ASTRAGUARD PULMONARY FUNCTION FILTER

K062913 · Sdi Diagnostics, Inc. · BZG · Jan 26, 2007 · Anesthesiology

Device Facts

• Record ID: K062913
• Device Name: ASTRAGUARD PULMONARY FUNCTION FILTER
• Applicant: Sdi Diagnostics, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

The AstraGuard Pulmonary Function Filter is intended for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications

Device Story

Disposable pulmonary function filter; electrostatic polypropylene medium enclosed in molded polystyrene shell; ultrasonically welded. Device placed in-line between patient and spirometer/pulmonary testing instrument. Acts as physical barrier to aerosols and particulates in exhaled gas; reduces risk of cross-contamination of testing equipment, valves, and hoses. Used in clinical diagnostic settings; operated by healthcare professionals. Benefits patient and staff by maintaining hygiene of diagnostic equipment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrostatic polypropylene filtration medium; molded polystyrene shell; ultrasonically welded construction. Passive device; no energy source or software. Single-use disposable.

Indications for Use

Indicated for use in patients undergoing pulmonary function testing to reduce bacterial and viral cross-contamination of spirometers and associated equipment.

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

• SDI Pulmoguard Filter (K934509)
• Alliance Tech Medical All Flow Filter (K043148)
• Koko Disposable PFT Filter II (K934475)

Submission Summary (Full Text)

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## Koco2913

| 510(k) Summary | JAN 26 2007 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [As Required by 21 CFR 807.92] | |
| Owner / Submitter of 510(k) | SDI Diagnostics, Inc.<br>Michael J. Boyle - President<br>10 Hampden Drive<br>Easton, MA 02375<br>e-mail: [e-mail] |
| Establishment Registration No.: | 1221256 |
| Contact: | Cosimo Cariolo<br>e-mail: [e-mail]<br>Tel: [phone], fax [phone] |
| Trade Name: | SDI AstraGuard Pulmonary Function filter |
| Common Name: | Disposable PFT Filter |
| Classification Name: | Filter, Bacterial |
| Regulation Number | 21 CFR 868.5260 |
| Classification Panel: | Anesthesiology |
| Regulatory Class: | II |
| Product Code: | CAH |
| Predicate Devices | 510(k) #K934509 SDI Pulmoguard Filter<br>510(k) #K043148 Alliance Tech Medical All Flow Filter<br>510(k) # K934475 Koko Disposable PFT Filter II |
| Device Description: | The SDI AstraGuard Pulmonary Function Filter is an<br>electrostatic polypropylene medium enclosed in a molded<br>polystyrene shell. The highly efficient medium is ultrasonically<br>welded to the shell body. |
| Intended Use: | The AstraGuard Pulmonary Function Filter is intended for use in<br>reducing possible bacterial and/or viral cross contamination of<br>spirometers and pulmonary testing instruments, associated<br>valves and hoses, from aerosols and particulates, which may be<br>present in a patient's exhaled gas. The device is indicated for<br>diagnostic applications |

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Cosimo Cariolo Director of Marketing SDI Diagnostics, Incorporated 10 Hampden Drive Easton, Massachusetts 02375

JAN 2 6 2007

Re: K062913

Trade/Device Name: AstraGuard Pulmonary Function Filter Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: January 10, 2007 Received: January 16, 2007

Dear Mr. Cariolo:

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. Cariolo

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 regulties. 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 82pirend 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/industry/support/index.html.

Sincerely yours,

Suyite Y. Michin Oms

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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SDI Diagnostics, Inc. AstraGuard Pulmonary Function filter 510(k) Submission

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known) K062913

AstraGuard Pulmonary Function Filter Device Name:

Indications for Use:

The AstraGuard Pulmonary Function Filter is intended to for use in reducing possible The AstraOuard Pulmonary Panonination of spirometers and pulmonary testing bacterial and/or viral cross contamination of epirements and particulates, which may be Instruments, associated varies and more is indicated for diagnostic applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matt Welch

on Sign-Cfi) on of Anesthesiology, General Hospital, . Tion Control, Dental Devices

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Prescription Use
(per 21 CFR 801.109

OR

Over-the-Counter Use (Optional Format 1-2-96)