(158 days)
Not Found
No
The summary describes a system for acquiring and displaying physiological signals (SSEP, EMG, NMJ) and does not mention any analytical or interpretive functions that would typically involve AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is used for monitoring neurological status and acquiring signals, not for treating or providing therapy.
Yes
Explanation: The device is intended for "monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ)," which are all methods of providing diagnostic information about the patient's neurological function. This monitoring helps clinicians assess conditions or changes during surgical procedures.
No
The device description explicitly states that the system consists of a Headbox, power supply, tablet computer, electrodes, stimulating probe/clip, and cables, in addition to the software application. The Headbox is responsible for hardware functions like stimulation and signal acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- EPAD 2 System Function: The EPAD 2 system directly interacts with the patient's body to record physiological signals (SSEP, EMG, NMJ). It does not analyze specimens in vitro.
- Intended Use: The intended use is for monitoring neurological status during surgical procedures by recording electrical activity from the patient's nerves and muscles. This is a direct physiological measurement, not an in vitro test.
Therefore, the EPAD 2 system falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, extracranial, 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.
Product codes (comma separated list FDA assigned to the subject device)
GWF, PDQ, GXY, GXZ, ETN, IKN
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, extracranial, intratemporal, extratemporal, neck, upper and lower extremities, spinal (lumbar, thoracic, cervical).
Indicated Patient Age Range
The stimulator is available for use on any patients as determined by the qualified medical personnel.
Intended User / Care Setting
Qualified medical personnel within a hospital or clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K132616, K083124, K061639, K110410, K162383
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
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
1
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
2
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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3
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 1003
Hunt Valley, MD 21031
(410) 891-5708 |
|----|------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Jeremy Markovich
Senior Manager, Regulatory and Clinical Affairs
Alphatec 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 Eclipse | |
| Neurological Workstation with TCD and vascular | ||
| Doppler CardioMon | November 1, 2006 | |
| K110410 | MS-120BK Electric Stimulator Extension Unit | August 4, 2011 |
| K162383 | Cadwell Sierra Summit | March 1, 2017 |
4
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 Integrity | ||||||
| Monitor 3.0 | ||||||
| (K083124) | Eclipse TCD | |||||
| Neurovascular | ||||||
| Workstation Eclipse | ||||||
| Neurological | ||||||
| Workstation with TCD | ||||||
| and vascular Doppler | ||||||
| CardioMon | ||||||
| (K061639) | MS-120BK Electric | |||||
| Stimulator Extension | ||||||
| Unit | ||||||
| (K110410) | Cadwell Sierra Summit | |||||
| (K162383) | ||||||
| Manufacturer | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. | ||||
| (formerly Axon Systems | ||||||
| Inc.) | NIHON KOHDEN CORP. | Cadwell Industries, Inc. | SafeOp Surgical, Inc. | SafeOp Surgical, Inc. | ||
| a subsidiary of Alphatec | ||||||
| Holdings, Inc. | ||||||
| Intended Use/ | ||||||
| Indications for | ||||||
| Use | Intended Use: | |||||
| The NIM 3.0 is | ||||||
| intended for locating | ||||||
| and identifying | ||||||
| cranial and peripheral | ||||||
| motor and mixed | ||||||
| motor-sensory nerves | ||||||
| during surgery, | ||||||
| including spinal cord | ||||||
| and spinal cord nerve | ||||||
| roots. The APS | ||||||
| electrode is an | ||||||
| accessory intended | ||||||
| for providing | ||||||
| automatic periodic | ||||||
| stimulation to nerves | ||||||
| when used with the | ||||||
| Medtronic Nerve | ||||||
| Monitoring Systems. | The systems are intended | |||||
| for use to monitor sensory | ||||||
| and motor pathways and to | ||||||
| provide information to | ||||||
| determine the state of | ||||||
| blood flow in the | ||||||
| intracranial and | ||||||
| extracranial vascular | ||||||
| arteries in adults. | ||||||
| The instrument uses | ||||||
| electroencephalography | ||||||
| (EEG), electromyography | ||||||
| (EMG), motor and sensory | ||||||
| evoked potentials and | ||||||
| nerve potentials and | ||||||
| Doppler analysis. | ||||||
| Transcranial stimulation | ||||||
| techniques for motor | ||||||
| evoked potentials are used | ||||||
| to assess for acute | ||||||
| dysfunction in axonal | When the Low output is | |||||
| selected the MS-120BK is | ||||||
| used as a nerve stimulator | ||||||
| for surgical procedures | ||||||
| and brain mapping during | ||||||
| treatment of patients with | ||||||
| seizure disorders. When | ||||||
| High output is selected the | ||||||
| MS-12OBK is used for the | ||||||
| intraoperative diagnosis of | ||||||
| acute dysfunction in | ||||||
| corticospinal axonal | ||||||
| conduction brought about | ||||||
| by mechanical trauma | ||||||
| (traction, shearing, | ||||||
| laceration, or | ||||||
| compression) or vascular | ||||||
| insufficiency. The system | ||||||
| is intended for use by | ||||||
| qualified medical | ||||||
| personnel within a hospital | Cadwell Sierra Summit: | |||||
| Cadwell Sierra Summit is | ||||||
| indicated for acquisition, | ||||||
| display, storage, | ||||||
| transmission, analysis, and | ||||||
| reporting of | ||||||
| electrophysiological and | ||||||
| environmental data | ||||||
| including | ||||||
| Electromyography (EMG), | ||||||
| Nerve Conduction Studies | ||||||
| (NCS), Evoked Potentials | ||||||
| (EP), and Autonomic | ||||||
| Reponses (RR Interval | ||||||
| Variability). The Cadwell | ||||||
| Sierra Summit is used to | ||||||
| detect the physiologic | ||||||
| function of the nervous | ||||||
| system, and to support the | ||||||
| diagnosis of | The EPAD is intended for | |||||
| use in monitoring | ||||||
| neurological status by | ||||||
| recording somatosensory | ||||||
| evoked potentials (SSEP) | ||||||
| or assessing the | ||||||
| neuromuscular junction | ||||||
| (NMJ). | 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 |
6
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 3.0
EMG Monitoring
Procedures include: | conduction of the
corticospinal tract. | or clinical environment.
The stimulator is available
for use on any patients as
determined by the
qualified medical
personnel. | neuromuscular diseases or
conditions. | percutaneous, lumbar,
thoracic, and cervical
surgical procedures. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intracranial,
Extracranial,
Intratemporal,
Extratemporal, Neck
Dissections, Thoracic
Surgeries, and Upper
and Lower
Extremities.
Indications for Spinal
procedures which may use
NIM 3.0 EMG monitoring
include:
Degenerative
Treatments, Pedicle
Screw Procedures,
Fusion Cages,
Rhizotomy,
Orthopedic Surgery,
Open and
Percutaneous Lumbar
and Cervical Surgical
Procedures, and
Thoracic Surgical
Procedures. | The system is used in the
operating room and critical
care areas to provide
health care professionals
with information to guide
surgery and to assess a
patient's neurological and
vascular status.
Doppler analysis is not to
be used for Obstetrics. | | The listed modalities do
include overlap in
functionality. In general,
Nerve Conduction Studies
measure the electrical
responses of the peripheral
nerve; Electromyography
measures the electrical
activity of the muscle, and
Evoked Potentials measure
the electrical activity from
the central nervous system.
The interface for third-
party non-invasive
imaging display and
control is used to visualize
the morphology and
location of nerves and
muscles, and serves as an
aid in confirming the
results of the
aforementioned
modalities.
Cadwell Sierra Summit is
indicated for use by
qualified medical
practitioners. This device
does not provide any
diagnostic conclusion
about the patient's
condition 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".
| Regulatory
Class/Code | Class II
GWF, ETN
(882.1870) | Class II
GWO, GWS, GWF,
GWVE, GWVJ, IKN,
IYN, ITX
(882.1870) | Class II
GYC, GWF
(882.1310) | Class II
IKN, GWF, JXE,
GWJ, GWE, GZP
(890.1375) | Class II
GWF, GXY, IKN
(882.1870) | Class II
GWF, 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 |
|-----------------------------|------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| 60601-1
Compliant | Yes | Yes | Yes | Yes | Yes | Yes | Maximum
Current Density | Unknown | Unknown | $46 mA RMS/cm^2$
smallest electrode
conductive surface area =
$0.04 cm^2$ | Unknown | $0.75 mA RMS/cm^2$
smallest electrode
conductive surface area
= $2 cm^2$ | $23.6 mA RMS/cm^2$
smallest electrode
conductive surface area
= $0.0816 cm^2$ |
| Operating
Modes | Triggered EMG
Free run EMG | Triggered EMG
Free run EMG
Evoked Potentials | When connect to the
Neuromaster, the
extension unit can output
high or low current pulses
to measure evoked
potentials:
(e.g., EEG, EMG, MEP,
and SSEP) | Triggered EMG
Free run EMG
Evoked Potentials | SSEP
NMJ | Triggered EMG
Free run EMG
SSEP
NMJ | Compatible
Accessories | Surface Electrodes
Needle Electrodes
Stimulating Probes
Cable, Electrode | Surface Electrodes
Needle Electrodes
Stimulating Probes
Cable, Electrode | Surface Electrodes
Needle Electrodes
Cable, Electrode | Surface Electrodes
Needle Electrodes
Cable, Electrode | Surface Electrodes
Needle Electrodes
Cable, Electrode | Surface Electrodes
Needle Electrodes
Stimulating Probes
Cable, Electrode |
| Total Amplifier
Channels | 1 to 8 | Up to 8 | 16 and 32 when connected
to the MEE 1000A
through the JB116BK or
JB-132BK amplifier | 1 to 12 | Up to 8 | Up to 8 | Biocompatibility
of patient
contacting
accessories
(ISO 10993-1) | Yes
Tissue/bone/dentin for a
limited duration of less than
or equal to 24 hours. | Unknown | Unknown | Unknown | Yes
Tissue/bone/dentin for a
limited duration of less
than or equal to 24 hours. | Yes
Tissue/bone/dentin for a
limited duration of less
than 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 per
phase
(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
9
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.