GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER

K031524 · Varian Medical Systems, Inc. · JAQ · Nov 26, 2003 · Radiology

Device Facts

• Record ID: K031524
• Device Name: GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GammaMedplus 3/24 is a remotely controlled afterloading brachytherapy device used to apply a radionuclide source into the body or to the surface of the body for radiation therapy. The system is designed to provide a predetermined dose of radiation to tissue and organs by means of manipulating a radioactive source from a shielded position within in the device into a catheter, applicator, or needle, which has been placed within or on a patient. The remote afterloading device must be contained in a shielded facility during extension of the radioactive source. The GammaMedplus 3/24 may optionally be configured as a transportable device.

Device Story

Remote afterloading brachytherapy system; delivers Iridium-192 radioactive source to patient via catheters, applicators, or needles. System comprises afterloading device, operator console, and optional trolley. Device houses source in shielded safe; uses motors and indexer to drive source through 5 treatment channels. Includes simulation source for pre-treatment verification of guide tubes and applicator connections. Operated by clinician in shielded facility; console controls source movement. Emergency hand crank allows manual source retraction. Provides predetermined radiation dose to tissue/organs; enables precise, remote-controlled delivery, minimizing radiation exposure to medical staff.

Clinical Evidence

Bench testing only. Evidence includes verification of source positioning accuracy (0.35% error), emergency retraction functionality, and radiation shielding performance. No clinical data presented.

Technological Characteristics

Remote afterloading brachytherapy system. Materials: stainless steel source capsule/cable, tungsten shielding. Energy: Iridium-192 radionuclide. 5 treatment channels. Features: electronic control circuit boards, battery backup, integrated Geiger-Muller area radiation monitor, emergency manual retraction crank. Connectivity: PC-based operator console. Software: GammaWin. Form factor: transportable trolley-mounted or stationary unit.

Indications for Use

Indicated for patients requiring radiation therapy via brachytherapy, where a radionuclide source is applied into or onto the body. No specific age or gender restrictions stated; contraindications not specified.

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

• GammaMed plus HDR Remote Afterloader (K983436)

Submission Summary (Full Text)

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NOV 26 2003

K031524

113

## 510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the GammaMed plus 3/24 High Dose Rate (HDR) Remote Afterloader

### 1. Submitter:

Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: [phone] [phone] Fax: Email: [e-mail] Date: September 22, 2003

### 2. Device Name:

GammaMed plus 3/24 High Dose Rate (HDR) Remote Afterloader System, Applicator, Radionuclide, Remote-Controlled Classification Name: GammaMed plus 3/24 HDR Remote afterloader Common/Usual Name: GammaMed plus 3/24 HDR Remote afterloader Proprietary Name:

### 3. Equivalent Device:

GammaMed plus HDR Remote Afterloader, K983436

### 4. Device Description:

The GammaMedplus 3/24 is a remote afterloading system used to deliver a radioactive source for use in high-dose rate brachytherapy. The Gammamed 3/24 is loaded with sources no greater than 10 curies. The GammaMedplus 3/24 differs from its predicate device in that it has only five treatment channels.

The GammaMedplus 3/24 consists of a remote afterloading device, an optional transportable trolley, and operator console. The GammaMedplus 3/24 remote afterloading device contains a radioactive source, a shielded safe in which to park the source when not in use, motors to drive the source, an indexer to determine the treatment channel for the source, position encoders for the source, electronic control circuit boards, a battery pack for backup power, and a power supply.

The radioactive material is sealed inside a stainless steel source capsule. The source capsule is attached to the source cable to form the source assembly. The source cable is also fabricated from stainless steel. The source assembly is housed inside a source tube. The source tube assembly is surrounded by tungsten metal which is used as shielding material. The radiation dose rate at a distance of one meter from the GammaMedplus 3/24 afterloading device when containing a source of the maximum activity is less than 3μGy/h.

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An electro-mechanical key lock is provided to prevent actuation of the source when the afterloading device is not in use.

The source quide tubes attach to the afterloading device by means of a special quick connector. The source may be exposed through a particular channel only if the source guide tube is properly attached to this channel. The applicators to be employed in a particular treatment are connected to the GammaMedplus indexer by way of the source quide tubes.

The afterloading device also contains a simulation ("dummy") source assembly. This simulation source assembly is identical to the actual source assembly except that it does not contain radioactive material. The simulation source makes it possible to test the condition and location of the source guide tube and the applicators and their connections before carrying out the actual treatment. The device is equipped with 5 access channels, through which the single iridium192 source can be manipulated. The source exit port can be raised or lowered into a position that is optimal in relation to the particular patient. The position of the exit port of the afterloading device can be varied from 900 millimeters (34 inches) above the floor to 1800 millimeters (51 inches) above the floor. A wide range of flexible and rigid applicators is available for a wide variety of brachytherapy techniques.

The afterloading device is equipped with an emergency hand crank to permit the emergency retraction of the source. The hand crank is a "one way" hand crank, which allows only retraction of the source. It is not possible to expose the source using this hand crank.

The afterloading device can be installed onto a trolley for transportation. The GammaMed trolley consists of a rectangular chassis with four large casters for easy movement of the equipment. It has a manually operated brake that reliably maintains its position during treatment.

- 5. Statement of Intended Use:
The GammaMedplus 3/24 is a remotely controlled afterloading brachytherapy device used to apply a radionuclide source into the body or to the surface of the body for radiation therapy. The GammaMedplus 3/24 may optionally be configured as a transportable device.

- 6. Comparison to substantially equivalent devices:

| Features / Products | | | |
|---------------------|-----------------------------------------------------------------------------|--------------------------------|--------------------------------|
| Device | | GAMMAMED plus | GAMMAMED plus 3/24 |
| | FDA clearance | K983436 | Pending |
| | Base Area | 57.5 cm x 51 cm | 57.5 cm x 51 cm |
| | Height | 105cm-145cm | 105cm-145cm |
| | Adjustable height position measured<br>in the center of the indexer | 90cm-130cm | 90cm-130cm |
| | Weight | 130kg | 130kg |
| | Transportable(USDOT-7A; Type A) | Yes | Yes |
| | Power Supply | 115 V<br>60 Hz | 115V<br>60 Hz |
| | Mobile | Yes | Yes |
| | HDR | Yes | Yes |
| | Number of Channels | 24 | 5 |
| | Features / Products | GAMMAMED plus | GAMMAMED plus 3/24 |
| Features / Products | | GAMMAMED plus | GAMMAMED plus 3/24 |
| | Shielding | Tungsten | Tungsten |
| Device:<br>Cont. | Maximum shielding activity | 555 GBq /15 ci | 555 GBq /15 ci |
| | Maximum treatment activity | 370 GBq /10 ci | 370 GBq /10 ci |
| | Maximum exposure rate at 1m.<br>distance containing the maximum<br>activity | 0.3mrm/hr<br>3 uSv/hr | 0.3mrem/hr<br>3 uSv/hr |
| | Dwell positions per each channel | 60 | 60 |
| | Area radiation monitor (integrated<br>Geiger - Muller) | Yes | Yes |
| | Device Control Software | GammaWin | GammaWin |
| | Maintained treatment data during<br>power failure (battery powered RAM) | Yes | Yes |
| | Simulator source | Yes | Yes |
| | Verification of channel length | Yes | Yes |
| | Verification of applicator connection | Yes | Yes |
| | Source positioning | Dixal to proximal | Dixal to proximal |
| | Maximum source position error over<br>treatment length | 0.35% referencing to<br>600 mm | 0.35% referencing to<br>600 mm |
| | Emergency container for the source | Yes | Yes |
| | Response to emergency signal | Automatic source<br>retraction | Automatic source<br>retraction |
| | Emergency manual retraction | Yes | Yes |
| Source | Isotope | Ir-192 | Ir-192 |
| | Maximum activity | 555 GBq /15 ci | 555 GBq /15 ci |
| | Maximum treatment activity | 370 GBq /10 ci | 370 GBq /10 ci |
| | Capsule dimensions | 4,52 x 0.9 mm | 4,52 x 0.9 mm |
| | Active dimensions | 3,5 x 0.6 mm | 3,5 x 0.6 mm |
| | Source extension length | 1300 mm | 1300 mm |
| Operator<br>Console | Operating console with Personal with<br>Personal Computer and Printer | Yes | Yes |
| | Keyswitch control | Yes | Yes |
| | Operating voltage | 24V from | 24V from |
| | | GammaMedplus | GammaMedplus 3/24 |

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# K031524

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines representing its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 2003

Mr. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K031524 Trade/Device Name: GammaMed Plus 3/24 HDR Remote Afterloader Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: September 25, 2003 Received: September 29, 2003

Dear Mr. 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. Iisting 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K031524 510(k) Number (if known): Device Name: GammaMed Model plus 3/24 HDR Remote afterloader

Indications For Use:

The GammaMedplus 3/24 is a remotely controlled afterloading brachytherapy device used to apply a radionuclide source into the body or to the surface of the body for radiation therapy. The system is designed to provide a predetermined dose of radiation to tissue and organs by means of manipulating a radioactive source from a shielded position within in the device into a catheter, applicator, or needle, which has been placed within or on a patient. The remote afterloading device must be contained in a shielded facility during extension of the radioactive source. The GammaMedplus 3/24 may optionally be configured as a transportable device.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

David R. Syrem

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

*Prescription Use*

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