(88 days)
Not Found
No
The document describes a surgical system for spinal procedures that includes navigation capabilities and nerve stimulation. While it uses imaging and a nerve response detection system, there is no mention of AI or ML being used for image analysis, navigation algorithms, or nerve response interpretation. The nerve stimulation feature relies on detecting a physical response (MMG) and alerting the surgeon, not on an AI/ML model interpreting complex signals.
No.
The device's intended use is to provide minimally invasive access, visualization, illumination, magnification, and discectomy of the surgical area of the spine, as well as to assist in locating anatomical structures and stimulating peripheral motor nerves during surgery. These functions are for surgical assistance and diagnosis, not for treating a disease or condition.
No.
The device is used to assist the surgeon in locating anatomical structures in either open or percutaneous procedures and to stimulate peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery. Its primary function is interventional, not diagnostic.
No
The device description explicitly lists hardware components such as a camera, ports, port holder, Access Probe, soft tissue retractor, port cutter cartridge, and bone graft delivery instruments. It also mentions compatibility with a nerve stimulation system (SENTIO MMG System) which involves sensors. While it has a navigation feature that likely involves software, the core device is a physical surgical kit with multiple hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- TELIGEN System Function: The TELIGEN System is described as providing minimally invasive access, visualization, illumination, magnification, discectomy, graft delivery, navigation, and peripheral motor nerve stimulation during surgical procedures. It directly interacts with the patient's body during surgery.
- No Specimen Analysis: There is no mention of the device analyzing any specimens taken from the patient's body. Its function is entirely focused on assisting the surgeon during the surgical procedure itself.
Therefore, the TELIGEN System falls under the category of surgical instruments and navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PDQ, OLO, HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
Spine, pelvis or a vertebrae, peripheral motor nerves, spinal nerve roots
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical spinal procedures, open or percutaneous procedures.
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 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: Electrical Safety Evaluation
Test Method Summary: Evaluation was performed in accordance with IEC 60601-1: 2005(R)2012.
Results: All evaluations passed acceptance criteria.
Test: Functional Performance Testing and Verification Analysis
Test Method Summary: Connector Compatibility Insulation Effectiveness SENTIO MMG System Compatibility Electrical Stimulation Density
Results: All samples and evaluations passed acceptance criteria.
Test: Sterility
Test Method Summary: Ethylene Oxide sterilization validation performed per ISO 11135.
Results: All samples passed acceptance criteria.
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.
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.
Not Found
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
§ 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.
0
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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.
1
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
2
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 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.
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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3
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 Locator | |||
| OLO - Orthopedic Stereotaxic Instrument | ||||
| HRX - 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:
4
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) (K223108) – OLO, HRX
Device Description E.
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.
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 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 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,
5
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.
6
| Attribute | Subject Device
TELIGEN System Peripheral
Motor Nerve Stimulation
Indications | Primary Predicate Device
SENTIO MMG Pedicle Access
Needles (K173134) | Substantially Equivalent |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
(peripheral motor
nerve stimulation
specific text in italic ) | 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 when used with
the compatible Universal Navigation
Adaptor Set (UNAS) and 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 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. | | Yes, substantially equivalent for
peripheral motor nerve stimulation
indications. |
| Attribute | Subject Device
TELIGEN System Peripheral
Motor Nerve Stimulation
Indications | Primary Predicate Device
SENTIO MMG Pedicle Access
Needles (K173134) | Substantially Equivalent |
| 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,
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. | 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. | | |
| Classification | Class II, Product Code PDQ,
added with this submission | Class II, Product Code PDQ | Yes |
| Instruments | Access Probe
Stimulation Wire | Pedicle Access Needle (Trocar and
Cannula)
Stimulation Wire | Yes |
| Compatible Nerve
Stimulation System | SENTIO MMG System | SENTIO MMG System | Yes |
| Stimulation device
distal tip geometry | Inline blunt tip | Trocar tip
Diamond tip
Beveled tip | Yes. Since the Pedicle Access
Needles provide the function of pilot
hole preparation (in addition to |
| Attribute | Subject Device
TELIGEN System Peripheral
Motor Nerve Stimulation
Indications | Primary Predicate Device
SENTIO MMG Pedicle Access
Needles (K173134) | Substantially Equivalent |
| | | | access), the tip design is defined as
trocar, diamond or bevel compared
to the blunt tip of TELIGEN Access
Probe. This difference does not raise
any new safety or performance
questions. |
| Electrical Insulation | The TELIGEN Access Probe has
biocompatible electrical insulation
applied to select portions. The
proximal and distal surface of the
instrument is selectively non-
insulated stainless steel to connect to
the stimulation wire and for tissue
stimulation, respectively. | The Pedicle Access Needles have
biocompatible electrical insulation
applied to select portions. The
proximal and distal surface of the
instrument is selectively non-
insulated stainless steel to connect to
the stimulation wire and for tissue
stimulation, respectively. | Yes |
| Proximal Stimulator
Connector | Yes | Yes | Yes |
| Patient contacting
materials | Stainless Steel, Parylene C Coating | Stainless Steel, Parylene C Coating | Yes |
| Delivery | Sterile via Ethylene Oxide
Single Use | Sterile via Ethylene Oxide
Single Use | Yes |
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8
9
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.
10
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.