MASTERSCREEN CPX AND OXYCON CPX

K040698 · Viasys Healthcare GmbH · BZC · Apr 7, 2004 · Anesthesiology

Device Facts

• Record ID: K040698
• Device Name: MASTERSCREEN CPX AND OXYCON CPX
• Applicant: Viasys Healthcare GmbH
• Product Code: BZC · Anesthesiology
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1880
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Viasys Masterscreen CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The Masterscreen CPX system allows the monitoring of metabolic parameters. The Masterscreen CPX system is intended to use with adults and children over the age of 14 years.

Device Story

Masterscreen CPX and Oxycon CPX are stationary pulmonary function test systems; monitor cardio-respiratory and metabolic parameters during stress testing, rehabilitation, and sports medicine. Used in clinical settings by healthcare professionals. Device inputs include physiological signals related to gas exchange and respiratory function; transforms inputs into metabolic data outputs for clinician review. Output assists in assessing patient performance and physiological response during exercise. Benefits include objective measurement of cardio-respiratory function to guide rehabilitation or sports medicine protocols.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Stationary pulmonary function test system; Class II device (21 CFR 868.1880); product code BZC. Functions as a calculator for pulmonary function data. Connectivity and specific material standards not detailed in provided text.

Indications for Use

Indicated for monitoring cardio-respiratory and metabolic parameters during stress testing, rehabilitation, sports medicine, and related activities in adults and children over 14 years of age.

Regulatory Classification

Identification

A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2004

Mr. Edmond Chu Sensormedics. Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887-4645

Re: K040698

Trade/Device Name: Masterscreen CPX and Oxycon CPX Regulation Number: 868.1880 Regulation Name: Calculator, Pulmonary Function Data Regulatory Class: II Product Code: BZC Dated: March 12, 2004 Received: March 17, 2004

Dear Mr. Chu:

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. Chu

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 (OS) 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,

fett Winterhausen

for

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): K040698

Device Name: MASTERSCREEN CPX

Indications for Use:

The Viasys Masterscreen CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The Masterscreen CPX system allows the monitoring of metabolic parameters. The Masterscreen CPX system is intended to use with adults and children over the age of 14 years.

February-12-2004 Tjeu Souren (Product Manager)

Prescription Use _ × (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)

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510(k) Numbe

neral Hospital.

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