STEP OPTION TO PRISM 2000

K960865 · Philips Medical Systems (Cleveland), Inc. · KPS · Sep 20, 1996 · Radiology

Device Facts

• Record ID: K960865
• Device Name: STEP OPTION TO PRISM 2000
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The STEP Option to the Prism Dual Head system is a modification of a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions.

Device Story

Modification to Prism Dual Head gamma camera system; adds hardware and software to perform attenuation correction. Operated by trained nuclear medicine professionals in clinical settings. Input: raw gamma camera imaging data. Processing: applies STEP correction algorithm to minimize body attenuation effects. Output: corrected diagnostic images. Benefit: improved image quality by reducing attenuation artifacts; assists clinicians in diagnostic interpretation of organs and lesions.

Clinical Evidence

Bench testing only. Laboratory tests demonstrated that the STEP option minimizes degrading effects of body attenuation compared to standard gamma cameras without correction. No clinical data provided.

Technological Characteristics

Gamma camera system modification; includes hardware and software for attenuation correction. Electrical safety certified to IEC-601 or UL-544 standards.

Indications for Use

Indicated for diagnostic imaging of organs and lesions in patients undergoing nuclear medicine 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)

{0}

SEP 20 1996
K 960865

# PICKER INTERNATIONAL 510(k) NOTICE

## STEP OPTION TO THE PRISM DUAL HEAD 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 513(f)(3) for the STEP for Prism Dual Head (system).

The STEP Option to the Prism Dual Head system is a modification of a gamma camera system. 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 STEP option to the Prism Dual Head system is substantially equivalent to legally marketed devices. The STEP option will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The STEP option 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 Manual) will be provided to the user of the equipment.

Laboratory tests have shown that the STEP option has minimized the degrading effects of body attenuation when compared to a standard gamma camera without STEP correction. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the STEP option to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device.

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

-53-