(15 days)
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No
The summary describes a standard attenuation correction method for SPECT imaging and does not mention AI, ML, or any related concepts.
No
The device is described as an "Attenuation Correction option" for a gamma camera system, used to measure and map attenuation for SPECT studies, which implies it's a diagnostic imaging accessory rather than a device that treats a disease or condition.
No
The device is described as an "Attenuation Correction option" for a gamma camera system used in SPECT studies. Its purpose is to measure and map the attenuation of gamma rays and compensate emission images for this attenuation, including scatter correction. It processes imaging data but does not appear to directly provide a diagnostic interpretation of medical conditions or diseases. Instead, it aids in improving the quality and accuracy of the images used for diagnosis, making it an image processing or image enhancement tool rather than a diagnostic one itself.
No
The summary describes an "Attenuation Correction option" for a "DDD CardioMD gamma camera system type 9CSY0799". This strongly implies the device is an add-on or feature for existing hardware (the gamma camera system), not a standalone software-only device. The description focuses on the function within the context of the hardware system.
Based on the provided text, the device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is used to "measure the attenuation of gamma rays within the body of a patient" and "map the measured attenuation into images that can be used to compensate emission images for the attenuation." This process involves analyzing data from the patient (the gamma rays) to provide information about their internal state (attenuation).
- Function: The core function is to correct SPECT images based on measurements taken from the patient. This is a diagnostic process, as it aims to improve the accuracy of the images used for diagnosis.
- Context: Attenuation correction in SPECT is a standard technique used in nuclear medicine for diagnostic imaging.
While the text doesn't explicitly use the term "In Vitro Diagnostic," the description of its function and intended use aligns with the definition of an IVD, which involves examining specimens or data derived from the human body to provide information for diagnostic purposes. In this case, the "specimen" is the gamma ray data emitted from the patient.
N/A
Intended Use / 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.
Product codes
90 KPS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
SPECT
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by flowing lines, facing to the right. The figures are stacked on top of each other, creating a sense of unity and collaboration.
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.
1
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
2
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:
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)