(71 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the interpretation as "manual or automatic interpretation," which is typical of traditional rule-based algorithms in ECG analysis, not necessarily AI/ML. The reliance on predicate devices with older technology further suggests the absence of AI/ML.
No.
The device is used to record and interpret electrocardiograms, which is a diagnostic function, not a therapeutic one. It does not treat or cure any medical condition.
Yes.
The device is used to record and interpret electrocardiograms, which involves analyzing physiological data to assist in the diagnosis of heart conditions.
No
The device description explicitly states it is a "portable, self-contained unit with an internal printer," indicating it includes hardware components beyond just software.
Based on the provided information, the Voyager 12 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Voyager 12 Function: The description clearly states that Voyager 12 records and interprets an electrocardiogram (ECG). An ECG is a measurement of the electrical activity of the heart, which is obtained directly from the patient's body using electrodes placed on the skin. This is an in vivo measurement, not an in vitro test on a sample.
Therefore, Voyager 12 falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests
- IEC 60601-1
- IEC 60601-2-25
- IEC 60601-2-51
- Validation tests
- IEC 60601-1-2
Clinical tests are not necessary since Voyager 12 uses the same technology as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
4. Description
NOV - 3 2006
P.1/2-
1
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.
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
-
- IEC 60601-2-25
-
- IEC 60601-2-51
-
- Validation tests
-
- 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.
2
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
3
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
4
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
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B. Hemmerman
Sign-Of on of Cardlovascular Devices 510(k) Number