KoKoMate is a diagnostic spirometer for use in the primary-care setting to measure and report the following spirometric values: Peak Expiratory Flow (PEF), One-Second (FEV1) and Six-Second (FEV6) Forced Expiratory Volumes, Forced Expiratory Flow averaged from 25 - 75% of total volume (FEF25-75%), and the ratio of FEV1/FEV6.

Device Description

KoKoMate is a hand-held, self-contained spirometer with disposable mouthpiece designed specifically to measure a few simple expiratory spirometry values in the primary-care setting for diagnostic and screening purposes. The meter features a 4-line by 16-character LCD display; four control buttons; a port to accept its mouthpiece/flow-tube; and an IR data-transfer port.

The device measures expiratory breath flow through its mouthpiece, which is designed for single use. For a maximal expiratory effort, the meter determines peak expiratory flow (PEF), one-second forced expiratory volume (FEV1), six-second forced expiratory volume (FEV6), and average forced expiratory flow from 25 - 75% of total volume (FEF25-75%). It reports these values plus the ratio of FEV1/FEV6 and an indication of how these values compare to recognized predicted values. In addition, the meter processes the signals from each expiratory maneuver to help determine the quality of the maneuver to aid the clinician or patient in determining whether the reported values are valid.

Along with the spirometer, the KoKoMate system can include one of two optional accessory products. These accessories act as data transfer conduits transferring data streams across optic and serial interfaces as they cradle the meter. One cradle is designed to couple the meter to a PC for data storage, printout, or analysis; the other links the meter directly to a printer for direct printout of a simple spirometry report.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the KoKoMate Office Spirometer, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric/Criteria	Device Performance
Measurement Accuracy (Spirometry Values)	Met or exceeded requirements published in the National Lung Health Education Program's consensus statement for office spirometry and in the American Thoracic Society's standard for diagnostic spirometry. (Specific reference: ATS diagnostic spirometry [2]).
Measurement-Quality Features (Ability to identify suspect quality maneuvers for PEF, FEV1, FEV6, FEF25-75%, and FEV1/FEV6)	The measurement-quality study demonstrated that the KoKoMate can appropriately provide information regarding a subject's PEF, FEV1, FEV6, FEF25-75%, and FEV1/FEV6 measurements and can identify measurements of suspect quality appropriately.
Safety (Conformance to medical electrical equipment standards)	Conformed to EN 60601-1:1988 (general safety) and EN 60601-1-2:1993 (electromagnetic compatibility).
Usability/Effectiveness in Primary-Care Setting (Patients and clinicians can safely and effectively use the device)	Demonstrated that patients and clinicians in a simulated primary-care environment can safely and effectively use the KoKoMate, and that the user's guide, physical design, and human-factor characteristics are appropriate for intended use.

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

Test Set Description: The summary describes two primary "effectiveness" tests:
- Bench Testing: An ATS-compatible automatic waveform generator was used. The specific number of waveforms or test runs is not provided.
- Simulated Clinical Setting Study: This involved patients and clinicians, but the sample size for patients and clinicians is not specified.
Data Provenance:
- Bench Testing: The data provenance is not explicitly stated in terms of country of origin. It was conducted "In-house and third-party testing."
- Simulated Clinical Setting Study: The location and country of origin for this simulated primary-care setting are not specified.
- Retrospective/Prospective: Neither study is explicitly labeled as retrospective or prospective, but the simulated clinical setting implies a prospective study involving human interaction.

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

Bench Testing (ATS-compatible automatic waveform generator): For this automated testing, the "ground truth" is typically defined by the precise, controlled output of the waveform generator itself, which is designed to meet established ATS standards. No human experts are explicitly mentioned as establishing ground truth for the test values in this context. The "experts" would be the designers and validators of the ATS standards and the waveform generator.
Simulated Clinical Setting Study: No explicit mention of experts defining "ground truth" for patient or clinician performance; rather, the study assessed the usability and effectiveness of the device in actual use conditions.

4. Adjudication Method for the Test Set

Bench Testing: No adjudication method is mentioned. The assessment would likely involve direct comparison of the device's measured values against the known, precise outputs of the waveform generator.
Simulated Clinical Setting Study: No adjudication method is explicitly stated. The evaluation was likely based on direct observation and possibly user feedback, but details on how effectiveness or safety was formally "adjudicated" are absent.

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

No, an MRMC comparative effectiveness study was not done. This document primarily describes the standalone performance and usability of the KoKoMate device, not its comparative effectiveness with or without AI assistance involving multiple readers. The device itself is a spirometer, not an AI-assisted diagnostic tool in the typical MRMC context.

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

Yes, a standalone performance assessment was conducted for the device's measurement capabilities. The "Effectiveness" section details "In-house and third-party testing, using an ATS-compatible automatic waveform generator, demonstrated that the measurement performance of the spirometer met or exceeded requirements..." This is a standalone assessment of the device's ability to accurately measure spirometry values without human interpretation of raw data. The device's ability to "identify measurements of suspect quality appropriately" also falls under standalone performance.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for spirometry measurements (PEF, FEV1, etc.) was established by an ATS-compatible automatic waveform generator. This represents an objective, standardized, and highly controlled "true" value for the tested parameters, based on recognized industry standards (American Thoracic Society standards).
Simulated Clinical Setting Study: The "ground truth" here is more about effective and safe usage in a real-world context, rather than a definitive medical diagnosis. It's implicitly based on ** direct observation of user interaction and outcomes within the simulated environment**, relative to accepted practices for device usability and patient safety.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This 510(k) summary describes a physical medical device (spirometer) that performs direct measurements, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's "training" would be its design, calibration, and engineering, which are not typically quantified in terms of a data "training set" like an AI model.

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

Not Applicable / Not Provided. As noted above, the concept of a "training set" and associated ground truth is not relevant to this type of device and its regulatory submission as described.

Summary

{0}------------------------------------------------

510(k) Number K022776

Date Date

KoKoMate Office Spirometer 510(k) Summary

Submitter
-----------	--

Company:	Pulmonary Data Services, Inc.908 Main Street, Louisville, Colorado 80027 USATel 303 666 5555, Fax 303 666 5588
Contact:	Jim Lewis
Prepared:	11 July 2002
Device Name
Trade:	KoKoMate
Common:	Office spirometer[1]
Classification:	Diagnostic spirometer, 21 CFR 868.1840; Class II
Product code:	73-BZG
Predicate Devices
Trade Name:	AccuTrax
510(k) Number:	K982995
Manufacturer:	PDS [under contract from Korr Medical Technologies
Trade Name:	Spirovit SP-2
510(k) Number:	K992823
Manufacturer:	Schiller AG

Device Description

KoKoMate is a hand-held, self-contained spirometer 31 with disposable mouthpiece designed specifically to measure a few simple expiratory spirometry values in the primary-care setting for diagnostic and screening purposes. The meter features a 4-line by 16-character LCD display; four control buttons; a port to accept its mouthpiece/flow-tube; and an IR data-transfer port.

1 Ferguson GT, Enright PL, Buist AS, Higgins MV. Office spirometry for lung health assessment in adults: A consensus statement from the National Lung Health Education Program. Chest 117:1146-1161, 2000.

2 American Thoracic Society. Standardization of spirometry: 1994 update. Am J Respir Crit Care Med 152:1107-1136, 1995.

{1}------------------------------------------------

maneuver to help determine the quality of the maneuver to aid the clinician or patient in determining whether the reported values are valid.

Indications for Use

Summary of Technological Characteristics

The KoKoMate measures flow by pneumotachometry (using differential pressure across a known restriction to indicate air flow). The flow path in the meter is a single-use element mounted in pneumatic communication with a durable, reusable handle contains . sensors and associated electronics for interpretation, storage, display, and communication of flow data and test results. The handle houses the battery, pneumatic sensor, analog-to-digital converter, embedded microprocessor, control buttons, multiple-line alphanumeric display, and infrared data port.

Data communication between the meter and a PC or printer may be made through IR data ports on the meter and in one of the optional data-transfer accessories. Data transfer, storage, and display on a PC is done with an existing Windows-based spirometry program available from PDS. Control firmware embedded in the Printer/PC Cradle allows direct printing of the data stored in the meter in a simple report format.

Summary of Non-Clinical Performance Data

Safety

KoKoMate units were examined and bench tested by third-party examiners to demonstrate conformance to two recognized international consensus standards for safety of medical electrical equipment. The standards are EN 60601-1:1988 with amendments for general safety and EN 60601-1-2:1993 for electromagnetic compatibility.

Effectiveness

In-house and third-party testing, using an ATS-compatible automatic waveform generator. demonstrated that the measurement performance of the spirometer met or exceeded requirements published in the National Lung Health Education Program's consensus statement for office spirometry11 and in the American Thoracic Society's standard for diagnostic spirometry [2].

Meter function was also tested using specialized most-probable-error flow waveforms to validate measurement-quality features. The measurement-quality study demonstrated that the KoKoMate can appropriately provide information regarding a subject's PEF, FEV1, FEV6, FEF25-75%, and FEV1/FEV6 measurements and can identify measurements of suspect quality appropriately.

{2}------------------------------------------------

Summary of Clinical Performance Data

Testing in a simulated primary-care setting demonstrated that patients and clinicians in that environment can safely and effectively use the KoKoMate under conditions of actual use and that the users guide, product physical design, and other human-factor characteristics of the KoKoMate system are appropriate for the product's intended use.

Equivalence to Predicate Devices

The KoKoMate's design is a direct design enhancement of the AccuTrax predicate: using the same technologies, design principles, and manufacturing approach; but extending its features and accuracy. The system is substantially equivalent to the Spirovit SP-2: using the same measurement principles; using similar construction, material, and energy source; and meeting the same performance characteristics. The differences are that KoKoMate has a simpler user interface and reports a reduced set of spirometry values compared to the Spirovit.

Technical Specifications

Meter

Dimensions: .
. Weight:
Operating temperature range: ●
. Operating humidity:
Accuracy, precision ●
Storage temperature:
. Display:
. Power:
Battery life: ●
. Memory capacity:
Data port:
Case material .
. Mouthpiece material

Cradle

Dimensions: .
Weight: .
Operating temperature range: .
Operating humidity: ●
Storage temperature: ●
Power: .
PC cradle:
Printer/PC cradle: ●
Data port:

●

Meter:
Computer/printer: .
Case material ●

170x70x40 mm 230 g 17 °C to 38 °C 0 to 80%. non-condensing Meets ATS diagnostic spirometry21 -20 °C to 60 °C LCD Display, 4 line x 16 character One 9 V alkaline battery Approximately 500 tests (3 months of expected usage) 8 sessions (including pre/post challenge) Infrared optical Impact polystyrene ABS Cycolac

200x150x60 mm 320 g 17 °C to 38 °C 0 to 80%, non-condensing -20 °C to 60 °C
Powered from serial port of PC 12 VDC via AC mains-power adapter

Infrared optical RS232 serial data port Impact polystyrene

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -

OCT 0 4 2002

Mr. Jim Lewis Director of Operations Pulmonary Data Services, Incorporated 908 Main Street Louisville, Colorado 80027

Re: K022276

Trade/Device Name: KoKoMate Office Spirometer Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: July 11, 2002 Received: July 15, 2002

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.

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.

{4}------------------------------------------------

Page 2 - Mr. Lewis

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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Les Celikourt

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known): Ko 2222220

Device Name: _ KoKoMate Office Spirometer

Indications for Use:

KoKoMate is a diagnostic spirometer for use in the primary-care setting to measure and report the following spirometric values: Peak Expiratory Flow, One-Second (FEV1) and Six-Second (FEV6) Forced Expiratory Volumes, Forced Expiratory Flow averaged from 25 – 75% of total volume, and the ratio of FEV1/FEV6.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

fs A. Wutrshm

(Optional Format 3-10-98)

Division of Anesthesiology, General Hospital. Infection Control, Dental

510(k) Number:

2-1

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).