(256 days)
Not Found
Not Found
No
The summary describes a mechanical device for mucus clearance and does not mention any AI or ML components or functionalities.
Yes
The device is described as exercising the patient's lungs and improving secretion clearance, which are therapeutic actions.
No
The device is described as a 'Mucus Clearing Device' and its purpose is to 'exercise patient's lungs and to improve secretion clearance'. These functions are therapeutic, not diagnostic. There is no mention of the device being used to identify, measure, or analyze a condition or disease.
No
The device description explicitly states it is a "Positive Expiratory Pressure PEP Device" and is designed to "work with PARI LC Nebulizers," indicating it is a physical hardware device, not software only.
Based on the provided information, the PARI RC Cornet Mucus Clearing Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "exercise patient's lungs and to improve secretion clearance." This is a therapeutic or physical therapy function, not a diagnostic one.
- Device Description: It's described as a "Positive Expiratory Pressure PEP Device," which is a type of respiratory therapy device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue) or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The PARI RC Cornet device does not fit this description.
N/A
Intended Use / Indications for Use
The PARI RC Cornet Mucus Clearing Device is a Positive Expiratory Pressure PEP Device and it was designed to exercise patient's lungs and to improve secretion clearance. The device was designed to work with PARI LC Nebulizers.
Product codes
73 BWF
Device Description
The PARI RC Cornet Mucus Clearing Device is a Positive Expiratory Pressure PEP Device and it was designed to exercise patient's lungs and to improve secretion clearance. The device was designed to work with PARI LC Nebulizers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 4 1999
Mr. Miquel A. Arrizon PARI Respiratory Equipment, Inc. 13800 Hull Street Road Midlothian, VA 23112
K983308 Re: RC Cornet, Model #44F50 Regulatory Class: II (two) Product Code: 73 BWF Dated: March 4, 1999 Received: March 8, 1999
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 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 Regulations, 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 Failure to comply with the GMP regulation may result in assumptions. 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 requlation (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. 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
May 28, 1999
Emil Wang FDA, CDRH Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850 USA
RE: K983308, Revised Indications For Use Statement
Dear Mr. Wang,
Following is the Revised Indications For Use Statement.
The PARI RC Cornet Mucus Clearing Device is a Positive Expiratory Pressure PEP Device and it was designed to exercise patient's lungs and to improve secretion clearance. The device was designed to work with PARI LC Nebulizers.
If you have any questions please contact me at extension 237.
Best Regards,
Miguel A. Arrizon
Regulatory Affairs Manager
cu. Suzarl for AAC.
07/
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number $_$K983308
Prescriptions use
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IN USA 13800 Hull Street Road Midlothian, VA 23112 US/ 1.800 FAST NEB ( 127.863 标-| 804.639.7235 Fax 804 639 7242
IN (.anaDa 3120 Glen Frin Drive Unit 10 Mississauga, Onlario 151 1 1 800,825.1637 Tel 905.828.9114 ト.rx サン5 .828.34.36
Specialists in effective drug inholman
Sués infistes de I Inhalothérapic etticace
Fspecializador, en inhaloterapia eficaz
634 P01 MAY 28 '99 12:38