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 Description

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

AI/ML Overview

The document describes a 510(k) submission for the SDI AstraSonic Diagnostic Spirometer. The study performed aims to demonstrate substantial equivalence to a predicate device, the ndd Medical Technologies EasyOne Spirometer.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state acceptance criteria in a quantitative table. Instead, it describes a comparison methodology to establish equivalence. The core "acceptance criterion" is that the AstraSonic spirometer's measurement accuracy for flow should be equivalent to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Measurement of flow should be equivalent in accuracy to the predicate device per American Thoracic Society (ATS) standards.	Testing was conducted to demonstrate that the measurement of flow by the device was equivalent in accuracy to the predicate device. A direct comparison using the 26 waveforms described by the American Thoracic Society was performed.
The device is substantially equivalent to the predicate device.	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.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The study utilized 26 waveforms. This refers to a standardized set of waveforms defined by the American Thoracic Society (ATS) for evaluating spirometer performance. These are likely simulated waveforms, not real patient data.
Data Provenance: The 'data' (waveforms) are predefined standards from the American Thoracic Society, not originating from a specific country or collected retrospectively/prospectively. They represent a standardized, objective input for testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The "ground truth" for the test set (the 26 ATS waveforms) is inherent in the definition of those waveforms themselves as a benchmark for spirometer accuracy, not established by human experts in this context.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of using standardized ATS waveforms, there wouldn't typically be a need for expert adjudication in the way it's applied to, for example, image interpretation. The device's measurements would be compared against the known characteristics of the input waveforms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance is affected by an AI system. The AstraSonic spirometer is a diagnostic device for measuring lung function, not an AI system assisting human readers with clinical interpretation.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was the primary method. The study involved a "direct comparison of the Astrasonic spirometer and the predicate device... using the 26 waveforms described by the American Thoracic Society." This means the device's algorithmic and mechanical performance was tested independently against a known standard, without human-in-the-loop interaction for performance evaluation.

7. The Type of Ground Truth Used

The ground truth used was standardized scientific benchmarks/specifications, specifically the 26 waveforms described by the American Thoracic Society.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Spirometers like the AstraSonic typically do not employ machine learning models that require "training sets" in the conventional sense. Their function relies on established physical principles (ultrasonic measurement of flow) and algorithms (to derive values from this flow).

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above (no typical "training set" for this type of device).

Summary

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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: mjboyle@sdidiagnostics.com

Establishment Registration No .: 1221256

Contact:

......

Cosimo Cariolo e-mail: ccariolo@sdidiagnostics.com

Tel: (508) 238-7033, fax (508) 230-8497

SDI AstraSonic Diagnostic Spirometer

Spirometer

868.1840

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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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 (800) 638-2041 or (301) 796-7100 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:

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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Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
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.(b)
Classification. Class II (performance standards).