(192 days)
No
The summary describes a mechanical pedicle screw system and its intended use and performance testing, with no mention of AI or ML capabilities.
Yes
The device is intended for posterior, noncervical pedicle fixation to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, which makes it a therapeutic device.
No
The F1-MPS is described as a system for posterior, noncervical pedicle fixation to provide immobilization and stabilization of spinal segments, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is composed of cannulated and non-cannulated pedicle screws made of Titanium and Titanium alloy or cobalt-chromium-molybdenum, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The F1 - Modular Pedicle Screw System is a surgical implant intended for posterior spinal fixation. It is used in vivo (within the body) to stabilize spinal segments. It does not analyze any biological samples.
The provided information clearly describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, noncervical pedicle fixation (T1-S1) 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 (Grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal tumor, Schuermann's disease, and failed previous fusion.
The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
The F1-MPS is also intended for posterior, non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, MNH, MNI
Device Description
The F1-Modular Pedicle Screw System is composed of cannulated and non-cannulated pedicle screws which are designed to accept a 5.5mm rod and are available in various sizes. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 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
noncervical pedicle (T1-S1), thoracic, lumbar, and sacral spine, L5-S1 vertebra
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed to demonstrate the DeGen Medical F1- Modular 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 strength via ASTM F543
Straight and angled static axial pull-apart testing
The results of these studies show the subject DeGen Medical F1-Modular Pedicle Screw System meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K130646 Medtronic CD Horizon
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K992739 Synthes Click'X, K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System, K950099 Cross Medical Synergy Posterior Spinal System, K121250 OrthoPediatrics Spine System
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
DeGen Medical % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K142531
Trade/Device Name: F1-Modular Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI Dated: February 10, 2015 Received: February 11, 2015
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
1
Page 2 - Linda Braddon, Ph.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
F1-Modular Pedicle Screw System
Indications for Use (Describe)
The F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, noncervical pedicle fixation (T1-S1) 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 (Grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal tumor, Schuermann's disease, and failed previous fusion.
The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
The F1-MPS is also intended for posterior, non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 F1-Modular Pedicle Screw System is provided below.
| Date Summary Prepared | March 5, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | 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 | F1-Modular Pedicle Screw System |
| Common Name | Pedicle screw spinal system |
| Code -Classification | NKB |
| 21 CFR 888.3070 : Class III | |
| MNH, MNI, OSH | |
| 21 CFR 888.3070 : Class II | |
| Primary Predicate Device | K130646 Medtronic CD Horizon |
| Reference Devices | K992739 Synthes Click'X |
| K933881, K953915, K982320, K982511, K982011, K983583, K992168, | |
| K011182, K030383 DePuy Moss Miami Spinal System | |
| K950099 Cross Medical Synergy Posterior Spinal System | |
| K121250 OrthoPediatrics Spine System | |
| Device Description | The F1-Modular Pedicle Screw System is composed of cannulated and |
| non-cannulated pedicle screws which are designed to accept a 5.5mm | |
| rod and are available in various sizes. The components can be rigidly | |
| assembled in a variety of constructs, each corresponding to the needs | |
| and anatomy of a specific patient. The system is provided in both sterile | |
| and non-sterile versions. The system is constructed from Titanium and | |
| Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 or cobalt- | |
| chromium-molybdenum per ASTM F1537. | |
| Indications for Use | The F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, |
| noncervical pedicle fixation (T1-S1) 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 (Grade 3 and 4) of the L5-S1 vertebra, degenerative | |
| spondylolisthesis with objective evidence of neurological impairment, spinal | |
| stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal | |
| tumor, Schuermann's disease, and failed previous fusion. | |
| The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to | |
| provide immobilization and stabilization of spinal segments in skeletally | |
| mature patients as an adjunct to fusion in the treatment of degenerative | |
| disc disease (back pain of discogenic origin with degeneration of the disc | |
| confirmed by history and radiographic studies) and spondylolisthesis other | |
| than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or | |
| degenerative spondylolisthesis with objective evidence of neurologic | |
| impairment. | |
| The F1-MPS is also intended for posterior, non-cervical fixation in pediatric | |
| patients indicated as an adjunct to fusion to treat adolescent idiopathic | |
| scoliosis. The device is intended to be used with autograft and/or allograft. | |
| Technological Characteristics | As was established in this submission, the subject F1-Modular Pedicle Screw |
| System is substantially equivalent to other predicate devices cleared by the | |
| FDA for commercial distribution in the United States. The subject device was | |
| shown to be substantially equivalent and has the same technological | |
| characteristics to its predicate devices through comparison in areas including | |
| design, intended use, material composition, function, and range of sizes. | |
| Non-Clinical Performance | |
| Testing Conclusion | Non-clinical testing was performed to demonstrate the DeGen Medical F1- |
| Modular 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 strength via ASTM F543 | |
| ● | |
| Straight and angled static axial pull-apart testing | |
| ● | |
| The results of these studies show the subject DeGen Medical F1-Modular | |
| 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) | Based on the indications for use, technological characteristics, performance |
| testing, and comparison to predicate devices, the subject DeGen Medical F1- | |
| Modular Pedicle Screw System has been shown to be substantially equivalent | |
| to legally marketed predicate devices. |
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