Who is the manufacturer of NEUROEPG SYSTEM?

Strohl Medical Technologies filed the 510(k) submission for NEUROEPG SYSTEM (K123843).

What is the FDA product code for NEUROEPG SYSTEM?

GWF. It is classified under 21 CFR 882.1870 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for NEUROEPG SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NEUROEPG SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NEUROEPG SYSTEM

Q: What are the predicate devices for NEUROEPG SYSTEM?

Intelligent Hearing System SmartEP (K070608).

K123843 · Strohl Medical Technologies · GWF · Jun 5, 2013 · Neurology

Device Facts

Record ID	K123843
Device Name	NEUROEPG SYSTEM
Applicant	Strohl Medical Technologies
Product Code	GWF · Neurology
Decision Date	Jun 5, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1870
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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).

Device Story

NeuroEPG System is an evoked response testing device; elicits, acquires, and measures auditory and somatosensory evoked potentials. Input: sensory stimuli (auditory clicks/tones or electrical somatosensory pulses). Output: recorded evoked response waveforms, response levels, noise levels, signal-to-noise ratios, response latencies, and frequency data. Used in hospitals, clinics, or operating rooms by trained personnel (surgeons, technologists). Device consists of a data acquisition unit integrating pre-amplifier electronics; connects to a PC via USB. Healthcare providers use output to assess sensory function or monitor neurological status during surgery. Benefits include objective diagnostic data for sensory disorders and intraoperative monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through comparison of technical specifications and adherence to electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40).

Technological Characteristics

Single, stand-alone data acquisition unit with integrated pre-amplifier. Energy source: electrical stimulation (constant current) for SEP; auditory stimuli for AEP. Connectivity: USB to PC. Patient isolation: Type BF (IEC 60601-1) via fiber optic link. Materials: disposable electrodes (ANSI/AAMI EC12, EC53). Software: embedded in acquisition unit, PC-based analysis. Sterilization: non-sterile.

Indications for Use

Indicated for patients 18 years and older requiring auditory or somatosensory evoked potential testing as a diagnostic aid for sensory disorders or for intraoperative monitoring.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

Intelligent Hearing System SmartEP (K070608)

Related Devices

K070608 — SMARTEP, MODEL M010000 · Intelligent Hearing Systems · Jul 18, 2007
K163326 — SmartEP · Intelligent Hearing Systems · Sep 29, 2017
K120979 — CAREFUSION NICOLET EDX · Carefusion 209, Inc. · Apr 25, 2012
K991077 — MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) · Microrecording Systems Consultants, LLC · Jun 9, 1999
K143670 — ICS CHARTR EP 200 WITH VEMP · Gn Otometrics A/S · Oct 23, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {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}------------------------------------------------ - . #### 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 | |---------------|---------| |---------------|---------|