ASTRASONIC SPIROMETER, MODEL 29-8000

K092813 · Sdi Diagnostics, Inc. · BZG · Jul 16, 2010 · Anesthesiology

Device Facts

• Record ID: K092813
• Device Name: ASTRASONIC SPIROMETER, MODEL 29-8000
• Applicant: Sdi Diagnostics, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Jul 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.

Device Story

AstraSonic Diagnostic Spirometer is a portable, handheld device for measuring patient breath flow and volume. It utilizes an ultrasonic transducer to measure flow; internal algorithms process these measurements to calculate lung function values. Data is presented to the operator via an integrated LCD display in both tabular and graphical formats. The device is intended for use by physicians or professional medical personnel in clinical, industrial, or hospital environments. It differs from the predicate by using a cleanable transducer with a disposable filter mouthpiece rather than an integrated disposable transducer circuit. The device provides objective lung function data to assist healthcare providers in clinical decision-making.

Clinical Evidence

Bench testing only. Performance was validated by comparing the device against the 26 standard waveforms defined by the American Thoracic Society (ATS) to demonstrate equivalent flow measurement accuracy to the predicate device.

Technological Characteristics

Hand-held diagnostic spirometer; ultrasonic transducer sensing principle; cleanable transducer with disposable filter mouthpiece; LCD display for data output; standalone operation.

Indications for Use

Indicated for basic lung function testing in adults and children over age four. Used by physicians or medical personnel in clinical, industrial, or hospital settings.

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

• ndd Medical Technologies EasyOne Spirometer (K993921)

Submission Summary (Full Text)

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# JUL 1 32010

#### 510(k) Summary

March 10, 2010

### [As Required by 21 CFR 807.92]

Owner / Submitter of 510(k)

SDI Diagnostics, Inc. Michael J. Boyle - President 10 Hampden Drive Easton, MA 02375 e-mail: [e-mail]

Establishment Registration No .: 1221256

Contact:

......

Cosimo Cariolo e-mail: [e-mail]

Tel: [phone], fax [phone]

SDI AstraSonic Diagnostic Spirometer

Spirometer

868.1840

ll

BZG

Anesthesiology

Spirometer, Diagnostic

Trade Name:

Common Name:

Classification Name:

Regulation Number

Classification Panel:

Regulatory Class:

Product Code:

Predicate Device

510(k) #K993921 ndd Medical Technologies EasyOne Spirometer

Device Description:

Intended Use:

measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.

The AstraSonic Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses an ultrasonic transducer that

The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four vears. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.

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The AstraSonic spirometer has the same technological Technological Comparison: characteristics as the predicate device, except that the predicate device has a disposable transducer mouthpiece that is an integral part of the circuit. The Astrasonic spirometer utilizes a cleanable transducer and a disposable filter mouthpiece that is inserted into the transducer. Testing was conducted to demonstrate that the measurement of flow by the device was equivalent in accuracy to the predicate device. A direct comparison of the Astrasonic spirometer and the Summary of Testing: predicate device was made using the 26 waveforms described by the American Thoracic Society to determine substantial equivalence.

Conclusion:

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Based on the above, we have concluded that the SDI AstraSonic Spirometer is substantially equivalent to the predicate device and is safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# JUL 1 5 2010

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

Re: K092813

Trade/Device Name: SDI AstraSonic Diagnostic Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: July 14, 2010 Received: July 15, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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:

Device Name: AstraSonic™ Spirometer

Indications for Use:

The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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