Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
Device Facts
| Record ID | K253580 |
|---|---|
| Device Name | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) |
| Applicant | Tedan Surgical Innovations |
| Product Code | PDQ · Ear, Nose, Throat |
| Decision Date | Apr 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Spine surgery for sequential dilation and to deliver an electrical stimulation to the tissue and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure. Navigated ø5mm Insulated Dilator is intended to be used during spinal surgery to assist the surgeon in precisely establishing the desired access trajectory. Navigated ø5mm Insulated Dilator is specifically designed for use with Medtronic Stealth™ Systems, where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, or fluoroscopy images.
Device Story
Sterile, single-use insulated dilators (5, 10, 16, 20mm) used in spine surgery; instruments deliver electrical stimulation to tissue/nerves for intraoperative neurophysiological monitoring (IONM) to identify nerve proximity. 5mm dilator features navigation capability for use with Medtronic Stealth™ Systems; tracks instrument position relative to CT/MR/fluoroscopy images. Surgeon operates device to incrementally dilate surgical site; stimulation feedback aids in avoiding nerve injury. Device connects to stimulation clip for signal transmission. Navigation integration assists in establishing precise access trajectory. Benefits include reduced risk of nerve/tissue pinching and improved surgical accuracy.
Clinical Evidence
No human clinical trials. Evidence includes bench testing (force, tolerance, electrical safety per IEC 60601-1), biocompatibility (ISO 10993-1), and sterilization validation (ISO 11135). Performance validated via human cadaver study (n=not specified) and live porcine study to confirm directional neuromonitoring capabilities and navigation accuracy. All acceptance criteria met.
Technological Characteristics
Materials: 17-4 PH H900 (5mm) and aluminum alloy (10-20mm). Principle: Unidirectional electrical stimulation for IONM. Dimensions: 5-20mm diameters; 222-295.5mm lengths. Connectivity: Navigated 5mm dilator compatible with Medtronic Stealth™ Systems. Sterilization: Ethylene oxide (EO) per ISO 11135. Biocompatibility: ISO 10993-1 compliant for limited contact (<24hr).
Indications for Use
Indicated for patients undergoing spine surgery requiring sequential tissue dilation and nerve localization via electrical stimulation. The 5mm navigated dilator is indicated for use with Medtronic Stealth™ Systems to assist surgeons in establishing access trajectories relative to anatomical structures.
Regulatory Classification
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.
Predicate Devices
- Phantom XL Insulated Dilators (K231691)
Reference Devices
- CD Horizon™ Navigated Instruments (K182121)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 26, 2026
Tedan Surgical Innovations
Arya Monticino-Larsen
RAQA Engineer
12320 Cardinal Meadow Dr.
Suite 150
Sugar Land, Texas 77478
Re: K253580
Trade/Device Name: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
Regulation Number: 21 CFR 874.1820
Regulation Name: Surgical Nerve Stimulator/Locator
Regulatory Class: Class II
Product Code: PDQ
Dated: March 26, 2026
Received: March 27, 2026
Dear Arya Monticino-Larsen:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K253580 - Arya Monticino-Larsen
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assistance/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,
JAY R. GUPTA -S
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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K253580 | ? |
| Please provide the device trade name(s). | | ? |
| Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S);
Sterile, Insulated Dilator, 20mm (MDT-0469S) | | |
| Please provide your Indications for Use below. | | ? |
| Spine surgery for sequential dilation and to deliver an electrical stimulation to the tissue and nerves at the
operative site to assist in locating those nerves at risk during the surgical procedure. Navigated ø5mm
Insulated Dilator is intended to be used during spinal surgery to assist the surgeon in precisely establishing
the desired access trajectory. Navigated ø5mm Insulated Dilator is specifically designed for use with
Medtronic Stealth™ Systems, where reference to a rigid anatomical structure, such as a vertebra, can be
identified relative to a CT or MR-based model, or fluoroscopy images. | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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K253580
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510(k) Summary
26-March-2026
**Company:**
TeDan Surgical Innovations, Inc.
12320 Cardinal Meadow Drive
Suite 150
Sugar Land, Texas 77478 USA
Telephone: (713) 726-0886
**Contact:**
Arya Monticino-Larsen (Primary)
RAQA Engineer
Email: amonticino@tedansurgical.com
Lynne Davies (Alternate)
VP of RAQA
Email: ldavies@tedansurgical.com
**Device Name:**
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile Insulated Dilator, 20mm (MDT-0469S)
**Common Name:**
Needle Electrode, Navigated Instrument
**Classification Name:**
Neurosurgical nerve locator (21 CFR §874.1820)
**Regulatory Class:**
Class II
**Product Code**
PDQ
**A. Predicate Device**
The legally marketed predicate devices are identified as below:
| Predicate | Primary Predicate | Reference Device |
| --- | --- | --- |
| Device Name | Phantom XL Insulated Dilators | CD Horizon™ Navigated Instruments |
| 510(k) Number | K231691 | K182121 |
| FDA Regulation | 21 CFR §882.1350, 21 CFR §874.1820 | 21 CFR §882.4560 |
| FDA Product Code | GXZ, PDQ | OLO |
| Manufacturer | TeDan Surgical Innovations, Inc. | Medtronic Sofamor Danek USA, Inc. |
These predicates have not been subject to a design-related recall.
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## B. Device Description
The TeDan Surgical Innovations, Inc. (TSI) Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurophysiological monitoring (IONM). The Insulated Dilators are available in four diameter sizes (5, 10, 16, & 20mm). They are supplied sterile, (single-use only) three (3) dilators per tray (MDT-0442S) or one (1) dilator per tray (MDT-0469S), one (1) tray per box. They are non-pyrogenic and are intended for single use only. The ø5mm dilator is made of stainless steel. The 10, 16, & 20mm dilators are made of aluminum alloy. The TSI Insulated Dilators are intended to incrementally dilate the surgical site. Product is intended to be used by trained surgeons. The ø5mm Insulated Dilator (MDT-0466) may be used as a navigated surgical instrument with Medtronic Stealth™ Systems (Medtronic computer assisted surgery system) to track the Insulated Dilator in the surgical field.
## C. Indications for Use
### The TeDan Surgical Innovations, Inc. (TSI) Sterile Insulated Dilators
Spine surgery for sequential dilation and to deliver an electrical stimulation to the tissue and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure. Navigated ø5mm Insulated Dilator is intended to be used during spinal surgery to assist the surgeon in precisely establishing the desired access trajectory. Navigated ø5mm Insulated Dilator is specifically designed for use with Medtronic Stealth™ Systems, where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, or fluoroscopy images.
### Phantom XL Insulated Dilators
Spine surgery for sequential dilation and to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.
The indications for use statement of the subject device is substantially equivalent to the primary predicate device, with additional language provided for clarifying how the device is used with the Medtronic Stealth™ Systems. The clarifying language and differences in indications for use do not change the intended use as a neurosurgical nerve locator, nor raise new questions of safety or effectiveness, as demonstrated by results of the risk-based verification and validation testing.
## D. Comparison of Technological Characteristics with Predicate Device
The use of unidirectional electrical stimulation for neuromonitoring is the technological principle for both the subject and predicate devices. At a high level, the subject and predicate devices are based on the following same technological elements:
- Sequential dilation – used to incrementally increase the dilation size of the access site
- Dilators connected to a stimulation clip to allow for transmission of electrical stimulus into the tissue to collect nerve location feedback
- Dilator has unidirectionally designed conductive surface characterized by a distal conductive surface and a proximal conductive collar
- Use of the dilators to aid in insertion of retractor blades into the surgical site to reduce risk of tissue/nerve pinching
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The following technological differences exist between the subject and predicate devices:
| Attribute | Subject Device Sterile Insulated Dilators | Primary Predicate Device Phantom XL Insulated Dilators |
| --- | --- | --- |
| Materials of Construction | | |
| Initial dilator base material | 17-4 PH H900 | 304 SST |
| Distal exposed surface | | |
| Distal Shape | Oval/Rounded Rectangle | Triangle |
| Electrode Surface Area | 20-25 mm² | 7.5 mm² |
| Dilator Body | | |
| Body Outer Diameters | 5, 10, 16, & 20 mm | 7, 8, 12, 13, 15, 18, & 22 mm |
| Wall thickness | 0.27-2.55 mm | 1.45-2.50 mm |
| Length | 222.00-295.50 mm | 195-255 |
| Geometry | - ø5mm dilator - Solid design with tapered tip; exposed proximal end features a square end and a notch to mate with system components - ø20mm dilator - Features grooves down its sides | All dilators are uniformly round for the majority of the length with a tapered distal tip. There is an exposed segment proximally with a knurled insulated region at the proximal end. |
| System Compatibility | | |
| Medtronic Stealth™ Systems, associated surgical instrumentation and accessories | Compatible | Not compatible |
# E. Performance Data
The Sterile Insulated Dilators presented in this Traditional 510(k) have been verified and validated according to TeDan Surgical Innovations' 21 CFR Part 820.30-compliant Design Control procedures. Non-clinical testing to confirm device performance for its intended use is summarized as follows:
| Test | Test Method Summary | Results/Conclusions |
| --- | --- | --- |
| Force Testing | Force testing was conducted to verify that the changes to material and geometry can withstand the forces experienced while dilating the psoas. | Results verify that the dilators meet force requirements. All acceptance criteria were met. |
| Tolerance Stack | Tolerance stack analysis was performed to verify that the Sterile Insulated Dilators mate appropriately with compatible components. | Results verify that the dilators meet requirements to mate appropriately with compatible components. |
| Human Cadaver Study | A human cadaver study was performed to validate that the dilators, when used as an integrated system with the Medtronic Stealth™ Systems navigation platform and associated surgical instrumentation and accessories, perform as intended in a simulated clinical environment. This evaluation supports that system-level use, and minor material, dimensional and geometric differences, do not alter the ability to insert the ø5mm dilator into the disc space, maintain trajectory, or withstand forces associated with clinical use. | Results validate the functionality of the dilators and the compatibility with Medtronic Stealth™ Systems for navigated use. All acceptance criteria were met. |
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| Test | Test Method Summary | Results/Conclusions |
| --- | --- | --- |
| Porcine Study | The live porcine study was performed as supportive evidence to evaluate whether the modified neuromonitoring electrode surface area and new system interfaces and dilator material preserve the fundamental functional capability to produce measurable, orientation-dependent electromyographic (EMG) responses. | Results validate the directional neuromonitoring capabilities of the dilators. All acceptance criteria were met. |
| Electrical Safety | Electrical safety and performance testing per IEC 60601--1 verified acceptability of material, geometry, and electrode surface area changes. | All samples passed acceptance criteria. |
| Sterility, Sterile Packaging and Shelf Life | Assessments were performed to support the qualification of the Sterile Insulated Dilators for sterilization using established ethylene oxide (EO) cycles which have been validated to achieve a sterility assurance level of 10^{-6} in accordance with ISO 11135:2014. Packaging system integrity and sterile barrier performance were evaluated per ISO 11607-1 and ISO 11607-2. Subject dilators were evaluated against predicate Phantom XL Insulated Dilators to assess shelf-life. | All acceptance criteria for sterilization, packaging integrity, and shelf-life validation were met, confirming suitability of the device design and packaging configuration to maintain sterility, functionality, and material stability throughout the intended shelf-life and distribution conditions. |
| Biocompatibility | The Sterile Insulated Dilators were evaluated per ISO 10993-1 requirements for Externally communicating devices with tissue/bone for limited duration (≤24hr). | All testing passed acceptance criteria for specified materials, manufacturing, sterilization, and clinical use; biological risk assessment concluded that the dilators can be considered biocompatible for use as intended. |
| Usability Evaluation | Usability testing was justified as not required for conformity to IEC 62366-1; Considering clinical history of the predicate devices defined in review and intended use of the subject dilators, all risks after implementing mitigations were deemed acceptable. No new information was identified in the review of hazards and hazardous situations related to usability risk analysis. | |
| Navigation accuracy analysis | Medtronic performed proprietary evaluation to ensure that the navigation system is acceptable. The details of the testing as well as the associated report have been provided to FDA in MAF#3952. The results of this testing demonstrate that devices meeting the defined system compatibility requirements are capable of being used with the system as intended. | |
Successful results for the aforementioned tests are included in this Traditional 510(k) submission. The non-clinical test results support a safety and effectiveness profile to establish substantial equivalence.
Design validation testing of the Sterile Insulated Dilator Kit was performed using human cadaver and porcine models with participation from practicing spine surgeons to ensure evaluation under clinically representative procedural conditions. The testing assessed device functionality, directional neuromonitoring performance, and its compatibility with the Medtronic Stealth™ Systems navigational system across all four dilator sizes (5 mm, 10 mm, 16 mm, and 20 mm).
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The testing demonstrated that the dilators provided reliable sequential dilation and produced clear, directional neuromonitoring responses consistent with identifying nerve location and proximity during surgical access. The navigated 5 mm Insulated Dilator was successfully calibrated and tracked with Medtronic Stealth™ Systems to establish and confirm surgical position and trajectory relative to anatomical structures.
Biocompatibility endpoints for cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogenicity were assessed according to the FDA Guidance within FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for an Externally Communicating Device with contact with Tissue/Bone/Dentin for a limited contact period (< 24 hours). A risk-based assessment was conducted to assess biocompatibility, and based on this the Medtronic Insulated Dilators were determined to be safe from a biocompatibility perspective.
All acceptance criteria were successfully met, confirming the device performs as intended and is suitable for its intended use. Overall, testing supports that the Sterile Insulated Dilators perform as intended for sequential dilation, directional neuromonitoring, and navigation-assisted access during spinal surgery.
F. Conclusion
Based upon the design, technology, performance, and intended use, the Sterile Insulated Dilators are substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act. The overall risk of the devices has been determined to be acceptable, confirming the Sterile Insulated Dilators are safe and effective.
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