VITALOGRAPH MICRO

K991412 · Vitalograph, Inc. · BZH · Feb 4, 2000 · Anesthesiology

Device Facts

• Record ID: K991412
• Device Name: VITALOGRAPH MICRO
• Applicant: Vitalograph, Inc.
• Product Code: BZH · Anesthesiology
• Decision Date: Feb 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

The Vitalograph Micro Spirometer is intended to measure, FVC, FEVI, PEF and FEV1% in patients with respiratory conditions such as Asthma, COPD, etc.

Device Story

Vitalograph Micro Spirometer is a handheld diagnostic device used to measure pulmonary function parameters: FVC, FEV1, PEF, and FEV1%. Operated by healthcare professionals in clinical settings, the device captures respiratory airflow data from patients. It processes these signals to calculate lung function metrics, which are displayed to the clinician to assist in the diagnosis and management of respiratory conditions like Asthma and COPD. The device provides objective data to support clinical decision-making regarding patient respiratory health.

Clinical Evidence

No clinical data provided; device cleared via 510(k) substantial equivalence pathway.

Technological Characteristics

Handheld spirometer designed for measurement of respiratory flow parameters. Operates as a diagnostic respiratory device (Product Code: 73 BZH).

Indications for Use

Indicated for patients with respiratory conditions, including Asthma and COPD, requiring measurement of FVC, FEV1, PEF, and FEV1%.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 2000

Mr. Phil Hemes Vitalograph Inc. 8347 Quivira Road Lenexa, KS 66215

Re : K991412 Vitalograph Micro Requlatory Class: II (two) Product Code: 73 BZH Dated: Auqust 13, 1999 Received: November 24, 1999

Dear Mr. Hemes:

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 reqistration, 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 requlations 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 assumptions. Failure to comply with the GMP requlation may result in In addition, FDA may publish further announcements regulatory action. 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 - Mr. Phil Hemes

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 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Jecino H. Watashmun 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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## Atalograph Micro Spirometer

## Indications for Use

The Vitalograph Micro Spirometer is intended to measure, FVC, FEVI, PEF and FEV1% in patients with respiratory conditions such as Asthma, COPD, etc.

JoAwetashereci
Division Sign Off

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1991412 510(k) Number

prescription use ✓

TC