The use of Voyager 12 is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram and a rhythm electrocardiogram.

Device Description

Voyager 12 is a 12-lead digital electrocardiograph with interpretation of the electrocardiogram. Voyager 12 is a portable, self-contained unit with an internal printer. It permits either manual or automatic interpretation of electrocardiograms.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Del Mar Reynolds Medical Voyager 12, based on the provided text:

No clinical studies were performed for the Del Mar Reynolds Medical Voyager 12 for its 510(k) submission. The submission states: "Clinical tests are not necessary since Voyager 12 uses the same technology as the predicate device."

Therefore, many of the requested categories regarding clinical study details cannot be filled as they are not applicable to this specific submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical performance data is provided for the Voyager 12 itself, and the submission relies on substantial equivalence to predicate devices, specific acceptance criteria in terms of clinical performance metrics are not detailed in the provided text. The "acceptance criteria" here would primarily relate to meeting recognized electrical and safety standards and demonstrating technological similarity to predicate devices.

Acceptance Criteria Category	Reported Device Performance
Electrical Safety Standard	Met IEC 60601-1
Specific ECG Standard	Met IEC 60601-2-25
Specific ECG Standard	Met IEC 60601-2-51
Electromagnetic Compatibility (EMC)	Met IEC 60601-1-2
Functionality	Passed "Validation tests" (details not provided)
Clinical Performance	Not applicable; demonstrated substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set was used for the Voyager 12's 510(k) submission. The device's performance was not evaluated through a separate clinical test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. No clinical test set required ground truth establishment by experts for this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not performed. The submission explicitly states: "Clinical tests are not necessary since Voyager 12 uses the same technology as the predicate device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable in the context of a standalone clinical performance study. While the device does have automated interpretation, its performance in this regard was not tested in a standalone clinical trial for this 510(k) submission. Instead, it relies on the predicate device's established performance.

7. The Type of Ground Truth Used

Not applicable for a clinical performance study. For the non-clinical tests, the "ground truth" would be the successful adherence to the standards listed (e.g., meeting specific electrical parameters, signal quality benchmarks defined by the IEC standards).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that undergoes a training phase with a specific dataset in the way modern AI devices do. Its "interpretation" functionality likely derives from fixed algorithms or rule-based systems, or algorithms validated with prior data by the predicate device.

9. How the Ground Truth for the Training Set Was Established

Not applicable due to the reasons stated in point 8.

Summary

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K062469 Del Mar Reynolds Medical Voyager 12 Added Information Page 19

Del Mar Reynolds Medical Ltd. Special 510(k) 510(k) Summary Voyager 12

Revised October 18, 2006

1. Submitter Information

Name: Del Mar 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 201-727-1703 Fax 201-727-1708

Date Prepared: 19 October 2006

2. Name of Device

Trade Namc: Voyager 12 Common Name: 12-Lead Digital Electrocardiograph Classification name: Electrocardiograph

3. Equivalent legally-marketed devices.

Del Mar Reynolds Medical CardioDirect 121, K024283
Burdick Eclipse 4, K946281

4. Description

NOV - 3 2006

P.1/2-

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ત્ત્વનું નિર્માનના

P. 4-12.

న. Intended Use

Voyager 12 is intended to be used record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram and a rhythm electrocardiogram.

6. Performance Data

(a) Non-clinical tests
- I. IEC 60601-1
- 1. IEC 60601-2-25
- 1. IEC 60601-2-51
- 1. Validation tests
- 1. IEC 60601-1-2
(b) Clinical tests

Clinical tests are not necessary since Voyager 12 uses the same technology as the predicate

device.

Conclusions (c)

Voyager 12 is equivalent in safety and efficacy to the legally marketed predicate devices.

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Public Health Service

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 stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. Surrounding the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

Medsys, Inc. c/o Mr. George Myers President 377 Route 17 S Hasbrouck Heights, NJ

Rc: K062469

Trade Name: Voyage 12 ECG Interpretation Cart Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: October 24, 2006 Received: October 25, 2006

Dear Mr. 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 cnclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the cnactment 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.

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

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Page 2 - Mr. George Myers

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 1000-1000. 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 logally marketed predicate device results in a classification for your device and thus, permitts vor 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may althus, other general information on your responsibilities under the Act from the Division of Vouall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Blymmmer 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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K062469 Del Mar Reynolds Medical Voyager 12 Added Information Page 39

Indications for Use 510(k) Number (if known): K062469 Device Name: Voyager 12

Indications for Use:

The use of Voyager 12 is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram and a rhythm electrocardiogram,

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page / of /

(Posted November 13, 2003) Back to the Indications for Use Page

B. Hemmerman

Sign-Of on of Cardlovascular Devices 510(k) Number

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).