(29 days)
The Radius® Spinal System is intended for anterior/anterolateral and posterior, noncervical 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); spinaly stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed nrevious fusion.
The Radius® Spinal System can also be linked to the Xia® Titanium Spinal System via the Ø5.5 mm to Ø6.0 mm Radius® rod-to-rod connector.
This 510(k) is intended to introduce an extension to the existing Radius® Spinal System. The proposed line extension includes the addition of a Vitallium rod.
This document is a 510(k) premarket notification for a medical device (Radius Spinal System Line Extension – Vitallium Rod). It does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/software devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical implantable device (spinal system with a Vitallium rod). Therefore, the questions related to AI/software performance metrics, training sets, and expert adjudication are not applicable to the content provided.
Here's an analysis based on the provided text, addressing the relevant aspects:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that the "acceptance criteria" for this 510(k) revolve around demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through:
- Material comparability.
- Design comparability.
- Indications for Use comparability.
- Compliance with FDA's "Guidance for Spinal System 510(k)'s May 3, 2004."
- Reported Device Performance:
Aspect Performance/Demonstration Material "Documentation is provided which demonstrates the new components of the Stryker Spine Radius® Spinal System to be substantially equivalent to the predicate devices in terms of material..." (Vitallium rod being the new material). Design "...substantially equivalent to the predicate devices in terms of... design..." Indications for Use "The Radius® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD)... spondylolisthesis; trauma... spinal stenosis; curvatures... tumor; pseudoarthrosis; and failed previous fusion." (This is identical to predicate devices). Engineering Analysis & Testing "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spine Radius® Spinal System, including the subject components."
2. Sample size used for the test set and the data provenance
- Not applicable. This submission is for a physical medical device, not a software/AI device that would use a "test set" in the context of performance evaluation with patient data. The "testing" mentioned refers to engineering and material testing, not clinical studies with patient data to establish performance metrics like sensitivity/specificity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. See point 2.
4. Adjudication method for the test set
- Not applicable. See point 2.
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
- No, not done. This is not an AI-assisted diagnostic or therapeutic device. It is a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used
- Not applicable for AI/software devices requiring ground truth from patient data. For this physical device, the "ground truth" relates to established engineering standards, material properties, and the established safety and efficacy of the predicate devices. The "truth" is that the new Vitallium rod is comparable in function, safety, and effectiveness to existing, legally marketed spinal rods.
8. The sample size for the training set
- Not applicable. See point 2.
9. How the ground truth for the training set was established
- Not applicable. See point 2.
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OCT 0 7 2008
Image /page/0/Picture/1 description: The image shows a sequence of characters that appear to be handwritten. The characters include 'K', 'U', '2', 'b', '6', and '8'. The characters are written in a simple, somewhat crude style, with varying line thickness and some imperfections.
Radius Spinal System Line Extension – Vitallium Rod
Special 510(k) Premarket Notification
| Special 510(k) Summary of Safety and Effectiveness:Line Extension to the Radius® Spinal System | |
|---|---|
| Proprietary Name: | Radius® Spinal System – Vitallium® Rod |
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class III |
| Orthosis, Spinal Pedicle Fixation, For DegenerativeDisc Disease | |
| 21 CFR 888.3070 | |
| Device Product Code: | NKB, KWP, KWQ, MNH, MNI |
| For Information contact: | Curtis Truesdale |
| Regulatory Affairs Project Manager | |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Telephone: (201) 760-8296 | |
| Fax: (201) 760-8496 | |
| Email: Curtis.Truesdale@Stryker.com | |
| Date Summary Prepared: | September 26, 2008 |
| Predicate Devices | Stryker Spine Radius® Spinal System, K070631,K062270 |
| Stryker Spine Xia® Spinal System, K060979. | |
| Medtronic Sofamor Danek CD Horizon SpinalSystem, K020709 |
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Radius Spinal System Line Extension – Vitallium Rod
Special 510(k) Premarket Notification
| Description of Device Modification | This 510(k) is intended to introduce an extension to theexisting Radius® Spinal System. The proposed lineextension includes the addition of a Vitallium rod. |
|---|---|
| Intended Use | The Radius® Spinal System is intended foranterior/anterolateral and posterior, noncervical pedicleand non-pedicle fixation for the following indications:degenerative disc disease (DDD) (defined as back painof discogenic origin with degeneration of the discconfirmed 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 failedprevious fusion.The Radius® Spinal System can also be linked to theXia® Titanium Spinal System via the Ø5.5 mm to Ø6.0mm Radius® rod-to-rod connector. |
| Summary of the TechnologicalCharacteristics | Documentation is provided which demonstrates thenew components of the Stryker Spine Radius® SpinalSystem to be substantially equivalent to the predicatedevices in terms of material, design, and indications foruse. Engineering analysis and testing to demonstratecompliance with FDA's Guidance for Spinal System510(k)'s May 3, 2004 was completed for the StrykerSpine Radius® Spinal System, including the subjectcomponents |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 7 2008
Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K082608
Trade/Device Name: Radius® Spinal System Line Extension- Vitallium® Rod Regulation Number: 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: August 11, 2008 Received: September 8. 2008
Dear Mr. Truesdale:
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.
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.
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Page 2- Mr. Curtis Truesdale
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities world the Act from the Division of Small Manufacturers, International and Consumer Assistance at itse free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Wilkerson
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): K082608
Device Name: Radius® Spinal System Line Extension – Vitallium® Rod
Indications for Use:
The Radius® Spinal System is intended for anterior/anterolateral and posterior, noncervical 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); spinaly stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed nrevious fusion.
The Radius® Spinal System can also be linked to the Xia® Titanium Spinal System via the Ø5.5 mm to Ø6.0 mm Radius® rod-to-rod connector.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dephna Nummms
(Division Sign-Off)
Dep 10/17/10
Division of General. Restorative. and Neurological Devices
Page _1_of
510(k) Number L082608
§ 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.