BEACON, MODEL 211060

K983948 · Philips Medical Systems (Cleveland), Inc. · KPS · Apr 16, 1999 · Radiology

Device Facts

• Record ID: K983948
• Device Name: BEACON, MODEL 211060
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

To detect or image the distribution of radionuclides in the body or organ, using the following technique(s): Tomographic imaging (SPECT) for non Positron emitter.

Device Story

Beacon-S is an add-on hardware and software system for Picker International Axis or Irix gamma cameras; provides non-uniform attenuation correction for SPECT imaging. Operates by processing radionuclide distribution data to improve image quality for diagnostic assessment of organs and lesions. Used in clinical nuclear medicine departments; operated by trained healthcare professionals. Output is viewed by physicians to assist in clinical decision-making regarding patient diagnosis. Benefits include enhanced image accuracy through attenuation correction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hardware and software add-on for gamma camera systems; supports SPECT imaging (50-550 keV). Certified to electrical safety standards IEC-601 or UL-544. Developed under ISO-9001 and FDA-OSR quality system regulations.

Indications for Use

Indicated for diagnostic imaging of organs and lesions via SPECT tomographic imaging of non-positron emitting radionuclides in patients requiring nuclear medicine diagnostic examinations.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Submission Summary (Full Text)

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# PICKER INTERNATIONAL 510(k) NOTICE

K983948

## BEACON S SYSTEM

# E: SUMMARY OF SAFETY AND EFFECTIVENESS

This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 807.92(c) for the Beacon system.

The Beacon system is a new option for non-uniform attenuation correction on the Axis or Irix gamma camera systems. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device. This device includes adding hardware and software to a gamma camera system.

Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units.

The Beacon system is substantially equivalent to legally marketed devices. Trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations will operate the system. The Beacon system will be certified to electrical safety standards (IEC-601 or UL-544) by a third party organization prior to use on human patients. Labeling (Product Bulletin and Operator's Guide) will be provided to the user of the equipment.

This device will be developed to our quality system which includes design controls. The quality standard procedure OI 2300 "Program Planning and Control System" defines how an engineering project goes from concept to closure. This procedure complies with the FDA-OSR regulation and the ISO-9001 standard.

Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the Beacon. In addition, all information contained in this 510(k) Notice is accurate and complete.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1999

Norman J. Yager Manager, OA/Regulatory Picker International, Inc. Nuclear Medicine Division 595 Miner Road Highland Heights. Ohio 44143 Re:

K983948

Beacon-S Model 211060 Dated: February 26, 1999 Received: March 1, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Yager:

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 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 vour 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 requlations,

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 requlation 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

APT 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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K983948 510(k) Number (if known): BEACON-S Device Name: ._

..............................................................................................................................................................................

### Nuclear Medicine Device

Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following tochnique(s).

| | | YES | NO | Energy Range (keV) |
|----|-------------------------------------------------------------------------|-----|------|--------------------|
| | A. Planar imaging | | X | |
| B. | Whole body imaging | | X | |
| | C. Tomographic imaging (SPECT) for non Positron emitter | X | | 50-550 |
| | D. Positron imaging by coincidence | | X | |
| E. | Po-itron imaging without coincidence | | X | |
| F. | Other indication(s) in the device label, but not included in above list | | N.A. | |

(Pliase do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

F'rescription Lise
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Formx 1-2-96)

(Division Sign-Of)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983948