VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER

K980576 · Varian Medical Systems, Inc. · JAQ · Nov 2, 1998 · Radiology

Device Facts

• Record ID: K980576
• Device Name: VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Nov 2, 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 Endometrial applicator which is the subject of this 510(k) is a component of the VariSource system.

Device Story

VariSource Endometrial Applicator is a component of the Varian VariSource Remote High Dose Rate (HDR) Afterloader system. The system uses an electromechanical device to enable remote-controlled delivery of a high-activity radionuclide source to internal or surface body locations for radiation brachytherapy. The applicator consists of a vaginal cylinder and irradiation tubes (one straight, two curved) made of stainless steel and polysulfone. It is operated by trained medical personnel in a clinical setting. The device facilitates precise source positioning for brachytherapy, allowing clinicians to deliver targeted radiation doses to treat specific anatomical sites, potentially improving therapeutic outcomes while minimizing radiation exposure to staff through remote operation.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: Polysulfone (vaginal cylinder), Stainless Steel (irradiation tubes). Components: Vaginal cylinder, 3 irradiation tubes (1 straight, 2 curved). Fixation: Pivot assembly lock. Operation: Remote HDR afterloading system. Connectivity: Coupling catheter fittings.

Indications for Use

Indicated for use by trained, licensed medical personnel to provide radiation brachytherapy in patients requiring internal or surface body location radiation treatment.

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., Hilaris-Nori Endometrial Applicator (K871216)

Submission Summary (Full Text)

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Attachment 3 Page 1 of 2

NOV 2 1998

K980576

## 510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92

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

February 12, 1998 Prepared: Revised: July 24, 1998

- VariSource Endometrial Applicator for Varian VariSource™ 2. Device Name: Remote High Dose Rate Afterloader.
- 3. Predicate Device: Mick Radio-Nuclear Instruments, Inc., Hilaris-Nori Endometrial Applicator, K871216.
- 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.
- 5. 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 Endometrial Applicator which is the subject of this 510(k) is a component of the VariSource system.
- 6. Technological See attached comparison chart. Characteristics

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## Comparison to Predicate Device

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| # | Feature | MRNI Hilaris-Nori Endometrial<br>Applicator, K871216 | VariSource Endometrial<br>Applicator<br>K980576 |
|---|-------------------------------|----------------------------------------------------------------|--------------------------------------------------|
| 1 | Afterloading Method | Manual | Remote HDR |
| 2 | Coupling Catheter<br>Fittings | No | Yes |
| 3 | Vaginal Cylinder | Yes | Yes |
| | Diameter and Length | 2.5 cm X 6, 7, 8, 10, & 12 cm<br>3.0 cm X 6, 7, 8, 10, & 12 cm | 3.1 cm X 10.2 cm |
| | Material | Delrin | Polysulfone |
| 4 | Irradiation Tubes | 3: 1 straight, 2curved | 3: 1 straight, 2curved |
| | Material | Stainless steel | Stainless Steel |
| | Diameter and Length | 6 mm X 24 cm | Straight: 3 mm X 38.1 cm<br>Curved: 3 mm X 36 cm |
| | Fixation | Snap Lock | Pivot Assembly Lock |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1998

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

K980576

Re:

VariSource Endometrial Appliator for VariSource HDR Afterloader Dated: August 13, 1998 Received: August 14, 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 (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 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/cdr/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

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

Charles Seuil

Charles H. Will, Manager Requlatory Compliance & Safety

February 12, 1998 Date

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 800.92(a)(5).

K980576
510(k) Number

510(k) Number

Elvin A. Segner

Division Sign-off Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _