The Surface Applicator Set with Leipzig-style cone-GM11010080 is indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy.

Device Description

The Surface Applicator Set with Leipzig-style Cone is a Brachytherapy applicator set. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumour 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 devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Surface Applicator Set with Leipzig-style Cone," used for brachytherapy. The submission focuses on demonstrating substantial equivalence to a predicate device and includes details about non-clinical testing.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

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

Acceptance Criteria	Reported Device Performance (as per "Non Clinical Tests Bericht" and "Conclusions")
Device functions correctly with the specified afterloaders.	Bench Testing showed conformance to applicable requirements and specifications.
Device can withstand the number of cycles of use that it will experience in its lifetime.	Bench Testing showed conformance to applicable requirements and specifications.
Device enables the radioactive source to be located to the accuracy required.	Bench Testing showed conformance to applicable requirements and specifications, and it was confirmed that "the positional accuracy of the source within the applicator is adequate."
Device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product.	Bench Testing showed conformance to applicable requirements and specifications.
Positional accuracy of the source within the applicator is adequate.	Bench Testing showed conformance to applicable requirements and specifications, and it was confirmed that "the positional accuracy of the source within the applicator is adequate."
Usability meets the requirements of IEC 62366:2007.	Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications.
Overall safety and effectiveness compared to the predicate device.	"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."

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

The text mentions "Non Clinical Tests Bericht Testing has been performed" which refers to bench testing. There is no information provided about a "test set" in the context of patient data, clinical studies, or country of origin. The testing described is entirely physical and functional testing of the device itself.

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. This device is not an AI/diagnostic device that requires expert opinion to establish ground truth for a test set. The acceptance criteria relate to engineering and functional performance, verified through bench testing.

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

Not applicable. As noted above, this device did not involve patient data or readings that would require an adjudication method.

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

No. This device is an applicator set for brachytherapy, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant and was not performed.

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

No. This device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not applicable.

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

For the non-clinical tests, the "ground truth" was established by engineering specifications, design requirements, and relevant international standards (e.g., IEC 62366:2007). For example, the "accuracy required" for source location would be defined by the design and safety specifications for brachytherapy devices.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable. As above, this device does not involve AI or machine learning algorithms, so there is no training set and no ground truth for a training set.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '123815'. The numbers are written in a cursive style, and there is a line above the number '5'.

PREMARKET NOTIFICATION

510(k) Summary

Surface Applicator Set with Leipzig-style Cone

As required by 21 CFR 807.92

MAR 1 1 2013

Submitter's Name:	Varian Medical Systems911 Hansen Way, M/S C-260Palo Alto CA94304
	Contact Name: Peter J. CoronadoPhone: 650/424.6320Fax:650/842.5051Date: 30 November 2012
Proprietary Name:	GM11010080 Surface Applicator Set with Leipzig-style Cone
Classification Name:	Remote controlled radionuclide applicator system21CFR892.5700Class II
Common/Usual Name:	Surface Applicator Set(s), Surface Applicator
Predicate Devices:	Surface Applicator as part of GammaMedplus HDR remoteafterloader system. K983436.
Device Description:	The Surface Applicator Set with Leipzig-style Cone is aBrachytherapy applicator set. Brachytherapy is a form ofradiotherapy using Gamma rays from a radioactive source placedat locations close to or within a tumour to a predefined treatmentplan. The treatment plan defines the positions and times for thesource to ensure the correct dose for the treatment area. Theapplicator acts to guide the radioactive source to the correctlocation or locations for treatment..The devices are intended to be used by trained and qualifiedpersonnel such as Radiation Oncologists, Physicians, Radiologists,Dosimetrists, Medical Physicists, and Nurses/MTRAs/RadiologyTechnicians/Radiographers in a hospital environment.
Indications for Use:	The Surface Applicator Set with Leipzig-style cone-GM11010080 isindicated for treatment of small skin tumours or other superficialdisease (such as keloid formations) with HDR brachytherapy.

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Technological Characteristics of the device compared with the predicate device:

	Surface Applicator	GM11010080 SurfaceApplicator Set with Leipzig-style Cone
PredicateDeviceClearanceNumber:	GammaMedplus Afterloader systemwith applicators and accessoriesK983436	N/A
CompatibleAfterloader	GammaMedplusGammaMed 12i(t)	GammaMedplus seriesVariSource Series
Intended use	The intended use of the GammaMedPlus transportable high-dose-rateremotely controlled afterloadingbrachytherapy device is for thetreatment of cancer by intracavitary,interstitial, intraluminal andintraoperative irradiation.	The Surface Applicator Set withLeipzig-style Cone is intended forthe treatment of small skin tumoursor other superficial disease (such askeloid formations) with HDRbrachytherapy.
Indications forUse	The intended use of the GammaMedPlus transportable high-dose-rateremotely controlled afterloadingbrachytherapy device is for thetreatment of cancer by intracavitary,interstitial, intraluminal andintraoperative irradiation.	The Surface Applicator Set withLeipzig-style Cone is intended forthe treatment of small skin tumoursor other superficial disease (such askeloid formations) with HDRbrachytherapy.
Targetpopulation	No specific population	No specific population
Design	Shielding for tubus with a verticalsource entrance:	Leipzig-style Cone with a horizontalsource entrance:
	Ø 10-25 mm and Ø 30-45 mm withfixation	Ø 30-45 mm, with holder and guide
	Surface tubus inset set:Ø10-25 mm, roundØ30-45 mm, roundØ30-45 mm, oval	Surface cone inset:Ø 30 mm, 35 mm, 40 mm, 45 mm,round
Materials	Shielding: Tungsten / Stainless SteelSurface tubus insets:Tungsten / PVC	Leipzig-style Cone:Tungsten / Stainless SteelSurface cone insets:Tungsten / PVC
Packing	individual	individual
Sterility	Non sterile	Non sterile
Sterilizationmethod	Devices are not sterilized.	Devices are not sterilized.
Biocompatibility	N/A. The use of a sterile plasticenvelope or surgical foil is required toprevent any parts of the applicatorfrom having body contact.	N/A. The use of a sterile plasticenvelope or surgical foil is requiredto prevent any parts of the applicatorfrom having body contact.
Anatomical sites	skin	skin
Where used	Brachytherapy Treatment Room	Brachytherapy Treatment Room

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Non Clinical Tests Berich Testing has been performed to demonstrate . that the device functions correctly with the specified afterloaders; . that the device can withstand the number of cycles of use that it will experience in its lifetime; that the device enables the radioactive source to be ● located to the accuracy required, . that 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; . that 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 the devices to be safe and effective and to perform as well or better than the predicate

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

March 11, 2013

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

Re: K123815

Trade/Device Name: Surface Applicator Set with Leipzing-style Cone Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 30, 2012 Received: December 12, 2012

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 vour 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 (OS) 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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Page 2-Mr. Coronado

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

fda.gov/MedicalDevices/ResourcesforYourIndustry/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 Form

510(k) Number (if known): K123815

Device Name: Surface Applicator Set with Leipzig-style Cone.

Indications for Use:

GM110010080 Surface Applicator Set with Leipzig-style Cone.

The Surface Applicator Set with Leipzig-style cone-GM11010080 is indicated for treatment of small short of the superficial disease (such as keloid formations) with HDR brachnerapy.
skin tumours or other superficial disease (such as keloid formations) with HDR brachytherap

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED. NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Offision Sign-Off ffice of In Vitro Diagnostic Device Safety 510/k)

Page 1 of _ 1

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.