(108 days)
No
The summary describes a mechanical spinal fixation system with no mention of software, algorithms, or any AI/ML related terms or functionalities.
Yes
The device is described as a spinal fixation system intended to help provide stabilization and immobilization of spinal segments as an adjunct to fusion for various spinal conditions, which are therapeutic goals.
No
The device is a spinal fixation system designed to help provide immobilization of spinal segments as an adjunct to fusion; it is an implant, not a diagnostic tool.
No
The device description explicitly states it is a spinal fixation system consisting of physical components like screws, rods, and connectors made from titanium and cobalt alloys. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The Preference Elite Pedicle Screw System is a spinal fixation system consisting of implants (screws, rods, etc.) designed to be surgically implanted into the lumbar and/or sacral spine to provide immobilization and aid in fusion.
- Lack of In Vitro Testing: The description and performance studies focus on mechanical testing of the implants (compression, torsion, pull-off) and their equivalence to predicate devices. There is no mention of testing biological specimens or providing diagnostic information based on such testing.
The device is a surgical implant used in vivo (within the body) to provide structural support, not to diagnose a condition by analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The Preference Elite Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:
The Preference Elite System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Preference Elite Pedicle Screw System is indicated for skeletally matures patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.
Product codes
NKB, MNH, MNI, KWP
Device Description
The Preference Elite Pedicle Screw System is a spinal fixation system consisting of a variety of components including screws, various types and sizes of rods, cross-connectors and accessories, as well as implant components from the Preference Pedicle Screw System. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient.
Implant components from the Preference Pedicle Screw System including the curved and straight rods, set-screws, and cross-connectors are compatible with the Preference Elite Pedicle Screw System.
The Preference Elite Pedicle Screw System implants and components are made from titanium alloy (Ti-6A1-4V) per ASTM F136 and Cobalt-28 Chromium-6 Molybdenum Alloy (Co-28Cr-6Mo) per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and/or sacral spine, non-cervical pedicle, fifth lumbar-first sacral (15-S1) vertebral joint
Indicated Patient Age Range
skeletally mature patients
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)
Testing and analyses were completed in accordance with the applicable standards.
- ASTM F1717 Static Axial Compression Bending
- ASTM F1717 Static Torsion
- ASTM F1717 Dynamic Axial Compression Bending
- ASTM F1798 Static Pull-off
The testing results demonstrate that the new system, Preference Elite Pedicle Screw System, is substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a single abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2016
Amedica Corporation Ms. Shanna Ryan Regulatory Affairs Project Manager 1885 West 2100 South Salt Lake City, Utah 84119
Re: K162160
Trade/Device Name: Preference Elite Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP Dated: October 24, 2016 Received: October 25, 2016
Dear Ms. Ryan:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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/ResourcesforYou/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,
Mark N. Melkerson -S
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) K162160
Device Name Preference Elite Pedicle Screw System
Indications for Use (Describe)
The Preference Elite Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:
The Preference Elite System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Preference Elite Pedicle Screw System is indicated for skeletally matures patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.
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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K162160 Page 1 of 3
Traditional 510(k) Summary
| 1. Submitted by: | Amedica® Corporation
1885 W 2100 S
Salt Lake City, UT 84119
Ph: 801-839-3562
Fax: 801-839-3605 |
| ------------------ | ------------------------------------------------------------------------------------------------------------ |
|---|
-
- Contact: Shanna Ryan
- Date of summary: October 24, 2016 3.
- Trade Name: Preference Elite Pedicle Screw System 4.
- Common Name: Pedicle Screw System న్.
-
- Product Code: NKB, MNH, MNI, KWP
- Classification Regulation: 7. 21 CFR 888.3070
-
- Class: III
- Orthopedic Panel: 9.
10. Predicate Device(s):
| 510K | Trade Name | Product Code | Classification | Manufacturer | |
|---|---|---|---|---|---|
| Primary | K081883 | Preference | |||
| Pedicle Screw | |||||
| System | MNH, MNI, | ||||
| NKB, | |||||
| KWQ, | |||||
| KWP | 21 CFR 888.3070 | ||||
| 21 CFR 888.3060 | |||||
| 21 CFR 888.3050 | US Spine | ||||
| (acquired by | |||||
| Amedica) | |||||
| Additional | K073430 | Valeo® PS | |||
| Pedicle Screw | |||||
| System | NKB, MNH, | ||||
| MNI | 21 CFR 888.3070 | Amedica | |||
| Corporation |
11. Device Description
The Preference Elite Pedicle Screw System is a spinal fixation system consisting of a variety of components including screws, various types and sizes of rods, cross-connectors and accessories, as well as implant components from the Preference Pedicle Screw System. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient.
Implant components from the Preference Pedicle Screw System including the curved and straight rods, set-screws, and cross-connectors are compatible with the Preference Elite Pedicle Screw System.
The Preference Elite Pedicle Screw System implants and components are made from titanium alloy (Ti-6A1-4V) per ASTM F136 and Cobalt-28 Chromium-6 Molybdenum Alloy (Co-28Cr-6Mo) per ASTM F1537.
4
-
- Purpose of 510k
The purpose of this Traditional 510(k) is to seek clearance for the Preference Elite Pedicle Screw System. The Preference Elite Pedicle Screw System is a new system comprised of new implants, components and instruments, in addition to previously cleared implants and components in the Preference Pedicle Screw System.
- Purpose of 510k
-
- Indications for use
The PREFERENCE ELITE Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:
- Indications for use
The PREFERENCE ELITE System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the PREFERENCE ELITE Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar- first sacral (L5-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.
-
- Technological Characteristics
The Preference Elite Pedicle screw system is substantially equivalent to the predicate devices. The device was shown to be equivalent to the predicates in intended use/ indications for use, function, materials, sizes and sterilization.
- Technological Characteristics
-
- Performance Data
Testing and analyses were completed in accordance with the applicable standards.
- Performance Data
-
ASTM F1717 Static Axial Compression Bending ●
-
ASTM F1717 Static Torsion .
-
ASTM F1717 Dynamic Axial Compression Bending ●
-
ASTM F1798 Static Pull-off o
The testing results demonstrate that the new system, Preference Elite Pedicle Screw System, is substantially equivalent to the predicates.
16. Guidance Referenced
- 2015 Food and Drug Administration, Guidance for Industry and FDA Staff -Processing/re-● processing Medical Devices in Healthcare Settings
- 2004 Food and Drug Administration, Guidance for Industry and FDA Staff- Spinal System ● 510(k)s.
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17. Conclusions
The Preference Elite Pedicle Screw System is substantially equivalent to the predicate systems in regards to intended use, indications for use, design, materials, sizes and sterility. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence to the predicate systems.