SPIROSOFT

K031194 · Viasys Healthcare GmbH · BTY · Jul 30, 2003 · Anesthesiology

Device Facts

• Record ID: K031194
• Device Name: SPIROSOFT
• Applicant: Viasys Healthcare GmbH
• Product Code: BTY · Anesthesiology
• Decision Date: Jul 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine. The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices. Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout. Federal U.S. law restricts this device to sale by or on the order of a physician.

Device Story

SpiroSoft is a portable pulmonary function diagnostic device; used by physicians in offices, hospitals, or occupational medicine settings. Device measures inspiratory and expiratory lung function parameters in patients aged 4 years and older; adheres to ATS recommendations. Data processed internally; results displayed graphically and numerically on screen; output provided via external printer. Internal memory stores data for later retrieval. Device aids clinicians in assessing lung function; supports diagnostic decision-making.

Clinical Evidence

No clinical data provided. Bench testing only, based on adherence to ATS recommendations for diagnostic pulmonary function devices.

Technological Characteristics

Portable pulmonary function diagnostic device. Measures inspiratory and expiratory lung function parameters. Includes internal memory for data storage. Output via screen and external printer. Operates according to ATS recommendations for diagnostic devices.

Indications for Use

Indicated for measurement of inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. Used by physicians in office, hospital, or occupational medicine settings.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with wavy lines below them, possibly representing water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2003

VIASYS Healthcare GmbH C/O Mr. Earl Draper Director Ouality Systems & Regulatory Affairs SensorMedics, Incorporated 22705 Savi Ranch Parkway Yorba Linda, California 92887-4645

Re: K031194

Trade/Device Name: SpiroSoft Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY Dated: June 25, 2003 Received: June 30, 2003

Dear Mr. Draper:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Draper

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 forth in the quality systems (QS) regulation (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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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6031194 510(k) Number:

SPIROSOFT Device Name:

Indications For Use:

The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine.

The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices.

Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout.

The following caution label appears on page 2 of the SpiroSoft Instruction Manual: "Federal U.S. law restricts this device to sale by or on the order of a physician."

April-03-2003 Dr. Jürgen Reinstädtler (Product Manager)

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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | K031194 |
|----------------|---------|
|----------------|---------|

| Prescription Use | <img alt="Check Mark" src="check_mark.png"/> | OR | Over-The-Counter Use |
|----------------------|----------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |