VIP PULMONARY FUNCTION SYSTEM

K080510 · Viasys Healthcare GmbH · BTY · Aug 20, 2008 · Anesthesiology

Device Facts

• Record ID: K080510
• Device Name: VIP PULMONARY FUNCTION SYSTEM
• Applicant: Viasys Healthcare GmbH
• Product Code: BTY · Anesthesiology
• Decision Date: Aug 20, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The VIP Pulmonary Function System has been designed and labeled as having the same indications for use as one or more of the predicate products of Cardinal Health. The intended use involves performing physician-prescribed pulmonary function and metabolic testing on paediatric and adult patients. More specific intended uses are listed below. · Differential diagnosis (heart/lungs) · Disability assessment • Rehabilitation evaluation - · Exercise prescription - · Sports medicine/research - · Energy assessment, substrate utilization - · Assessment of supplemental O2 requirement - · Evaluation of medication effects - · Pulmonary Function testing for adults and children - · Document effectiveness of bronchodilator therapy - Pulmonary disability evaluation - · Industrial surveillance · Bronchial challenge testing - · Exercise induced bronchial spasm - · Pre-surgical risk evaluation - Bedside lung function

Device Story

VIP Pulmonary Function System performs pulmonary function and metabolic testing; inputs include patient physiological data during respiratory maneuvers and exercise; system processes data to calculate pulmonary function values; used in clinical settings by healthcare professionals; output provides diagnostic and assessment data for clinical decision-making regarding respiratory health, medication efficacy, and surgical risk; benefits include standardized evaluation of lung function and metabolic status.

Clinical Evidence

No clinical data provided; substantial equivalence based on intended use and technological characteristics.

Technological Characteristics

Predictive pulmonary-function value calculator; class II device (21 CFR 868.1890); product code BTY.

Indications for Use

Indicated for pediatric and adult patients requiring physician-prescribed pulmonary function and metabolic testing, including differential diagnosis, disability assessment, rehabilitation, exercise prescription, sports medicine, energy/substrate assessment, O2 requirement assessment, medication effect evaluation, bronchodilator therapy monitoring, industrial surveillance, bronchial challenge testing, exercise-induced bronchial spasm evaluation, and pre-surgical risk assessment.

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 logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Rust Manager Regulatory Affairs VIASYS Healthcare GmbH Leibnizstrasse 7 Hoechberg GERMANY 97204

AUG 2 0 2008

Re: K080510

Trade/Device Name: VIP Pulmonary Function System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY Dated: June 17, 2008 Received: June 19, 2008

Dear Mr. Rust:

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. Rust

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

H. Kamuela Rener

Chiu Lin. Ph.D. 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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## Indications for Use

510(k) Number (if known): K

Device Name:

VIP Pulmonary Function System

Indications for Use:

The VIP Pulmonary Function System has been designed and labeled as having the same indications for use as one or more of the predicate products of Cardinal Health. The intended use involves performing physician-prescribed pulmonary function and metabolic testing on paediatric and adult patients. More specific intended uses are listed below.

· Differential diagnosis (heart/lungs)

· Disability assessment

• Rehabilitation evaluation

- · Exercise prescription
- · Sports medicine/research
- · Energy assessment, substrate utilization
- · Assessment of supplemental O2 requirement
- · Evaluation of medication effects
- · Pulmonary Function testing for adults and children
- · Document effectiveness of bronchodilator therapy
- Pulmonary disability evaluation
- · Industrial surveillance · Bronchial challenge testing
- · Exercise induced bronchial spasm
- · Pre-surgical risk evaluation
- Bedside lung function

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Will Malf fa M. Hubbard

(Division Sian-Um) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080510

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