← Product Code [BTY](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY) · K020745

# COSMED MICROQUARK (K020745)

_Cosmed Srl · BTY · Jan 2, 2003 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K020745

## Device Facts

- **Applicant:** Cosmed Srl
- **Product Code:** [BTY](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY.md)
- **Decision Date:** Jan 2, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1890
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Indications for Use

The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation).

## Device Story

COSMED microQuark is a modular laboratory system for pulmonary function testing. Device performs basic spirometry, including Forced Vital Capacity (FVC), Slow Vital Capacity (SVC), and Maximum Voluntary Ventilation (MVV). System is used by clinicians in laboratory settings to assess lung function. Output provides diagnostic data to healthcare providers to assist in evaluating respiratory health and clinical decision-making.

## Clinical Evidence

No clinical data provided; device is a laboratory pulmonary function testing system.

## Technological Characteristics

Modular laboratory device for pulmonary function testing. Performs basic spirometry (FVC, SVC, MVV).

## Regulatory 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OSMED SRL C/O Dr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue West Caldwell. New Jersey 07006

Re: K020745

Trade Name: COSMED microQuark Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary Function Data Calculator Regulatory Class: II Product Code: 73 BZC, BTY Dated: December 17, 2002 Received: December 18, 2002

Dear Dr. Schiff:

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 - Dr. Robert Schiff

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## 510(k) PREMARKET NOTIFICATION COSMED SRL, ITALY COSMED microQUARK

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Device Name:

Not assigned yet k0207YS
COSMED microQuark

Indications for Use:

The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation).

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFER 801.109) (Optional Format 1-2-96)

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K020745](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K020745)

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