Who is the manufacturer of ATEC IOM Accessory Instruments?

Alphatec Spine, Inc. filed the 510(k) submission for ATEC IOM Accessory Instruments (K191723).

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 (K182617); Rhythmlink Disposable Concentric Stimulating Probe (K132138).

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

K191723 · Alphatec Spine, Inc. · PDQ · Oct 18, 2019 · Ear, Nose, Throat

Device Facts

Record ID	K191723
Device Name	ATEC IOM Accessory Instruments
Applicant	Alphatec Spine, Inc.
Product Code	PDQ · Ear, Nose, Throat
Decision Date	Oct 18, 2019
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 tools providing electrical stimulation to locate/identify nerves during spine surgery. Instruments include drills, taps, awls, probes, screwdrivers, dilators, guidewires, and needles. Devices connect to common FDA-cleared neuromonitoring consoles via compatible clips or probes. During surgery, the surgeon uses the instruments to deliver electrical stimulation; the neuromonitoring system measures nerve proximity and integrity. This feedback assists the surgeon in targeting, bone preparation, and implant placement (e.g., pedicle screws, fusion cages). Used in open or percutaneous minimally invasive approaches. Benefits include improved nerve identification and reduced risk of nerve injury during spinal instrumentation. Reusable instruments are steam-sterilized; single-use instruments are provided sterile.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), reliability testing, and functional performance testing (insulation effectiveness and electrical resistance). Biocompatibility testing was conducted per ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility.

Technological Characteristics

Instruments include drills, taps, awls, probes, screwdrivers, dilators, guidewires, and needles. Materials are consistent with legally marketed devices. Electrical stimulation principle; compatible with standard neuromonitoring consoles. Compliant with IEC 60601-1 (Clause 56.3(c) protected pin design). Biocompatibility per ISO 10993-1. Sterilization via steam (reusable) or EtO (single-use).

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 (K182617)
Rhythmlink Disposable Concentric Stimulating Probe (K132138)

Related Devices

K182617 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · May 9, 2019
K221821 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · Sep 23, 2022
K140400 — ES2 NEUROMONITORING ACCESSORY INSTRUMENTS · Stryker Corporation · Jul 1, 2014
K171807 — ES2 Neuromonitoring Accessory Instruments · Stryker Corporation · Jul 18, 2017
K110419 — AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS · Stryker Spine · Jul 28, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ October 18, 2019 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. Ms. Ruby Zheng Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008 Re: K191723 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: September 16, 2019 Received: September 17, 2019 Dear Ms. Ruby Zheng: 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 medical devices and radiation-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) K191723 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) | |-------------------------------------------------| |-------------------------------------------------| | <div> × Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------------------| | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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 logo consists of a green square with a white stylized "a" inside of it. To the right of the square is the word "tec" in white font, with a trademark symbol in the upper right corner. 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 Real Carlsbad, CA 92008 Phone: (760) 431-9286 Fax: (760) 431-0289 | |----|------------------------|-------------------------------------------------------------------------------------------------------------------| | | Contact Person: | Ruby Zheng Regulatory Affairs Specialist | | | Date Summary Prepared: | September 16, 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 | |---------|----------------------------------------------------|----------------| | K182617 | ATEC IOM Accessory Instruments | May 9, 2019 | | K132138 | Rhythmlink Disposable Concentric Stimulating Probe | April 11, 2014 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Atec logo. The logo consists of a green square with rounded corners and a white letter "a" inside. To the right of the square is the word "tec" in white font, with a trademark symbol in the upper right corner. The background is a dark blue color. #### 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. #### 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. See Table 1 below. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white design inside, followed by the word "atec" in white. The background of the logo is a dark blue color. The logo is simple and modern, and the colors are eye-catching. | | Primary Predicate K182617 | Additional Predicate K132138 | Subject Device | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | ATEC IOM Instruments | Rhythmlink Disposable Concentric Stimulating Probe | 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 Rhythmlink Disposable Concentric Stimulating Probe is used to perform Intended Use(s) localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery. The Rhythmlink Disposable Concentric Stimulating Probe is a single patient use device | 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. | | Regulation Number. Product Code, & | 21 CFR 874.1820 PDQ, ETN | 21 CFR 874.1820 ETN | 21 CFR 874.1820 PDQ, ETN | | Classification | Class II | Class II | Class II | | IEC 60601 Compliant | Yes Protected Pin Design via compatible clip/probe Clause 56.3(c) | Yes DIN 42 802 touch proof connectors Clause 56.3(c) | 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 | Probes | 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) | | Biocompatible | Yes | Yes | Yes | | Surgical approach | Open or Percutaneous/Minimally Invasive | Not specified | Open or Percutaneous/Minimally Invasive | | | Primary Predicate K182617 | Additional Predicate K132138 | Subject Device | | Attribute | ATEC IOM Instruments | Rhythmlink Disposable Concentric Stimulating Probe | ATEC IOM Instruments | | Sterility | Non-sterile Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of 10-6 | Sterile via EtO | Sterile via EtO and non-sterile Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of 10-6 | | Reusable/Single Use | Guidewires, Targeting Needles and Dilators - Single Use Awls, Drills/Taps, Probes, Dilators (Sleeves), and Screwdrivers - 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 | | Compatible with Common Neuromonitoring Consoles & Software | Yes | Yes | Yes | | Minimum exposed surface area | 8.6 mm2 | 14.6 mm2 | 8.6 mm2 | ## Table 1: Summary of Technological Comparison to Predicates {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Atec. The logo features a green square with a white alpha symbol inside of it. To the right of the square is the word "tec" in white font with a trademark symbol in the upper right corner. The background of the logo is a dark blue color. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white design inside, followed by the word "tec" in white. The background of the logo is dark blue. There is a trademark symbol after the word "tec". #### VII. PERFORMANCE DATA Performance testing includes IEC 60601-1 testing, reliability testing, and functional testing on insulation effectiveness and electrical resistance. Table 2 below summarizes the testing which was performed on the Subject Devices to show substantial equivalence to the Testing results demonstrated the subject ATEC IOM Accessory predicate device. Instruments are appropriate for neuromonitoring applications and do not introduce a new worst case 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. | All samples passed acceptance criteria | | Reliability Testing | Testing was performed to verify that there is no adverse effect on the safety or effectiveness of the subject devices based on the intended environment and storage conditions. | All samples passed acceptance criteria | | Functional Performance Testing and Verification Analysis | Insulation Effectiveness Electrical Resistance | All samples passed acceptance criteria | ## Table 2: Summary of Performance Testing ## Clinical Information Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data. #### BIOCOMPATIBILITY DATA VIII. 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 conducted per ISO 10993-1. - Cytotoxicity - Sensitization - Irritation/Intracutaneous - Reactivity ● - Acute Systemic Toxicity ● - Material Mediated Pyrogenicity ● - . Hemocompatibility {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white "a" inside of it, followed by the word "tec" in white. The background of the logo is dark blue. In conclusion, the ATEC IOM Accessory Instruments are manufactured from the same materials as other legally US-marketed devices. #### CONCLUSION IX. 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.