(467 days)
The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical caregivers, paramedics and other trained personnel for patient ventilation during respiratory distress or insufficiency in the rescue, pre-hospital and alternative site arenas.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "babyPAC." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
This document does not contain the information necessary to describe:
- Acceptance criteria and reported device performance.
- Details about a study proving the device meets acceptance criteria (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Training set details.
Therefore, I cannot fulfill your request based on the given input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 28 1998
Mr. Norman Gray President pneuPAC. Incorporated 814 Parkway Broomall, PA 19008
K970158 Re: Trade Name: BabyPac Requlatory Class: II Product Code: MNT Dated: September 27, 1997 Received: April 14, 1998
Dear Mr. Gray:
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 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
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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.
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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree 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. Allelson
Thomas J. Callehan, 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): K970158
babyPAC Device Name:
Indications for Use:
The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical caregivers, paramedics and other trained personnel for patient ventilation during respiratory distress or insufficiency in the rescue, pre-hospital and alternative site arenas.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109) ✓
Over the Counter Use (Optional Format 1-2-96)
Mr. Reyes
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
NG/JAP/p7092
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).