The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy.

Device Description

The Mould Applicator Set is an applicator for intraoperative, interstitial, intraluminal or surface 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 Mould Applicator Set can be steam sterilized with common parameters using Pre-vacuum sterilization. The mould probes Ø 2.8mm (GM11002280), which are part of the set, have a maximum implantation time of up to 24 hours. According to ISO 10993-1 they are categorised as medical devices, external communicating with tissue/bone communicating and a limited contact duration (A). They can be steam sterilized and used 25 times. The mould probes Ø 1.8mm (GM11002290) have a maximum implantation time of up to 7 days. According to ISO 10993-1 they are categorised as a medical device, external communicating with tissue/bone communicating and prolonged contact duration (B). When steam sterilised, they are a single use product and can be used for IORT, interstitial and intraluminal treatments. If only disinfected the probe can be used up to 10 times for treatment of superficial diseases. The Mould Applicator Set is CT compatible. The Mould Applicator Set is MR conditional for 1.5 and 3 Tesla when the mandrins have been removed from the mould probes after insertion in the patient.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called "Mould Applicator Set" manufactured by Varian Medical Systems, Inc. The document primarily focuses on establishing substantial equivalence to a predicate device (GammamedPlus HDR Afterloading System).

Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the tests performed within a section titled "Non Clinical Tests Bench Testing." The acceptance criteria are implied by statements such as "demonstrate that..." and "conformance to applicable requirements and specifications." The reported performance is the positive conclusion that all tests met these criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Correct functioning with specified afterloader	Conformance to applicable requirements and specifications
Withstanding specified number of use cycles	Conformance to applicable requirements and specifications
Enabling radioactive source location with required accuracy	Conformance to applicable requirements and specifications
Construction from materials not significantly affected by radiation	Conformance to applicable requirements and specifications
Effective sterilization	Conformance to applicable requirements and specifications
Safe and effective use/sterilization for specified number of times	Conformance to applicable requirements and specifications
Adequate positional accuracy of the source	Conformance to applicable requirements and specifications
Biocompatibility as per ISO 10993 standards	Conformance to applicable requirements and specifications
Safe and effective use in CT environments	Conformance to applicable requirements and specifications
Safe use in MRI environments under specified conditions	Conformance to applicable requirements and specifications
Usability meeting IEC 62366:2007 requirements	Conformance to applicable requirements and specifications

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

The document explicitly states: "No clinical tests have been included in this pre-market submission." Therefore, there is no sample size for a test set of patient data, nor is there any provenance information for such data. The testing mentioned (bench testing) would have used physical samples of the device components. The number of such samples is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical studies were performed, there was no expert review of patient data to establish ground truth in the context of diagnostic or treatment efficacy. The "experts" involved would have been the engineers and testers performing the bench tests, verifying compliance with technical standards and design specifications. Their specific number or qualifications are not detailed.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used. The bench testing would involve direct measurement and verification against predefined technical specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted. The document states, "No clinical tests have been included in this pre-market submission." Therefore, there is no information about the effect size of AI improving human readers' performance, as the device is a physical applicator and not an AI-assisted diagnostic or treatment planning tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical "Mould Applicator Set" for brachytherapy, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device itself is designed to perform its function (guiding a radioactive source) without continuous human intervention during the source guidance, but it is always used by a human operator within a clinical workflow.

7. Type of Ground Truth Used:

For the non-clinical bench tests, the ground truth was based on engineering specifications, design requirements, and recognized industry standards (e.g., ISO 10993 for biocompatibility, IEC 62366 for usability, and internal Varian standards for accuracy and durability).

8. Sample Size for the Training Set:

Not applicable. The "Mould Applicator Set" is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

March 24, 2017

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

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

Re: K162615 Trade/Device Name: Mould Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: February 22, 2017 Received: February 23, 2017

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)

K162615

Device Name Mould Applicator Set

Indications for Use (Describe)

The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease 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)

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)

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:

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"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."

FORM FDA 3881 (1/14)

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PREMARKET NOTIFICATION

510(k) Summary

Mould Applicator Set

As required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E110Palo Alto CA94304
	Contact Name: Peter J. CoronadoPhone: 650/424.6320Fax: 650/646.9200Date: 9th Sep 2016
Proprietary Name:	Mould Applicator Set
Classification Name:	Remote controlled radionuclide applicator system21CFR892.5700Class II
Common/Usual Name:	Mould Applicator Set
Predicate Devices:	GammamedPlus HDR Afterloading System (K983436).
Device Description:	The Mould Applicator Set is an applicator for intraoperative,interstitial, intraluminal or surface brachytherapy. Brachytherapyis a form of radiotherapy using Gamma rays from a radioactivesource placed at locations close to or within a tumor or othertreatment area to a predefined treatment plan. The treatmentplan defines the positions and times for the source to ensure thecorrect dose for the treatment area. The applicator acts to guidethe radioactive source to the correct location or locations fortreatment.
	The Mould Applicator Set can be steam sterilized with commonparameters using Pre-vacuum sterilization.
	The mould probes Ø 2.8mm (GM11002280), which are part of theset, have a maximum implantation time of up to 24 hours.According to ISO 10993-1 they are categorised as medical devices,external communicating with tissue/bone communicating and alimited contact duration (A). They can be steam sterilized andused 25 times.
	The mould probes Ø 1.8mm (GM11002290) have a maximumimplantation time of up to 7 days. According to ISO 10993-1 they

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are categorised as a medical device, external communicating with tissue/bone communicating and prolonged contact duration (B). When steam sterilised, they are a single use product and can be used for IORT, interstitial and intraluminal treatments. If only disinfected the probe can be used up to 10 times for treatment of superficial diseases. The Mould Applicator Set is CT compatible. The Mould Applicator Set is MR conditional for 1.5 and 3 Tesla when the mandrins have been removed from the mould probes after insertion in the patient. Indications for Use: The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or

other superficial disease using HDR or PDR brachytherapy.

	1.5 and 2.8mm Catheters as part ofGammaMedplus HDR Afterloading	Mould Applicator set
	System K983436.
Intended use	Covered by intended use of completeafterloader system in original submission:The intended use of the GammaMed Plustransportable high-dose-rate remotelycontrolled afterloading brachytherapydevice is for the treatment of cancer byintracavitary, interstitial, intraluminal andintraoperative irradiation.	The Mould Applicator Set is intended forIORT, interstitial and intraluminaltreatments of cancer and treatments ofcancer or other superficial disease usingHDR or PDR brachytherapy.
Indications for Use	Covered by indication for use of completeafterloader system in original submission:The intended use of the GammaMed Plustransportable high-dose-rate remotelycontrolled afterloading brachytherapydevice is for the treatment of cancer byintracavitary, interstitial, intraluminal andintraoperative irradiation.	The Mould Applicator Set is indicated forIORT, interstitial and intraluminaltreatments of cancer and treatments ofcancer or other superficial disease usingHDR or PDR brachytherapy.
Compatible Afterloader	GammaMedplus	GammaMedplus
Design	Catheters:• Diameter: 1.5 or 2.8mm• Length: 130cm	Mould Probe Diameter: 1.8 or 2.8mmLength: 320 mm1.8mm Mould Probe supplied with mandrin
Materials	1.5mm Catheter: Polyamide2.8mm Catheter: Fluorinated ethylenepropylene (FEP)Probe connectors: Stainless steel	1.8mm Mould Probe: Polyamide (PA)2.8mm Mould Probe: Fluorinated ethylenepropylene (FEP)Probe connectors: TitaniumMandrin: Stainless steel
Packing	individual	Individual
Sterility	Provided non sterile	Provided non sterile

Technological Characteristics:

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Sterilization method	Steam sterilization	1.8mm and 2.8mm Mould Probes:Manual Cleaning, Steam sterilization.1.8mm Mould Probe is a single use productwhen steam sterilized.
Biocompatibility	Full biocompatibility	Full biocompatibilityMax 24 hours contact for the 2.8mm MouldProbe.Max7 days contact for 1.8mm Mould Probe
Compatibility with theenvironment and otherdevices	No CT or MR claims	CT compatible, MR conditional 1.5 and 3 T
Where used	Brachytherapy treatment room	Brachytherapy treatment room

Non Clinical Tests Bench Testing has been performed to demonstrate that

the devices function correctly with the specified afterloader;
. 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 ISO10993 standards
the devices can be used safely and effectively in CT environments
testing of the Mould Applicator in MRI environments has demonstrated it is 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

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.