ONEFLOW

K980951 · Sti Medical · BZH · Feb 25, 2000 · Anesthesiology

Device Facts

• Record ID: K980951
• Device Name: ONEFLOW
• Applicant: Sti Medical
• Product Code: BZH · Anesthesiology
• Decision Date: Feb 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Indications for Use

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.

Device Story

STI OneFlow is a handheld, battery-operated electronic spirometer; measures PEFR and FEV1. Device stores up to 120 readings in internal memory. Optional software allows data download and statistical analysis based on pre-set criteria. Used by patients for monitoring asthma or other respiratory conditions; requires physician or licensed healthcare professional oversight. Output provides objective respiratory data to assist in clinical management and patient monitoring. Calibrated per American Thoracic Society 1994 standards.

Clinical Evidence

Bench testing only; device calibrated according to American Thoracic Society 'Standardization of Spirometry, 1994 Update'.

Technological Characteristics

Handheld, battery-operated electronic spirometer. Measures PEFR and FEV1. Internal memory capacity: 120 readings. Calibrated to American Thoracic Society 1994 standards. Includes optional software for data download and statistical analysis.

Indications for Use

Indicated for monitoring peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) in patients with respiratory conditions such as asthma. Intended for OTC use under the direction of a physician or licensed healthcare professional.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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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## 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