CARDIOMD-AC

K040616 · Danish Diagnostic Development A/S · KPS · Mar 24, 2004 · Radiology

Device Facts

• Record ID: K040616
• Device Name: CARDIOMD-AC
• Applicant: Danish Diagnostic Development A/S
• Product Code: KPS · Radiology
• Decision Date: Mar 24, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

CardioMD-AC is an attenuation and scatter correction software option for the DDD CardioMD gamma camera system (type 9CSY0799). It acquires additional data during SPECT imaging to measure gamma ray attenuation within the patient body. The system maps these measurements to generate correction images, which are then applied to emission images to compensate for varying attenuation and scatter. Used in clinical settings by trained operators (technicians/physicians) to improve image quality for diagnostic interpretation. The output provides corrected SPECT images, aiding clinicians in more accurate visualization of physiological structures and potentially improving diagnostic confidence.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Software-based attenuation and scatter correction module for DDD CardioMD gamma camera system (type 9CSY0799). Operates via acquisition of additional data during SPECT procedures to calculate and apply attenuation maps to emission images. Connectivity is integrated with the host SPECT system.

Indications for Use

Indicated for patients undergoing SPECT studies using the DDD CardioMD gamma camera system to provide attenuation and scatter correction of emission images.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 | [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. 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

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B-2 FDA Indications for Use Form

## Indications for Use Form

510(k) Number (if known): __

Device Name: CARDIOMO-AC

Indications For Use:

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.

(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)

OR

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)