(90 days)
The Cardio Spectrum Diagnostic System intended to be used as an aid to diagnosis by means of analysis of the ECG waveform in the frequency domain (power spectral estimate).
Not Found
This FDA 510(k) clearance letter for the Cardio Spectrum Diagnostic System (K042849) does not contain the detailed information required to answer your questions about acceptance criteria, study design, and performance metrics.
The document primarily focuses on:
- Confirming the device's substantial equivalence to a predicate device.
- Stating its classification and regulation number.
- Listing general regulatory requirements for the manufacturer.
- Defining the intended use (Indications For Use).
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not include specific performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: No information on test sets or data sources (country, retrospective/prospective) is provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: The text does not mention experts, ground truth establishment, or their qualifications.
- Adjudication method: No adjudication method is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: There is no mention of an MRMC study or any comparison of human readers with and without AI assistance.
- If a standalone performance study was done: The document does not describe any standalone algorithm performance studies.
- The type of ground truth used: No ground truth type (expert consensus, pathology, outcomes data) is specified.
- The sample size for the training set: There is no information about a training set or its size.
- How the ground truth for the training set was established: This is not discussed.
To obtain this information, you would typically need to refer to the original 510(k) submission document itself, which contains the detailed technical and clinical performance data submitted by the manufacturer to the FDA. The clearance letter is a summary of the FDA's decision, not the full submission.
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Public Health Service
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JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CardioBioMedical Corporation c/o Mr. James F. Mongiardo Chief Executive Officer 2 Briar Lane Natick, MA 01760
Re: K042849
Trade Name: Cardio Spectrum Diagnostic System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 15, 2004 Received: October 15, 2004
Dear Mr. Mongiardo:
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.
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Page 2 - Mr. James F. Mongiardo
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. 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 (240) 276-0120. 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,
Bltimmo for
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042849
Device Name: Cardio Spectrum Diagnostic System
Indications For Use: The Cardio Spectrum Diagnostic System intended to be used as an aid to diagnosis by means of analysis of the ECG waveform in the frequency domain (power spectral estimate).
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blymmma
(D. on Sign-Off)
Divison of Cardlovascular Devices 510ml) Number
Page 1 of
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).