(28 days)
The Xia Stainless Steel 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
This 510(k) is intended to introduce a new Stainless Steel material grade for the previously cleared Xia long arm Monoaxial and Polyaxial screws (K061854). The Xia® Stainless Steel 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The provided document, K063428, is a Special 510(k) Premarket Notification for a device modification to the Xia® Stainless Steel Spinal System. It focuses on changing the material grade of previously cleared Xia long arm monoaxial and polyaxial screws. As such, the document primarily addresses substantial equivalence based on material, design, and intended use, rather than presenting a clinical study with acceptance criteria for device performance in the way a diagnostic AI device would.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of regulatory submission. This document describes a modification to an existing device, and the demonstration of substantial equivalence relies on engineering analysis and testing to ensure the new material grade performs comparably to the predicate device, not on a clinical effectiveness study measuring human improvement with AI or ground truth established by experts.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies acceptance criteria through discussions of:
- Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.
- No new types of safety or effectiveness problems raised by the material change.
- Demonstration of substantial equivalence to predicate devices in terms of material, design, and indications for use.
- Comparison of design features, materials, intended use, and performance characteristics.
The specific quantitative pass/fail values for material properties (e.g., tensile strength, fatigue life) are not provided in this summary but would be part of the underlying engineering analysis.
- Reported Device Performance: The document states that "Engineering analysis and testing... was completed for the Stryker Spine Xia® Stainless Steel modified long arm screws." However, the results (i.e., specific performance metrics against quantitative criteria) are not reported in this summary. It only states that the testing was completed to demonstrate compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA's Guidance for Spinal System 510(k)'s 2004 | "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed..." (Specific results not detailed in this summary). |
| No new types of safety or effectiveness problems | "...the device has been demonstrated through a comparison of design features, materials, intended use, and performance characteristics, to be substantially equivalent to existing Xia® Stainless Steel Spinal System screw and hook components." |
| Substantial equivalence to predicate devices | "Documentation is provided which demonstrates the new long arm screws... to be substantially equivalent to its predicate devices in terms of its material, design, and indications for use." "The device modification... raises no new types of safety or effectiveness problems..." (Specific comparative results not detailed in this summary, but the conclusion is affirmative). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a modification to an existing mechanical device (spinal screws), not a diagnostic device involving a "test set" of patient data in the typical sense. The "testing" mentioned refers to engineering and laboratory analysis of the device's material and mechanical properties, not a clinical study on human subjects or a dataset for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. As mentioned above, there is no "test set" requiring expert ground truth in the context of this device modification. Expert input might be involved in defining material specifications or testing protocols, but not in a manner consistent with an AI/diagnostic device evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable.
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
- Not Applicable. This document is for a spinal implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This document is for a mechanical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the context of AI/diagnostic devices). The "ground truth" for this device modification would relate to established material science properties, mechanical testing standards, and predicate device performance characteristics. For example, material composition would be verified against industrial standards, and mechanical strength would be measured against specific thresholds derived from biomechanical requirements.
8. The sample size for the training set
- Not Applicable. As this is not an AI/diagnostic device, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable.
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K063428
Special 510(k) Premarket Notification
| Special 510(k): Device ModificationSummary of Safety and Effectiveness forXia® Stainless Steel Long Arm Screws | DEC 1 1 2006 | |
|---|---|---|
| Proprietary Name: | Xia® Stainless Steel Spinal System | |
| Common Name: | Spinal Fixation Appliances | |
| Proposed Regulatory Class: | Class IIISpinal Interlaminal Fixation Orthosis,21 CFR 888.3050Spinal Intervertebral Body Fixation Orthosis,21 CFR 888.3060Pedicle Screw Spinal System21 CFR 888.3070(b)(1) and (b)(2) | |
| Device Product Code: | NKB, MNH, MNI, KWP, KWQ | |
| For Information contact: | Simona VoicRegulatory Affairs Project Manager2 Pearl CourtAllendale, NJ 07401Telephone: (201) 760-8145Fax: (201) 760-8345Email: Simona.Voic@stryker.com | |
| Date Summary Prepared: | November 9, 2006 | |
| Predicate Devices | Stryker Spine:• Xia® Spinal System: K061854, K012870, K031090• Osteonics Spinal System, K951725 |
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K063428
Special 510(k) Premarket Notification
Description of Device Modification This 510(k) is intended to introduce a new Stainless Steel material grade for the previously cleared Xia long arm Monoaxial and Polyaxial screws (K061854). The Xia® Stainless Steel Spinal System is intended for Intended Use 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Summary of the Technological Documentation is provided which demonstrates the Characteristics new long arm screws of the Stryker Spine Xia Stainless Steel Spinal System to be substantially equivalent to its predicate devices in terms of its material, design, and indications for use. 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 Xia®
Stainless Steel modified long arm screws.
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Special 510(k) Premarket Notification
Class III Summary
A Class III Summary has been submitted in predicate 510(k) #K060361 for the entire Stryker Xia Spinal System line, including the Xia Stainless Steel Spinal System. The Class III summary submitted in 510(k) #K060361 also applied to the Xia® long arm titanium alloy and stainless steel screws and hooks cleared via K061854. The Class III summary, incorporated into the current Special 510(k) by reference, reviewed information relevant to the types of safety and effectiveness problems reported for pedicle screw/rod systems when used for the Class III indications 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).
The conclusion of the Class III Summary was that current literature and MAUDE experience reports suggest that the types of safety and effectiveness problems associated with pedicle screw and rod systems are well known and include: device-related events such as screw breakage, component disassembly, pedicle fracture, component migration/loosening/fracture, and infection; and procedure-related events such as intraoperative assembly difficulty, and events associated with any major surgical procedure (such as myocardial infarction, deep vein thrombosis, and urinary tract infection). Complications can lead to revision surgery, and are sometimes associated with neural injury. Further, surgery does not always achieve its goals of stability and pain relief, and patients can develop instability or pain at adjacent spinal segments. The information presented in this summary does not suggest that the Class III use of pedicle screw/rod systems as described in 21 CFR 888.3070 is associated with any different types of safety and effectiveness problems than are seen with the Class II uses of the same pedicle screw/rod systems.
The device modification of the previously cleared Xia® Stainless Steel long arm screws (K061854), to change from one grade of implantable Stainless Steel to another, raises no new types of safety or effectiveness problems, as the devices have been demonstrated through a comparison of design features, materials, intended use, and performance characteristics, to be substantially equivalent to existing Xia® Stainless Steel Spinal System screw and hook components.
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CLASS III CERTIFICATION
Certification of Adverse Safety and Effectiveness Information Pursuant to 513(f) of the Federal Food, Drug and Cosmetic Act
I certify that, in my capacity as Senior Director of Regulatory and Clinical Affairs of Stryker Spine I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety and effectiveness problems that have been reported for pedicle screws. I further certify that I am aware of the types of problems to which pedicle screws are susceptible and that, to the best of my knowledge, the summary of the types and causes of safety and/or effectiveness problems about pedicle screws reported in K060361 are complete and accurate.
Susan Kearney
Susan Krasny, RAC, Ph.D. Senior Director, Regulatory and Clinical Affairs
Date: 2 Nov 2006
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
DEC 1 1 2006
Re: K063428
Trade/Device Name: Xia Stainless Steel Spinal System
Regulation Number: 21 CFR 888.3070
Regulation Name: Pedicle screw spinal system
Regulatory Class: Class III
Product Code: NKB, KWP, KWQ, MNI, MNH
Dated: November 9, 2006
Received: November 13, 2006
Dear Ms. Voic:
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 - Ms. Simona Voic
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buching
Mark N. Melkerson Director Division of General, Restorative, and Neurologic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOb 3428
Device Name: Xia® Stainless Steel Spinal System
Indications for Use:
The Xia Stainless Steel 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buckner for MCM (Page 1 of 1)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K06 3428
§ 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.