(35 days)
The Del Mar Avionics Model 464 OmniCorder™ is intended for use as a Holter ECG cardiac-monitoring tool.
The Model 464 OmniCorder™ is a compact Holter ECG magnetic tape recorder utilizing standard C60 and C90 cassettes. The recorder may be used to record 2 channel ECG, 3 channel ECG, or 2 channel ECG + pseudo pacer pulses. A fourth track on the tape records a timing track for synchronized playback. Recording may be preset to a tape speed of .75 mm/sec, 1.0 mm/sec or 1.5 mm/sec. Amplitude may be preset to full or half gain. A patient event button records patient items of note on tape while maintaining the ECG signal.
The provided text is a 510(k) summary for the Del Mar Avionics Model 464 OmniCorder™, a Holter ECG magnetic tape recorder. It describes the device, its intended use, and compares it to a predicate device (Model 461 Pacercorder® 510(k) #K950020).
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The FDA letter also does not include this information, as its purpose is to acknowledge the 510(k) submission and confirm substantial equivalence.
Therefore, I cannot provide the requested table and study details based on the input text. The 510(k) summary focuses on device description and equivalence to a predicate device, not on detailed performance study results against specific acceptance criteria.
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510(k) SUMMARY
Submitted by:
Del Mar Avionics 1621 Alton Parkway Irvine, CA 92606 (949) 250-3200
Raphael Henkin Contact Person:
December 31, 1998 Date Prepared:
Model 464 OmniCorder™ Proprietary Name:
Holter Cassette Recorder Common Name:
Medical Magnetic Tape Recorder (21 CFR §870.2800) Classification Name:
Model 461 Pacercorder® 510(k) #K950020
Description of Device:
Predicate Device:
The Model 464 OmniCorder™ is a compact Holter ECG magnetic tape recorder utilizing standard C60 and C90 cassettes. The recorder may be used to record 2 channel ECG, 3 channel ECG, or 2 channel ECG + pseudo pacer pulses. A fourth track on the tape records a timing track for synchronized playback. Recording may be preset to a tape speed of .75 mm/sec, 1.0 mm/sec or 1.5 mm/sec. Amplitude may be preset to full or half gain. A patient event button records patient items of note on tape while maintaining the ECG signal.
The Model 464 OmniCorder™ is intended primarily as a Holter Intended Use of Device: Recorder; recording up to three channels of ECG. The OmniCorder™ is also able to derive from ECG signals pseudopacer pulses representing output spikes from an implanted cardiac pacemaker. These derived pulses may be analyzed, using the Del Mar Pacer Analyzer®, to evaluate pacemaker performance and cardiac response.
Technology Considerations: The Model 464 OmniCorder™ is similar to its predicate device with the addition of speed choice and an update to current operational amplifier technology. The motor control circuitry has been enhanced to improve high frequency noise rejection.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1999
Raphael Henkin, Ph.D. Vice President, Technolgy and business Development Del Mar Avionics 1621 Alton Parkway Irvine, CA 92606-4878
Re: K990027 OmniCorder, Model 464 Trade Name: Requlatory Class: II (Two) Product Code: DSH Dated: December 31, 1998 Received: January 5, 1998
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 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 qeneral 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Druq 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 Reqister. 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
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Page 2 - Dr. Raphael Henkin
under the Electronic Product Radiation 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 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) 594-4639. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas & . Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K
Holter OmniCorder™ , Model 464 Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Del Mar Avionics Model 464 DigiCorder™ is a 3-channel ECG analog cassette tape recorder. By an operator settable dip switches the recorder will perform either conventional 3recorder. By an operater detection recording 2 channels of ECG and 1 channel of "pseudo" pacemaker pulses each time the patient's implanted pacemaker produces a pseddo pacemanor palood out. the selectable dip switch allows selection of recording speed at 0.5 mm/S, 1.0 mm/S or 1.5 mm/S.
The Del Mar Avionics Model 464 OmniCorder™ is intended for use as a Holter ECG cardiac-monitoring tool.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
V. Qaleta
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K990027
§ 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).