SPIROTEL, MODEL 29-1020

K031643 · Sdi Diagnostics, Inc. · BZG · Dec 9, 2003 · Anesthesiology

Device Facts

• Record ID: K031643
• Device Name: SPIROTEL, MODEL 29-1020
• Applicant: Sdi Diagnostics, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Dec 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

The spirotel spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in people of all ages. It is a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.

Device Story

Spirotel is a portable spirometer for measuring lung function. Device captures respiratory airflow data from patient; processes data to calculate lung function parameters; displays results for review by physician or respiratory therapist. Used in home, clinical, or industrial settings. Facilitates remote or point-of-care monitoring of respiratory health; assists clinicians in diagnosing or managing pulmonary conditions. Single-patient use design.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable spirometer for lung function assessment. Single-patient use device. Operates as a diagnostic spirometer (21 CFR 868.1840).

Indications for Use

Indicated for lung function testing in patients of all ages under the instruction of a physician or respiratory therapist. Single-patient use only. No specific contraindications listed.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2003

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

Re: K031643

Trade/Device Name: Spirotel, Model 29-1020 Regulation Number: 21 CFR 868.1840 Regulation Name: Spirometer, Diagnostic Regulatory Class: II Product Code: BZG Dated: not dated Received: October 28, 2003

Dear Mr. Boyle:

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.

{1}------------------------------------------------

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. 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 vours,

Susan Ruar

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K031643

Device Name: Spirotel

Indications For Use: The spirotel spirometer is intended to be used by a patient under indications For 500. The opirator epiratory therapist to test lung function in people of all the matraction of a priyation of a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.

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)

Hineh Pinto

· General Hospital, Infection Control, Dental Devices

Page 1 of

510(k) Number: k031643