(30 days)
The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondvlolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The Titanium and Vitallium rods from the Stryker Spine RADIUS® Spinal System are also intended to be used with other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.
This 510(k) is intended to introduce an extension to the existing MANTIS® Spinal System. The proposed line extension includes the addition of titanium Reduction Screws, and use of Stryker Spine Radius titanium and Vitallium® rods with other components of the MANTIS® and MANTIS® Redux Spinal Systems.
This is a 510(k) premarket notification for a medical device (MANTIS® Spinal System and MANTIS® Redux Spinal System) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for a new drug or a novel AI diagnostic might.
Therefore, many of the requested fields cannot be directly extracted from this document as they are not relevant to a 510(k) for a spinal fixation system line extension. The information provided is primarily about mechanical testing and conformity to existing standards, showing the new components perform similarly to the predicate devices.
Here's an attempt to answer the questions based on the provided text, with explanations where information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
The document states that "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems." This implies that the acceptance criteria are generally established by this FDA guidance and relevant consensus standards (e.g., relating to mechanical strength, fatigue, etc. for spinal fixation devices). However, specific quantitative acceptance criteria and reported performance values are not detailed in this summary.
| Acceptance Criteria (Implied by FDA Guidance/Standards) | Reported Device Performance (Implied by Submission) |
|---|---|
| Mechanical Strength | Demonstrated compliance through engineering analysis and testing |
| Fatigue Life | Demonstrated compliance through engineering analysis and testing |
| Biocompatibility (via materials) | Titanium and Vitallium® rods are known biocompatible materials used in predicate devices; assumed to meet standards. |
| Substantial Equivalence | Device is substantially equivalent to predicate devices in terms of material, design, and indications for use. |
2. Sample size used for the test set and the data provenance
The document mentions "Engineering analysis and testing." For mechanical devices, this typically involves testing a sample number of components and assemblies. The specific sample size for the mechanical testing is not provided in this summary.
- Test Set Sample Size: Not specified.
- Data Provenance: The testing would have been conducted by the manufacturer (Stryker Spine) or a contracted lab, likely in the US (Allendale, NJ is mentioned). It is a prospective generation of data for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to a 510(k) for a spinal fixation system line extension. "Ground truth" in the context of clinical expert review is relevant for diagnostic devices or AI algorithms evaluating patient data. For a mechanical device, performance is established through physical and engineering tests, not expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, typically in clinical studies or AI algorithm validation. Mechanical tests have objective outputs.
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 is a mechanical device, not an AI diagnostic or assistance system. MRMC studies are for evaluating the performance of human readers, sometimes aided by AI, on clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
For mechanical testing, the "ground truth" is typically the physical properties and performance characteristics of the materials and device components, measured against established engineering standards (e.g., tensile strength, fatigue limits, compression strength, etc.).
8. The sample size for the training set
Not applicable. This concept applies to AI/ML models. For mechanical testing, there is no "training set" in this sense.
9. How the ground truth for the training set was established
Not applicable.
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Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: MANTIS® Spinal System - Line Extension
SEP 2 5 2009
| Proprietary Name: | MANTIS® Spinal System & MANTIS Redux Spinal System |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | 1) Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 |
| 2) Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060 | |
| 3) Pedicle Screw Spinal System, 21 CFR §888.3070 (b) (1) & (b) (2) | |
| Device Product Code: | NKB, KWP, KWQ, MNH, MNI |
| Proposed Regulatory Class: | Class III |
| 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: | August 4, 2009 |
| Predicate Devices | Stryker Spine MANTIS Spinal System, K061812, K073151;Stryker Spine Xia® Spinal System, K013823, K043473;Stryker Spine Xia® II Spinal System, K063428;Stryker Spine Osteonics Spinal System, K951725; and |
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Description of Device Modification
Intended Use
Summary of the Technological Characteristics
This 510(k) is intended to introduce an extension to the existing MANTIS® Spinal System. The proposed line extension includes the addition of titanium Reduction Screws, and use of Stryker Spine Radius titanium and Vitallium® rods with other components of the MANTIS® and MANTIS® Redux Spinal Systems.
The MANTIS® & MANTIS® Redux Spinal Systems: 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 titanium and Vitallium® rods from the Stryker Spine Radius® Spinal System are intended to be used with the other components of MANTIS® & MANTIS® Redux Spinal Systems.
The Stryker Spine MANTIS® & MANTIS® Redux Spinal Systems, with the incorporation of the subject components, is substantially equivalent to the predicate devices in terms of 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 were completed for the systems.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is a circular seal with the department's name written around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manger 2 Pearl Court Allendale, New Jersey 07401
SEP 2 5 2009
Re: K092631
Trade/Device Name: MANTIS® Spinal System and MANTIS® Redux Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, KWO Dated: August 5, 2009 Received: August 26, 2009
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 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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Page 2 - Mr. Curtis Truesdale
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jambau Buellmo
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: MANTIS® Spinal System and MANTIS® Redux Spinal System
Indications for Use:
The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondvlolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The Titanium and Vitallium rods from the Stryker Spine RADIUS® Spinal System are also intended to be used with other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.
X Prescription Use (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Karen S. Burney for MXM
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K092631
§ 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.