The TELIGEN Procedure Kit is part of the TELIGEN System. It is a sterile, single use kit intended for use in surgical spinal procedures to allow for access, visualization, discectomy and graft delivery.

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

The TELIGEN HD Camera Control System (CCS) is part of the TELIGEN System. It operates the TELIGEN Camera which is used for illumination and visualization of the surgical site. The image collected at the camera head, is transferred to the CCS and subsequently displayed on the monitor.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or specific study results to prove device performance. The document is an FDA 510(k) premarket notification letter and a 510(k) Summary for the TELIGEN System. This type of document declares substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and performance data, but it does not typically include detailed clinical study results with specific acceptance criteria and outcome metrics in the way your request describes.

The "Performance Data" section (Section I) only lists the types of evaluations conducted (e.g., Design Verification and Validation Testing, Human Factor/Usability, Electrical Safety, Thermal Safety & EMC Testing, Software and Systems Testing), but it does not provide the results, acceptance criteria, or study details such as sample size, provenance, expert qualifications, or ground truth methodology.

Therefore, I cannot provide the requested table or information regarding the study that proves the device meets acceptance criteria based on the provided text.

Summary

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October 18, 2022

Medos International, SARL Daria Bochenek Senior Regulatory Affairs Specialist Chemin-Blanc 38 Le Locle, CH-NE 2400 Switzerland

Re: K213978

Trade/Device Name: TELIGEN Procedure Kit Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 16, 2022 Received: September 16, 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.

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

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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 (OS) 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 mediation-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,

For

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic 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) K213978

Device Name TELIGEN System

Indications for Use (Describe)

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

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
	510(k) Sponsor:Medos International, SARLContact Person:Daria Bochenek, Senior Regulatory Affairs SpecialistEimattstrasse 34436 OberdorfSwitzerlandTelephone:+41 61 965 61 54Fax:+41 61 965 66 16Email:dbochene@its.jnj.com	510(k) Sponsor:	Medos International, SARL	Contact Person:	Daria Bochenek, Senior Regulatory Affairs SpecialistEimattstrasse 34436 OberdorfSwitzerland	Telephone:	+41 61 965 61 54	Fax:	+41 61 965 66 16	Email:	dbochene@its.jnj.com
510(k) Sponsor:	Medos International, SARL
Contact Person:	Daria Bochenek, Senior Regulatory Affairs SpecialistEimattstrasse 34436 OberdorfSwitzerland
Telephone:	+41 61 965 61 54
Fax:	+41 61 965 66 16
Email:	dbochene@its.jnj.com
B.	Date Prepared
	15 September 2022
C.	Device Name
	Trade/Proprietary Name:TELIGEN SystemCommon/Usual Name:HRX – Arthroscope;Device Classification and Regulation:Class IIHRX – 21 CFR §888.1100Classification Product and Panel CodeHRX – Orthopedic	Trade/Proprietary Name:	TELIGEN System	Common/Usual Name:	HRX – Arthroscope;	Device Classification and Regulation:	Class IIHRX – 21 CFR §888.1100	Classification Product and Panel Code	HRX – Orthopedic
Trade/Proprietary Name:	TELIGEN System
Common/Usual Name:	HRX – Arthroscope;
Device Classification and Regulation:	Class IIHRX – 21 CFR §888.1100
Classification Product and Panel Code	HRX – Orthopedic
D.	Predicate Device Names
	Primary Predicate Device:Voyant System (K191579) – HRXAdditional Predicate Devices:XTool™ MIS Discectomy Device (K122861) – HRXReference device:OVS1 Video System (K123359) – FCW, GCJ	Primary Predicate Device:	Voyant System (K191579) – HRX	Additional Predicate Devices:	XTool™ MIS Discectomy Device (K122861) – HRX	Reference device:	OVS1 Video System (K123359) – FCW, GCJ
Primary Predicate Device:	Voyant System (K191579) – HRX
Additional Predicate Devices:	XTool™ MIS Discectomy Device (K122861) – HRX
Reference device:	OVS1 Video System (K123359) – FCW, GCJ

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E. Device Description

The TELIGEN Procedure Kit includes a camera, ports and port holder, TELIGEN Clear, 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.

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

The technological characteristics, including design, material and performance as well as intended use of the TELIGEN System are consistent with those of the predicate devices.

H. Materials

. TELIGEN Camera: glass lens, plastic (polycarbonate, acrylonitrile butadiene styrene, polyvinyl chloride, PEEK), stainless steel.
. TELIGEN Ports: plastic (polypropylene).
TELIGEN Port Holder: plastic (polycarbonate, glass fiber reinforced . polyarylamide).
. TELIGEN Clear: stainless steel.

I. Performance Data

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

Design Verification and Validation Testing, Human Factor/Usability, Electrical Safety, Thermal Safety & EMC Testing, Software and Systems Testing.

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J. Conclusion

The indications for use of the TELIGEN System are consistent with those of the predicate devices. The technological characteristics of the TELIGEN System in terms of design, materials and performance are consistent with those of the predicate devices. The TELIGEN System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.