(83 days)
No
The summary describes a portable gamma camera and its intended use, focusing on hardware and minor modifications for intraoperative use. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology.
No
The device is a gamma camera used for imaging and detection, not for treating diseases or conditions.
Yes
The device images the distribution of radionuclides in the human body, providing information that aids in diagnosis.
No
The device description explicitly states it is a "portable gamma camera utilizing a solid state detector" and describes hardware components like a "cadmium-zinc-tellurium detector" and a "detector array made from pixelized cadmium-zinc-telluride (CZT) crystals." This indicates it is a hardware device with associated software, not a software-only medical device.
Based on the provided text, the Anzai eZ-Scope AN Portable Gamma Camera is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "image the distribution of radionuclides in the human body using planar imaging techniques." This describes an in vivo (within a living organism) imaging procedure, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: The description details a gamma camera used for imaging, which is consistent with in vivo nuclear medicine procedures.
- Intended User/Care Setting: The mention of "intraoperatively or on pathological specimens" refers to the location or type of imaging being performed, but the core function remains imaging radionuclides within or from the human body. While pathological specimens are ex vivo, the device is still imaging the distribution of radionuclides that were introduced in vivo.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (like blood, urine, tissue) in a laboratory setting to diagnose a condition.
Therefore, the Anzai eZ-Scope AN Portable Gamma Camera is a medical imaging device used for in vivo procedures, not an IVD.
N/A
Intended Use / 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 intraoperatively or on pathological specimens if a protective sheath is used.
Product codes
90 IYX
Device Description
The Anzai EZ-Scope AN Portable Gamma Camera is a currently marketed portable gamma camera. utilizing 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 arrav is made from pixelized cadmium-zinc-telluride (CZT) crystals, with each of the 256 pixels having dimensions of 2 x 2 mm. The system is available in two configurations, eZ-Scope AN and eZ-Scope Light. 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.
The present 510(k) is for an addition to the indications for use statement (see next section) pertaining to intraoperative use. The user manual has been modified to include instructions for disinfecting the camera head and covering it with a protective plastic sheath to prevent contamination of a sterile field in case of an accidental puncture of the sheath during intraoperative use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma Camera
Anatomical Site
Human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No new performance testing was necessary for the present submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
KD22-3-2
OCT 0 9 2002
510(k) Summary
Anzai eZ-Scope AN Portable Gamma Camera
Common/Classification Name: Gamma Camera, 21 CFR 892.1110
Anzai Medical Company, Ltd. 3-6-25 Nishi-Shinaqawa Shinagawa-ku Tokvo 141-0033 Japan
Contact: T. Kaneko, Prepared: July 17, 2002
LEGALLY MARKETED PREDICATE DEVICES A.
The eZ-Scope AN Gamma Camera is substantially equivalent to the currently marketed eZ-Scope AN Gamma Camera, which was cleared by FDA on May 28, 2002 as K020643. For the new indication for use, intraoperastive use, it is also substantially equivalent to 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 currently marketed portable gamma camera. utilizing 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 arrav is made from pixelized cadmium-zinc-telluride (CZT) crystals, with each of the 256 pixels having dimensions of 2 x 2 mm. The system is available in two configurations, eZ-Scope AN and eZ-Scope Light. 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.
The present 510(k) is for an addition to the indications for use statement (see next section) pertaining to intraoperative use. The user manual has been modified to include instructions for disinfecting the camera head and covering it with a protective plastic sheath to prevent contamination of a sterile field in case of an accidental puncture of the sheath during intraoperative use.
C. INTENDED USE
The Anzai eZ-Scope Portable Gamma Camera is indicated for use to
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image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used intraoperatively or on pathological specimens if a protective sheath is used.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The eZ-Scope is a medical device, and it has the same indications for use, except for the addition of the phrase pertaining to intraoperative use, as the currently marketed version of the device. The indications for use for the Neoprobe gamma detector cover the indication for intraoperative use. The intended diagnostic effect is the same as the predicate devices. The eZ-Scope has the same (identical) technological characteristics as the currently marketed device.
E. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are the same as those of the currently marketed eZ-Scope.
F. TESTING
No new performance testing was necessary for the present submission.
G. CONCLUSIONS
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text around the perimeter appears to be the name of a department or organization. The symbol in the center consists of three curved lines that are stacked on top of each other. The logo is black and white.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
OCT 0 9 2002
Anzai Medical Company, Ltd. % T. Whit Athey, Ph.D. Senior Consultant Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 BROOKVILLE MD 20833-2233
Re: K022342
Trade/Device Name: Anzai EZ-Scope AN Portable Gamma Camera Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: 90 IYX Dated: July 17, 2002 Received: July 18, 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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Page 2
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. Snogdon
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): K 022342
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 intraoperatively or 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 V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
David G. Kappel
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
000025