The CardioTech Spirometry System, Model GT-105, is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health environments.

Device Description

The CardioTech GT-105 Spirometry System measures a wide range of physiological parameters such as SVC, FVC, MVV, and MV and consists of a spirometer and a flow sensor.

The flow sensor head, which includes a flow air resistance element, is mounted on the flow sensor body. Via a disposable mouthpiece and filter, the patient breathes as instructed through the flow sensor head. The pressure transducer in the spirometer then measures the differential pressure in the flow sensor head which is digitized into 12 bit data by an A/D converter.

The data can be transferred via RS-232C/USB interfaces to a PC in which Spirobank software is installed. Since the software includes a number of screens and 'buttons' that help to logically perform the function, the medical practitioner (e.g., technician) can print (reports), save and recall the data/results.

AI/ML Overview

The provided document is a 510(k) summary for the CardioTech GT-105 Spirometer. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer all the questions about specific acceptance criteria and the comprehensive study proving its performance.

The document mentions performance testing in accordance with the American Thoracic Society (ATS) standard, but it does not provide the acceptance criteria values or the specific results from that testing. It also does not describe an AI-driven device, so questions related to AI performance, such as MRMC studies, human reader improvement with AI, or standalone algorithm performance, are not applicable.

Here's a breakdown of what can be answered and what cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document
(The document states testing was done "in accordance with the industry standard developed by the American Thoracic Society," but does not list specific numerical acceptance limits or the device's measured performance against them.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the document.
Data Provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. The device is a diagnostic spirometer, which directly measures physiological parameters. Ground truth for its performance would typically be established by comparing its measurements to a gold standard measurement system or a reference standard, rather than expert consensus on images or interpretations. The document does not describe such a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See explanation above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. The device described is a spirometer, a hardware device for measuring lung function. It is not an AI-driven diagnostic imaging device or an AI assistant for human readers. There is no indication of AI or human interpretation in its function.

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

Not Applicable. See explanation above. The device is a spirometer with software for data display and management, not a standalone algorithm performing diagnostic interpretations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document implies that performance testing was conducted against the "industry standard developed by the American Thoracic Society." For a spirometer, this would typically involve comparing measurements (e.g., FVC, FEV1) to reference values established by the ATS standard or to a highly accurate calibration device, rather than expert consensus or pathology in the context of imaging. However, the exact nature of this "ground truth" or reference standard for testing is not detailed in the provided text.

8. The sample size for the training set

Not Applicable. The device described is a spirometer, a hardware device with embedded software for data acquisition and display. It is not an AI/ML device that requires a training set in the typical sense.

9. How the ground truth for the training set was established

Not Applicable. See explanation above.

Summary

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K090646

510(k) Summary (per 21 CFR 807.92(c))

Applicant

JUL 2 3 2009

CHEST M. I., Inc. 3-6-10 Hongo Bunkyo Tokyo, Japan 113-0033

Hiroaki Hoki, General Manager, International Sales & Marketing, Export & Import Division Tel: (81) 3 3812 7251 Fax: (81) 3 3812 7220 E-mail: nw008@nifty.com

Date Prepared: January 19, 2009

1. Device Name
  CardioTech GT-105 Spirometer Trade Name: Common/ Usual Name: Spirometer, Diagnostic Classification Name: Diagnostic Spirometer Regulation Number: 868.1840 Product Code: BZG Classification: II Panel: Anesthesiology

3. Predicate Devices

The CardioTech Spirometer is substantially equivalent to the following devices:

510(k) Number	Device	Applicant
K022103	PB700 Renaissance II Spirometry System	Puritan Bennett Inc.
K031102	Microlab Spirometer	Micro Direct, Inc.

4. Indications for Use

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5. Description of the Device

The CardioTech GT-105 Spirometry System measures a wide range of physiological parameters such as SVC, FVC, MVV, and MV and consists of a spirometer and a flow sensor.

6. Summary of the Technical Characteristics

Electrical Testing .

The CardioTech Spirometry System was tested in accordance with the medical electrical equipment requirements defined by IEC 60601-1-2:2001 + A1:2005 and IEC 60601-1:1998 + A1:1991 + A2:1995 for electromagnetic compatibility and electrical safety, respectively.

Performance Testing .

The CardioTech Spirometry System was tested in accordance with the industry standard developed by the American Thoracic Society. 3

7. Safety and Effectiveness

The CardioTech GT-105 Spirometry System is a safe and effective device and is substantially equivalent to the predicate devices listed in this 510(k) submission; that is, the CardioTech GT-105 Spirometry System has the same indications for use and is similar in both design and function. Any differences in technological characteristics between the CardioTech GT-105 Spirometry System and the predicate devices `do not raise issues of safety and effectiveness.

4 American Thoracic Society Standardization of Spirometry 1994 Update. Am J Respir Crit Care Med 1995, 152: 1107-1136.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

JUL 2:3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chest M.I. Incorporated C/O Ms. Jean Asquith Senior Regulatory Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

Re: K090646

Trade/Device Name: CardioTech Spirometry System, Model GT-105 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: July 6, 2009 Received: July 8, 2009

Dear Ms. Asquith:

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 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- Ms. Asquith

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ph far

Susan Runner, D.D.S., M.A. Acting 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 (if known):

Device Name: CardioTech Spirometry System, Model GT-105

Indications for Use:.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulten

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090646

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).