(84 days)
The Xia® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The Xia® Growth Rod Conversion Set may be used with any cleared Xia® 4.5 Spinal System rod construct. The Xia® Growth Rod Conversion Set is not intended for use in conjunction with staples.
The Xia® Growth Rod Conversion Set consists of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The Xia® Growth Rod Conversion Set components are manufactured from titanium alloy and are designed to interact with constructs consisting of hooks, screws, connectors, and 4.5mm diameter rods. The Xia® Growth Rod Conversion Set is intended for use only with Xia® 4.5 Spinal System fusion constructs cleared for pediatric use.
The provided text describes the Xia® Growth Rod Conversion Set, a medical device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity for an AI-powered device).
This document is a 510(k) premarket notification for a medical device (Xia® Growth Rod Conversion Set), which primarily focuses on demonstrating substantial equivalence to a predicate device.
Specifically, the "Summary of the Performance Data" section (Page 4, Table "510(k) Summary") states:
"Engineering analysis demonstrated that introduction of the Growth Rod Conversion Set does not adversely affect performance of the Xia® 4.5 Spinal System and does not represent a new, worst case scenario. No additional performance data was provided."
This indicates that the "study" conducted was an engineering analysis to ensure the new component does not negatively impact the performance of an existing, cleared system, rather than a clinical study evaluating diagnostic accuracy or a specific set of performance metrics against acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the provided text. The document is about a different type of medical device review process (510(k) for a physical implantable device) that relies on substantial equivalence and engineering analysis, not diagnostic performance metrics or human reader studies.
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July 29, 2022
Stryker Spine Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K142114
Trade/Device Name: Xia® Growth Rod Conversion Set Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGM
Dear Dr. Hayeck:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 27, 2014. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, (301)796-5650, Ronald.Jean@fda.hhs.gov
Sincerely,
Ronald P. Jean -S
Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2014
Stryker Spine Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K142114
Trade/Device Name: Xia® Growth Rod Conversion Set Regulatory Class: Unclassified Product Code: PGM Dated: July 31, 2014 Received: August 4, 2014
Dear Dr. Hayeck:
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 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Ronald P. Jean -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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Indications for Use
510(k) Number (if known) K142114
Device Name Xia® Growth Rod Conversion Set
Indications for Use (Describe)
The Xia® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, earlyonset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The Xia® Growth Rod Conversion Set may be used with any cleared Xia® 4.5 Spinal System rod construct. The Xia® Growth Rod Conversion Set is not intended for use in conjunction with staples.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary: Stryker Spine Xia® Growth Rod Conversion Set | |
|---|---|
| Submitter | Stryker Spine2 Pearl CourtAllendale, NJ 07401 |
| Contact Person | Garry T. Hayeck, Ph.D.Senior Regulatory Affairs SpecialistPhone: 201-760-8043Fax: 201-760-8406E-mail: garry.hayeck@stryker.com |
| Date Prepared | September 29, 2014 |
| Trade Name | Xia® Growth Rod Conversion Set |
| Common Name | Growing Rod System |
| Proposed Class | Unclassified |
| Product Code | PGM |
| Predicate andReference Devices | The Xia® Growth Rod Conversion Set was shown to be substantiallyequivalent to the primary predicate device listed below:Medtronic Sofamor Danek, CD HORIZON® Growth Rod ConversionSet, K133904The following reference device was also cited in support of thissubmission:Stryker Spine, Xia® 4.5 Spinal System, K121342 |
| Device Description | The Xia® Growth Rod Conversion Set consists of connectors designedto convert a traditional fusion construct into a non-fusion growthenabling construct that can be surgically lengthened on a periodicbasis as the patient grows.The Xia® Growth Rod Conversion Set components are manufacturedfrom titanium alloy and are designed to interact with constructsconsisting of hooks, screws, connectors, and 4.5mm diameter rods.The Xia® Growth Rod Conversion Set is intended for use only with Xia®4.5 Spinal System fusion constructs cleared for pediatric use. |
| Indications for Use | The Xia® Growth Rod Conversion Set is indicated in patients withpotential for additional spinal growth under 10 years of age whorequire surgical treatment to obtain and maintain correction ofsevere, progressive, life-threatening, early-onset spinal deformitiesassociated with thoracic insufficiency, including early-onset scoliosis.The Xia® Growth Rod Conversion Set may be used with any clearedXia® 4.5 Spinal System rod construct. The Xia® Growth Rod ConversionSet is not intended for use in conjunction with staples. |
| Summary ofTechnologicalCharacteristics | Characteristics of the Xia® Growth Rod Conversion Set aresubstantially equivalent to those of the above mentioned CDHORIZON® Growth Rod Conversion Set based on material, geometry,intended use, and fundamental scientific technology, |
| Summary of thePerformance Data | Engineering analysis demonstrated that introduction of the GrowthRod Conversion Set does not adversely affect performance of theXia® 4.5 Spinal System and does not represent a new, worst casescenario. No additional performance data was provided. |
| Conclusion | This system is as safe and effective as the previously cleared CDHORIZON® Growth Rod Conversion Set listed above due to theirshared technological and material characteristics, and principles ofoperation. |
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§ 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.