The DeGen Medical E3 MIS Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the DeGen Medical E3 MIS Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The DeGen Medical E3 MIS Pedicle Screw System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

Device Description

DeGen Medical E3 MIS Pedicle Screw System composed of cannulated and non-cannulated pedicle screws of various lengths and diameters which are designed to accept a 5.5mm rod in various lengths. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. Additionally, the DeGen Medical E3 MIS Pedicle Screw System may be used interchangeably with the DeGen Medical F1 MPS system including the CONNECT-L Transverse Connector and JOUST minimally invasive rods. This submission addresses both the the DeGen Medical E3 MIS Pedicle Screw System and minor design changes for manufacturability of the F1 MPS. The DeGen Medical E³ MIS Pedicle Screw System is provided non-sterile. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 and/or cobalt-chromium-molybdenum per ASTM F1537.

AI/ML Overview

This document describes a 510(k) premarket notification for the DeGen Medical E3 MIS Pedicle Screw System. It is a submission for a medical device seeking substantial equivalence to legally marketed predicate devices, not an AI/ML powered medical device. Therefore, the information typically found in an AI/ML device submission regarding acceptance criteria, study methodologies, training/test sets, human expert involvement, and ground truth establishment is not present in this document.

The document discusses non-clinical performance testing for the mechanical properties of the pedicle screw system to demonstrate substantial equivalence to existing devices.

Key information provided in the document related to testing:

Acceptance Criteria and Reported Device Performance: This information would typically be detailed in the test reports themselves, demonstrating compliance with specific ASTM standards. The document states:
- Acceptance Criteria/Standards: ASTM F1717 (Static and dynamic compression testing), ASTM F543 (Screw pullout strength), ASTM F1798 (Static tulip head disassembly, Dynamic flexion-extension testing).
- Reported Device Performance: "The results of these studies show the subject DeGen Medical E³ MIS Pedicle Screw System meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent." (Page 5, "Non-Clinical Performance Testing Conclusion" table entry). Specific quantitative performance metrics are not provided in this summary.
Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing of a pedicle screw system. The "test set" here refers to the physical devices undergoing mechanical stress tests, not a dataset of patient information.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is defined by the physical properties and performance metrics specified in the ASTM standards. Testing is performed by qualified technicians and engineers in a lab setting, not by medical experts establishing a diagnostic ground truth from patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is relevant for clinical or diagnostic studies involving human review, not mechanical testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical device, not an AI/ML algorithm requiring human interpretation of output.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is established by the specified mechanical performance requirements of the relevant ASTM standards (e.g., specific loads, displacements, and failure modes).
The sample size for the training set: Not applicable. There is no AI/ML training set for this device.
How the ground truth for the training set was established: Not applicable. There is no AI/ML training set for this device.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (pedicle screw system) through non-clinical mechanical performance testing against established ASTM standards, rather than evaluating an AI/ML algorithm's performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a sans-serif font. The word "Administration" is on a separate line below "U.S. Food & Drug".

January 29, 2018

DeGen Medical % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickorv Flat Highwav, Suite 120 Woodstock, Georgia 30188

Re: K173814

Trade/Device Name: DeGen Medical E MIS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: December 14, 2017 Received: December 15, 2017

Dear Dr. 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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173814

Device Name DeGen Medical E3 MIS Pedicle Screw System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 201 Subpart D)
□ Over-The-Counter Use (21 CFR 201 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/0 description: The image shows the logo for DeGen Medical. The logo consists of a blue abstract design on the left and the words "DeGen Medical" on the right. The abstract design features three curved lines emanating from three blue circles. The word "DeGen" is in a larger, bolder, blue font, while the word "Medical" is in a smaller, lighter gray font.

510(k) Summary of Safety and Effectiveness

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical E MIS Pedicle Screw System is provided below.

Date SummaryPrepared	January 29, 2018
Submitter	DeGen Medical1321-C North Cashua DriveFlorence, SC 29501Phone 877-240-7838Fax 843-407-0545
510(k) Contact	Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681LGB@SecureBME.com
Trade Name	DeGen Medical E3 MIS Pedicle Screw System
Common Name	Pedicle screw spinal system
Code -Classification	NKB, KWP21 CFR 888.3070 : Class II
Primary Predicate	K172101 ROMEO 2 Posterior Osteosynthesis System
Additional Predicates	K142531 & K160926 F1 MPS Modular Pedicle Screw SystemK161363 Alphatec Spine, Inc. Arsenal™ Spinal Fixation System
Device Description	DeGen Medical E3 MIS Pedicle Screw System composed of cannulated and non-cannulated pedicle screws of various lengths and diameters which are designedto accept a 5.5mm rod in various lengths. The components can be rigidlyassembled in a variety of constructs, each corresponding to the needs andanatomy of a specific patient.Additionally, the DeGen Medical E3 MIS Pedicle Screw System may be usedinterchangeably with the DeGen Medical F1 MPS system including theCONNECT-L Transverse Connector and JOUST minimally invasive rods. Thissubmission addresses both the the DeGen Medical E3 MIS Pedicle Screw Systemand minor design changes for manufacturability of the F1 MPS.The DeGen Medical E³ MIS Pedicle Screw System is provided non-sterile. Thesystem is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) perASTM F136 and F67 and/or cobalt-chromium-molybdenum per ASTM F1537.

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Image /page/4/Picture/0 description: The image shows the logo for DeGen Medical. The logo consists of a stylized graphic on the left and the company name on the right. The graphic features three curved lines emanating from three circles, all in shades of blue. To the right of the graphic, the word "DeGen" is written in a larger, bolder blue font, and below it, the word "Medical" is written in a smaller, gray font.

Intended Use	The DeGen Medical E³ MIS Pedicle Screw System is intended to provideimmobilization and stabilization of spinal segments in skeletally mature patientsas an adjunct to fusion in the treatment of the following acute and chronicinstabilities or deformities of the thoracic, lumbar, and sacral spine: degenerativedisc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinaltumor; and failed previous fusion (pseudarthrosis).When used for posteriornoncervical pedicle screw fixation in pediatric patients, the DeGen Medical E³ MISPedicle Screw System is indicated as an adjunct to fusion to treat adolescentidiopathic scoliosis. The DeGen Medical E³ MIS Pedicle Screw System is intendedto be used with autograft and/or allograft. Pediatric pedicle screw fixation islimited to a posterior approach.
TechnologicalCharacteristics	As was established in this submission, both additions and minor changes to theF1 MPS are substantially equivalent to other predicate devices cleared by the FDAfor commercial distribution in the United States.The subject device, DeGen Medical E³ MIS Pedicle Screw System, was shown tobe substantially equivalent and has the same technological characteristics to itspredicate devices through comparison in areas including design, intended use,
Non-ClinicalPerformance TestingConclusion	material composition, function, and range of sizes.Non-clinical testing was performed to demonstrate the DeGen Medical E³ MISPedicle Screw System is substantially equivalent to other predicate devices inaccordance with "Guidance for Industry and FDA Staff, Guidance for SpinalSystem 510(k)s", May 3, 2004. The following tests were performed:Static and dynamic compression testing per ASTM F1717 Static torsion testing per ASTM F1717 Screw pullout strength via ASTM F543 Static tulip head disassembly via ASTM F1798 Dynamic flexion-extension testing via ASTM F1798 The results of these studies show the subject DeGen Medical E³ MIS Pedicle ScrewSystem meets or exceeds the performance of the predicate devices, and thedevice was therefore found to be substantially equivalent.
SubstantialEquivalenceSummary(Conclusion)	The subject the DeGen Medical E³ MIS Pedicle Screw System has been shown tobe substantially equivalent to legally marketed predicate devices and can beinterchanged with components from the DeGen Medical F1 MPS System andaccessories, CONNECT-L Transverse Connector and the JOUST™ minimallyinvasive rods.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.