SEASPINE MONOPOLAR PROBE SYSYEM by SEASPINE, INC.

The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine.

Device Description

The SeaSpine Monopolar Probes conduct electrical stimulation to nervous tissue that may be present in close proximity of the surgical corridor to the spine. This system is not comprised of a nerve stimulator or recorder; instead it will use conventional stimulators found in the market. The SeaSpine Monopolar Probes are insulated by a biocompatible PEEK (polyetheretherketone) layer all around one or more conductive stainless steel wire(s) with the exception of the distal and proximal ends. The distal end contacts the target tissue and the proximal end connects to standard intraoperative neuromonitoring monopolar stimulator) that offers triggered electromyography (EMG) capability. Triggered EMG is a standard intraoperative practice where motor nerves are stimulated and their corresponding muscle group response is recorded, allowing for avoidance of nervous tissue during surgical approach. The proximal connector design meets the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.

AI/ML Overview

The provided text describes a 510(k) submission for the SeaSpine Monopolar Probe System, which is a medical device for nerve stimulation and tissue dilation during spinal surgery. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way one might find for a novel diagnostic or therapeutic algorithm.

Therefore, the study design and acceptance criteria metrics requested in the prompt do not directly apply to this type of regulatory submission. The "acceptance criteria" here are effectively satisfied by demonstrating that the device is "as safe, as effective, and performs as well as or better than" the legally marketed predicate devices through engineering analysis, materials comparison, and adherence to relevant standards.

However, I will extract the available information to address the prompt's points as closely as possible within the context of this 510(k) submission.

Summary of Acceptance Criteria and Device Performance (based on Substantial Equivalence)

The "acceptance criteria" in this context are met by demonstrating substantial equivalence to the predicate devices. The "reported device performance" is essentially that it functions similarly to the predicates.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (vs. Predicates)
Indications for Use: Similar or identical	The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine. This is deemed substantially equivalent to predicates that perform tissue dissection and stimulation of motor nerves for location and identification during surgery, including spinal nerve roots.
Materials: Similar or identical	Manufactured from similar or identical materials as predicate devices (Stainless Steel, PEEK). The biocompatibility was assessed per ISO 10993 and USP Class VI. Materials have a long track record of use in the medical device industry.
Design: Similar or identical	Electrical conduit insulated with exception to distal tip and proximal connector (same as predicates). Electrical conduction material (Stainless Steel - same as Medtronic, similar to Nuvasive which also uses Aluminum). Electrical patient contact surface (Stainless Steel - same as Medtronic, similar to Nuvasive). Proximal Stimulator Connector (Yes - same as predicates). Biocompatible plastic electrical insulation (Yes - same as predicates). Steam Sterilizable Reusable (Yes - same as Medtronic, similar to Nuvasive).
Functionality: Similar or identical	Functions similarly; employs conventional stimulators for triggered electromyography (EMG) capability to allow avoidance of nervous tissue during surgical approach. Considered substantially equivalent.
Safety and Effectiveness: No new issues raised	Demonstrated through engineering analysis, specifications, labeling, and comparison to predicates. Conforms to IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12 for electrical safety.

Given that this is a 510(k) submission based on substantial equivalence, the following points address what is available in the document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document does not describe a clinical "test set" in the traditional sense of a clinical trial for performance evaluation of an AI/ML device. The evaluation is primarily based on engineering analysis, material comparisons, and adherence to existing standards, comparing the new device to established predicate devices already on the market. Therefore, there's no sample size or specific data provenance mentioned for a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth, in this context, is the established safety and effectiveness of the predicate devices and the relevant industry standards (ISO 10993, USP Class VI, IEC 60601-1). There is no mention of experts establishing ground truth for a novel "test set" for this device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication process is described in this 510(k) submission.
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. This device is not an AI/ML diagnostic or assistive technology and no MRMC study was conducted or is relevant to this type of device submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical instrument (monopolar probe) and not an algorithm or software-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (Medtronic Xomed Stimulus Dissection Instruments (K014165) and Nuvasive Neurovision JJB System (K051718)), along with adherence to recognized performance and safety standards (ISO 10993 for biocompatibility, USP Class VI for adhesive, and IEC 60601-1 for electrical safety).
The sample size for the training set
- Not applicable. This device is not an AI/ML device requiring a training set.
How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML device requiring a training set.

Summary

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SeaSpine Monopolar Probe System 510(k)

510(k) Summary In accordance with 21CFR807.92 21CFR807.92(a){1}: Company Name: SeaSpine, Inc. 2302 La Mirada Drive Vista, CA 92081 Contact person: Dan Miller e-mail: dmiller@seaspine.com Phone: (760) 727-8399 Ext: 239, Fax: (760) 727-8809 Date prepared: June 13, 2011 21CFR807.92(a)(2): SeaSpine Monopolar Probe System Trade name: (Trade name has not been finalized at this time) Common name: Nerve Stimulator Surgical Nerve Stimulator/locator Classification: 21 CFR 874.1820 Class II Product Code: ETN 21CFR807.92(a)(3): Predicate Device: Manufacturer: Medtronic Xomed Trade Name: Stimulus Dissection Instruments Product Code: ETN 510(k): K014165 Manufacturer: Nuvasive Trade Name: Nuvasive Neurovision JJB System Product Code: ETN, GWF 510(k): K051718 21CFR807.92(d){4}: The SeaSpine Monopolar Probes conduct electrical stimulation to nervous Device Description: tissue that may be present in close proximity of the surgical corridor to the spine. This system is not comprised of a nerve stimulator or recorder; instead it will use conventional stimulators found in the market. The SeaSpine are insulated by a biocompatible PEEK Monopolar Probes (polyetheretherketone) layer all around one or more conductive stainless steel wire(s) with the exception of the distal and proximal ends. The distal end contacts the target tissue and the proximal end connects to standardi intraoperative neuromonitoring monopolar stimulator) that offers triggered electromyography (EMG) capability. Triggered EMG is a standard intraoperative practice where motor nerves are stimulated and their

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21CFR807.92(0)(5): Intended use:

2.1CFR807.92(a){6}: Substantial Equivalence: corresponding muscle group response is recorded, allowing for avoidance of nervous tissue during surgical approach. The proximal connector design meets the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.

KII671

The SeaSpine Monopolar Probe System has indications for use which are substantially equivalent to those of the predicate devices and other legally marketed devices. The SeaSpine Monopolar Probe System is manufactured from similar or identical materials as the predicate devices. The design features and function of the SeaSpine Monopolar Probe System are substantially equivalent or the same to predicate devices and other legally marketed devices, and the SeaSpine Monopolar Probe System does not raise any new safety or effectiveness issues.

TechnologicalCharacteristic	Subject Device	MedtronicXomedStimulusDissectionInstruments(K014165)	NuvasiveNeuroVision JJBSystem(K051718)
IndicationsFor Use	The SeaSpineMonopolar ProbeSystem isindicated fortissue dilation andnervous tissuestimulation bymeans ofelectrical currentto assess locationand identificationof motor nerves(including spinalnerve roots) fornervous tissueavoidance duringa routine surgicalapproach to thespine.	Tissue dissectionand stimulation ofcranial andperipheral motornerves forlocation andidentificationduring surgery,including spinalnerve roots.	The NeuroVisionJJB System is usedfor intraoperativemonitoring andneurologicalstatus assessmentby theadministration ofbrief electricalstimulus pulses toneural tissues andthe EMGmonitoring of theassociated musclegroups. Thesystem is used inconjunction withother Nuvasivedevices to assistin gainingcontrolled accessto, andvisualization of,the spine.

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Design	Electrical Conduitinsulated allaround withexception todistal tip andproximalconnector	Electrical Conduitinsulated allaround withexception todistal tip andproximalconnector	Electrical Conduitinsulated allaround withexception todistal tip andproximalconnector
ElectricalConductionMaterial	Stainless Steel	Stainless Steel	Stainless Steelor Aluminum
ElectricalPatientContactSurface	Stainless Steel	Stainless Steel	Stainless Steelor Aluminum
ProximalStimulatorConnector	Yes	Yes	Yes
Biocompatibleplasticelectricalinsulation	Yes	Yes	Yes
SteamSterilizableReusable	Yes	Yes	Yes*

*also cleared for disposable probes.

The biocompatibility of the subject device was assessed per ISO 10993. The biocompatibility of the adhesive used internally was assessed per USP Class VI testing. The probes are manufactured from stainless steel and PEEK with a long track record of use in the medical device industry and in instruments that directly contact tissue. The tissue contact duration of the SeaSpine Monopolar Probe System is brief (<1 hour), and this level of testing far exceeds the requirements for similar instruments and contact duration per ISO 10993-1. Electrical Safety of the SeaSpine Monopolar Probe System conforms to IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.

Engineering analysis, specifications, and labeling have established that the SeaSpine Monopolar Probe System is similar or identical to legally marketed predicates in terms of indications for use, materials, design, and functionality. Therefore, we have demonstrated that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.

21CFR807.92(b)(1)(2): Disscussion :

21CFR807.92(b){3): Conclusions:

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

DEC 2 8 2011

SeaSpine, Inc. % Mr. Dan Miller 2302 La Mirada Dr Vista, CA 92081-7862

Re: K111671

Trade Name: SeaSpine Monopolar Probe System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: November 28, 2011 Received: November 30, 2011

Dear Mr. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave and have 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 r ou mayy more or ovisions 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 r lease be actised that I Dr. Mar 1978 the 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 Or FF ar or 7), accesses (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerety yours,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K111671

Device Name: SeaSpine Monopolar Probe System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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A. Binoy Mathews

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Division of Devices vision Sign-Off) Division on Throat Devices

K111671

510(k) Numbe

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.