(258 days)
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:
- Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
- Spondylolisthesis
- Spinal Stenosis
- Trauma (i.e. Fracture or Dislocation)
- Atlanto/axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors
Occipital Plates / Occipital Bone Screws / Hooks:
The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks and rods:
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Polyaxial screws/Connectors:
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.
The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured from titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications and in PEEK OPTIMA LT1 conforming to ASTM E2026 specifications.
The PASS OCT Spinal System is a spinal fixation device. No AI/ML components are mentioned in the provided text. The device's substantial equivalence to predicate devices was determined through non-clinical testing.
Here's the information based on the provided text, focusing on the mechanical performance of the device rather than AI/ML related criteria:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|
| Multi-axial screws & Rods Constructs | |
| Static Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Static Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Occipital Plates, Occipital Screws & Dual Diameter Rod Constructs | |
| Static Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Static Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
Study Details
- Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of AI/ML. The performance data presented is for non-clinical (mechanical) tests. The sample sizes for these mechanical tests are not explicitly stated. Data provenance is not applicable in the context of device mechanical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by mechanical testing standards, not expert clinical interpretation.
- Adjudication method for the test set: Not applicable. Mechanical testing is typically evaluated against defined scientific standards and acceptable ranges, not human adjudication.
- 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 device is a physical spinal fixation system, not an AI/ML diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal fixation system and does not contain an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by mechanical testing standards (e.g., ASTM F2706-08) and FDA guidance for spinal systems, which define acceptable physical properties and performance under various loading conditions.
- The sample size for the training set: Not applicable. This device is a physical spinal fixation system; there is no training set as would be used for an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.
Conclusion from non-clinical data: MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to several predicate devices (SUMMIT System, Mountaineer OCT Spinal System, Vertex Reconstruction System, and PASS 2 Spinal System) in terms of intended use, materials, design, mechanical safety, and performance. The device is considered safe and effective.
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A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
MAR 2 1 2013
| K Number | K121979 | ||
|---|---|---|---|
| Submitter Information | |||
| Name | MEDICREA INTERNATIONAL | ||
| Address | 14 Porte du Grand Lyon01700 Neyron, FRANCE | ||
| Phone number | 04 72 01 87 87 | ||
| Fax number | 04 72 01 87 88 | ||
| EstablishmentregistrationNumber | 1000432246 | ||
| For InformationContact | Audrey VIONRegulatory Affairs ManagerMEDICREA INTERNATIONAL14 Porte du Grand Lyon01700 NEYRONFranceTelephone : 04 72 01 87 87Fax : 04 72 01 87 88Email : avion@medicrea.com | ||
| Date Prepared | March 20, 2013 | ||
| Name of Device | |||
| Trade orProprietary Name | PASS OCT Spinal System | ||
| Common or Usualname | Spinal Fixation Appliances | ||
| Classification nameand Reference | Spinal Interlaminal Fixation Orthosis 21 CFR 888.3050 | ||
| Classification | Class II | ||
| Product code(s) | KWP: Appliance, Fixation, Spinal Interlaminal | ||
| Legally marketeddevice(s) to whichequivalence isclaimed | 510(k)Number | Title | DateCleared |
| K002733 | Summit Occipito-Cervico-Thoracic(OCT) Spinal System | 12/15/00 | |
| K042508 | Mountaineer OCT Spinal System | 7/10/04 | |
| K062136 | PASS 2 Spinal System | 6/10/06 | |
| K003780 | Vertex Reconstruction System | 9/28/01 | |
| Device Description | The PASS OCT Spinal System is a posterior system, which consistsof a variety of shapes and sizes of rods, hooks, polyaxial screws,occipital plates, occipital bone screws, and connectingcomponents, which can be rigidly locked to the rod in a variety ofconfigurations. See package insert of the system for labelinglimitations.The implants are manufactured from titanium alloy Ti-6Al-4V ELIconforming to ISO 5832-3 specifications and ASTM F136specifications and in PEEK OPTIMA LT1 conforming to ASTME2026 specifications |
:
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Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use any of the PASS OCT Spinal System implant components with components from any other systems or manufacturer unless specifically labeled to do so in this or another MEDICREA INTERNATIONAL document. As with all orthopedic and neurosurgical implants, none of the PASS OCT Spinal components should ever be reused under any circumstances. MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F136-11 & ISO 5832-30 and PEEK OPTIMA LT1® according to the ASTM F2026-10. MEDICREA" INTERNATIONAL PASS OCT implants are designed to Intended use of the device help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thotacic spine (occiput-T3). These devices should not be used in the inferior thoracic, lumbar and sacral region. These implants are designed to stabilize the spine during normal development of solid bony consolidation. After this period the device is no longer strictly necessary and may be removed. Indications for use When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for: - Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. - Spondylolisthesis - Spinal Stenosis - Trauma (i.e. Fracture or Dislocation) - Atlanto/axial fracture with instability - Revision of previous cervical spine surgery - Tumors Occipital Plates / Occipital Bone Screws / Hooks: The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only. The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs. Hooks and rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Polyaxial screws/Connectors: The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine. The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.
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| Performance Data | |
|---|---|
| SUMMARY OF NON-CLINICAL TEST CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE | |
| Performance test Summary-New Device | |
| Characteristic | Standard/Test/FDA Guidance |
| Multi-axial screws & Rods Constructs | |
| Static Compression | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| DynamicCompression | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Static Torsion | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Occipital Plates, Occipital Screws & Dual Diameter Rod Constructs | |
| Static Compression | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| DynamicCompression | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Static Torsion | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Dynamic Torsion | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| Not Applicable | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to theSUMMIT System (K002733), the Mountaineer OCT Spinal System (K042508), the VertexReconstruction System (K052734), in terms of intended use, materials used, design,mechanical safety and performances. | |
| And MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent tothe PASS 2 Spinal System (K062136) in terms of materials used and design. | |
| The MEDICREA® INTERNATIONAL PASS OCT Spinal System is safe and effective andperforms as well as the predicates SUMMIT Spinal System (K041203), the MountaineerOCT Spinal System (K042508), the Vertex Reconstruction System (K52734), and thePASS 2 Spinal System (KO62136). |
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Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines representing its wings and body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2013
Medicrea International % Ms. Audrey Vion Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron France
Re: Kil21979
Trade/Device Name: PASS OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: January 16, 2013 Received: February 15, 2013
Dear Ms. Vion:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Audrey Vion
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin Deith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K121979
Device Name: PASS OCT Spinal System
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:
- Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration
- of the disc as confirmed by patient history and radiographic studies.
- Spondylolisthesis
- Spinal Stenosis
- Trauma (i.e. Fracture or Dislocation)
- . Atlanto/axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors
Occipital Plates / Occipital Bone Screws / Hooks:
The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks and rods:
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Polyaxial screws/Connectors:
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Erin l Keith
Division of Orthopedic Devices
510(k) Number: K121979
§ 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.