(224 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System is indicated for the following :
(a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
(b) spondylolisthesis,
(c) spinal stenosis
(d) trauma (i.e., fracture or dislocation).
(e) Atlanto-axial fracture with instability;
(f) Occipito-cervical dislocation:
(g) Tumors:
(h) Revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1 - T3) for anchoring of the OCT construct only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1 - T3). The hooks are intended to be placed from C1 to T3. The cable (titanium) system to be used with the Centurion POCT System allows for wire/cable attachment to the posterior cervical spine.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.
The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium alloy or Cobalt Chrome alloy, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, parallel axial connectors, and lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.
The Orthofix Centurion POCT System is a spinal fixation system intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction. The system's acceptance criteria are based on its substantial equivalence to predicate devices, demonstrated primarily through mechanical strength testing as per relevant ASTM standards.
Here's an overview of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Strength | ASTM F2706-08 (Static Axial Compression Bending, Static Torsion) | Demonstrates comparable mechanical and functional properties. | Tested under a vertebrectomy model. |
| ASTM F1798 (Static Axial Gripping Capacity, Static Axial Torque Gripping Capacity, Dynamic Axial Gripping Capacity, Dynamic Axial Torque Gripping Capacity, Static Transverse (y) Mechanical Property Test) | Demonstrates comparable mechanical and functional properties. | Followed Guidance for Industry and FDA Staff Spinal System 510(k)s May 3, 2004. | |
| ASTM F1717 (Static Axial Compression, Static Torsion, Dynamic Axial Compression, Dynamic Torsion) | Demonstrates comparable mechanical and functional properties. | Followed Guidance for Industry and FDA Staff Spinal System 510(k)s May 3, 2004. | |
| Material Equivalence | Commercially pure titanium/titanium alloy with option for cobalt chrome rods. | Subject and predicate devices are made from commercially pure titanium/titanium alloy with the option of titanium/titanium alloy or cobalt chrome rods. | Ensures material compatibility and established biomechanical properties. |
| Intended Use Equivalence | Identical to predicate device. | Intended use is identical to predicate devices. | Ensures the device is appropriate for the same clinical applications. |
| Design Equivalence | Substantially equivalent to predicate devices. | Features of subject components are substantially equivalent to predicate devices. | Relies on structural and functional similarities. |
| Packaging & Sterilization | Identical to predicate device. | Packaging and sterilization of the predicate and subject components are identical. | Ensures safety and efficacy in handling and use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each mechanical test. However, "Mechanical testing" implies multiple units were tested to demonstrate performance against the specified ASTM standards.
- Data Provenance: The mechanical testing was conducted to support the substantial equivalence claim for the Centurion POCT System. This is typically done prospectively as part of product development and regulatory submission by the manufacturer (Orthofix Inc., a US company). The data would be considered prospective in the context of demonstrating performance for regulatory approval. The country of origin for the data is implicitly the United States as Orthofix Inc. is a US-based sponsor and the submission is to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not applicable to this type of submission. The "ground truth" for medical device mechanical performance is established by standardized testing protocols (ASTM standards) and engineering principles, not by human expert consensus or clinical pathology. The "experts" are the engineers and testing laboratory personnel who conduct and analyze these mechanical tests, adhering to the specified standards.
4. Adjudication Method for the Test Set:
- This is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments. Mechanical tests yield objective, quantitative results directly comparable to established standards.
5. 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:
- This is not applicable. The device described is a spinal implant for mechanical fixation, not an AI-powered diagnostic or interpretive tool that would involve human readers or image analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used:
- For mechanical testing, the "ground truth" is defined by the established performance criteria within the specified ASTM standards and the "Guidance for Industry and FDA Staff Spinal System 510(k)s" document. The device components must meet or exceed these predetermined mechanical thresholds to be considered substantially equivalent and safe/effective. This is an objective, quantitative ground truth.
8. The Sample Size for the Training Set:
- This is not applicable. As a physical implant, this device does not utilize a "training set" in the context of machine learning or AI development. The design and manufacturing processes are informed by engineering principles and prior device knowledge, rather than a data training set.
9. How the Ground Truth for the Training Set was Established:
- This is not applicable for the reasons stated in point 8.
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.
| Date Prepared: | June 19, 2013 |
|---|---|
| Purpose for Submission: | New Product Offering |
| Sponsor: | Orthofix Inc.Jacki Geren3451 Plano ParkwayLewisville, TX 75056214-937-2100 |
| Device Name: | Centurion POCT System |
| Product Code: | KWP |
| Classification: | Class II - 21 CFR §888.3050 - Spinal Interlaminal Fixation Orthosis |
| Predicate Device: | Ascent POCT System (K030197)Ascent POCT System (K111183)¹Synthes Synapse 4.0mm System (K091689)Biomet Spine Nextgen Altius OCT System (K122378) |
| Device Description: | The Centurion POCT System is a temporary, multiple component systemcomprised of a variety of non-sterile, single use components made ofTitanium alloy or Cobalt Chrome alloy, that allow the surgeon to build aspinal implant construct. The Centurion POCT System consists of anassortment of rods, set screws, parallel axial connectors, and lateral offsetadapters, multi-axial screws, hooks, occipital plates, bone screws, andcables. |
| Intended Use: | When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System isindicated for the following :(a) degenerative disc disease (neck pain of discogenic origin withdegeneration of the disc as confirmed by patient history andradiographic studies)(b) spondylolisthesis,(c) spinal stenosis(d) trauma (i.e., fracture or dislocation).(e) Atlanto-axial fracture with instability;(f) Occipito-cervical dislocation:(g) Tumors:(h) Revision of previous cervical spine surgeryThe occipital bone screws are limited to occipital fixation only. The use ofthe multi-axial screws is limited to placement in the upper thoracic spine(T1 - T3) for anchoring of the OCT construct only. They are not intendedto be placed in the cervical spine. The lateral offset adapter is indicatedfor use in the upper thoracic spine (T1 - T3). The hooks are intended tobe placed from C1 to T3. The cable (titanium) system to be used with theCenturion POCT System allows for wire/cable attachment to the posteriorcervical spine.The Centurion POCT System can also be linked to the Orthofix SpinalFixation System using the Axial or Parallel Rod Connector. |
| SubstantialEquivalence: | The features of the subject components are substantially equivalent to thepredicate devices based on similarities in intended use and design. |
:
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Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devise in regards to mechanical strength. In addition, the intended use, packaging, and sterilization of the predicate and subject components are identical.
The subject and predicate devices are made from commercially purc titanium/ titanium alloy with the option of titanium/titanium alloy or cobalt chrome rods. Functional and mechanical testing demonstrates the comparable mechanical & functional propertics of the subject Centurion POCT System to the predicate devices.
Testing conducted to support the substantial equivalence for the Centurion POCT System was aimed to assess static and dynamic axial compression bending and static torsion testing per:
ASTM F2706-08, "Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model".
Additional testing of the Centurion POCT System was conducted per:
ASTM F 1798 / Static Axial Gripping Capacity / Static Axial Torque Gripping Capacity / Dynamic Axial Gripping Capacity / Dynamic Axial Torque Gripping Capacity / Static Transverse (y) Mechanical Property Test / Guidance for Industry and FDA Staff Spinal System 510(k)s May 3, 2004
ASTM F1717, ASTM F2706 / Static Axial Compression / Static Torsion / Dynamic Axial Compression / Dynamic Torsion / Guidance for Industry and FDA Staff Spinal System 510(k)s May 3, 2004
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2014
Orthofix, Incorporated Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K131833
Trade/Device Name: Centurion POCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 11, 2013 Received: December 18, 2013
Dear Ms. Geren:
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. Ilisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Jacki Geren
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Vincent Devlin -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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510(k) Number (if known): K131833
Centurion POCT System Device Name:
Indications for Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the Centurion POCT System is indicated for the following:
- a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies);
- spondylolisthesis; b)
- spinal stenosis; c)
- d) trauma (i.e., fracture or dislocation);
- e) atlanto-axial fracture with instability;
- occipito-cervical dislocation; ர்)
- g) tumors;
- h) revision of previous cervical spine surgery;
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1 - T3) for anchoring of the OCT construct only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (TI - T3). The hooks are intended to be placed from C1 to T3. The cable (titanium) system to be used with the Centurion POCT System allows for wire/cable attachment to the posterior cervical spine.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.
x_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
AND/OR
Zane W. Wyatt Division of Orthopedic Devices
· 510(k) Number: K131833
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.