CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH

K013367 · Reynolds Medical , Ltd. · DPS · Dec 13, 2001 · Cardiovascular

Device Facts

• Record ID: K013367
• Device Name: CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
• Applicant: Reynolds Medical , Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Reynolds CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.

Device Story

CardioCollect is a portable, battery-powered digital electrocardiograph; used by technicians to acquire 12-lead ECGs from patients. Device features keypad for patient data entry; stores data for up to 40 patients. Output provided via direct printer connection or digital transfer to computer records. Device facilitates clinical documentation of cardiac electrical activity; assists healthcare providers in diagnostic assessment. Used in clinical settings.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing for safety and electromagnetic compatibility (ANSI/AAMI EC11, EN 60601-1-2) and a series of electrocardiograms to demonstrate tracing quality.

Technological Characteristics

Portable, rechargeable-battery-powered digital electrocardiograph. Features keypad for data entry, digital storage, and direct printer connectivity. Complies with ANSI/AAMI EC11 and EN 60601-1-2 standards.

Indications for Use

Indicated for use by technicians to acquire 12-lead ECGs from patients. No specific age or disease state contraindications provided.

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.

Predicate Devices

• Agilent M2662A (K002459)

Submission Summary (Full Text)

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K013367 p.1/2

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| DEC 1 3 2001 | Reynolds Medical Ltd<br>510(k) Submission<br>CardioCollect<br>510(k) Summary |
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### Submitter Information (1)

Name: Reynolds Medical Ltd.

Address:

1 Harforde Court John Tate Road Hertford, Herts. SG13 7NW ENGLAND

Telephone Number: 44-1992-507700

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: October 3, 2001

### (2) Name of Device

Trade Name: CardioCollect Common Name: Ambulatory electrocardiograph without analysis Classification name: Electrocardiograph (74DPS, 870.2340)

#### (3) Equivalent legally-marketed devices.

Agilent M2662A, K002459

#### Description (4)

CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a

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# Reynolds CardioCollect

printer. Typical recording time is ten seconds; all leads are recorded prince. Typical "recording" time "is "is "ifications for 12-lead electrocardiographs. It has a provision for entry of patient data using its keypad.

Records include basic data on patients (name, number, and date of birth) as well Records morade basis and these can be printed with the tracing.

### Intended Use (5)

The Reynolds CardioCollect is a small, portable rechargeable-battery-powered The Reynolds Cardroomeer is a intended to be used by technicians to aquire 12ulghal ciccitiveardiograph that is as as then print them or store them digitally in the patient's record in a computer (or both).

### Performance Data (6)

- (a) Non-clinical tests
CardioCollect has passed the tests for ANSI/AAMI EC11, electrocardiographs, CardioConcer has passed usafety) and EN 60601-1-2 (electromagnetic compatibility).

(b) Clinical tests

A series of electrocardiograms has been taken with CardioCollect to show the quality of the tracings made.

## (c) Conclusions

CardioCollect is equivalent in safety and efficacy to the legally-marketed predicate devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three overlapping profiles, suggesting a sense of community and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2001

Reynolds Medical Ltd. c/o George H. Myers, Sc.D. Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604

Re: K013367

K013507
Trade Name: CardioCollect Portable Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: October 8, 2001 Received: October 10, 2001

Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQC ) premaince is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure, to tegally manced the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue, commerce prior to May 28, 1976, the elaculient and of the Federal Food, Drug, devices that have been reclassified in accordance when as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approval applications of th and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject could registration, listing of
general controls provisions of the Act include requires misbranding and general controls provisions of the Act merade roquisitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mito crain in persuations affecting your device can
may be subject to such additional controls. Existing major regulations allection may be subject to such additional controlis. Existing mays organisan In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may
11, 2 be found in the Code of Federal Regarations on the Federal Register.

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Page 2 - George H. Myers, Sc.D.

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,

Dakota Tillah

Bram 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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Reynolds CardioCollect

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Indications for Use Form

Device Name: CardioCollect

Indications for Use:

rechargeable-battery-powered is digital CardioCollect electrocardiograph intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a to 10 patiently (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use __________ | X |
|-----------------------------|---|
| Use __________ | |
| (Per 21 CFR 810.109) | |

OR

Over-the-Counter

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number KC13367