The DSG™ Threaded Drill System is intended to be used for the preparation of pedicle screw holes. The DSG™ Threaded Drill 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 DSG™ Threaded Drill System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. The DSG™ Threaded Drill System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.

The DSG™ Threaded Drill System 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 DSG™ Threaded Drill System is designed to prepare pedicle screw holes. The sensor at the distal 3mm of the shaft detects the electrical impedance of the tissue immediately surrounding the sensor and provides real-time audio and visual information to the surgeon to assist the surgeon to determine the relative density of the tissue at the tip of the shaft. A skilled surgeon can interpret the varying pitch and cadence of the feedback to determine potential breaches of the cortical wall. The first 6mm at the instrument are very similar to the cleared PediGuard models, with a pointy awl type design to penetrate the bone. After that, a threaded portion of 25mm in length, featuring cutting flutes, allows for an easy insertion in bone. The threads allow for a smooth and progressive penetration in bone that results in steady and consistent readings of the impedance of the tissue, making the determination of potential breaches of the cortical wall easy for the surgeon.

AI/ML Overview

The provided text describes the SpineGuard DSG™ Threaded Drill System (K152747) which is a modification to a previously cleared device, the PediGuard System (K143159). The document focuses on demonstrating substantial equivalence to the predicate device rather than presenting a standalone study with specific acceptance criteria for performance metrics like sensitivity and specificity. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device in terms of technological characteristics and performance tests.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to a predicate device, the "acceptance criteria" aren't explicitly stated as quantitative targets (e.g., sensitivity > X%). Instead, the acceptance criteria are met by demonstrating that the new device's performance is equivalent to the predicate device, particularly in areas that could be impacted by the device modifications.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance
Mechanical Performance	The SpineGuard DSG™ Threaded Drill System was "tested mechanically (bending tests of the shaft) to show the sensor characteristics were identical to the predicate devices."
Detection Performance	"The detection performance of the new length of pins was also demonstrated to be equivalent to the predicates." This refers to its ability to detect impedance changes indicating tissue contact.
Durability	"In addition, the device durability was tested." (Demonstrated to meet predicate levels for similar use).
Cleaning and Sterilization	"Cleaning and sterilization validation demonstrated that the reusable components can be adequately cleaned and sterilized prior to reuse."
Compliance with Recognized Standards	The device complies with a list of ASTM, IEC, and ISO standards related to materials, electrical safety, biological evaluation, packaging, and sterilization (as listed on pages 4-5). This indicates that the device has met the requirements within these standards.

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

The document does not provide details on the sample size used for performance testing (e.g., number of shafts tested for bending, number of trials for detection performance) or the specific data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned ("tested mechanically," "demonstrated to be equivalent," "device durability was tested") appear to be bench or lab-based tests confirming feature equivalency and safety, not clinical studies with patient data.

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

Not applicable. The document describes performance tests related to mechanical properties, detection equivalency, durability, cleaning, and sterilization, which do not typically involve human expert interpretation for "ground truth" in the way clinical diagnostic or AI performance studies would. The device provides "feedback to the surgeon via visual and audible alerts," and a "skilled surgeon can interpret the varying pitch and cadence of the feedback," but the 510(k) submission focuses on the device's functional equivalence, not a study of surgeon performance metrics.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance tests described are not clinical studies requiring adjudication of outcomes or diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No MRMC comparative effectiveness study is described in the provided text. The device is a surgical tool that provides real-time feedback, not an AI diagnostic tool for human readers.

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

The device is inherently "human-in-the-loop," as its function is to provide real-time feedback to a surgeon during a procedure for their interpretation. Therefore, a standalone (algorithm only) performance assessment without human input would not be relevant or possible in its intended use context. The "detection performance" discussed relates to the sensor's ability to identify impedance changes, which is a standalone technical characteristic, but its clinical utility is always in conjunction with a surgeon.

7. The Type of Ground Truth Used

For the specific performance tests mentioned:

Mechanical performance (bending tests): Ground truth would be defined by engineering specifications and physical measurements.
Detection performance: Ground truth would be the known electrical impedance properties of different tissues or the physical presence of soft tissue/vertebral cortex perforation as confirmed by other means (e.g., direct observation in a test setup or anatomical models).
Durability, cleaning, sterilization: Ground truth is established by relevant industry standards and test methodologies (e.g., sterility testing, material degradation analysis).

8. The Sample Size for the Training Set

Not applicable. The device described is a physical surgical instrument with sensors, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "performance" is based on its physical and electrical characteristics as designed and manufactured, not on learning from a dataset.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures representing health, services, and human aspects.

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

June 10, 2016

SpineGuard, S.A. c/o Dr. John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004

Re: K152747

Trade/Device Name: SpineGuard DSGTM Threaded Drill System Regulation Number: 21 C.F.R. §874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: PDQ Dated: May 9, 2016 Received: May 9, 2016

Dear Dr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21 CFR 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,

William J.
Heetderks -A

Digitally signed by William J. Heetderks -A
DN: c=US, o=U.S. Government, ou=HHS, ou=NI
ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -A
Date: 2016061013-50-34-04'00'

for

Carlos L. Peña. PhD, MS 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)

K152747

Device Name DSGTM Threaded Drill System

Indications for Use (Describe)

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

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.A.'s DSG™ Threaded Drill System (K152747)

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

SpineGuard, S.A. 10 cours Louis Lumière 94300 Vincennes - France France Phone: +(33) 1 45 18 45 19

Contact Person: Stephane Bette Chief Technology Officer SpineGuard, S.A. 1388 Sutter Street Suite 510 San Francisco, CA 94109 Phone + 1 415 512 2504
Date Prepared: June 7, 2016

Name of Device

SpineGuard DSG™ Threaded Drill System

Common or Usual Name

Nerve Stimulator

Classification Name

21 C.F.R. §874.1820 Surgical Nerve Stimulator/Locator, PDQ

Predicate Devices

SpineGuard S.A., Cannulated PediGuard Nerve Detector (K143159)

Purpose of the 510(k) notice

The DSG™ Threaded Drill System is a modification to the cleared PediGuard System intended to add additional options for the surgeon to create pilot holes for pedicles screw systems.

Indication for Use

The DSG™ Threaded Drill System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal

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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.

Technological Characteristics

Performance Data

The SpineGuard DSG™ Threaded Drill System was tested mechanically (bending tests of the shaft) to show the sensor characteristics were identical to the predicate devices. The detection performance of the new length of pins was also demonstrated to be equivalent to the predicates. In addition, the device durability was tested. Cleaning and sterilization validation demonstrated that the reusable components can be adequately cleaned and sterilized prior to reuse.

The SpineGuard DSG™ Threaded Drill System complies with the following recognized standards:

. ASTM F138-13, Standard specification for wrought 18 chromium-14 nickel-2.5 molybdenum stainless steel bar and wire for surgical implants (2013).
. ASTM F899-12b, Standard specification for wrought stainless steel for surgical instruments (2012).
. IEC 60601-1 Medical Electrical Equipment - Part 1: General requirements for safety, Amendment 1 (2007).
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 (2010).
. ISO 10993-7, Biological evaluation of medical devices: Ethylene Oxide sterilization residuals (2008).
. ISO 10993-10, Biological Evaluation of Medical Devices: Tests for irritation and sensitization (2010).
ISO 10993-11, Biological Evaluation of Medical Devices: Tests for systemic toxicity (2009).
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).
. 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 (2010).

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ASTM D4169, Standard practice for performance testing of shipping containers and systems . (2014).
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 . dve penetration.
. ASTM F1980, Standard guide for accelerated aging of sterile medical device packages (2011).
. 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 (2014).
ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for . the development, validation and routine control of a sterilization process for medical devices (2006).

Substantial Equivalence

The SpineGuard DSG™ Threaded Drill System has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared PediGuard System. The minor differences in the DSG™ Threaded Drill System's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the SpineGuard DSG™ Threaded Drill System is substantially equivalent to the cleared PediGuard System.

	Subject DSG™ Threaded DrillSystem (K152747)	Cannulated PediGuard® models(K143159)
Intended Use / Indicationsfor Use	The DSG™ Threaded Drill Systemis intended to be used for thepreparation of pedicle screw holes.The DSG™ Threaded Drill Systemis indicated for use during pediclescrew pilot hole drilling to providefeedback to the surgeon via visualand audible alerts that indicate achange in impedance at the tip ofthe probe and may indicatecontact of the tip with soft tissuesand possible vertebral cortexperforation.	The PediGuard® is indicated foruse during 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.
	The DSG™ Threaded Drill Systemis indicated for use in both openand percutaneous (MIS) surgicalapproaches to the spine. TheDSG™ Threaded Drill System isalso indicated for use withfluoroscopic guidance inpercutaneous (MIS) surgicalapproaches to the spine.	The PediGuard System isindicated for use in both open andpercutaneous (MIS) surgicalapproaches to the spine.PediGuard is also indicated foruse with fluoroscopic guidance inpercutaneous (MIS) surgicalapproaches to the spine.
	The DSG™ Threaded Drill Systemalso is specifically indicated foruse in intraoperativeelectromyographic ("EMG")	The PediGuard also is specificallyindicated for use in intraoperativeelectromyographic ("EMG")surveillance to assist in the

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	surveillance to assist in thelocation and evaluation of spinalnerves during surgery of the spine,by administration of low voltageelectrical energy to tissues andnerves at the operative site, andEMG monitoring of muscle groupsassociated with those nerves.	location and evaluation of spinalnerves during surgery of thespine, by administration of lowvoltage electrical energy to tissuesand nerves at the operative site,and EMG monitoring of musclegroups associated with thosenerves.
Handle Shape	T-Handle with Ratchet	T-Handle
Components	Stainless Steel shaft, plastichandle, ceramic insulator, modularwith removable handle, ratchetand reusable shaft	Stainless Steel shaft, plastichandle, ceramic insulator, modularwith removable handle
Shaft Material	Inner electrode: 316L StainlessSteel (ASTM F138) Outerelectrode and/or shaft:304 Stainless Steel (ASTM F899),316L Stainless Steel and/or 17-4PH (ASTM F899); CeramicZirconium Oxide Insulator	Inner electrode: 316L StainlessSteel (ASTM F138) Outerelectrode and/or shaft:304 Stainless Steel (ASTM F899),316L Stainless Steel and/or 17-4PH (ASTM F899); CeramicZirconium Oxide Insulator
Safety Features	Device cannot be turned off untilbattery exhausted. Preventsreuse of device.	Device cannot be turned off untilbattery exhausted. Prevents reuseof device.
Power Source	Lithium-Ion Battery	Lithium-Ion Battery
Sterility	Sterile/Non-sterile	Sterile
Single Use or Reusable	Single-use (T-Handle and ActiveStylet)Re-usable (Ratcheting Handle,Threaded Drill Shaft and Sleeve)	Single Use
Distal Shaft Shape	Straight (cannulated) and activestylet	Straight (cannulated) withremovable inner starter stylet(optional) and active stylet
Dimensions	1.7mm inner diameter (hole)cannulated metal shaft withflanges (threads) and cuttingedges; Thread outer diameters of4.0, 5.5 and 8.0mm.	Cannulated, inner diameter:2.5mm; Tapered shaft outerdiameter from 3 to 4mm.
Circuit Board	Capacitors, Resistors and Diodes- Firmware (programmable chip)on circuit board	Capacitors, Resistors and Diodes- Firmware (programmable chip)on circuit board

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.