Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a system for neuromonitoring using evoked potentials and EMG, detailing hardware components and a graphical user interface. There is no mention of AI, ML, or any related concepts in the provided text. The performance studies focus on functional, system, software, electrical safety, and usability testing, not on the performance of any AI/ML algorithms.

Therapeutic

No.

The device is intended for monitoring neurological status by recording evoked potentials and electromyography, which are diagnostic and monitoring functions, not therapeutic.

Diagnostic

Yes
The device is described as being used in the operating room to "display nerve and muscle responses" which the user can then "use these responses to diagnose insults to the peripheral or central nerves". This direct indication of aiding in diagnosis makes it a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a "SafeOp head unit with power supply and IV pole mount," an "Alpha Informatix Tablet with docking station and power supply," and a "data transfer USB cable," in addition to disposable accessories. The head unit is described as containing "a complete data acquisition system that has builtin stimulators, amplifiers, relays, A/D Converters, Digital Signal Processors, CPUs, and storage devices." This clearly indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SafeOp 2: Neural Informatix System is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
SafeOp 2 Function: The SafeOp 2 System directly interacts with the patient's body to record electrical signals (SSEPs, EMG, NMJ) from nerves and muscles. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states monitoring neurological status by recording electrical potentials and assessing the neuromuscular junction during surgical procedures. This is a direct physiological measurement, not an in vitro analysis.
Device Description: The description details a system with stimulators, amplifiers, and data acquisition for direct patient contact and measurement of nerve and muscle responses.

Therefore, the SafeOp 2 System falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 (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.

Product codes

GWF, GXY, GXZ, IKN, PDQ, ETN

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

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. SSEP: Upper/lower limbs and head/neck.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained healthcare professionals / intraoperative neuromonitoring during various surgical procedures

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K182542

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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)

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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 Roble
Carlsbad, CA 92008
Phone: (760) 494-6711
Fax: (760) 431-0289 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Gramse
Sr. Director, Regulatory and Clinical Affair
Alphatec 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.

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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 trained
healthcare professionals as a diagnostic device
that provides intraoperative neuromonitoring
during various surgical procedures.

The EPAD 2 system is intended for use in
monitoring neurological status by recording
somatosensory evoked potentials (SSEP),
electromyography (EMG), or assessing the
neuromuscular junction (NMJ). Neuromonitoring
procedures include intracranial, extracranial,
intratemporal, extratemporal, neck dissections,
upper and lower extremities, spinal degenerative
treatments, pedicle screw fixation, intervertebral
fusion cages, rhizotomy, orthopedic surgery, open
or percutaneous, lumbar, thoracic, and cervical
surgical procedures. | The 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.