(227 days)
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.
The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws).
The document provided is a 510(k) premarket notification for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, functionality, and performance testing. However, it explicitly states:
"Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
This means the submission does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human-in-the-loop studies involving AI. The acceptance criteria and performance data provided are related to functional, electrical safety, biocompatibility, and reprocessing aspects of the surgical instruments themselves, not their performance in a clinical diagnostic or prognostic context with AI assistance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/clinical performance study.
The document covers the following types of acceptance criteria and proven performance for the ATEC IOM Accessory Instruments (which are surgical tools, not an AI diagnostic device):
1. Table of Acceptance Criteria and Reported Device Performance (Summary of Engineering/Safety Tests):
| Test | Acceptance Criteria (Implied by Test Method) | Reported Device Performance |
|---|---|---|
| Functional performance testing and verification analysis | Insulation Effectiveness, Electrical Resistance, Current Density (as per standard engineering principles for electrical stimulation instruments) | "All functional performance testing passed. Substantial equivalence has been shown via analysis and testing." |
| Electrical safety testing and/or evaluation | Compliance with IEC 60601-1: 2005 for medical electrical equipment. | "Subject devices passed electrical safety testing and/or evaluation, demonstrating that the devices meet the requirements." |
| Biocompatibility testing | Compliance with ISO 10993 for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility. Risk analysis performed considering body contact and duration. | "A risk analysis was performed taking into account nature of body contact and duration to categorization the use of existing data, end-specific testing, and endpoint assessment to cover the identified test methods. Additionally, data was leveraged by other means (e.g., authorized use of Master File, predicate and reference devices, well known and characterized materials) to support the biocompatibility of the subject devices." |
| Reprocessing (Cleaning and Sterilization) | Cleaning validation study based on AAMI TIR30:2011 acceptance criteria. Steam sterilization validation performed per ANSI/AAMI/ISO 17665-1:2006/(R)2013 to assure an SAL of 10^-6. | "The subject devices can be adequately cleaned and steam sterilized prior to use." |
The document does NOT provide information for the following points, as they are not relevant to a device submission for surgical instruments focused on substantial equivalence based on material and functional safety rather than AI performance:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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May 9, 2019
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Alphatec Spine, Inc Jeremy Markovich Senior Manager, Regulatory and Clinical Affairs 5818 El Camino Real Carlsbad, California 92008
Re: K182617
Trade/Device Name: ATEC IOM Accessory Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN Dated: April 5, 2019 Received: April 8, 2019
Dear Jeremy Markovich:
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 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
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Carlos L. Peña, PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182617
Device Name ATEC IOM Accessory Instruments
Indications for Use (Describe)
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.
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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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.5818 El Camino RealCarlsbad, CA 92008Phone: (760) 431-9286Fax: (760) 431-0289 |
|---|---|---|
| Contact Person: | Jeremy MarkovichSenior Manager, Regulatory and Clinical AffairsContact Phone: (760) 431-9286 | |
| Date Summary Prepared: | May 8, 2019 |
II. DEVICE
| Trade or Proprietary Name: | ATEC IOM Accessory Instruments |
|---|---|
| Common Name: | Surgical nerve stimulator/locator. |
| Classification Name: | Neurosurgical Nerve Locator |
| Regulation Number: | 21 CFR 874.1820 |
| Classification: | Class II |
| Product Code: | PDQ, ETN |
III. LEGALLY MARKETED PREDICATE DEVICES
| Predicate Device(s): | |
|---|---|
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K171807 | Stryker ES2 Neuromonitoring Accessory Instruments | July 18, 2017 |
| K142438 | Pioneer Surgical Nerve Monitoring Cable System | March 5, 2015 |
| K182542 | The EPAD 2 System | February 22, 2019 |
Reference Device(s):
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K183705 | IdentiTi Porous Ti Interbody System | March 1, 2019 |
| K161363 | Arsenal Posterior Fixation System | June 10, 2016 |
| K133221 | Arsenal Posterior Fixation System | March 13, 2014 |
| K123623 | Illico MIS Posterior Fixation System | February 14, 2013 |
| K110170 | Raptor Facet Fixation System | November 28, 2011 |
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DEVICE DESCRIPTION IV.
The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws).
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Image /page/5/Picture/0 description: The image shows the "atec" logo. The logo consists of a green square with a white stylized "a" inside it, followed by the word "tec" in white. There is a trademark symbol after the word "tec". The background is dark blue.
| Predicate DeviceK171807 | Predicate DeviceK142438 | Predicate DeviceK182542 | Subject Device | |
|---|---|---|---|---|
| Attribute | Stryker ES2Neuromonitoring AccessoryInstruments | Pioneer Surgical NerveMonitoring Cable System | The EPAD 2 System | ATECIOM Instruments |
| Indications forUse | The ES2 Neuromonitoringinstruments (Awls, Taps,Screwdriver and LITe Y-NEEDLE 200, 300 and 400) canbe used by the surgeon to assistin location of the spinal nervesby providing proximityinformation before, during orafter bone preparation andplacement of bone screws inopen and percutaneousminimally invasive posteriorsurgical approaches of the non-cervical spine. | The Nerve Monitoring Cable inconjunction with dilators,pedicle probes, taps, awls orscrew drivers, are intended fortissue dilation/dissection andstimulation of peripheral nervesincluding spinal nerve roots forlocation and identificationduring spinal surgery.The dilators are also intended foruse in surgical procedures toprovide surgical access bydilating the soft tissue to theintended surgical site to allowpassage of current from a pointon the proximal end to anuninsulated portion of the distaltip. The purpose of this is toallow controlled monitoring ofneural elements near and aroundthe point of access. Thedilators are offered sterile/singleuse. | The EPAD 2 system is intendedfor use in monitoringneurological status by recordingsomatosensory evoked potentials(SSEP), electromyography(EMG), or assessing theneuromuscular junction (NMJ).Neuromonitoring proceduresinclude 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 cervicalsurgical procedures. | The ATEC IOM AccessoryInstruments are utilized in spinesurgical procedures to assist inlocation of the nerves during orafter preparation and placementof implants (intervertebral fusioncages and pedicle screw fixationdevices) in open andpercutaneous minimally invasiveapproaches. |
| Regulation,Product Code, &Class | 21 CFR 874.1820PDQClass II | 21 CFR 874.182021 CFR 882.1350PDQ, ETN, GXZClass II | 21 CFR 882.187021 CFR 874.182021 CFR 882.135021 CFR 882.1320GWF, ETN, PDQ, GXY, GXZClass II | 21 CFR 874.1820PDQ, ETNClass II |
| IEC 60601Compliant | YesProtected Pin Design viacompatible clip/probeClause 56.3(c) | YesProtected Pin Design viacompatible clip/probeClause 56.3(c) | YesProtected Pin Design viacompatible clip/probeClause 56.3(c) | YesProtected Pin Design viacompatible clip/probeClause 56.3(c) |
| Instrument Type(Description) | Awls, Taps, Screwdrivers,Guidewires (K-wires), and 200,300, 400 LITE Y-Needles | Dilators, Pedicle Probes, Taps,Awls and Screwdrivers | Probes, Dilators, Electrodes | Drills, Taps, Awls, Probes,Screwdrivers, Dilators (Sleeves),Guidewires, and Needles |
| BiocompatibilityPatient ContactDuration | Limited patient duration contact(≤ 24 hours) | Limited patient duration contact(≤ 24 hours) | Limited patient duration contact(≤ 24 hours) | Limited patient duration contact(≤ 24 hours) |
| Biocompatible | Yes(Characterizatio | Yes | Yes | Yes |
| SurgicalApproach | Open or Percutaneous/Minimally Invasive | Open or Percutaneous/Minimally Invasive | Open or Percutaneous/Minimally Invasive | Open or Percutaneous/Minimally Invasive |
| Sterility | Sterile and Non-sterileNon-sterile devices are providedwith validated steam sterilizationparameters to assure an SAL of$10^{-6}$ | Sterile and Non-sterileNon-sterile devices are providedwith validated steam sterilizationparameters to assure an SAL of$10^{-6}$ | Sterile and Non-sterile | Non-sterileNon-sterile devices are providedwith validated steam sterilizationparameters to assure an SAL of$10^{-6}$ |
| Reusable/Single Use | 200, 300, and 400 LITE YNeedles – Single UseAwls, Taps, and Screwdrivers -Reusable | Dilators – Single UsePedicle probes, taps, awls andscrew drivers - Reusable | Single Use | Guidewires, Targeting Needlesand Dilators – Single UseAwls, Drills/Taps, Probes,Dilators (Sleeves), andScrewdrivers - Reusable |
| Compatible withCommonNeuromonitoringConsoles &Software | Yes | Yes | Yes | Yes |
| Connection toNeuromonitoringUnit | Clip or probe(based on Neuromonitoringsystem) | Clip or probe(based on Neuromonitoringsystem) | Clip or probe(based on Neuromonitoringsystem) | Clip or probe(based on Neuromonitoringsystem) |
| Minimumexposed surfacearea duringtissuestimulation | 0.53 mm² | 12.9032 mm²(0.02 in²) | Unknown | 8.6 mm² |
Table 1: Comparison for Substantial Equivalence
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| Table 2: Comparison for Substantial Equivalence for Reference Device(s) | |||||
|---|---|---|---|---|---|
| Attribute | Reference DeviceK183705 | Reference DeviceK110170 | Reference DeviceK123623 | Reference DeviceK133221K161363 | Subject Device |
| Regulation,Product Code, &Class | IdentiTi Porous TiInterbody System21 CFR 888.3080MAXClass II | Raptor Facet FixationSystem21 CFR 888.4540LXHClass I | Illico MIS PosteriorFixation System21 CFR 888.4540LXHClass I | Arsenal PosteriorFixation System21 CFR 888.4540LXHClass I | ATECIOM Instruments21 CFR 874.1820PDQ, ETNClass II |
| Instrument Type(Description) | Inserter | Screwdrivers, Guidewires | Guidewires, Dilators(Sleeves) | Screwdrivers | Drills, Taps, Awls, Probes,Screwdrivers, Dilators(Sleeves), Guidewires, andTargeting Needles |
| BiocompatibilityPatient ContactDuration | Limited patient durationcontact(≤ 24 hours) | Limited patient durationcontact(≤ 24 hours) | Limited patient durationcontact(≤ 24 hours) | Limited patient durationcontact(≤ 24 hours) | Limited patient durationcontact(≤ 24 hours) |
| Biocompatible | Yes (Data provided tocharacterize materials)Non-sterile | Yes (Data provided tocharacterize materials)Non-sterile | Yes (Data provided tocharacterize materials)Non-sterile | Yes (Data provided tocharacterize materials)Non-sterile | YesNon-sterile |
| Sterility | Non-sterile devices areprovided with validatedsteam sterilizationparameters to assure anSAL of 10-6 | Non-sterile devices areprovided with validatedsteam sterilizationparameters to assure anSAL of 10-6 | Non-sterile devices areprovided with validatedsteam sterilizationparameters to assure anSAL of 10-6 | Non-sterile devices areprovided with validatedsteam sterilizationparameters to assure anSAL of 10-6 | Non-sterile devices areprovided with validatedsteam sterilizationparameters to assure anSAL of 10-6 |
| Reusable/Single Use | Inserter - Reusable | Guidewires - Single UseScrewdrivers - Reusable | Guidewires - Single UseDilator - Reusable | Screwdrivers - Reusable | Guidewires, TargetingNeedles and Dilators -Single UseAwls, Drills/Taps, Probes,Dilators (Sleeves), andScrewdrivers - Reusable |
| Compatible withCommonNeuromonitoringConsoles &Software | No | No | No | No | Yes |
| Connection toNeuromonitoringUnit | Not applicable | Not applicable | Not applicable | Not applicable | Clip or probe(based on Neuromonitoringsystem) |
Table 2: Comparison for Substantial Equivalence for Reference Device(s)
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Image /page/9/Picture/0 description: The image shows the logo for a company called "atec". The logo consists of a green square with a white stylized "a" inside of it, followed by the white text "tec" with a trademark symbol. The background of the logo is a dark blue color. The logo is simple and modern, and the colors are eye-catching.
V. INDICATIONS FOR USE
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.
TECHNOLOGICAL COMPARISON TO PREDICATES VI.
The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
Performance testing demonstrates the subject ATEC IOM Accessory Instruments are appropriate for neuromonitoring applications and do not introduce a new worst case for minimum exposed surface area during tissue stimulation compared to other legally marketed devices cleared by FDA.
The table below summarizes the testing which was performed on the subject devices to show substantial equivalence to the predicate devices.
| Test | Test Method Summary | Results |
|---|---|---|
| Functionalperformance testingand verificationanalysis | Insulation Effectiveness Electrical Resistance Current Density | All functional performance testingpassed. Substantial equivalence has beenshown via analysis and testing. |
| Electrical safetytesting and/orevaluation | Evaluation and testing was performedon the subject devices in accordancewith IEC 60601-1: 2005. | Subject devices passed electrical safetytesting and/or evaluation, demonstratingthat the devices meet the requirements. |
| Biocompatibilitytesting | Biocompatibility testing conductedper ISO 10993. Cytotoxicity Sensitization Irritation/IntracutaneousReactivity Acute Systemic Toxicity Material Mediated Pyrogenicity Hemocompatibility | A risk analysis was performed takinginto account nature of body contact andduration to categorization the use ofexisting data, end-specific testing, andendpoint assessment to cover theidentified test methods. Additionally,data was leveraged by other means (e.g.,authorized use of Master File, predicateand reference devices, well known andcharacterized materials) to support thebiocompatibility of the subject devices. |
| Reprocessing | Cleaning validation study basedon acceptance criteria fromAAMI TIR30:2011 Steam sterilization validationperformed per ANSI/AAMI/ISO17665-1:2006/(R)2013. | The subject devices can be adequatelycleaned and steam sterilized prior to use. |
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Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
CONCLUSION VIII.
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.