(89 days)
The SafeOp 2: Neural Informatix 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, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.
The SafeOp™ 2: Neural Informatix System (SafeOp 2 System), formerly known as EPAD 2 (K182542), consists of the SafeOp head unit with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, and stimulating probe or clip contained in various kits. The SafeOp 2 System head unit contains a complete data acquisition system that has builtin stimulators, amplifiers, relays, A/D Converters, Digital Signal Processors, CPUs, and storage devices. The head unit interfaces with other equipment through communication ports and serves as the patient-contacting portion of the system where it is close to the surgical field. The head unit hardware contains an eight acquisition (input) channel and six-output channel Evoked Potential Stimulator that is used in the operating room to display nerve and muscle responses. The user can use these responses to diagnose insults to the peripheral or central nerves and to determine relative nerve location, proximity, and integrity data. The SafeOp 2 System application provides the primary graphical user interface and controls for the SafeOp 2 System. The application runs on a touchscreen tablet mobile device which connects to the head unit either via wired USB cable or wireless via Wi-Fi, 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 is a 510(k) summary for the SafeOp 2: Neural Informatix System. It primarily focuses on demonstrating substantial equivalence to a predicate device (EPAD™ 2 System, K182542) rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the typical sense of a clinical study measuring diagnostic accuracy or treatment efficacy. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various specifications. The "acceptance criteria" for this submission would broadly be that the device's specifications and performance are comparable to the predicate, with any differences not introducing new safety or effectiveness concerns.
| Specification/Property | Predicate Device (EPAD™ 2 System, K182542) | Subject Device (SafeOp™ 2 System) | Performance/Rationale |
|---|---|---|---|
| Intended Use/Indications for Use | Identical | Identical | Identical |
| Device Class | II | II | Identical |
| Product Code | GWF, GXY, GXZ, IKN, PDQ, ETN | GWF, GXY, GXZ, IKN, PDQ, ETN | Identical |
| Regulation Number | §882.1870, §882.1320, §882.1350, §890.1375, §874.1820, §874.1820 | §882.1870, §882.1320, §882.1350, §890.1375, §874.1820, §874.1820 | Identical |
| Device Classification Name | Stimulator, Electrical, Evoked Response | Stimulator, Electrical, Evoked Response | Identical |
| Monitoring Modalities | EMG, SSEP, NMJ | EMG, SSEP, NMJ | Identical |
| Head Unit Power Supply | 100 to 240 VAC, 50-60 Hz (input); 15 VDC, 2.5A (output) | 100 to 240 VAC, 50-60 Hz (input); 12 VDC, 2.5A (output) | Head unit power supply does not impact device performance when compared to the predicate. The change in power does not introduce new risks, or impact existing risks. Therefore, this difference does not affect device safety or effectiveness. |
| Mode of Operation | Continuous | Continuous | Identical |
| Dimensions | 12"W x 8"H x 2"D | 12"W x 8"H x 2"D | Identical |
| Weight | < 2 lbs | < 2 lbs | Identical |
| Operating Modes | Triggered EMG, Free run EMG, SSEP, NMJ | Triggered EMG, Free run EMG, SSEP, NMJ | Identical |
| Total Amplifier Channels | Up to 8 | Up to 8 | Identical |
| Waveform | Monophasic, Rectangular | Monophasic, Rectangular | Identical |
| Pulse Duration | 50 to 300 µsec | 300 µsec (SSEP), 200 µsec (EMG) | Identical (The provided predicate range encompasses the subject device's specific values, which are typical for each modality, implying no significant difference in capability or safety). |
| Frequency (Pulse Rate) | 0.1 to 50 Hz | 0.1 to 50 Hz | Identical |
| Current Range | 0 to 100 mA | 0 to 100 mA | Identical |
| Input Impedance | > 50 MΩ (at DC) | > 50 MΩ (at DC) | Identical |
| Low Frequency Filter | 10 Hz (SSEP), 30 Hz (EMG) | 10 Hz (SSEP), 30 Hz (EMG) | Identical |
| High Frequency Filter | 2.7 kHz (SSEP & EMG) | 2.7 kHz (SSEP & EMG) | Identical |
| Notch Filter | 50 or 60 Hz | 50 or 60 Hz | Identical |
| AlphaInformatix (AIX) Tablet OS | Android powered tablet | Windows 10 powered tablet | Completed V&V testing successfully demonstrates that the differences in the Operating Systems (OS) have no impact on device performance when compared to the predicate. The OS change does not introduce new risks, or impact existing risks. Therefore, this difference does not affect device safety or effectiveness. |
| Remote Access | No | No | Identical |
| Surface Electrode Anatomical Sites | SSEP: Upper/lower limbs and head/neck | SSEP: Upper/lower limbs and head/neck | Identical |
| Surface Electrode Type | Customer cutaneous electrodes for use with SafeOp only. Single, double and triple electrodes. | Customer cutaneous electrodes for use with SafeOp only. Single, double and triple electrodes. | Identical |
| Conductive Surface Area | 20x25mm | 25.4x25.4mm (1x1in.) | Completed V&V testing successfully demonstrates that the differences in the surface area has no impact on device performance when compared to the predicate. The change does not introduce new risks, or impact existing risks. Therefore, this difference does not affect device safety or effectiveness. |
| Conductive Gel | Wet gel | Solid gel | Completed V&V testing successfully demonstrates that the differences in the conductive gel has no impact on device performance when compared to the predicate. The change does not introduce new risks, or impact existing risks. Therefore, this difference does not affect device safety or effectiveness. |
| Connectors | Nicomatic three pin | Nicomatic three pin | Identical |
| Current Density | < 0.75 mArms/cm2 | < 0.75 mArms/cm2 | Identical |
| Sterility | Non-sterile, single patient use, disposable | Non-sterile, single patient use, disposable | Identical |
| Surface Contact Time | ≤ 24 hours | ≤ 24 hours | Identical |
| Other Accessories | Needle Electrodes, Stimulating Probes, Cable, Electrode | Needle Electrodes, Stimulating Probes, Cable, Electrode | Identical |
| Biocompatibility (ISO 10993-1) | Yes (Tissue/bone/dentin for ≤ 24 hours) | Yes (Tissue/bone/dentin for ≤ 24 hours) | Identical |
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: "Determination of substantial equivalence is not based on an assessment of clinical performance data." This indicates that there was no human test set or clinical data involved in proving substantial equivalence for this submission. The evaluation was based on nonclinical performance testing.
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)
Not applicable, as no human test set or clinical data was used to establish substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human test set or clinical data was used to establish substantial equivalence.
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 device is for intraoperative neuromonitoring, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study for diagnostic improvement. The document explicitly states: "Determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that "Nonclinical performance testing demonstrates that the subject SafeOp 2 System meets the functional, system, and software requirements." This indicates that standalone performance testing was conducted for the device's functions (e.g., EMC, electrical safety, usability), but this refers to the system as a whole, not a specific algorithm's performance in isolation from a human user in a diagnostic or interpretive capacity. It does not provide details on the specific performance metrics (e.g., accuracy, sensitivity, specificity) for standalone algorithm performance in interpreting neurological signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical performance testing (EMC, Electrical Safety, Usability), the ground truth would be based on engineering standards and predetermined functional specifications. For example, for electrical safety, the ground truth is compliance with recognized electrical safety standards (e.g., 60601-1). For usability, the ground truth is that the device "presents no adverse effect within the intended environment."
8. The sample size for the training set
Not applicable. The submission is for a neuromonitoring system and does not describe an AI/machine learning model that would require a "training set" in the conventional sense. The "training" here would refer to the development and testing of the engineering system.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/machine learning model.
{0}------------------------------------------------
March 9, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alphatec Spine, Inc. David Gramse Sr. Director, Regulatory & Clinical Affairs 1950 Camino Vida Roble Carlsbad. California 92008
Re: K213849
Trade/Device Name: SafeOp 2: Neural Informatix System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, GXY, GXZ, IKN, PDQ, ETN Dated: December 9, 2021 Received: December 10, 2021
Dear David Gramse:
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 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
{1}------------------------------------------------
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
SafeOp 2: Neural Informatix System
Indications for Use (Describe)
The SafeOp 2: Neural Informatix System is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMI). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Atec. The logo is a stylized wordmark with the letters "atec" in a sans-serif font. The "a" is green, while the rest of the letters are a dark blue color. There is a trademark symbol to the right of the "c".
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. SUBMITTER: | Alphatec Spine, Inc.1950 Camino Vida RobleCarlsbad, CA 92008Phone: (760) 494-6711Fax: (760) 431-0289 |
|---|---|
| Contact Person: | David GramseSr. Director, Regulatory and Clinical AffairAlphatec Spine, Inc.Contact Phone: (760) 494-6711 |
| Date Summary Prepared: | December 8, 2021 |
II. DEVICE
| Trade Name: | SafeOp™ 2: Neural Informatix System |
|---|---|
| Common or Usual Name: | Intraoperative Neuromonitoring |
| Classification Name: | Stimulator, Electrical, Evoked Response(21 CFR 882.1870) |
| Regulatory Class: | Class II |
| Product Code: | GWF |
| Subsequent Codes: | GXY, GXZ, IKN, PDQ, ETN |
III. LEGALLY MARKETED PREDICATE DEVICES
Primary Predicate:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K182542 | EPAD™ 2 System | February 2019 |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for a company called "atec". The "a" is green and the "tec" is dark blue. There is a green swoosh over the "tec" portion of the logo. The letters are all lowercase and the logo has a trademark symbol in the upper right corner.
IV. DEVICE DESCRIPTION
The SafeOp™ 2: Neural Informatix System (SafeOp 2 System), formerly known as EPAD 2 (K182542), consists of the SafeOp head unit with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, and stimulating probe or clip contained in various kits.
The SafeOp 2 System head unit contains a complete data acquisition system that has builtin stimulators, amplifiers, relays, A/D Converters, Digital Signal Processors, CPUs, and storage devices. The head unit interfaces with other equipment through communication ports and serves as the patient-contacting portion of the system where it is close to the surgical field. The head unit hardware contains an eight acquisition (input) channel and six-output channel Evoked Potential Stimulator that is used in the operating room to display nerve and muscle responses. The user can use these responses to diagnose insults to the peripheral or central nerves and to determine relative nerve location, proximity, and integrity data.
The SafeOp 2 System application provides the primary graphical user interface and controls for the SafeOp 2 System. The application runs on a touchscreen tablet mobile device which connects to the head unit either via wired USB cable or wireless via Wi-Fi, 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 SafeOp 2: Neural Informatix 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/percutaneous, lumbar, thoracic, and cervical surgical procedures.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The subject device was compared to the predicate device in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. Any technological differences within this 510(k), between the subject device and the predicate device, does not impact substantially equivalence, or safety and effectiveness.
{5}------------------------------------------------
Table 1: Comparison for Substantial Equivalence
| Specification/Property | Predicate Device | Subject Device | SE Rationale(if not identical) |
|---|---|---|---|
| 510(k) | EPAD™ 2 System(K182542) | SafeOp™ 2 System | |
| Intended Use/Indications for Use | The EPAD 2 system is intended for use by trainedhealthcare professionals as a diagnostic devicethat provides intraoperative neuromonitoringduring various surgical procedures.The EPAD 2 system is intended for use inmonitoring neurological status by recordingsomatosensory evoked potentials (SSEP),electromyography (EMG), or assessing theneuromuscular junction (NMJ). Neuromonitoringprocedures include intracranial, extracranial,intratemporal, extratemporal, neck dissections,upper and lower extremities, spinal degenerativetreatments, pedicle screw fixation, intervertebralfusion cages, rhizotomy, orthopedic surgery, openor percutaneous, lumbar, thoracic, and cervicalsurgical procedures. | The SafeOp 2: Neural Informatix System isintended for use by trained healthcare professionalsas a diagnostic device that provides intraoperativeneuromonitoring during various surgical procedures.The SafeOp 2: Neural Informatix System isintended for use in monitoring neurological statusby recording somatosensory evoked potentials(SSEP), electromyography (EMG), or assessing theneuromuscular junction (NMJ). Neuromonitoringprocedures include intracranial, extracranial,intratemporal, extratemporal, neck dissections,upper and lower extremities, spinal degenerativetreatments, pedicle screw fixation, intervertebralfusion cages, rhizotomy, orthopedic surgery,open/percutaneous, lumbar, thoracic, and cervicalsurgical procedures. | Identical |
| Device Class | II | II | Identical |
| Product Code | GWF, GXY, GXZ, IKN, PDQ, ETN | GWF, GXY, GXZ, IKN, PDQ, ETN | Identical |
| Regulation Number(21 CFR) | §882.1870, §882.1320, §882.1350, §890.1375,§874.1820, §874.1820 | §882.1870, §882.1320, §882.1350, §890.1375,§874.1820, §874.1820 | Identical |
| Specification/Property | Predicate Device | Subject Device | SE Rationale(if not identical) |
| 510(k) | EPAD™ 2 System(K182542) | SafeOp™ 2 System | |
| Device ClassificationName | Stimulator, Electrical, Evoked Response | Stimulator, Electrical, Evoked Response | Identical |
| MonitoringModalities | Electromyography (EMG)Somatosensory Evoked Potentials (SSEP)Neuromuscular Junction Testing (NMJ) | Electromyography (EMG)Somatosensory Evoked Potentials (SSEP)Neuromuscular Junction Testing (NMJ) | Identical |
| Head Unit Power Supply | |||
| 60601-1 Compliant | Yes | Yes | Identical |
| Head Unit PowerSupply | 100 to 240 VAC, 50-60 Hz (input); 15 VDC, 2.5A(output) | 100 to 240 VAC, 50-60 Hz (input); 12 VDC, 2.5A(output) | Head unit power supply does not impact deviceperformance when compared to the predicate.The change in power does not introduce newrisks, or impact existing risks. Therefore, thisdifference does not affect device safety oreffectiveness. |
| Mode of Operation | Continuous | Continuous | Identical |
| Dimensions | 12"W x 8"H x 2"D | 12"W x 8"H x 2"D | Identical |
| Weight | < 2 lbs | < 2 lbs | Identical |
| Principles of Operation | |||
| Operating Modes | Triggered EMGFree run EMGSSEPNMJ | Triggered EMGFree run EMGSSEPNMJ | Identical |
| Total AmplifierChannels | Up to 8 | Up to 8 | Identical |
| Specification/Property | Predicate Device | Subject Device | SE Rationale |
| 510(k) | EPAD™ 2 System(K182542) | SafeOp™ 2 System | (if not identical) |
| Waveform | Monophasic, Rectangular | Monophasic, Rectangular | Identical |
| Pulse Duration | 50 to 300 µsec | 300 µsec (SSEP)200 µsec (EMG) | Identical |
| Frequency(Pulse Rate) | 0.1 to 50 Hz | 0.1 to 50 Hz | Identical |
| Current Range | 0 to 100 mA | 0 to 100 mA | Identical |
| Input Impedance | > 50 MΩ (at DC) | > 50 MΩ (at DC) | Identical |
| Low FrequencyFilter | 10 Hz (SSEP)30 Hz (EMG) | 10 Hz (SSEP)30 Hz (EMG) | Identical |
| High FrequencyFilter | 2.7 kHz (SSEP & EMG) | 2.7 kHz (SSEP & EMG) | Identical |
| Notch Filter | 50 or 60 Hz | 50 or 60 Hz | Identical |
| AlphaInformatix (AIX) Tablet | |||
| Operating System | Android powered tablet | Windows 10 powered tablet | Completed V&V testing successfullydemonstrates that the differences in theOperating Systems (OS) have no impact ondevice performance when compared to thepredicate. The OS change does not introducenew risks, or impact existing risks. Therefore,this difference does not affect device safety oreffectiveness. |
| Remote Access | No | No | Identical |
| Specification/Property | Predicate Device | Subject Device | SE Rationale(if not identical) |
| 510(k) | EPAD™ 2 System(K182542) | SafeOp™ 2 System | |
| Surface Electrodes | |||
| Anatomical Sites | SSEP: Upper/lower limbs and head/neck | SSEP: Upper/lower limbs and head/neck | Identical |
| Type | Customer cutaneous electrodes for use with SafeOp only. Single, double and triple electrodes. | Customer cutaneous electrodes for use with SafeOp only. Single, double and triple electrodes. | Identical |
| Conductive SurfaceArea | 20x25mm | 25.4x25.4mm (1x1in.) | Completed V&V testing successfullydemonstrates that the differences in the surfacearea has no impact on device performance whencompared to the predicate. The change does notintroduce new risks, or impact existing risks.Therefore, this difference does not affect devicesafety or effectiveness. |
| Conductive Gel | Wet gel | Solid gel | Completed V&V testing successfullydemonstrates that the differences in theconductive gel has no impact on deviceperformance when compared to the predicate.The change does not introduce new risks, orimpact existing risks. Therefore, this differencedoes not affect device safety or effectiveness. |
| Connectors | Nicomatic three pin | Nicomatic three pin | Identical |
| Current Density | < 0.75 mArms/cm2 | < 0.75 mArms/cm2 | Identical |
| Sterility | Non-sterile, single patient use, disposable | Non-sterile, single patient use, disposable | Identical |
| Surface ContactTime | ≤ 24 hours | ≤ 24 hours | Identical |
| Specification/Property | Predicate Device | Subject Device | SE Rationale(if not identical) |
| 510(k) | EPAD™ 2 System(K182542) | SafeOp™ 2 System | |
| Other Accessories | |||
| Needle Electrodes | Yes | Yes | Identical |
| Stimulating Probes | Yes | Yes | Identical |
| Cable, Electrode | Yes | Yes | Identical |
| Biocompatibility ofpatient contactingaccessories(ISO 10993-1) | YesTissue/bone/dentin for a limited duration of lessthan or equal to 24 hours. | YesTissue/bone/dentin for a limited duration of lessthan or equal to 24 hours. | Identical |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Atec. The "a" in Atec is green, and the rest of the letters are dark blue. There is a trademark symbol in the upper right corner of the logo. A black line is underneath the logo.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for a company called "atec". The "a" in "atec" is green, and the rest of the letters are black. There is a black line underneath the logo.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for a company called "atec". The "a" in "atec" is green, and the rest of the letters are black. There is a black line underneath the logo.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for a company called "atec". The "a" in "atec" is green, while the rest of the letters are dark blue. There is a trademark symbol to the right of the "c".
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for a company called "atec". The first letter of the company name is green, and the rest of the letters are black. There is a green swoosh above the letters "tec".
VII. PERFORMANCE DATA
Nonclinical performance testing demonstrates that the subject SafeOp 2 System meets the functional, system, and software requirements.
EMC and Electrical Safety Testing of the SafeOp 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 SafeOp 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
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 device, SafeOp 2 System, is substantially equivalent to the legally marketed primary predicate device 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).