C-PET PLUS IMAGING SYSTEM

K042839 · Philips Medical Systems (Cleveland), Inc. · KPS · Oct 29, 2004 · Radiology

Device Facts

• Record ID: K042839
• Device Name: C-PET PLUS IMAGING SYSTEM
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: Oct 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

Device Story

C-PET Plus Imaging System is a nuclear medical imaging device for fixed or mobile clinical environments. It acquires, processes, and displays PET images of radioisotope distribution in the head and body. Operated by medical personnel, the system transforms detected radiation signals into attenuation and non-attenuation corrected images. These images are reviewed by clinicians to assist in diagnostic interpretation. The device benefits patients by providing anatomical distribution data of radioisotopes for clinical assessment.

Clinical Evidence

Bench testing only. Device performance measured in accordance with NEMA NU-2 standards. Electrical and mechanical safety verified via adherence to IEC 60601-1 series standards.

Technological Characteristics

Positron Emission Tomography (PET) system. Fixed or mobile form factor. Compliant with NEMA NU-2 performance standards and IEC 60601-1 electrical/mechanical safety standards. Software-based image reconstruction and NEMA NU-2 calculation.

Indications for Use

Indicated for use as a PET imaging system to produce attenuation and non-attenuation corrected images of single photon and positron emitting radioisotopes within the head, body, or total body for interpretation by medical personnel.

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.

Predicate Devices

• Sentry Imaging System (K973396)
• Allegro Imaging System (K033782)

Submission Summary (Full Text)

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OCT 2 9 2004

K042839

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### General Information

- Submitter/ Contact Person: A.

| Philips Medical Systems (Cleveland), Inc.<br>595 Miner Rd.<br>Cleveland, OH 44143 | | | | Rae Ann Farrow |
|-----------------------------------------------------------------------------------|----------------------|--------------------------------------------------|------|------------------------------------------------|
| | | | Tel: | [phone] |
| | | | Fax: | [phone] |
| B. | Device Trade Name: | C- PET Plus Imaging System | | |
| | Common Name: | Positron Emission Tomography | | |
| | Classification Name: | System, Emission Computed Tomography, (892.1200) | | |
| | Device Class: | 21CFR 892.1200, Class II | | |
| | Product Code: | 90 KPS | | |
| C. | Date prepared: | August 20, 2004 | | |
| D. | Predicate Device: | Sentry Imaging System<br>Allegro Imaging System | | (K973396, 01/21/1998)<br>(K033782, 12/19/2003) |

- E. Performance Standards: NEMA NU-2
#### F. Intended Use:

The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

#### G. Device Description:

The C-PET Plus Imaging System is a Positron Emission Tomography (PET) system, a nuclear medical imaging system with capabilities to acquire, process, and display clinical images that can be utilized in both conventional, fixed installations or mobile environments. It is intended to produce attenuation and non-attenuation corrected images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the head, body, or total body for interpretation by medical personnel.

#### H. System Performance Test/ Summary of Studies:

To minimize electrical, mechanical and radiation hazards, Philips Medical Systems, Inc. adheres to recognized and established industry practice. Electrical and mechanical safety is assured by adherence and certification to the applicable standards in the IEC 60601-1 series. The device performance was measured in accordance with NEMA-NU2 standard.

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#### I. Comparison to Predicate Device

The C-PET Plus Imaging System software is an evolution of the features and functionalities of the Sentry (K973396, 01/21/1998). Design modifications include enhancements in image reconstruction and NEMA NU 2 calculation software. Similarities and differences between the device and its predicates are described within the 510(k) submission. In conclusion, the device is substantially equivalent to the predicate devices based upon similar intended use, technological comparison, and system performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

OCT 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems (Cleveland), Inc. c/o Ms. Denise Klinker Program Reviewer Underwriters Laboratories Inc.® 1655 Scott Blvd. SANTA CLARA CA 95050

Re: K042839

Trade/Device Name: C-PET Plus Imaging System Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: October 11, 2004 Received: October 14, 2004

Dear Ms. Klinker:

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 as host 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 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 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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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. I rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Not Known

510(k) Number (if known): ~~Not Known~~ K042839

Device Name: C-PET Plus

Indications for Use.

The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

## Prescription Use ✓ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Hogdon

vision Sian-Off) ision of Reproductive, Abdomi I Radiological Devices . O(k) Number _

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