(31 days)
No
The summary describes a data compression system and standard electrical and software validation, with no mention of AI or ML.
No
The device is a Holter recorder, which is used for diagnostic purposes (recording ECG data), not for direct treatment or therapy.
Yes
The device is a Holter recorder, which records a patient's ambulatory electrocardiogram (ECG). ECGs are used to diagnose heart conditions by monitoring electrical activity of the heart. Therefore, the device serves a diagnostic purpose.
No
The device description explicitly states it is a "portable Holter recorder" and mentions hardware components like a "flashcard and battery," indicating it is a physical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Reynolds Lifecard CF 7-Day Holter recorder records the patient's ambulatory electrocardiogram (ECG). This is a measurement of the electrical activity of the heart, taken from the body (in vivo).
- Intended Use: The intended use is to record the patient's ECG, not to analyze samples taken from the body.
Therefore, based on the provided information, the device is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Lifecard CF is a portable Holter recorder intended to record the patient's ambulatory electrocardiogram for up to seven days (with the appropriate flashcard and announatory clectrocardiograms can then be analyzed by Holter analyzers. The unit does no analysis.
The Reynolds Lifecard CF 7-Day Holter recorder is a modification of the Reynolds Lifecard CF Holter Recorder, K001025. It is indicated when it is desired to record the patient's ambulatory electrocardiogram.
It is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven days.
Product codes
MWJ
Device Description
The device is a portable Holter recorder designed to record the patient's ambulatory The device is a portable frecer days (with the appropriate flashcard and battery).
The unit uses a data compression system to store seven days of ECG data in extended mode. In "standard" mode (up to two days of recording) the unit is identical to the predicate device.
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
Non-clinical tests: The Lifecard CF 7-Day Holter recorder meets the requirements of AAMI EC38, IEC 601-1 and IEC 601-1-2. The software has undergone extensive validation testing. The compression algorithm has been separately tested.
Clinical tests: None required.
Conclusions: The Lifecard CF 7-Day Holter recorder is equivalent in safety and efficacy to the legally-marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Summary
Page A 2
JUL 1 3 2001
Reynolds Medical Ltd. Special 510(k) Lifecard CF 7-Day Holter Recorder
510(k) Summary
(1) Submitter Information
Name: Reynolds Medical Ltd.
Address:
1 Harforde Court John Tate Court 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: June 8th, 2001
(2) Name of Device
Trade Name: Lifecard CF 7-Day Holter recorder Common Name: Holter Recorder. Common Name: Recorder, Magnetic Tape, Medical (please note that this device does not use magnetic tape)
(3) Equivalent legally-marketed device.
Reynolds Lifecard CF Holter recorder, K001025
(4) Description
The device is a portable Holter recorder designed to record the patient's ambulatory The device is a portable frecer days (with the appropriate flashcard and battery). The
1
use of the modified device as described in its labeling has not changed. The fundamental science technology of the device has not changed.
The unit uses a data compression system to store seven days of ECG data in extended mode. In "standard" mode (up to two days of recording) the unit is identical to the predicate device.
(5) Intended Use
The Lifecard CF is a portable Holter recorder intended to record the patient's ambulatory electrocardiogram for up to seven days (with the appropriate flashcard and announatory clectrocardiograms can then be analyzed by Holter analyzers. The unit does no analysis.
(6) Performance Data
(a) Non-clinical tests
The Lifecard CF 7-Day Holter recorder meets the requirements of AAMI EC38, IEC 601-1 and IEC 601-1-2.
The software has undergone extensive validation testing. The compression algorithm has been separately tested.
(b) Clinical tests
None required.
(c) Conclusions
The Lifecard CF 7-Day Holter recorder is equivalent in safety and efficacy to the legally-marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2001
Reynolds Medical, Ltd. George H. Myers, Sc.D. Designated Agent c/o Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K011837
Trade Name: LifeCard CF 7-day Holter Recorder Regulation Number: 870.2800 Regulatory Class: II (Two) Product Code: MWJ Dated: June 7, 2001 Received: June 12, 2001
Dear Dr. Myers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have
3
Page 2 - George H. Myers, Sc.D.
under sections 531 through 542 of the Act for devices under the Electronic Product Radiation i Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication. The I Drivening sification 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 and 11 you dealer openits arrivitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, (2017) 591-1010. Tradition for at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your copy 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,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Page 2
Page 1 1837 510(k) Number (if known):
Indications for Use Form
Device Name: Lifecard CF 7-Day Holter recorder
Indications for Use:
The Reynolds Lifecard CF 7-Day Holter recorder is a modification of the Reynolds Lifecard CF Holter Recorder, K001025. It is indicated when it is desired to record the patient's ambulatory electrocardiogram.
It is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven days.
(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-
of Cardiovascula 510(k) Number
(Optional Format 1-2-96)