CARDIODIRECT, MODELS 12M, 12I, 12S

K024283 · Reynolds Medical , Ltd. · DPS · Aug 1, 2003 · Cardiovascular

Device Facts

• Record ID: K024283
• Device Name: CARDIODIRECT, MODELS 12M, 12I, 12S
• Applicant: Reynolds Medical , Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The use of CardioDirect is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram, a rhythm electrocardiogram, or a stress electrocardiogram (such as might be taken during an exercise stress test).

Device Story

CardioDirect is a 12-lead digital electrocardiograph system based on a standard personal computer. It utilizes a specialized interface unit to connect external ECG electrodes, treadmills, and blood-pressure devices to the computer. The system captures cardiac electrical signals and provides both manual and automatic interpretation of the ECG data. It is intended for use in clinical settings for resting, rhythm, and exercise stress testing. Healthcare providers use the interpreted output to assist in cardiac assessment and clinical decision-making. The device benefits patients by facilitating diagnostic cardiac monitoring and stress testing.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including AAMI EC11 compliance, validation testing, and adherence to ISO 60601-1 and ISO 60601-1-2 safety standards.

Technological Characteristics

12-lead digital electrocardiograph; PC-based architecture with specialized interface unit for ECG electrodes, treadmill, and blood-pressure device connectivity. Complies with AAMI EC11, ISO 60601-1, and ISO 60601-1-2 standards.

Indications for Use

Indicated for patients requiring resting, rhythm, or stress electrocardiogram recording and interpretation.

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

• Reynolds CardioCollect (K013367)
• H&C Cardiette (K002074)
• GE Mac 5000 (K014108)
• Spacelabs Burdick Quest Exercise Stress System (K011339)

Submission Summary (Full Text)

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## K024283 510(k) Summary

## CardioDirect

### November 19, 2002

### 1. Submitter Information

Name: Reynolds Medical Ltd.

Address:

l 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: December 11, 2002

### 2. Name of Device

Trade Name: CardioDirect 12-Lead Digital Electrocardiograph Common Name: Classification name: Electrocardiograph

### 3. Equivalent legally-marketed devices.

- ロ Reynolds CardioCollect, K013367
- H&C Cardiette, K002074
- GE Mac 5000, K014108
- 0 Spacelabs Burdick Quest Exercise Stress System, K011339 This system also includes automatic interpretation.

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K024283

## K024283 510(k) Summary

Page 2 of 2

### 4. Description

CardioDirect is a 12-lead digital electrocardiograph with interpretation of the electrocardiogram based on a standard personal computer. It can also be used for a stress test if purchased with the proper interfaces. CardioDirect, when used as an . electrocardiograph, has a special interface unit between the external connections (ECG electrodes, treadmill and blood-pressure device) and the computer. It permits either manual or automatic interpretation of electrocardiograms.

### Intended Use ട.

The use of CardioDirect is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram, a rhythm electrocardiogram, or a stress electrocardiogram (such as might be taken during an exercise stress test).

### 6. Performance Data

- (a) Non-clinical tests
- 1. AAMI EC11 tests
- 2. Validation tests
- 3. ISO 60601-1, ISO 60601-1-2
- (b) Clinical tests

Clinical tests are not necessary since CardioDirect uses the same technology as the

predicate device.

- (c) Conclusions
CardioDirect is equivalent in safety and efficacy to the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K024283

> Trade Name: CardioDirect Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: May 2, 2003 Received: May 5, 2003

Dear Dr. Myers:

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.

AUG = 1 2003

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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), 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 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,

W. Rees-Mogg, MP

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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Reynolds CardioCollect

Page 2011 - of of 1

Ko24283 510(k) Number (if known):

Indications for Use Form

Device Name: CardioDirect

Indications for Use:

The use of CardioDirect is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram, a rhythm electrocardiogram, or a stress electrocardiogram (such as might be taken during an exercise stress test).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
Use

(Per 21 CFR 810.109)

OR

Over-the-Counter

(Optional Format 1-2-96)

Quarta

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K020283