The SENTIO MMG Pedicle Access Needles are indicated for use in pedicle pilot hole preparation and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Device Description

The SENTIO MMG Pedicle Access Needles are surgical instruments that incorporate insulated probes with standard connectors to ensure maximum ease of use and compatibility with the Sentio MMG Nerve Mapping and Avoidance System for use during surgeries in which a motor nerve is at risk. The SENTIO MMG Pedicle Access Needles are utilized for pedicle preparation in spine surgery with application of dynamic stimulation for nerve detection. They are provided sterile (ethylene oxide) and have two components: Needle (cannula and trocar) and 2.5m Stimulation Cable. The cannula is marked with equidistant reference depth markers (1cm) relative to the distal [to user] end.

AI/ML Overview

The provided document is a 510(k) Summary for the SENTIO MMG Pedicle Access Needles (K173134). This document pertains to the clearance of a medical device and describes non-clinical performance testing. It does not describe a study involving an AI algorithm or human readers. Therefore, I cannot provide details on AI-specific criteria, sample sizes for test/training sets for AI, expert adjudication of AI results, MRMC studies, or standalone algorithm performance.

However, I can extract the acceptance criteria and performance data for the non-clinical tests that were performed for this device.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Implied from "Conclusion")	Reported Device Performance
Durability	The materials and mating interfaces survive the force of entering the pedicle. The interface between handles remains intact. The stylet is sufficiently sharp to pass through bone. The needle cannula beveled edge is sufficient to dig into bone.	"All samples passed the acceptance criteria. The durability of the subject device has been determined substantially equivalent to the predicate." (Testing used simulated bone material.)
Wire to Plug Connection	The connection wire component part, when inserted into a test sample to accommodate a resistance fit, must not disconnect when subjected to tensile force up to a certain threshold (implied by "All samples passed the acceptance criteria").	"All samples passed the acceptance criteria. The subject device connection assembly has been determined substantially equivalent to the predicate." (The sample construct was subject to tensile force until the wire disconnected from the sample handle, implying a successful withstand up to a predefined force or that disconnection occurred above a limit, or that no disconnection occurred.) "The wire to plug connection of the subject device was tested for tensile force resistance. The plug from the connection wire component part was inserted into a test sample intended to accommodate a resistance fit. The sample construct was subject to tensile force until the wire disconnected from the sample handle."
System Compatibility	The device must maintain compatibility with the NeuralMAS™ (K100992) predicate and provide electrical isolation such that energy delivery is focused only from the distal tip of the needle.	"Test results demonstrated subject device compatibility with the predicate NeuralMAS™ (K100992) system."
Electrical Stimulation	Compatibility with electrical stimulation sources of 100V, 200V, and 300V.	"Compatibility with electrical stimulation sources was verified, supporting substantial equivalence of the subject device."
Biocompatibility	Compliant with ISO 10993-1 for an external communicating device for tissue/bone contact of limited duration. Cleaning validations confirm removal of processing reagents.	"The biocompatibility of the subject device has been assessed as substantially equivalent to the predicate." (Patient contacting materials: Stainless Steel with Parylene C coating, unchanged from predicate. Stainless Steel has a history of clinical use and biocompatibility.)
Sterility	Sterilization method validated per ISO 11135-1 with a Sterility Assurance Level (SAL) of 10⁻⁶. Sterilization residual levels comply with ISO 10993-7.	"The subject devices will be provided sterile with a SAL of 10⁻⁶. The sterilization residual levels were determined compliant with ISO 10993-7 for limited exposure devices. Delivery state of the subject device is determined to be substantially equivalent to the predicate."

Regarding the AI-specific questions (which are not applicable to this document):

Sample size used for the test set and the data provenance: Not applicable, no AI algorithm described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI algorithm described.
Adjudication method: Not applicable, no AI algorithm described.
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: Not applicable, no AI algorithm or human-in-the-loop study described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no standalone AI algorithm described.
The type of ground truth used: Not applicable, no AI algorithm described. For the physical device, the "ground truth" for performance was based on engineering and material science standards and testing protocols.
The sample size for the training set: Not applicable, no AI algorithm described.
How the ground truth for the training set was established: Not applicable, no AI algorithm described.

Summary

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March 22, 2018

Medos International SARL % Sheree Geller Regulatory Affairs Specialist DePuy Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767

Re: K173134

Trade/Device Name: SENTIO MMG Pedicle Access Needles Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDO Dated: February 20, 2018 Received: February 21, 2018

Dear Sheree Geller:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for 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) K173134

Device Name SENTIO MMG Pedicle Access Needles

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

A.	Submitter Information
	Manufacturer:	Medos International SARLChemin-Blanc 382400 Le Locle, Switzerland
	Submitter:	DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767
	Contact Person:Telephone:Fax:Email:	Sheree Geller325 Paramount DriveRaynham, MA 02767(508) 828-3291(508) 828-3797sgeller1@its.jnj.com
B.	Date Prepared	March 22, 2018
C.	Device Name
	Trade/Proprietary Name:	SENTIO MMG® Pedicle Access Needles
	Common/Usual Name:	Nerve Stimulator/Locator
	Classification Name:	21 CFR §874.1820Surgical nerve stimulator/locator
	Regulatory Class:	II
	Product Code & Review Panel:	PDQ; Neurology
D.	Predicate Device Names
	Primary Predicate:	NeuralMAS™ (K100992)
	Additional Predicate:	NuVasive® Stimulation/DissectionInstruments (K112709)

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E. Device Description

F. Intended Use

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Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use G.

The intended use and technological characteristics, including material, design, and performance, of the SENTIO MMG Pedicle Access Needles are consistent with those of the predicate devices.

	Predicate Devices		Subject Device
	NeuralMASTM (K100992)	NuVasive® Stimulation/DissectionInstruments (K112709)	SENTIO MMG® Pedicle AccessNeedles	SubstantiallyEquivalent
Intended Use	NeuralMAS is intended for use insurgical procedures to assist in locatingand mapping motor nerves through theuse of mechanomyographic (MMG)signals and electrical stimulus of nerves.This device is indicated for locating andidentifying spinal nerve roots andperipheral motor nerves originationfrom spinal levels C3-T1 and L2-S2.	The Stimulation/Dissection Instrumentsare indicated for tissue dissection andstimulation of peripheral motor nervesfor location and identification duringsurgery, including spinal nerve roots.	The SENTIO MMG® Pedicle AccessNeedles are indicated for use in pediclepilot hole preparation and stimulation ofperipheral motor nerves for location andidentification during surgery, includingspinal nerve roots.	Yes
Product Code	ETN	ETN	PDQ	Yes
Regulation	21 CFR §874.1820	21 CFR §874.1820	21 CFR §874.1820	Yes
ElectricalInsulation	The sterile stimulation instruments havebiocompatible electrical insulationapplied to select portions. The distalsurfaces of the instruments areselectively non-insulated stainless steelto provide for mechanical, manualdissection, probing, cannulation, andtissue stimulation.	Some instruments have electricalinsulation on surfaces not intended toprovide electrical contact with thepatient and connection while others areused with an insulation accessory thatprovides electrical insulation on surfacesnot intended to provide electricalcontact with the patient and connection.	The subject devices have biocompatibleelectrical insulation applied to selectportions. The distal surfaces of theinstruments are selectively non-insulated stainless steel to provide formechanical, manual dissection, probing,cannulation, and tissue stimulation.	Yes
ProximalStimulatorConnector	Yes	Yes	Yes	Yes
PatientContactingMaterial	Biocompatible:Stainless SteelParylene C	Biocompatible:Stainless Steel,Anodized AluminumRadel	Biocompatible:Stainless SteelParylene C	Yes
Delivery	Sterile for single use	Some instruments are provided sterilefor single use only while others areprovided as non-sterile reusableinstruments.	Sterile for single use	Yes

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H. Materials

The patient contacting materials of the subject devices are biocompatible stainless steel with Parylene C conformal coating.

I. Performance Data

Non-clinical testing was conducted to demonstrate the safety and effectiveness of the subject devices. The SENTIO MMG Pedicle Access Needles were evaluated as follows:

Characteristic	Evaluation Summary	Conclusion
Durability	Durability testing served to determine that materials andmating interfaces of the subject device survive the forceof entering the pedicle, the interface between the top andbottom handles remains intact, the stylet is sufficientlysharp to pass through bone, and the needle cannulabeveled edge is sufficient to dig into bone. Testing wascompleted using simulated bone material.	All samples passed the acceptancecriteria. The durability of the subjectdevice has been determinedsubstantially equivalent to thepredicate.
Wire to PlugConnection	The wire to plug connection of the subject device wastested for tensile force resistance. The plug from theconnection wire component part was inserted into a testsample intended to accommodate a resistance fit. Thesample construct was subject to tensile force until thewire disconnected from the sample handle.	All samples passed the acceptancecriteria. The subject deviceconnection assembly has beendetermined substantially equivalent tothe predicate.
SystemCompatibility	Needle stimulation testing was conducted to verify thatthe subject device maintains compatibility with theNeuralMAS™ (K100992) predicate, and provideselectrical isolation such that energy delivery is focusedfrom only the distal tip of the needle.	Test results demonstrated subjectdevice compatibility with thepredicate NeuralMAS™ (K100992)system.
ElectricalStimulation	The subject device was tested for compatibility withelectrical stimulation sources of 100V, 200V, and 300V.	Compatibility with electricalstimulation sources was verified,supporting substantial equivalence ofthe subject device.
Biocompatibility	Per ISO 10993-1, the subject device is categorized as anexternal communicating device for tissue/bone contact oflimited duration. The Parylene C conformal coatingremains unchanged from the NeuralMAS™ (K100992)predicate. Stainless Steel has a history of clinical use andbiocompatibility; cleaning validations were conducted toconfirm removal of processing reagents.	The biocompatibility of the subjectdevice has been assessed assubstantially equivalent to thepredicate.
Sterility	The ethylene oxide sterilization method was validated perISO 11135-1 for the subject device. Sterilization residuallevels were tested for compliance to ISO 10993-7.	The subject devices will be providedsterile with a SAL of 10⁻⁶. Thesterilization residual levels weredetermined compliant with ISO10993-7 for limited exposure devices.Delivery state of the subject device isdetermined to be substantiallyequivalent to the predicate.

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J. Conclusion

Evaluation of the subject device intended use, technological characteristics, and performance data demonstrates substantial equivalence with the predicate devices.

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.