(174 days)
Not Found
No
The summary describes a standard evoked potential testing device and does not mention any AI or ML capabilities.
No
The device is described as a "testing and diagnostic device" for measuring evoked potentials and is used as a "diagnostic aid," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The NeuroEPG System is an evoked response testing and diagnostic device..." and "The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders...".
No
The device description and intended use clearly indicate the use of hardware components such as sound delivery ear buds and electrodes for eliciting, acquiring, and measuring evoked potentials. This is not a software-only device.
Based on the provided information, the NeuroEPG System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The NeuroEPG System directly interacts with the patient's body (ear canal, head, limbs) to measure bio-potentials in response to stimuli. It does not analyze samples like blood, urine, or tissue.
- The intended use describes direct patient contact and measurement of physiological responses. The device elicits, acquires, and measures evoked potentials from the patient's body.
- The anatomical sites of contact are external to the body or involve direct contact with the body surface. This is characteristic of in vivo diagnostic devices, not in vitro ones.
Therefore, the NeuroEPG System falls under the category of an in vivo diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring and measuring auditory and somatosensory evoked potentials.
The intended use of the NeuroEPG System is to objectively record evoked responses from patients 18 years of age and older, 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) and in surgical procedures for intraoperative monitoring.
Product codes (comma separated list FDA assigned to the subject device)
GWF, GWF, GWJ, GXY
Device Description
The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring, and measuring auditory and somatosensory evoked potentials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 ear bud), and the patient's head and possibly other body sites (with the contact object being 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 (with the contact object being skin-surface electrodes) and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
Indicated Patient Age Range
18 years of age and older
Intended User / Care Setting
The NeuroEPG System is intended to be used by trained personnel in a hospital, clinic, EEG/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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
JUN
5 2013
Strohl Medical NeuroEPG
Premarket Notification 510(k) Section 5 - 510(k) Summary
510(k) Summary Page 1 of 7 15-Oct-2012
510(k) Summary
Prepared By:
Strohl Medical Technologies, Inc. 126 Prospect Street Norwell, MA 02061
(888) 374-8877
(617) 249-2120
Heather Strohl
October 15, 2012
NeuroEPG System
18 years of age and older
physician's office, operating room
Telephone:
FAX:
Contact Person:
Date Summary prepared:
Name of the Device:
Common Name:
Classification Name:
Patient Population:
Environment of Use:
Contraindications:
None
Predicate Device(s):
Intelligent Hearing System SmartEP (K070608)
Evoked Response System, Nerve Stimulator/Monitor
Hospital, clinic, EEG/EP technologist's, surgeon's, or
Electrical Evoked Response Stimulator (per CFR882.1870)
Auditory Evoked Response Stimulator (per CFR 882.1900)
Device Description:
The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring, and measuring auditory and somatosensory evoked potentials.
The NeuroEPG System is intended to objectively record evoked responses from patients 18 years The Nedroid of System is nresentation of sensory stimuli. The product is indicated for use as a
1
510(k) Summary Page 2 of 7 15-Oct-2012
diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory) and in surgical procedures for intraoperative monitoring.
Indications for Use:
The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring and measuring auditory and somatosensory evoked potentials.
The intended use of the NeuroEPG System is to objectively record evoked responses from patients 18 years of age and older, 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) and in surgical procedures for intraoperative monitoring.
The NeuroEPG System is intended to be used by trained personnel in a hospital, clinic, EEG/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 ear bud), and the patient's head and possibly other body sites (with the contact object being 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 (with the contact object being skin-surface electrodes) and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
Table of Comparison and Differences vs. Predicates
The modifications described in this table are only concerned with the Auditory Evoked Potentials (AEP) and the Somatosensory Evoked Potential (SEP) testing aspects of the predicate device.
2
.
510(k) Summary
| | Predicate Device
SmartEP (K070608) | The NeuroEPG System |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | SEP:
Stimulate, record, and process
somatosensory evoked potentials
AEP:
Stimulate, record, and process
auditory evoked potentials | Same |
| Indications for Use | The recording and analysis of
physiological data necessary for
the diagnosis of somatosensory
and auditory related disorders. | Same |
| Target Population | All Ages | 18 years and older |
| Design | External box housing circuitry
connected to CPU via a USB
connection | Same |
| Sterility | Non-sterile | Same |
| Anatomical Sites | SEP:
Upper/lower limbs and Head
AEP:
Head | Same |
| Energy Delivery | SEP:
Stimulation of upper or lower
limbs with surface electrical
signals
AEP:
Stimulation of ears with auditory
stimulus | Same |
| Where Used | Clinical Setting | Same |
| Safety | Conforms to IEC 60601-1 | Same |
| Parameter | Predicate Device
SmartEP (K070608) | The NeuroEPG System |
| Patient Isolation | Type BF (IEC 60601-1)
Fiber Optic Signal Link | Same |
| Somatosensory Stimuli | | |
| Types | Constant Current or Voltage | Constant Current |
| Mode | User selectable:
Single, Dual, or Stimulus Train | Same |
| Shape | Mono or Biphasic pulses | Same |
| Repetition Rate | 0.1 - 100 Hz | Same |
| Phase/Polarity | Positive or Negative | Same |
| Duration /Pulse Width | 10 - 1000 μs | Same |
| Stimulus Intensity
Levels | Current: 0 - 100 mA
Voltage: 0 - 400V
(Continuous adjustable level with
user selectable maximum range
into a 4000 Ohms load) | Current: 0 - 25 mA
Voltage: 0 - 50V
(Continuous adjustable level with
user selectable maximum range
into a 2000 Ohms load) |
| Auditory Stimuli | | |
| Types | Clicks, Pure Tones,
Multifrequency Stimuli | Same |
| Duration | 25-5000 μs | Same |
| Envelopes | Linear, Blackman, Gaussian,
Hanning, Rectangular, Triangular,
Trapezoidal, Exact Blackman,
Cosine, Cosine Squared, Cosine
Cubed | Same |
| Intensity | 0-125 dB SPL | Same |
| Parameter | Predicate Device
SmartEP (K070608) | The NeuroEPG System |
| Repetition Rate | 1-100 Hz | Same |
| Test Frequencies | 500-16,000 Hz | Same |
| Presentation | Monaural or Binaural | Same |
| Masking | White Noise Programmable | Same |
| Transducers | Insert Earphones, Bone Vibrator,
Headphones, Sound Field, Ear
Probe | Ear buds only |
| Measurement Parameters | | |
| Analysis Window | Variable (up to 2.5 msec) | Same |
| Artifact Rejection
Threshold | User Selectable | 25μV |
| Measured Values | Response Level (μV)
Noise Level (μV)
Signal to Noise Ratio (dB)
Response Latency (msec)
Frequency (Hz) | Same plus left versus right
comparison |
| Computer Requirements | | |
| Computer Type | Personal Computer | Same |
| Operating System | Microsoft Windows 2000 or XP | Same |
| Interface Connection | USB (Universal Serial Bus) | Same |
3
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510(k) Summary Page 4 of 7
15-Oct-2012 、
4
.
510(k) Summary Page 5 of 7 15-Oct-2012
Technological Characteristics:
.
The NeuroEPG System hardware is based on modifications to the predicate device. Modifications were made by Intelligent Hearing Systems, the OEM of the predicate.
5
510(k) Summary Page 6 of 7 15-Oct-2012
The NeuroEPG hardware is very similar in electronics design to the predicate device hardware, except that the electronics hardware has been repackaged into a single, smaller, stand-alone unit. Unlike the predicate devices, there is no separate pre-amplifier unit connected to the patient in the NeuroEPG System. Instead, all of the pre-amplifier electronics have been embedded inside of the NeuroEPG Data Acquisition Unit. The same patient isolation methods are used.
The software changes within the data acquisition unit are minor and do not alter the safety and effectiveness of the device in any way. The software incorporates a reduced range of testing and analysis parameters so a broader set of personnel can perform an evoked response test. Strohl Medical has additional software that operates on the data from the data acquisition unit. Safety and Effectiveness:
The NeuroEPG System utilizes the same design principles, circuit designs, and operating principles as are used in the predicate device.
The NeuroEPG System meets the requirements of IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility respectively. It also meets the requirement of IEC 60601-2-40 for electromyographs and evoked response equipment. The disposable (PIK) meets the requirements of ANSVAAMI EC12 for Disposable ECG Electrodes and ANSI/AAMI EC53 for ECG Cables and Leadwires as well as clause 56.3c of IEC 60601-1 (1998) [21CFR898].
Substantial Equivalence
The stimulation and response mechanism are identical to the predicate. The fundamental scientific technology of the NeuroEPG System is identical to the predicate. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.
Indications - Equivalent to the predicate
Technology - The technology is identical
Operating specifications - Equivalent
Materials – The patient contact materials are identical to those in other legally marketed devices.
Environment of Use - Identical
Patient Population - Restricted to adults
Differences:
There are no significant differences between the proposed device and the predicate device.
6
510(k) Summary Page 7 of 7 15-Oct-2012
Comparative Performance and Specifications
Comparative I circler is substantially equivalent to the SmartEP device marketed by Intelligent Hearing systems with FDA 510(k) clearance number K070608.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/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 symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 5, 2013
Strohl Medical Technologies c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K123843
Trade/Device Name: NeuroEPG System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, GWF, GWJ, GXY Dated: May 14, 2013 Received: May 15, 2013
Dear Mr. Job:
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. Iisting 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.
8
Page 2 - Mr. Mark Job
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D.
Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K123843
Device Name: NeuroEPG System
Indications For Use:
The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring and measuring auditory and somatosensory evoked potentials.
The intended use of the NeuroEPG System is to objectively record evoked responses from patients 18 years of age and older, 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) and in surgical procedures for intraoperative monitoring.
The NeuroEPG System is intended to be used by trained personnel in a hospital, clinic, EEG/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 ear bud), and the patient's head and possibly other body sites (with the contact object being 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 (with the contact object being skin-surface electrodes) and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
| Prescription Use_X ___________________________________________________________________________________________________________________________________________________________ | _Over-The-Counter_Use ________________________________________________________________________________________________________________________________________________________ | |
|---|---|---|
| and and the program and the comments of the comments of the comments of the country of the country of the country of the country of the country of the county of the county of | ||
| (Part-21-CFR-801-Subpart-D)- | -(21-EFR-801-Subpart C)- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Joyce M. Whang -S |
|---|
| ------------------- |
| (Division Sign Off) |
|---|
| Division of Neurological and Physical Medicine |
| Devices (DNPMD) |
| 510(k) Number | K123843 |
|---|---|
| --------------- | --------- |