This AccuTrax EPF840device is intended for monitoring PEF and FEV; for patient home and work use. The EPF840 is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the EPF840 is used to watch lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advise is required to understand the meaning and importance of the measures reported by the AccuTrax 840, and how to decide on an appropriate treatment plan. This treatment plan will tell you what action to take when there are changes in your PEF/FEV; numbers.

Device Description

The EPF840 is an electronic PEF/FEV; monitor. It can store PEF/FEV; test results, symptom scoring, and inhaler usage with a time and date stamp. The physician may retrieve data for analysis and trending using a personal computer. The physician may customize color zone indicators to the patient's needs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ACCUTRAX EPF840 Electronic Peak Flow Meter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily compares the ACCUTRAX EPF840 to a predicate device (Vitalograph 2110) against ATS (American Thoracic Society) standards. The acceptance criteria are implicitly the ATS standards for monitoring devices.

Parameter	Acceptance Criteria (ATS Standard for Monitoring Devices)	ACCUTRAX Model EPF840 Performance	Predicate Device (2110) Performance
Back pressure	< 1.5 cmH2O / Liter / second	< 1.5 cmH2O / Liter / second (complies with ATS standards)	< 1.5 cmH2O / Liter / second (complies with ATS standards)
Maximum recorded flow rate	Above ATS standard (implied reference)	875 L/minute	999 Liter/minute
Maximum recorded volume	Above ATS standard (implied reference)	8.50 Liter	9.99 Liter
Volume measuring accuracy	$\pm$ 5% or $\pm$ 0.100 L whichever is greater (for monitoring)	$\pm$ 5% or $\pm$ 0.100 L whichever is greater	$\pm$ 3% or $\pm$ 0.050 L whichever is greater (for diagnostic)
Flow measuring accuracy	$\pm$ 10% or $\pm$ 24 L/min whichever is greater (for monitoring)	$\pm$ 10% or $\pm$ 24 L/min whichever is greater	$\pm$ 5% or $\pm$ 12 L/min whichever is greater (for diagnostic)
Both devices operated within the 10% specification of the ATS standard for peak flow. (This indicates a specific acceptance criteria met.)	Within 10% of ATS standard for peak flow	Operated within 10% specification of ATS standard for peak flow	Operated within 10% specification of ATS standard for peak flow
"Both PEF and FEV1 values were well within the required ATS accuracy specifications using the 24 standard waveforms and the 26 flow-time waveforms."	Within required ATS accuracy specifications	Well within required ATS accuracy specifications	(Not explicitly stated for predicate device in this section, but stated to meet ATS recommendations)
Inter-device and intra-device variability	Complies with all variability requirements	Complies with all variability requirements	(Not explicitly stated for predicate device in this section)

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

Test Set Description: The device was tested using a "precision waveform generator" and "24 standard waveforms and the 26 flow-time waveforms."
Sample Size: The number of unique waveform "tests" is explicitly stated as "24 standard waveforms and the 26 flow-time waveforms." This implies 50 distinct waveform tests. An additional test involved "Waveform #24 using a range of scale factors" (0.8, 1.0, 1.2, 1.6, 2.0, 2.4, 2.8, 3.0, 4.0, and 5.7) which would add 10 more tests for both devices.
Data Provenance: The testing was "at an independent laboratory" and "Performance testing at LDS Hospital (Salt Lake City, UT)". The data is prospective, generated specifically for this regulatory submission. Country of origin for the data is primarily the USA (Salt Lake City, UT).

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

No human experts were used to establish ground truth for the test set. The ground truth was established by the "precision waveform generator" which produces known, reproducible PEF and FEV1 values.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was generated by a machine (precision waveform generator), so there was no need for expert adjudication.

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

No MRMC comparative effectiveness study was done, and no AI components are mentioned in the device description. The device is a standalone electronic peak flow meter.

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

Yes, a standalone performance study was done. The ACCUTRAX EPF840 electronic peak flow meter was tested in isolation against precisely generated waveforms to evaluate its accuracy and repeatability.

7. The Type of Ground Truth Used

The ground truth used was machine-generated reference values from a "precision waveform generator."

8. The Sample Size for the Training Set

No information is provided regarding a training set. This device is a measurement instrument, not a machine learning or AI-based system that would typically require a training set.

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

Not applicable, as no training set is mentioned or implied for this type of device.

Summary

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4 1998 DEC

1998 k

II 510(k) Summary

2.0 General

In accordance with the Safe Medical Devices Act of 1990 (SMDA), this section is a summary of the safety and effectiveness information for this premarket notification upon which an equivalence determination could be based (510(k) summary) [21 CFR & 807.31.

2.1 Submitter Information

Applicant:	KORR Medical Technologies, Inc.
Contact:	Scott A. Kofoed
Address:	3090 East 3300 South Suite 3BSalt Lake City, UT 84109
Phone:	(801) 483-2080
Fax:	(801) 483-2123
Date Prepared:	Friday, August 21, 1998
Trade name:	ACCUTRAX Electronic Peak Flow Meter
Common Name:	Peak Flow Meter
Model:	EPF840

Classification name:	Meter, Peak Flow, Spirometry
Product Code:	AN-BZH

CFR Section: .................................................................................................................................................................

Classification: ...................................................... Class II

Predicate Device: ................. Vitalograph 2110 Electronic Flow Meter

510(k) Number: K943678

2.2 Device Description

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2.3 Intended Use

The product literature contains the text, "CAUTION: Federal Law restricts this device to sale by or on the order of a physician."

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KORR Medical Technologies, Inc. Section II: 510(k) Summary

Peak Flow Meter - 510(k) premarket notification 08/25/98

	ParameterCompared	ACCUTRAX Model EPF840	Predicate Device(2110)	Difference Between
1	Manufacture	KORR Medical Technologies	Vitalograph
2	Model Name	AccuTrax Model EPF840 electronicPeak Flow Meter	2110 electronic PEF/FEV₁ Diary
3	FDA Number	(pending)	K943678
4	Parameters Measured	PEF FEV1	PEF FEV1	No difference
5	Flowhead
	Flow detectionprinciple	Air pressure reducing mess in a flowhead is applied to a pressuretransducer.	Air pressure reducing mess in a flowhead is applied to a pressuretransducer.	No difference
	Back pressure	< 1.5 cmH2O / Liter / second (complieswith ATS standards)	< 1.5 cmH2O / Liter / second (complieswith ATS standards)	No difference
	Cleaning	Single patient use. Clean with warmsoapy water daily. Disposable.	Cold liquid recommended ordisposable.	The EPF840 does not recommendcould liquid sterilization since it has notbeen verified or validated on thisdevice.
6	Volume measurement	Flow integration	Flow integration	No difference
7	Maximum recordedflow rate	875 L/minute	999 Liter/minute	2110 reports higher flow rate. Bothdevices above ATS standard.
8	Maximum recordedvolume	8.50 Liter	9.99 Liter	2110 reports higher volume. bothdevices above ATS standard.
9	Volume measuringaccuracy	$\pm$ 5% or $\pm$ 0.100 L whichever is greater	$\pm$ 3% or $\pm$ 0.050 L whichever is greater	The 2110 specification is that of the"diagnostic" recommendation for theATS standard. The EPF840 is that of
Section II: 510(k) Summary				08/25/98
	ParameterCompared	ACCUTRAX Model EPF840	Predicate Device(2110)	Difference Between
10	flow measuringaccuracy	$± 10% or ± 24 L/min whichever isgreater$	$± 5% or ± 12 L/min whichever is greater$	the "monitoring" recommendation forthe ATS standard.The EPF specification is that of therecommendation of the ATS standardfor "diagnostic" use. The 2110predicate device did not test within thereported $± 5%$ tolerance duringcomparison testing on waveform #24.
11	Test duration	1 to 2 seconds	1 to 2 seconds	No difference
12	Back extrapolation	FEV1	FEV1	No difference
13	Good/Bad Test criteria	Best PEF value of three tests	Best two PEF values within 10%	The EPF840 stores only the valuesassociated with the maneuver with thebest PEF value.
14	Test acceptancecriteria	Time to PEF < 300 msec	40msec < Time to PEF < 300 msec	The EPF840 does not require aminimum time to the peak flow value.
15	Correction Factors
	BTPS	YES	YES	No difference
	Altitude	NO	NO	No difference
	Humidity	NO	NO	No Difference
16	# of Results stored	480 Tests	200 tests	The EPF840 stores more tests
17	Storage medium	Non-volatile EEPROM	Non-volatile EEPROM	No difference
18	Time/Date	Real-time clock	Real-time clock	No difference
19	Alert User Alarm	No alert alarms	up to 4 / day	The 2110 can be configured to "wakeup" and alarm the user to use thedevice. The EPF840 can not.
Section II. 510(k) Summary					08/25/98
	ParameterCompared	ACCUTRAX Model EPF840	Predicate Device(2110)	Difference Between
20	User Warnings
	Low battery	YES	YES	No difference
	Memory low	NO	YES	EPF840 Uses a circular buffer wherethe oldest data is overwritten by thenewest data.
	Memory full	NO	YES	EPF840 Uses a circular buffer wherethe oldest data is overwritten by thenewest data.
	Alarm Type	LCD Display & Audible buzzer	LCD Display & Audible buzzer	No difference
21	Event marker	Time and date stamp	Time and date stamp	No difference
22	Symptom scoring	Text based configurable by physician	Numeric rating of symptoms	The EPF840 has a character baseddisplay which allows for text basedsymptom entry.
23	Result printing	NO	Serial to printer	No direct printing from EPF840
24	Results download	Serial to personal computer	Serial to personal computer	No difference
25	Color zones	3 zones	3 or 4 configurable zones	The 2110 also has a purple zone.
26	Device configuration	via PC	via PC or using device keys	The EPF840 does not allow setupdirectly using the device to preventpatient tampering.
27	Testing temperature	15 to 35 Degree C	17 to 35 Degree C	Similar range
28	Power source
	Primary source	Alkaline 9-volt battery	Alkaline 9-volt battery	No difference
	RTC backup	Lithium 3V battery CR2032	Lithium 3V battery CR2032	No difference
29	Automatic power off	3 minutes	4 minutes	EPF840 shuts off 1 minute sooner. The
	ParameterCompared	ACCUTRAX Model EPF840	Predicate Device(2110)	Difference Between
				3 minute timer in the EPF840 is the timefrom the last key press or PEFmaneuver.
30	Display	LCD	LCD	No difference
31	Keyboard	Tactile switches under a front paneloverlay	Rubber membrane	Both switch technologies provide goodenvironmental protection
32	Unit Dimensions	88 mm x 112 mm x 48mm	145mm x 70mm x 87mm	The EPF840 is slightly smaller
33	Unit weight	184g with battery	190g with battery	Weights are very similar
34	Materials
	Flowhead	ABS, Cycolac 2502 (GE Plastics)	ABS, Magnum 3453	Both use ABS plastic
	Unit Body	ABS, Cycolac 2502 (GE Plastics)	ABS, Magnum 3453	Both use ABS plastic
	Flowhead to unitpneumatic connection	Silicone foam	Silicone rubber	The 2110 uses silicone rubber pre-formed tubing to pneumatically connectto the pressure transducer. TheEPF840 uses a stamped silicone foam.

2.4 Technical Comparison to Predicate Device

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KORR Medical Technologies, Inc. Section II: 510(k) Summary

Peak Flow Meter - 510(k) premarket notification 08/25/98

ート (1) 【 100mm 【 100mm

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KORR Medical Technologies, Inc. Section II: 510(k) Summary

Peak Flow Meter - 510(k) premarket notification 08/25/98

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KORR Medical Technologies, Inc. Section II: 510(k) Summary

Peak Flow Meter - 510(k) premarket notification 08/25/98

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2.5 Non-clinical Performance Data

The ACCUTRAX EPF840 electronic peak flowmeter was tested at an independent laboratory using a precision waveform generator. The peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) measurements from the EPF840 were compared against the generated values. Both PEF and FEV1 values were well within the required ATS accuracy specifications using the 24 standard waveforms and the 26 flow-time waveforms. Inter-device and intra-device variability testing demonstrated the EPF840 to comply with all variability requirements. Our evaluation showed the EPF840 to be accurate and extremely repeatable in all tests

Both the EPF840 and the predicate device was tested using Waveform #24 using a range of scale factors. The generator multiplies each flow by the scale factor. PEF reported by the EPF 840 is compared to the values reported by the generator. The scale factors tested are 0.8, 1.0, 1.2, 1.6, 2.0, 2.4, 2.8, 3.0, 4.0, and 5.7.

Both devices operated within the 10% specification of the ATS standard for peak flow.

2.6 Clinical Data

Determination of substantial equivalence is not based on assessment of clinical data.

2.7 Substantial Equivalence Conclusion

Both devices demonstrate product safety by successful completion of testing to the IEC601-1 standard. The ACCUTRAX EPF840 successfully completed independent laboratory testing for electromagnetic compatibility to the IEC601-1-2 standard.

Both devices claim to meet the American Thoracic Society (ATS) recommendations for spirometry. Performance testing at LDS Hospital (Salt Lake City, UT) demonstrates that the EPF840 meets the ATS standard recommendations.

The following decision tree was used to determine if the EPF840 is substantially equivalent to the predicate device.

2.7.1 Does the new device have same indication statements?

Yes. The new device and the predicate device report the same parameters, namely; Peak Expired Flow Rate (PEF), and Forced expired volume (FEV 1).

Both devices have a red-yellow-green zone indication based upon the peak flow rate measured. The physician is required to setup the zone indications on both devices,

Both devices provide a means for the patient to enter symptom and medication usage.

2.7.2 Does the new device have same technological characteristics in design and materials?

Yes. Both devices use a pneumotach (flowhead) with fixed obstruction that generates a backpressure in response to the measured flow rate. Both

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pneumotachs are made from ABS plastic. The enclosures are also ABS plastic. The mouthpiece on both devices has the same taper and outer diameter.

The measured pressure is used to calculate the flow rate. The flow rate is integrated to obtain volume. Both devices use a back extrapolation method to determine the start of the FEV, maneuver.

Both devices are powered from a 9-volt alkaline battery. Both devices use a CN3032 3-volt lithium battery to power the internal real-time clock.

Both devices store the FEV1/PEF values in non-volatile memory with a time and date stamp. On both devices, these data are available to the physician through a communication port adapter to a personal computer. On both devices the communication connector is a modular 4 pin connector located under the battery door.

2.7.3 Are the descriptive characteristics precise enough to ensure equivalence?

No. Performance data is also required.

2.7.4 Are performance data available to assess equivalence?

Yes. The new device was tested to and passed the ATS standard waveforms using a waveform generator.

2.7.5 Does performance data demonstrate equivalence?

Yes. Both devices meet ATS standards for monitoring devices.

2.7.6 Substantially equivalent determination:

From the above information we conclude that the new device (ACCUTRAX EPF840) is substantially equivalent to the predicate device (Vitalograph 2110 Electronic Flow Meter)

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Image /page/8/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 & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 4 1998

Mr. Scott A. Kofoed Korr Medical Technologies, Inc. 3090 East 3300 South, Suite 3B Salt Lake City, UT 84109

K982995 Re: AccuTrax Model EPF840 Requlatory Class: II (two) Product Code: 73 BZH Dated: November 3, 1998 November 6, 1998 Received:

Dear Mr. Kofoed:

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 A substantially equivalent determination assumes compliance to 895. 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 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. Scott A. Kofoed

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" (21CFR 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. Callahon

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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2.3 Intended Use

The product literature contains the text, "CAUTION: Federal Law restricts this device to sale by or on the order of a physician."

Mark Krause

PRESCRIPTION USE

OVER THE COUNTER 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).