CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)

K042849 · Cardiobiomedical Corporation · DQK · Jan 13, 2005 · Cardiovascular

Device Facts

• Record ID: K042849
• Device Name: CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
• Applicant: Cardiobiomedical Corporation
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 Story

Cardio Spectrum Diagnostic System performs frequency domain analysis of ECG waveforms; computes power spectral estimates to aid clinical diagnosis. Used in clinical settings by healthcare professionals to interpret cardiac electrical activity. Device processes raw ECG signals to generate spectral data; output assists clinicians in evaluating cardiac conditions. Benefits include enhanced diagnostic insight through frequency-based signal characterization.

Clinical Evidence

No clinical data provided; document contains only regulatory clearance information.

Technological Characteristics

Programmable diagnostic computer; performs frequency domain analysis (power spectral estimate) of ECG waveforms. Operates as a software-based diagnostic tool for signal processing.

Indications for Use

Indicated for use as an aid to diagnosis via ECG waveform analysis in the frequency domain (power spectral estimate).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [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,

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

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