The Titanium Fletcher-style Applicator Set with defined geometry was developed for brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Titanium Fletcher-Style Applicator Set," based on the provided 510(k) summary:

This device is not an AI/ML device, but a physical medical device. Therefore, the questions related to AI/ML specific studies (MRMC comparative effectiveness study, standalone algorithm performance, training set details) are not applicable. The provided document is a 510(k) summary which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results of performance against acceptance criteria in the way an AI/ML device would.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Titanium Fletcher-Style Applicator Set does not explicitly state "acceptance criteria" in terms of performance metrics (like accuracy, sensitivity, specificity) as one would expect for a diagnostic or AI-based device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device (K980590 Henschke Type GYN Applicator Set) through a comparison of technological characteristics. The performance is measured by compliance with these characteristics and validation of new features.

Feature/Specification	Predicate Device (K980590 Henschke Type GYN Applicator Set)	New Device (Titanium Fletcher-Style Applicator Set-Defined Geometry)	Acceptance Criteria (Implied)	Reported Device Performance
Clearance Number	K980590	N/A	N/A	N/A
Compatible Afterloader	VariSource	GammaMed plus, GammaMed 12i(t), VariSource	Compatibility with afterloaders for brachytherapy.	The new device is compatible with GammaMed plus, GammaMed 12i(t), and VariSource afterloaders, demonstrating broader compatibility while retaining compatibility with the VariSource (like the predicate).
Intended Use	Radiation brachytherapy in the uterus and cervix.	To treat cancer of the uterus, cervix, endometrium, and vagina.	Same or similar intended use for brachytherapy.	The intended use for the new device is consistent with the predicate, with explicit mention of endometrium and vagina, suggesting a slightly expanded, but still within scope, application for brachytherapy.
Indications for Use	HDR radiation treatment of the cervix and uterus.	Brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina.	Same or similar indications for use.	Indications are for brachytherapy in the uterus and cervix (like predicate) and additionally includes endometrium and vagina. This is considered substantially equivalent.
Design	Rigid intra-uterine tandem and interlocking colpostats.	Intrauterine Probe with stopper (30°, lengths: 40mm, 60mm, 80mm; optional 30mm, 50mm, 70mm); Colpostats: 20mm, 25mm, 30mm spread.	Functional design for intracavitary radiotherapy.	The new device features an intrauterine probe with specific angles and lengths, and colpostats with defined spreads, indicating a compatible and regulated design for intracavitary application.
Materials	Stainless Steel, Polysulphone, Tungsten	PEEK Titanium, stainless steel, PPSU.	Biocompatible materials suitable for medical devices.	Uses PEEK Titanium, stainless steel, and PPSU, which are common and accepted materials for medical devices, expected to be biocompatible and robust.
Packing	Individual	Individual	Individual packaging for hygiene and sterility maintenance.	Consistent with predicate.
Sterility	Provided Non-sterile	Provided Non-sterile	Device is intended for post-purchase sterilization by user.	Consistent with predicate.
Sterilization Method	EtO Gas sterilization or Steam sterilization	Steam sterilization	Validated sterilization method suitable for the device materials.	Validated for Steam sterilization (15min @ 121°C, 5min @ 134°C, 18min @ 134°C), which is a common and effective method.
Sterilization Conditions	30 minutes ±2 minutes at 250°F±5°F (121°C±1°C).	15minutes @121°C, 5 minutes @134°C, 18 minutes @134°C	Effective sterilization parameters.	Specific steam sterilization parameters are provided, demonstrating validated sterilization efficacy for the device.
Biocompatibility	Not mentioned.	Full biocompatibility	Device materials are biocompatible for patient contact.	Explicitly states "Full biocompatibility," indicating testing and compliance with relevant standards. (This is an improvement/clarification over the predicate but supports safety).
Anatomical Sites	Uterus, cervix.	Uterus, cervix, endometrium, vagina.	Anatomical sites consistent with intended use.	Expanded to include endometrium and vagina, which aligns with the slightly broadened indications for use and is considered safe and effective in the context of brachytherapy.
Compatibility with environment/other devices	Not stated to be CT compatible or MR Conditional for 3 Tesla.	CT compatible, MR Conditional for 3 Tesla.	Functionality in modern imaging environments.	The new device is CT compatible and MR Conditional for 3 Tesla, which are significant improvements over the predicate, enhancing its usability in modern clinical settings. This adds utility without changing the fundamental safety or effectiveness of brachytherapy delivery.
Rectal Retractor	Not included as optional accessory.	Included as optional accessory.	Provision of necessary accessories for safe and effective use.	The inclusion of a rectal retractor as an optional accessory enhances a clinician's ability to protect adjacent organs, improving safety and functionality.

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

For a 510(k) submission of a physical medical device like this, there isn't a "test set" in the sense of a dataset of patient images or clinical outcomes used for an algorithm's performance evaluation.

Instead, "testing" involves:

Engineering verification and validation (e.g., material testing, sterilization validation, dimensional accuracy, compatibility with afterloaders).
Biocompatibility testing.
MR compatibility testing.

The document does not specify numerical "sample sizes" for these tests in terms of patient data. The provenance of such testing data would typically be from in-house lab testing, vendor testing, and potentially external accredited labs. Such testing is based on established engineering and materials standards, not patient data in the context of a "test set" for an AI device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable. The device is a physical medical instrument, not an AI/ML algorithm that requires expert-established ground truth from diagnostic images or clinical data.

4. Adjudication Method for the Test Set

This question is not applicable. There is no "adjudication method" in the context of a physical device's engineering validation or biocompatibility testing. These tests are evaluated against predefined specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not applicable to a physical brachytherapy applicator.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" used for its validation would be:

Engineering Specifications and Standards: Compliance with dimensional tolerances, material strength, compatibility interfaces.
Biocompatibility Standards: Compliance with ISO 10993 series.
Sterilization Validation Protocols: Efficacy of sterilization cycle.
MR Compatibility Standards: Performance under MR conditions.

It's not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical instrument and does not involve a "training set" in the context of machine learning.

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

This question is not applicable. The device is a physical instrument and does not involve a machine learning training set or its associated ground truth establishment.

Summary

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PREMARKET NOTIFICATION

510(k) Summary

Titanium Fletcher-Style Applicator Set

As required by 21 CFR 807.92

Submitter's Name:

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:

Classification Name:

Common/Usual Name:

Predicate Devices:

Device Description:

Indications for Use:

GM11006200 Titanium Fletcher-Style Applicator Set-Defined Geometry

Remote controlled radionuclide applicator system 21CFR892.5700 Class H

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.

Technological Characteristics:

FEATURE AND/OR	CLEARED DEVICE	NEW DEVICE
SPECIFICATION OF	FEATURE/SPECIFICATION
NEW/MODIFIED DEVICE
Predicate DeviceClearance Number:	Henschke Type GYN ApplicatorSet K980590	N/A
Compatible Afterloader	VariSource	GammaMed plusGammaMed 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

K120731

JUN - 6 2012

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and the control control control control controlled in the consideration of the consistential

Sales of the same of the same

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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 emblem, which consists of a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem. The emblem 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

6 2012

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

Re: K120731

Trade/Device Name: Titanium Fletcher-style Applicator Set-Defined Geometry Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: March 7, 2012 Received: March 9, 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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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):

Device Name: Titanium Fletcher-style Applicator Set-Defined Geometry

Indications for Use:

The Titanium Fletcher-style Applicator Set with defined geometry was developed for brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina.

Prescription Use (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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe 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.