POSITRON OPTION, MODEL NSCO-050A

K983514 · Toshiba America Medical Systems, In.C · KPS · Dec 23, 1998 · Radiology

Device Facts

• Record ID: K983514
• Device Name: POSITRON OPTION, MODEL NSCO-050A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: KPS · Radiology
• Decision Date: Dec 23, 1998
• 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): Positron Imaging by Coincidence and Positron Whole Body Imaging by Coincidence.

Device Story

The Positron Kit, Model NSCO-050A, is a software reconstruction option for the GMS-5500A/UI image processor within the E.CAM dual-detector digital gamma camera system. It enables coincidence planar or SPECT imaging of positron-emitting radiopharmaceuticals (e.g., FDG) without the use of physical collimators. The system detects coincidence events and processes the data to produce images of radionuclide distribution. Used in clinical settings by trained nuclear medicine personnel, the device provides diagnostic images that assist clinicians in evaluating physiological processes. By enabling PET-type imaging on a gamma camera platform, it offers a cost-effective alternative for facilities without dedicated PET scanners, potentially improving patient access to metabolic imaging.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological similarity to the predicate device and established scientific principles of positron nuclide imaging.

Technological Characteristics

Software-based reconstruction option for dual-detector digital gamma camera systems. Enables coincidence detection for positron nuclides without physical collimators. Increases camera energy range to 560 keV. Operates as an integrated component of the GMS-5500A/UI image processor.

Indications for Use

Indicated for patients requiring detection or imaging of radionuclide distribution in the body or organ via positron imaging by coincidence or positron whole body imaging by coincidence using positron nuclides (e.g., FDG-type PET radiopharmaceuticals).

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

• Siemens E.CAM Coincidence Mode Option

Submission Summary (Full Text)

{0}------------------------------------------------

DEC 2 3 1998

# 1983516

## 510(k) Summary

| Date: | September 10, 1998 |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name:<br>Submitter's Address: | Toshiba America Medical Systems, Inc.<br>P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Donelle Krajewski, Regulatory Affairs Specialist,<br>[phone], Extension 4121 |
| Device Proprietary Name:<br>Classification Name:<br>Common Name: | Positron Kit, Model NSCO-050A<br>Emission Computed Tomography System<br>Gamma Camera Option<br>[Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] |
| Predicate Devices: | Siemens E.CAM Coincidence Mode Option |
| Reason for Submission | New option for existing product |

#### Description of this Device:

The Positron Kit, Model NSCO-050A reconstruction software option will be installed into the GMS-5500A/UI image processor, which is part of the E.CAM dual-detector digital gamma camera system.

### Summary of Intended Uses:

This Positron Kit, Model NSCO-050A, will make it possible to perform coincidence planar or SPECT studies using positron nuclides (mainly FDG-type, PET radiopharmaceuticals) without using collimators. Toshiba America Medical Systems, Inc. believes that this device is safe and effective in that it offers no new intended uses that are not in use on existing marketed devices.

#### Technological Characteristics:

This device employs the same technological characteristics as the predicate device. Both systems employ the use of software to allow positron imaging by coincidence. Positron nuclide imaging is well understood and is documented in peer reviewed scientific publications.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1998

Donelle Krajewski Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781-2068

Re: K983514

Toshiba's Positron Kit, Model NSCO-050A Dated: September 10, 1998 Received: October 7, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Krajewski:

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). 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 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 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 requlatory 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 vitto 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.gov/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

{2}------------------------------------------------

510 (k) Number (If Known):

K98 3514

#### Toshiba's Positron Kit, Model NSCO-050A Device Name:

#### Nuclear Medicine Device

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

| | | YES | NO | Energy Range<br>(keV) |
|----|------------------------------------------------------|-----|----|-----------------------------------------|
| A. | Planar Imaging | | × | |
| B. | Whole Body Imaging | | × | |
| C. | Tomographic Imaging (SPECT) for non Positron Emitter | | × | |
| D. | Positron Imaging by Coincidence | × | | Camera range<br>increases to<br>560 keV |
| E. | Positron Imaging without Coincidence | | × | |
| F. | Positron Whole Body Imaging by Coincidence | × | | Camera range<br>increases to<br>560 keV |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use