(158 days)
The EPAD 2 system is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open or percutaneous, lumbar, thoracic, and cervical surgical procedures.
The EPAD 2 System consists of the EPAD 2 Headbox and power supply, a tablet computer, electrodes, stimulating probe or clip and cables. The Headbox is responsible for the stimulation and acquisition of signals for the intraoperative neurophysiologic monitoring (IONM) functions. The Headbox contains onboard firmware and is mounted on the operating room (OR) bed by clipping it to the bed side bar. The EPAD application provides the primary graphical user interface and controls for the EPAD II System. The application runs on a touchscreen tablet mobile device which connects wirelessly or via a wired USB cable to the Headbox. The application serves as the interface to the EPAD Headbox, enabling both user input (e.g., patient and procedure information, adjustment of stimulus and acquisition parameters) and display of output (e.g., display of acquired waveforms, data, messages and alerts to the clinician).
The provided text primarily focuses on the 510(k) clearance of the EPAD 2 System, demonstrating its substantial equivalence to predicate devices rather than presenting data from a specific study designed to meet acceptance criteria for novel performance claims. Therefore, much of the requested information regarding acceptance criteria, reported performance, and study details is not explicitly available in the provided document.
However, I can extract information related to the device's characteristics and the types of testing performed to support its substantial equivalence.
Here's an analysis based on the given document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics in the way one would expect for a study proving new performance claims. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance data mentioned are related to meeting functional, system, and software requirements, and compliance with safety standards.
| Characteristic | Acceptance Criteria (Implied by substantial equivalence) | Reported Device Performance (Summary from text) |
|---|---|---|
| Intended Use | Similar to predicate devices | EPAD 2 system is intended for monitoring neurological status by recording SSEP, EMG, or assessing NMJ during various surgical procedures. (Matches expanded indications of predicates) |
| Technology | Similar to predicate devices (waveform, pulse width, frequency, current range) | Monophasic, Rectangular waveform; 50-300 µsec pulse width; 0.1-50 Hz frequency; 0-100 mA current range. (Within ranges of predicate devices and their combinations) |
| Safety | Compliance with recognized electrical safety standards (e.g., 60601-1) | EMC and Electrical Safety Testing performed to ensure all functions are electrically safe and comply with recognized electrical safety standards. |
| Usability | No adverse effect within the intended environment | Usability testing performed to demonstrate no adverse effect. |
| Functional, System, Software Requirements | Meeting defined requirements | Nonclinical performance testing demonstrates that the EPAD 2 System meets these requirements. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
This indicates that:
- There was no clinical test set in the traditional sense for evaluating novel performance claims against acceptance criteria.
- The data provenance, sample size, or retrospective/prospective nature of a clinical study are not specified because such a study was not the basis for clearance.
- The performance data cited are from nonclinical performance testing, EMC, electrical safety, and usability testing, which typically involve device-level assessments rather than patient-based test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since there was no clinical test set for evaluating novel performance claims, there is no information provided regarding experts establishing ground truth for such a test set. The substantial equivalence determination relies on comparisons to already cleared predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring ground truth adjudication for novel performance claims was used as the basis for this 510(k) clearance.
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 EPAD 2 System is an Evoked Response Electrical Stimulator used for neuromonitoring, not an AI-assisted diagnostic imaging device that would typically involve a multi-reader multi-case study or "human readers improve with AI" metrics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the EPAD 2 System. The device is an instrument used by qualified medical personnel for neuromonitoring and does not operate as a standalone "algorithm only" device for making diagnoses or performing interventions without human-in-the-loop interaction. Its function is to acquire and display physiological signals for interpretation by a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical performance, EMC, electrical safety, and usability testing, the "ground truth" would be established by:
- Engineering specifications and regulatory standards: For functional, system, and software requirements, and for EMC/electrical safety, the device's performance is compared against pre-defined engineering specifications and national/international standards (e.g., IEC 60601-1).
- User feedback/observation: For usability testing, the "ground truth" is typically the observation of user interaction and compliance with usability engineering principles, identifying potential use errors or safety concerns.
There is no mention of pathology or outcomes data as ground truth for this 510(k) submission, as it explicitly states that clearance is "not based on an assessment of clinical performance data."
8. The sample size for the training set
Not applicable. This device is cleared through the 510(k) pathway which demonstrates substantial equivalence to predicate devices. It is not an AI/ML device that typically requires a large "training set" in the machine learning sense for its core functionality. While there might be firmware/software development which internally used data, the submission does not detail such a training set for regulatory review.
9. How the ground truth for the training set was established
Not applicable, as no training set in the AI/ML context is described or relevant for this 510(k) cleared device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 22, 2019
SafeOp Surgical, Inc. % Jeremy Markovich Senior Manager, Regulatory and Clinical Affairs Alphatec Spine, Inc. 5818 El Camino Real Carlsnad, California 92008
Re: K182542
Trade/Device Name: The EPAD 2 System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, PDQ, GXY, GXZ, ETN, IKN Dated: September 14, 2018 Received: September 17, 2018
Dear Jeremy Markovich:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For 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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Indications for Use
510(k) Number (if known) K182542
Device Name EPAD 2 System
Indications for Use (Describe)
The EPAD 2 system is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NM). Neuromonitoring procedures include intracranial, extracranial, intratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open or percutaneous lumbar, thoracic, and cervical surgical procedures.
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) |
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Image /page/3/Picture/0 description: The image shows two logos side by side. The logo on the left is for ATEC, and it features a green graphic element next to the text "atec" in white, all set against a dark blue background. The logo on the right is for SafeOp Surgical, and it includes a stylized human figure composed of dots, along with the text "SafeOp" in bold and "SURGICAL" in smaller letters below it.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | SafeOp Surgical, Inc.11350 McCormick Rd, Suite 1003Hunt Valley, MD 21031(410) 891-5708 |
|---|---|---|
| Contact Person: | Jeremy MarkovichSenior Manager, Regulatory and Clinical AffairsAlphatec Spine, Inc.Contact Phone: (760) 431-9286 | |
| Date Summary Prepared: | January 23, 2019 |
II. DEVICE
| Trade or Proprietary Name: | EPAD™ 2 System |
|---|---|
| Common Name: | Evoked Response Electrical Stimulator |
| Classification Name: | Evoked Response Electrical Stimulator |
| Regulation Number: | 21 CFR 882.1870 |
| Classification: | Class II |
| Product Code: | GWF |
| Subsequent Code: | GXY, GXZ, PDQ, ETN, IKN |
III. LEGALLY MARKETED PREDICATE DEVICES
| Primary Predicate: | |
|---|---|
| -- | -------------------- |
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K132616 | EPAD™ (Evoked Potential Assessing Device) | January 24, 2014 |
Additional Predicates:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K083124 | Nerve Integrity Monitor 3.0 | February 27, 2009 |
| K061639 | Eclipse TCD Neurovascular Workstation EclipseNeurological Workstation with TCD and vascularDoppler CardioMon | November 1, 2006 |
| K110410 | MS-120BK Electric Stimulator Extension Unit | August 4, 2011 |
| K162383 | Cadwell Sierra Summit | March 1, 2017 |
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Image /page/4/Picture/0 description: The image shows two logos side by side. The first logo is for "atec" and features a green graphic element with the text "tec" in white, all set against a dark blue background. The second logo is for "SafeOp SURGICAL" and includes a stylized human figure with dots on the back, along with the text "SafeOp" in a bold font and "SURGICAL" underneath.
IV. DEVICE DESCRIPTION
The EPAD 2 System consists of the EPAD 2 Headbox and power supply, a tablet computer, electrodes, stimulating probe or clip and cables. The Headbox is responsible for the stimulation and acquisition of signals for the intraoperative neurophysiologic monitoring (IONM) functions. The Headbox contains onboard firmware and is mounted on the operating room (OR) bed by clipping it to the bed side bar. The EPAD application provides the primary graphical user interface and controls for the EPAD II System. The application runs on a touchscreen tablet mobile device which connects wirelessly or via a wired USB cable to the Headbox. The application serves as the interface to the EPAD Headbox, enabling both user input (e.g., patient and procedure information, adjustment of stimulus and acquisition parameters) and display of output (e.g., display of acquired waveforms, data, messages and alerts to the clinician).
V. INDICATIONS FOR USE
The EPAD 2 system is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open or percutaneous, lumbar, thoracic, and cervical surgical procedures.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The modified design of the subject device was compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. The technological differences within this 510(k) that were shown to be substantially equivalent to the predicates including the addition of an EMG modality.
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Image /page/5/Picture/0 description: The image shows the "atec" logo. The logo consists of a green symbol that looks like a stylized letter "a" inside a rounded square. To the right of the symbol, the word "atec" is written in white letters. The background of the logo is a dark blue color.
Image /page/5/Picture/1 description: The image contains the logo for SafeOp Surgical. The logo features a stylized human figure with dots on its body, placed within a dark blue circle. To the right of the figure, the text "SafeOp" is written in a bold, dark blue font, with "SURGICAL" written in smaller letters below it.
| Table 1: Comparison for Substantial Equivalence | ||||||
|---|---|---|---|---|---|---|
| Characteristic | 510(k) | Predicate Devices | Subject Device | |||
| Nerve IntegrityMonitor 3.0(K083124) | Eclipse TCDNeurovascularWorkstation EclipseNeurologicalWorkstation with TCDand vascular DopplerCardioMon(K061639) | MS-120BK ElectricStimulator ExtensionUnit(K110410) | Cadwell Sierra Summit(K162383) | |||
| Manufacturer | Medtronic Xomed, Inc. | Medtronic Xomed, Inc.(formerly Axon SystemsInc.) | NIHON KOHDEN CORP. | Cadwell Industries, Inc. | SafeOp Surgical, Inc. | SafeOp Surgical, Inc.a subsidiary of AlphatecHoldings, Inc. |
| Intended Use/Indications forUse | Intended Use:The NIM 3.0 isintended for locatingand identifyingcranial and peripheralmotor and mixedmotor-sensory nervesduring surgery,including spinal cordand spinal cord nerveroots. The APSelectrode is anaccessory intendedfor providingautomatic periodicstimulation to nerveswhen used with theMedtronic NerveMonitoring Systems. | The systems are intendedfor use to monitor sensoryand motor pathways and toprovide information todetermine the state ofblood flow in theintracranial andextracranial vasculararteries in adults.The instrument useselectroencephalography(EEG), electromyography(EMG), motor and sensoryevoked potentials andnerve potentials andDoppler analysis.Transcranial stimulationtechniques for motorevoked potentials are usedto assess for acutedysfunction in axonal | When the Low output isselected the MS-120BK isused as a nerve stimulatorfor surgical proceduresand brain mapping duringtreatment of patients withseizure disorders. WhenHigh output is selected theMS-12OBK is used for theintraoperative diagnosis ofacute dysfunction incorticospinal axonalconduction brought aboutby mechanical trauma(traction, shearing,laceration, orcompression) or vascularinsufficiency. The systemis intended for use byqualified medicalpersonnel within a hospital | Cadwell Sierra Summit:Cadwell Sierra Summit isindicated for acquisition,display, storage,transmission, analysis, andreporting ofelectrophysiological andenvironmental dataincludingElectromyography (EMG),Nerve Conduction Studies(NCS), Evoked Potentials(EP), and AutonomicReponses (RR IntervalVariability). The CadwellSierra Summit is used todetect the physiologicfunction of the nervoussystem, and to support thediagnosis of | The EPAD is intended foruse in monitoringneurological status byrecording somatosensoryevoked potentials (SSEP)or assessing theneuromuscular junction(NMJ). | The EPAD 2 system isintended for use inmonitoring neurologicalstatus by recordingsomatosensory evokedpotentials (SSEP),electromyography (EMG),or assessing theneuromuscular junction(NMJ). Neuromonitoringprocedures includeintracranial, extracranial,intratemporal,extratemporal, neckdissections, upper andlower extremities, spinaldegenerative treatments,pedicle screw fixation,intervertebral fusion cages.rhizotomy, orthopedicsurgery, open or |
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Image /page/6/Picture/0 description: The image shows the Atec logo. The logo features a green square with a stylized white "a" inside. To the right of the square is the word "tec" in white, with a trademark symbol above the "c". The logo has a blue background.
Image /page/6/Picture/1 description: The image contains the logo for SafeOp Surgical. The logo features a stylized human figure with dots on the torso and limbs, positioned to the left of the text "SafeOp". Below "SafeOp" is the word "SURGICAL" in a smaller font size. The logo is in a dark blue color.
| Indications for NIM 3.0EMG MonitoringProcedures include: | conduction of thecorticospinal tract. | or clinical environment.The stimulator is availablefor use on any patients asdetermined by thequalified medicalpersonnel. | neuromuscular diseases orconditions. | percutaneous, lumbar,thoracic, and cervicalsurgical procedures. |
|---|---|---|---|---|
| Intracranial,Extracranial,Intratemporal,Extratemporal, NeckDissections, ThoracicSurgeries, and Upperand LowerExtremities.Indications for Spinalprocedures which may useNIM 3.0 EMG monitoringinclude:DegenerativeTreatments, PedicleScrew Procedures,Fusion Cages,Rhizotomy,Orthopedic Surgery,Open andPercutaneous Lumbarand Cervical SurgicalProcedures, andThoracic SurgicalProcedures. | The system is used in theoperating room and criticalcare areas to providehealth care professionalswith information to guidesurgery and to assess apatient's neurological andvascular status.Doppler analysis is not tobe used for Obstetrics. | The listed modalities doinclude overlap infunctionality. In general,Nerve Conduction Studiesmeasure the electricalresponses of the peripheralnerve; Electromyographymeasures the electricalactivity of the muscle, andEvoked Potentials measurethe electrical activity fromthe central nervous system.The interface for third-party non-invasiveimaging display andcontrol is used to visualizethe morphology andlocation of nerves andmuscles, and serves as anaid in confirming theresults of theaforementionedmodalities.Cadwell Sierra Summit isindicated for use byqualified medicalpractitioners. This devicedoes not provide anydiagnostic conclusionabout the patient'scondition to the user. |
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Image /page/7/Picture/0 description: The image shows two logos side by side. The logo on the left is for "atec" and features a green abstract design within a dark blue square. The logo on the right is for "SafeOp SURGICAL" and features a dark blue silhouette of a person with dots on their body inside a circle, with the text "SafeOp" above the text "SURGICAL".
| RegulatoryClass/Code | Class IIGWF, ETN(882.1870) | Class IIGWO, GWS, GWF,GWVE, GWVJ, IKN,IYN, ITX(882.1870) | Class IIGYC, GWF(882.1310) | Class IIIKN, GWF, JXE,GWJ, GWE, GZP(890.1375) | Class IIGWF, GXY, IKN(882.1870) | Class IIGWF, GXY, GXZ,PDQ, ETN, IKN(882.1870) | Current Range | 0.01 to 30 mA | Unknown | 0 to 15 mA | 0 to 100 mA | 0 to 100 mA | 0 to 100 mA |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 60601-1Compliant | Yes | Yes | Yes | Yes | Yes | Yes | MaximumCurrent Density | Unknown | Unknown | $46 mA RMS/cm^2$smallest electrodeconductive surface area =$0.04 cm^2$ | Unknown | $0.75 mA RMS/cm^2$smallest electrodeconductive surface area= $2 cm^2$ | $23.6 mA RMS/cm^2$smallest electrodeconductive surface area= $0.0816 cm^2$ |
| OperatingModes | Triggered EMGFree run EMG | Triggered EMGFree run EMGEvoked Potentials | When connect to theNeuromaster, theextension unit can outputhigh or low current pulsesto measure evokedpotentials:(e.g., EEG, EMG, MEP,and SSEP) | Triggered EMGFree run EMGEvoked Potentials | SSEPNMJ | Triggered EMGFree run EMGSSEPNMJ | CompatibleAccessories | Surface ElectrodesNeedle ElectrodesStimulating ProbesCable, Electrode | Surface ElectrodesNeedle ElectrodesStimulating ProbesCable, Electrode | Surface ElectrodesNeedle ElectrodesCable, Electrode | Surface ElectrodesNeedle ElectrodesCable, Electrode | Surface ElectrodesNeedle ElectrodesCable, Electrode | Surface ElectrodesNeedle ElectrodesStimulating ProbesCable, Electrode |
| Total AmplifierChannels | 1 to 8 | Up to 8 | 16 and 32 when connectedto the MEE 1000Athrough the JB116BK orJB-132BK amplifier | 1 to 12 | Up to 8 | Up to 8 | Biocompatibilityof patientcontactingaccessories(ISO 10993-1) | YesTissue/bone/dentin for alimited duration of less thanor equal to 24 hours. | Unknown | Unknown | Unknown | YesTissue/bone/dentin for alimited duration of lessthan or equal to 24 hours. | YesTissue/bone/dentin for alimited duration of lessthan or equal to 24 hours. |
| Waveform | Monophasic, Rectangular | Biphasic | Multiphasic, Rectangular | Biphasic | Monophasic, Rectangular | Monophasic, Rectangular | |||||||
| Pulse Width | 50 to 250 µsec | 50 to 500 µsec | 0.05 msec to 0.3 msec perphase(50 to 300 µsec) | 0.05 to 1 ms(50 to 1000 µsec) | 50 to 300 µsec | 50 to 300 µsec | |||||||
| Frequency(Pulse Rate) | 1 to 10 Hz | Unknown | 0.1 to 50 Hz | Up to 50 Hz | 0.1 to 50 Hz | 0.1 to 50 Hz |
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Image /page/8/Picture/0 description: The image is a logo for a company called "tec". The logo consists of a green rounded square with a white stylized letter "a" inside of it. To the right of the square is the word "tec" in white letters. The entire logo is set against a dark blue background.
Image /page/8/Picture/1 description: The image is a logo for SafeOp Surgical. The logo consists of a stylized human figure with dots on the body, next to the text "SafeOp" in a bold, sans-serif font. Below "SafeOp" is the word "SURGICAL" in a smaller font. The logo is simple and modern, and the use of the human figure suggests a focus on patient safety.
Traditional 510(k) Premarket Notification K182542 EPAD™ 2 System
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Image /page/9/Picture/0 description: The image shows two logos side by side. The logo on the left is a dark blue rectangle with a green leaf-like shape and the word "atec" in white. The logo on the right is a human figure with dots on the body and the words "SafeOp SURGICAL" in blue and gray. The logos appear to be for medical or surgical companies.
VII. PERFORMANCE DATA
Nonclinical performance testing demonstrates that the subject EPAD 2 System meets the functional, system, and software requirements.
EMC and Electrical Safety Testing of the EPAD 2 System was performed to ensure all functions of the system and its accessories are electrically safe, and comply with recognized electrical safety standards
Usability testing was performed to demonstrate that the subject EPAD 2 System presents no adverse effect within the intended environment, and the subject device was therefore found to be substantially equivalent to the predicate.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.
§ 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).