CAIRD TECHNOLOGY HOLTER 2000

K012686 · Caird Technology · DPS · Dec 13, 2001 · Cardiovascular

Device Facts

• Record ID: K012686
• Device Name: CAIRD TECHNOLOGY HOLTER 2000
• Applicant: Caird Technology
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Designed for Adult and Pediatric Patients. For Hospital and Clinic use only. For Prescription use only. Some of the conditions for use are as follows: Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia. Evaluation of ECG documentation therapeutic intervention in individual or groups of patients. Evaluation of patients for ST segment Changes. Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery). Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death. Clinical and epidemiological research studies.

Device Story

Holter 2000 is a diagnostic electrocardiograph system; records and analyzes ECG signals to detect arrhythmias and myocardial ischemia. Used in hospitals and clinics by healthcare professionals. Device captures cardiac electrical activity; performs computerized ECG analysis to assist clinicians. Output includes ECG data and analysis reports; intended to support, not replace, physician diagnosis. Clinicians review reported data to verify accuracy before making clinical decisions. Benefits include improved detection of cardiac events and monitoring of therapeutic interventions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Electrocardiograph system; 21 CFR 870.2340; Class II; product code DPS. System performs computerized ECG analysis. Intended for hospital and clinic use.

Indications for Use

Indicated for adult and pediatric patients requiring evaluation of symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, post-MI or post-cardiac surgery recovery, or assessment of sudden death risk. For hospital and clinic use by prescription only.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 3 2001

Mr. James H. Brown Caird Technology, Inc. 205 Camden Chase Columbia, SC 29223

Re: K012686

Trade Name: Caird Technology Holter 2000 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: November 17, 2001 Received: November 21, 2001

Dear Mr. Brown:

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 H. Brown

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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). 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,

N. Oa. Telle

am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012686 510(k) Number:

DEC 1 3 2001 Holter 2000 Device Name:

Indications for use:

- · Designed for Adult and Pediatric Patients.
- · For Hospital and Clinic use only.
- · For Prescription use only.

Some of the conditions for use are as follows:

- Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia. .
- Evaluation of ECG documentation therapeutic intervention in individual or groups of patients. .
- Evaluation of patients for ST segment Changes t
- . Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).
- Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death. .
- Clinical and epidemiological research studies. ●

Precaution:

Computerized ECG Analysis should not replace diagnosis by a qualified physician. The physician should verify that the reported data is accurate before applying clinical conclusions.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Confidential

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

l'age 2 of 3

Caird Technology Inc. 205 Camden Chuse Columbia, S.C. 29223

Deddy Tudd