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 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.

AI/ML Overview

The Anzai eZ-Scope AN Portable Gamma Camera's 510(k) summary (K020643) does not provide a robust study detailing specific acceptance criteria and device performance in a clinical setting.
Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and general performance testing relevant to medical devices, rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy.

Here's an analysis based on the provided text, highlighting the absence of some requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The submission focuses on substantial equivalence to predicate devices (Notebook Imager, Siemens E.CAM, Neoprobe 2000 Isotope Probe) and general device safety and performance, rather than specific diagnostic accuracy metrics.

The document states:

"For most characteristics, this premarket notification will describe the characteristics of the eZ-Scope in sufficient detail to assure substantial equivalence."
"For a few characteristics, performance data are provided to assure equivalence."

The "E. TESTING" section lists the types of tests conducted:

Electrical Safety
Electromagnetic Compatibility
NEMA Performance Standard
Sample Clinical Images

However, it does not provide specific acceptance criteria (e.g., minimum sensitivity, specificity, spatial resolution thresholds) or the quantitative results of these tests that would typically be reported in a table of device performance against such criteria. The "Sample Clinical Images" would likely have been presented qualitatively to demonstrate image acquisition capabilities, but no quantitative performance metrics from these images are reported in the summary.

2. Sample Size Used for the Test Set and Data Provenance

Not available. The document mentions "Sample Clinical Images" were part of the testing, but it does not specify:

The number of images or patients (sample size) in this test set.
The country of origin of the data.
Whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not available. Since details about a specific clinical test set are absent, there is no information on how ground truth was established or the experts involved.

4. Adjudication Method for the Test Set

Not available. Without a defined clinical test set and expert review process, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention an MRMC study comparing human reader performance with and without AI assistance. The eZ-Scope is a gamma camera, not an AI-driven image interpretation tool that would typically undergo such a study.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Yes, implicitly. The performance testing on "NEMA Performance Standard" and "Sample Clinical Images" would represent a standalone (device-only) performance assessment in terms of its image acquisition capabilities, but not a standalone algorithm performance in the context of AI. The device itself is the "algorithm" that acquires the images. However, no quantitative results are provided in the summary.

7. The Type of Ground Truth Used

Not explicitly stated for the "Sample Clinical Images." For the NEMA Performance Standards, the "ground truth" would be the established physical and imaging characteristics defined by the NEMA standards themselves, where the device's output is compared to expected physical parameters. For "Sample Clinical Images," it's highly likely that the images were qualitatively assessed for their ability to depict radionuclide distribution, possibly compared with images from predicate devices or clinical expectations.

8. The Sample Size for the Training Set

Not applicable. The eZ-Scope AN Portable Gamma Camera is a hardware device for image acquisition, not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary of Device Rationale for Acceptance:

The acceptance of the Anzai eZ-Scope AN Portable Gamma Camera (K020643) was primarily based on demonstrating substantial equivalence to already legally marketed predicate devices, particularly the Digirad Notebook Imager (K961004), Siemens E.CAM (K992731), and Neoprobe 2000 Isotope Probe (K971320).

The key arguments for substantial equivalence were:

Similar Indications for Use: "The eZ-Scope is a medical device, and it has similar indications for use and target population as the legally marketed predicate devices."
Similar Technological Characteristics: "The eZ-Scope has the same technological diagnostic effect. characteristics as the predicate devices." and "The technological characteristics are the same as those of the predicate devices."
Performance Testing: While specific quantitative results are not provided, general performance testing in key areas (Electrical Safety, EMC, NEMA standards, and sample clinical images) was performed. This testing aimed to confirm that the device operates safely and performs as expected for a gamma camera, aligning with the performance of predicate devices.

The FDA's review letter (K020643) confirms this approach, stating: "We have... determined the device is substantially equivalent... to legally marketed predicate devices..." This implies that the device met the unstated "acceptance criteria" through comparison with well-established devices in the market and by passing general safety and performance tests applicable to gamma cameras. The acceptance criteria were therefore largely defined by the characteristics and performance of the specified predicate devices and relevant industry standards (like NEMA).

Summary

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

். INTENDED USE

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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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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Anzai eZ-Scope Portable Gamma Camera Device Name: ___

Indications For Use:

(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)

Over-The-Counter Use

David A. Bryson

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

Regulation Number and Section

§ 892.1100 Scintillation (gamma) camera.

(a)
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.(b)
Classification. Class I (general controls).