(115 days)
No
The summary describes a system for recording and monitoring various neurophysiological signals (MEP, SSEP, EMG, NMJ). It details the hardware components and the types of signals recorded. There is no mention of AI, ML, or any algorithms that would process these signals using such techniques for interpretation, prediction, or automated analysis beyond standard signal processing. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a neurologial monitoring system that records evoked potentials and electromyography, and is used to assist in nerve location during surgical procedures. It does not provide treatment or alter the body's function.
No
The device is intended for monitoring neurological status by recording evoked potentials and electromyography, assisting in the location of nerves during surgical procedures. It does not provide a diagnosis.
No
The device description explicitly lists hardware components such as a patient interface, tablet, power supplies, cables, and various disposable accessories (electrodes, activators, etc.).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ)." This involves monitoring physiological signals directly from the patient's body during surgical procedures.
- Device Description: The device description details a system that records electrical signals from the patient using electrodes and a patient interface. This is consistent with a device used for physiological monitoring, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition or provide information about a patient's health status based on the analysis of these samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The SafeOp 3 System's function is to monitor the patient's neurological responses in vivo during surgery.
N/A
Intended Use / 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, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhitotomy, 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.
Product codes (comma separated list FDA assigned to the subject device)
GWF, GXY, GXZ, IKN, PDQ, ETN
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 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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurological status; intracranial, extratemporal, neck, upper and lower extremities, spinal, lumbar, thoracic, and cervical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel; operating room environments of hospitals and surgical centers.
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 3 System meets the functional, system, and software requirements.
EMC and Electrical Safety Testing of the SafeOp 3 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 3 System presents no adverse effect within the intended environment, and the subject device was therefore found to be substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
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)
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)
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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
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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. | | | | |
| Device Class | II | II | II | II | Identical to
predicate and
reference devices |
| Product Code | GWF, DQA, ETN, GWE, GWJ, GWQ, GZO,
IKN, JXE, OLT | PDQ, ETN | GWF, GXY, GXZ, IKN, PDQ, ETN | GWF, GXY, GXZ, IKN, PDQ, ETN | Identical to
predicate and
reference devices |
| Regulation
Number (21
CFR) | §882.1870, §870.2700, §874.1820, §882.1890,
§882.1900, §882.1400, §882.1540, §890.1375,
§882.1550 | §874.1820 | §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 to
predicate and
reference devices |
| Device
Classification
Name | Stimulator, Electrical, Evoked Response | Surgical nerve
stimulator/locator | Stimulator, Electrical, Evoked Response | Stimulator, Electrical, Evoked Response,
Surgical nerve stimulator/locator | Identical to
predicate and
reference devices |
| Monitoring
Modalities/Oper
ating Modes | • Electrode Impedance Test
• Evoked potential (EP) in the form of:
• Brainstem auditory
• Visual
• Somatosensory
• Transcranial electrical motor evoked
potential (TcMEP)
• Electromyography (EMG)
• Electroencephalogram (EEG)
• Nerve conduction studies in the form of:
• NCV
• F wave
• H reflex
• Train of four (TOF)
• SpO2 and heart rate values | N/A | • Electrode Test
• Electromyography (EMG)
• Somatosensory Evoked Potentials (SSEP)
• Neuromuscular Junction Testing - Train of
Four (TO4) | • Electrode Test
• Electromyography (EMG)
• Somatosensory Evoked Potentials (SSEP)
• Motor Evoked Potential (TCMEP or MEP)
• Neuromuscular Junction Testing - Train of Four
(TO4) | Identical to
predicate 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 | |
| | • Threshold mode | | | | |
| 60601-1
Compliant | Yes | N/A | Yes | Yes | Identical to
predicate and
reference devices |
| Total Amplifier
Channels | Supports Up to 48 | N/A | Up to 8 | Up to 16 | Substantially
Equivalent to the
predicates and
reference device |
| Operating
System | Windows 7 Professional (SP1, 64-bit) or
Windows 10. Windows 10 | N/A | Windows 10 powered tablet | Windows 10 powered tablet | Identical to
predicate, SafeOp 2
System (K213849) |
| Remote Access | No | N/A | No | No | Identical to
predicate and
reference devices |
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Image /page/7/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green and the "tec" is dark blue. There is a trademark symbol to the right of the "c".
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Image /page/8/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 trademark symbol to the right of the "c". There is a black line underneath the logo.
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10
B. Discussion of the MEP modality
Moor Evised Potentials (MEP) is a rearmonity used in suggaal procedures to periodically assess the integrity of more news for the suger. The ME modity has been aded to the subject Sale of 3 System o provincity of essere ingrity of decembry of tecs and support the standed prociee of mille mailing which provides assessment of both ascending (sensory) and descending (motor) spinal pathways.
Comparison to MEP functionality in the reference device, Cascade IOMAX Intraoperative System (K162199):
The effection a with mage of nearmations while sunal sual vised putatials (ER), electronials (ER), electronially (EX), becamily group) (EXG), tection yearly (ENG), teascanial evalentials (1) MEP) direct cortual studies and Train of Four (TOP) and Jour (TOP) and Joses on similified and Doced or spinal neuromnitioning aplications portually, the capitiines of the subject of the MEP modaliy are a subset of the reference cover Control (K1219). The Inited stimulation and aquisition paraments of the subject Sate of 3 System eist as subset of the reference Montors (K162.99) specification rage to best serve the intended use of spinsh newmanning Title 2 below povies a dealed compunism of technologial cheven the subject Sale of 3 System and relieve, Casade IOMAX Intragreative Morine (KM2199) specific on the MEP modility The ormprisen novided in Ta demonstrates that the MEP modiet Safel p 3 System on be considered substantially quivalent to the reference device, Cassade OMAX Intraoperative Monion (K162.99)
| Feature | Cascade IOMAX Intraoperative
Monitor (K162199) | SafeOp 3 System (subject device) | Comparison | Substantial Equivalence Rationale |
|-----------------------------------------------|------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MEP Stim
outputs | Nine outputs, each selectable as
anode or cathode | Four outputs, arranged in two
pairs, polarity selectable | The subject SafeOp 3 System has a defined quadripolar stim montage
which is accommodated with the four outputs arranged in two pairs. The
MEP Stim Outputs are used to deliver stimulation to the motor cortex via
four transcranial electrodes. Bipolar stim montage has traditionally been
used to induce a response for MEP stimulation but quadripolar stimulation
is also commonly used because of less patient movement and increased
likelihood of evoking motor response at lower stimulation levels¹. The
SafeOp 3 System used a quadripolar stim montage to elicit a response at
lower stimulation levels. | • Testing which covers the system level
delivery of MEP Pulses as set by the user,
across the settable range of pulse
configurations. |
| Total
Amplifier
Channels | Up to 48 | Up to 16 | The subject SafeOp 3 System is specific for use in spine. The system
utilizes the 16 amplifier channels in the following manner:
- 6 bilateral channels for EMG acquisition (12 total, leveraged by
the Train of Four, sEMG, tEMG, and MEP Modalities). This
supports adequate coverage for the monitoring modalities stated
above and case types supported. - 3 channels for SSEP acquisition. This supports cortical and trans-
cortical SSEP acquisition montages, which is adequate coverage
for the monitoring modalities and case types supported. - 1 extra channel for either EMG of SSEP acquisition. | • Testing which covers the acquisition
sensitivity of MEP Responses across
all available channels |
| | | | Since the reference device Cascade IOMAX Intraoperative Monitor
(K162199) is used in neuromonitoring applications in addition to spine,
the reference device requires additional channels to perform other
neuromonitoring activities such as EEG. As described above, the subject
SafeOp 3 System only requires 16 amplifier channels to perform
neuromonitoring for all modalities. Therefore, the differences in number | • Testing which covers firmware MEP
stimulation energy limits and stimulation
diagnostics |
| | | | | The above listed system level and firmware
level testing demonstrate that the specifications
have been met through V&V Testing
individually and as part of the system, no
significant failures or deviations were observed. |
| Feature | Cascade IOMAX
Intraoperative Monitor
(K162199) | SafeOp 3 System (subject device)
(K162199) | Comparison | Substantial Equivalence Rationale |
| Stim
Waveform | Positive, Negative, Biphasic | Positive, Negative | The reference device, Cascade IOMAX Intraoperative Monitor
(K162199) uses optional biphasic stim waveforms for MEPs to limit
stimulus artifact with longer pulse durations. The subject SafeOp 3
System has a shorter pulse duration and therefore does not need biphasic
waveforms for the MEP modality of the SafeOp 3 System to function as
intended. | Completed V&V testing successfully
demonstrates that the differences in the
technological characteristics have no impact on
the performance, safety and effectiveness of the
subject SafeOp 3 System when compared to the
reference device, Cascade IOMAX Intraoperative
Monitor (K162199). |
| Voltage Range | 50-1000 V | 50-1000 V | Same range as the reference device, Cascade IOMAX Intraoperative
Monitor (K162199) | The differences in the technological
characteristics between subject SafeOp 3 System
and the reference device, Cascade IOMAX
Intraoperative Monitor (K162199) do not
introduce any new risks that are not already |
| Current Range | 50-1500 mA | 50-1500 mA | Same range as the reference device, Cascade IOMAX Intraoperative
Monitor (K162199) | inherent to clinical use of the MEP Modality. All
risks related to the addition of the MEP
Modality have been adequately mitigated. |
| Output Control
Mode | Constant voltage or constant current | Constant voltage | the subject SafeOp 3 can be considered substantially equivalent to the
reference device, Cascade IOMAX Intraoperative Monitor (K162199),
since both systems provide the constant voltage as an output control
mode. The Constant Voltage output control mode is most commonly used
in intraoperative MEP monitoring according to MacDonald, D.B., et al2,
and therefore was chosen as the preferred Output Control Mode for the
subject SafeOp 3 System. | Therefore, these differences in technological
characteristics do not affect device safety or
effectiveness and can be considered
Substantially Equivalent to the reference device
Cascade IOMAX Intraoperative Monitor
(K162199). |
| Pulse Duration | 50 usec - 500 µsec | 50 µsec - 150 µsec | The pulse duration required to evoke a motor response is 50µsec. The
subject SafeOp 3 System has pulse duration range from 50µsec to
150µsec to provide the user with flexibility in parameters to optimize the
likelihood of evoking a response. In addition, since the subject SafeOp3
System uses a quadripolar montage, a motor response can be evoked at
the range specified for the subject device. The SafeOp 3 System uses a
subset of the Cascade IOMAX Intraoperative Monitor that is generally
used in clinical practice. Verification and Validation testing demonstrate
that the MEP modality of the SafeOp 3 System functions as intended. | |
| Maximum
energy into 1
kohm
impedance | 50 mJ/pulse | 50 mJ/pulse | Same as the reference Cascade IOMAX Intraoperative Monitor. | |
| Repetition rate | 1 Hz max | 1 Hz max | Same | |
| Low
Frequency
Filter | 0.3 Hz-100 Hz | 1-30Hz | The low frequency filter range of 1-30 Hz for the subject SafeOp 3
System is the same as the predicate SafeOp 2 System. This frequency
range allows the signal of interest to pass through the filter. Addition of
MEP modality does not affect the frequency range of signal of interest.
MacDonald, DB, et al2, found that filter settings of 10-100 Hz to 1500-
3000 Hz are appropriate for limb muscles. Stimulus artifact may obscure
cranial MEPs with these settings: opening the low frequency filter to 0.2- | |
| Feature | Cascade IOMAX
Intraoperative Monitor
(K162199) | SafeOp 3 System (subject device) | Comparison | Substantial Equivalence Rationale |
| High
Frequency
Filter | 30Hz - 5kHz | 1.5 - 3kHz | 2 Hz or constraining it to 150-300 Hz can help. Therefore, although the
subject SafeOp 3 System has a smaller low frequency filter range as
compared to reference Cascade IOMAX Intraoperative Monitor
(K162199), the differences in the range do not affect the safety or
effectiveness of the device or its ability to function as intended.
The high frequency filter range of 1.5 - 3kHz for the subject SafeOp 3
System is the same as the predicate SafeOp 2 System. This frequency
range allows the signal of interest to pass through the filter. Addition of
MEP modality has does not affect the frequency range of signal of
interest. MacDonald, DB, et al 2, found that filter settings of 10-100 Hz to
1500–3000 Hz are appropriate for limb muscles. Therefore, although the
subject SafeOp 3 System has a smaller high frequency filter range as
compared to reference Cascade IOMAX Intraoperative Monitor
(K162199), the differences in the range do not affect the safety or
effectiveness of the device or its ability to function as intended. | |
| Impedance
Measurement | All outputs | All outputs | Same | |
Table 2: Comparison of Technological Characteristics
' Schwartz, SL., et.al, (202). "Quadripolation for Motor Evokel Potentials. J.C.in! Neurophysiology, 39(1), 92-97, doi: 10.1097WNY 20000000000751
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PERFORMANCE DATA VII.
Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements.
EMC and Electrical Safety Testing of the SafeOp 3 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 3 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 3 System, is substantially equivalent to the legally marketed primary predicate device in regards to indications for use, intended use, design, technology, and performance.