(714 days)
When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. This product will be sold as an OTC device with the appropriate FDA cautionary labeling.
The STI OneFlow is a hand held, battery operated, electronic peak flow (PEFR) and FEV1 monitoring device with internal memory capable of storing 120 sets of readings. The product is available with or without software that downloads stored readings from the device and statistically analyzes this data as per criteria set in the patient information section of the program.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "OneFlow Tester," indicating it has been found substantially equivalent to a legally marketed predicate device.
The letter mentions:
- The device is a handheld, battery-operated electronic peak flow (PEFR) and FEV1 monitoring device.
- It has internal memory for 120 sets of readings.
- It's available with or without software for data download and statistical analysis.
- It's to be used under the direction of a physician for monitoring conditions like asthma.
- It will be sold as an OTC device with appropriate FDA cautionary labeling.
- It has been calibrated according to the American Thoracic Society "Standardization of Spirometry, 1994 Update."
However, none of this constitutes a description of acceptance criteria for a study or details of a study conducted to demonstrate performance against such criteria. The document is primarily an FDA regulatory approval notice.
Therefore, for all the requested information categories (1-9), the answer is: Not provided in the given text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird, with three curved lines representing its wings or feathers.
Public Health Service
FEB 2 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lauren R. Ziegler STI Medical c/o Healthscan Products, Inc. 908 Pompton Avenue Cedar Grove, NJ 07009
Re: K980951 OneFlow Tester Requlatory Class: II (two) Product Code: 73 BZH December 22, 1999 Dated: Received: December 23, 1999
Dear Ms. Ziegler:
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 A substantially equivalent determination assumes compliance to 895. 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.
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Page 2 - Ms. Lauren R. Ziegler
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 requlation 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,
Christy Louman for
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K980651
Device Name: OneFlow Tester
The STI OneFlow is a hand held, battery operated, electronic peak flow (PEFR) and FEV1 monitoring device with internal memory capable of storing 120 sets of readings. The product is available with or without software that downloads stored readings from the device and statistically analyzes this data as per criteria set in the patient information section of the program. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. This product will be sold as an OTC device with the appropriate FDA cautionary labeling. This product has been calibrated according to the American Thoracic Society "Standardization of Spirometry, 1994 Update".
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use √
Chucky Youman
(Division Sign-Off)
of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).