The Mini Gamma Camera MGC500-101U and MGC500-301U are indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC500-101U and MGC500-301U may also be used intraoperatively if a protective sheath is used.

Device Description

The Mini Gamma Camera MGC500-101U and MGC500-301U , are nuclear medical imagers (commonly known as a scintillation or gamma camera) that are smaller, lighter and more portable than most existing gamma cameras. The MGC500-101U and MGC500-301U are 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 MGC500-101U and MGC500-301U incorporate solid-state CdTe semiconductor detectors. This allows the device to be smaller, lighter, and more portable. Both of the modified models have a new high-uniformity mode and the Model MGC500-301U has been reconfigured into a more compact design.

AI/ML Overview

The provided 510(k) summary for the Mini Gamma Camera MGC500-101U and MGC500-301U does not contain specific acceptance criteria or an explicit study that proves the device meets such criteria in terms of a quantifiable performance metric (e.g., sensitivity, specificity, accuracy) compared to a gold standard or a statistically significant improvement over a predicate.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (MGC500, K040587). This typically means showing that the new device has the same intended use, the same technological characteristics, and raises no new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing your points where possible:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical metrics (e.g., diagnostic accuracy, sensitivity, specificity). The primary "acceptance criteria" here is substantial equivalence to the predicate device, meaning it performs similarly and safely for its intended use.

However, the submission mentions compliance with performance standards and safety regulations:

Acceptance Criteria Category	Reported Device Performance
Performance Standard Compliance	Tested to the specifications of the NEMA Performance Standard for scintillation cameras.
Electrical Safety Compliance	Tested to the requirements of the IEC-60601-1 for electrical safety.
Technological Equivalence	Uses a detector head with CdTe detectors, similar to the predicate, with unchanged technological characteristics.
Intended Use Equivalence	Same indications for use as the legally marketed predicate device.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a sample size for a test set in the context of clinical performance evaluation (e.g., number of patients or images).
- The testing primarily involved compliance with industry standards (NEMA, IEC) and verification/validation activities, not a clinical study on a patient cohort.
- Data provenance is not directly relevant here as it's not a clinical performance study with patient data.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. There is no mention of a test set with ground truth established by experts for diagnostic performance evaluation. The device's performance was assessed against engineering and imaging standards, not clinical diagnostic accuracy.
Adjudication Method for the Test Set:
- Not applicable. There was no clinical test set requiring adjudication of ground truth.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted or reported in this submission. This type of study would typically be used to assess the impact of an AI algorithm on human reader performance, which is not the focus of this 510(k).
Standalone (Algorithm Only) Performance Study:
- Yes, implicitly. The device itself is a standalone imaging system. Its performance was evaluated against NEMA and IEC standards directly, without human-in-the-loop performance being a specific endpoint. The "device performance" in this context refers to its ability to acquire and process gamma ray emissions according to established technical specifications.
Type of Ground Truth Used:
- For the NEMA and IEC standards testing, the "ground truth" would be the defined technical specifications and measurement protocols of those standards. For example, spatial resolution might be measured against a known phantom with precisely defined features. It's an engineering/physical ground truth, not a clinical outcome or pathology.
Sample Size for the Training Set:
- Not applicable. This device is a hardware imaging system, not an AI algorithm that requires a training set in the conventional machine learning sense. The "training" for such a device would involve engineering design, calibration, and manufacturing processes.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as point 7.

Summary of Approach in the 510(k):

This 510(k) submission leverages the concept of substantial equivalence. The manufacturer argues that the modified Mini Gamma Camera (MGC500-101U and MGC500-301U) is sufficiently similar to its predicate device (MGC500) that extensive new clinical performance trials are not necessary. The changes primarily involve a "new high-uniformity mode" and a more compact design for one model. The technological characteristics (CdTe detectors, signal processing) are stated to be unchanged from the original version.

To support substantial equivalence, the submission relies on:

Comparison of intended use and technological characteristics to the predicate device.
Compliance with recognized electrical safety (IEC-60601-1) and performance standards (NEMA) for scintillation cameras. These standards define how imaging devices should perform in terms of attributes like spatial resolution, sensitivity, uniformity, etc., under controlled conditions. The "testing" mentioned is likely the verification that the device meets these established technical standards, rather than proving a specific diagnostic accuracy in a clinical setting.
Internal verification/validation activities carried out under the manufacturer's quality system.

Summary

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K043293

DEC 17 2004

510(k) Summary

Mini Gamma Camera MGC500-101U and MGC500-301U

Classification Name: Scintillation Camera 21 CFR 892.1100

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

Phone: (+081) 98-934-8960 Fax: (+081) 98-934-8961

Contact: Atsushi Kyan, Prepared: November 29, 2004

LEGALLY MARKETED PREDICATE DEVICE A.

The Mini Gamma Camera Models MGC500-101U and MGC500-301U are substantially equivalent to the currently marketed MGC500 (K040587).

B. DEVICE DESCRIPTION

Both of the modified models have a new high-uniformity mode and the Model MGC500-301U has been reconfigured into a more compact design.

C. INTENDED USE

The Mini Gamma Camera MGC500-101U and MGC500-301U are indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC500-101U and MGC500

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301U may also be used intraoperatively if a protective sheath is used.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The MGC-500-101U and MGC500-301U are medical devices, and they have the same indications for use and target population as the legally marketed predicate device. The MGC-500-101U and MGC500-301U have the same technological characteristics as the predicate device. Many of the characteristics of the device are sufficiently precise that performance data are not required, but for others, performance data were collected. The verification/validation activities carried out under Acrorad's procedures for medical device development and modification ensure that the new versions of the device are substantially equivalent to the currently marketed version of the device.

TECHNOLOGICAL CHARACTERISTICS ய்

The proposed and predicate devices both use a detector head with CdTe detectors that convert photon energy into electrical signals. The electrical signals generated by the incoming gamma photons are proportional to energy of the photons. Discriminators are used in hardware or software in both proposed and predicate devices to limit acceptable detection events to the gamma energy of the radiopharmaceutical being used for imaging. The location of a gamma detection event is determined by the location of the channel of the detector, and standard image processing algorithms are used to present the image to the user. These technological characteristics are unchanged from the original version of the device.

TESTING ட்

The Mini Gamma Camera MGC500-101U and MGC500-301U were tested to the specifications of the NEMA Performance 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 1110 pro marked 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.

The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in 1 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(l)(1) of the Federal Food, Drug, and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines extending from its body, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

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

Re: K043293 Trade/Device Name: Mini Gamma Camera MGC500-101U and MGC500-301U Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: II Product Code: 90 KPS Dated: November 29, 2004 Received: November 29, 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 (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 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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/dsmadsmam.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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Indications for Use

510(k) Number (if known):	K043293
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Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Mini Gamma Camera MGC500-101U and MGC500-301U are indicated for use in imaging the distribution of radionuclides in the human body using planer imaging tinaging and The MGC500-101U and MGC500-301U may also be used intraoperatively if a protective sheath is used.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Leyman

(Division Sign-Off Division of Reproductive and Radiological Devic 510(k) Number

Page 1 of 1

000030

Regulation Number and Section

N/A