Who is the manufacturer of Nerve Monitoring Cable System?

Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) filed the 510(k) submission for Nerve Monitoring Cable System (K142438).

What is the FDA product code for Nerve Monitoring Cable System?

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 Nerve Monitoring Cable System?

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

What are the predicate devices for Nerve Monitoring Cable System?

Nerve Monitoring Cable System (K073229); Biomet Probes/Guidewires and Dilators (K132373); ES2® Neuromonitoring Accessory Instruments (K140400).

Who can help prepare an FDA 510(k) submission like Nerve Monitoring Cable System?

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.

Nerve Monitoring Cable System

K142438 · Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · PDQ · Mar 5, 2015 · Ear, Nose, Throat

Device Facts

Record ID	K142438
Device Name	Nerve Monitoring Cable System
Applicant	Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.)
Product Code	PDQ · Ear, Nose, Throat
Decision Date	Mar 5, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended Use

The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery. The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use.

Device Story

Nerve Monitoring Cable System facilitates tissue dilation and peripheral nerve stimulation during spinal surgery; used in open or percutaneous/minimally invasive procedures. System consists of Nerve Monitoring Cables (1.5 mm female DIN connector) and stimulation accessories (pedicle probes, taps, awls, screw drivers, and sterile/single-use dilators). Dilators are hollow tubes (Aluminum 6061-T6) with Parylene C insulation; distal tip remains uninsulated to deliver electrical current. Surgeon connects cable to an FDA-cleared neuromonitoring console (Type BF or CF rating) and stimulation accessory. Current passes from proximal end to distal tip to monitor neural elements near access site. Provides proximity information to surgeon; assists in nerve identification; helps avoid neural injury during surgical access and instrumentation.

Clinical Evidence

No human clinical data. Evidence includes bench testing (electrical resistance, insulation/Hipot testing, charge/current/power density calculations) and a porcine animal study to assess performance, functionality, and safety. Biocompatibility testing per ISO 10993-1 confirmed non-cytotoxic, non-irritant, non-sensitizing, and non-systemically toxic status. Sterilization, packaging, and shelf-life validated per ISO 11137-2, ISO 11607, and ASTM D4169.

Technological Characteristics

Materials: Aluminum 6061-T6 (ASTM B221) with Parylene C insulation. Form factor: Hollow tubes for tissue dilation. Energy: Electrical stimulation via external neuromonitoring console. Connectivity: Wired connection via 1.5 mm female DIN connector to console; clip connection to accessories. Sterilization: Sterile, single-use. Electrical safety: Compliant with IEC 60601-1.

Indications for Use

Indicated for patients undergoing spinal surgery requiring tissue dilation/dissection and stimulation of peripheral nerves, including spinal nerve roots, for location and identification.

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

Nerve Monitoring Cable System (K073229)
Biomet Probes/Guidewires and Dilators (K132373)
ES2® Neuromonitoring Accessory Instruments (K140400)

Related Devices

K073229 — NERVE MONITORING CABLE · Pioneer Surgical Technology · Jun 6, 2008
K221821 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · Sep 23, 2022
K111671 — SEASPINE MONOPOLAR PROBE SYSYEM · Seaspine, Inc. · Dec 28, 2011
K191723 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · Oct 18, 2019
K182617 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · May 9, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, ribbon-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 5, 2015 Pioneer Surgical Technology, Inc. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, MI 49855 USA Re: K142438 Trade/Device Name: Nerve Monitoring Cable System Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ, ETN, GXZ Dated: January 30, 2015 Receive: February 2, 2015 Dear Ms. Pleaugh: 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. 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 mav 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 {1}------------------------------------------------ CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Felipe Aquel -S Carlos L. Peña, Ph.D., M.S. for Carlos L Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K142438 Device Name Nerve Monitoring Cable System #### Indications for Use (Describe) The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery. The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use. X Prescription Use (Part 21 CFR 801 Subpart D) 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}------------------------------------------------ ## 510(k) Summary Pursuant to 21 CFR 807.92 K142438 | 510(k) Owner: | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 USA Ph.: (906) 225-5861 Fax: (906) 226-4459 Contact: Sarah (McIntyre) Pleaugh Prepared: January 30, 2015 | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name: | Nerve Monitoring Cable System | | Common name: | Neurosurgical Nerve Locator | | Classification: | Class II; 21 CFR 874.1820, PDQ, Neurosurgical nerve locator and ETN, Nerve stimulator 21 CFR 882.1350, GXZ, Needle electrode | | Predicate Devices: | K073229 Pioneer Surgical Technology, Inc. - Nerve Monitoring Cable System K132373 Biomet Spine - Biomet Probes/Guidewires and Dilators K140400 Stryker Spine - ES2® Neuromonitoring Accessory Instruments | | Device Description: | The Nerve Monitoring Cable System, which consists of Nerve Monitoring Cables in conjunction with various stimulation accessories, allow for tissue dilation and stimulation of peripheral nerve roots for location and identification during open and percutaneous / minimally invasive spinal surgery. The Nerve Monitoring Cable includes a 1.5 mm female DIN connector for use with a stimulating console with a Type BF or CF rating. The other end of the Nerve Monitoring Cable includes a clip for connection to the stimulation accessories of this system. The stimulation accessories include general manual orthopedic surgical instruments previously cleared via K073227 (i.e. pedicle probes, taps, awls and screw drivers) and also include sterile/ single-use dilators which are subject of this submission. The subject dilators are a series of hollow tubes that fit over one another for the purpose of dilating tissue in preparation for spinal surgery. Similar to the predicate instrument accessories, they are made from a conducting metal (Aluminum 6061- T6) with an insulated outer coating (Parylene C) to allow passage of current from a point on the proximal end where it connects to the Nerve Monitoring Cable to an un-insulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The subject dilators are offered sterile/single-use. | | Intended Use: | The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery. The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and | {4}------------------------------------------------ | around the point of access. The dilators are offered sterile/single use. | | | | | | | | | | | | | | | | | |--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | Technological Characteristics: | The subject dilators are substantially equivalent to the predicate devices in terms of design, function, principles of operation, technological characteristics, intended use, and performance. As compared to the Biomet predicate, the subject dilators are similar in that they are a series of hollow tubes intended for tissue dilation and stimulation of nerves for neuromonitoring applications. They are made from metal with an insulated outer coating. Similar to the Biomet and Stryker predicates, the electrical signal is supplied via FDA cleared neuromonitoring systems attached to a clip or probe that is attached to the neuromonitoring contact zone on the proximal end. The electrical signal is then transferred to a point on the distal end which is uninsulated (minimum exposed surface area is SE to the predicate devices). | | | | | | | | | | | | | | | | | Materials: | The subject dilators are made from Aluminum 6061-T6 conforming to ASTM B221 with an insulated outer coating (Parylene C). | | | | | | | | | | | | | | | | | Biocompatibility: | Biocompatibility testing was conducted on the subject dilators in accordance with the testing recommendations in ISO 10993-1 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing). The test results are summarized in the table below: Test Results Conclusion Cytotoxicity No evidence of cytotoxicity. Non-cytotoxic Irritation No evidence of irritation. Non-irritant Sensitization No evidence of sensitization. Non-sensitizing Systemic Toxicity No evidence of toxicity. Not systemically toxic | | | | | | | | | | | | | | | | | | As shown in the table, biocompatibility testing found the subject dilators to be non- cytotoxic, non-irritant, non-sensitizing, and not systemically toxic. | | | | | | | | | | | | | | | | | Summary of Performance Data: | This 510(k) premarket notification is seeking clearance of subject dilators as accessory instruments during neuromonitoring applications. Performance testing and engineering calculations were performed to demonstrate that the subject devices are substantially equivalent to the identified predicates in terms of design, performance and intended use. Engineering analysis confirmed the maximum charge, current, and power densities of the subject devices fall within the range of predicate devices. IEC 60601-1 testing for electrical safety on applicable devices of the subject system was supplied. A porcine animal study was conducted to assess the performance, functionality, and safety or the subject dilators as neuromonitoring accessory instruments. Electrical/resistance bench testing confirmed the subject dilators are capable of transferring an electrical current with little or no resistance in a similar manner to predicate devices. This bench testing, along with in-process Hipot testing, also confirmed the coating of each device provides adequate electrical insulation. Sterilization, packaging, and shelf-life validations were also completed per applicable test standards (ISO 11137-2, ISO 11607, and ASTM D4169 respectively). | | | | | | | | | | | | | | | | {5}------------------------------------------------ | The performance data confirmed the substantial equivalence of the subject devices | |-------------------------------------------------------------------------------------| | and demonstrates the subject devices are as safe, as effective, and perform as well | | as, or better than, the predicate devices. | ### Substantial Equivalence Summary - Comparison of Subject and Predicate Systems | Characteristic | Subject K142438 Nerve Monitoring Cable System | Predicate K073229 Nerve Monitoring Cable and Reusable Accessory Instruments | Predicate K132373 Biomet Spine Probes/ Guidewires and Dilators | Predicate K140400 ES2® Neuro- monitoring Accessory Instruments | Substantial Equivalence | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Neuromonitoring Accessories Instruments | Dilators | General, manual orthopedic reusable surgical instruments (e.g. probes, awls, taps, inserters) | Probes, guidewires and dilators | Awls, Taps and Screwdriver to be used with Dilators or Tap Sleeves | Yes | | Use of Dilators | Dilators | No dilators in K073229 | Dilators | Dilators or Tap Sleeve | Yes | | Compatible with Common Neuromonitoring Consoles & Software | Compatible with FDA cleared neuromonitoring systems | Compatible with FDA cleared neuromonitoring systems | Compatible with FDA cleared neuromonitoring systems | Compatible with FDA cleared neuromonitoring systems | Yes | | Connection to Neuromonitoring Unit | Clip | Clip | Clip or Probe | Clip or Probe (based on Neuromonitoring System used) | Yes | | Materials | ASTM B221 6061 Aluminum (UNS A96061) with Parylene C Coating | -ASTM F899 17-4 SST with Halar® 6014 Coating -Detachable silicone handles or RADEL® handles | ASTM F899 Stainless steel with polymeric dielectric coating | -Awl, Taps, & Screwdriver: Surgical Grade Stainless Steel -Dilators & Tap Sleeve: RADEL® | Yes | | Indications for Use | The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/ dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery. The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point | The Pioneer Nerve Monitoring Cable, in conjunction with Pioneer pedicle probes, taps, awls or screw drivers, is intended to stimulate peripheral motor nerves during surgery for the purpose of locating and identifying these nerves, including spinal nerve roots during the incision and removal of soft and hard tissue or bone. | The Biomet probes/ guidewires and dilators are intended for tissue dilation and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery. | The ES2® Awl, ES2® Taps, and ES2® Screwdriver can be used 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 posterior surgical approaches of the non-cervical spine. | Yes – There are no new or different intended uses as compared to the predicates. The subject and predicate instruments are employed in the same manner when used for tissue dilation and as tools to assist the surgeon in locating spinal nerves before, during, or after surgery for open and | {6}------------------------------------------------ | | on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use. | | | | percutaneous surgical approaches. | |-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Sterilization | Instruments provided as single- use sterile packed devices. | Neuromonitoring Clip provided as single-use sterile packed devices. Accessory instruments provided as reusable non- sterile devices with validated sterilization parameters to assure a SAL of 10-6 | Instruments provided as single-use sterile packed devices. | Instruments provided as reusable non- sterile devices with validated sterilization parameters to assure a SAL of 10-6 | Yes | | Surgical Approach | Open or Percutaneous/ Minimally Invasive | None specified | None specified | Open or Percutaneous/ Minimally Invasive | Yes | | Electromagnetic Compatibility & Electrical Safety | IEC 60601-1 | IEC 60601-1 | ASTM D149: 2009 | IEC 60601-1 IEC 60601-1-2 IEC 60601-3-2 IEC 60601-3-3 | Yes - Subject system compliant with applicable sections of IEC 60601-1. | | Min. exposed sur- face area during tissue stimulation | 0.02 in2 | 0.02 in2 | .167 cm2 (.026 in2) | 0.53 mm2 (.0008 in2) | Yes | | Maximum Charge Density ( $\mu$ C/cm2) | 0.108 | N/A | 0.097 | 0.306 | Yes | | Maximum Current Density (mA/cm2) | 1.080 | N/A | 0.970 | 3.057 | Yes | | Maximum Power Density (500 Ω load) (mW/cm2) | 0.087 | N/A | 0.079 | 0.248 | Yes | | Maximum Power Density (10kΩ load) (mW/cm2) | 1.750 | N/A | 1.571 | 4.952 | Yes | | Conclusion: | Based on the information included in this premarket notification, the subject system is substantially equivalent to the predicates. The subject dilators are employed in the same manner, have similar intended uses, principles of operation, technological characteristics, and performance. There are no new issues of safety or efficacy. | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|