VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER

• K Number: K980601
• Device Name: VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER
• Manufacturer: VARIAN ASSOC., INC.
• Date Cleared: 1998-10-21 ( 246 days)
• Product Code: JAQ
• Regulation Number: 892.5700
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K890485
• Predicate For: K061241 , K070659 , K081677

Intended Use

The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Wright Vaginal Cuff applicator which is the subject of this 510(k) is a component of the VariSource system.

Device Description

Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.

AI/ML Overview

The provided text is a 510(k) summary for the "VariSource Wright Vaginal Cuff Applicator" and does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information. It appears the document is not a performance study report but rather regulatory submission for market clearance based on substantial equivalence.

Summary

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OCT 2 | 1998

Attachment 3 Page 1 of 2

varian@ oncology systems

510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92

K980601

• 1. Submitter: Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304
     Linda S. Nash. Manager Contact: Regulatory Compliance & Radiation Safety Phone [phone] FAX [phone] [e-mail]

Prepared: February 12, 1998 July 23, 1998 Revised:

• VariSource Wright Vaginal Cuff Applicator for Varian 2. Device Name: VariSource™ Remote High Dose Rate Afterloader.
• 3. Predicate Device: Mick Radio-Nuclear Instruments, Inc., Wang Front Loading Applicator, K890485.
• Applicators for the Varian VariSource Remote High Dose Rate 4. Description: Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.
• The Varian VariSource Remote High Dose Rate 5. Intended Use: Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy The VariSource Wright Vaginal Cuff Applicator which is the subject of this 510(k) is a component of the VariSource system.
• 6. Technological See attached comparison chart. Characteristics

Image /page/0/Picture/13 description: The image shows the logo for "Partners for Life". The word "Partners" is stacked on top of the word "For", which is stacked on top of the word "Life". The word "Life" is written in a cursive font.

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Comparison to Predicate Device

#	Feature	MRNI Wang FrontLoading Applicator,K89045	VariSource WrightVaginal Cuff ApplicatorK980601
1	Afterloading Method	Manual	Remote HDR
2	Coupling CatheterFittings	No	Yes
3	Vaginal Cylinder
	Diameter and Length	3.0 cm X 7.0cm	3.4 cm X 12.0 cm
	Material	Polysulfone	Solid Water insidePolysulfone Shell
4	Irradiation Tubes	2	4
	Material	Stainless steel	Stainless Steel
	Configuration	1 central and 1 lateralwith source positionedperpendicular tocentral.	4 central at 0, 90, 180,and 270 degrees. Endscome together to formdome (eggbeater) shape.

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Image /page/2/Picture/16 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 an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 1998

Linda Nash Regulatory Compliance and Radiation Safety Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto. CA 94304

Re:

K980601 VariSource Wright Cuff Applicator for VariSource HDR Afterloader Dated: June 24, 1998 Received: August 4, 1998 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAQ

Dear Ms. Nash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmadsmam.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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varian@

STATEMENT of INDICATIONS for USE*

I state in my capacity as Manager, Regulatory Compliance and Safety, of Varian Oncology Systems that the Product which is the subject of this premarket notification, is intended to be used for the following:

The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Wright Vaginal Cuff applicator which is the subject of this 510(k) is a component of the VariSource system.

Charles Howell

Charles H. Will, Manager Regulatory Compliance & Safety

February 12, 1998

Date

*Suggested language and format to meet the requirements of section 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and 21 CFR sections 801.4 and 809.92(a)(5).

K98060/

510(k) Number

William Yin

Division Sign-off Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

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.