DeGen Navigated Instrumentation

K213918 · Degen Medical · OLO · Feb 9, 2022 · Neurology

Device Facts

• Record ID: K213918
• Device Name: DeGen Navigated Instrumentation
• Applicant: Degen Medical
• Product Code: OLO · Neurology
• Decision Date: Feb 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F 1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation is specifically designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Story

Nonsterile, reusable stainless steel surgical drivers; used with Medtronic StealthStation System for spinal screw placement. Surgeon uses instruments in open or minimally invasive procedures to navigate anatomical structures. Device provides physical interface for screw preparation/placement; navigation functionality provided by Medtronic system. Benefits include precise anatomical localization during spinal surgery.

Clinical Evidence

Bench testing only. Included dimensional analysis and anatomical simulated use/navigation accuracy testing. No clinical data presented.

Technological Characteristics

Stainless steel (ASTM F899); reusable; nonsterile; manual surgical instrumentation; designed for integration with Medtronic StealthStation navigation system.

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of DeGen Medical F1 MPS and E3 MIS screws, where stereotactic surgery is appropriate and anatomical structures can be referenced via CT, MR, fluoroscopy, or digitized landmarks.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• DeGen Medical Navigated Instrumentation (K203816)

Reference Devices

• Medtronic Navigated CD Horizon Solera Screwdriver / Taps (K140454)

Submission Summary (Full Text)

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February 9, 2022

DeGen Medical % Linda Braddon CEO Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K213918

Trade/Device Name: DeGen Navigated Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 14, 2021 Received: December 15, 2021

Dear Linda Braddon:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. 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

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### Indications for Use

510(k) Number (if known) K213918

Device Name DeGen Medical Navigated Instrumentation

#### Indications for Use (Describe)

The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F 1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation is specifically designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> </span> <span style="font-size: 10pt;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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Image /page/3/Picture/0 description: The image shows the logo for DeGen Medical. The logo features three curved lines emanating from a point, with each line ending in a blue circle. The lines are blue and appear to be in motion. Below the graphic is the text "DeGen" in a bold, blue font, with the word "Medical" in a smaller, gray font underneath.

## 510(k) Summary: DeGen Medical Navigated Instrumentation K213918

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Navigated Instrument is provided below.

| Date Prepared | 01/31/2022 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | DeGen Medical<br>1321-C North Cashua Drive<br>Florence, SC 29501<br>Phone [phone]<br>Fax [phone]<br>FDA Registration: 3010663372 |
| 510(k) Contact | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway<br>Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>[e-mail] |
| Trade Name | DeGen Medical Navigated Instrumentation |
| Common Name | Navigated Instruments |
| Classification Name | Sterotaxic Instrument |
| Code-Classification | OLO<br>21 CFR 882.4560 : Class II |
| Primary Predicate | K203816 DeGen Medical Navigated Instrumentation |
| Reference Device | K140454 Medtronic Navigated CD Horizon Solera Screwdriver / Taps |
| Device Description | The DeGen Navigated Instrumentation is nonsterile, reusable drivers that<br>are intended to be used with the Medtronic StealthStation® Application<br>1.2.0 (1.2.0-20) and are manufactured from stainless steel per ASTM<br>F899. |
| Materials | Stainless Steel per ASTM F899 |
| Indications for Use | The DeGen Medical Navigated Instrumentation is intended to be used<br>during the preparation and placement of DeGen Medical F1 MPS and E3<br>MIS screws during spinal surgery to assist the surgeon in precisely<br>locating anatomical structures in either open or minimally invasive<br>procedures. DeGen Medical Navigated Instrumentation is specifically<br>designed for use with the Medtronic StealthStation® System, which is<br>indicated for any medical condition in which the use of stereotactic<br>surgery may be appropriate, and where reference to a rigid anatomical<br>structure such as vertebra, can be identified relative to a CT or MR based<br>model, fluoroscopy images, or digitized landmarks of the anatomy. |
| Technological<br>Characteristics | The technological design features of the subject system were compared to<br>the predicate in intended use, indications for use, design, function and<br>technology and it was demonstrated that they are substantially equivalent. |

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# 510(k) Summary: DeGen Medical Navigated Instrumentation K213918

Image /page/4/Picture/1 description: The image shows the logo for DeGen Medical. The logo features a stylized graphic of three curved lines emanating from a point, with each line ending in a small circle. The lines are blue, and the circles are a darker shade of blue. Below the graphic, the text "DeGen" is written in a bold, blue font. Below "DeGen", the word "Medical" is written in a smaller, gray font.

| Non-Clinical Test<br>Summary | The following analyses were conducted:<br>• Dimensional analysis compared to predicate<br>• Anatomical simulated use and navigation accuracy<br>The results of these evaluations indicate the subject device is<br>equivalent to the predicate device. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions | The comparison of technological characteristics and non-clinical<br>performance data demonstrates that the Subject Device is as safe and<br>effective when compared to Predicate Devices that are currently marketed<br>for the same intended use. |