The Cleaning Cap is intended to close the lumens of applicator parts during and disinfection process. New sterilized Cleaning Caps can be placed onto applicators during patient insertion if this is desired.

The Leak Stop Buttons are intended to prevent liquid entering the applicator or source guide tube connector during implantation and treatment. They are also used for fixation of the individual channel marker clips.

The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid entering the applicator or source guide tube connectors.

Device Description

The Cleaning Caps, the Leak Stop Buttons and Leak Stop Channel Marker Sets are brachytherapy applicator accessories. The Cleaning Cap is used to close the lumens of applicator parts during the cleaning and disinfection process. During treatment the Leak Stop Buttons and Leak Stop Channel Marker Sets prevent blood or liquid from entering the source guide tube connector.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for Varian Medical Systems, Inc.'s Cleaning Caps, Leak Stop Buttons, and Leak Stop Channel Marker Sets. This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically:

No specific measurable acceptance criteria are listed for the device's performance. The device is a set of accessories for brachytherapy applicators, primarily intended for closing lumens during cleaning/disinfection and preventing liquid ingress, along with marking channels. Its performance is assessed through general compliance with safety and biocompatibility standards rather than quantitative performance metrics.
No detailed study is described that would demonstrate the device meets specific performance acceptance criteria. The document refers generally to "verification and validation testing" and "non-clinical 10993 standard testing" and states that "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." However, it does not provide details of such a study, including sample sizes, data provenance, ground truth establishment, or specific performance metrics.

Therefore, I cannot populate the requested table or detail most of the bullet points as the necessary information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the document, and what is missing:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as measurable criteria with thresholds. The document broadly states "conformance to applicable requirements specifications" and "assured hazard safeguards functioned properly."
- Reported Device Performance: The document concludes that the devices "are as safe, effective and performs as well as or better than the legally marketed device identified in section III above" (the predicate device). This is a statement of equivalence rather than a report of specific performance metrics against defined acceptance criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided.
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)
- This information is not provided. The testing mentioned appears to be related to engineering, materials, and safety standards rather than clinical performance requiring expert ground truth in the way an AI diagnostic device would.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided.
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
- This is not applicable. The devices are physical accessories, not AI software, and no MRMC study or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The devices are physical accessories, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these devices would likely be defined by engineering specifications, material standards (e.g., biocompatibility), and functional tests (e.g., ability to physically close lumens, prevent liquid ingress). These are not clinical ground truths as seen in diagnostic AI. The document broadly refers to "verification and validation testing" and "Biocompatibility testing requirements" and "Cleaning validation test requirements" as being met, implying the "truth" is established by adherence to these technical requirements.
The sample size for the training set
- This is not applicable. The device is not an AI model requiring a training set.
How the ground truth for the training set was established
- This is not applicable because there is no training set for this type of device.

In summary, the provided document is a regulatory submission for physical medical device accessories and does not contain the detailed performance study information, acceptance criteria, or AI-specific data (like training/test sets, ground truth establishment for AI, expert involvement for diagnostic assessment) requested for a typical AI/software-as-a-medical-device product.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.

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

September 11, 2015

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

Re: K152018

Trade/Device Name: Varian Cleaning Caps, Leak Stop Buttons, Leak Stop Channel Marker Sets Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: July 14, 2015 Received: July 21, 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 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

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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)

K152018

Device Name

Cleaning Cap, Leak Stop Buttons & Leak Stop Channel Marker Sets

Indications for Use (Describe)

The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid entering the applicator or source guide tube connectors.

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 Paperwork Reduction Act (PRA) Staff 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."

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Premarket Notification [510(k)] Summary Cleaning Caps, Leak Stop Channel Markers & Leak Stop Buttons

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

I. Submitter's Name:	Varian Medical Systems, Inc.3120 Hansen Way C-260Palo Alto, CA 94304Contact Name: Peter J. CoronadoPhone: 650.424.5731Fax: 650.842.5040Date: July 2015
II. Trade Name:	Varian Cleaning Caps, Leak Stop Channel Marker Sets & Leak Stop Buttons
Common Name:	Cleaning Caps, Leak Stop Channel Marker Sets & Leak Stop Buttons
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5700, Class IIProduct Code: JAQ
III. Predicate Device:	Plastic interstitial needles: K141624
IV. Device Description:	The Cleaning Caps, the Leak Stop Buttons and Leak Stop Channel Marker Sets are brachytherapy applicator accessories. The Cleaning Cap is used to close the lumens of applicator parts during the cleaning and disinfection process. During treatment the Leak Stop Buttons and Leak Stop Channel Marker Sets prevent blood or liquid from entering the source guide tube connector.
V. Intended Use Statement:	The Cleaning Cap, the Leak Stop Channel Marker Sets and the Leak Stop Buttons are designed for brachytherapy treatment in areas such as the head and neck, gynecological, breast and prostate.
Indications for Use Statement	The Cleaning Cap is intended to close the lumens of applicator parts during the cleaning and disinfection process. New sterilized Cleaning Caps can be placed onto applicators during patient insertion if this is desired.The Leak Stop Buttons are intended to prevent liquid entering the applicator or source guide tube connector during implantation and treatment. They are also used for fixation of the individual channel marker clips.The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid

entering the applicator or source guide tube connectors.

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Premarket Notification [510(k)] Summary Cleaning Caps, Leak Stop Channel Markers & Leak Stop Buttons

VI. Technological Characteristics:

FEATURE/SPECIFICATION	PLASTIC INTERSTITIAL NEEDLES510(k) ID # K141624	CLEANING CAPS, LEAK STOP CHANNELMARKER SETS & LEAK STOP BUTTONS
Materials:	Needles: PEEK/TitaniumObturator/Mandrin: Stainless SteelCleaning Caps: SiliconeLeak Stop Channel Marker: SiliconeLeak Stop Buttons: Silicone	Cleaning Caps: SiliconeLeak Stop Channel Marker: SiliconeLeak Stop Buttons: Silicone
Compatibility with theenvironment and otherdevices	CT compatible, MR conditional for1.5 and 3.0T	CT compatible; MR safeDesigned to be used with all Varianapplicator probes, tandems or needleswith the ClickFit™ connector.
Dimensions	Plastic needle:• Diameter: 2 mm• Length: 113, 200, 320mm• Tip styles:Sharp tipBlunt tip (320mm length only)Cleaning Caps:• Diameter: 5.1mm• Length: 13.5mmLeak Stop Channel Marker:• Diameter: 10.0mm• Length: 2.0mmLeak Stop Buttons:• Diameter: 10.0mm• Length: 2.0mm	Cleaning Caps:• Diameter: 5.1mm• Length: 13.5mmLeak Stop Channel Marker:• Diameter: 10.0mm• Length: 2.0mmLeak Stop Buttons:• Diameter: 10.0mm• Length: 2.0mm
Packing	Individual packaging for needlesCleaning Caps: Pack of 25Leak Stop Channel Marker:• Sets contain packs of 25 (foreach channel);• Sets are Channels 1-12,Channels 13-24, and Channels25-30Leak Stop Buttons: Pack of 50	Cleaning Caps: Pack of 25Leak Stop Channel Marker:• Sets contain packs of 25 (for eachchannel);• Sets are Channels 1-12, Channels 13-24, and Channels 25-30Leak Stop Buttons: Pack of 50

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Premarket Notification [510(k)] Summary Cleaning Caps, Leak Stop Channel Markers & Leak Stop Buttons

VII. Summary of performancetesting:	Results of verification and validation testing showed conformance toapplicable requirements specifications and assured hazard safeguardsfunctioned properly.Biocompatibilty testing requirements for irritation, sensitization, andacute systemic injection have been met.Cleaning validation test requirements have been met.
Standards conformance:	The Varian Cleaning Caps, Leak Stop Channel Marker Sets & Leak StopButtons conform in whole or in part with the following standards:IEC 62366:2007ANSI/AAMI/ISO 10993-5:2009ANSI/AAMI/ISO 10993-6:2007ANSI/AAMI/ISO 10993-11:2010	ISO 14971:2012ISO 10993-1:2009ISO 10993-10:2010ISO 10993-12:2012
Conclusion:	Based on the verification, validation and non-clinical 10993 standardtesting, the The Varian Cleaning Caps, Leak Stop Channel Marker Sets &Leak Stop Buttons are as safe, effective and performs as well as orbetter than the legally marketed device identified in section III above.

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.