Who is the manufacturer of PEDIGUARD NERVE DETECTOR SYSTEM?

Spineguard S.A. filed the 510(k) submission for PEDIGUARD NERVE DETECTOR SYSTEM (K123390).

What is the FDA product code for PEDIGUARD NERVE DETECTOR 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 PEDIGUARD NERVE DETECTOR SYSTEM?

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

Who can help prepare an FDA 510(k) submission like PEDIGUARD NERVE DETECTOR 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.

PEDIGUARD NERVE DETECTOR SYSTEM

Q: What are the predicate devices for PEDIGUARD NERVE DETECTOR SYSTEM?

PediGuard Nerve Detector (K030526).

K123390 · Spineguard S.A. · PDQ · Aug 8, 2013 · Ear, Nose, Throat

Device Facts

Record ID	K123390
Device Name	PEDIGUARD NERVE DETECTOR SYSTEM
Applicant	Spineguard S.A.
Product Code	PDQ · Ear, Nose, Throat
Decision Date	Aug 8, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Indications for Use

The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

Device Story

Single-use, handheld surgical probe; stainless steel shaft with distal sensor; plastic handle containing electronics/battery. Measures electrical impedance of tissues at sensor tip during pedicle screw pilot hole drilling. Transforms impedance data into real-time visual and audible alerts for the surgeon; indicates potential soft tissue contact or vertebral cortex perforation. Also delivers low-voltage electrical energy for intraoperative EMG nerve surveillance. Used in OR by surgeons. Provides immediate feedback to guide drilling, helping avoid nerve injury or cortical breach. Benefits patient by reducing risk of pedicle wall perforation and nerve damage during spinal instrumentation.

Clinical Evidence

Bench testing only. Performance evaluated via static bending tests, electrical signal emission, impedance detection actability, and audible signal volume. Firmware verified and validated. Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-irritating, non-sensitizing, and non-toxic status.

Technological Characteristics

Single-use, sterile, handheld probe. Materials: 316L/304 stainless steel (ASTM F138/F899), ceramic/PEEK insulators. Sensing: Electrical impedance measurement at distal tip. Energy: Silver oxide or Lithium-Ion battery. Connectivity: Standalone. Sterilization: Ethylene oxide. Firmware-based control on internal circuit board.

Indications for Use

Indicated for patients undergoing spinal surgery requiring pedicle screw pilot hole drilling. Used by surgeons for real-time feedback on tissue impedance to detect potential vertebral cortex perforation and for intraoperative EMG surveillance to locate and evaluate spinal nerves.

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

PediGuard Nerve Detector (K030526)

Submission Summary (Full Text)

{0}------------------------------------------------ ## 123390 #### 8 2013 AUG #### 510(k) SUMMARY ### SpineGuard's PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS model (P1-U451) and Cannulated PediGuard Needle#2 model (P2ND1002) Submitter: SpineGuard, S.A. 5-7 rue l' Amiral Courbet 94160 Saint Mande France Phone: +(33) 1 45 18 45 19 Contact Person: Donald W. Guthner Orgenix LLC 111 Hill Road Douglassville, PA 19518 646-460-2984 Phone: Facsimile: 484-363-5879 July 30, 2013 Date Prepared: Name of Device: PediGuard 2.5mm XS (Model P1-AU414) PediGuard Curv XS (Model P1-AU451) Cannulated PediGuard Needle#2 (Model P2ND1002) Common or Usual Name: Classification Name: Review Panel: Product Code: Device Class: Regulation: Nerve Stimulator Surgical Nerve Stimulator/Locator Neurology PDQ and ETN Class II 21 C.F.R. §874.1820 Predicate Devices SpineGuard S.A., PediGuard Nerve Detector (K030526) #### Device Description The PediGuard® 2.5mm XS and PediGuard® Curv XS are single use, single piece devices composed of stainless steel and plastic that are provided sterile, and consist of a handle containing the electronics and a stainless steel shaft with distal sensor for measuring electrical impedance of the tissues immediately in contact with the sensor during use. The devices product visual and audible signal to indicate changes in impedance associated with possible vertebral perforation. NDC・(13865)2000000) - 4712449 \ 2 1 {1}------------------------------------------------ The Cannulated PediGuard® Needle #2 is the needle part of a single-use modular device provided sterile, consisting of a handle containing the electronics, a stainless steel cannulated outer shaft and a stainless steel inner sensor needle for measuring electrical impedance of the tissues immediately in contact with the sensor during use. PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) provide realtime visual and auditory feedback to the surgeon during the preparation of the pedicle screw pilot holes, sounding an alert when the tip of the sensor senses a change in the impedance of the surrounding tissues, which may indicate that the tip is in contact with soft tissues and a possible vertebral cortex perforation. #### Intended Use/Indications for Use The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. #### Substantial Equivalence The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) have the same intended use/indications for use, and similar technological characteristics and principles of operation as the cleared PediGuard Nerve Detector. The materials in the modified devices are directly comparable to the predicate and the impedance detection algorithm is identical. The minor differences in shaft diameter, shaft materials or electronics (firmware and power source) do not raise any new questions of safety or effectiveness. Performance data that evaluated static bending, electrical signal emission, impedance detection actability and the ability to convey changes in impedance to the user demonstrate that the PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are as safe and effective as the cleared PediGuard Nerve Detector, Thus, the PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and. Cannulated PediGuard® Needle#2 (model P2ND1002) are substantially equivalent to the predicate device. #### Substantial Equivalence Chart | SpineGuard Cleared Device | PediGuard® 2.5mm XS (P1- | Cannulated PediGuard Needle#2 | |---------------------------|-----------------------------------------|-------------------------------| | PediGuard (K030526) | AU414) PediGuard® Curv XS (P1-AU451) | (P2ND1002) | いDC - 038659/00000】 - 47 12-419 12 {2}------------------------------------------------ | Intended Use / Indications for Use | The SpineGuard, PediGuard Nerve Detector System is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. | The PediGuard® 2.5mm XS (model P1-AU414), and PediGuard® Curv XS (model P1-AU451) are indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. | The PediGuard® Cannulated PediGuard® Needle#2 (model P2ND1002) Is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Handle Shape | Straight - screwdriver | Gearshift T-Handle | T-handle | | Components | Single Piece or Modular, Stainless Steel shaft, plastic handle, PEEK insulator | Single Piece, Stainless Steel shaft, plastic handle, ceramic insulator | Modular unit with Cannulated outer shaft, active sensory needle, and ceramic insulation | | Shaft Material | Inner electrode: 316L Stainless Steel (ASTM F138) Outer electrode: 316L Stainless Steel (ASTM F138) | Inner electrode: 316L Stainless Steel (ASTM F138) Outer electrode or shaft: 316L Stainless Steel and/or 17-4PH (ASTM F899) | Inner electrode: 316L Stainless Steel (ASTM F138) (Electrode) Outer electrode and shaft: 304 Stainless steel (ASTM F899) | | Safety Features | Device cannot be turned off until battery exhausted. Prevents reuse of device. | Device cannot be turned off until battery exhausted. Prevents reuse of device. | Device cannot be turned off until battery exhausted. Prevents reuse of device. | | Power Source | Silver Oxide Battery | Lithium-Ion Battery | Lithium-Ion Battery | | Sterility | Sterile | Sterile | Sterile | | Single Use or Reusable | Single-use | Single-use | Single-use | | Distal Shaft shape | Straight | Curved or straight | Straight with removable inner starter stylet (optional) and sensory needle. | | Dimensions | 3.2mm and 4.0 mm shaft diameter | 2.5mm shaft diameter / tapered for 2mm to 4mm | 3.0mm shaft diameter | | Circuit board | Capacitors, Resistors and Diodes | Capacitors, Resistors and Diodes - Firmware (programmable chip) on circuit board | Capacitors, Resistors and Diodes - Firmware (programmable chip) on circuit board | #### Biocompatibility Biocompatibility testing was conducted on the PediGuard® models in accordance with the testing recommendations in ISO 10993 -1 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) and the FDA's Blue Book Memorandum # G95-1for a device in limited (≤ 24 hours) contact with tissue/bone. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The tests and results are summarized in the table below. {3}------------------------------------------------ | Tests | Results1 | Conclusion1 | |------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------| | In vitro Cytotoxicity test (ISO MEM Elution assay with quantitative evaluation of cytotoxicity) - ISO 10993-5 | No evidence of cytotoxicity | Non-cytotoxic | | Intracutaneous Reactivity test (irritation) - ISO 10993-10 | No evidence of irritation | Non-irritant | | Sensitization test (Guinea pig maximization) - ISO 10993-10 | No evidence of sensitization | Non-sensitizing | | Acute Systemic Toxicity test - ISO 10993-11 | No signs of toxicity | Not systemically toxic | 1Separate biocompatibility testing was conducted for the PediGuard Curv, PediGuard Curv XS, and the Cannulated PediGuard models. Results and conclusions are summarized for all three models unless otherwise noted. As shown in the table, biocompatibility testing found the PediGuard® models to be non-cytotoxic, non-irritating, non-sensitizing, and non-toxic (acute systemic). #### Performance Data Static bending testing was performed on the shafts. All device models performed as intended in a manner directly comparable to the predicate devices. All device models have completed firmware verification and validation testing. The PediGuard® models conform to the following standards: - ASTM F138-08, Standard specification for wrought 18 Chromium 14 Nickel . - 2.5 Molybdenum Stainless Steel Bar and Wire for surgical implants (UNS S31673) (Version 8) (2008). - ASTM F899-1, Standard specification for wrought stainless steel for surgical . instruments (Version 11) (2009). - IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for . safety. Amendment 1. Amendment 2. - IEC 60601-1-4. Medical Electrical Equipment Part 1-4: General . requirements for safety, Collateral Standard. Programmable electrical medical systems, Edition 1.1 - ISO 10993-5, Biological Evaluation of Medical Devices: Tests for in vitro . cytotoxicity (1999). - ISO 10993-10, Biological Evaluation of Medical Devices: Tests for irritation . and sensitization. - ISO 10993-11. Biological Evaluation of Medical Devices: Tests for systemic ● toxicity. - ISO 11135-1, Sterilization of health care products Ethylene oxide: . Requirements for the development, validation and routine control of a sterilization process for medical devices (2007). いDC・038654910(x)(x)) ・・・ 7 | 244 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ {4}------------------------------------------------ - ISO 10993-7, Biological evaluation of medical devices: Ethylene Oxide . sterilization residuals (2008). - ISO 11737-1. Sterilization of medical devices Microbiological methods: . Determination of a population of microorganisms on products (2006). - ISO 11737-2. Sterilization of medical devices Microbiological methods: . Tests of sterility performed in the definition, validation and maintenance of a sterilization process (2000). - ISO 11607-1. Packaging for terminally sterilized medical devices: . Requirements for materials, sterile barrier systems and packaging systems (2006). - ISO 11607-2. Packaging for terminally sterilized medical devices: Validation . requirements for forming, sealing and assembly processes (2006). - ASTM F88, Standard test method for seal strength of flexible barrier materials . (2009). - ASTM F1929. Standard test method for detecting seal leaks in porous ● medical packaging by dye penetration. - ASTM F1980, Standard guide for accelerated aging of sterile medical device ● packages (2007). - ASTM D4169. Standard practice for performance testing of shipping . containers and systems (2005). - In addition to these standards, testing was conducted on the devices to demonstrate that the electrical signal emitted by the modified PediGuard was directly comparable to that of the predicate. The ability to measure changes in impedance and the volume of the audible signal emitted by the device were also measured and found to be directly comparable. The following design verification and validation testing was performed to support the substantial equivalence of the modification to the original predicate performance levels: Surgeon testing, Bending tests, Sensor Testing, Drill durability testing. Compliance with ASTM standards, Compliance with biocompatibility standards, 100% testing of firmware, Battery function testing, and Destructive testing. #### Conclusion The comparison to the predicate devices demonstrates that the PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1- AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are safe and effective for its intended use and are substantially equivalent to the predicate devices {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Aveque Document Control Center - WO66-G609 Silver Spring MD 20993-0002 August 8, 2013 SpineGuard, S.A. c/o Mr. John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004 Re: K123390 Trade/Device Name: PediGuard 2.5mm XS (Model P1-AU414) PediGuard Curv XS (Model P1-AU451) Cannulated PediGuard Needle#2 (Model P2ND1002) Regulation Number: 21 C.F.R. §874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ and ETN Dated: November 2, 2012 Received: December 11, 2012 Dear Mr. Smith We have reviewed your Section 510(k) premarket notification of intent to market the device we nove and have determined the device is substantially equivalent (for the indications for use stated in the cnclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce provisions 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). and Costlette Act (Act) that of not roquine to the general controls provisions of the Act. The I bu may, alcreible, market the act include requirements for annual registration, listing of general connois provisions of are feel 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 It may be subject to additional controlor and to 898. In addition, FDA may Iound in the Code of I casia. Nogeraing your device in the Federal Register, Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subscribes with other requirements of the Act that FDA has made a octorinination in administered by other Federal agencies. You must or any Federal Statutes and regulations annualing, but not limited to: registration and listing (ZI CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK Fall 607), labeling (21 OFR 803); good manufacturing practice requirements as set {6}------------------------------------------------ #### Page 2 - Mr. John J. Smith forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/defuult.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 Small Manufacturers, International and Consumer Assistance 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, # Joyce M. Whang -S for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ### Indications for Use 510(k) Number (if known): _ K123390 Device Name: PediGuard 2.5mm XS (Model P1-AU414) PediGuard Curv XS (Model P1-AU451) Cannulated PediGuard Needle#2 (Model P2ND1002) Indications For Use: The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |------------------------------------------------------------------------------------|---------| | Joyce M. Whang -S | | | (Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD) | | | 510(k) Number | K123390 | Page 1 of 1

PEDIGUARD NERVE DETECTOR SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

PEDIGUARD NERVE DETECTOR SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!