K Number
K042849
Device Name
CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
Date Cleared
2005-01-13

(90 days)

Product Code
Regulation Number
870.1425
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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).
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary does not mention AI, ML, or related terms, and the description of the analysis method (frequency domain analysis of ECG) does not inherently imply the use of AI/ML.

No
The device is intended for diagnosis ("aid to diagnosis"), not for treating or alleviating a disease or condition.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used as an aid to diagnosis."

Unknown

The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. While the intended use describes analysis of an ECG waveform, it doesn't explicitly state that the device is solely software and doesn't include any hardware components for acquiring or processing the ECG data.

Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:

  • Intended Use: The intended use is "analysis of the ECG waveform in the frequency domain (power spectral estimate)" as an aid to diagnosis. This involves analyzing a physiological signal (electrical activity of the heart) obtained directly from the patient, not a sample of biological material taken from the patient.
  • Input: The input is an "ECG waveform," which is a direct measurement of electrical activity from the body. IVDs typically analyze biological samples like blood, urine, tissue, etc.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with IVD devices.

In summary, the Cardio Spectrum Diagnostic System analyzes a physiological signal (ECG) obtained directly from the patient's body, which is characteristic of a medical device that is not an IVD. IVDs are designed to perform tests on samples taken from the body.

N/A

Intended Use / 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).

Product codes

DQK

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

Public Health Service

Image /page/0/Picture/2 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized bird-like figure with three curved lines representing its wings or feathers.

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

2

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

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