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).

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.

AI/ML Overview

The provided K123843 document, concerning the Strohl Medical NeuroEPG, does not include a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity for diagnostic accuracy.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Intelligent Hearing System SmartEP K070608) primarily through comparison of technological characteristics and safety standards. There is no mention of a clinical performance study involving human subjects to assess the device's diagnostic or monitoring accuracy against a defined ground truth.

Here's an analysis based on the information provided, highlighting the absence of certain requested details:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative outcomes are provided in the document. The NeuroEPG System demonstrates equivalence through shared design principles, circuit designs, operating principles, and compliance with safety standards as outlined in the "Comparative Performance and Specifications" section.

Feature/Parameter	Acceptance Criteria (Not explicitly stated as such, but inferred from predicate equivalence)	Reported Device Performance (NeuroEPG System)
Intended Use	Same as Predicate	Same (SEP and AEP: Stimulate, record, process evoked potentials)
Indications for Use	Same as Predicate	Same (Recording and analysis of physiological data for diagnosis of somatosensory and auditory related disorders)
Target Population	All Ages (Predicate)	18 years and older (Difference noted, but deemed non-significant for safety/effectiveness by the submission)
Design	External box circuitry connected to CPU via USB	Similar; repackaged into a single, smaller, stand-alone unit; pre-amplifier embedded. Considered "modifications" but not "significant differences."
Sterility	Non-sterile	Non-sterile
Anatomical Sites	SEP: Upper/lower limbs and Head; AEP: Head	Same
Energy Delivery	SEP: Surface electrical signals; AEP: Auditory stimulus	Same
Where Used	Clinical Setting	Same (Hospital, clinic, etc.)
Safety (Electrical & EMC)	Conforms to IEC 60601-1 and related standards	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40. Disposable PIK meets ANSVAAMI EC12, EC53, and IEC 60601-1 (1998) [21CFR898].
Somatosensory Stimuli	Predicate values for Types, Mode, Shape, Repetition Rate, Phase/Polarity, Duration	Same as Predicate (Constant Current, Single/Dual/Train, Mono/Biphasic, 0.1-100Hz, Pos/Neg, 10-1000 µs)
Stimulus Intensity Levels (SEP)	Current: 0-100 mA; Voltage: 0-400V (into 4000 Ohms)	Current: 0-25 mA; Voltage: 0-50V (into 2000 Ohms) (Difference noted, considered non-significant)
Auditory Stimuli	Predicate values for Types, Duration, Envelopes, Intensity, Repetition Rate, Frequencies, Presentation, Masking	Same as Predicate (Clicks/Pure Tones, 25-5000 µs, various envelopes, 0-125 dB SPL, 1-100 Hz, 500-16000 Hz, Monaural/Binaural, White Noise Programmable)
Transducers (Auditory)	Insert Earphones, Bone Vibrator, Headphones, Sound Field, Ear Probe	Ear buds only (Difference noted, considered non-significant)
Measurement Parameters	Predicate values for Analysis Window, Artifact Rejection Threshold, Measured Values	Analysis Window (Variable up to 2.5 msec), Artifact Rejection Threshold (25µV fixed, vs. user selectable on predicate). Measured Values (Same plus L vs. R comparison).
Computer Requirements	PC, Windows 2000/XP, USB	Same
Fundamental Technology	Identical to predicate	Identical (stimulation and response mechanisms, scientific technology)
Software Changes	Minor, not altering safety/effectiveness (predicate)	Minor (reduced range of testing/analysis parameters due to additional software, but core data acquisition unit changes considered minor)

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

The document does not describe a specific test set or study with human subjects to evaluate the device's diagnostic performance. Therefore, there is no sample size for a test set, nor is there information on data provenance (e.g., country of origin, retrospective/prospective).
The comparison is primarily against the specifications and previous clearance of the predicate device (K070608).

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

Not applicable, as no human subject test set or ground truth establishment for diagnostic performance is described in this submission.

4. Adjudication method for the test set

Not applicable, as no human subject test set or adjudication process for diagnostic performance is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The NeuroEPG System is an evoked response testing and diagnostic device, not an AI-assisted diagnostic tool that aids human readers in interpreting images or other data. This submission does not describe an MRMC study.

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

The NeuroEPG System is presented as a device for eliciting, acquiring, and measuring evoked potentials. While it performs objective measurements, the ultimate diagnostic interpretation is still expected to be performed by trained personnel (physicians, technologists). The submission does not describe a "standalone" algorithmic performance study in the context of AI or automated diagnostic decisions, but rather the performance of the measurement system itself against its specifications and the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of diagnostic accuracy. The "ground truth" for the substantial equivalence claim relies on the established safety and performance characteristics of the predicate device and compliance with relevant industry standards (e.g., IEC 60601-1).

8. The sample size for the training set

Not applicable, as this submission does not describe a machine learning or AI-based device that requires a training set.

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

Not applicable, as this submission does not describe a machine learning or AI-based device.

In summary, this 510(k) submission for the NeuroEPG System establishes substantial equivalence by demonstrating that its technological characteristics, intended use, indications for use, and safety comply with relevant standards and are either identical or insignificantly different from a legally marketed predicate device. It does not contain a clinical performance study with defined acceptance criteria for diagnostic accuracy, nor does it address AI-specific evaluation metrics.

Summary

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K123843

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

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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 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.

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.

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510(k) Summary

	Predicate DeviceSmartEP (K070608)	The NeuroEPG System
Intended Use	SEP:Stimulate, record, and processsomatosensory evoked potentialsAEP:Stimulate, record, and processauditory evoked potentials	Same
Indications for Use	The recording and analysis ofphysiological data necessary forthe diagnosis of somatosensoryand auditory related disorders.	Same
Target Population	All Ages	18 years and older
Design	External box housing circuitryconnected to CPU via a USBconnection	Same
Sterility	Non-sterile	Same
Anatomical Sites	SEP:Upper/lower limbs and HeadAEP:Head	Same
Energy Delivery	SEP:Stimulation of upper or lowerlimbs with surface electricalsignalsAEP:Stimulation of ears with auditorystimulus	Same
Where Used	Clinical Setting	Same
Safety	Conforms to IEC 60601-1	Same
Parameter	Predicate DeviceSmartEP (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 IntensityLevels	Current: 0 - 100 mAVoltage: 0 - 400V(Continuous adjustable level withuser selectable maximum rangeinto a 4000 Ohms load)	Current: 0 - 25 mAVoltage: 0 - 50V(Continuous adjustable level withuser selectable maximum rangeinto 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, CosineCubed	Same
Intensity	0-125 dB SPL	Same
Parameter	Predicate DeviceSmartEP (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, EarProbe	Ear buds only
Measurement Parameters
Analysis Window	Variable (up to 2.5 msec)	Same
Artifact RejectionThreshold	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 rightcomparison
Computer Requirements
Computer Type	Personal Computer	Same
Operating System	Microsoft Windows 2000 or XP	Same
Interface Connection	USB (Universal Serial Bus)	Same

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510(k) Summary Page 4 of 7

15-Oct-2012 、

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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.

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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.

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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.

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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.

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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

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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 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.

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
---------------	---------

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

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