FLOSENSE II, MODEL 29-8040

K033939 · Sdi Diagnostics, Inc. · BZG · Jan 30, 2004 · Anesthesiology

Device Facts

• Record ID: K033939
• Device Name: FLOSENSE II, MODEL 29-8040
• Applicant: Sdi Diagnostics, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

The Flosense II is intended to be used as a disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers which currently use the Puritan Bennett FSII Flow Sensor.

Device Story

FloSense II is a disposable pneumotach accessory designed for use with the Puritan-Bennett Renaissance II Spirometer. It functions as a flow sensor, replacing the Puritan Bennett FSII Flow Sensor. The device is used in clinical settings by healthcare professionals to measure respiratory airflow during spirometry testing. By providing a disposable interface, it facilitates hygienic pulmonary function assessment. The output is processed by the host spirometer to assist clinicians in diagnosing and monitoring respiratory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable pneumotach flow sensor; designed for compatibility with Puritan-Bennett Renaissance II Spirometers; replaces existing FSII Flow Sensor.

Indications for Use

Indicated for use as a disposable pneumotach accessory for the Puritan-Bennett Renaissance II Spirometer system to facilitate pulmonary function testing.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Predicate Devices

• Puritan Bennett FSII Flow Sensor

Submission Summary (Full Text)

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JAN 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael J. Boyle President SDI Diagnostics, Incorporated 10 Hampden Drive Easton, MA 02375

Re: K033939

Trade/Device Name: FloSense II, Model 29-8040 Regulation Number: 21 CFR 868.1840 Regulation Name: Spirometer, Diagnostic (Accessory to) Regulatory Class: Il Product Code: BZG Dated: January 23, 2004 Received: January 26, 2004

Dear Mr. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yourse determined the device is substantially equivalent (for the referenced doore and has not osure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Annendinens, or to do roviets and Cosmetic Act (Act) that do not require approval of a premarket the I cucrar I vou, Drag, and Counting, therefore, market the device, subject to the general approvin uppreation (the Act. The general controls provisions of the Act include controls provinces or 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 If your device is classified (oos as a difional controls. Existing major regulations affecting (1 MA), it may of Subject to Back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fountish further announcements concerning your device in the Eederal Register.

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Page 2 – Mr. Michael J. Boyle

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. or the Fet of any a 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 and instille (2) CF CF rett 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 procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n for a contact the Office of Compliance at [phone]. Also, please note the regulation cntitled, "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,

Chiu Lin, Ph.D.

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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January 23, 2004

SDI Diagnostics, Inc.

## Statement of Intended Use

The Flosense II is intended to be used as a disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers which currently use the Puritan Bennett FSII Flow Sensor.

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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: