SafeOp 2: Neural Informatix System

{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. 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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) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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. 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SUBMITTER: | Alphatec Spine, Inc.<br>1950 Camino Vida Roble<br>Carlsbad, CA 92008<br>Phone: (760) 494-6711<br>Fax: (760) 431-0289 | |------------------------|-----------------------------------------------------------------------------------------------------------------------| | Contact Person: | David Gramse<br>Sr. Director, Regulatory and Clinical Affair<br>Alphatec Spine, Inc.<br>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<br>(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/<br>Property | Predicate Device | Subject Device | SE Rationale<br>(if not identical) | |---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | EPAD™ 2 System<br>(K182542) | SafeOp™ 2 System | | | Intended Use/<br>Indications for Use | The EPAD 2 system is intended for use by trained<br>healthcare professionals as a diagnostic device<br>that provides intraoperative neuromonitoring<br>during various surgical procedures.<br><br>The EPAD 2 system is intended for use in<br>monitoring neurological status by recording<br>somatosensory evoked potentials (SSEP),<br>electromyography (EMG), or assessing the<br>neuromuscular junction (NMJ). Neuromonitoring<br>procedures include intracranial, extracranial,<br>intratemporal, extratemporal, neck dissections,<br>upper and lower extremities, spinal degenerative<br>treatments, pedicle screw fixation, intervertebral<br>fusion cages, rhizotomy, orthopedic surgery, open<br>or percutaneous, lumbar, thoracic, and cervical<br>surgical procedures. | The SafeOp 2: Neural Informatix System is<br>intended for use by trained healthcare professionals<br>as a diagnostic device that provides intraoperative<br>neuromonitoring during various surgical procedures.<br><br>The SafeOp 2: Neural Informatix System is<br>intended for use in monitoring neurological status<br>by recording somatosensory evoked potentials<br>(SSEP), electromyography (EMG), or assessing the<br>neuromuscular junction (NMJ). Neuromonitoring<br>procedures include intracranial, extracranial,<br>intratemporal, extratemporal, neck dissections,<br>upper and lower extremities, spinal degenerative<br>treatments, pedicle screw fixation, intervertebral<br>fusion cages, rhizotomy, orthopedic surgery,<br>open/percutaneous, lumbar, thoracic, and cervical<br>surgical procedures. | Identical | | Device Class | II | II | Identical | | Product Code | GWF, GXY, GXZ, IKN, PDQ, ETN | GWF, GXY, GXZ, IKN, PDQ, ETN | Identical | | Regulation Number<br>(21 CFR) | §882.1870, §882.1320, §882.1350, §890.1375,<br>§874.1820, §874.1820 | §882.1870, §882.1320, §882.1350, §890.1375,<br>§874.1820, §874.1820 | Identical | | Specification/<br>Property | Predicate Device | Subject Device | SE Rationale<br>(if not identical) | | 510(k) | EPAD™ 2 System<br>(K182542) | SafeOp™ 2 System | | | Device Classification<br>Name | Stimulator, Electrical, Evoked Response | Stimulator, Electrical, Evoked Response | Identical | | Monitoring<br>Modalities | Electromyography (EMG)<br>Somatosensory Evoked Potentials (SSEP)<br>Neuromuscular Junction Testing (NMJ) | Electromyography (EMG)<br>Somatosensory Evoked Potentials (SSEP)<br>Neuromuscular Junction Testing (NMJ) | Identical | | Head Unit Power Supply | | | | | 60601-1 Compliant | Yes | Yes | Identical | | Head Unit Power<br>Supply | 100 to 240 VAC, 50-60 Hz (input); 15 VDC, 2.5A<br>(output) | 100 to 240 VAC, 50-60 Hz (input); 12 VDC, 2.5A<br>(output) | Head unit power supply does not impact device<br>performance when compared to the predicate.<br>The change in power does not introduce new<br>risks, or impact existing risks. Therefore, this<br>difference does not affect device safety or<br>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 | | Principles of Operation | | | | | Operating Modes | Triggered EMG<br>Free run EMG<br>SSEP<br>NMJ | Triggered EMG<br>Free run EMG<br>SSEP<br>NMJ | Identical | | Total Amplifier<br>Channels | Up to 8 | Up to 8 | Identical | | Specification/<br>Property | Predicate Device | Subject Device | SE Rationale | | 510(k) | EPAD™ 2 System<br>(K182542) | SafeOp™ 2 System | (if not identical) | | Waveform | Monophasic, Rectangular | Monophasic, Rectangular | Identical | | Pulse Duration | 50 to 300 µsec | 300 µsec (SSEP)<br>200 µsec (EMG) | Identical | | Frequency<br>(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<br>Filter | 10 Hz (SSEP)<br>30 Hz (EMG) | 10 Hz (SSEP)<br>30 Hz (EMG) | Identical | | High Frequency<br>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 | | | | | Operating System | Android powered tablet | Windows 10 powered tablet | Completed V&V testing successfully<br>demonstrates that the differences in the<br>Operating Systems (OS) have no impact on<br>device performance when compared to the<br>predicate. The OS change does not introduce<br>new risks, or impact existing risks. Therefore,<br>this difference does not affect device safety or<br>effectiveness. | | Remote Access | No | No | Identical | | Specification/<br>Property | Predicate Device | Subject Device | SE Rationale<br>(if not identical) | | 510(k) | EPAD™ 2 System<br>(K182542) | SafeOp™ 2 System…