(201 days)
Not Found
Not Found
No
The summary describes a mechanical device (Valved Holding Chamber and Positive Expiratory Pressure device) and makes no mention of AI or ML.
Yes
The device is intended to be used as a Positive Expiratory Pressure (PEP) device, which is a therapeutic technique used to help clear airways and improve lung function.
No
The device description indicates it is a combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device, used for administering aerosolized medication and as a PEP device alone, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it is a "combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device," which are physical hardware components used in respiratory therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for respiratory therapy (PEP and VHC for medication delivery). This is a therapeutic and drug delivery function, not a diagnostic test performed on samples outside the body.
- Device Description: The description confirms it's a combination respiratory device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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 .
Product codes
73 BWF
Device Description
AeroPEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three thick, curved lines that suggest movement and flight. The text is in a simple, sans-serif font and is evenly spaced around the circle.
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.
1
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
2
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)