(305 days)
Not Found
No
The document describes standard signal processing techniques (signal averaging) and biofeedback mechanisms based on user-defined thresholds, not AI/ML algorithms. There is no mention of AI, ML, or related concepts like training/test sets for model development.
No
The device is described as an "evoked response testing and diagnostic device" and its "intended use" is "as a diagnostic aid and adjunctive tool in sensory related disorders." It records evoked responses to aid in diagnosis, rather than to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "SmartEP is an evoked response testing and diagnostic device" and "The product is indicated for use as a diagnostic aid."
No
The device description explicitly states that the SmartEP device is a "Windows OS personal computer (PC) based system composed of software modules, an external main hardware unit, an optional biofeedback box, and peripheral stimulus delivery and recording components and accessories." This indicates the presence of significant hardware components beyond just the software.
Based on the provided text, the SmartEP device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SmartEP Functionality: The SmartEP device works by applying sensory stimuli (auditory, somatosensory, visual, vestibular, nerve) to the patient and measuring the resulting electrical activity (evoked potentials) from the body (scalp, limbs, etc.). This is an in vivo process, meaning it's performed on a living organism, not on a sample taken from the body.
- No Mention of Samples: The description of the device and its intended use does not mention the collection or analysis of any biological samples.
Therefore, the SmartEP device falls under the category of a medical device used for physiological measurement and diagnosis, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, visual, and vestibular evoked myogenic potential data, as well as providing nerve stimulation and monitoring.
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual, and vestibular) and in surgical procedures for inter-operative nerve monitoring.
The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.
The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient's upper/lower limbs and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and to the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for visual evoked potential (VEP) testing are the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The possible anatomical sites of contact for nerve stimulation and monitoring testing are the patient's nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient's tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).
Product codes (comma separated list FDA assigned to the subject device)
GWJ, GWF, GWE, ETN
Device Description
The SmartEP device records evoked potentials by using delivery of auditory, somatosensory, visual, or nerve sensory stimuli and using signal averaging techniques to extract the evoked potential from the uncorrelated electrical activity of the brain (electroencephalography or EEG) and muscles (electromyography or EMG). The device has options for Auditory Evoked Potentials (AEPs), Somatosensory Evoked Potentials (SEPs), Visual Evoked Potentials (VEPs), Vestibular Evoked Myogenic Potentials (VEMPs), and nerve stimulation and monitoring. The SEP, VEP, and nerve stimulation and monitoring functionality. operating principles, and intended uses are the same as on the predicate SmartEP device. On the SmartEP device with VEMP modality, the AEP modality has been modified to facilitate VEMP recording and analysis with optional biofeedback. The VEMP features added are comparable to those found in the ICS Chartr 200 predicate device. The VEMP modality does not provide a diagnosis. Diagnosis is made by a medical professional.
The SmartEP device is a Windows OS personal computer (PC) based system composed of software modules, an external main hardware unit, an optional biofeedback box, and peripheral stimulus delivery and recording components and accessories. The biofeedback box, stimulation, and recording devices are connected to the main hardware unit which is connected to the PC via a Universal Serial Bus cable. Software on the computer is used for the user interface to facilitate test parameter specification and for data display and analysis purposes.
The SmartEP with VEMP device has an optional biofeedback hardware accessory (VEMP feedback box) or uses a computer monitor for indicating EMG levels during VEMP testing. The VEMP feedback box has LEDs that indicate that the measured EMG level is either below the minimum value set by the user (Low - orange LED), or is between the minimum and maximum values set by the user (Satisfactory green LED), or is above the maximum value as set by the user (High – orange LED). The computer monitor displays a bar graph and pictorial face that indicates that the measured EMG level is either below the minimum value set by the user (Low - small pink bar and sad face), or is between the minimum and maximum values set by the user (Satisfactory - medium green bar and happy face), or is above the maximum value as set by the user (High - large pink bar and sad face). Recording of VEMPs can be set to occur when the EMG level is within the user programmed satisfactory range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's ear, patient's scalp and possibly other body sites, patient's upper/lower limbs and head, patient's nerve tissue, patient's tympanic membrane and cochlear promontory, patient's head and neck
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
trained personnel in a hospital, nursery, clinic, audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.
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
First Study:
- Sample Size: 215 normal subjects
- Study Design: P1 latency values from cVEMP recordings were acquired from subjects tested on two different days.
- Results: No statistically significant differences in P1 latency values acquired from the same subjects on different days and no statistically significant differences in P1 latency values obtained from different subjects tested at two different test locations. IQR P1 latency values were low, indicating clustering near the median.
Second Study:
- Sample Size: Ten adult normal subjects
- Study Design: Right and left side cVEMP and oVEMP recordings were acquired. Subjects were tested in two test sessions on separate dates. Subject and equipment positions were changed for each session to simulate different testing locations and configurations. Acquisition parameters for cVEMP and oVEMP recordings were detailed (Transducer: Insert Earphones, Stimulus: 500Hz Blackman, Intensity: 95 dBnHL, Polarity: Rarefraction, Rate: 5.1, Number of Channels: 2, Sweeps Total: 500, Gain: 5k (cVEMP) / 100k (oVEMP), High Pass Filter: 10 Hz, Low Pass Filter: 1 kHz, Sampling Rate: 5 kHz).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing Data:
- Study Type: Conformance to standards (ES60601-1, IEC60601-1-2, IEC60601-1-6, IEC62366, IEC60601-2-40, IEC60601-1), compliance with "Premarket Notification Review Guidance for Evoked Response Stimulators" (FDA Document Number 593). Verification and validation testing.
- Key Results:
- Functionality of VEMP testing features verified through bench testing, proving equivalence to ICS Chartr EP 200 with VEMP.
- Operation of optional VEMP feedback box accessory and computer monitor for biofeedback verified to be accurate, proving equivalence to ICS Chartr EP 200 with VEMP.
- All instrument-measurable parameters acquired with calibrated instruments traceable to NIST standards.
Clinical Testing Summary:
- Study Type: Two studies performed to confirm VEMP recording repeatability and reproducibility.
- Study 1 (Repeatability of P1 latency values):
- Sample Size: 215 normal subjects.
- Key Results: No statistically significant differences in P1 latency values from cVEMP recordings across different days or different test locations. Low IQR for P1 latency values.
- Study 2 (Repeatability and Reproducibility of cVEMP and oVEMP waveforms):
- Sample Size: 10 adult normal subjects.
- Key Results (Test-Retest Repeatability - Cross Correlation Measures between two sets of 250 sweeps within each session):
- cVEMP Session 1: Left Side (Mean: 0.911, Median: 0.928, IQR: 0.103), Right Side (Mean: 0.915, Median: 0.932, IQR: 0.047)
- cVEMP Session 2: Left Side (Mean: 0.921, Median: 0.943, IQR: 0.076), Right Side (Mean: 0.941, Median: 0.956, IQR: 0.053)
- oVEMP Session 1: Left Side (Mean: 0.956, Median: 0.972, IQR: 0.049), Right Side (Mean: 0.944, Median: 0.966, IQR: 0.083)
- oVEMP Session 2: Left Side (Mean: 0.955, Median: 0.969, IQR: 0.040), Right Side (Mean: 0.951, Median: 0.969, IQR: 0.055)
- High degree of test-retest repeatability for both cVEMPs and oVEMPs with low IQR values.
- Key Results (Test Reproducibility - Cross Correlation Measures between grand averages of 500 sweeps across two sessions):
- cVEMP Session 1 Vs Session 2: Left Side (Mean: 0.868, Median: 0.883, IQR: 0.084), Right Side (Mean: 0.847, Median: 0.873, IQR: 0.117)
- oVEMP Session 1 vs Session 2: Left Side (Mean: 0.940, Median: 0.971, IQR: 0.062), Right Side (Mean: 0.902, Median: 0.950, IQR: 0.022)
- High degree of test reproducibility for both cVEMPs and oVEMPs with low IQR values. Reproducibility results indicate that subject position and equipment position did not affect the results.
- Comparison to Predicate: Mean correlation values for both cVEMP and oVEMP recordings obtained with the SmartEP with VEMP device for test-retest repeatability and reproducibility are similar or higher than those reported for the ICS Chartr EP 200 with VEMP device (K143670), which reported: cVEMP Right: 0.915, cVEMP Left: 0.916, oVEMP Right: 0.926, oVEMP Left: 0.93.
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.
Intelligent Hearing Systems SmartEP, Model M010000 (K070608), GN Otometrics ICS Chartr EP 200 with VEMP (K143670)
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
Not Found
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the largest and the third profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
Intelligent Hearing Systems Edward Miskiel President & CEO 6860 SW 81st St Street Miami. Florida 33143
Re: K163326
Trade/Device Name: SmartEP Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ, GWF, GWE, ETN Dated: August 28, 2017 Received: August 29, 2017
Dear Mr. Miskiel:
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 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) 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 general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163326
Device Name SmartEP
Indications for Use (Describe)
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, visual, and vestibular evoked myogenic potential data, as well as providing nerve stimulation and monitoring.
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnotive tool in sensory related disorders (i.e., auditory, somatosensory, visual, and vestibular) and in surgical procedures for inter-operative nerve monitoring.
The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.
The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring biopotentials).
The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient's upper/lower limbs and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and to the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
(Continued on next page.)
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K163326
Device Name SmartEP
Indications for Use (Describe)
(Continued from previous page.)
The anatomical sites of contact for visual evoked potential (VEP) testing are the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The possible anatomical sites of contact for nerve stimulation and monitoring testing are the patient's nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient's tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are twith the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image is a logo for Intelligent Hearing Systems. The logo has a blue graphic on the left side that looks like sound waves. The words "Intelligent Hearing" are in large, bold, black letters above the word "Systems", which is written in white letters on black squares.
510(k) Summary
Date Summary Prepared:
August 28, 2017
Submitter's Name and Address:
Intelligent Hearing Systems 6860 SW 81st Street Miami, FL 33143
Contact Person:
Edward Miskiel, Ph.D. Telephone: (305) 668-6102 Fax: (305) 668-6103
Device Name and Classification Panel Information:
| Trade Name: | SmartEP |
|---|---|
| Model: | M010000 |
| Common Names: | Evoked Response System, Nerve Stimulator/Monitor |
| Classification Names: | Evoked Response Auditory Stimulator (21 CFR 882.1900, GWJ) |
| Evoked Response Electrical Stimulator (21 CFR 882.1870, GWF) | |
| Evoked Response Photic Stimulator (21 CFR 882.1890, GWE) | |
| Surgical Nerve Stimulator/Locator (21 CFR 874.1820, ETN) |
Predicate Devices:
The legally marketed devices to which equivalence is claimed:
Intelligent Hearing Systems SmartEP, Model M010000 (K070608) GN Otometrics ICS Chartr EP 200 with VEMP (K143670)
Device Description
The SmartEP device records evoked potentials by using delivery of auditory, somatosensory, visual, or nerve sensory stimuli and using signal averaging techniques to extract the evoked potential from the uncorrelated electrical activity of the brain (electroencephalography or EEG) and muscles (electromyography or EMG). The device has options for Auditory Evoked Potentials (AEPs), Somatosensory Evoked Potentials (SEPs), Visual Evoked Potentials (VEPs), Vestibular Evoked Myogenic Potentials (VEMPs), and nerve stimulation and monitoring. The SEP, VEP, and nerve stimulation and monitoring functionality. operating principles, and intended uses are the same as on the predicate SmartEP device. On the SmartEP device with VEMP modality, the AEP modality has been modified to facilitate VEMP recording and analysis with optional biofeedback. The VEMP features added are comparable to those found in the ICS Chartr 200 predicate device. The VEMP modality does not provide a diagnosis. Diagnosis is made by a medical professional.
5
The SmartEP device is a Windows OS personal computer (PC) based system composed of software modules, an external main hardware unit, an optional biofeedback box, and peripheral stimulus delivery and recording components and accessories. The biofeedback box, stimulation, and recording devices are connected to the main hardware unit which is connected to the PC via a Universal Serial Bus cable. Software on the computer is used for the user interface to facilitate test parameter specification and for data display and analysis purposes.
The SmartEP with VEMP device has an optional biofeedback hardware accessory (VEMP feedback box) or uses a computer monitor for indicating EMG levels during VEMP testing. The VEMP feedback box has LEDs that indicate that the measured EMG level is either below the minimum value set by the user (Low - orange LED), or is between the minimum and maximum values set by the user (Satisfactory green LED), or is above the maximum value as set by the user (High – orange LED). The computer monitor displays a bar graph and pictorial face that indicates that the measured EMG level is either below the minimum value set by the user (Low - small pink bar and sad face), or is between the minimum and maximum values set by the user (Satisfactory - medium green bar and happy face), or is above the maximum value as set by the user (High - large pink bar and sad face). Recording of VEMPs can be set to occur when the EMG level is within the user programmed satisfactory range.
Intended Use
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual, and vestibular) and in surgical procedures for inter-operative nerve monitoring.
Comparison with Predicate Devices
Comparison of Indications for Use
Device Under Review: SmartEP, M010000 with VEMP
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, visual, and vestibular evoked myogenic potential data, as well as providing nerve stimulation and monitoring.
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual, and vestibular) and in surgical procedures for inter-operative nerve monitoring.
The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.
The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient's upper/lower limbs and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and to the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for visual evoked potential (VEP) testing are the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio
6
potentials).
The possible anatomical sites of contact for nerve stimulation and monitoring testing are the patient's nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient's tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).
Predicate Device: SmartEP, M010000 (K070608)
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring.
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual) and in surgical procedures for inter-operative nerve monitoring.
The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.
The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient's upper/lower limbs and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and to the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for visual evoked potential (VEP) testing are the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring biopotentials).
The possible anatomical sites of contact for nerve stimulation and monitoring testing are the patient's nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient's tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
Predicate Device: ICS Chartr EP 200 with VEMP (K143670)
The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.
Intelligent Hearing Systems considers that the different phrasings in the indications for use are not critical to the intended use of the device and do not affect the safety and effectiveness of the device when used as labelled.
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Comparison of Technological Characteristics
The SEP, VEP, and nerve stimulation and monitoring technological characteristics are the same as on the predicate SmartEP device (K070608). With the modified SmartEP with VEMP device, the AEP modality has been modified to facilitate VEMP recording and analysis with optional biofeedback.
Comparisons of technological characteristics with respect to VEMP testing of the SmartEP device with the GN Otometrics ICS Chartr EP 200 with VEMP predicate device (K143670) are given in the table below:
| Parameter for
Comparison | Predicate Device
ICS Chartr EP 200 with VEMP
(K143670) [VEMP Modality] | Device Under Review
SmartEP
[VEMP Modality] | Impact of
Difference(s) on
Safety and
Effectiveness
[Blank if No
Difference] |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| VEMP Testing
Modality | System features for VEMP testing | Same | |
| Configuration/
Hardware
Implementation | Windows OS personal computer-
based system composed of software
modules, an external main hardware
unit, and peripheral stimulus delivery
and recording components and
accessories (Universal Serial Bus
interface) | Same | |
| Power | AC line power | Same | |
| Energy Used
and/or
Delivered | Stimulation of vestibular/auditory
system with auditory stimuli | Same | |
| Configuration
Photo | Image: Chartr EP 200 | Image: SmartEP | |
| Size/Weight | Chartr EP 200 main unit:
4.9cm x 34.2cm x 28.7cm
(2in x 13.6in x 11.3in),
2.7kg (5lbs 7oz)
Chartr EP 200 preamplifier:
3cm x 9.9cm x 16.4cm
(1.19in x 3.88in x 6.44in),
0.27kg (9.5oz) | Main hardware unit
(includes internal
preamplifier):
4.76cm x 38.20cm x 25.00cm
(1.87in x 15.04in x 9.84in),
1.13kg (2.50lbs) | Differences in the
dimensions/weight
of these
components have
no impact on safety
or effectiveness. |
| VEMP
Biofeedback | Enclosure with three LEDs for
indicating that EMG level is either
below the set minimum value, or
between the set minimum and
maximum values, or is above the set
maximum value | Same with optional
biofeedback display on
computer monitor | |
| VEMP Feedback
Box
Photo | Image: VEMP MONITOR | Image: Feedback | Differences in the
color of the
feedback boxes
have no impact on
safety or
effectiveness. |
| VEMP Feedback
Box
Size/Weight | 2.9cm x 6.2cm x 9.5cm
(1.13in x 2.44in x 3.75in),
0.13kg (4.5oz) | 2.50cm x 5.00cm x 10.00cm
(0.98in x 1.97in x 3.94in),
0.1kg (2.9oz) | Differences in the
size/weight of the
feedback box have
no impact on safety
or effectiveness. |
| Human Factors | Personal computer software user
interface
Simple, easy-to-follow instructions | Same | |
| Biocompatibility | Assumed all patient-contacting
accessories for VEMP testing are
biocompatible | All patient-contacting
accessories used with the
SmartEP device for VEMP
testing are biocompatible
These accessories have either
received FDA market
clearance by their respective
manufacturers, or are pre-
amendment devices (i.e., sold
prior to May 28, 1976), or are
Class I devices exempt from
the 510(k) process (e.g.,
earphone cushions/tips for
audiometric testing per CFR
874.1100) | Since both devices
use biocompatible
patient-contacting
accessories, there is
no impact on safety
or effectiveness. |
| Sterility | None Required | Same | |
| Safety
Standards | EN60601-1 + A1 + A2
EN60601-1-2 | Same | |
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Performance Testing Data
The modified SmartEP device conforms to the following standards:
- · ES60601-1, Edition 3.1, 2012, "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance." 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. (FDA Recognition Number 19-4)
- · IEC60601-1-2, Edition 3.0, 2007, "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests." (FDA Recognition Number 19-1)
- · IEC60601-1-6, Edition 3.1, 2013, "Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability." (FDA Recognition Number 5-89)
- · IEC62366, Edition 1.0, 2014, "Medical Devices Part 1: Application of Usability Engineering to Medical Devices." (FDA Recognition Number 5-87)
- · IEC60601-2-40, Edition 1.0, 1998, "Medical Electrical Equipment, Part 2-40: Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment."
- · IEC60601-1, Edition 2.0, 1995, "Medical Electrical Equipment, Part 1: General Requirements for Safety." 1988 and A1:1991 and A2:1995
The modified SmartEP device meets the requirements of the FDA guidance document "Premarket Notification Review Guidance for Evoked Response Stimulators" (FDA Document Number 593).
Verification and validation testing was performed on the SmartEP device to ensure that the output parameters meet the design input specifications and that the device meets its intended uses. The functionality of the VEMP testing features were verified through bench testing using different input signals and user-settings. The operation of the VEMP testing modality of the SmartEP device was validated and proved to be equivalent to the operation of the VEMP testing modality of the ICS Chartr EP 200 with VEMP predicate device (K143670).
The operation of the optional VEMP feedback box accessory and the optional computer monitor for biofeedback (indication of measured EMG levels) were verified to be accurate with different userspecified voltage monitoring settings and different voltage levels supplied to the device amplifier inputs. The operation of the optional VEMP feedback box accessory for the modified SmartEP device proved to be equivalent to the operation of the optional VEMP feedback box accessory for the ICS Chartr EP 200 with VEMP predicate device (K143670).
All instrument-measureable parameters for the SmartEP device were acquired with calibrated instruments traceable to NIST standards.
Clinical Testing Summarv
Two studies were performed with using the SmartEP with VEMP device to confirm VEMP recording repeatability and reproducibility.
In the first study, P1 latency values from cVEMP recordings acquired from 215 normal subjects who were tested on two different days were analyzed. There were no statistically sigmificant differences in P1 latency values acquired from the same subjects on different days and there were no statistically
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significant differences in P1 latency values obtained from different subjects tested at two different test locations. In addition, the IQR (75th – 25th percentile) P1 latency values were also low, indicating a clustering of values near the median.
The second study was performed to confirm the repeatability of cVEMP and oVEMP waveforms. Right and left side cVEMP and oVEMP recordings were acquired from ten adult normal subjects. Subjects were tested in two test sessions on separate dates. The subject and equipment positions were changed for each session in order to simulate different testing locations and configurations. The acquisition parameters are listed in the table below:
| cVEMP | oVEMP | |
|---|---|---|
| Transducer | Insert Earphones | Insert Earphones |
| Stimulus | 500Hz Blackman | 500Hz Blackman |
| Intensity | 95 dBnHL | 95 dBnHL |
| Polarity | Rarefraction | Rarefraction |
| Rate | 5.1 | 5.1 |
| Number of Channels | 2 | 2 |
| Sweeps Total | 500 | 500 |
| Gain | 5k | 100k |
| High Pass Filter | 10 Hz | 10 Hz |
| Low Pass Filter | 1 kHz | 1 kHz |
| Sampling Rate | 5 kHz | 5 kHz |
Acquisition Parameters for cVEMP and oVEMP recordings
Test-Retest Repeatability based on the cross correlation measures between two sets of 250 sweeps acquired within each session are presented in the two tables below.
Correlation cVEMP waveforms (5-35 ms) - Session 1
| Left Side | Right Side | |
|---|---|---|
| Mean: | 0.911 | 0.915 |
| Median: | 0.928 | 0.932 |
| IQR (75th - 25th percentile) | 0.103 | 0.047 |
Correlation of cVEMP waveforms (5-35 ms) - Session 2
| Left Side | Right Side | |
|---|---|---|
| Mean: | 0.921 | 0.941 |
| Median: | 0.943 | 0.956 |
| IQR (75th – 25th percentile) | 0.076 | 0.053 |
Correlation oVEMP waveforms (4-20 ms) - Session 1
| Left Side | Right Side | |
|---|---|---|
| Mean: | 0.956 | 0.944 |
| Median: | 0.972 | 0.966 |
| IQR (75th - 25th percentile) | 0.049 | 0.083 |
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Correlation oVEMP waveforms (4-20 ms) - Session 2
| Left Side | Right Side | |
|---|---|---|
| Mean: | 0.955 | 0.951 |
| Median: | 0.969 | 0.969 |
| IQR (75th - 25th percentile) | 0.040 | 0.055 |
Based on the mean and median cross correlation measures obtained within each session, the results indicate a high degree of test-retest repeatability for both cVEMPs. The IQR (75" – 25th percentile) values were also low, indicating a clustering of values near the median.
Test Reproducibility based on the cross correlation measures between grand averages of 500 sweeps acquired across two sessions are presented in the table below.
| Correlations of cVEMP Waveforms - Session 1 Vs Session 2 | ||
|---|---|---|
| Left Side | Right Side | |
| Mean: | 0.868 | 0.847 |
| Median: | 0.883 | 0.873 |
| IQR (75th - 25th percentile) | 0.084 | 0.117 |
Correlations of cVEMP waveforms - Session 1 vs Session 2
Correlations of oVEMP waveforms - Session 1 vs Session 2
| Left Side | Right Side | |
|---|---|---|
| Mean: | 0.940 | 0.902 |
| Median: | 0.971 | 0.950 |
| IQR (75th - 25th percentile) | 0.062 | 0.022 |
Based on the mean and median cross correlation measures obtained across sessions, the results indicate a high degree of test reproducibility for both cVEMPs and oVEMPs. The IQR (75th - 25th percentile) values were also low, indicating of values near the median. The reproducibility results indicate that subject position and equipment position did not affect the results.
In the 510(k) Summary for the predicate ICS Chartr EP 200 with VEMP device (K143670), the following data correlation values were reported in the table below.
| | cVEMP (5 -
35ms) | | oVEMP (4 - 20
ms) | |
|----------|---------------------|-------|----------------------|------|
| | Right | Left | Right | Left |
| Mea
n | 0.915 | 0.916 | 0.926 | 0.93 |
Correlation values for predicate device (K143670)
The mean correlation values for both cVEMP and oVEMP recordings obtained the SmartEP with VEMP device for both test-retest repeatability and reproducibility are similar or higher than those reported for the ICS Chartr EP 200 with VEMP device.
Substantial Equivalence
Based on the comparison of technological characteristics and performance testing data, the modified SmartEP device is substantially equivalent with respect to Vestibular Evoked Myogenic testing to the ICS Chartr EP 200 with VEMP device (K143670), and is equivalent to the predicate SmartEP device (K070608) with respect to Auditory, Somatosensory, and Visual Evoked Potentials, and nerve stimulation and monitoring.
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Conclusions
Based on design controls, comparison of technological characteristics, and performance testing data, the modified SmartEP device is as safe and effective as, and is substantially equivalent to the identified predicate devices.