(45 days)
No
The description focuses on the mechanical components and materials of a pedicle screw system, with no mention of AI/ML capabilities or related performance metrics.
Yes
The device is intended to immobilize spinal segments and treat various spinal instabilities and deformities, which are therapeutic actions.
No
The device is described as a pedicle screw system intended for immobilization of spinal segments as an adjunct to fusion, which is a treatment and not a diagnostic function.
No
The device description explicitly states it is composed of physical components like pedicle screws, rods, and connectors made of titanium and cobalt-chromium-molybdenum. It also details non-clinical performance testing related to the mechanical properties of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to stabilize the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws and rods made of specific materials, designed for surgical implantation. This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties and structural integrity (compression, torsion, pullout strength), which are relevant to surgical implants, not diagnostic tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
NKB, KWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for adolescent idiopathic scoliosis)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing was performed to demonstrate the DeGen Medical E³ MIS Pedicle Screw System is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 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 Screw System meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
K172101 ROMEO 2 Posterior Osteosynthesis System, K142531 F1 MPS Modular Pedicle Screw System, K160926 F1 MPS Modular Pedicle Screw System, K161363 Alphatec Spine, Inc. Arsenal™ Spinal Fixation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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
2
Indications for Use
510(k) Number (if known)
K173814
Device Name DeGen Medical E3 MIS Pedicle Screw System
Indications for Use (Describe)
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.
| 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 Summary
| Prepared | January 29, 2018 |
|---|---|
| Submitter | DeGen Medical |
| 1321-C North Cashua Drive | |
| Florence, SC 29501 | |
| Phone 877-240-7838 | |
| Fax 843-407-0545 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| LGB@SecureBME.com | |
| Trade Name | DeGen Medical E3 MIS Pedicle Screw System |
| Common Name | Pedicle screw spinal system |
| Code -Classification | NKB, KWP |
| 21 CFR 888.3070 : Class II | |
| Primary Predicate | K172101 ROMEO 2 Posterior Osteosynthesis System |
| Additional Predicates | K142531 & K160926 F1 MPS Modular Pedicle Screw System |
| K161363 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 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. |
4
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 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: 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. Pediatric pedicle screw fixation is
limited to a posterior approach. |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | As was established in this submission, both additions and minor changes to the
F1 MPS are substantially equivalent to other predicate devices cleared by the FDA
for commercial distribution in the United States.
The subject device, DeGen Medical E³ MIS Pedicle Screw System, was shown to
be substantially equivalent and has the same technological characteristics to its
predicate devices through comparison in areas including design, intended use, |
| Non-Clinical
Performance Testing
Conclusion | material composition, function, and range of sizes.
Non-clinical testing was performed to demonstrate the DeGen Medical E³ MIS
Pedicle Screw System is substantially equivalent to other predicate devices in
accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal
System 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 Screw
System meets or exceeds the performance of the predicate devices, and the
device was therefore found to be substantially equivalent. |
| Substantial
Equivalence
Summary
(Conclusion) | The subject the DeGen Medical E³ MIS Pedicle Screw System has been shown to
be substantially equivalent to legally marketed predicate devices and can be
interchanged with components from the DeGen Medical F1 MPS System and
accessories, CONNECT-L Transverse Connector and the JOUST™ minimally
invasive rods. |