E.CAM EXTRA HIGH ENERGY COLLIMATOR

K982387 · Siemens Medical Solutions USA, Inc. · KPS · Oct 6, 1998 · Radiology

Device Facts

• Record ID: K982387
• Device Name: E.CAM EXTRA HIGH ENERGY COLLIMATOR
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: Oct 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

Anatomical Region: All Diagnostic Uses: Imaging

Device Story

The E.CAM Extra High Energy Collimator is a hardware component for nuclear medicine imaging systems. It functions as a physical radiation filter/collimator attached to a gamma camera to restrict the angle of incident gamma rays, enabling spatial localization of radionuclide emissions. It supports planar, whole-body, and non-coincidence positron imaging. The device is used in clinical nuclear medicine departments by trained technologists or physicians. The output is a projection image of radionuclide distribution, which clinicians use to diagnose physiological or anatomical abnormalities. It provides diagnostic imaging benefits by allowing the visualization of specific radiopharmaceutical uptake in patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extra high energy collimator for gamma camera systems. Designed for imaging radionuclides up to 588 keV. Mechanical component; no software or electronic sensing elements.

Indications for Use

Indicated for detecting or imaging the distribution of radionuclides in the body or organ using planar imaging, whole body imaging, and positron imaging without coincidence (up to 588 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)

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Redical Systems, Inc., Nuclear Medicine Group E.CAM Extra High Energy Collimator

OCT

K982387

## SUMMARY OF SAFETY AND EFFECTIVENESS July 8, 1998

| I. General Information | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | System, Tomography, Computed Emission |
| Product Code: | 90KPS |
| Device Trade Name: | E.CAM 511keV Collimator |
| Classification: | Class II Medical Device |
| Intended Uses: | Anatomical Region: All<br>Diagnostic Uses: Imaging |
| Establishment Name and Address: | Siemens Medical Systems, Inc.<br>Nuclear Medicine Group<br>2501 N. Barrington Road<br>Hoffman Estates, Illinois 60195-7372 |
| Establishment Registration Number: | Owner/Operator No. 9010023 |
| Performance Standard: | None established under Section 514 of the<br>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 Extra High Energy Collimator is a product which is substantially equivalent to legally marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 1998

Andrea DiSani Regulatory Affairs Associate Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-7372 Re:

K982387

E.CAM Extra High Energy Collimator Dated: July 8, 1998 Received: July 9, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. DiSani:

We have reviewed your Section \$10(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 Beckeral Food, Drug, and Cosmetion of Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing gractice, 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 ecuivalience compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices of cenerative (21 CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Rederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 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 viro 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.ida.govedrividsmaldsmamain.html".

Sincerely yours,

Lillian Yip, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Siemens Medical Systems, Inc., Nuclear Medicine Group E.CAM Extra High Energy Collimator

ﺎ

510(k) Number (If known): K982387

Siemens E.CAM Extra High Energy Collimator Option Device Name:

## Nuclear Medicine Device

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

| | | YES | NO | Energy Range (keV) |
|----|---------------------------------------------------------|-----|----|--------------------------------------|
| | | | | |
| A. | Planar Imaging | X | | |
| B. | Whole Body Imaging | X | | |
| C. | Tomographic Imaging (SPECT) for non<br>Positron emitter | | X | |
| D. | Positron imaging by coincidence | | X | |
| E. | Positron imaging with out coincidence | X | | Camera range increases<br>to 588 keV |
| | | | | |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use_ (per 21 CFR 801.109)

OR

Over-the counter Use

(Optional Format 1-2-96)

David L. Severson

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(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number

510(k) Submission Section 1 - Page 2