The EVOX Electro Diagnostic Device is intended for the testing of sacral reflexes, pudendal nerve terminal motor latency (PNTML) studies. electromyography (EMG), and cerebral pudendal somatosensory evoked potential (SEP).

Device Description

The EVOX Electro-Diagnostic Device utilizes Laborie Urodynamic equipment 510(k) exempt under section § 876.1620 or with another microprocessor that is compatible with the required capability.

The Laborie EVOX Electro Diagnostic Device will help diagnose and perform evaluation tests for urinary and fecal incontinence as well as other neurological and physiological assessment, including:

Pudendal Nerve Terminal Motor Latency with St Marks Electrodes Anal Sphincter CN EMG

Cerebral Pudendal Somatosensory Evoked Potential

Sacral Reflexes

Calculations will include: latency, peak, duration, conduction velocity and area.

The equipment includes the Evox Electro-diagnostic Software and the hardware required to perform the stated tests which include:

Laborie 94-based Hardware with Integrated Electrodiagnostic Stimulation .
. Ring/Bar Stimulation Electrodes
Needle/Cup/Patch EMG/ECG Electrodes .
St. Mark's Electrode and Cable .
EMG/ECG Cabling .

AI/ML Overview

The provided 510(k) summary for the KOR2614 Laborie EVOX Electro Diagnostic Device does not contain the detailed study results, acceptance criteria, or performance data typically found in a comprehensive clinical or performance study report.

Instead, this document focuses on establishing substantial equivalence to predicate devices through technical characteristics and intended use. The "Testing" section explicitly states that "Bench studies have confirmed the efficacy of the EVOX Electro Diagnostic Device. Safety testing included electrical safety testing and electromagnetic compatibility testing to recognized standards." This indicates that the device's efficacy was confirmed via bench testing, not through a clinical study with human subjects, ground truth, or expert review in the way a diagnostic AI/ML device would be evaluated.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Efficacy (via bench testing)	Confirmed by bench studies (details not provided)
Electrical Safety	Complies with IEC 60601-1 and IEC 60601-2-10 standards.
Electromagnetic Compatibility	Complies with recognized standards (details not provided).
Technical Characteristics	Detailed in the "Summary of the Technical Characteristics" table, showing the Laborie EVO's specifications against predicate devices. The implicit acceptance criterion here is that the technical specifications are comparable to, or better than, the predicate devices for achieving the intended use. (See full technical table in the original document for specific values like Common Mode Rejection, Noise, etc.)

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

Not applicable. The document states "Bench studies have confirmed the efficacy," implying a technical verification rather than a clinical test set from patient data.

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

Not applicable. No clinical test set or human ground truth described.

4. Adjudication method for the test set

Not applicable. No clinical test set or human ground truth described.

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 study was done. This device is an electro-diagnostic tool and not an AI-assisted diagnostic software in the context of this 510(k) summary.

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

This is a standalone electro-diagnostic device. Its performance is inherent in its technical capabilities for signal acquisition and processing. The "bench studies" mentioned would represent this standalone performance, although specific metrics are not detailed in this summary.

7. The type of ground truth used

For efficacy, the ground truth would have been established by comparing the device's output signals and measurements (e.g., latency, peak, duration, conduction velocity, area) against known, accurate electrical stimuli and reference measurements in a laboratory setting (bench testing).

For safety, the ground truth is established by the specified electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-10).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. This is not an AI/ML device that requires a training set of data.

Summary

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KOR2614

510(k) Summary (per 21 CFR 807.92)

MAR = $ 2009

I. Applicant

Laborie Medical Technologies, Inc. 6415 Northwest Drive, Unit 10 Mississauga Ontario Canada L4V 1X1

Contact Person: Barbara Mornet. Regulatory Affairs Deputy Tel: (802) 857-1300 Fax: (802) 878-1122 Email: bmornet@laborie.com

July 30, 2008 Date Prepared:

II. Device Name

Laborie EVOX Electro Diagnostic Device Proprietary Name: Common/ Usual Name: Classification Name: Stimulator, Electrical, Evoked Response Regulation Number: 882.1870 and 882.1550 GWF, JXE Product Codes: Classification: 2 Classification Panel: Neurology

III. Predicate Device

The Laborie Evo Electro Diagnostic Device is substantially equivalent to the Dantec Kevpoint K944547 and the Cadwell K962455 in its intended use and in its technical characteristics as well as the safety and effectiveness of the device as a diagnostic tool.

IV. Intended Use of the Device

V. Description of the Device

The EVOX Electro-Diagnostic Device utilizes Laborie Urodynamic equipment 510(k) exempt under section § 876.1620 or with another microprocessor that is compatible with the required capability.

The Laborie EVOX Electro Diagnostic Device will help diagnose and perform evaluation tests for urinary and fecal incontinence as well as other neurological and physiological assessment, including:

Pudendal Nerve Terminal Motor Latency with St Marks Electrodes Anal Sphincter CN EMG

Cerebral Pudendal Somatosensory Evoked Potential

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510(k) Summary

(per 21 CFR 807.92)

Sacral Reflexes

Calculations will include: latency, peak, duration, conduction velocity and area.

The equipment includes the Evox Electro-diagnostic Software and the hardware required to perform the stated tests which include:

Laborie 94-based Hardware with Integrated Electrodiagnostic Stimulation .
. Ring/Bar Stimulation Electrodes
Needle/Cup/Patch EMG/ECG Electrodes .
St. Mark's Electrode and Cable .
EMG/ECG Cabling .

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510(k) Summary

(per 21 CFR 807.92)

Summary of the Technical Characteristics

Componentsand or Features	Laborie EVO	Predicate Device- DantecKeypointK944547	Cadwell Sierra/Cadwell6200A K962455
Safety	Complies withIEC 60601-1standards andIEC 60601-2-10standards.		Designed to comply withrequirements of UL 544;Isolated patient connectionIEC 601-1: Type BF
Electrodeinputs	2 ElectrodeInputs: Bar,Ring, Needle,Cup or St. MarkElectrodes.	5-pin Din connectors	4 Buffered electrodeinputs with separate activeand reference 1.5 mmtouch proof connectors or5 pin DIN connector
IsolatedGroundConnections	There is mainpower supplydouble/reinforcedisolation betweenthe UDS systemandLive/Neutral/Earth, which actas anotherisolation barrier.		2 Connections
Isolation ModeRejection	No isolationamplifier is used.For IMRRinstrumentationamplifier is used.		> 150dB
Common ModeRejection	100dB	> 100 dB	90dB
Sensitivities	2,100MicroV/div	.5μV to +/- 20,00µV/div	2,5,10,20,50,100,200,500Micro V/div; 1,2,5,10,20m V/div.
Noise	6 microV peak topeak		2 micro V peak to peak(10Hz to 10kHz)
InputImpedance	> 1,000 Mohms(common mode)		> 1,000 Mohms (common mode)
Notch Filter	50-60Hz	50-60 Hz	50-60Hz
Low-cut Filters	FIR filterSelectable at 10,50, 100, 300, 500,1000, 2000, 3000,4000 Hz	Filter selectable at20, 50,100,200,300,500,1000,2000,3000,5000,10000 Hz	1-2 pole filterSelectable at 0.04, 0.1, 1,3, 10, 30, 100, 500 Hz
High-cut filters	N/A	Filter selectable at 0,0.1,0.2,0.5,1,2,5,10,20,50,100,200,500,1000,2000,3000 Hz	2-pole filter Selectable at30, 50,100,200,300,500 Hz;1, 1.5,2,3,5,10,15kHz
Commonrecordingreference input	1 input	1 input	1 input
Temperatureprobe input	N/A	20 to 45°C
StimulationSignal	MonophasicCurrent controlledfor a maximum ofup to 100mA and270 V	Biphasic and monophasic
Signal Capture-EMG	+/- 1mV range	+/-5µV to +/- 20,000 µV range available +/-1to 50mV used for test
Signal Capture-EEG	+/- 20µV range	+/-5µV to +/- 20,000 µV range available +/-5µV to 50 µV used for test
MultipleSampleAcquisition forAccuracy	Yes	Yes	Yes
Event Marking	Yes	Yes	Yes
Software DataAnalysis	Yes	Yes	Yes
ReportGeneration &Data Storage	Yes	Yes	Yes
Patient Info	Yes	Yes	Yes

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510(k) Summary

(per 21 CFR 807.92) ,

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510(k) Summary (per 21 CFR 807.92)

VI. Testing

Bench studies have confirmed the efficacy of the EVOX Electro Diagnostic Device. Safety testing included electrical safety testing and electromagnetic compatibility testing to recognized standards.

VII. Safety & Effectiveness

The Laborie EVOX Electro-Diagnostic Device is substantially equivalent to the Dantec Keypoint and the Cadwell Sierra.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the bird figure.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laborie Medical Technologies, Inc. % Ms. Barbara Mornet Regulatory Affairs Deputy 400 Avenue D, Suite 10 Williston, VT 05495-7828

MAR - 6 2009

Re: K082614

Trade/Device Name: Laborie EVOX Electro Diagnostic Device Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF, JXE Dated: January 23, 2009 Received: January 26, 2009

Dear Ms. Mornet:

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 for association 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 I va may, annols 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 rr your device to such additional controls. Existing major regulations affecting your device can may or cally of 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 r tease oc acrised that I be roundevice complies with other requirements of the Act that I Drives Intacted and regulations administered by other Federal agencies. You must or any I 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

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Page 2 - Ms. Barbara Mornet

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark McMillan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K082614

Device Name: Laborie EVOX Electro Diagnostic Device

Indications For Use:

The EVOX Electro Diagnostic Device is intended for the testing of sacral reflexes, pudendal nerve terminal motor latency (PNTML) studies, electromyography (EMG), and cerebral pudendal somatosensory evoked potential (SEP).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K08 2614
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Page 1 of ____

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).