(64 days)
The PARI PEP Device is an Expiratory Resistance Exerciser and ii was designed to help patients exercise their lungs properly, improve secretion clearance. This expiratory resistance exerciser will be used with patients for whom a physician has prescribed lung exercise treatments at home. doctor's office, hospitals and clinics.
The PARI PEP Device is an Expiratory Resistance Exerciser. The PARI PEP was designed to work with the PARI Nebulizers.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance metrics, or details of a study with a test set, training set, or expert involvement to establish ground truth. The document is an FDA letter regarding the substantial equivalence of the PARI PEP® Positive Expiratory Pressure Therapy System, which primarily discusses regulatory classification and marketing authorization. It does not include a technical or clinical study summary.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Miquel A. Arrizon PARI Respiratory Equipment, Inc. 13800 Hull Street Road …… 1 - 1 - 1 - 1 - 1 -Midlothian, Virqinia 23112
AUG - 5 1997
K972042 Re : PARI PEP® Positive Expiratory Pressure Therapy System Regulatory Class: II (two) Product Code: 73 BWF Dated: May 30, 1997 Received: June 2, 1997
Dear Mr. Arrizon:
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, Druq, 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, qood 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QC) 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 - Mr. Miquel A. Arrizon
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}------------------------------------------------
3.2 Statement of Intended Use _
The PARI PEP Device is an Expiratory Resistance Exerciser and ii was designed to help patients exercise their lungs properly, improve secretion clearance. This expiratory resistance exerciser will be used with patients for whom a physician has prescribed lung exercise treatments at home. doctor's office, hospitals and clinics.
The PARI PEP was designed to work with the PARI Nebulizers.
M. Puge
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 197204Z 510(k) Number _
prescription use √
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).