(178 days)
Not Found
No
The document describes a standard electro-diagnostic device for neurological and physiological assessments, focusing on hardware and software for signal acquisition and calculation of standard metrics (latency, peak, duration, etc.). There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The calculations described are typical for this type of device and do not imply AI/ML processing.
No
The device is described as an "Electro Diagnostic Device" used for testing and diagnosis, not for treating conditions.
Yes
The device is explicitly named "EVOX Electro Diagnostic Device" and its intended use is for "testing of sacral reflexes, pudendal nerve terminal motor latency (PNTML) studies, electromyography (EMG), and cerebral pudendal somatosensory evoked potential (SEP)," all of which are diagnostic procedures.
No
The device description explicitly states that the equipment includes both the software and the hardware required to perform the tests, listing several hardware components.
Based on the provided information, the EVOX Electro Diagnostic Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The device description clearly states that the EVOX performs tests directly on the patient's body (sacral reflexes, pudendal nerve, anal sphincter, cerebral). It uses electrodes to stimulate and record electrical activity within the body.
- The tests performed are electrophysiological. The tests listed (PNTML, EMG, SEP, Sacral Reflexes) are all methods of measuring the electrical activity of nerves and muscles. This is a direct measurement of physiological function, not an analysis of a biological sample.
- The device description focuses on hardware for direct patient connection. The listed components like stimulation electrodes, needle/cup/patch electrodes, and cabling are all designed for direct contact with the patient.
In summary, the EVOX Electro Diagnostic Device is an in vivo diagnostic device used to assess neurological and muscular function by measuring electrical signals within the body, not an IVD which analyzes samples outside the body.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
GWF, JXE
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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
1
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 .
2
510(k) Summary
(per 21 CFR 807.92)
,
Summary of the Technical Characteristics
| Components
and or Features | Laborie EVO | Predicate Device- Dantec
KeypointK944547 | Cadwell Sierra/Cadwell
6200A K962455 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Safety | Complies with
IEC 60601-1
standards and
IEC 60601-2-10
standards. | | Designed to comply with
requirements of UL 544;
Isolated patient connection
IEC 601-1: Type BF |
| Electrode
inputs | 2 Electrode
Inputs: Bar,
Ring, Needle,
Cup or St. Mark
Electrodes. | 5-pin Din connectors | 4 Buffered electrode
inputs with separate active
and reference 1.5 mm
touch proof connectors or
5 pin DIN connector |
| Isolated
Ground
Connections | There is main
power supply
double/reinforced
isolation between
the UDS system
and
Live/Neutral/
Earth, which act
as another
isolation barrier. | | 2 Connections |
| Isolation Mode
Rejection | No isolation
amplifier is used.
For IMRR
instrumentation
amplifier is used. | | > 150dB |
| Common Mode
Rejection | 100dB | > 100 dB | 90dB |
| Sensitivities | 2,100
MicroV/div | .5μV to +/- 20,00
µV/div | 2,5,10,20,50,100,200,500
Micro V/div; 1,2,5,10,20
m V/div. |
| Noise | 6 microV peak to
peak | | 2 micro V peak to peak
(10Hz to 10kHz) |
| Input
Impedance | > 1,000 Mohms
(common mode) | | > 1,000 Mohms (common mode) |
| Notch Filter | 50-60Hz | 50-60 Hz | 50-60Hz |
| Low-cut Filters | FIR filter
Selectable at 10,
50, 100, 300, 500,
1000, 2000, 3000,
4000 Hz | Filter selectable at
20, 50,
100,200,300,500,1000,
2000,3000,5000,
10000 Hz | 1-2 pole filter
Selectable 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 at
30, 50,100,200,300,500 Hz;
1, 1.5,2,3,5,10,15kHz |
| Common
recording
reference input | 1 input | 1 input | 1 input |
| Temperature
probe input | N/A | 20 to 45°C | |
| Stimulation
Signal | Monophasic
Current controlled
for a maximum of
up to 100mA and
270 V | Biphasic and monophasic | |
| Signal Capture-
EMG | +/- 1mV range | +/-5µV to +/- 20,000 µV range available +/-1
to 50mV used for test | |
| Signal Capture-
EEG | +/- 20µV range | +/-5µV to +/- 20,000 µV range available +/-5
µV to 50 µV used for test | |
| Multiple
Sample
Acquisition for
Accuracy | Yes | Yes | Yes |
| Event Marking | Yes | Yes | Yes |
| Software Data
Analysis | Yes | Yes | Yes |
| Report
Generation &
Data Storage | Yes | Yes | Yes |
| Patient Info | Yes | Yes | Yes |
3
510(k) Summary
(per 21 CFR 807.92) ,
4
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.
5
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
6
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
7
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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