Who is the manufacturer of SafeOp 3: Neural Informatix Systeem?

Alphatec Spine, Inc. filed the 510(k) submission for SafeOp 3: Neural Informatix Systeem (K234092).

What is the FDA product code for SafeOp 3: Neural Informatix Systeem?

GWF. It is classified under 21 CFR 882.1870 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for SafeOp 3: Neural Informatix Systeem?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SafeOp 3: Neural Informatix Systeem?

SafeOp2: Neural Informatix System (K213849).

Who can help prepare an FDA 510(k) submission like SafeOp 3: Neural Informatix Systeem?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SafeOp 3: Neural Informatix Systeem

K234092 · Alphatec Spine, Inc. · GWF · Apr 19, 2024 · Neurology

Device Facts

Record ID	K234092
Device Name	SafeOp 3: Neural Informatix Systeem
Applicant	Alphatec Spine, Inc.
Product Code	GWF · Neurology
Decision Date	Apr 19, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1870
Device Class	Class 2

Intended Use

The SafeOp 3: Neural Informatix System is intended for use by trained healthcare professionals as a diagnostic device that provides intraoperative neuromonitoring during various surgical procedures.

Device Story

SafeOp 3: Neural Informatix System provides intraoperative neuromonitoring (IONM) in hospital operating rooms. System components include patient interface, power supply, IV pole mount, Alpha Informatix Tablet, docking station, and disposable accessories (electrode harness, surface/subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators, stimulating probes/clips). Device records SSEP, MEP, TO4, tEMG, and sEMG. Trained healthcare professionals (neurophysiologists/technologists) operate the system to monitor neurological integrity during spine and orthopedic surgeries. Output is displayed on the tablet for real-time clinical assessment of nerve status. Monitoring helps surgeons avoid nerve injury during procedures like pedicle screw fixation or fusion. The system uses a quadripolar stimulation montage for MEPs to evoke responses at lower stimulation levels.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical performance testing, including system-level V&V, EMC/electrical safety testing, and usability testing.

Technological Characteristics

Class II device (21 CFR 882.1870). Components: patient interface, tablet, docking station, disposable electrodes/probes. 16 amplifier channels. Constant voltage stimulation (50-1000V). Quadripolar stim montage. Connectivity: USB data transfer. Software: Windows 10 tablet-based. Compliant with 60601-1 electrical safety standards.

Indications for Use

Indicated for monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). 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. Accessories assist in nerve location during/after implant placement.

Regulatory Classification

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.

Predicate Devices

SafeOp2: Neural Informatix System (K213849)

Reference Devices

Cascade IOMAX Intraoperative Monitor (K162199)
ATEC IOM Accessory Instruments (K221821)

Related Devices

K252842 — SafeOp 3: Neural Informatix System · Alphatec Spine, Inc. · Jan 11, 2026
K213849 — SafeOp 2: Neural Informatix System · Alphatec Spine, Inc. · Mar 9, 2022
K132694 — NUVASIVE NVM5 SYSTEM · Nu Vasive, Incorporated · May 16, 2014
K040543 — NUVASIVE NEUROVISION JJB SYSTEM · Nuvasive, Inc. · Apr 1, 2004
K123307 — NUVASIVE NVM5 SYSTEM · Nuvasive, Inc. · Apr 23, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ April 19, 2024 Image /page/0/Picture/1 description: The image shows 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. Unnati Bhuptani Sr. Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008 Re: K234092 Trade/Device Name: SafeOp 3: Neural Informatix Systeem 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: March 21, 2024 Received: March 21, 2024 Dear Unnati Bhuptani: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Patrick Antkowiak -S for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional {2}------------------------------------------------ Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K234092 Device Name SafeOp 3: Neural Informatix System ## Indications for Use (Describe) The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), 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. SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches. 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green and the "tec" is black. There is a trademark symbol in the upper right corner of the logo. 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 Roble Carlsbad, CA 92008 Phone: (760) 432-9286 Fax: (760) 431-0289 | |----|-----------------|----------------------------------------------------------------------------------------------------------------------| | | Contact Person: | Unnati Bhuptani | Sr. Regulatory Affairs Specialist Alphatec Spine, Inc. Contact Phone: (760) 356-6711 March 20, 2024 Date Summary Prepared: #### II. DEVICE | Trade Name: | SafeOp™ 3: 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 | |---------|-----------------------------------|----------------| | K213849 | SafeOp2: Neural Informatix System | March 9, 2022 | #### IV. DEVICE DESCRIPTION The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface 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, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits. The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical {5}------------------------------------------------ Image /page/5/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 small trademark symbol in the upper right corner of the logo. centers. System setup may be performed by both clinical and trained non-clinical personnel. The subject device records the following modalities: - Somatosensory evoked potentials (SSEP) - Motor evoked potentials (MEP), - . Train-of-four neuromuscular junction (TO4), - Triggered electromyography (tEMG) and ● - . Free run electromyography (sEMG) #### INTENDED USE AND INDICATIONS FOR USE V. ## Intended Use The SafeOp 3: Neural Informatix System is intended for use by trained healthcare professionals as a diagnostic device that provides intraoperative neuromonitoring during various surgical procedures. ## Indications for Use The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), 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. SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches. #### TECHNOLOGICAL COMPARISON TO PREDICATES VI. 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. {6}------------------------------------------------ # Table 1: Comparison for Substantial Equivalence | Specification/ Property | Reference Device | Primary Predicate Device | Subject Device | SE Rationale (if not identical) | | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | 510(k) | Cascade IOMAX Intraoperative Monitor (K162199) | ATEC IOM Accessory Instruments (K221821) | SafeOp 2: Neural Informatix System (K213849) | SafeOp 3: Neural Informatix System | | | Intended Use/ Indications for Use | The Cascade IOMAX™ Intraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The acquired data are necessary to perform somatosensory, auditory and visual evoked potentials (EPs), electroencephalography (EEG). electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures. Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, displays, records, and stores the electrical activity of the nervous system in response to the stimulation. EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head. Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live | The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches. | Intended use The SafeOp 2: Neural Informatix System is intended for use by trained healthcare professionals as a diagnostic device that provides intraoperative neuromonitoring during various surgical procedures. 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. | Intended use The SafeOp 3: Neural Informatix System is intended for use by trained healthcare professionals as a diagnostic device that provides intraoperative neuromonitoring during various surgical procedures. Indications for Use The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), 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. SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches. | Same as predicates and reference devices | | Specification/ Property | Reference Device | Primary Predicate Device | Subject Device | SE Rationale (if not identical) | | | 510(k) | Cascade IOMAX Intraoperative Monitor (K162199) | ATEC IOM Accessory Instruments (K221821) | SafeOp 2: Neural Informatix System (K213849) | SafeOp 3: Neural Informatix System | | | | stream of mechanically induced myotome contractions. | | | | | | | TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. | | | | | | | Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex. | | | | | | | Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle. | | | | | | | Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. | | | | | | | Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, displays, records, and stores the compound muscle action potential amplitude fade for analysis. | | | | | | | SpO2: IOMAX measures and displays oxygen saturation and heart rate information. | | | | | | | Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room. | | | | | | | IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for | | | | | | Specification/ Property | Reference Device | | Primary Predicate Device | Subject Device | SE Rationale (if not identical) | | 510(k) | Cascade IOMAX Intraoperative Monitor (K162199) | ATEC IOM Accessory Instruments (K221821) | SafeOp 2: Neural Informatix System (K213849) | SafeOp 3: Neural Informatix System | | | | pre-operative, intraoperative and post-operative testing. | |…