(369 days)
TZ Medical adult disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
PadTac Adult Defibrillate/Cardiovert/Pace Pad Fac Addit Dollahilator - TZ Medical Inc.
The provided text is a 510(k) premarket notification approval letter for the "PADTAK Adult Defib/Cardiovert/Pace/Monitoring Electrodes." This document primarily indicates the FDA's finding of substantial equivalence to a predicate device and permits the marketing of the device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot extract the requested information regarding performance, sample size, ground truth, or study details from the provided text.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 5 1999
Mr. Byron Zahler TZ Medical, Inc. 15858 S.W. Upper Boones Ferry Road Lake Oswego, OR 97035
K983196 Re : PADTAK Adult Defib/Cardiovert/Pace/Monitoring Electrodes Regulatory Class: III (three) Product Code: 74 DRO Dated: June 9, 1999 Received: June 11, 1999
Dear Mr. Zahler:
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 Requlations, 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 requlation 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 - Mr. Byron Zahler
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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Collelo
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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510(k) Number (if known)_
983196
Device Name:
PadTac Adult Defibrillate/Cardiovert/Pace Pad Fac Addit Dollahilator - TZ Medical Inc.
Indications For Use:
TZ Medical adult disposable electrodes are used by trained professionals in hospitals,
the submit and The secures w Medical Services for adult low-energy TZ Medical adult disposable electious are uices for adult low-energy
doctors offices and Emergency medical Services for adult low-energy doctors offices and Emergency Mediour Oct.ress of these in and monitoring.
defibrillation, transcutaneous pacing, cardioversion and monitoring.
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Concurrence Of CDRH, Office OF Device Evaluation (ODE)
s.M. R
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_
escription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use_
(Optional Format 1-2-96)
§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
(a)
Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.(b)
Classification. Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”