(29 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
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.
The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.
The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.
The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior cervico-thoracic spine. The subject devices share the same intended use and fundamental scientific technology as the predicate.
The provided document describes a medical device submission (K062505) for the Nex-Link Spinal Fixation System by Abbott Spine, Inc. This submission focuses on design modifications, specifically the addition of Poly-axial Offset Connectors, to an already cleared predicate device.
The document states that the Nex-Link Spinal Fixation System is intended for fixation to and stabilization of the cervicothoracic spine (C1-T3) to promote fusion.
Based on the information provided, here's a breakdown of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (demonstrated via equivalence to predicate, and non-clinical testing) | Non-Clinical Performance: "Laboratory and bench testing results demonstrate that the proposed devices are safe and effective in use as intended, in accordance with the indications for use of the Nex-Link System." Clinical Performance: "Clinical data and conclusions were not needed for this submission." |
| Substantial Equivalence to Predicate Device | "The subject device is the result of design modifications to the predicate device; they have the same intended use and are substantially equivalent to the predicate devices." (Predicate devices: Nex-Link Spinal Fixation System, K031985; OctaFix Occipital Cervical Plating System, K021009) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission explicitly states, "Clinical data and conclusions were not needed for this submission." The evaluation for this 510(k) was based on non-clinical (laboratory and bench) testing and substantial equivalence to predicate devices, not on a clinical test set.
- Data Provenance: Not applicable for clinical data. For non-clinical testing, the provenance is internal laboratory and bench testing by Abbott Spine, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. No clinical test set with human ground truth establishment was conducted for this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set was conducted.
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
- MRMC Study: No. This submission is for a medical implant (spinal fixation system), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This document is for a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for the device's performance was established through non-clinical laboratory and bench testing demonstrating mechanical safety and effectiveness, and through comparison to legally marketed predicate devices for substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of the device are based on engineering principles, materials science, and testing against performance standards, not a data-driven training set in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for this medical device submission.
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ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
SEP 26 2006
| SUBMITTER: | Abbott Spine, Inc. |
|---|---|
| ESTABLISHMENT REGISTRATIONNUMBER: | 1649384 |
| CONTACT PERSON: | Noah BartschSenior Specialist, Regulatory AffairsTelephone:512.533.1840Fax:512.918.2784 |
| DATE: | August 25, 2006 |
| TRADE NAME: | Nex-Link Spinal Fixation SystemPoly-axial Offset Connectors |
| COMMON NAME: | Posterior Spinal Implant |
| CLASSIFICATION NAME: | K WP: Spinal Interlaminal Fixation OrthosisMNI: Pedicle Screw Spinal System |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3050, 888.3070 |
| PREDICATE DEVICE SYSTEM(S): | The Nex-Link Spinal Fixation System, K031985,cleared on September 11, 2003. |
| The OctaFix Occipital Cervical Plating System,K021009, cleared on June 18, 2002. |
DEVICE DESCRIPTION:
The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.
The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior cervico-thoracic spine. The subject devices share the same intended use and fundamental scientific technology as the predicate.
INDICATIONS:
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the NexLink Spinal Fixation System is indicated for the following:
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DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
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.
The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.
| COMPARISON TO PREDICATE DEVICE: | The subject device is the result of design modifications to the predicate device; they have the same intended use and are substantially equivalent to the predicate devices. |
|---|---|
| PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL): |
| NON-CLINICAL PERFORMANCE AND CONCLUSIONS: |
|---|
| Laboratory and bench testing results demonstrate that the proposed devices are safe and effective in use as intended, in accordance with the indications for use of the Nex-Link System. |
| CLINICAL PERFORMANCE AND CONCLUSIONS: |
|---|
| Clinical data and conclusions were not needed for this submission. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three bars across its body, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 26 2006
Abbott Spine Incorporated c/o Mr. Noah Bartsch Regulatory Affairs Specialist 5301 Riata Park Court, Bldg. F Austin, Texas 78727
Re: K062505
Trade Name: Nex-Link™ Spinal Fixation System - Addition of Offset Connectors Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, KWP Dated: August 25, 2006 Received: August 31, 2006
Dear Mr. Bartsch:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Mr. Noah Bartsch
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K062505
Device Name:
Nex-LinkTM Spinal Fixation System
Indications for Use:
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
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.
The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.
Prescription Usc _X AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pntz
(Division Sign Off)
Division of General, Restorative. and Neurological General, Rest
510(k) Number K062505
§ 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.