(221 days)
Not Found
No
The description mentions "manual or automatic interpretation of electrocardiograms" and "interpretation of the electrocardiogram based on a standard personal computer," but there is no mention of AI, ML, or related terms. The performance studies section also does not describe any AI/ML specific validation.
No
The device is described as an electrocardiograph used to record and interpret electrocardiograms, which is a diagnostic function, not a therapeutic one. It does not actively treat or modify a patient's condition.
Yes
The device is described as an electrocardiograph with "interpretation of the electrocardiogram," indicating its use in analyzing and diagnosing heart conditions.
No
The device description explicitly states it includes a "special interface unit between the external connections (ECG electrodes, treadmill and blood-pressure device) and the computer," indicating hardware components beyond just software.
Based on the provided information, the CardioDirect device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "record and interpret an electrocardiogram of a patient." This involves measuring electrical activity of the heart directly from the patient's body.
- Device Description: The device description confirms it's a "12-lead digital electrocardiograph" that connects to "ECG electrodes, treadmill and blood-pressure device." These are all components used for in vivo (within a living organism) measurements.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a physiological or pathological state. The CardioDirect does not process such specimens.
Therefore, the CardioDirect is a medical device used for in vivo diagnostic purposes, specifically for electrocardiography, rather than an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes
DPS
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.
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
(a) Non-clinical tests
- AAMI EC11 tests
- Validation tests
- 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.
Key Metrics
Not Found
Predicate Device(s)
K013367, K002074, K014108, K011339
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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
-
- AAMI EC11 tests
-
- Validation tests
-
- 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.
2
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
3
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
4
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).
(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)
OR
Over-the-Counter
(Optional Format 1-2-96)
Quarta
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K020283