For personal monitoring of expiratory-breath function at home under direction of a physician. It measures, logs, and reports events related to respiration and the spirometric values of peak expiratory flow (P.EF), zone and percent of PEF compared to a reference value, timed forced expiratory volumes over 1 second (FEV1) and 6 seconds (FEV6), and the ration of FEV1/FEV6.

Device Description

KP+ LFM is a model variation of the KoKo Peak KP and KP+ peak flow meters. The KoKo Peak KP+, complete with data-communication accessory and dedicated PC display software, was cleared for over-the-counter sale in 510(k) notification K010009. The LFM is identical to its predicate device-the KP+-physically, technologically, and logically.

This new variation extends some KP+ features-namely, an additional timed flow measurement and extended electronic features. These variations make the LFM a prescription device, rather than an over-the-counter one, like its predicate.

All KP flow meters are personal, electronic, flow meters for measuring the rate at which a person blows through them. Approximately 5x2x1 inches in size, the devices are batterypowered, hand-held, single-user instruments with a mouthpiece removable for cleaning. The meter has a custom liquid-crystal display, one-button operation, and an infrared data port for communicating to a serial port of a PC through an optional data-communication link.

Selecting between the models is done during manufacture by simply setting appropriate flags in the device's memory. This selection can be done during initial calibration at the factory, only. The model is then designated by packaging and labeling.

LFM features include

Performing all KoKo Peak KP+ features and functions
Measuring six-second forced expiratory volume (FEV6) by continuing to integrate the breath flow measurement over a 6-s period and displaying the value after a test session
Displaying the FEV1/FEV6 ratio on meter's front panel after a test session
Enabling diary logs to be expanded to up to 16 entries from the 5 entries preprogrammed into the KP+
Enabling options for uploading diary ranges, zone ranges, reference PEF, data-clear command, and alarm-clock settings directly to meter's memory from a PC

AI/ML Overview

The provided 510(k) summary for the KP+ LFM Flow Meter for Spirometry states that no clinical testing or performance study was conducted to establish acceptance criteria or demonstrate device performance, because the device is deemed identical to its predicate device with only enhanced features.

Therefore, many of the requested sections regarding the study design and results cannot be filled from the provided text.

Here's an attempt to answer based on the available information:

Acceptance Criteria and Device Performance Study

The submission states that "Since the device is identical to its predicate device and the added features are simply enhancements or extensions of features already available on the predicate device, no clinical testing was necessary or performed."

Instead, the submission relies on demonstrating substantial equivalence to its predicate device (KoKo Peak KP+, K010009) and compliance with the American Thoracic Society (ATS) standard for spirometry.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance metrics for the KP+ LFM. Instead, it refers to compliance with the ATS standard for spirometry as the benchmark.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)	Source
Meet or exceed American Thoracic Society (ATS) standard for spirometry (for monitoring devices)	Met or exceeded ATS standard for spirometry	Non-Clinical Performance Data Section
Physical, technological, and logical identity to predicate device (KoKo Peak KP+)	Identical to predicate device	Description of Device Section
All KoKo Peak KP+ features and functions	Performs all KoKo Peak KP+ features and functions	LFM Features Section
Accurate measurement of FEV6	Measures FEV6 (integrates breath flow over 6s)	LFM Features Section
Accurate display of FEV1/FEV6 ratio	Displays FEV1/FEV6 ratio on meter's front panel	LFM Features Section

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable, as no dedicated clinical test set study was performed. The device's performance was evaluated against the ATS standard using an "automatic waveform generator."
Data Provenance: Not applicable. The "testing to ATS standard was performed successfully in-house" using an "industry-recognized automatic waveform generator." This indicates controlled lab testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no human expert-established ground truth was used for a test set. The ground truth was established by the ATS standard and verified using an automatic waveform generator.

4. Adjudication method for the test set:

Not applicable, as no human-adjudicated test set was used.

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. This device is a flow meter for spirometry, not an AI-assisted diagnostic imaging device for human interpretation. No MRMC study was conducted.

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

The device itself is a standalone measurement device. No clinical study specifically assessing its "standalone" performance on human subjects was conducted or reported in the 510(k) summary beyond the in-house testing against the ATS standard using an automatic waveform generator. This can be considered a form of standalone technical performance verification.

7. The type of ground truth used:

The primary "ground truth" used for performance verification was the American Thoracic Society (ATS) standard for spirometry. This standard defines the expected accuracy and performance characteristics for spirometry devices. Compliance was demonstrated using an "industry-recognized automatic waveform generator," which generates standardized airflow patterns to simulate human breaths.

8. The sample size for the training set:

Not applicable. This device does not appear to utilize machine learning or AI that would require a "training set" in the conventional sense. Its functionality is based on established engineering principles for flow measurement.

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

Not applicable, as no training set was used.

Summary

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Date

510(k) Summary -- KP+ LFM Flow Meter for Spirometry

Submitter:

Company:	PDS Healthcare Products, Inc.908 Main Street, Louisville, Colorado 80027303 666 6340, 303 666 6380 Fax
Contact:	Jim Lewis, Regulatory Associate

19 October 2001 Prepared:

Device Name:

Trade:	KP+ LFM
Common:	Flow meter for spirometry
Classification:	Peakflow meter for spirometry [21 CFR 868.1860]

Predicate Device:

Trade Name:	KoKo Peak KP+
510(k) Number:	K010009
Manufacturer:	PDS Healthcare Products, Inc.

Description of Device:

LFM features include

Performing all KoKo Peak KP+ features and functions
Measuring six-second forced expiratory volume (FEV6) by continuing to integrate the ● breath flow measurement over a 6-s period and displaying the value after a test session
. Displaying the FEV1/FEV6 ratio on meter's front panel after a test session

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Enabling diary logs to be expanded to up to 16 entries from the 5 entries . preprogrammed into the KP+
Enabling options for uploading diary ranges, zone ranges, reference PEF, data-clear . command, and alarm-clock settings directly to meter's memory from a PC

Indications for Use:

Summary of Technological Characteristics:

There are no technological differences between the LFM and its predicate device.

Summary of Non-Clinical Performance Data:

Since LFM and its predicate, KP+, are physically identical, they meet the same standards for safety of medical electrical equipment.

Both KP+ LFM and its predicate device meet or exceed each aspect of American Thoracic Society standard for spirometry' as it relates to monitoring devices. Testing to ATS standard was performed successfully in-house using industry-recognized automatic waveform generator built specifically for that purpose.

Summary of Clinical Performance Data:

Since the device is identical to its predicate device and the added features are simply enhancements or extensions of features already available on the predicate device, no clinical testing was necessary or performed.

Technical Specifications:

Meter

• Dimensions:	120 x 70 x 20 mm
• Weight:	85 g
• Operating Temperature:	10 to 38 °C
• Operating Humidity:	0 to 100 %RH, non-condensing
• Storage Temperature:	-20 to 60 °C
• Display:	Reflective liquid crystal, 21x40 mm
• Power:	Two 1.5-volt silver-oxide batteries
• Battery Symbol:	Low battery
• Battery Life:	1 year (3 test sessions per day)
• Memory Capacity:	64 test sessions (FIFO overflow)
• Data port:	Infrared optical

1 American Thoracic Society. Standardization of spirometry: 1994 update. Am J Respir Crit Care Med 152:1107-36, 1995.

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90 x 60 x 40 mm

10 to 38 °C

-40 to 70 °C

Infrared optical

serial port available

1 year

50 g (without batteries)

0 to 100 %RH, non-condensing

Four AAA alkaline batteries

Data cradle

Dimensions: ●
Weight: ●
Operating Temperature: ●
Operating Humidity: ●
Storage Temperature: .
Power: .
Battery Life: .
Meter data port: .
PC data port: .
Computer requirement: .

PC software

Computer requirements: ● Accessories:
Operating system: Memory: Processor speed: Disk capacity:
Program size: .
Physical media: .

SVGA monitor and graphic card, or better, CD-ROM drive Windows 95, 98, or NT 32 MB of RAM Pentium 120 MHz or faster processor 500 MB of available space 33.2 MB CD

3-conductor wire to RS232 9-pin connector

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

Food and Drug Àdministration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2001

Mr. Jim Lewis PDS Healthcare Products, Inc. 908 Main Street Louisville, CO 80027

Re: K013489 KP+ LFM Regulation Number: 868.1860 Regulation Name: Peak Flow Meter Regulatory Class: Class II (two) Product Code: BZH Dated: October 19, 2001 Received: October 22, 2001

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. Jim 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 Of It 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,

Salih Tilah

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K013489

KP+ LFM __ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

For personal monitoring of expiratory-breath function at home under direction of a physician. It r or personal monitoring or expiration and the spirometric values of peak measures, flow (PEF), zone and percent of PEF compared to a reference value, timed forced expiratory now (r Lr ); 2010 and person) on the eseconds (FEV6), 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)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013489

(Optional Format 3-10-98)

PRESCRIPTION USE

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).