Who is the manufacturer of ATEC IOM Accessory Instruments?

Alphatec Spine, Inc. filed the 510(k) submission for ATEC IOM Accessory Instruments (K221821).

What is the FDA product code for ATEC IOM Accessory Instruments?

PDQ. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for ATEC IOM Accessory Instruments?

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

What are the predicate devices for ATEC IOM Accessory Instruments?

ATEC IOM Accessory Instruments (K191723); ES2 Neuromonitoring Accessory Instruments (K171807); Neurovision Ink Printed Endotracheal Tube Electrode (K110989); ISIS Headbox 5042XX and ISIS Neurostimulator (K212166).

Who can help prepare an FDA 510(k) submission like ATEC IOM Accessory Instruments?

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.

ATEC IOM Accessory Instruments

K221821 · Alphatec Spine, Inc. · PDQ · Sep 23, 2022 · Ear, Nose, Throat

Device Facts

Record ID	K221821
Device Name	ATEC IOM Accessory Instruments
Applicant	Alphatec Spine, Inc.
Product Code	PDQ · Ear, Nose, Throat
Decision Date	Sep 23, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended 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.

Device Story

ATEC IOM Accessory Instruments are surgical instruments (drills, taps, awls, probes, dilators, guidewires, needles) used in spine surgery. Devices provide electrical stimulation to locate/identify nerves; compatible with standard neuromonitoring platforms via clips or probes. Surgeon operates device in OR during open or percutaneous minimally invasive procedures. Output (nerve location, proximity, integrity) is displayed on neuromonitoring console; assists surgeon in targeting, bone preparation, and implant placement. Benefits include improved nerve identification and reduced risk of nerve injury during spinal instrumentation. New dilators feature conductive silver ink, aluminum alloy, and dielectric coating.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), functional performance (insulation effectiveness, electrical resistance), and reprocessing validation (AAMI TIR30, ANSI/AAMI/ISO 17665-1).

Technological Characteristics

Materials: conductive silver ink, aluminum alloy, dielectric coating. Energy: electrical stimulation. Form factor: surgical instruments (drills, taps, awls, probes, dilators, guidewires, needles). Connectivity: wired via compatible clip/probe to neuromonitoring consoles. Sterilization: EtO (sterile) or steam (reusable). Compliance: IEC 60601-1.

Indications for Use

Indicated for use in spine surgical procedures to assist in nerve location during or after preparation and placement of intervertebral fusion cages and pedicle screw fixation devices in open and percutaneous minimally invasive approaches.

Regulatory Classification

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.

Predicate Devices

ATEC IOM Accessory Instruments (K191723)
ES2 Neuromonitoring Accessory Instruments (K171807)
Neurovision Ink Printed Endotracheal Tube Electrode (K110989)
ISIS Headbox 5042XX and ISIS Neurostimulator (K212166)

Related Devices

K182617 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · May 9, 2019
K191723 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · Oct 18, 2019
K142438 — Nerve Monitoring Cable System · Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · Mar 5, 2015
K132373 — BIOMET ACCESS SYSTEM · Biomet Spine (Aka Ebi, LLC) · Mar 27, 2014
K140400 — ES2 NEUROMONITORING ACCESSORY INSTRUMENTS · Stryker Corporation · Jul 1, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ September 23, 2022 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. Sandy Gill Sr. Regulatory Affairs Specialist 1950 Camino Vido Roble Carlsbad, CA 92008 Re: K221821 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: August 29, 2022 Received: August 30, 2022 Dear Sandy Gill: 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 {1}------------------------------------------------ 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) K221821 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) | | |----------------------------------------------------------------------------------|--| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | | <input type="checkbox"/> 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the "tec" is dark blue. There is a black line underneath 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) 431-9286 Fax: (760) 431-0289 | |----|------------------------|----------------------------------------------------------------------------------------------------------------------| | | Contact Person: | Sandy Gill Sr. Regulatory Affairs Specialist | | | Date Summary Prepared: | August 29, 2022 | #### 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 Primary Predicate Device: | 510(k) | Product Name | Clearance Date | |---------|--------------------------------|------------------| | K191723 | ATEC IOM Accessory Instruments | October 18, 2019 | Additional Predicate Devices: | 510(k) | Product Name | Clearance Date | |---------|--------------------------------------------------------|----------------------| | K171807 | ES2 Neuromonitoring Accessory Instruments | July 18, 2017 | | K110989 | Neurovision Ink Printed Endotracheal Tube Electrode | November 03, 2011 | | K212166 | ISIS Headbox 5042XX and ISIS Neurostimulator | January 07, 2022 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a black line underneath the logo. #### 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). All sterile instruments are single use only and all reusable instruments are offered non-sterile to be steam sterilized by the end user. The purpose of this submission is to gain clearance for new dilators made of conductive sliver ink, aluminum alloy, and dielectric coating. #### 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. #### VI. TECHNOLOGICAL COMPARISON TO PREDICATES 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. See Table 1 below. {5}------------------------------------------------ | Table 1: Summary of Technological Comparison to Predicates | | | | | | |------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Primary Predicate K191723 | Additional Predicate K171807 | Additional Predicate K110989 | Additional Predicate K212166 | Subject Device | | Attribute | ATEC IOM Instruments | Stryker ES2 Neuromonitoring Accessory Instruments | Neurovision Ink Printed Endotracheal Tube Electrode | ISIS Headbox 5042XX and ISIS Neurostimulator | ATEC IOM Instruments | | 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. | The ES2 Neuromonitoring instruments (Awls, Taps, Screwdriver and LITe Y- NEEDLE 200, 300 and 400) can be used by the surgeon to assist in location of the spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws in open and percutaneous minimally invasive posterior surgical approaches of the non- cervical spine. | The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation. | ISIS Headbox 5042xx products: The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues. The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP). The products are not intended for monitoring life- sustaining functions. ISIS Neurostimulator 504180: The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous | 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. | | Attribute | Primary Predicate K191723 | Additional Predicate K171807 | Additional Predicate K110989 | Additional Predicate K212166 | Subject Device | | | ATEC IOM Instruments | Stryker ES2 Neuromonitoring Accessory Instruments | Neurovision Ink Printed Endotracheal Tube Electrode | ISIS Headbox 5042XX and ISIS Neurostimulator | ATEC IOM Instruments | | | | | | the following fields:- Transcranialelectrical stimulation (TES) - Direct cortical stimulation (DCS)- Direct nerve stimulation (DNS) - Transcutaneous electrical nerve stimulation (TNS) — Direct muscle stimulation (DMS) | | | Regulation Number. Product Code, & Classification | 21 CFR 874.1820 PDQ, ETN Class II | 21 CFR 874.1820 PDQ Class II | 21 CFR 874.1820 ETN, BTR, GWF Class II | 21 CFR 882.1870 GWF, ETN, GWE, GWJ, GWQ, IKN | 21 CFR 874.1820 PDQ, ETN Class II | | IEC 60601 Compliant | Yes Protected Pin Design via compatible clip/probe Clause 56.3(c) | Yes Protected Pin Design via compatible clip/probe Clause 56.3(c) | Unknown | Yes | Yes Protected Pin Design via compatible clip/probe Clause 56.3(c) | | Instrument Type (Description) | Drills/Taps. Awls. Probes, Screwdrivers, Dilators (Sleeves), Guidewires, and Needles | Awls, Taps, Screwdrivers, Guidewires (K-wires), and 200, 300, 400 LITE Y- Needles | ET Tube | ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress Accessories | Drills/Taps. Awls. Probes, Screwdrivers, Dilators (Sleeves). Guidewires, and Needles | | Biocompatibility Patient Contact Duration | Limited patient duration contact (< 24 hours) | Limited patient duration contact (< 24 hours) | Limited patient duration contact (< 24 hours) | Unknown | Limited patient duration contact (< 24 hours) | | Surgical approach | Open or Percutaneous/Minimally Invasive | Open or Percutaneous/ Minimally Invasive | Unknown | Unknown | Open or Percutaneous/Minimally Invasive | | Sterility | Sterile via EtO and non- sterile Non-sterile devices are provided with validated steam sterilization | Sterile and Non-sterile Non-sterile devices are provided with validated steam sterilization | Sterile | Unknown | Sterile via EtO and non- sterile Non-sterile devices are provided with validated steam sterilization | | Attribute | Primary Predicate K191723 | Additional Predicate K171807 | Additional Predicate K110989 | Additional Predicate K212166 | Subject Device | | | ATEC IOM Instruments | Stryker ES2 Neuromonitoring Accessory Instruments | Neurovision Ink Printed Endotracheal Tube Electrode | ISIS Headbox 5042XX and ISIS Neurostimulator | ATEC IOM Instruments | | | parameters to assure an SAL of 10-6 | parameters to assure an SAL of 10-6 | | | parameters to assure an SAL of 10-6 | | Reusable/Single Use | Guidewires, Targeting Needles and Dilators – Single Use SafeOp Ball Tip Probe – Single Use Awls, Drills/Taps, Probes, Dilators (Sleeves), and Screwdrivers – Reusable | 200, 300, and 400 LITe Y Needles – Single Use Awls, Taps, and Screwdrivers – Reusable | Single Use | Unknown | Guidewires, Targeting Needles and Dilators – Single Use SafeOp Ball Tip Probe – Single Use Awls, Drills/Taps, Probes, Dilators (Sleeves), and Screwdrivers – Reusable | | Compatible with Common Neuromonitoring Consoles & Software | Yes | Yes | Yes | N/A includes Neuromonitoring Console and Software | Yes | | Minimum exposed surface area | 8.6 mm² | 0.53 mm² | Unknown | 2.0 mm² | 5.94 mm² | # Tablo 1: Summary of Taghnological Camparicon to Prodicatos {6}------------------------------------------------ {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is dark blue. There is a horizontal line underneath the word. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are dark blue. There is a black line underneath the logo. #### VII. PERFORMANCE DATA Performance testing includes IEC 60601-1 testing, and functional testing on insulation effectiveness and electrical resistance. Table 2 summarizes testing that was performed on the subject device to show substantial equivalence to the predicate devices. Testing results demonstrated the subject ATEC IOM Accessory Instruments are appropriate for neuromonitoring applications and are substantially equivalent when compared to other legally marketed devices cleared by FDA. | Test | Test Method Summary | Results | |----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------| | Electrical Safety Testing and/or Evaluation | Evaluation and testing was performed on the subject devices in accordance with IEC 60601-1: 2005(R)2012. | All samples passed acceptance criteria | | Functional Performance Testing and Verification Analysis | • Insulation Effectiveness • Electrical Resistance | All samples passed acceptance criteria | | Reprocessing | • Cleaning validation or adoption study based on acceptance criteria from AAMI TIR30:2011 • Steam sterilization validation or adoption performed per ANSI/AAMI/ISO 17665- 1:2006/(R)2013. | All samples passed acceptance criteria | ## Table 2: Summarv of Performance Testing ## Clinical Information Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data. #### VIII. BIOCOMPATIBILITY DATA 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. Biocompatibility testing evaluated per ISO 10993-1. - Cytotoxicity - Sensitization ● - Irritation/Intracutaneous ● - Reactivity - Acute Systemic Toxicity - Material Mediated Pyrogenicity ● {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for "actec". The "a" is green, and the rest of the letters are dark blue. There is a horizontal line underneath the word. In conclusion, the ATEC IOM Accessory Instruments are manufactured from the same materials as other legally US-marketed devices. #### IX. CONCLUSION 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.