VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER

K980590 · Varian Medical Systems, Inc. · JAQ · Oct 22, 1998 · Radiology

Device Facts

• Record ID: K980590
• Device Name: VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

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 Henschke Type GYN applicator which is the subject of this 510(k) is a component of the VariSource system.

Device Story

VariSource Henschke Type GYN Applicator is a component of the VariSource Remote High Dose Rate (HDR) Afterloader system. Device facilitates remote-controlled delivery of high-activity radionuclide sources to internal or surface body locations for radiation brachytherapy. System includes electromechanical components for remote source positioning, reducing radiation exposure to medical personnel compared to manual afterloading. Applicator consists of stainless steel tandems and colpostats, with polysulfone ovoids, caps, and inserts containing tungsten shielding. Used in clinical settings by trained medical personnel to treat gynecological conditions via brachytherapy. Output is the precise placement of radioactive sources for therapeutic radiation delivery, enabling targeted treatment of target tissues.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless steel (tandem/colpostat), Polysulfone (ovoids/caps/inserts), Aluminum (spacing/locking bracket), Tungsten (shields). Energy source: Remote HDR radionuclide source. Form factor: GYN applicator set including tandems, colpostats, and ovoids. Connectivity: Integrates with VariSource remote afterloader system. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring radiation brachytherapy, administered by trained and licensed medical personnel in clinical settings.

Regulatory Classification

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.

Predicate Devices

• Mick Radio-Nuclear Instruments, Inc., Henschke Afterloading Applicator (K871217)

Submission Summary (Full Text)

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OCT 2 2 1998

Attachment 2 Page 1 of 2

Image /page/0/Picture/2 description: The image shows the logo for Varian Oncology Systems. The word "varian" is in bold, black letters on the top line, with a circled "VA" symbol to the right. Below that, the words "oncology systems" are in a smaller, non-bold font.

## 510K SUMMARY AS REQUIRED BY 21 CFR 807.92

Kg80590

- Varian Oncology Systems 1. Submitter: 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 |
|-----------|-------------------|
| Revised: | July 23, 1998 |

- VariSource Henschke Type GYN Applicator for Varian 2. Device Name: VariSource™ Remote High Dose Rate Afterloader.
- 3. Predicate Device: Mick Radio-Nuclear Instruments, Inc., Henschke Afterloading Applicator, K871217.
- 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 Henschke Type GYN Applicator which is the subject of this 510(k) is a component of the VariSource system.
- 6.Technological See attached comparison sheet. Characteristics

Image /page/0/Picture/13 description: The image shows a logo for "Partners for Life". The word "Partners" is stacked on top of the word "For", and the word "Life" is written in cursive to the right of the other two words. The logo is in black and white.

Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304-1129 U.S.A. 415.493.4000 FAX: [phone]

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## Comparison to Predicate Device

ﺰ

| # | Feature | MRNI Henschke<br>Afterloading Applicator<br>K871217 | VariSource Henschke<br>Type GYN Applicator<br>K980590 |
|---|-------------------------------|-----------------------------------------------------|-------------------------------------------------------|
| 1 | Afterloading Method | Manual | Remote HDR |
| 2 | Coupling Catheter<br>Fittings | No | Yes |
| 3 | Tandem | | |
| | Diameter and material | 6 mm, Stainless steel | 6/3 mm, Stainless Steel |
| | Configuration | Straight, Medium Curved,<br>& Maximum Curved | Straight, Medium Curved,<br>& Maximum Curved |
| | Cervical Stop | Yes | Yes |
| 4 | Colpostat | | |
| | Diameter and material | 6 mm, Stainless steel | 6/3 mm, Stainless Steel |
| | Configuration | 1 left, 1 right | 1 left, 1 right |
| 5 | Spacing/locking Bracket | Aluminum | Aluminum |
| 6 | Hemispherical Ovoids | | |
| | Diameter and material | 2 cm, Delrin | 2cm, Polysulfone |
| 7 | Ovoid Caps | | |
| | Diameter and material | 2.5 cm & 3.0 cm, Delrin | 2.5 cm & 3.0 cm,<br>Polysulfone |
| 8 | Ovoid Inserts | Tungsten shields and<br>Delrin fillers | Tungsten shields and<br>Polysulfone fillers |

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Image /page/2/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 1998

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

K980590

Re:

VariSource Henschke Type GYN Applicator for VariSource HDR Afterloader Dated: July 24, 1998 Received: July 28, 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 (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 (OS) 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 801 and additionally 809.10 for in vitro disgnostic 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 finternet address "http://www.fda.gov/cdrf/dsma/dsmamain.html".

Sincerely yours,

William Yi, Ph.D.

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

Enclosure

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## 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 Henschke Type GYN applicator which is the subject of this 510(k) is a component of the VariSource system.

Charles Seibel

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).

K980590

Daniel h. Symm

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Division Sign-off Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use