(90 days)
AirWatch II Zoneless 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.
The AirWatch II Zoneless 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 Zoneless includes an LCD for displaying PEF and FEV1 information to the user, 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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: AirWatch II Zoneless (K982675)
Predicate Device: ENACT Products, Inc. AirWatch Monitor (K941226)
Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| I. Non-Clinical Performance | ||
| Electrical, Mechanical, and Environmental Performance | Meets applicable electrical, mechanical, and environmental performance requirements as per the "Reviewers Guidance for Premarket Notification Submissions, Appendix A." | The AirWatch II Zoneless and its predicate device meet all applicable electrical, mechanical and environmental performance requirements given in the Reviewers Guidance for Premarket Notification Submissions, Appendix A. |
| Compliance with National Asthma Education Program Standards | Conforms to the National Asthma Education Program's Statement on Technical Standards for peak flow meters. | The AirWatch II Zoneless and its predicate device conform to the National Asthma Education Program's Statement on Technical Standards for peak flow meters. |
| ATS Standards for Peak Flow Meters | Meets "American Thoracic Society 1994 Standards for accuracy, precision, linearity, and back pressure." | The AirWatch II Zoneless meets the American Thoracic Society 1994 Standards for accuracy, precision, linearity, and back pressure. (Predicate device met 1987 Standards) |
| II. Clinical Performance / User Factors | ||
| Proper Measurement & Quality Identification | Appropriately provide information regarding a subject's PEF and FEV1 measurements. Appropriately identify PEF measurements of suspect quality due to poor technique (effort check warning feature). | The Validation/Measurement Quality Study demonstrated that the AirWatch II Zoneless can appropriately provide information regarding a subject's PEF and FEV1 measurements and can appropriately identify PEF measurement of suspect quality. |
| Safe and Effective Use | Consumers can safely and effectively use the AirWatch II Zoneless under conditions of actual use. | Studies demonstrated that consumers can safely and effectively use the AirWatch II Zoneless under conditions of actual use. |
| Interpretation of Readings | Consumers can interpret the AirWatch II Zoneless' display readings and take appropriate actions. | Studies demonstrated that consumers can interpret the AirWatch II Zoneless' display readings and take appropriate actions. |
| Human Factors & Documentation Usability | The Quick Reference Guide, User Guide, AirWatch II Zoneless' physical design, and other human factors characteristics are appropriate for consumers. | Studies demonstrated that the Quick Reference Guide, User Guide, AirWatch II Zoneless' physical design, and other human factors characteristics are appropriate for consumers. |
Study Details:
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Sample size used for the test set and the data provenance:
- Test Set Size: 20 subjects for each of the following studies: Validation/Measurement Quality Study; Home Use Study; User Guide Study; and Quick Reference Guide Study.
- Data Provenance: Not explicitly stated, but the studies were conducted by the submitter (ENACT Health Management Systems, Inc.) and are described as testing on "study subjects," implying prospective data collection for the purpose of the submission. The country of origin is not specified, but the company is based in Mountain View, CA, suggesting U.S. participants.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth for the clinical studies. The focus appears to be on the device's ability to measure PEF/FEV1, identify suspect quality, and be usable by consumers, rather than on expert interpretation of results for ground truth.
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Adjudication method for the test set:
- The document does not mention an adjudication method (like 2+1 or 3+1) for the clinical studies. The nature of the device (a direct measurement tool with an effort check) means adjudication of readings by experts would be less relevant than the device's direct performance against known standards or its usability.
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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:
- No MRMC study was done. This device is a direct measurement tool (peak flow meter), not an AI-assisted diagnostic imaging or interpretation system that would involve human readers. Therefore, the concept of "improving human readers with AI" is not applicable here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Validation/Measurement Quality Study" essentially represents the standalone performance of the device's measurement and "effort check" algorithm. It demonstrated that the device "can appropriately provide information regarding a subject's PEF and FEV1 measurements and can appropriately identify PEF measurement of suspect quality."
- Other studies focused on human-in-the-loop aspects (usability, interpretation), but the core measurement and warning functionality is standalone.
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The type of ground truth used:
- For physical/electrical conformances (non-clinical): Ground truth was established by conformance to the "Reviewers Guidance for Premarket Notification Submissions, Appendix A," "National Asthma Education Program's Statement on Technical Standards for peak flow meters," and "American Thoracic Society 1994 Standards for accuracy, precision, linearity, and back pressure." These are established technical and clinical standards.
- For clinical performance (PEF/FEV1 measurement and suspect quality identification): The primary ground truth would likely be established through comparison to a gold standard spirometry device or carefully controlled maneuvers, though the document doesn't explicitly detail the methodology for the "Validation/Measurement Quality Study." The device's "effort check warning feature" inherently sets its own ground truth for "suspect quality" based on predefined algorithmic criteria.
- For usability studies: Ground truth was established by observing and evaluating consumers' ability to safely and effectively use the device, interpret readings, and interact with the physical design and documentation. This would typically involve user observation and feedback.
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The sample size for the training set:
- The document does not mention a training set in the context of device development or performance evaluation. This device is a hardware-based measurement instrument with an embedded "effort check" algorithm, not a machine learning model that typically requires a large training dataset.
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How the ground truth for the training set was established:
- As no training set is mentioned or implied for this type of device, this question is not applicable. The "effort check" feature is likely based on pre-defined physiological or technical criteria rather than a trained AI model.
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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 Zoneless
Common Name:
Peak Flow Meter
Classification Name:
Peak-flow meter for spirometry (as per 21CFR868.1860)
Predicate Device:
ENACT Products, Inc. AirWatch Monitor (K941226)
Description of Device:
The AirWatch II Zoneless 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 Zoneless includes an LCD for displaying PEF and FEV1 information to the user, 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 Zoneless 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.
Summary of Technological Characteristics:
The primary technological difference between the AirWatch II Zoneless and its predicate device is the addition of an effort check warning feature.
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The technique required to perform a peak expiratory flow rate measurement is effort dependent. Poor technique can result in measurements of suspect quality which do not accurately represent airway status. The AirWatch II Zoneless checks every measurement with three effort check tests. Warning symbols will 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 Zoneless does not display PEF information, or percentage of personal best PEF. This device is designed to accommodate consumers who may be suffering from chronic respiratory diseases other than asthma, therefore rendering the zone management system an unnecessary feature.
The AirWatch II Zoneless 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 Zoneless 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 Zoneless and its predicate device also conform to the National Asthma Education Program's Statement on Technical Standards for peak flow meters. The AirWatch II Zoneless 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 Zoneless and its labeling were 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 Zoneless 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 Zoneless under conditions of actual use; that consumers can interpret the AirWatch II Zoneless' display readings and take appropriate actions; and that the Quick Reference Guide, User Guide, AirWatch II Zoneless' physical design, and other human factors characteristics are appropriate for consumers.
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Technical Specifications:
- Dimensions:
- . Weight:
- Temperature Range: ●
- Storage Temperature: ◆
- Operating Humidity: ●
- Display: .
- Power:
- . 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: ●
L x 4.00 in, W x 2.56 in, D x 0.93 in.
- 3.3 oz.
- 41°F to 104°F (5°C to 40°C)
- -4°F to 140°F (-20°C to 60°C)
- 0% to 95%, non-condensing
LCD Display
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1998
Mr. James Lyon ENACT Health Management Systems, Inc. 1975 El Camino Real, Suite 306 Mountain View, CA 94040-2218
Re: K982675 AirWatch II Zoneless 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, qood 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 regulation (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 requlatory 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 requlation (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 1 of 1
K98267 510(k) Number (if known):_
Device Name: AND WATCH II FONELESS
Indications For Use:
. ··
AirWatch II Zoneless 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF : NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
rome
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number .
Prescription Use (Per 21 CFR 801.109)
§ 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).