EZ-SCOPE AN & EZ-SCOPE AN LITE

K020643 · Health Policy Resorters Group, LLC · IYX · May 28, 2002 · Radiology

Device Facts

• Record ID: K020643
• Device Name: EZ-SCOPE AN & EZ-SCOPE AN LITE
• Applicant: Health Policy Resorters Group, LLC
• Product Code: IYX · Radiology
• Decision Date: May 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1100
• Device Class: Class 1

Intended Use

The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used on pathological specimens if a protective sheath is used.

Device Story

Portable gamma camera for planar imaging of radionuclide distribution in human body or pathological specimens. Utilizes solid-state pixelized cadmium-zinc-telluride (CZT) detector array (256 pixels, 2x2 mm each) instead of traditional scintillators for gamma ray detection; provides energy discrimination and spatial resolution. Available in two configurations: eZ-Scope AN (desktop computer on cart) and eZ-Scope Life (laptop). Operated by healthcare professionals. System captures gamma emissions, processes data via connected computer, and displays images for clinical review. Output assists clinicians in diagnostic assessment of radionuclide distribution. Benefits include portability and improved energy/spatial resolution compared to conventional systems.

Clinical Evidence

Bench testing only. Performance testing included electrical safety, electromagnetic compatibility, NEMA performance standards, and sample clinical images.

Technological Characteristics

Solid-state detector array using pixelized cadmium-zinc-telluride (CZT) crystals; 256 pixels, 2x2 mm each. Planar imaging technique. Configurations: desktop (cart-mounted) or laptop. Connectivity via computer interface.

Indications for Use

Indicated for imaging radionuclide distribution in the human body via planar imaging techniques; may be used on pathological specimens with protective sheath. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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

• Notebook Imager (Digirad) (K961004)
• Siemens E.CAM gamma camera (K992731)
• Neoprobe 2000 Isotope Probe (based on K971320 for the Neo 1500)

Submission Summary (Full Text)

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K020643

# MAY 2 8 2002

## 510(k) Summary

# Anzai eZ-Scope AN Portable Gamma Camera

Common/Classification Name: Gamma Camera, 21 CFR 892.1100

Anzai Medical Company, Ltd. 3-6-25 Nishi-Shinagawa Shinagawa-ku Tokyo 141-0033 Japan

Contact: Masao Jimbo, Prepared: May 10, 2002

#### LEGALLY MARKETED PREDICATE DEVICES A.

The eZ-Scope AN Portable Gamma Camera is substantially equivalent to the Notebook Imager made by Digirad, which was cleared by FDA on May 28, 1997 as K961004. For some characteristics, it is also substantially equivalent to the Siemens E.CAM gamma camera (K992731) and the Neoprobe 2000 Isotope Probe (based on K971320 for the Neo 1500).

#### B. DEVICE DESCRIPTION

The Anzai eZ-Scope AN Portable Gamma Camera is a new and innovative portable gamma camera. The camera utilizes a solid state detector, rather than a scintilator, to detect gamma rays. The cadmium-zinc-tellurium detector allows sharp energy discrimination and spatial resolution.

The detector array is made from pixelized cadmium-zinc-telluride (CZT) crystals, with each of the 256 pixels having dimensions of 2 x 2 mm.

The system will be available in two configurations, eZ-Scope AN and eZ-Scope Life. These differ primarily in the computer, the former model using a desktop computer and the latter a laptop. In the desktop version, the computer is mounted on a cart, while the laptop version does not have a cart.

## ். INTENDED USE

The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used on pathological specimens if a protective sheath is used.

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### SUBSTANTIAL EQUIVALENCE SUMMARY D.

The eZ-Scope is a medical device, and it has similar indications for use and target population as the legally marketed predicate devices. However, the differences in indications for use do not affect the intended The eZ-Scope has the same technological diagnostic effect. characteristics as the predicate devices. For most characteristics, this premarket notification will describe the characteristics of the eZ-Scope in sufficient detail to assure substantial equivalence.1 For a few characteristics, performance data are provided to assure equivalence.

### TECHNOLOGICAL CHARACTERISTICS E.

The technological characteristics are the same as those of the predicate devices.

#### E. TESTING

Performance testing addressed the following issues:

- Electrical Safety; (1)
- Electromagnetic Compatibility; (2)
- NEMA Performance Standard; and (3)
- Sample Clinical Images (4)

#### CONCLUSIONS G.

This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

し The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in this 510(K) is limited to the way they are defined in, and used by FDA in accordance with, Sections 513(f)(1) and 513(i)(1) of the Federal Food, Drug, and Cosmetic Act.

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Food and Drug Administration 200 Corporate Boulevard - 1 Rockville MD 20850

T. Whit Athey, Ph.D. Senior Consultant Health Policy Resources Group 2305 Gold Mine Road BROOKVILLE MD 20833

Re: K020643

Trade/Device Name: EZ-Scope AN & EZ-Scope AN Lite Portable Gamma Camera Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: 90 IYX Dated: February 27, 2002 Received: February 27, 2002

Dear Dr. Athey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (if known): | K020643 |
|---------------------------|---------|
|---------------------------|---------|

Anzai eZ-Scope Portable Gamma Camera Device Name: ___

Indications For Use:

The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used on pathological specimens if a protective sheath is used.

(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

David A. Bryson

(Division Sign-Off Division of Reprodu and Radiological De 510(k) Number