The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.

The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. TELIGEN Clear, when used with UNAS, can be precalibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System, where other navgation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.

Device Description

The TELIGEN Procedure Kit Pro is a sterile, single use kit intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation.

The TELIGEN Procedure Kit Pro includes a camera, ports and port holder, TELIGEN Clear, an Access Probe, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments.

The TELIGEN Access Probe is part of the DePuy Synthes Navigation Ready Instruments Portfolio and is designed for navigated and non-navigated use. Navigation of this instrument is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

The TELIGEN Access Probe is intended to stimulate peripheral motor nerves, including spinal nerve roots, for location and identification during surgery. It contains an insulated probe compatible with the SENTIO MMG System. The SENTIO MMG sensors serve to measure a mechanomyographic (MMG) response and the SENTIO MMG System's detection of this response alerts the surgeon of nerve location in the proximity of the TELIGEN Access Probe's distal tip.

AI/ML Overview

The provided FDA 510(k) summary describes the TELIGEN System's "Peripheral Motor Nerve Stimulation Indications." This section details the acceptance criteria and the studies performed to demonstrate equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Electrical Safety Evaluation	In accordance with IEC 60601-1: 2005(R)2012	All evaluations passed acceptance criteria.
Functional Performance Testing and Verification Analysis	Pass criteria for: Connector Compatibility, Insulation Effectiveness, SENTIO MMG System Compatibility, Electrical Stimulation Density	All samples and evaluations passed acceptance criteria.
Sterility	Ethylene Oxide sterilization validated per ISO 11135	All samples passed acceptance criteria.
Biocompatibility (endpoints per ISO 10993-1)	Satisfactory results for: Physical/chemical information, Cytotoxicity, Acute Systemic Toxicity, Irritation or Intracutaneous Reactivity, Sensitization, Material mediated pyrogenicity	Leveraged existing data, testing, and assessments; all endpoints covered.

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

The document does not explicitly state the specific sample sizes for each test listed (Electrical Safety, Functional Performance, Sterility). It refers to "All samples and evaluations passed acceptance criteria." The data provenance (country of origin, retrospective or prospective) is not specified, but these are typically in-house engineering and lab tests.

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

This information is not applicable. The device is a surgical instrument for nerve stimulation, and the performance evaluations are based on engineering and laboratory testing against established standards (e.g., IEC 60601-1, ISO 11135) and internal design specifications, not on clinical interpretation or expert consensus on a "ground truth" derived from patient data.

4. Adjudication Method for the Test Set

This is not applicable. The evaluations are objective measurements and assessments against predefined technical standards and specifications, not subjective interpretations requiring adjudication.

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

There was no MRMC comparative effectiveness study, as this device is a surgical instrument and not an AI-powered diagnostic imaging tool or a system involving human "readers."

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

This is not applicable. The device is a physical surgical instrument for nerve stimulation and does not have an "algorithm-only" performance component as understood in the context of AI/software as a medical device. Its performance is related to its physical and electrical characteristics.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance claims of the TELIGEN Access Probe as a nerve stimulator is based on established engineering and electrical standards, and the known physiological response of peripheral motor nerves to electrical stimulation. For biocompatibility, it's based on ISO 10993-1.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical instrument, not an algorithm, and therefore does not have a "training set" in the context of machine learning.

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

This is not applicable as there is no training set for this device.

Summary

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February 10, 2023

Medos International, SARL % Daria Bochenek Senior Regulatory Affairs Specialist Synthes Gmbh Eimattstrasse 3 4436 Oberdorf Switzerland

Re: K223438

Trade/Device Name: TELIGEN System Peripheral Motor Nerve Stimulation Indications Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, OLO, HRX Dated: November 14, 2022 Received: November 14, 2022

Dear Daria Bochenek:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Patrick Antkowiak -S

for

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223438

Device Name

TELIGEN System Nerve Stimulation Indications

Indications for Use (Describe)

The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.

· the use of stereotactic surgery may be appropriate, and

The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.

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

A.	Submitter Information
	510(k) Sponsor:	Medos International, SARL
	Contact Person:	Daria Bochenek, Senior Regulatory Affairs
		Specialist
		Eimattstrasse 3
		4436 Oberdorf
		Switzerland
	Telephone:	+41 61 965 61 54
	Fax:	+41 61 965 66 16
	Email:	dbochene@its.jnj.com
B.	Date Prepared	01 February 2023
C.	Device Name
	Trade/Proprietary Name:	TELIGEN System Nerve Stimulation Indications
	Common/Usual Name:	PDQ - Neurosurgical Nerve LocatorOLO - Orthopedic Stereotaxic InstrumentHRX - Arthroscope
	Device Classification and	Class II
	Regulation:	PDQ – 21 CFR §874.1820
		OLO – 21 CFR §882.4560
		HRX – 21 CFR §888.1100
	Classification Product and	PDQ - Neurology
	Panel Code	OLO, HRX – Orthopedic
D.	Predicate Device Names
	Primary Predicate Device:	SENTIO MMG Pedicle Access Needles (K173134) – PDQ

Secondary Predicate Device:

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TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) (K223108) – OLO, HRX

Device Description E.

The TELIGEN Procedure Kit Pro includes a camera, ports and port holder, TELIGEN Clear, an Access Probe, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments.

F. Indications for Use

The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.

● the use of stereotactic surgery may be appropriate, and

. reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. TELIGEN Clear, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System,

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where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.

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

The technological characteristics, including design, material and performance as well as indications for use of the Nerve Stimulating TELIGEN Access Probe are consistent with those of the predicate devices.

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Attribute	Subject DeviceTELIGEN System PeripheralMotor Nerve StimulationIndications	Primary Predicate DeviceSENTIO MMG Pedicle AccessNeedles (K173134)	Substantially Equivalent
Indications for Use(peripheral motornerve stimulationspecific text in italic )	The TELIGEN System is indicatedto provide minimally invasiveaccess, visualization, illumination,magnification and discectomy of thesurgical area of the spine.The TELIGEN Access Probe andTELIGEN Clear are NavigationReady Instruments when used withthe compatible Universal NavigationAdaptor Set (UNAS) and areintended to assist the surgeon inlocating anatomical structures ineither open or percutaneousprocedures. The navigation featureis used in surgical spinal procedures,in which:• the use of stereotacticsurgery may be appropriate, and• reference to a rigidanatomical structure, such as thepelvis or a vertebrae can beidentified relative to the acquiredimage (CT, MR, 2D fluoroscopicimage or 3D fluoroscopic imagereconstruction) and/or an image databased model of the anatomy using anavigation system and associatedtracking arrays.		Yes, substantially equivalent forperipheral motor nerve stimulationindications.
Attribute	Subject DeviceTELIGEN System PeripheralMotor Nerve StimulationIndications	Primary Predicate DeviceSENTIO MMG Pedicle AccessNeedles (K173134)	Substantially Equivalent
These procedures include but are notlimited to spinal fusion. TELIGENClear, when used with UNAS, canbe pre-calibrated with the BrainlabNavigation System. TELIGENAccess Probe, when used withUNAS, can be pre-calibrated withthe Brainlab Navigation System,where other navigation systemsrequire manual calibration andtracking arrays supplied by thenavigation system manufacturer.The TELIGEN Access Probe isindicated for stimulation ofperipheral motor nerves, includingspinal nerve roots, for location andidentification during surgery.	The SENTIO MMG Pedicle AccessNeedles are indicated for use inpedicle pilot hole preparation andstimulation of peripheral motornerves for location andidentification during surgery,including spinal nerve roots.
Classification	Class II, Product Code PDQ,added with this submission	Class II, Product Code PDQ	Yes
Instruments	Access ProbeStimulation Wire	Pedicle Access Needle (Trocar andCannula)Stimulation Wire	Yes
Compatible NerveStimulation System	SENTIO MMG System	SENTIO MMG System	Yes
Stimulation devicedistal tip geometry	Inline blunt tip	Trocar tipDiamond tipBeveled tip	Yes. Since the Pedicle AccessNeedles provide the function of pilothole preparation (in addition to
Attribute	Subject DeviceTELIGEN System PeripheralMotor Nerve StimulationIndications	Primary Predicate DeviceSENTIO MMG Pedicle AccessNeedles (K173134)	Substantially Equivalent
			access), the tip design is defined astrocar, diamond or bevel comparedto the blunt tip of TELIGEN AccessProbe. This difference does not raiseany new safety or performancequestions.
Electrical Insulation	The TELIGEN Access Probe hasbiocompatible electrical insulationapplied to select portions. Theproximal and distal surface of theinstrument is selectively non-insulated stainless steel to connect tothe stimulation wire and for tissuestimulation, respectively.	The Pedicle Access Needles havebiocompatible electrical insulationapplied to select portions. Theproximal and distal surface of theinstrument is selectively non-insulated stainless steel to connect tothe stimulation wire and for tissuestimulation, respectively.	Yes
Proximal StimulatorConnector	Yes	Yes	Yes
Patient contactingmaterials	Stainless Steel, Parylene C Coating	Stainless Steel, Parylene C Coating	Yes
Delivery	Sterile via Ethylene OxideSingle Use	Sterile via Ethylene OxideSingle Use	Yes

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H. Materials

. TELIGEN Access Probe: Stainless Steel, Parvlene C Coating

I. Performance Data

The performance data for the subject device consists of the following evaluations:

Electrical Safety Evaluation, Functional Performance Testing and Verification Analysis as well as Sterility. The table below summarizes testing and/or evaluations that were performed on the subject device to show substantial equivalence to the predicate device. Results demonstrated that the subject device is appropriate for peripheral motor nerve stimulation and is substantially equivalent when compared to the legally marketed primary predicate device cleared by FDA.

Test	Test Method Summary	Results
Electrical Safety Evaluation	Evaluation was performed in accordance with IEC 60601-1: 2005(R)2012.	All evaluations passed acceptance criteria.
Functional Performance Testing and Verification Analysis	Connector Compatibility Insulation Effectiveness SENTIO MMG System Compatibility Electrical Stimulation Density	All samples and evaluations passed acceptance criteria.
Sterility	Ethylene Oxide sterilization validation performed per ISO 11135.	All samples passed acceptance criteria.

J. Biocompatibility Data

The TELIGEN Access Probe is manufactured from the same materials as the predicate devices.

A risk analysis was performed taking into account the categorization of body contact and duration of use of the medical device. Existing data, endpoint-specific testing, and endpoint assessments were analyzed to cover the identified test methods in Annex A of ISO 10993-1. Additionally, data was leveraged by other means (e.g., authorized use of Master File, predicate and reference devices, well known and characterized materials) to support the biocompatibility of the subject devices.

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Biocompatibility endpoints evaluated per ISO 10993-1:

Physical and/or chemical information
Cytotoxicity
Acute Systemic Toxicity
Irritation or Intracutaneous Reactivity
Sensitization
Material mediated pyrogenicity

K. Conclusion

The indications for use of the Nerve Stimulating TELIGEN Access Probe and Stimulation Wire are consistent with those of the predicate devices. The technological characteristics of the Nerve Stimulating TELIGEN Access Probe and Stimulation Wire in terms of design, materials and performance are consistent with those of the predicate devices. The Nerve Stimulating TELIGEN Access Probe and Stimulation Wire are substantially equivalent to 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.