MULTISPECT 2 511 KEV COLLIMATOR

K972360 · Siemens Medical Solutions USA, Inc. · KPS · Sep 23, 1997 · Radiology

Device Facts

• Record ID: K972360
• Device Name: MULTISPECT 2 511 KEV COLLIMATOR
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: Sep 23, 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

The MULTISPECT 2 511 keV Collimator is an accessory for nuclear medicine imaging systems. It functions as a physical component to facilitate the detection and imaging of radionuclide distribution within the body. It supports planar imaging, whole body imaging, and positron imaging without coincidence. The device is used in clinical settings by trained nuclear medicine personnel. It enables the imaging system to operate at an increased energy range up to 588 keV. By allowing the detection of specific radionuclides, it assists clinicians in visualizing physiological processes, thereby supporting diagnostic decision-making.

Clinical Evidence

No clinical data provided. The submission relies on the determination of substantial equivalence to legally marketed devices.

Technological Characteristics

The device is a collimator designed for nuclear medicine imaging systems. It functions as a physical radiation-shielding and beam-directing component. It extends the energy range of the host camera system to 588 keV. It is a mechanical accessory with no electronic or software components.

Indications for Use

Indicated for detection or imaging of radionuclide distribution in the body or organ via planar imaging, whole body imaging, and positron imaging without coincidence. Applicable to all anatomical regions.

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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K972360

Siemens Medical Systems, Inc., Nuclear Medicine Group MULTISPECT 2 511 ke V Collimator

# SUMMARY OF SAFETY AND EFFECTIVENESS June 20, 1997

| I. General Information | SEP 23 1997 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | System, Tomography, Computed Emission |
| Product Code: | 90KPS |
| Device Trade Name: | MULTISPECT 2 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 MULTISPECT 2 511keV 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

Paul G. Oris Manager, Regulatory Affairs SIEMENS Medical Systems, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195-5203 SEP 2 3 1997

Re: K972360 Siemens MULTISPECT 2 511 keV Collimator Dated: September 4, 1997 Received: September 5, 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, 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 (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 (OS) for Medical Devices: General regulation (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 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 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 question 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.

W. Hiau Yu

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

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510(k) Number (If Known): __ K 912360

Siemens MULTISPECT 2 511 Kev 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 technique(s).

| | | YES | NO | Energy Range (keV) |
|----|--------------------------------------|-----|----|--------------------------------------|
| A. | Planar Imaging | X | | |
| B. | Whole Body Imaging | X | | |
| C. | Tomographic Imaging (SPECT) for non | | X | |
| | Positron emitter | | | |
| D. | Positron imaging by coincidence | | X | |
| E. | Positron imaging without coincidence | X | | Camera range<br>increases to 588 keV |
| F. | Other | | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the Counter Use

(Optional Format 1-2-96)

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number

Siemens Medical Systems, Inc., Nuclear Medicine Group MS2 511 KeV Collimator 510(k) Submission

510(k) Submission Section 2 - Page 2