PHOTON RADIOSURGERY SYSTEM (PRS)

K992577 · Photoelectron Corporation · JAD · Sep 23, 1999 · Radiology

Device Facts

• Record ID: K992577
• Device Name: PHOTON RADIOSURGERY SYSTEM (PRS)
• Applicant: Photoelectron Corporation
• Product Code: JAD · Radiology
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Photon Radiosurgery System is intended to be used for radiation therapy treatment. The PRS Spherical Applicators are intended to be used with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments.

Device Story

Photon Radiosurgery System (PRS) is a miniature, high-dose rate, low-energy X-ray source; emits radiation from 3 mm diameter probe tip. System includes PRS X-ray source, spherical applicators, radiation shields, and interface adapters. Used in clinical settings for intracavitary or intraoperative radiation therapy; operated by medical professionals. Spherical applicators facilitate dose delivery to tumor margins or beds; radiation shields protect surrounding healthy tissue. Interface adapters connect system to surgical support hardware. Device provides localized radiation therapy; benefits patients by enabling targeted treatment of tumors in various anatomical locations beyond intracranial sites.

Clinical Evidence

Bench testing only. Dosimetry data submitted for Spherical Applicators demonstrating uniformity of radiation dose delivered to tumor margins.

Technological Characteristics

Miniature high-dose rate, low-energy X-ray source; 3 mm diameter probe. Includes spherical applicators, radiation shields, and interface adapters for surgical support system connectivity. Operates as an X-ray radiation therapy system.

Indications for Use

Indicated for radiation therapy treatments, including intracavity or intraoperative radiotherapy to deliver prescribed doses to tumor beds or treatment margins.

Regulatory Classification

Identification

An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Nucletron-Oldelft microSelectron-HDR brachytherapy device (K953946)
• Varian VariSource Remote Afterloader for High Dose Brachytherapy (K945383)
• Intraop Medical MOBETRON System (K981112)

Submission Summary (Full Text)

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K992577

SEP 2 3 1999

## Photoelectron Corporation's Photon Radiosurgery System (PRS)

- 1. SPONSOR
Photoelectron Corporation 5 Forbes Road, Suite 2 Lexington, MA 02421-7305

| Contact Person: | Paul A. Pelletier<br>Director of Regulatory Affairs and Quality Assurance |
|-----------------|---------------------------------------------------------------------------|
| Telephone: | 781-861-2069 |

July 30, 1999 Date Prepared:

### 2. DEVICE NAME

| Proprietary Name: | Photon Radiosurgery System (PRS) |
|----------------------|--------------------------------------------------------------------------------|
| Common/Usual Name: | Miniature X-ray source with control and calibration<br>systems and accessories |
| Classification Name: | X-ray Radiation Therapy System and Accessories |

#### 3. PREDICATE DEVICES

The PRS and PRS Spherical Applicators are substantially equivalent to the following devices:

- Nucletron-Oldelft microSelectron-HDR brachytherapy device (K953946) .
- Varian VariSource Remote Afterloader for High Dose Brachytherapy (K945383) .
- Intraop Medical MOBETRON System (K981112) .

#### 6. DEVICE DESCRIPTION

The Photoelectron Corporation Photon Radiosurgery System (PRS) is a miniature, high-dose rate, low energy X-ray source that emits X-ray radiation from the tip of a 3 mm diameter probe. The original PRS Model was cleared for marketing in the 510(k) K964947. The PRS was subsequently modified and

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cleared for marketing in 510(k) K980526 (PRS400). The PRS was cleared by these 510(k)s for the irradiation of intracranial tumors.

Since the currently cleared PRS400 is restricted to treatment of intracranial tumors, Photoelectron Corporation is also proposing in this 510(k) to modify the PRS indications for use to permit use of the PRS to irradiate tumors other than at intracranial locations.

This 510(k) is also being submitted to add the use of PRS Spherical Applicators to the PRS System. The Spherical Applicators will permit the PRS to be used for intracavitary or intraoperative radiation therapy. In addition, two accessories for use with the Spherical Applicators are also being added to the PRS: the Radiation Shields, which protect surrounding tissue and/or organs from radiation, and the PRS Interface Adapters, which provide a means for connecting the PRS X-ray Source (XRS), and the Spherical Applicators to various commercially available surgical support systems for non-stereotactic applications.

#### 7. INTENDED USE

The Indications for Use for the PRS400 will be revised to read as follows:

"The Photon Radiosurgery System is intended to be used for radiation therapy treatment".

The proposed Indications for Use for the Spherical Applicators are:

"The PRS Spherical Applicators are intended to be used with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments".

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The proposed PRS intended use is substantially equivalent to commercially available brachytherapy and LINAC devices. All of the devices are intended to deliver a high radiation dose to tumors with low to minimal dose to healthy tissue. In addition, all of the devices have been used for treatment of tumors in a wide variety of anatomical locations, such as brain and breast tumors. All

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systems provide a variety of applicators to facilitate radiation treatment in the various anatomical locations.

### 7.0 TESTING

Photoelectron submitted dosimetry data on the Spherical Applicators that demonstrates the uniformity of dose delivered to tumor margins.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

Mr. Paul A. Pelletier Director of Regulatory and Quality Assurance Photoelectron Corporation 5 Forbes Road, Suite 2 Lexington, MA 02421-7305 Re:

K992577 Photelectron Radiosurgery System (PRS) Dated: July 30, 1999 Received: August 2, 1999 Product Code: 90 JAD Regulatory Class: II (two) 21 CFR 892.5900

Dear Mr. Pelletier:

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 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 redassified 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 reguirements 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 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 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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510(k) Number (if known):

K992577

Device Name: Photon Radiosurgery System (PRS)

Indications For Use:

The Photon Radiosurgery System (PRS) is indicated for radiation therapy treatments.

The PRS Spherical Applicators are indicated for use with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or turnor bed during intracavity or intraoperative radiotherapy treatments.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segmen

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 299257 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use