(56 days)
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.
The DeGen Navigated Instrumentation is nonsterile, reusable drivers that are intended to be used with the Medtronic StealthStation® Application 1.2.0 (1.2.0-20) and are manufactured from stainless steel per ASTM F899.
I'm sorry, but this document does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria. Specifically, the document is a 510(k) clearance letter and summary, which confirms regulatory clearance but does not include:
- A table of acceptance criteria and reported device performance. The document mentions "Anatomical simulated use and navigation accuracy" as a non-clinical test, but no specific performance metrics or acceptance thresholds are provided.
- The sample size used for the test set or its provenance.
- The number and qualifications of experts used to establish ground truth.
- The adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human improvement with AI assistance.
- Whether standalone (algorithm only) performance was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.), though it implies simulated use.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, indications for use, design, function, technology, and non-clinical tests (dimensional analysis and anatomical simulated use/navigation accuracy). It concludes that the device is "as safe and effective" as the predicate based on these comparisons, but does not provide the specific performance data you are looking for.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 Medical1321-C North Cashua DriveFlorence, SC 29501Phone 877-240-7838Fax 843-407-0545FDA Registration: 3010663372 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com |
| Trade Name | DeGen Medical Navigated Instrumentation |
| Common Name | Navigated Instruments |
| Classification Name | Sterotaxic Instrument |
| Code-Classification | OLO21 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 thatare intended to be used with the Medtronic StealthStation® Application1.2.0 (1.2.0-20) and are manufactured from stainless steel per ASTMF899. |
| Materials | Stainless Steel per ASTM F899 |
| Indications for Use | The DeGen Medical Navigated Instrumentation is intended to be usedduring the preparation and placement of DeGen Medical F1 MPS and E3MIS screws during spinal surgery to assist the surgeon in preciselylocating anatomical structures in either open or minimally invasiveprocedures. DeGen Medical Navigated Instrumentation is specificallydesigned for use with the Medtronic StealthStation® System, which isindicated for any medical condition in which the use of stereotacticsurgery may be appropriate, and where reference to a rigid anatomicalstructure such as vertebra, can be identified relative to a CT or MR basedmodel, fluoroscopy images, or digitized landmarks of the anatomy. |
| TechnologicalCharacteristics | The technological design features of the subject system were compared tothe predicate in intended use, indications for use, design, function andtechnology 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 TestSummary | The following analyses were conducted:• Dimensional analysis compared to predicate• Anatomical simulated use and navigation accuracyThe results of these evaluations indicate the subject device isequivalent to the predicate device. |
|---|---|
| Conclusions | The comparison of technological characteristics and non-clinicalperformance data demonstrates that the Subject Device is as safe andeffective when compared to Predicate Devices that are currently marketedfor the same intended use. |
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).