour 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 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'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

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Indications for Use

510(k) Number (if known) K172611

Device Name Universal Cylinder Applicator Family

Indications for Use (Describe)

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

X 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

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 CA 94304
	Contact Name: Peter J. Coronado
	Phone: 650/424.6320
	Fax: 650/646.9200
	Date: 30 August 2017
Proprietary Name:	Universal Cylinder Applicator Family
Classification Name:	Remote controlled radionuclide applicator system
	21 CFR892.5700
	Class II
Common/Usual Name:	Universal Segmented Cylinder Applicator Set
	Universal Stump Applicator Set
	Universal Cervix Probe Sets
	Universal Titanium Cervix Probe Sets
Predicate Devices:	K160516 - Universal Cylinder Applicator Family
Indications for Use:	The Universal Segmented Cylinder Applicator Set and UniversalStump Applicator Set are indicated for use for cancer treatment ofthe vagina, vaginal stump and rectum using HDR or PDRbrachytherapy.
	The Universal Cervix Probe Sets in combination with the UniversalSegmented Cylinder Applicator Set and the Universal StumpApplicator Set are indicated for use for cancer treatment of thevagina, vaginal stump, cervix, uterus and endometrium using HDRor PDR brachytherapy.
	The Universal Titanium Cervix Probe Sets in combination with theUniversal Segmented Cylinder Applicator Set and the UniversalStump Applicator Set are indicated for use for cancer treatment ofthe vagina, vaginal stump, cervix, uterus and endometrium usingHDR or PDR brachytherapy.

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Technological Characteristics:

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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 cycle limits the positional accuracy of the source in the devices is adequate the devices are biocompatible as per ISO 10933 standards the devices can be used safely and effectively in CT environments
	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 the devices to be safe and effective and to perform as well or better than the predicate.

Regulation Number and Section

N/A

FeatureComparisonChart	Predicate Device:Universal Cylinder Applicator Family(K160516)	Subject Device:Universal Cylinder Applicator Family
Sets within theUniversalCylinderApplicatorFamily (UCAF)	• Universal Segmented CylinderApplicator Set• Universal Stump Applicator Set• Universal Cervix Probe Sets	• Universal Segmented CylinderApplicator Set• Universal Stump Applicator Set• Universal Cervix Probe Sets• Universal Titanium Cervix ProbeSets
CompatibleAfterloader	All Sets:GammaMed Plus seriesVariSource 200 and iX	All Sets:GammaMed Plus seriesVariSource 200 and iX
Design	Universal Segmented CylinderApplicator Set:Cylinder Segment Dimension:diameters 20, 25, 30, 35, 40 mm;length 30 mmFront Segment: 1 front segment forvaginal wall and vaginal stumptreatmentFront Segment Dimension: diameter20, 25, 30, 35, 40 mm; length 50 –60 mmGuiding Tube & Applicator Probe:straight rigid $ø$ 3.2 mm; length 200and 250 mmUniversal Stump Applicator Set:Cylinder Dimension:diameters 20, 25, 30, 35 mm; length140 mmApplicator Probe Dimension:$ø$ 3.2 mm; inner length 200 and 250mm	Universal Segmented CylinderApplicator Set:Cylinder Segment Dimension:diameters 20, 25, 30, 35, 40 mm;length 30 mmFront Segment: 1 front segment forvaginal wall and vaginal stumptreatmentFront Segment Dimension: diameter20, 25, 30, 35, 40 mm; length 50 –60 mmGuiding Tube & Applicator Probe:straight rigid $ø$ 3.2 mm; length 200and 250 mmUniversal Stump Applicator Set:Cylinder Dimension:diameters 20, 25, 30, 35 mm; length140 mmApplicator Probe Dimension:$ø$ 3.2 mm; inner length 200 and 250mm
FeatureComparisonChart	Predicate Device:Universal Cylinder Applicator Family(K160516)	Subject Device:Universal Cylinder Applicator Family
	Universal Cervix Probe Sets:Diameter: 6.3 mmInner Length: 320 mmCervix Length:30, 40, 50, 60, 70, 80 mmProbe Tip Shapes: Straight or Curvedwith 15°, 30°	Universal Cervix Probe Sets:Diameter: 6.3 mmInner Length: 320 mmCervix Length:30, 40, 50, 60, 70, 80 mmProbe Tip Shapes: Straight or Curvedwith 15°, 30°
		Universal Titanium Cervix ProbeSets:Diameter: 3 mmInner Length: 320 mmCervix Length:30, 40, 50, 60, 70, 80 mmProbe Tip Shapes:Curved with 15°, 30°, or 45°
Packing	All Sets: Individual	All Sets: Individual
Sterility	All Sets: Provided non-sterile	All Sets: Provided non-sterile
SterilizationMethod	All Sets: Steam sterilization132 °C for 4 min134 °C for 3 min134 °C for 5 min	All Sets: Steam sterilization132 °C for 4 min134 °C for 3 min134 °C for 5 min
Biocompatibility	All Sets: Full biocompatibility	All Sets: Full biocompatibility
Materials	Universal Segmented CylinderApplicator Set:Cylinder: PPSU plastic whiteGuiding Tube & Applicator Probe:PEEK plastic natural, TitaniumUniversal Stump Applicator Set:Cylinder: PPSU plastic whiteApplicator Probe: PEEK plasticnatural, TitaniumUniversal Cervix Probe Sets:PEEK plastic natural, FEP, Titanium	Universal Segmented CylinderApplicator Set:Cylinder: PPSU plastic whiteGuiding Tube & Applicator Probe:PEEK plastic natural, TitaniumUniversal Stump Applicator Set:Cylinder: PPSU plastic whiteApplicator Probe: PEEK plasticnatural, TitaniumUniversal Cervix Probe Sets:PEEK plastic natural, FEP, TitaniumUniversal Titanium Cervix Applicator
FeatureComparisonChart	Predicate Device:Universal Cylinder Applicator Family(K160516)	Subject Device:Universal Cylinder Applicator Family
		Sets:Titanium

Anatomical Sites	Universal Segmented CylinderApplicator Set and Universal StumpApplicator Set:Vagina, vaginal stump and rectum	Universal Segmented CylinderApplicator Set and Universal StumpApplicator Set:Vagina, vaginal stump and rectum
	Universal Cervix Probe Sets:Vagina, vaginal stump, cervix, uterusand endometrium	Universal Cervix Probe Sets andUniversal Titanium Cervix ProbeSets:Vagina, vaginal stump, cervix, uterusand endometrium
Compatibility w/Environment &Other Devices	All Sets:CT compatibleUniversal Segmented CylinderApplicator Set, Universal StumpApplicator Set, and Universal CervixProbe Sets: MR conditional	All Sets:CT compatibleUniversal Segmented CylinderApplicator Set, Universal StumpApplicator Set, and Universal CervixProbe Sets: MR conditional
		Universal Titanium Cervix ProbeSets:MR Unsafe
Where Used	All Sets:Brachytherapy treatment room	All Sets:Brachytherapy treatment room