E. CAM COINCIDENCE MODE (CM)

K970627 · Siemens Medical Solutions USA, Inc. · KPS · Sep 4, 1997 · Radiology

Device Facts

• Record ID: K970627
• Device Name: E. CAM COINCIDENCE MODE (CM)
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: Sep 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

Anatomical Region: All Diagnostic Uses: Imaging

Device Story

E.CAM Coincidence Mode Option is an add-on for Siemens E.CAM nuclear medicine systems. It enables positron imaging by coincidence detection, allowing the system to detect radionuclides at energy levels up to 560 keV. The device transforms radiation detection signals into tomographic images. It is used in clinical settings by trained nuclear medicine personnel. The output provides clinicians with diagnostic images of radionuclide distribution, aiding in the assessment of physiological processes and disease states. The benefit is enhanced diagnostic capability for positron-emitting isotopes using existing SPECT camera hardware.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nuclear medicine tomography system component. Enables coincidence detection for positron imaging. Increases system energy range to 560 keV. Operates as an option for the E.CAM platform.

Indications for Use

Indicated for positron imaging by coincidence and positron whole body imaging by coincidence to detect or image the distribution of radionuclides in the body or organ. Camera energy range increases to 560 keV.

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}

Siemens Medical Systems, Inc.
Nuclear Medicine Group
E.CAM Coincidence Mode Option

# SUMMARY OF SAFETY AND EFFECTIVENESS K970627

SEP - 4 1997

## General Information

**Classification Name:** System, Tomography, Computed Emission
**Product Code:** 90KPS
**Device Trade Name:** E.CAM Coincidence Mode Option
**Classification:** Class II Medical Device
**Intended Uses:**
Anatomical Region: All
Diagnostic Uses: Imaging
**Establishment Name and Address:** Siemens Medical Systems, Inc.
Nuclear Medicine Group
2501 N. Barrington Road
Hoffman Estates, Illinois 60195-7372
**Establishment Registration Number:** Owner/Operator No. 9010023
**Performance Standard:** None established under Section 514 of the Food, Drug and Cosmetic Act

## II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

**General Safety and Effectiveness Concerns:**
The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.

**Substantial Equivalence**
The Siemens E.CAM Coincidence Mode Option is a product which is substantially equivalent to legally marketed devices.

Page 179 of 179

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP - 4 1997

Paul G. Oris
Manager, Regulatory Affairs
Siemens Medical Systems, Inc.
Nuclear Medicine Group
2501 North Barrington Road
Hoffman Estates, IL 60195-5203

Re: K970627
E.CAM™ Coincidence Mode Option (CM)
Dated: June 5, 1997
Received: June 6, 1997
Regulatory class: II
21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Oris:

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 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 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 requirement, 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.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
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): K970627

Device Name: Siemens E.CAM Coincidence Mode Option

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 (keV) |
| --- | --- | --- | --- | --- |
| | | | | |
| A. | Planar Imaging | | X | |
| B. | Whole Body Imaging | | X | |
| C. | Tomographic Imaging (SPECT) for non Positron emitter | | X | |
| D. | Positron imaging by coincidence | X | | Camera range increases to 560 keV |
| E. | Positron imaging without coincidence | | X | |
| F. | Positron Whole Body Imaging by coincidence. | X | | Camera range increases to 560 keV |
| | | | | |
| | | | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Description Use ☑ (Per 21 CFR 801.109)

OR

Over-the Counter Use


(Optional Format 1-2-96)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970627