The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).

Device Description

The EPAD system consists of the following components/accessories:

EPAD Headbox EPAD Headbox Power Supply EPAD Tablet Computer (includes power supply and USB cable) Stimulator Left Blue Cable Assembly (110 inches) Stimulator Right Yellow Cable Assembly (110 inches) Acquisition Left Red Cable Assembly (91 inches) Acquisition Right White Cable Assembly (92 inches) Stimulator Left Blue Short Cable Assembly (67 inches) Stimulator Right Yellow Short Cable. Assembly (67 inches) Acquisition Left Red Short Cable Assembly (44 inches) Acquisition Right White Short Cable Assembly (72 inches) Adapter Cable for EPAD Headbox (for leakage current testing)

Upper Limb Electrodes package

Lower Limb Electrodes package

The EPAD Headbox contains a complete data acquisition system that has built-in amplifiers, analog to digital converters, and digital signal processors. User interface is via tablet touchscreen computer provided with the EPAD System and running the Android operating system. The EPAD software application is preloaded onto the tablet. Data can be transferred to an external computer for archiving purposes. Communication between the EPAD Headbox and tablet is via Bluetooth wireless or USB connection.

Electrode cables are provided for left and right stimulation and left and right acquisition, color coded for correct connection to the EPAD Headbox: Custom cutaneous electrodes for stimulus and acquisition are provided by SafeOp for use with the EPAD. A total of 11 electrodes are applied for full patient monitoring (upper and lower limbs). The SafeOp electrodes are wet qel, single patient use, disposable, and biocompatible for short term (<24 hours) use on intact skin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EPAD™ device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the EPAD™ primarily establishes substantial equivalence through a comparison with predicate devices and nonclinical testing that confirms safety and performance against established standards. Direct "acceptance criteria" for diagnostic performance (like sensitivity/specificity) are not explicitly stated for a clinical study comparing the AI's diagnostic ability to a gold standard. Instead, the acceptance is based on meeting technical specifications and demonstrating safety and effectiveness.

However, we can infer performance criteria from the non-clinical testing performed and the comparison to predicate devices. The "reported device performance" refers to the results of these tests.

Category	Acceptance Criteria (Inferred/Stated from Predicates/Standards)	Reported Device Performance	Study proving compliance
Alert Algorithm Performance	Ability to detect waveform changes of reduced amplitude (>50%) and increased latency (>10%) under minimal, moderate, and extreme noise conditions.	The EPAD was able to detect waveform changes of reduced amplitude (>50%) and increased latency (>10%) under all noise conditions (minimal, moderate, and extreme).	Alert Algorithm Testing
Software Efficacy	All software requirements are fulfilled and all software hazards mitigated with no unresolved anomalies.	All software requirements have been fulfilled and all software hazards have been mitigated. There are no unresolved anomalies in the EPAD software.	Software verification and validation testing
Biocompatibility	Safe for short-term (<24 hours) contact with intact skin (meeting ISO 10993-1 requirements for cytotoxicity, sensitization, and irritation/intracutaneous reactivity).	Electrodes are safe for short-term (<24 hours) contact with intact skin. Specific testing included cytotoxicity, sensitization, and irritation/intracutaneous reactivity, meeting ISO 10993-1.	Biocompatibility testing on patient-contacting materials
Shelf Life (Electrodes)	15-month shelf life with all functional tests passed following accelerated aging (including Impedance monitoring, visual inspection, ANSI/AAMI EC12:2000 Section 5.2.2 for Disposable ECG Electrodes tests, Electrode Impedance values on forearm, and Electrode evoked potential responses).	All tests conducted following accelerated aging of the electrodes in their final packaging were passed, establishing a 15-month shelf life. This included impedance monitoring, visual inspection, ANSI/AAMI EC12:2000 tests, electrode impedance values on forearm, and electrode evoked potential responses.	Accelerated aging testing
Electrical Safety	Compliance with UL60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-40 standards.	All tests passed with no need for device modifications for UL60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-40.	Electrical Safety and Electromagnetic Compatibility Testing
EMC	Compliance with IEC 60601-1-2 standard.	All tests passed with no need for device modifications for IEC 60601-1-2.	Electrical Safety and Electromagnetic Compatibility Testing
FCC Certification	Compliance with FCC regulations under 47 CFR Part 15 for Bluetooth wireless technology.	All tests passed related to FCC Certification for the Bluetooth wireless technology.	FCC Certification Testing (conducted by tablet manufacturer)
Signal Quality	Acceptable noise level peak-to-peak, CMRR adjustment, LF/HF filter performance, DC offset, cross-talk, gain, and impedance circuit qualification on each channel.	Tests validate the quality of waveform signals from Headbox to Tablet, including noise level peak-to-peak, CMRR adjustment, filter performance (LF, HF), DC offset, cross-talk, gain, and impedance circuit qualification. All test results met the test protocol acceptance criteria. (Specific quantitative results not provided in summary).	EPAD Signal Quality Tests (Functional Performance Testing)
Wireless Coexistence	No observed decline in data transmission between the EPAD Headbox and Tablet in the presence of multiple simultaneously transmitting wireless devices.	There was no observed decline in data transmission between the EPAD Headbox and Tablet under the test conditions (multiple wireless devices transmitting simultaneously).	Wireless Coexistence Testing (Functional Performance Testing)
Electrode Functional	Meet requirements per AAMI/ANSI EC12:2000: Disposable ECG Electrodes (Section 5.2.2: 10-Hz AC impedance, individual pair; Combined offset instability and internal noise; DC voltage offset, Bias test).	EPAD electrodes meet functional test requirements per AAMI/ANSI EC12:2000: Disposable ECG Electrodes (specifically Section 5.2.2 tests: 10-Hz AC impedance, combined offset instability and internal noise, and DC voltage offset/bias test).	Accelerated aging testing (as part of shelf-life) and likely separate functional performance testing specifically for electrodes.
Max Voltage	Within acceptable range compared to predicates (similar expected max current). Protektor 32 has 400VDC with 4kΩ load.	380 VDC with 3.8 kΩ load impedance. Deemed substantially equivalent as "Slightly lower maximum driving voltage but same expected maximum current."	(Comparison to Predicate)
Pulse Duration	Within range offered by predicates and appropriate for EPAD modes. Predicates range from 0.05 msec to 1.0 msec.	Choose from 0.1, 0.2 or 0.3 msec settings. Deemed appropriate for EPAD modes.	(Comparison to Predicate)
Repetition Rate	Within range offered by predicates and appropriate for EPAD modes. Predicates range from 0.1 Hz to 1000 Hz.	0.1 to 50 Hz. Deemed appropriate for EPAD modes.	(Comparison to Predicate)
Timebase	Within range offered by predicates and appropriate for EPAD modes. Protektor 32 has 0.5 ms/division to 500 ms/division.	2 ms/division to 10 ms/division. Deemed appropriate for EPAD modes.	(Comparison to Predicate)
Sensitivity	Within range offered by predicates and appropriate for EPAD modes. Protektor 32 has 0.1 µV/division to 5 mV/division.	0.5 µV/division to 20 µV/division. Deemed appropriate for EPAD modes.	(Comparison to Predicate)
High Frequency Filter	Appropriate for EPAD modes (SSEP and NMJ tests requiring HFF of 3 kHz), even if different from general-purpose predicate devices. Predicate Protektor 32 has 30 Hz to 15 kHz.	30 Hz to 3 kHz. Justified as appropriate for SSEP and NMJ tests.	(Comparison to Predicate)

2. Sample Size Used for the Test Set and Data Provenance

Test Set: Non-clinical testing mainly involved hardware, software, and component-level assessments rather than a clinical "test set" of patient data for diagnostic performance.
- For the Alert Algorithm Testing, the summary states it was tested "under minimal, moderate, and extreme noise conditions," implying simulated or laboratory conditions rather than patient data. No specific number of cases or data provenance is mentioned.
- For Electrode Functional Testing (AAMI/ANSI EC12:2000), these are standard bench tests on electrode samples. The sample size would be number of electrodes tested, but this is not specified.
- For Biocompatibility Testing, the sample size would be biological assays and animal tests. Not specified in summary.
- Data Provenance: Not applicable for most non-clinical tests mentioned. For any implicitly simulated data (like for the alert algorithm), no provenance (country, retrospective/prospective) is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the summary. Since the testing described is primarily non-clinical (engineering, software, biocompatibility), there was no "ground truth" derived from human experts for a diagnostic task in the traditional sense. The alert algorithm's performance criteria (amplitude and latency changes) are predefined thresholds not requiring expert adjudication in the context of this summary.

4. Adjudication Method for the Test Set

Not applicable / None described. The non-clinical testing does not appear to involve human observers or an adjudication process for ground truth.

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

No MRMC comparative effectiveness study was done or described in this 510(k) summary. The EPAD incorporates an alert algorithm, but its performance is evaluated in a standalone manner against predefined thresholds, not as an AI-assisted diagnostic tool for human readers in a clinical study.

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

Yes, a form of standalone performance was assessed for the "Alert Algorithm Testing." The algorithm's ability to detect waveform changes (reduced amplitude and increased latency) was tested independently under various noise conditions.
- Performance: "The EPAD was able to detect waveform changes of reduced amplitude (>50%) and increased latency (>10%) under all noise conditions."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the Alert Algorithm: The "ground truth" was defined by predefined quantitative thresholds for waveform changes: >50% amplitude reduction and >10% latency increase. This is a technical, rather than a clinical, ground truth.
For other non-clinical tests (e.g., electrical safety, biocompatibility, signal quality), the ground truth is compliance with established engineering standards and specifications.

8. The Sample Size for the Training Set

The summary does not provide information on a training set sample size. As a 510(k) submission for a device primarily focused on evoked potential recording and basic alert logic, it doesn't describe the development of a complex machine learning model requiring a distinct training set. If the alert algorithm involved any learned parameters, this information is not detailed.

9. How the Ground Truth for the Training Set was Established

Not detailed / Not applicable as a distinct training set and its ground truth establishment are not discussed in this 510(k) summary. If the alert algorithm's thresholds were derived from clinical data, the method for establishing that ground truth is not provided.

Summary

{0}------------------------------------------------

EPAD™ 510(k)

Revised Section 4: 510(k) Summary

K132616

4.1 Date Prepared	January 23, 2014	JAN 24 2014
4.2 Contact Person	Curt LaBelle, MDCEO, SafeOp Surgical, Inc.T: (203) 629-8700Curt@Safeopsurgical.com
4.3 Device Trade Name	EPAD TM (Evoked Potential Assessing Device).
4.4 Classification Nameand Regulation	Evoked Response Electrical Stimulator21 CFR 882.1870, GWF, Class II
4.5 Device Manufacturer	SafeOp Surgical, Inc.263 Tresser BlvdStamford, CT 06901
4.6 Predicate Device(s)	Protektor 32, K093304NeuroEPG, K123843

4.7 Indications for Use

The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).

Summary Device Description 4.8

The EPAD system consists of the following components/accessories:

Revised 510(k) Summary - Page 1 of 14

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Revised Section 4: 510(k) Summary

Acquisition Right White Short Cable Assembly (72 inches) Adapter Cable for EPAD Headbox (for leakage current testing)

Upper Limb Electrodes package

Lower Limb Electrodes package

Technological Comparison to Predicate Device 4.8

The following table provides a detailed side-by-side comparison of technical characteristics of the proposed device to the named predicate devices. The table also includes a discussion of each difference and iustification for substantial equivalence.

{2}------------------------------------------------

feOp Surgical,

ction 4: 510(k) Summ

Discussion of
Differences &
ustification for S EPAD modes are a sub
he modes offered by the modes offered by th
Protektor. lo differenc Predicate
NeuroEPG
K123843)* SSEP, AE Yes SEP, BAEP, AEP, VE
EG, TcMEP, EMG Predicate
rotektor 32
K093304)* res Proposed
afeOp EPAD שירות המורשים של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המ SEP, NM neral Specification (es Aicroprocesso
controlled Categor dications Operating modes use

ction 4 - Page 3

PAD™ 510(

{3}------------------------------------------------

EPAD™ 510(k)

SafeOp Surgical, Inc.

Section 4: 510(k) Summary

Category	ProposedSafeOp EPAD™	PredicateProtektor 32(K093304)*	PredicateNeuroEPG(K123843)**	Discussion ofDifferences &Justification for SE
User interface	Tablet (Google Nexus 7)	Laptop or desktop PC	PC	Alternate I/O technology:touchpad tablet vs keyboardcomputer. Hardware andsoftware testing presented in510(k) demonstrate safety,effectiveness and SE.
OperatingSystem	Google Android	Windows XP	Microsoft Windows(2000 or XP)	Alternate operating system.Android OS validated forEPAD as part of softwareV&V.
Interfaceconnection	Bluetooth or USB	USB	USB	Alternate communicationprotocol. Compliance withFDA guidance for RFWireless Technology inMedical Devices andapplicable FCC regulations..
Power supply	100 to 240 VAC, 50-60 Hz(input); 15 VDC, 1.6A(output)	90 to 264 VAC, 47-63 Hz	Not stated	No difference

Section 4 - Page 4 of 14

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feOp Surgical, I

ction 4: 510(k) Summ

Physical size different design. EPP
EPA Discussion of
Differences &
istification for S annot compare, weight
ated for predicates. PAD has lower power
Sumption in du features
Sumption in du fersioner in the count
Province and management in the comments of the comments of the comments of stimulation st o difference NeuroEPG
K123843)* Predicate Not stated Not stated lot state lot state ative humidity: 36 rotektor 3
K093304)* nperature: 10°C Predicate lot stated 60 W 5% .8" x 4.7" x 0.4"
19.9cm x 12cm x 1 cr mperature: 10° to 40
ax 35°C for Tablet ax 35°C for Tablet ax 35°C for supply)
wer supply)
lative Humidity: 30% Proposed
feOp EPAD eadbox:
eadbox: < 2 | ablet: < 1 Ib 24 W Category Power
consumptio Operating
nvironmer Dimension Veigh

ection 4 - Page 5

PAD™ 510(

{5}------------------------------------------------

feOp Surgical,

PAD™ 510(

ction 4: 510(k) Summ

Discussion of
Differences &
stification for S difference from Prote Trigger in/out not needs
三PAD because EPAD because EPAD o
not support external
stimulators. wer stimulus channels were stimulus No difference No differenc No differenc e BF (IEC 60601-1)
er optic signal link ontinuously
djustable level with
ser selectable level with
taximum range int urrent: 0 to 25 m
oltage: 0 to 50 V Predicate
NeuroEPG
K123843)* onstant curre Not statec lot stated fot stated 2KΩ load es, TTL pulse throu
NC connector be BF (IEC 60601)
parate isolation bo Predicate
rotektor 32
K093304)* onstant currer 0 to 100 mA Up to 16 imulus (for peripheral nerve stimulation modes onl Yes , stimulus and acquisit
th handled via EPAD;
port for external e BF (IEC 60601-11)
Jation amplifiers wit
AD Headbox Proposed
feOp EPAD onstant currer to 100 m/ imulators Jp to 6 (es fety feature Patient isolation Stimulus
intensity levelt Electrocauter
detection rigger in/ou imulus typ Categor Number of
stimulator channels

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10
9
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5
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{6}------------------------------------------------

EPAD™ 510(k)

SafeOp Surgical, Inc.

Section 4: 510(k) Summary

Category	ProposedSafeOp EPAD™	PredicateProtektor 32.(K093304)*	PredicateNeuroEPG(K123843)**	Discussion ofDifferences &Justification for SE
Max voltage	380 VDC with 3.8 kΩ loadimpedance	400 VDC with 4 kΩ loadimpedance	Not stated	Slightly lower maximumdriving voltage but sameexpected maximum current.
Pulse duration(pulse width)	Choose from 0.1, 0.2 or 0.3msec settings	Choose from 0.05,0.1,.0.2, 0.5 and 1.0 msecsettings	10 µsec to 1 msec	EPAD pulse durations arewithin those offered bypredicates, appropriate forEPAD modes.
Repetition rate	0.1 to 50 Hz	0.3 to 1000 Hz	0.1 to 100 Hz	EPAD frequencies are withinthose offered by predicates,appropriate for EPADmodes.
Stim outputindicator	Yes - Amber LED	Yes - Amber LED	Not stated	No difference
Category	ProposedSafeOp EPADTM	PredicateProtektor 32(K093304)*	PredicateNeuroEPG(K123843)**	Discussion ofDifferences &Justification for SE
Waveform AcquisitionNumber ofacquisitionchannels	Up to 8, 6 currently active	32	Not stated	Fewer acquisition channelsneeded for EPAD due tofewer operatingmodes/electrodes.
Waveformdisplay	Yes	Yes	Yes	No difference
Timebase	2 ms/division to 10ms/division	0.5 ms/division to 500ms/division	Not stated	Timebase range for EPADwaveforms is within thatoffered by predicates,appropriate for EPADmodes.
Sensitivity	0.5 µV/division to 20µV/division	0.1 µV/division to 5mV/division	Not stated	EPAD sensitivity range iswithin that offered bypredicates, appropriate forEPAD modes.
Rejection	Independent rejection foreach channel plus cauterydetection ground lead	Independent rejection foreach channel	Yes, artifact rejectionthreshold of 25 μV	No difference
InputImpedance	>50 MΩ	>50 MΩ	Not stated	No difference
Common moderejection ratio(CMRR)	>93 dB	>93 dB	Not stated	No difference
Category	ProposedSafeOp EPAD™	PredicateProtektor 32(K093304)*	PredicateNeuroEPG(K123843)**	Discussion ofDifferences &Justification for SE
Low frequencyfilter	0.1 Hz to 500 Hz	0.1 Hz to 500 Hz	Not stated	No difference
High frequencyfilter	30 Hz to 3 kHz	30 Hz to 15 kHz	Not stated	The Protektor is a generalpurpose device with broadneurological monitoringmodes. As such it iscapable of acquiring signalsusing high frequency filters(HFF) up to 15 kHz. TheSSEP and NMJ tests of theEPAD only require a HFF of3 kHz.
Notch filter	50 or 60 Hz	50 or 60 Hz	Not stated	No difference
Noise level	< 20nV/√Hz	< 20nV/√Hz	Not stated	No difference
Electrodes
Anatomicalsites	SSEP: Upper/lower limbsand head/neck	SSEP: Upper/lower limbsand head/neckAEP: Head	SSEP: Upper/lowerlimbs and head/neckAEP: Head	EPAD electrodes areappropriate for peripheralnerve monitoring
Type	Custom cutaneouselectrodes for use withEPAD onlySingle, double and tripleelectrodes	Any standard surface orneedle electrodes withstandard lead wire	Custom cutaneouselectrodes for use withNeuroEPG onlyMultiple electrodeconfigurations available	EPAD electrodes meetfunctional test requirementsper AAMI/ANSI EC12:2000:Disposable ECG Electrodes

. '

. .

Section 4 - Page 7 of 14

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Section 4: 510(k) Summary

、

EPAD™ 510(k)

Section 4 - Page 8 of 14

4-page of

{8}------------------------------------------------

Section 4: 510(k) Summary

EPAD™ 510(K)

Section 4 - Page 9 of 14

{9}------------------------------------------------

feOp Surgical,

ction 4: 510(k) Summ

PAD electrodes meet
Inctional test requirement
er AAMI/ANSI EC1200
isposable ECG Electroni VAD electrodes meet
notional test requirements
r AAMI/ANSI Est requirements
sposable ECG Electronic 9AD electrodes meet
notional test requirement
r AAMI/ANSI Ecolorized
sposable ECG Electronical
sposable ECG Electron Discussion of
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ustification for S lo differenc on-sterile, single
atient use, disposab . NeuroEPG
K123843)* Predicate Not stated lot statec lot stated 6 mm "TouchProof"
pport any standard rotektor 32
K093304)* Predicate Not applicable Not applicab lot applicab wires lon-sterile, single patier
se, disposable afeOp EPAD Proposed comatic three 0.75 mArms/c Wet gel . onductive ge rrent densit Category onnector Sterility

Protektor User and Service Ma

NeuroEPG 510(k) Summary for K123

ection 4 - Page 10 -

PAD™ 510(K

{10}------------------------------------------------

Section 4: 510(k) Summary

4.9 Discussion of Differences

The key differences between the EPAD and the predicate devices are as follows:

. The EPAD is used for a limited subset of testing (SSEP NMJ) as compared to the predicate devices that perform these types of tests in addition to others (e.g., auditory and visual evoked potentials). This is the main reason driving the technical differences. However, all of the technical characteristics for EPAD are within those previously cleared for these types of devices.
. The EPAD System includes an algorithm to detect changes in evoked potential latency and amplitude as compared to baseline and alert the user to check the waveforms for artifact or possible position deficit. This feature is not offered on the predicate devices. However, this does not raise new questions of safety and effectiveness because it is an optional adjunct to standard waveform viewing.
The EPAD System includes custom electrodes while the Protektor . is labeled for use with off-the-shelf cutaneous electrodes. However, other evoked potential devices have been cleared with custom electrodes, including the named NeuroEPG. The EPAD electrode design is based on well-established principles for cutaneous electrodes and the electrodes meet the requirements of the ANSI/AAMI EC12:2000 standard (Section 5.2.2, Tests for Functionality).

4.10 Nonclinical Testing

The following nonclinical testing was conducted to demonstrate the safety and effectiveness of the EPAD System and support substantial equivalence to the predicate devices.

Software verification and validation testing was conducted in accordance with FDA's Guidance on the Content of Premarket Submissions for Software Contained in Medical Devices. The results of this testing demonstrated that all software requirements have been fulfilled and all software hazards have been mitigated. There are no unresolved anomalies in the EPAD software.

{11}------------------------------------------------

Section 4: 510(k) Summary

Biocompatibility testing on the patient contacting materials of the EPAD electrodes to the requirements of ISO 10993-1: Biological evaluation of medical devices-Part 1, Evaluation and Testing, demonstrated that the electrodes are safe for short term (<24 hours) contact with intact skin. Specific testing included cytotoxicity, sensitization, and irritation/intracutaneous reactivity.

Accelerated aging testing was conducted on the EPAD electrodes to establish a 15 month shelf life. All tests conducted following the accelerated aging of the electrodes in their final packaging were passed. The testing included the following:

. Impedance monitoring
Visual inspection .
Testing in accordance with section 5.2.2 of ANSI/AAMI . EC12:2000 for Disposable ECG Electrodes:
- 10-Hz AC impedance, individual pair o
- Combined offset instability and internal noise ୍
- DC voltage offset, Bias test
Electrode Impedance values on forearm .
Electrode evoked potential responses .

Electrical Safety and electromaqnetic compatibility testing was

conducted to the following standards. All tests passed with no need for device modifications:

UL60601-1: Medical Electrical Equipment Part 1: General . Requirements for Safety, 186 ed with revisions through April 2006
IEC 60601-1-1: Medical Electrical Equipment Part 1-1: General . Requirements for Safety-Collateral Standard: Safety Requirements for Medical Electrical Systems, 200 ed, 2000
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General . Requirements for Safety -; Electromagnetic Compatibility -Requirements and Tests, 3rd ed, 2007
IEC 60601-2-40: Particular Requirements for the Safety of . Electromyographs and Evoked Response Equipment, 1st ed, 1998

{12}------------------------------------------------

Section 4: 510(k) Summary

FCC Certification Testing was conducted by the manufacturer of the EPAD Tablet to certify the Bluetooth wireless technology component to the FCC regulations under 47 CFR Part 15. All tests passed.

Functional Performance Testing was conducted by the EPAD system contract manufacturer to validate system performance requirements. All test results met the test protocol acceptance criteria

EPAD Signal Quality Tests These tests were conducted to . validate the quality of the waveform signals from the Headbox to the Tablet
- Noise level peak to peak on each channel ୍
- CMRR adjustment on each channel o
- Low Frequency Filter on each channel ୍
- High Frequency Filter on each channel ্
- DC offset on each channel ○
- Cross talk between each channel o
- Gain on each channel ੇ
- o Qualification of impedance circuit on each lead of each channel
Wireless Coexistence Testing To evaluate the EPAD Bluetooth communication performance in the presence of multiple wireless devices all transmitting simultaneously. There was no observed decline in data transmission between the EPAD Headbox and Tablet under the test conditions.
Alert Algorithm Testing The functionality of the EPAD algorithm . designed to alert the clinician to check the evoked potential waveforms for evidence of possible position deficit was tested under minimal, moderate, and extreme noise conditions. The EPAD was able to detect waveform changes of reduced amplitude (>50%) and increased latency (>10%) under all noise conditions.

Conclusions Regarding Substantial Equivalence 4.11

The information and testing presented in this 510(k) demonstrate that the EPAD Evoked Potential Assessing Device is safe and effective for its intended use and substantially equivalent to the named predicate devices. The EPAD has the same intended use and substantially equivalent

{13}------------------------------------------------

Section 4: 510(k) Summary

indications for use. The main difference between the EPAD and the predicate devices is that the EPAD was designed specifically for peripheral nerve response (somatosensory evoked potential (SSEP)) and neuromuscular junction (NMJ) monitoring, while the predicate devices offer a broader range of monitoring modes, including auditory evoked responses. However, the technical specifications for electrical stimulation and waveform acquisition using the EPAD are within those of the predicate devices based on the publicly available information.

{14}------------------------------------------------

Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 24, 2014

Safeop Surgical, Inc. c/o Ms. Sheila Hemeon-Heyer 125 Cherry Lane Amherst, MA 01002

Re: K132616

Trade/Device Name: EPAD Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response clectrical stimulator Regulatory Class: Class II Product Code: GWF. IKN, GXY Dated: December 23, 2013 Received: December 27, 2013

Dear Ms. Hemeon-Heyer:

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 cvaluate 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 cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Tixisting 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

{15}------------------------------------------------

Page 2 - Ms. Hemeon-Heyer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practicc 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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/ReportalProblem/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/Industrv/default.htm.

Sincerely vours.

Carlos L. Pena -S

Carlos L. Peña. PhD. MS | Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132616

Device Name EPAD

Indications for Use (Describe)

The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).

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)

、------ -- -------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S 2014.01.24 17:44:37 -05'00'

FORM FDA 3881 (1/14)

1774174741131134146741

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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).