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 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.

AI/ML Overview

The provided 510(k) summary for the CardioDirect device does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the study proving the device meets those criteria. The summary explicitly states that clinical tests were not necessary because the CardioDirect uses the same technology as the predicate device.

Therefore, the device's equivalence was established through non-clinical tests (AAMI EC11, validation tests, ISO 60601-1, ISO 60601-1-2) compared to a predicate device, rather than a standalone clinical study with specific acceptance criteria as you've outlined.

Below is a breakdown of the information that can be extracted or deduced from the provided document, along with explanations for the missing information.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
No specific quantitative acceptance criteria related to clinical performance are listed in the provided document. The primary acceptance criteria were likely related to compliance with AAMI EC11 tests, general validation tests, ISO 60601-1, and ISO 60601-1-2 for electrical safety and performance, as the device was deemed "equivalent in safety and efficacy to the legally marketed predicate devices."	The device was found to be "equivalent in safety and efficacy to the legally marketed predicate devices" based on compliance with AAMI EC11 tests, general validation tests, and ISO 60601-1, ISO 60601-1-2.

Acceptance Criteria

Reported Device Performance

No specific quantitative acceptance criteria related to clinical performance are listed in the provided document. The primary acceptance criteria were likely related to compliance with AAMI EC11 tests, general validation tests, ISO 60601-1, and ISO 60601-1-2 for electrical safety and performance, as the device was deemed "equivalent in safety and efficacy to the legally marketed predicate devices."

The device was found to be "equivalent in safety and efficacy to the legally marketed predicate devices" based on compliance with AAMI EC11 tests, general validation tests, and ISO 60601-1, ISO 60601-1-2.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The summary explicitly states, "Clinical tests are not necessary since CardioDirect uses the same technology as the predicate device." Therefore, there was no clinical test set for performance evaluation in the way typically required for new clinical claims. The evaluation was based on demonstrating equivalence to predicate devices through technical standards compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As no clinical test set requiring ground truth establishment was conducted for the CardioDirect device itself, this information is not available.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No: The document does not mention any MRMC study. This device is an electrocardiograph with automatic interpretation, but the clearance was based on equivalence to predicate devices, not on a human-AI comparative effectiveness study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No (in the context of clinical performance): While the device has "automatic interpretation," its standalone clinical performance (algorithm only) was not evaluated through a separate study for this 510(k) clearance. The clearance was based on technical standards and equivalence.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: No clinical test set for performance evaluation.
The sample size for the training set
- Not Applicable / Not Provided: As "clinical tests are not necessary," and the device uses existing technology, there is no mention of a new training set or its size for the CardioDirect device in this submission. The "automatic interpretation" likely relies on algorithms common to the predicate devices, which would have been developed and validated previously.
How the ground truth for the training set was established
- Not Applicable / Not Provided: For the same reasons as #7, this information is not available in the provided summary.

Summary

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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 201-727-1703 Fax 201-727-1708

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.

6. Performance Data

(a) Non-clinical tests
- 1. AAMI EC11 tests
- 1. Validation tests
- 1. 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.

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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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use

(Per 21 CFR 810.109)

Over-the-Counter

(Optional Format 1-2-96)

Quarta

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K020283

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).