(236 days)
The Del Mar Avionics Models 471/472 Sentinel Recorders are ambulatory Electrocardlographic (ECG) recorders intended to acquire multiple brief episodes of ECG Information. Acquisition of ECG information is initiated by the patient, normally in response to encountered symptoms. The Model 471 Sentinel Recorder acquires a single channel of FCG. The Model 472 Sentinel Recorder acquires one or two channels of ECG. The Models 471 and 472 Sentinel Recorders are intended to be used as an ECG Cardiac Monitoring Instrument.
Models 471/472 Sentinel ™ Recorders
The provided document is a 510(k) premarket notification letter from the FDA to Del Mar Avionics regarding their Models 471/472 Sentinel Solid-State Event/Loop Recorders. This type of document declares substantial equivalence to a predicate device, which means a comprehensive study with acceptance criteria, human reader comparisons, and detailed ground truth establishment as you've requested is typically not included in the submission or the FDA's response.
A 510(k) submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical trials with specific acceptance criteria as you've described for AI/ML devices.
Therefore, based solely on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria, study design, expert qualifications, or AI-specific performance metrics. These details are not part of a standard 510(k) clearance letter.
However, I can extract some limited information:
Indications for Use (from the document):
The Del Mar Avionics Models 471/472 Sentinel Recorders are ambulatory Electrocardiographic (ECG) recorders intended to acquire multiple brief episodes of ECG Information. Acquisition of ECG information is initiated by the patient, normally in response to encountered symptoms.
- The Model 471 Sentinel Recorder acquires a single channel of ECG.
- The Model 472 Sentinel Recorder acquires one or two channels of ECG.
- The Models 471 and 472 Sentinel Recorders are intended to be used as an ECG Cardiac Monitoring Instrument.
- The Models 471 and 472 Sentinel Recorders are not suitable for monitoring infants weighing less than 22 pounds (10 kg).
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states the device is "substantially equivalent" to predicate devices. It does not contain specific performance metrics or acceptance criteria for a new clinical study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe test sets, sample sizes, or data provenance. This information would be relevant for a de novo marketing application or a clinical trial, but not typically for a 510(k) clearance where substantial equivalence is demonstrated.
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)
- Cannot be provided. Ground truth establishment, expert review, and qualifications are not mentioned as this relates to a clinical study proving performance, which is not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is described because no specific test set or study results are presented.
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
- Cannot be provided. This is a clearance letter for a 1997 medical device. AI assistance and MRMC studies in the context of AI are not applicable to the technology or regulatory process described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. The device described (event/loop recorder) is a hardware device for acquiring ECG information, not an algorithm for diagnosis or interpretation in the way AI/ML devices typically function. Therefore, "standalone algorithm" performance as you describe is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth is detailed for performance assessment, as the clearance is based on substantial equivalence, not a new clinical validation study in the traditional sense.
8. The sample size for the training set
- Cannot be provided. This document is from 1997. The device described is an ECG recorder, not an AI/ML system that would have a "training set" in the modern sense.
9. How the ground truth for the training set was established
- Cannot be provided. As above, the concept of a "training set" and associated ground truth establishment is not applicable to the context of this 1997 device clearance.
In summary: The provided FDA 510(k) clearance letter indicates that the device (Models 471/472 Sentinel Solid-State Event/Loop Recorders) was found substantially equivalent to a predicate device. This regulatory pathway means that the manufacturer did not need to conduct extensive new clinical trials with clearly defined acceptance criteria, performance metrics, and detailed study designs as might be required for a novel device or an AI/ML product today. The fundamental assumption is that if it's equivalent to an already approved device, it meets the necessary safety and effectiveness standards.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.
Rockville MD 20857
DEC 3 0 1997
Raphael Henkin, Ph.D. Del Mar Avionics 1621 Alton Parkway Irvine, CA 92606-4878
Re: K971696 Models 471/472 Sentinel Solid-State Event/Loop Recorders Regulatory Class: II (two) Product Code: 74 DXH September 30, 1997 Dated: Received: October 1, 1997
Dear Dr. Henkin:
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 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 (QS) 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 under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2 - Raphael Henkin, Ph.D.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Rockville MD 20857
DEC 3 0 1997
Raphael Henkin, Ph.D. Del Mar Avionics 1621 Alton Parkway Irvine, CA 92606-4878
Re: K971696 Models 471/472 Sentinel Solid-State Event/Loop Recorders Regulatory Class: II (two) Product Code: 74 DXH September 30, 1997 Dated: Received: October 1, 1997
Dear Dr. Henkin:
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 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 (QS) 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 under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Raphael Henkin, Ph.D.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
12/20 14/17
2 724 201 2322 1022 1022 17-1 - 2020-03
| TO: | C. HO, PH.D. |
|---|---|
| FDA | |
| FROM: | E. Crespin |
| Del Mar Avionics | |
| 714/250-3200 |
Del Mar Avionics Re: K971696 Sentinel™ Solid-State Event/Loop Recorders Models 471/472-
APPENDIX B
Page 32 of 32
い
510(k) Number (if known):
Device Name: __Models 471/472 Sentinel ™ Recorders
Indication:; For Use:
The Del Mar Avionics Models 471/472 Sentinel Recorders are ambulatory Electrocardlographic (ECG) recorders intended to acquire multiple brief episodes of ECG Information. Acquisition of ECG information is initiated by the patient, normally in response to encountered symptoms.
The Model 471 Sentinel Recorder acquires a single channel of FCG.
The Model 472 Sentinel Recorder acquires one or two channels of ECG.
The Models 471 and 472 Sentinel Recorders are intended to be used as an ECG Cardiac Monitoring Instrument.
The Models 471 and 472 Sentinel Recorders are not suitable for monitoring infants: weighing less than 22 (10 kg) pounds.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K971696 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | Over-The-Counter Use |
(Optional Format 1-2-96)
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).