The Flowhandy ZAN100 USB is an open, personal-computer-based spirometry system with optional shutter for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects for use by pulmonologists, allergists, general practitioners, and occupationalmedicine practitioners in lung-function diagnosis.

Device Description

The Flowhandy ZAN100 USB is a pneumotachometer spirometry system. The system comprises a Windows personal computer (sold separately) for data collection, analysis, storage, and display; proprietary Betterflow ZAN100 USB software program for the PC; and a Flowlandy, hand-held pneumotach with reusable variable-orifice core, differential pneumatic pressure sensor, and USB interface. An optional computer-controlled shutter may be added to the air passageway to interrupt flow to allow pressure measurements using the on-board pressure sensor.

The ZAN100 measures the pressure drop across the known orifice to indicate the rate of breath flow both in and out of the air passageway. Knowing the flow rate of air from a subject allows the calculation of the most recognized spirometric values for the subject. Closing off the passageway with the optional shutter enables the pressure sensor to take important pressure measurements for the subject's breathing as well.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Flowhandy ZAN100 USB, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary only explicitly mentions meeting American Thoracic Society (ATS) requirements. While specific numerical acceptance criteria for each measurement are not detailed, the summary states that performance met or exceeded these requirements.

Performance Metric	Acceptance Criteria (from ATS)	Reported Device Performance (Flowhandy ZAN100 USB)
Max linearity error	(Not explicitly stated)	2.5% (corrected)
Volume resolution	(Not explicitly stated)	<5 ml
Flow resolution	(Not explicitly stated)	<1 ml/s
Flow resistance	(Not explicitly stated)	<0.03 kPa/l/s
Overall Measurement Performance	American Thoracic Society requirements	Meets or exceeded ATS requirements

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

The document does not specify the sample size used for the effectiveness testing.

The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It only mentions "in-house and third-party testing."

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

The 510(k) summary does not provide any information about the number or qualifications of experts used to establish ground truth for the effectiveness testing.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for establishing ground truth for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not performed or reported. The device is a spirometer, which typically performs direct physiological measurements rather than diagnostic interpretations from images, making MRMC studies less relevant in this context. The study focuses on the accuracy and precision of the measurement itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the effectiveness testing reported is a standalone performance evaluation of the device's ability to accurately measure spirometric values. The "in-house and third-party testing" assesses the device's intrinsic measurement capabilities against established standards (ATS requirements). There is no "human-in-the-loop" aspect being evaluated in this context.

7. The Type of Ground Truth Used

The ground truth used for effectiveness testing was based on American Thoracic Society (ATS) requirements. This implies comparison of the device's measurements against accepted standards for spirometry performance, likely using calibrated flow/volume generators or established physiological models.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set or any machine learning approach that would require one. The device is a direct measurement instrument (pneumotachometer) that uses established physical principles rather than learning from a dataset.

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

Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable. The device's operation is based on its physical design and calibration against known standards.

Summary

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510(k) Number K052176

Date

Flowhandy ZAN100 USB 510(k) Summary

Submitter

Company:	ZAN Messgeräte GmbHSchlimpfhofer Strasse 14, D-97723 Oberthulba, GermanyTel +49 97 36 81810, Fax +49 97 36 818120
Contact:	Jim LewisFerraris Respiratory Inc, 908 Main Street, Louisville CO 80027, USATel 303 666 5555, Fax 303 666 5588
Prepared:	August 2005
Device Name
Trade:	Flowhandy ZAN100 USB
Common:	Spirometer
Classification:	Diagnostic spirometer, 21 CFR 868.1840; Class II
Product code:	73-BZG
Predicate Devices
Trade Name:	MasterScreen Pneumo
510(k) Number:	K933839
Manufacturer:	Erich Jaeger Gmbh

Device Description

Indications for Use

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Summary of Technological Characteristics

The Flowhandy uses the pressure difference in the air stream across a variable-orifice diaphragm to measure a subject's airflow rate (pneumotachometry) throughout established breathing maneuvers to provide spirometric analysis. The instantaneous flow rate values are acquired on a personal computer, where the data is analyzed, stored, and displayed. The optional shutter is a solenoid-activated valve for interrupting airflow.

Technical Specifications

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Operating temperature range: 10 to 40 °C Operating humidity: 20 to 90%, non-condensing Storage temperature: 0 to 40 °C Storage humidity: 10 to 90%, non-condensing Material: POM (polyoxymethylene) Enclosure rating: IPX1 Type of applied part: BF (subject floating) Flow sensing Measuring principle: Pressure difference with variable diaphragm (pneumotachometry) Dimensions: 100x90x45 mm Weight: 250 a Power supply: 5 VDC, 0.2 Wmax (powered from USB port) Pressure transducer: Semiconductor; 0 to 1.4 kPa; 0.1% accuracy Volume resolution: <5 ml Flow resolution: <1 ml/s Range: 0 to 15 l/s, bi-directional Max linearity error (corrected): 2.5% Flow resistance: <0.03 kPa/l/s Effective dead space: <50 ml
Shutter valve for mouth/nasal pressure reading Dimensions: ● 180x50x80 mm
Weight: . 420 q Additional dead space: . <30 ml
Mouth/Nasal pressure transducer: .
- Semiconductor; 0 to 7 kPa; 0.2% accuracy Power supply: 5 VDC, 0.5 Wmax (powered from USB port)

Summary of Non-Clinical Performance Data

Safety

The Flowhandy was examined and bench tested by third-party examiners to demonstrate conformance to three recognized international consensus standards for safety of medical electrical equipment: EN 60601-1 for general medical-device safety of medical electrical safety, and EN 60601-1-2 for electromagnetic compairity,

Effectiveness

ln-house and third-party testing demonstrate that Flowhandy measurement performance meets or exceeded published American Thoracic Society requirements and the claimed performance meeting requirements under stated and anticipated operating conditions.

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Summary of Clinical Performance Data

CE marking and years of successful operation in Europe demonstrate that patients and clinicians can safely and effectively use the Flowhandy under actual-use conditions and that the users guide, product physical design, and other human-factor characteristics of the Flowlandy system are appropriate for the product's intended use.

Equivalence to Predicate Devices

The Flowhandy design uses the same technologies and design principles as its predicate devices. The system is substantially equivalent to Jaeger's MasterScreen Pneumo: using the same measurement principles; similar construction, material, and energy source; and meeting the same performance characteristics and intended uses.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2006

Zan Messgerate GmbH C/O Mr. Jim Lewis Ferraris Respiratory, Incorporated 908 Main Street Louisville, Colorado 80027

Re: K052176

Trade/Device Name: Flowhandy ZAN100 USB Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: December 27, 2005 Received: December 28, 2005

Dear Mr. Lewis:

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 such 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. Lewis

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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: Flowhandy ZAN100 USB

Indications for Use:

The Flowhandy ZAN100 USB is an open, personal-computer-based spirometry system with optional shutter for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects for use by pulmonologists, allergists, general practitioners, and occurationalmedicine practitioners in lung-function diagnosis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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: General Hospital

Services

K052176

Intended Use

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).