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 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.

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.

AI/ML Overview

The provided text describes different models of SpineGuard's PediGuard devices and their substantial equivalence to a predicate device, the PediGuard Nerve Detector (K030526). This submission is for a 510(k) premarket notification, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness criteria.

For this type of submission, "acceptance criteria" are usually based on meeting established standards (e.g., ISO, ASTM, IEC) and demonstrating comparable performance to the predicate device in specific technical and functional aspects, rather than clinical efficacy metrics like sensitivity or specificity. The "study" here refers to the various verification and validation tests performed.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for SpineGuard PediGuard Devices

The acceptance criteria for the PediGuard® 2.5mm XS, PediGuard® Curv XS, and Cannulated PediGuard® Needle#2 are primarily based on demonstrating substantial equivalence to their predicate device, the SpineGuard S.A., PediGuard Nerve Detector (K030526). This involves meeting relevant industry standards and showing comparable performance in key areas.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implicitly defined by compliance with recognized standards and demonstration of performance comparable to the predicate device. The device performance listed below demonstrates this equivalence.

Aspect	Acceptance Criteria (Deemed Met by Substantial Equivalence and Standards)	Reported Device Performance
Intended Use / Indications	Maintain the same intended use/indications for use as the predicate device: providing visual and audible feedback during pedicle screw pilot hole drilling to indicate changes in impedance at the tip, potentially indicating contact with soft tissues and possible vertebral cortex perforation. Also, for intraoperative EMG surveillance to assist in nerve location and evaluation during spinal surgery.	The PediGuard® 2.5mm XS, PediGuard® Curv XS, and Cannulated PediGuard® Needle#2 have the same intended use/indications for use as the predicate.
Technological Characteristics	Maintain similar technological characteristics and principles of operation to the predicate device, with minor differences not raising new safety/effectiveness questions (e.g., shaft diameter, shaft materials, electronics firmware/power source).	The devices have similar technological characteristics and principles of operation as the cleared PediGuard Nerve Detector. The impedance detection algorithm is identical. Minor differences in shaft diameter, materials, or electronics are stated not to raise any new questions of safety or effectiveness.
Biocompatibility	Compliance with ISO 10993 -1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 for devices in limited (≤ 24 hours) contact with tissue/bone.	Non-cytotoxic, Non-irritating, Non-sensitizing, and Not systemically toxic as demonstrated by ISO 10993-5, 10993-10, and 10993-11 testing.
Mechanical Performance	Maintain structural integrity and perform as intended under mechanical stress (e.g., bending).	Static bending testing showed all device models performed as intended in a manner directly comparable to the predicate devices.
Electrical Performance	Emit electrical signals comparable to the predicate device, accurately measure changes in impedance, and convey changes via audible signals with comparable volume.	Electrical signal emission was directly comparable to the predicate. The ability to measure impedance changes and the volume of the audible signal were also measured and found to be directly comparable. Firmware verification and validation testing completed.
Material Standards	Compliance with material specifications for implantable stainless steel (e.g., ASTM F138, ASTM F899).	Compliance with ASTM F138-08 and ASTM F899-11 demonstrated. The materials in the modified devices are directly comparable to the predicate.
Electrical Safety	Compliance with general safety requirements for medical electrical equipment (e.g., IEC 60601-1 and its collateral standards).	Compliance with IEC 60601-1 and IEC 60601-1-4 demonstrated.
Sterilization & Packaging	Compliance with standards for sterilization, residuals, microbiological methods, and packaging for terminally sterilized medical devices (e.g., ISO 11135-1, ISO 10993-7, ISO 11737-1/2, ISO 11607-1/2, ASTM F88, F1929, F1980, D4169).	Devices are sterile and were tested against ISO 11135-1, ISO 10993-7, ISO 11737-1, ISO 11737-2, ISO 11607-1, ISO 11607-2, ASTM F88, ASTM F1929, ASTM F1980, and ASTM D4169.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data, as this is a 510(k) submission primarily relying on design verification and validation (bench testing, material compliance) rather than a clinical trial with a patient cohort. The testing involved various quantities of the devices themselves for mechanical, electrical, and biocompatibility evaluations. For "Surgeon testing," the number of surgeons or cases is not specified.
Data Provenance: The studies are primarily in-house design verification and validation activities conducted by SpineGuard or contracted laboratories.
- Country of Origin: France (SpineGuard, S.A. is located in Saint Mande, France).
- Retrospective or Prospective: These are laboratory and bench tests, not clinical studies. Therefore, the terms "retrospective" or "prospective" as applied to patient data do not directly apply. They are prospective tests conducted on the devices as part of their development and regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in a way that aligns with establishing ground truth for a clinical test set. The document refers to "Surgeon testing" but does not specify the number or qualifications of surgeons involved or how their input was used to establish a "ground truth." For biocompatibility, testing was conducted under 21 CFR, Part 58, Good Laboratory Practices, implying certified labs and personnel, but not "experts establishing ground truth" in a clinical sense.

4. Adjudication Method for the Test Set

Not applicable in the context of this 510(k) submission, which focuses on device performance validation against engineering and safety standards, and equivalence to a predicate, rather than human expert adjudication of clinical outcomes or images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

No MRMC or comparative effectiveness study involving human readers or AI assistance was mentioned or conducted, as this device (PediGuard) is a surgical tool providing real-time feedback, not an imaging or diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device explicitly provides "real-time visual and auditory feedback to the surgeon." The "impedance detection algorithm is identical" to the predicate. The device is designed to be used with a human surgeon in the loop. Therefore, a standalone algorithm-only performance assessment in the absence of human interaction (as understood in AI/imaging contexts) is not relevant or described. The firmware of the device, which contains the algorithm, underwent verification and validation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering and performance standards, and comparison to the predicate device.
- Biocompatibility: Based on established biological response criteria (e.g., absence of cytotoxicity, irritation, sensitization, systemic toxicity) as defined by ISO 10993 standards and tested in GLP-compliant laboratories.
- Mechanical & Electrical Performance: Based on objective measurements against engineering specifications and direct comparability to the predicate device's measured performance (e.g., bending strength, electrical signal emission, impedance detection actability, audible signal volume).
- Material Composition: Based on compliance with ASTM material standards.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm in the contemporary sense requiring a "training set" of data to learn from. The impedance detection algorithm is stated to be "identical" to the predicate and is based on established principles of electrical impedance measurement. The firmware itself was subject to verification and validation, but this does not involve a "training set" as understood in AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for the type of device and submission described.

Summary

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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

NDC・(13865)2000000) - 4712449 \ 2

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Intended Use/Indications for Use

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

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Intended Use / Indicationsfor Use	The SpineGuard, PediGuardNerve Detector System isindicated for use during pediclescrew pilot hole drilling to providefeedback to the surgeon viavisual and audible alerts thatindicate a change in impedanceat the tip of the probe and mayindicate contact of the tip withsoft tissues and possiblevertebral cortex perforation. ThePediGuard also is specificallyindicated for use in intraoperativeelectromyographic ("EMG")surveillance to assist in thelocation and evaluation of spinalnerves during surgery of thespine, by administration of lowvoltage electrical energy totissues and nerves at theoperative site, and EMGmonitoring of muscle groupsassociated with those nerves.	The PediGuard® 2.5mm XS(model P1-AU414), andPediGuard® Curv XS (modelP1-AU451) are indicated foruse during pedicle screw pilothole drilling to provide feedbackto the surgeon via visual andaudible alerts that indicate achange in impedance at the tipof the probe and may indicatecontact of the tip with softtissues and possible vertebralcortex perforation. ThePediGuard also is specificallyindicated for use inintraoperativeelectromyographic ("EMG")surveillance to assist in thelocation and evaluation ofspinal nerves during surgery ofthe spine, by administration oflow voltage electrical energy totissues and nerves at theoperative site, and EMGmonitoring of muscle groupsassociated with those nerves.	The PediGuard® CannulatedPediGuard® Needle#2 (modelP2ND1002) Is indicated for useduring pedicle screw pilot holedrilling to provide feedback to thesurgeon via visual and audiblealerts that indicate a change inimpedance at the tip of the probeand may indicate contact of the tipwith soft tissues and possiblevertebral cortex perforation. ThePediGuard also is specificallyindicated for use in intraoperativeelectromyographic ("EMG")surveillance to assist in thelocation and evaluation of spinalnerves during surgery of thespine, by administration of lowvoltage electrical energy totissues and nerves at theoperative site, and EMGmonitoring of muscle groupsassociated with those nerves.
Handle Shape	Straight - screwdriver	Gearshift T-Handle	T-handle
Components	Single Piece or Modular,Stainless Steel shaft, plastichandle, PEEK insulator	Single Piece, Stainless Steelshaft, plastic handle, ceramicinsulator	Modular unit with Cannulatedouter shaft, active sensoryneedle, and ceramic insulation
Shaft Material	Inner electrode: 316L StainlessSteel (ASTM F138) Outerelectrode: 316L Stainless Steel(ASTM F138)	Inner electrode: 316L StainlessSteel (ASTM F138) Outerelectrode or shaft: 316LStainless Steel and/or 17-4PH(ASTM F899)	Inner electrode: 316L StainlessSteel (ASTM F138) (Electrode)Outer electrode and shaft: 304Stainless steel (ASTM F899)
Safety Features	Device cannot be turned off untilbattery exhausted. Preventsreuse of device.	Device cannot be turned offuntil battery exhausted.Prevents reuse of device.	Device cannot be turned off untilbattery exhausted. Preventsreuse 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 innerstarter stylet (optional) andsensory needle.
Dimensions	3.2mm and 4.0 mm shaftdiameter	2.5mm shaft diameter / taperedfor 2mm to 4mm	3.0mm shaft diameter
Circuit board	Capacitors, Resistors and Diodes	Capacitors, Resistors andDiodes - Firmware(programmable chip) on circuitboard	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.

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Tests	Results1	Conclusion1
In vitro Cytotoxicity test(ISO MEM Elution assay withquantitative evaluation ofcytotoxicity) - 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 pigmaximization) - ISO 10993-10	No evidence ofsensitization	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).

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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

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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

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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

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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:

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

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.