(115 days)
No
The description focuses on the mechanical components and intended use of a surgical implant system, with no mention of AI or ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
Explanation: The device is intended to hold the lamina open following a laminoplasty procedure, which is a therapeutic intervention to treat a medical condition in the spine.
No
The device is an implantable system designed to hold the lamina open after a laminoplasty procedure, not to diagnose a medical condition.
No
The device description explicitly states it consists of implants (expandable laminoplasty plate, hinge plate, bone screws) and instruments, all made of Titanium alloy. This indicates a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (laminoplasty) to hold the lamina open in the spine. This is a physical intervention on the body.
- Device Description: The device consists of implants (plates, screws) and instruments used in surgery. These are physical devices used to modify the body's structure.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly describes a surgical implant system, not a diagnostic test performed on in vitro samples.
N/A
Intended Use / 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.
Product codes
NQW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing conducted to demonstrate substantial equivalence to the predicate devices included: static and dynamic compression loading (modified ASTM 1717-11a), screw driving insertion 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 substantially equivalent to the predicate devices currently on the market and have met all mechanical test requirements based on the engineering rationale.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Centerpiece™ Plate Fixation System (K050082), Synthes Arch™ Fixation System (K032534)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KII3802
Stryker Spine Escalate™ Laminoplasty System
.
. ·
Traditional 510(k) Premarket Notification
APR 1 6 2012
510(k) Summary: Escalate™ Laminoplasty System | |
---|---|
Submitter: | Stryker Spine |
2 Pearl Court | |
Allendale, New Jersey 07401 | |
Contact Person | Ms. Simona Voic |
Sr. Regulatory Affairs Project Manager | |
Phone: 908-522-3482/ Fax: 201-760-8482 | |
Email: simona.voic@stryker.com | |
Date Prepared | April 13, 2012 |
Trade Name | Escalate™ Laminoplasty System |
Proposed Class | Class II |
Classification Name | |
and Number | Spinal interlaminal fixation orthosis, 21 CFR §888.3050 |
Product Code | NQW |
Predicate Devices | The Escalate™ Laminoplasty System was shown to be substantially |
equivalent 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 lower |
cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. | |
The system is intended to hold the lamina open following a | |
laminoplasty procedure. | |
Summary of the | |
Technological | |
Characteristics | The technological characteristics of the Escalate™ Laminoplasty |
System are the same or similar to the predicate devices commercially | |
distributed. | |
Performance Data | The performance testing conducted to demonstrate substantial |
equivalence to the predicate devices included: static and dynamic | |
compression loading (modified ASTM 1717-11a), screw driving | |
insertion 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 substantially | |
equivalent to the predicate devices currently on the market and have met | |
all mechanical test requirements based on the engineering rationale. | |
Substantial | |
Equivalence | The Escalate™ Laminoplasty System was determined to be |
substantially equivalent to the above referenced predicate devices. The | |
subject system does not present any new issues of safety and | |
effectiveness. | |
Conclusion | The Escalate™ Laminoplasty System is substantially equivalent to its |
predicate devices. Mechanical testing as well as other supporting | |
information sufficiently demonstrates the substantial equivalence of the | |
Escalate™ Laminoplasty System to the other laminoplasty fixation | |
systems. Based on this information, the subject system does not raise | |
any new issues regarding the safety or efficacy. |
1
Stryker Spine Escalate™ Laminoplasty System
.
.
Traditional 510(k) Premarket Notification
2
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.
3
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
4
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