(201 days)
The "AERO PEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device can be used as a PEP device alone or in conjunction with the r roosal of aerosolized medication from a pressurized metered dose inhaler (pMDI) as prescribed by a physician or health care provider .
AeroPEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device
I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document is a clearance letter from the FDA regarding a 510(k) premarket notification for a medical device called AeroPEP™. It establishes substantial equivalence to a predicate device and provides regulatory information, but it does not include the specifics of performance testing or clinical studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Mr. Tom Holbrook Trudell Medical International 725 Third Street London, Ontario, CANADA N5V 5G4
Re: K012368 AeroPEPTM Regulation Number: 868.5690 Regulation Name: Spirometer, Therapeutic (Incentive) Regulatory Class: Class II (two) Product Code: 73 BWF Dated: November 13, 2001 Received: November 15, 2001
Dear Mr. Holbrook:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreases)776, the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1970, are cannon with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mans 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 (PMA), it If your device is elassinod (600 at 11) be and of regulations affecting your device can may or defocus to access to and Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Tom Holbrook
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I currents and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 6017; adoming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premailer hedicated 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 11 you desire bpoeint and 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of Compliance at (300) of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general mistmation turers, International and Consumer 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,
Odeh Hell
Bram D. Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 8
INDICATIONS FOR USE
Device Name: AeroPEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device
Indications for Use:
The "AERO PEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device can be used as a PEP device alone or in conjunction with the r roosal of aerosolized medication from a pressurized metered dose inhaler (pMDI) as prescribed by a physician or health care provider .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dek Hell
Division of Cardiovascular & Respiratory Devices
510(k) Number K012368
Prescription Use (per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).