Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS

K143159 · Spineguard S.A. · PDQ · Jan 23, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K143159
• Device Name: Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS
• Applicant: Spineguard S.A.
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Jan 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The PediGuard 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 System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. 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

PediGuard is a single-use, sterile, handheld surgical probe for pedicle screw pilot hole drilling. Device features a stainless steel shaft with a distal sensor measuring real-time electrical impedance of surrounding tissues. During drilling, device provides visual and audible alerts upon detecting impedance changes, signaling potential soft tissue contact or vertebral cortex perforation. Additionally, device performs intraoperative EMG surveillance by delivering low-voltage electrical energy to tissues/nerves, with EMG monitoring of associated muscle groups. Used by surgeons in open or percutaneous (MIS) spinal procedures, often with fluoroscopic guidance. Feedback assists surgeons in avoiding nerve injury and optimizing screw placement. Device includes a lithium-ion battery and is designed for single-use, preventing reuse via battery exhaustion.

Clinical Evidence

Clinical evidence includes a cadaver trial (T10-L5 level) comparing Cannulated PediGuard to a Jamshidi needle, showing a 60% reduction in screw breach and 86.8% reduction in fluoroscopy shots. A clinical study comparing open posterior pedicle screw fixation (PPSF) and MIS posterior spine arthrodesis procedures showed no difference in optimal screw placement between the two approaches using PediGuard.

Technological Characteristics

Materials: 316L Stainless Steel (ASTM F138), 304 Stainless Steel (ASTM F899), 17-4PH (ASTM F899), and plastic. Sensing: Electrical impedance measurement at distal tip. Energy: Lithium-ion battery. Form factor: Handheld probe with T-handle, straight or curved shafts (120mm-165mm). Connectivity: Standalone. Sterilization: Ethylene oxide. Software: Firmware on programmable chip (capacitors, resistors, diodes). Standards: IEC 60601-1, IEC 60601-1-4, ISO 10993 series, ISO 11135-1, ISO 11607.

Indications for Use

Indicated for patients undergoing spinal surgery requiring pedicle screw pilot hole drilling or intraoperative EMG surveillance for spinal nerve location and evaluation. Applicable to both open and percutaneous (MIS) surgical 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

• PediGuard Nerve Detector (K030526; K123390)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right. The profiles are connected by a flowing line that forms a wave-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2015

Donald W. Guthner Orgenix LLC 111 Hill Road Douglassville, PA 19518

Re: K143159

Trade/Device Name: Modular Models

P2ND1001 - Cannulated PediGuard® Needle#1 (165mm) P2ND1002 - Cannulated PediGuard® Needle#2 (165mm) P2ND1101 - Cannulated PediGuard® Needle (120mm) P2HE1000 - Cannulated PediGuard® Handle Single-Piece Models P1-AU411 - PediGuard® Tri Tip Ø4.0mm P1-AU412 - PediGuard® Tr Tip Ø3.2mm P1-AU413 - PediGuard® Tri Tip Ø2.5mm P1-AU414 - PediGuard® Ø2.5mm XS P1-AU450 - PediGuard® Curv P1-AU451 - PediGuard® Curv XS Regulation Number: 21 CFR §874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II

Product Code: PDO, ETN

Dated: November 3, 2014 Received: November 3, 2014

Dear Dr. Guthner:

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

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Page 2 - Dr. Donald W. Guthner

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Felipe Aquel -S

Carlos L. Peña, PhD, MS for Carlos L 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) K143159

#### Device Name

Cannulated PediGuard® Needle - P2ND1001, P2ND1002, P2ND1101; Cannulated PediGuard® Handle - P2HE1000 PediGuard® Tri Tip - P1-AU411, P1-AU412, P1-AU413; PediGuard® Ø2.5mm XS - P1-AU414; PediGuard® Curv - P1-AU450, P1-AU451

#### Indications for Use (Describe)

The PediGuard 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 System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) SUMMARY

#### SpineGuard's PediGuard®

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 Phone: [phone] Facsimile: 484-363-5879

Date Prepared: December 19, 2014

Name of Device:

Modular Models P2ND1001 - Cannulated PediGuard® Needle#1 (165mm) P2ND1002 - Cannulated PediGuard® Needle#2 (165mm) P2ND1101 - Cannulated PediGuard® Needle (120mm) P2HE1000 - Cannulated PediGuard® Handle Single-Piece Models P1-AU411 - PediGuard® Tri Tip Ø4.0mm P1-AU412 - PediGuard® Tr Tip Ø3.2mm P1-AU413 - PediGuard® Tri Tip Ø2.5mm P1-AU414 - PediGuard® Ø2.5mm XS P1-AU450 - PediGuard® Curv

P1-AU451 - PediGuard® Curv XS

| Common or Usual Name: | Nerve Stimulator |
|-----------------------|-----------------------------------|
| Classification Name: | Surgical Nerve Stimulator/Locator |
| Review Panel: | Neurology |
| Product Code: | PDQ and ETN |
| Device Class: | Class II |
| Regulation: | 21 C.F.R. §874.1820 |

Predicate Devices

SpineGuard S.A., PediGuard Nerve Detector (K030526; K123390)

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## Device Description

The PediGuard® modular and single-piece devices are single use, devices composed of stainless steel and plastic, and are provided sterile. The PediGuard devices 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 produce visual and audible signals to indicate changes in impedance associated with possible vertebral perforation.

All PediGuard® models provide real-time 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 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 System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic quidance in percutaneous (MIS) surgical approaches to the spine.

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 subject PediGuard® models are identical with the corresponding predicate models. No hardware or software changes were made to the current devices to prepare for the requested change to the Indications for Use statement. The only technological difference between the subject PediGuard and the predicate device is the introduction of a 120mm Cannulated PediGuard. The 120mm length device is identical in all aspects (materials, electronics, connectors and dimensions) to the cleared 160mm Cannulated PediGuard, with the exception of being shorter. These minor technological raise no new issues of safety or effectiveness. Thus, the subject PediGuard is substantially equivalent to the cleared predicated PediGuard (K123390).

## Substantial Equivalence Chart

| | Subject PediGuard® models | Cleared PediGuard® models<br>(K123390) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for Use | The PediGuard® is indicated for use<br>during pedicle screw pilot hole drilling<br>to provide feedback to the surgeon<br>via visual and audible alerts that | The PediGuard® is indicated for use<br>during pedicle screw pilot hole drilling<br>to provide feedback to the surgeon<br>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 System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.<br><br>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. | 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 | Gearshift T-Handle | |
| Components | Single Piece, Stainless Steel shaft, plastic handle, ceramic insulator or modular with removable handle | |
| Shaft Material | Inner electrode: 316L Stainless Steel (ASTM F138) Outer electrode and/or shaft: 304 Stainless Steel (ASTM F899), 316L Stainless Steel and/or 17-4PH (ASTM F899) | |
| Safety Features | Device cannot be turned off until battery exhausted. Prevents reuse of device. | |
| Power Source | Lithium-Ion Battery | |
| Sterility | Sterile | |
| Single Use or Reusable | Single-use | |
| Distal Shaft shape | Curved or straight; or straight (cannulated) with removable inner starter stylet (optional) and sensory needle. | |
| Dimensions | 2.5mm shaft diameter / tapered for 2mm to 4mm; 3.0 mm shaft diameter (cannulated) | |
| Circuit board | Capacitors, Resistors and Diodes - Firmware (programmable chip) on | |

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| circuit board | circuit board |
|---------------|---------------|
|---------------|---------------|

## Performance Data

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).
- . 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 support of this clarification to the indications for use of the PediGuard, SpineGuard conducted a cadaver trial in which thoracolumbar pedicle screws were placed at T10-L5 level in cadavers. The

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results show a 60% reduction in screw breach and an 86.8% reduction of total fluoroscopy shots when using the Cannulated PediGuard over use of the Jamshidi needle. In addition, the company submitted a clinical study of PediGuard in both open posterior pedicle screw fixation (PPSF) procedures and MIS posterior spine arthrodesis procedures. The results of this study showed no difference in optimal screw placement when using the PediGuard in either open or MIS surgery.

## Conclusion

The PediGuard has the same intended use and similar indications for use and technological characteristics as the predicate PediGuard. As confirmed through bench and clinical testing data, the PediGuard® is as safe and effective for its intended use as its predicate device. Accordingly, the PediGuard is substantially equivalent.