(31 days)
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.
The device is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reynolds Medical Ltd. Lifecard CF 7-Day Holter Recorder:
Based on the provided text, the device is explicitly stated to not have clinical testing requirements, as it is considered substantially equivalent to a predicate device. Therefore, many of the requested categories related to clinical study design and performance metrics against ground truth are not applicable or cannot be extracted from this document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Stated/Inferred) | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | Adherence to AAMI EC38 | Meets AAMI EC38 requirements |
| Adherence to IEC 601-1 | Meets IEC 601-1 requirements | |
| Adherence to IEC 601-1-2 | Meets IEC 601-1-2 requirements | |
| Software Validation | Extensive validation testing | Undergone extensive validation testing |
| Compression Algorithm | Separately tested | Separately tested |
| Safety and Efficacy | Equivalent to predicate device K001025 | Equivalent in safety and efficacy to legally-marketed predicate device. |
| Intended Use | Record patient's ambulatory ECG for up to 7 days; no analysis performed by the unit itself. | Designed to record ambulatory ECG for up to 7 days; "unit does no analysis." |
| Fundamental Science/Technology | No change from predicate device | "fundamental science technology of the device has not changed." |
| Use of Modified Device | As described in labeling | "use of the modified device as described in its labeling has not changed." |
| Regulatory Equivalence | Substantial Equivalence to K001025 | FDA determined substantial equivalence to K001025. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document explicitly states "Clinical tests: None required." The performance data section focuses on non-clinical tests and equivalence to a predicate device, not clinical performance against a test set.
3. 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. As no clinical tests were required or performed, there was no test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set.
5. 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
- Not Applicable. This device is a Holter recorder and explicitly states it "does no analysis." It is not an AI-assisted diagnostic tool, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device performs no analysis. Its function is data recording. The "compression algorithm has been separately tested," which is a standalone evaluation of that specific component, but not in the context of an overall diagnostic algorithm's performance against clinical ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable for clinical performance. For the non-clinical tests (AAMI EC38, IEC 601-1, IEC 601-1-2), the "ground truth" would be the specifications and requirements defined within those standards, which are typically measured against calibrated instruments and known electrical signals, not clinical outcomes or expert consensus. The software validation and compression algorithm tests would rely on their own internal verification and validation criteria, which would involve comparing outputs to expected results for known inputs.
8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning or deep learning model that would require a "training set" in the conventional sense for clinical performance. The software and compression algorithm validation would involve internal test data, but not a "training set" like in AI/ML applications.
9. How the ground truth for the training set was established
- Not Applicable. No training set for a clinical algorithm.
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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
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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.
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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
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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
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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)
§ 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).