(236 days)
Not Found
Not Found
No
The summary describes a standard ECG recorder and does not mention any AI or ML capabilities.
No
The device is described as an ECG recorder and cardiac monitoring instrument, which is for diagnostic purposes, not therapeutic intervention.
Yes
The device is an "ECG Cardiac Monitoring Instrument" that acquires "ECG information" initiated by the patient "in response to encountered symptoms." This information is used to monitor the heart, which is a diagnostic purpose.
No
The device description explicitly states "Models 471/472 Sentinel ™ Recorders" and describes them as "ambulatory Electrocardlographic (ECG) recorders," indicating a physical hardware component for acquiring ECG information.
Based on the provided information, the Del Mar Avionics Models 471/472 Sentinel Recorders are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living organism (in vitro).
- Device Function: The Sentinel Recorders acquire ECG information directly from the patient's body (in vivo). They are used to monitor the electrical activity of the heart, not to analyze samples taken from the body.
- Intended Use: The intended use clearly states it's an "ambulatory Electrocardlographic (ECG) recorder" and an "ECG Cardiac Monitoring Instrument." This aligns with in vivo monitoring, not in vitro testing.
Therefore, the Del Mar Avionics Models 471/472 Sentinel Recorders are considered a medical device for in vivo monitoring, but not an IVD.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DXH
Device Description
Models 471/472 Sentinel Solid-State Event/Loop Recorders
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
The Models 471 and 472 Sentinel Recorders are not suitable for monitoring infants: weighing less than 22 (10 kg) pounds.
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)
Not Found
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.
Not Found
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
§ 870.2920 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).
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)