ACCUTRAX, MODEL EPF840

K982995 · Korr Medical Technologies, Inc. · BZH · Dec 4, 1998 · Anesthesiology

Device Facts

• Record ID: K982995
• Device Name: ACCUTRAX, MODEL EPF840
• Applicant: Korr Medical Technologies, Inc.
• Product Code: BZH · Anesthesiology
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

AccuTrax EPF840 is an electronic peak flow meter for home/work monitoring of PEF and FEV1. Device uses a pneumotach (flowhead) with fixed obstruction to generate backpressure; pressure transducer converts air pressure to flow signals. Flow rate is integrated to calculate volume; back extrapolation determines FEV1 start. Device stores 480 test results, symptom scores, and inhaler usage in non-volatile EEPROM with time/date stamps. Operated by patient; physician configures color zones and retrieves data via serial connection to PC. Provides LCD/audible feedback. Benefits include longitudinal tracking of lung function to support asthma management plans defined by healthcare professionals.

Clinical Evidence

Bench testing only. Device tested at an independent laboratory using a precision waveform generator with 24 standard waveforms and 26 flow-time waveforms. Results confirmed compliance with ATS accuracy and variability requirements for monitoring devices. No clinical data provided.

Technological Characteristics

Materials: ABS plastic (Cycolac 2502) for flowhead and body; silicone foam for pneumatic connection. Sensing: Pneumotach with fixed obstruction and pressure transducer. Energy: 9V alkaline battery (main), CR2032 lithium battery (RTC). Dimensions: 88mm x 112mm x 48mm. Connectivity: Serial port for PC data download. Software: Embedded firmware for signal processing and data storage.

Indications for Use

Indicated for monitoring Peak Expiratory Flow (PEF) and Forced Expiratory Volume in 1 second (FEV1) in pediatric to adult patients for home and work use. Intended for patients under the care of a licensed healthcare professional for lung conditions such as asthma.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

• Vitalograph 2110 Electronic Flow Meter (K943678)

Submission Summary (Full Text)

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

#### 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 3B<br>Salt Lake City, UT 84109 |
| Phone: | [phone] |
| Fax: | [phone] |
| 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

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.

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

# 2.3 Intended Use

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.

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

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

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

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

| | Parameter<br>Compared | ACCUTRAX Model EPF840 | Predicate Device<br>(2110) | Difference Between | |
|----------------------------|------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| 1 | Manufacture | KORR Medical Technologies | Vitalograph | | |
| 2 | Model Name | AccuTrax Model EPF840 electronic<br>Peak Flow Meter | 2110 electronic PEF/FEV₁ Diary | | |
| 3 | FDA Number | (pending) | K943678 | | |
| 4 | Parameters Measured | PEF FEV1 | PEF FEV1 | No difference | |
| 5 | Flowhead | | | | |
| | Flow detection<br>principle | Air pressure reducing mess in a flow<br>head is applied to a pressure<br>transducer. | Air pressure reducing mess in a flow<br>head is applied to a pressure<br>transducer. | No difference | |
| | Back pressure | < 1.5 cmH2O / Liter / second (complies<br>with ATS standards) | < 1.5 cmH2O / Liter / second (complies<br>with ATS standards) | No difference | |
| | Cleaning | Single patient use. Clean with warm<br>soapy water daily. Disposable. | Cold liquid recommended or<br>disposable. | The EPF840 does not recommend<br>could liquid sterilization since it has not<br>been verified or validated on this<br>device. | |
| 6 | Volume measurement | Flow integration | Flow integration | No difference | |
| 7 | Maximum recorded<br>flow rate | 875 L/minute | 999 Liter/minute | 2110 reports higher flow rate. Both<br>devices above ATS standard. | |
| 8 | Maximum recorded<br>volume | 8.50 Liter | 9.99 Liter | 2110 reports higher volume. both<br>devices above ATS standard. | |
| 9 | Volume measuring<br>accuracy | $\pm$ 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<br>"diagnostic" recommendation for the<br>ATS standard. The EPF840 is that of | |
| Section II: 510(k) Summary | | | | 08/25/98 | |
| | Parameter<br>Compared | ACCUTRAX Model EPF840 | Predicate Device<br>(2110) | Difference Between | |
| 10 | flow measuring<br>accuracy | $± 10% or ± 24 L/min whichever isgreater$ | $± 5% or ± 12 L/min whichever is greater$ | the "monitoring" recommendation for<br>the ATS standard.<br>The EPF specification is that of the<br>recommendation of the ATS standard<br>for "diagnostic" use. The 2110<br>predicate device did not test within the<br>reported $± 5%$ tolerance during<br>comparison 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 values<br>associated with the maneuver with the<br>best PEF value. | |
| 14 | Test acceptance<br>criteria | Time to PEF < 300 msec | 40msec < Time to PEF < 300 msec | The EPF840 does not require a<br>minimum 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 "wake<br>up" and alarm the user to use the<br>device. The EPF840 can not. | |
| Section II. 510(k) Summary | | | | | 08/25/98 |
| | Parameter<br>Compared | ACCUTRAX Model EPF840 | Predicate Device<br>(2110) | Difference Between | |
| 20 | User Warnings | | | | |
| | Low battery | YES | YES | No difference | |
| | Memory low | NO | YES | EPF840 Uses a circular buffer where<br>the oldest data is overwritten by the<br>newest data. | |
| | Memory full | NO | YES | EPF840 Uses a circular buffer where<br>the oldest data is overwritten by the<br>newest 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 based<br>display which allows for text based<br>symptom 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 setup<br>directly using the device to prevent<br>patient 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 | |
| | Parameter<br>Compared | ACCUTRAX Model EPF840 | Predicate Device<br>(2110) | Difference Between | |
| | | | | 3 minute timer in the EPF840 is the time<br>from the last key press or PEF<br>maneuver. | |
| 30 | Display | LCD | LCD | No difference | |
| 31 | Keyboard | Tactile switches under a front panel<br>overlay | Rubber membrane | Both switch technologies provide good<br>environmental 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 unit<br>pneumatic connection | Silicone foam | Silicone rubber | The 2110 uses silicone rubber pre-<br>formed tubing to pneumatically connect<br>to the pressure transducer. The<br>EPF840 uses a stamped silicone foam. | |
| | | | | | |

# 2.4 Technical Comparison to Predicate Device

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

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

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

ート (1) 【 100mm 【 100mm

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

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

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

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

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

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

1

{6}------------------------------------------------

# 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

{7}------------------------------------------------

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)

{8}------------------------------------------------

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.

{9}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{10}------------------------------------------------

# 2.3 Intended Use

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.

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

or

OVER THE COUNTER USE