VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402

K981352 · Ge Medical Systems F.I. Haifa · KPS · Jul 13, 1998 · Radiology

Device Facts

• Record ID: K981352
• Device Name: VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Jul 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The VPC-94 collimators are designed for high-energy (511 KeV) NM imaging, with the Apex Varicam and Millennium VG Dual-Head Variable-Angle Gamma Cameras.

Device Story

VPC-94 is a high-energy (511 KeV) collimator accessory for Apex VariCam and Millennium VG dual-head variable-angle gamma cameras. Device includes two high-energy collimators and a dedicated cart. Operates by collimating high-energy photons emitted from administered positron-emitting radiopharmaceuticals within the patient body to enable nuclear medicine imaging. Used in clinical settings by nuclear medicine technologists or physicians. Provides improved resolution at comparable sensitivity relative to single-head systems by utilizing dual-detector head geometry. Output is processed by the host gamma camera system to generate diagnostic images, aiding clinicians in visualizing radiopharmaceutical distribution for diagnostic decision-making.

Clinical Evidence

Bench and clinical data provided to support substantial equivalence. No specific metrics (e.g., sensitivity, specificity) or sample sizes reported in the summary.

Technological Characteristics

High-energy (511 KeV) collimator set designed for dual-head variable-angle gamma cameras. Includes collimator cart. Mechanical accessory for radiation detection systems. No software or electronic components integral to the collimator itself.

Indications for Use

Indicated for obtaining nuclear medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body.

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

• Dyna Camera 2C 615-211 High Energy Collimator (pre-amendment)

Reference Devices

• Apex VariCam (K953801)
• Millennium VG (K953801)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "JUL 1 3 1998" on the top left corner. Below the date, the word "ELGEMS" is written in a stylized font. The letter "G" in "ELGEMS" has a circular design element incorporated into it.

ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• TEL: [phone] • FAX: [phone]

K98/352

# 9. 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))

#### Device Name

VPC-94: High Energy (511 KeV) Collimator for Dual-Head Variable-Angle Gamma Camera.

### Establishment Name and Registration Number of Submitter

ELGEMS Ltd.

Name: Registration Number: Corresponding Official:

9613299 Yair Friedman - VP, Quality and Regulatory Affairs ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL

#### Device Classification

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Nuclear Medicine 90 123 KPS Panel Identification: Classification Code: (Radiology) Class II Product Classification Class:

#### Reason for 510(k) Submission

Modification of legally marketed device.

#### Identification of Legally Marketed Equivalent Devices

Dyna Camera 2C - no K number available, pre-amendment device. The Dyna Camera 2C is a single-head gamma camera. It can be equipped with the 615-211 High Energy Collimator, having an energy range of 44 - 525 KeV.

#### Device Description

The VPC-94 high-energy (511 KeV) collimators and cart is an option for the Apex VariCam and Millennium VG gamma camera (K953801). It comprises two high-energy collimators and a collimator cart.

#### Description of Change or Modification

The VPC-94 is equivalent to the Dyna Camera 2C 615-211 apart from the VPC-94 resolution, which is better at a comparable sensitivity, since two detector heads are used for the VariCam instead of one for the Dyna 2C.

#### Intended Use of Device

The VPC-94 collimators are designed for high-energy (511 KeV) NM imaging, with the Apex Varicam and Millennium VG Dual-Head Variable-Angle Gamma Cameras.

#### Summary of Studies

Bench data and Clinical data show that the VPC-94 option achieves its intended use.

## Conclusion

In the opinion of ELGEMS Ltd., the VPC-94 is substantially equivalent to the Dyna Camera 2C 615-211 high-energy collimator. The VPC has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with three lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 3 1998

Yair Friedman VP. Quality and Regulatory Affairs Elgems Ltd. P.O. BOX 170 Tirat Hacarmel 30200 Israel

Re:

K981352

VPC-94 High Energy (511 KeV) Collimator for Dual-Head Variable-Angle Gamma Dated: April 9, 1998 Received: April 14, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Friedman:

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially econvalent (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 requirements, as set forth in the Quality System Regulation (QS) 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 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 deving 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/dsmaldsmam.html".

Sincerely yours,

Kilian Yin

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

Enclosure

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CAKNOWN K981352 510(k) Number (if known): VPC-94: High Energy (511 KeV) Collimator for Device Name: Dual-Head Variable-Angle Gamma Camera

Indications For Use:

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To obtain Nuclear Medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body.

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

( Concurrence of CDRH, Office of Device Evaluation (ODE) )

Daniel A. Skym

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 8135c 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use OR