MINI GAMMA CAMERA, MODEL MGC-500

K040587 · Acrorad Co., Ltd. · IYX · May 14, 2004 · Radiology

Device Facts

• Record ID: K040587
• Device Name: MINI GAMMA CAMERA, MODEL MGC-500
• Applicant: Acrorad Co., Ltd.
• Product Code: IYX · Radiology
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1100
• Device Class: Class 1

Intended Use

The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively if a protective sheath is used.

Device Story

MGC-500 is a portable nuclear medical scintillation camera; collects gamma ray emissions from administered radiopharmaceuticals; utilizes solid-state CdTe semiconductor detector instead of traditional sodium iodide crystal/photomultiplier tube; enables smaller, lighter form factor. Used in nuclear medicine and intraoperative settings; operated by clinical staff. Device converts gamma photons directly into electrical signals; hardware/software discriminators limit energy range based on radiopharmaceutical; standard image processing algorithms generate visual output for user. Output assists clinicians in visualizing radionuclide distribution for diagnostic or intraoperative guidance; benefits include improved portability and ease of use in surgical environments.

Clinical Evidence

Bench testing only. Device tested to performance standards for scintillation cameras and IEC-60601-1 electrical safety requirements. No clinical data provided.

Technological Characteristics

Solid-state CdTe semiconductor detector; converts gamma photons directly to electrical signals. Hardware/software discriminators for energy windowing. Portable form factor. Complies with IEC-60601-1 electrical safety and scintillation camera performance standards.

Indications for Use

Indicated for imaging radionuclide distribution in the human body via planar imaging techniques; may be used intraoperatively with a protective sheath. Patient population not specified.

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

• Digirad 2020 Notebook Imager (K961104)
• Neoprobe 1500/2000 radioisotope detector (K971320)

Submission Summary (Full Text)

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K040587

# 510(k) Summary

# Mini Gamma Camera MGC-500

Classification Name: Scintillation Camera 21 CFR 892.1100

> Acrorad Company, Ltd. 13-23 Suzaki Gushikawa-shi Okinawa 904-2234 JAPAN

Phone: [phone] Fax: [phone]

Contact: Mivoko Nishikawa, Prepared: March 4, 2004

## LEGALLY MARKETED PREDICATE DEVICE A.

The MGC-500 is substantially equivalent to the Digirad 2020 Notebook Imager, which was cleared by FDA on May 28, 1997 as K961104. For characteristic of intraoperative use, the MGC-500 is also the substantially equivalent to the Neoprobe 1500/2000 radioisotope detector (K971320).

#### DEVICE DESCRIPTION B.

The Mini Gamma Camera, MGC500, is a nuclear medical imager (commonly known as a scintillation or gamma camera) that is smaller, lighter and more portable than the existing gamma cameras. The MGC500 is intended for use in nuclear medicine procedures, including intraoperative procedures. To collect such information, it extracorporeally detects and visualizes the gamma ray emitted from an administered radiopharmaceutical. While previous gamma cameras have consisted of a sodium iodide scintillating crystal and photomultiplier tube (PMT), the design of the MGC-500 incorporates a solid-state CdTe semiconductor detector. This allows the device to be smaller, lighter, and more portable.

#### C. INTENDED USE

The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging The MGC-500 may also be used intraoperatively if a techniques. protective sheath is used.

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# SUBSTANTIAL EQUIVALENCE SUMMARY D.

The MGC-500 is a medical device, and it has the same indications for use The MOO on a mount as the legally marketed predicate devices. The and targer population as the onomical characteristics as the predicate MGC-300 Thas the Same toonnistics of the device are sufficiently precise that performance data are not required, but for others, performance data that performance auta are no. The performance data and descriptions in is provided in this oubmison will demonstrate that the MGC-500 is substantially equivalent1 to the predicate devices.

## TECHNOLOGICAL CHARACTERISTICS E.

The proposed and predicate devices both use a detector head that converts The proposed and prodicate al signals. The predicate device uses a photor chergy into bloosonvert gamma photon energy into visible light scirithlauing oct oryotar to our of the sensed by photo diodes and converted into electrical signals. The proposed Acrorad device converts gamma photons directly into electrical signals through use of a CdTe detector.

The electrical signals generated by the incoming gamma photons are The Clection of Signale generations. Discriminators are used in hardware proportional to onorg proposed and predicate devices to limit acceptable of soltware in both proposed of the radiopharmaceutical being used for imaging. The location of a gamma detection event is determined used for imaging. The channel of the detector, and standard image by the fissal algorithms are used to present the image to the user.

### TESTING F.

The Mini Gamma Camera MGC-500 was tested to the specifications of the The Minn Surmance Standard for scintillation cameras. It was also tested to the requirements of the IEC-60601-1 for electrical safety.

### CONCLUSIONS G.

This pre-market notification has demonstrated Substantial Equivalence as rms pro mainer stood in Sections 513(f)(1) and 513(i)(1) of the Federal delined and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in l this 510(k) is limited to the terms "oubstance in, and used by FDA in accordance with, Sections this STO(K) is limited to the trefy they they they the Federal Food, Drug, and Cosmetic Act.

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Public Health Service · ·

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2004

Acrorad Company, Ltd. % T. Whit Athey, Ph.D. Senior Consultant The Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 BROOKEVILLE MD 20833-2233

Re: K040587

Trade/Device Name: Mini Gamma Camera MGC-500 Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) Camera Regulatory Class: II Product Code: 90 IYX Dated: March 5, 2004 Received: March 5, 2004

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 such 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brigdon

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): ____________________________________________________________________________________________________________________________________________________

Mini Gamma Camera MGC-500 Device Name:

Indications For Use:

The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively 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 ﺳﮯ (Per 21 CFR 801.109)

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Over-The-Counter Use

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number.

000059