(115 days)
The Escalate™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.
The Escalate™ System consists of a comprehensive set of implants and instruments designed for a systematic approach to cervical laminoplasty procedures. The system features an expandable laminoplasty plate, a hinge (“Base”) plate, bone screws for fixation, and a set of instrumentation to assist in the implantation and removal of the implants. The plates have screw holes, which allow for attachment to the vertebral body. The screws to be used with the plates are available in a variety of lengths and diameters and are designed to match the anatomical requirements. The Escalate™ Laminoplasty plates and screws are manufactured from Titanium alloy and will be provided non-sterile.
The Stryker Spine Escalate™ Laminoplasty System is a mechanical device intended to hold the lamina open following a laminoplasty procedure. The acceptance criteria and the study that proves the device meets those criteria are detailed below, as per the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
For mechanical devices like the Escalate™ Laminoplasty System, "acceptance criteria" generally refer to established engineering standards or performance thresholds that the device must meet to demonstrate safety and effectiveness for its intended use. "Reported device performance" refers to the results of tests designed to measure how the device performs against these standards.
| Acceptance Criteria (Standard/Test Type) | Reported Device Performance (Outcome) |
|---|---|
| Static Compression Loading | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (Modified ASTM 1717-11a) |
| Dynamic Compression Loading | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (Modified ASTM 1717-11a) |
| Screw Driving Insertion Torque | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (ASTM F543-07) |
| Screw Removal Torque | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (ASTM F543-07) |
| Screw Torque to Failure | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (ASTM F543-07) |
| Axial Screw Pull-Out | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (ASTM F543-07) |
| Substantial Equivalence | The Escalate™ Laminoplasty System was determined to be substantially equivalent to the predicate devices (Medtronic Centerpiece™ Plate Fixation System (K050082) and Synthes Arch™ Fixation System (K032534)). The subject system does not present any new issues of safety and effectiveness. |
Study Proving Acceptance Criteria are Met:
The study proving the device meets the acceptance criteria was a series of performance tests conducted to demonstrate substantial equivalence to existing legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The provided 510(k) summary does not specify the exact sample sizes (e.g., number of implants tested, number of screws tested) for each biomechanical test. It only states that "performance testing was conducted."
- Data Provenance: This information is not explicitly stated in terms of country of origin. Given that Stryker Spine is in New Jersey, USA, and is submitting to the US FDA, it is highly probable that the testing was conducted in the USA or by a testing facility compliant with US regulatory standards. The data is retrospective in the sense that it describes tests performed on physical device prototypes, not data gathered from a clinical trial in patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for mechanical performance is established by the specifications of the ASTM standards and engineering principles, not by expert consensus in the way a medical image diagnosis would be. The "experts" involved would be biomechanical engineers and technicians conducting and analyzing the tests, but their specific number and detailed qualifications are not typically reported in this summary format.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical outcomes where there might be disagreement, such as in reading medical images. For biomechanical testing, the results are quantitative measurements against established standards, not subject to subjective adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for diagnostic devices where human readers interpret medical data, often with or without AI assistance, to assess diagnostic performance. The Escalate™ Laminoplasty System is a surgical implant, and its evaluation focuses on mechanical integrity and equivalence, not diagnostic accuracy or human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to this device. A "standalone" performance evaluation typically refers to the performance of an AI algorithm independent of human input. The Escalate™ Laminoplasty System is a physical implant; it does not involve an algorithm.
7. The Type of Ground Truth Used
For this device, the "ground truth" is defined by:
- Established engineering standards and specifications: Specifically, the ASTM standards (ASTM 1717-11a for compression loading and ASTM F543-07 for screw-related tests) provide the benchmarks for acceptable performance.
- Performance of predicate devices: The "ground truth" for substantial equivalence is that the subject device performs similarly to or better than predicate devices already on the market and deemed safe and effective.
8. The Sample Size for the Training Set
This question is not applicable. The Escalate™ Laminoplasty System is a mechanical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by established engineering principles and prior device experience, but not by a machine learning training dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no training set for this mechanical device.
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KII3802
Stryker Spine Escalate™ Laminoplasty System
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Traditional 510(k) Premarket Notification
APR 1 6 2012
| 510(k) Summary: Escalate™ Laminoplasty System | |
|---|---|
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 |
| Contact Person | Ms. Simona VoicSr. Regulatory Affairs Project ManagerPhone: 908-522-3482/ Fax: 201-760-8482Email: simona.voic@stryker.com |
| Date Prepared | April 13, 2012 |
| Trade Name | Escalate™ Laminoplasty System |
| Proposed Class | Class II |
| Classification Nameand Number | Spinal interlaminal fixation orthosis, 21 CFR §888.3050 |
| Product Code | NQW |
| Predicate Devices | The Escalate™ Laminoplasty System was shown to be substantiallyequivalent to the devices listed below:Medtronic Centerpiece™ Plate Fixation System (K050082) Synthes Arch™ Fixation System (K032534) |
| Device Description | The Escalate™ System consists of a comprehensive set of implants and instruments designed for a systematic approach to cervical laminoplasty procedures. The system features an expandable laminoplasty plate, a hinge (“Base”) plate, bone screws for fixation, and a set of instrumentation to assist in the implantation and removal of the implants. The plates have screw holes, which allow for attachment to the vertebral body. The screws to be used with the plates are available in a variety of lengths and diameters and are designed to match the anatomical requirements. The Escalate™ Laminoplasty plates and screws are manufactured from Titanium alloy and will be provided non-sterile. |
| 510(k) Summary: Escalate™ Laminoplasty System | |
| Intended Use/Indications for Use | The Escalate™ Laminoplasty System is intended for use in the lowercervical and upper thoracic spine (C3-T3) in laminoplasty procedures.The system is intended to hold the lamina open following alaminoplasty procedure. |
| Summary of theTechnologicalCharacteristics | The technological characteristics of the Escalate™ LaminoplastySystem are the same or similar to the predicate devices commerciallydistributed. |
| Performance Data | The performance testing conducted to demonstrate substantialequivalence to the predicate devices included: static and dynamiccompression loading (modified ASTM 1717-11a), screw drivinginsertion torque (ASTM F543-07), screw removal torque (ASTM F543),screw torque to failure (ASTM F543-07), and axial screw pull-out(ASTM F543-07).The performance data verifies that the subject devices are substantiallyequivalent to the predicate devices currently on the market and have metall mechanical test requirements based on the engineering rationale. |
| SubstantialEquivalence | The Escalate™ Laminoplasty System was determined to besubstantially equivalent to the above referenced predicate devices. Thesubject system does not present any new issues of safety andeffectiveness. |
| Conclusion | The Escalate™ Laminoplasty System is substantially equivalent to itspredicate devices. Mechanical testing as well as other supportinginformation sufficiently demonstrates the substantial equivalence of theEscalate™ Laminoplasty System to the other laminoplasty fixationsystems. Based on this information, the subject system does not raiseany new issues regarding the safety or efficacy. |
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Stryker Spine Escalate™ Laminoplasty System
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Traditional 510(k) Premarket Notification
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Spinc % Ms. Simona Voic Senior Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K113802
Trade/Device Name: Escalate™ Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: March 22, 2012 Received: March 23, 2012
APR 1 6 2012
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. 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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Page 2 - Ms. Simona Voic
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
OR
Enclosure
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Stryker Spine Escalate™ Laminoplasty System
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K | 113802
Device Name: Stryker Spine Escalate™ Laminoplasty System
Indications For Use:
The Escalate™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113802
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.