EVOX ELECTRO DIAGNOSTIC DEVICE

K082614 · Laborie Medical Technologies, Inc. · GWF · Mar 6, 2009 · Neurology

Device Facts

• Record ID: K082614
• Device Name: EVOX ELECTRO DIAGNOSTIC DEVICE
• Applicant: Laborie Medical Technologies, Inc.
• Product Code: GWF · Neurology
• Decision Date: Mar 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended 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).

Device Story

EVOX Electro Diagnostic Device performs neurological/physiological assessments for urinary and fecal incontinence. System inputs include electrical signals from patients via bar, ring, needle, cup, or St. Mark's electrodes. Hardware utilizes Laborie 94-based platform or compatible microprocessor to perform stimulation and signal acquisition. Device delivers monophasic, current-controlled stimulation (max 100mA, 270V). Software processes captured signals to calculate latency, peak, duration, conduction velocity, and area. Output provided to clinicians for diagnostic decision-making. Used in clinical settings by healthcare professionals. Benefits include objective quantification of nerve and muscle function to aid in incontinence diagnosis.

Clinical Evidence

Bench testing only. Safety and efficacy confirmed via electrical safety testing and electromagnetic compatibility testing to recognized standards. No clinical trial data provided.

Technological Characteristics

Monophasic, current-controlled stimulator (max 100mA, 270V). 2 electrode inputs (bar, ring, needle, cup, St. Mark). FIR low-cut filters (10-4000 Hz). Common mode rejection 100dB. Input impedance >1,000 Mohms. Complies with IEC 60601-1 and IEC 60601-2-10. Software-based analysis and report generation.

Indications for Use

Indicated for patients requiring diagnostic evaluation of urinary and fecal incontinence, and other neurological and physiological assessments involving sacral reflexes, PNTML, EMG, and cerebral pudendal SEP.

Regulatory Classification

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.

Predicate Devices

• Dantec Keypoint (K944547)
• Cadwell Sierra/Cadwell 6200A (K962455)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

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

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).

#### 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

| Components<br>and or Features | Laborie EVO | Predicate Device- Dantec<br>KeypointK944547 | Cadwell Sierra/Cadwell<br>6200A K962455 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Safety | Complies with<br>IEC 60601-1<br>standards and<br>IEC 60601-2-10<br>standards. | | Designed to comply with<br>requirements of UL 544;<br>Isolated patient connection<br>IEC 601-1: Type BF |
| Electrode<br>inputs | 2 Electrode<br>Inputs: Bar,<br>Ring, Needle,<br>Cup or St. Mark<br>Electrodes. | 5-pin Din connectors | 4 Buffered electrode<br>inputs with separate active<br>and reference 1.5 mm<br>touch proof connectors or<br>5 pin DIN connector |
| Isolated<br>Ground<br>Connections | There is main<br>power supply<br>double/reinforced<br>isolation between<br>the UDS system<br>and<br>Live/Neutral/<br>Earth, which act<br>as another<br>isolation barrier. | | 2 Connections |
| Isolation Mode<br>Rejection | No isolation<br>amplifier is used.<br>For IMRR<br>instrumentation<br>amplifier is used. | | > 150dB |
| Common Mode<br>Rejection | 100dB | > 100 dB | 90dB |
| Sensitivities | 2,100<br>MicroV/div | .5μV to +/- 20,00<br>µV/div | 2,5,10,20,50,100,200,500<br>Micro V/div; 1,2,5,10,20<br>m V/div. |
| Noise | 6 microV peak to<br>peak | | 2 micro V peak to peak<br>(10Hz to 10kHz) |
| Input<br>Impedance | > 1,000 Mohms<br>(common mode) | | > 1,000 Mohms (common mode) |
| Notch Filter | 50-60Hz | 50-60 Hz | 50-60Hz |
| Low-cut Filters | FIR filter<br>Selectable at 10,<br>50, 100, 300, 500,<br>1000, 2000, 3000,<br>4000 Hz | Filter selectable at<br>20, 50,<br>100,200,300,500,1000,<br>2000,3000,5000,<br>10000 Hz | 1-2 pole filter<br>Selectable at 0.04, 0.1, 1,<br>3, 10, 30, 100, 500 Hz |
| High-cut filters | N/A | Filter selectable at 0,<br>0.1,0.2,0.5,1,2,5,10,<br>20,50,100,200,500,<br>1000,2000,3000 Hz | 2-pole filter Selectable at<br>30, 50,100,200,300,500 Hz;<br>1, 1.5,2,3,5,10,15kHz |
| Common<br>recording<br>reference input | 1 input | 1 input | 1 input |
| Temperature<br>probe input | N/A | 20 to 45°C | |
| Stimulation<br>Signal | Monophasic<br>Current controlled<br>for a maximum of<br>up to 100mA and<br>270 V | Biphasic and monophasic | |
| Signal Capture-<br>EMG | +/- 1mV range | +/-5µV to +/- 20,000 µV range available +/-1<br>to 50mV used for test | |
| Signal Capture-<br>EEG | +/- 20µV range | +/-5µV to +/- 20,000 µV range available +/-5<br>µV to 50 µV used for test | |
| Multiple<br>Sample<br>Acquisition for<br>Accuracy | Yes | Yes | Yes |
| Event Marking | Yes | Yes | Yes |
| Software Data<br>Analysis | Yes | Yes | Yes |
| Report<br>Generation &<br>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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K08 2614 |
|---------------|----------|
|---------------|----------|

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