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 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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the PediGuard device:

Important Note: The provided document is a 510(k) summary for a medical device (PediGuard). 510(k) submissions typically focus on demonstrating "substantial equivalence" to a predicate device, rather than strictly defining and proving specific acceptance criteria in the same way a de novo or PMA submission might. Therefore, the "acceptance criteria" here are largely implied by the performance of the predicate device and the new device's ability to achieve similar or improved results in specific tests. Direct, quantified "acceptance criteria" for each performance metric are not explicitly stated in a dedicated table format within this document.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit quantitative acceptance criteria are not presented in a table. However, we can infer the targets based on the comparison to the predicate device and the results of the cadaver and clinical studies.

Performance Metric	Implied Acceptance Criteria (relative to predicate)	Reported Device Performance
Safety	- Conformance to relevant safety standards (e.g., IEC 60601-1, ISO 10993 series for biocompatibility and sterilization).- No new issues of safety compared to the predicate device.- Device cannot be turned off until battery exhausted (safety feature).- Single-use.	- Conforms to ASTM F138-08, ASTM F899-1, IEC 60601-1, IEC 60601-1-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 11135-1, ISO 10993-7, ISO 11737-1, ISO 11737-2, ISO 11607-1, ISO 11607-2, ASTM F88, ASTM F1929, ASTM F1980, ASTM D4169.- 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 changes raise no new issues of safety or effectiveness.- Device cannot be turned off until battery exhausted. Prevents reuse of device.- Single-use.
Effectiveness (Screw Breach)	Improved or equivalent performance in reducing pedicle screw breach compared to Jamshidi needle (cadaver study).	60% reduction in screw breach when using the Cannulated PediGuard over use of the Jamshidi needle (cadaver study).
Effectiveness (Fluoroscopy Use)	Improved or equivalent performance in reducing fluoroscopy shots compared to Jamshidi needle (cadaver study).	86.8% reduction of total fluoroscopy shots when using the Cannulated PediGuard over use of the Jamshidi needle (cadaver study).
Effectiveness (Optimal Placement)	No difference or improved optimal screw placement when using PediGuard in both open and MIS surgery compared to predicate (clinical study - implied, or standard of care if predicate wasn't directly compared).	No difference in optimal screw placement when using the PediGuard in either open or MIS surgery (clinical study). This suggests it is at least equivalent to standard practice.
Functional Equivalence/Features	Same intended use, similar indications for use, and technological characteristics as the predicate PediGuard.	The PediGuard is identical with the corresponding predicate models, with one technological difference: introduction of a shorter 120mm Cannulated PediGuard (otherwise identical). The device provides real-time visual and auditory feedback to the surgeon, indicating impedance changes for possible vertebral cortex perforation and EMG surveillance for spinal nerves.

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

Cadaver Trial:
- Sample Size: Not explicitly stated as a number of cadavers or pedicle screws. It states "a cadaver trial in which thoracolumbar pedicle screws were placed at T10-L5 level in cadavers." This implies multiple screws per cadaver.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in method as the data was collected after the procedures, but the experiment itself (placing screws) would be prospective/controlled.
Clinical Study:
- Sample Size: Not explicitly stated. It mentions "a clinical study of PediGuard in both open posterior pedicle screw fixation (PPSF) procedures and MIS posterior spine arthrodesis procedures."
- Data Provenance: Not explicitly stated (e.g., country of origin, specific institutions). The nature of a "clinical study" implies human subjects in a real-world surgical setting. It's likely prospective if designed to assess the PediGuard's performance.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for either the cadaver or clinical studies. In spine screw placement studies, "ground truth" for screw breach is typically established by post-placement imaging (e.g., CT scan) reviewed by a radiologist or surgeon, or direct dissection in cadaver studies. For optimal screw placement, similar methods or direct surgical assessment could be used.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, as typically applied to image reading algorithms, was not done. This device is an intraoperative tool providing real-time feedback, not an imaging diagnostic tool where multiple readers interpret cases.

However, a comparative effectiveness study was done in the sense that the PediGuard's performance was compared against a traditional method (Jamshidi needle) in one outcome (reduction in screw breach and fluoroscopy shots).

Effect Size of human readers improvement with AI (PediGuard) vs without AI assistance: Not applicable in the typical MRMC sense. The PediGuard is the "AI assistance" (or rather, the intelligent feedback system) for the surgeon.
- Effect vs. Jamshidi Needle:
  - Reduction in screw breach: 60%
  - Reduction in total fluoroscopy shots: 86.8%

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

The device's function is inherently "human-in-the-loop." It provides visual and audible alerts to the surgeon who then uses this information to guide their actions. Therefore, a standalone (algorithm only) performance study would not be relevant or possible given the device's intended use. The performance data is the human-in-the-loop performance.

7. The Type of Ground Truth Used

Cadaver Trial: "Screw breach" and "total fluoroscopy shots." The ground truth for screw breach would typically be determined by post-insertion CT imaging or direct dissection, and fluoroscopy shots are objective counts.
Clinical Study: "Optimal screw placement." The ground truth for "optimal screw placement" would likely be determined by post-operative imaging (e.g., CT scans) interpreted against established criteria, possibly with expert consensus.

8. The Sample Size for the Training Set

The document does not mention any "training set." This type of device relies on established physical principles (electrical impedance changes) and real-time sensing, not on a machine learning model that requires a distinct training set in the typical AI/ML sense. The feedback system is presumably pre-calibrated and validated based on biophysical properties, not trained on a dataset of cases.

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

Since no training set is mentioned or implied for this device, this question is not applicable.

Summary

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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 (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, 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)

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

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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: 646-460-2984 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

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.

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(K123390)
Intended Use /Indications for Use	The PediGuard® is indicated for useduring pedicle screw pilot hole drillingto provide feedback to the surgeonvia visual and audible alerts that	The PediGuard® is indicated for useduring pedicle screw pilot hole drillingto provide feedback to the surgeonvia 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.	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.

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.