CARDIOMD-AC by DANISH DIAGNOSTIC DEVELOPMENT A/S

Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.

The intended use of the CardioMD-AC Attenuation Correction option is to provide the costumer with means to measure the attenuation of gamma rays within the body of a patient, when using a DDD CardioMD gamma camera system type 9CSY0799 for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The CardioMD-AC includes additional acquisition of data for scatter correction of these images.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) letter for the CardioMD-AC device does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study proving the device meets those criteria.

The 510(k) letter is a regulatory document confirming substantial equivalence to a predicate device, allowing the CardioMD-AC to be marketed. It does not typically include:

A table of acceptance criteria and reported device performance: This type of data would be found within the 510(k) submission itself, not the FDA's decision letter.
Sample sizes, data provenance, or expert qualifications for test sets.
Details on adjudication methods.
Information about MRMC comparative effectiveness studies.
Results of standalone algorithm performance studies.
Specifics on ground truth types or how ground truth was established for training and test sets.
Training set sample sizes.

The letter primarily focuses on:

Confirming the device name and regulation details.
Stating the FDA's finding of substantial equivalence.
Outlining regulatory responsibilities for the manufacturer.
Providing the "Indications for Use" statement (on page 2 of the provided text, which states the purpose of attenuation correction and its intended use with the CardioMD gamma camera system).

To obtain the information you're looking for, you would typically need to review the full 510(k) marketing submission document, which may be publicly available through the FDA's website, though often in redacted form.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2004

3D, Danish Diagnostic Development A/S Re: K040616 % Ms. Susan Gill Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995

Trade/Device Name: CardioMD-AC Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system

Regulatory Class: II Product Code: 90 KPS Dated: March 8, 2004 Received: March 9, 2004

Dear Ms. Gill:

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	(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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Ogden

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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CardioMD AC 510(K) SUBMISSION

12 February 2004

র

Page

of I

DDD

1 PMN0543-B02

B-2 FDA Indications for Use Form

Indications for Use Form

510(k) Number (if known): __

Device Name: CARDIOMO-AC

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)

David R. Lynn

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

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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 II.