(302 days)
No
The summary describes a system for minimally invasive spinal surgery focusing on access, visualization, and discectomy. It mentions a camera system for illumination and visualization, but there is no mention of AI, ML, image processing beyond simple display, or any performance metrics typically associated with AI/ML algorithms (like AUC, sensitivity, specificity). The performance studies listed are standard for medical devices (verification, validation, safety, software testing) and do not indicate AI/ML evaluation.
Yes
The device is described as providing "minimally invasive access, visualization, magnification and discectomy of the surgical area of the spine" and "graft delivery," all of which are direct interventions aimed at treating a medical condition within the spine. "Discectomy" specifically refers to the surgical removal of disc material to relieve pressure on nerves, which is a therapeutic procedure.
No
The device description indicates its purpose is for minimally invasive surgical access, visualization, magnification, and discectomy, which are interventional procedures rather than diagnostic ones.
No
The device description explicitly lists hardware components such as a camera, ports, port holder, retractor, port cutter cartridge, bone graft delivery instruments, and a camera control system. The performance studies also include electrical safety, thermal safety, and EMC testing, which are relevant to hardware components.
Based on the provided information, the TELIGEN System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "minimally invasive access, visualization, magnification and discectomy of the surgical area of the spine." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The components listed (camera, ports, retractor, instruments) are all tools used during a surgical procedure to access and manipulate tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status. The TELIGEN System does not perform this function.
The TELIGEN System is a surgical device used for visualization and intervention during spinal procedures.
N/A
Intended Use / Indications for Use
The TELIGEN System is indicated to provide minimally invasive access, visualization, magnification and discectomy of the surgical area of the spine.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Voyant System (K191579), XTool™ MIS Discectomy Device (K122861)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
OVS1 Video System (K123359)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 Specialist | |||||||||||
| Eimattstrasse 3 | |||||||||||
| 4436 Oberdorf | |||||||||||
| SwitzerlandTelephone:+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 Specialist | |||||||
| Eimattstrasse 3 | |||||||||||
| 4436 Oberdorf | |||||||||||
| Switzerland | 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 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 | ||||||||||
| 15 September 2022 | |||||||||||
| C. | Device Name | ||||||||||
| Trade/Proprietary Name:TELIGEN SystemCommon/Usual Name:HRX – Arthroscope;Device Classification and Regulation:Class II | |||||||||||
| HRX – 21 CFR §888.1100Classification Product and Panel CodeHRX – Orthopedic | Trade/Proprietary Name: | TELIGEN System | Common/Usual Name: | HRX – Arthroscope; | Device Classification and Regulation: | Class II | |||||
| HRX – 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 II | ||||||||||
| HRX – 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 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.
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.