(94 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 Medronic SteathStation® 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.
The provided text describes the DeGen Medical Navigated Instrumentation and its 510(k) summary, but does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document focuses on regulatory approval (510(k)) and establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed results.
Here's what can be extracted and what cannot:
Information Present in the Document:
- Device Name: DeGen Medical Navigated Instrumentation
- K Number: K203816
- Indications for Use: Intended to be used during the preparation and placement of DeGen Medical F1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Specifically designed for use with the Medtronic StealthStation® System.
- Predicate Devices: K140454 Medtronic Navigated CD Horizon Solera Screwdriver / Taps and K172166 Astura Olympic Navigated Instruments.
- Non-Clinical Test Summary: "Dimensional analysis compared to predicate Anatomical simulated use and navigation accuracy." The document states, "The results of these evaluations indicate the subject device is equivalent to the predicate device."
- Type of Ground Truth Used (Indirectly): The "non-clinical test summary" mentions "navigation accuracy" and "anatomical simulated use," which implies that the ground truth for these tests would likely be based on physical measurements against established anatomical models or precise reference points, rather than expert consensus, pathology, or outcomes data in a clinical setting.
Information NOT Present in the Document:
- A table of acceptance criteria and reported device performance: The document only states that evaluations were conducted and "indicate the subject device is equivalent to the predicate device," but no specific numerical performance criteria or results are provided.
- Sample size used for the test set and data provenance: No details on the number of cases, specimens, or the origin (country, retrospective/prospective) of the data for the "anatomical simulated use and navigation accuracy" tests.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as the ground truth appears to be based on physical measurements/simulations rather than human expert interpretation of images or clinical data.
- Adjudication method for the test set: Not applicable based on the information provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No indication of such a study. The device is a navigated instrumentation, not an AI diagnostic tool that would typically involve human readers.
- If a standalone (algorithm only without human-in-the-loop performance) was done: This device is physical instrumentation used with a navigation system, not an algorithm in the typical sense of AI standalone performance.
- The sample size for the training set: Not applicable, as this is a physical device, not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The document is a 510(k) clearance letter and summary for a medical device. Its purpose is to demonstrate substantial equivalence to existing legally marketed devices, not to detail the performance of an AI/ML algorithm or a new diagnostic tool using a large-scale clinical study dataset. The "study" mentioned is a "Non-Clinical Test Summary" which included "Dimensional analysis compared to predicate Anatomical simulated use and navigation accuracy." The conclusion is that these evaluations demonstrated the device is "equivalent to the predicate device" in terms of safety and effectiveness, based on "technological characteristics and non-clinical performance data."
To answer your request comprehensively, you would need a more detailed performance report or study design document for the DeGen Medical Navigated Instrumentation, which is not included in these FDA communication pages.
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April 2, 2021
DeGen Medical % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K203816
Trade/Device Name: DeGen Navigated Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 11, 2021 Received: March 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/cdrb/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 -S
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
Enclosure
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Indications for Use
510(k) Number (if known) K203816
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 Medronic SteathStation® 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) |
|---|---|
| --------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------- |
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/1 description: The image shows the logo for DeGen Medical. The logo features a stylized graphic above the text "DeGen Medical". The graphic consists of three curved lines emanating from a central point, each terminating in a small circle. The lines and circles are in a gradient of blue, transitioning from a darker shade to a lighter one. The text "DeGen" is in a bold, sans-serif font, while the word "Medical" is in a smaller, lighter font and is positioned below and slightly to the right of "DeGen".
510(k) Summary: DeGen Medical Navigated Instrumentation K203816
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 | 3/10/2021 |
|---|---|
| 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 | K140454 Medtronic Navigated CD Horizon Solera Screwdriver / Taps |
| Additional Predicate | K172166 Astura Olympic Navigated Instruments |
| Device Description | 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. |
| Materials | Stainless Steel per ASTM F899 |
| Indications for Use | The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F1 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 StealthStation® 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 |
| TechnologicalCharacteristics | The technological design features of the subject system werecompared to the predicate in intended use, indications for use,design, function and technology and it was demonstrated that theyare substantially equivalent. |
| Non-Clinical TestSummary | The following analyses were conducted:Dimensional analysis compared to predicate Anatomical simulated use and navigation accuracy The 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 safeand effective when compared to Predicate Devices that arecurrently marketed for the same intended use. |
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510(k) Summary: DeGen Medical Navigated Instrumentation K203816
Image /page/4/Picture/2 description: The image contains the logo for DeGen Medical. The logo features three curved lines in blue, each ending in a small circle, resembling a stylized representation of medical technology or a network. Below the graphic is the text "DeGen" in a larger, bolder font, followed by "Medical" in a smaller font size. The overall design is clean and professional, suggesting a company in the healthcare or medical technology sector.
§ 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).