The GammaMed Titanium Fletcher-style Applicator Set with defined geometry was developed to treat cancer of the uterus, cervix, endometrium and vagina.

The Interstitial Plastic Needles are designed for interstitial brachytherapy treatments in areas such as the head and neck, gynecological, breast and prostate.

Device Description

The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.

Intrauterine Probe with stopper 30 °, length: 40mm, 60mm, 80mm (optional 30mm, 50mm, 70mm Colpostats: 20mm, 25mm, 30mm spread

AI/ML Overview

The provided text is for a 510(k) Premarket Notification for the "Titanium Fletcher-Style Applicator Set" and "Interstitial Plastic Needles". It describes the device, its intended use, and a comparison to a predicate device.

However, the document does not describe a study involving an AI model or a device that uses AI. The "acceptance criteria" and "reported device performance" are related to biocompatibility, sterilization, bench testing (functionality, durability, material radiation resistance, positional accuracy), MRI compatibility, and usability for a physical medical device (an applicator set and needles) used in brachytherapy.

Therefore, many of the requested elements for describing an AI study, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth for training/test sets, cannot be answered from the provided text.

Below is the information that can be extracted or inferred from the provided document, but please note it is primarily focused on the physical device's non-clinical performance and a declaration of substantial equivalence, not an AI model.

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Biocompatibility	Compliance with ISO 10933-1:2009 and 510(k) Memorandum - #G95-1. Specifically: No leachable cytotoxic materials, no sensitization reactions, no irritant/corrosive effect.	- Released no leachable cytotoxic materials - Caused no reactions identified as sensitization - Showed no irritant/corrosive effect - Requirements of BS EN ISO 10993-1:2003 and FDA#G95-1 have been met
Sterilization & Shelf Life	Verify effectiveness of proposed cleaning, disinfection, and sterilization cycles. Verify suitability of design and material by inspecting for damage affecting safety or effectiveness after proposed number of cycles.	Tests verified effectiveness of cycles and suitability of design/materials, with no damage affecting safety/effectiveness.
Bench Testing	Demonstrate correct function with VariSource and GammaMedplus afterloaders. Withstand lifetime use cycles. Materials not significantly affected by radiation over lifetime. Adequate positional accuracy. Assess effects of MRI on the device. Usability assessed to IEC 62366:2007.	- Functions correctly with both VariSource and GammaMedplus afterloaders. - Can withstand lifetime use cycles. - Materials not significantly affected by radiation. - Positional accuracy is adequate. - Effects of MRI assessed (CT compatible, MR Conditional for 3 Tesla). - Usability assessed to IEC 62366:2007 requirements.

Information Relevant to AI Studies (Not Applicable / Not Provided)

Given that the provided document is a 510(k) for a physical medical device (applicator set and needles) and does not describe an AI/software as a medical device (SaMD), the following points cannot be addressed from the input.

Sample size used for the test set and the data provenance: Not applicable, as no algorithm test set is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert-derived ground truth for an algorithm is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no algorithm ground truth is mentioned.
The sample size for the training set: Not applicable, as no algorithm training set is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary based on document content:

The document describes premarket notification for a physical medical device (Titanium Fletcher-Style Applicator Set and Interstitial Plastic Needles). The acceptance criteria and performance data are entirely related to the physical and material properties, functionality, safety (biocompatibility, sterilization), and compatibility of this hardware device. There is no mention of any artificial intelligence, machine learning, or software algorithm, therefore, none of the questions pertinent to an AI-driven device can be answered. The study referenced is a series of non-clinical bench tests and biocompatibility evaluations confirming the device's safety and effectiveness compared to a predicate device.

Summary

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KI20341

PREMARKET NOTIFICATION

510(k) Summary

Titanium Fletcher-Style Applicator Set

As required by 21 CFR 807.92

Submitter's Name: (Paragraph (a) (1))

Varian Medical Systems 3100 Hansen Way, m/s E110 Palo Alto CA94304

Contact Name: Vy Tran Phone: 650/424.5731 Fax:650/842.5040 Date: 07 October 2011

Proprietary Name: (Paragraph (a) (2))

Classification Name: (Paragraph (a) (2))

Common/Usual Name: (Paragraph (a) (2))

Predicate Devices: (Paragraph (a) (3))

Device Description: (Paragraph (a) (4))

Intended Use: (Paragraph (a) (5)) GM11006200 Titanium Fletcher-Style Applicator Set-Defined Geometry

Remote controlled radionuclide applicator system 21CFR892.5700 Class II

GM11006200 Titanium Fletcher-Style Applicator Set

K980590Henschke Type GYN Applicator Set

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.

The Fletcher Style Applicator Sets (defined geometry) are intended to treat cancer of the uterus, cervix, endometrium and vagina

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Technological Characteristics of the device compared with the predicate device: (Paragraph (a) (6))

FEATURE AND/ORSPECIFICATION OFNEW/MODIFIED DEVICE	CLEARED DEVICEFEATURE/SPECIFICATION	NEW DEVICE
Predicate DeviceClearance Number:	Henschke Type GYN ApplicatorSet K980590	N/A
Compatible Afterloader	VarlSource	GammaMedplusGammaMed 12i(t)VariSource
Intended use	The Varian VariSource RemoteHigh Dose Rate Afterloader(system including applicatorsand accessories) is a deviceintended to be used by trainedand licensed medical personnelto provide radiationbrachytherapy. The VariSourceHenschke Type GYN applicatorwhich is the subject of this510(k) is a component of theVariSource system.	The GammaMed TitaniumFletcher-style Applicator Setwith defined geometry wasdeveloped to treat cancer of theuterus, cervix, endometriumand vagina.
Indications for Use	The Henschke Type Applicatoris indicated for use in any casewhere High Dose Rate (HDR)radiation treatment of thecervix and uterus Is acceptedclinical practice.	The GammaMed TitaniumFletcher-style Applicator Setwith defined geometry wasdeveloped to treat cancer of theuterus, cervix, endometriumand vagina.
Design	Rigid intra-uterine tandem anda pair of interlocking colpostatswith Henschke type ovoids. Thehemispsherical ovoids aresegemented and will accepteither tungsten or plasticinserts so that shielding isoptional. Distance betweenovoids is adjustable. Threetandems are provided: onestraight and two with aminimum and maximumcurvature of the distal end toaccommodate intrauterine tilt.	Intrauterine Probe with stopper30 °, length: 40mm, 60mm,80mm (optional 30mm, 50mm,70mmColpostats: 20mm, 25mm,30mm spread
Materials	Stainless Steel, Polysulphone,Tungsten	PEEK Titanium, stainless steel,PPSU.
Packing	individual	individual
Sterility	Provided Non sterile	Provided Non sterile
Sterilization method	EtO Gas sterilization or Steamsterilization	Steam sterilization
Sterilization conditions	30minutes ±2 minutes at250°F±5°F (121°C±1°C).	15minutes @121°C5 minutes @134°C18 minutes @134°C
Biocompatibility	Biocompatibility notmentioned.	Full biocompatibility
Anatomical sites	uterus, cervix,	uterus, cervix, endometrium,vagina
Compatibility with theenvironment and otherdevices	Not stated to be CT compatibleor MR Conditional for 3 Tesla	CT compatibleMR Conditional for 3 Tesla
Rectal Retractor	Rectal Retractor not included asoptional accessory	Rectal Retractor included asoptional accessory

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Non Clinical Tests (Paragraph (b) (1))

Biocompatibility tests were selected by reference to ISO 10933-1:2009, Biologicol Evaluation of Medical Devices Part 1: Evoluation & Testing and 510(k) Memorandum - #G95-1 Initial Evaluation Tests for Consideration. The over- all results for the materials were as follows:

1.Released no leachable cytotoxic materials

Caused no reactions identified as sensitization

1. Showed no irritant/corrosive effect

Requirements of BS EN ISO 10993-1:2003 Biological evaluation of Medical Devices Part 1 and FDA#G95-1 have been met

Sterilization and Shelf Life tests have been undertaken on components that are representative of the Titanium Fletcher-style Applicator. The first group of tests was to verify that the proposed cleaning, disinfection and sterilization cycles were effective. The second was to verify the suitability of the design and material of the applicator components by inspecting for damage that might affect safety or effectiveness caused by the proposed number of cycles. In both types of test, components from other applicators that were representative of the components in the GM11006200 were used.

Other Bench Testing was performed to demonstrate that the device, functions correctly with both VariSource and GammaMedplus afterloaders; that the device can withstand the number of cycles of use that it will endure in its lifetime; that materials used are not significantly affected by the radiation they meet in the lifetime of the product; that the positional accuracy is adequate. The effects of Magnetic Resonance Imaging on the device when in patent contact were assessed. Usability was assessed to the requirements of IEC 62366:2007.

Clinical Tests
(Paragraph (b) (2))

Conclusions (Paragraph (b) (2)) No Clinical Tests have been included in this pre-market submission

All the tests that were performed met the applied pass criteria. Varian considers the device to be safe and effective and to perform as well or better than the predicate.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304

APR 2 7 2012

Re: K120341

Trade/Device Name: Interstitial Plastic Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 20, 2012 Received: February 3, 2012

Dear Ms. Tran:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K12034

Device Name: Interstitial Plastic Needles

Indications for Use:

The Interstitial Plastic Needles are designed for interstitial brachytherapy treatments in areas such as the head and neck, gynecological, breast and prostate.

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)

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

Marlon D. Odom

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and 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.