SENTINEL RECORDER, MODELS 471/472

K971696 · Del Mar Avionics · DXH · Dec 30, 1997 · Cardiovascular

Device Facts

• Record ID: K971696
• Device Name: SENTINEL RECORDER, MODELS 471/472
• Applicant: Del Mar Avionics
• Product Code: DXH · Cardiovascular
• Decision Date: Dec 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Pediatric

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. The Models 471 and 472 Sentinel Recorders are not suitable for monitoring infants: weighing less than 22 (10 kg) pounds.

Device Story

Sentinel Models 471/472 are ambulatory ECG recorders; capture brief ECG episodes initiated by patient upon symptom onset. Model 471 records single-channel ECG; Model 472 records one or two channels. Solid-state loop recording technology; patient-activated. Used in clinical or home settings; operated by patients. Output consists of stored ECG data for physician review to assist in cardiac rhythm diagnosis and clinical decision-making.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Solid-state ambulatory ECG recorder; single-channel (Model 471) or one/two-channel (Model 472) acquisition; loop recording capability; patient-initiated event capture.

Indications for Use

Indicated for ambulatory ECG monitoring in patients weighing 10 kg or more. Contraindicated for infants weighing less than 10 kg.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)