AIRWATCH II ZONE by ENACT HEALTH MANAGEMENT SYSTEMS

AirWatch II Zone is a medical instrument which is intended to be used for the monitoring of asthma and other chronic respiratory diseases. The instrument measures both Peak Expiratory Flow (PEF) and Forced Expiratory Volume-One Second (FEV1). The instrument is designed for use by consumers from 5 years of age to adults.

Device Description

The AirWatch II Zone is a pocket-sized, personal electronic device which monitors respiratory status by measuring peak expiratory flow (PEF) rate in liters per minute and forced expiratory volume in one second (FEV1) in liters. The AirWatch II Zone includes an LCD for displaying PEF and FEV1 information to the consumer, three control buttons, a removable mouthpiece, and an RJ-11C telephone connector which can be used to transfer data stored in the AirWatch to a remote computer.

AI/ML Overview

The AirWatch II Zone is a pocket-sized, personal electronic device designed to monitor respiratory status by measuring peak expiratory flow (PEF) rate and forced expiratory volume in one second (FEV1). It includes an LCD display, control buttons, a removable mouthpiece, and an RJ-11C telephone connector for data transfer to a remote computer.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformance to National Asthma Education Program's Statement on Technical Standards for peak flow meters	Device conforms to these standards.
Conformance to American Thoracic Society (ATS) 1994 Standards for accuracy	Device meets ATS 1994 Standards for accuracy.
Conformance to American Thoracic Society (ATS) 1994 Standards for precision	Device meets ATS 1994 Standards for precision.
Conformance to American Thoracic Society (ATS) 1994 Standards for linearity	Device meets ATS 1994 Standards for linearity.
Conformance to American Thoracic Society (ATS) 1994 Standards for back pressure	Device meets ATS 1994 Standards for back pressure.
Appropriate provision of information regarding PEF and FEV1 measurements	Demonstrated in the Validation/Measurement Quality Study.
Appropriate identification of PEF measurements of suspect quality using effort check tests	Demonstrated in the Validation/Measurement Quality Study (device includes three effort check tests and displays warning symbols when a measurement fails any test).
Safe and effective use by consumers under actual use conditions	Demonstrated in the Home Use Study.
Consumer interpretation of display readings and ability to take appropriate actions	Demonstrated in other studies (presumably part of the Home Use or User Guide studies).
Appropriateness of Quick Reference Guide, User Guide, physical design, and other human factors characteristics for consumers	Demonstrated in the User Guide Study and Quick Reference Guide Study.
Meets applicable electrical, mechanical, and environmental performance requirements stated in the Reviewers Guidance for Premarket Notification Submissions, Appendix A	Device meets all specified requirements.

2. Sample Size and Data Provenance

Sample Size for Test Set: 20 study subjects were used for each of the four studies: Validation/Measurement Quality Study, Home Use Study, User Guide Study, and Quick Reference Guide Study.
Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as it involved "study subjects" and "testing."

3. Number of Experts and their Qualifications

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). This type of detail is often omitted for devices like peak flow meters where the "ground truth" might be established by other calibrated devices or established physiological measurements, rather than expert interpretation.

4. Adjudication Method

The document does not mention an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. The AirWatch II Zone is a direct measurement device rather than an interpretative one in the same vein as imaging diagnostics.

6. Standalone Performance Study

A standalone performance study was done for the device, specifically the "Validation/Measurement Quality Study." This study aimed to demonstrate that the device itself could:

Appropriately provide information regarding a subject's PEF and FEV1 measurements.
Appropriately identify PEF measurements of suspect quality.

7. Type of Ground Truth Used

For the AirWatch II Zone, the ground truth for performance assessment would likely be established using:

Calibrated reference instruments: For accuracy and precision of PEF and FEV1 measurements (e.g., comparing the device's readings to those from a highly accurate and calibrated spirometer).
Established physiological criteria: For the "effort check" feature, the ground truth would be based on physiological parameters that indicate a valid vs. suspect respiratory effort.
User feedback and observation: For user interface, ease of use, and interpretability (as indicated by the Home Use, User Guide, and Quick Reference Guide studies).

The document states the device "meets the American Thoracic Society 1994 Standards for accuracy, precision, linearity, and back pressure." These standards inherently define the ground truth for those technical performance aspects.

8. Sample Size for the Training Set

The document does not mention a training set, as the AirWatch II Zone is a traditional medical device (peak flow meter) and not an AI/machine learning-based device that typically undergoes a training phase.

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

Summary

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K982676

OCT 2 9 1998

510(k) Summary (as per 21CFR807.92)

July 31, 1998

Submitter and Contact Person:

James Lyon Director, Engineering and Manufacturing Operations ENACT Health Management Systems, Inc. 1975 El Camino Real, Suite 306 Mountain View, CA 94040-2218 (650) 967-0379 (650) 967-9223 Fax

Trade Name:

AirWatch II Zone

Common Name:

Peak Flow Meter

Classification Name:

Peak-flow meter for spirometry (as per 21 CFR868.1860)

Predicate Device:

ENACT Products, Inc. AirWatch Monitor (K941226)

Description of Device:

The AirWatch II Zone includes an LCD for displaying PEF and FEV1 information to the consumer, three control buttons, a removable mouthpiece, and an RJ-11C telephone connector which can be used to transfer data stored in the AirWatch to a remote computer.

Indications for Use:

AirWatch II Zone is a medical instrument which is intended to be used for the monitoring of asthma and other chronic respiratory diseases. The instrument measures both Peak Expiratory Flow (PEF) and Forced Expiratory Volume-One Second (FEVI). The instrument is designed for use by consumers from 5 years of age to adults.

Summary of Technological Characteristics:

There is one technological difference between the AirWatch II Zone and its predicate device, the addition of an effort check warning feature.

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measurements which do not accurately represent airway status. The AirWatch II Zone checks every measurement with three effort check tests. Warning symbols appear on the display when a measurement fails any one or more of these tests. The appearance of the warning symbols will alert the consumer that the monitor has detected a measurement of suspect quality as a result of poor technique.

The AirWatch II Zone also differs from its predicate device by conforming to the new American Thoracic Society 1994 Standards versus the 1987 Standards.

Summary of Non-Clinical Performance Data:

The AirWatch II Zone and its predicate device meet all applicable electrical, mechanical and environmental performance requirements given in the Reviewers Guidance for Premarket Notification Submissions, Appendix A.

The AirWatch II Zone and its predicate device also conform to the National Asthma Education Program's Statement on Technical Standards for peak flow meters. The AirWatch II Zone meets the American Thoracic Society 1994 Standards for accuracy, precision, linearity, and back pressure. The predicate device meets the American Thoracic Society 1987 Standards.

Summary of Clinical Performance Data:

The AirWatch II Zone was tested on 20 study subjects in each of the following studies: Validation/Measurement Quality Study; Home Use Study; User Guide Study; and Quick Reference Guide Study.

In summary, the Validation/Measurement Quality Study demonstrated that the AirWatch II Zone can appropriately provide information regarding a subject's PEF and FEV1 measurements and can appropriately identify PEF measurement of suspect quality. Other studies demonstrated that consumers can safely and effectively use the AirWatch II Zone under conditions of actual use; that consumers can interpret the AirWatch II Zone's display readings and take appropriate actions; and that the Quick Reference Guide, User Guide, AirWatch II Zone's physical design, and other human factors characteristics are appropriate for consumers.

Technical Specifications:

Dimensions: L x 4.00 in, W x 2.56 in, D x 0.93 in.
Weight:

3.3 oz.
Temperature Range: 41°F to 104°F (5°C to 40°C)
Storage Temperature: -4'F to 140'F (-20°C to 60°C)
Operating Humidity: 0% to 95%, non-condensing
. Display:

LCD Display

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Battery Symbol: ●
Battery Life: .
Automatic Turn-Off . Period:
Test Session Memory ● Capacity:
. Memory Life With Batteries Removed or While Battery Drawer Is Open:
Telephone Connector: ◆

Two Type CR2032 3-Volt lithium Batteries

Low Battery

Approximately 1 year with an average daily usage of 3 test sessions per day

30 to 90 seconds, depending on display mode

480 test sessions (maximum)

2 minutes (minimum) Type RJ-11C (standard household jack)

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & H. MAN. TPITS, USA" around the perimeter. Inside the seal is an abstract symbol of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 29 1998

Mr. James Lyon ENACT Health Management Systems, Inc. 1975 El Camino Real, Suite 306 Mountain View, CA 94040-2218

Re: K982676 AirWatch II Zone Regulatory Class: II (two) Product Code: 73 BZH Dated: July 31, 1998 Received: July 31, 1998

Dear Mr. Lyon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James Lyon

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known):_K982676

Device Name: ANR WATOH II ZONE

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

: . ·

тиате

Over-The-Counter Use 1

(Optional Format 1-2-96)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

Regulation Number and Section

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).