(225 days)
The SureFix Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (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); and/or tumor. The SureFix Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
The JG Spine SureFix Interspinous Fusion System device is a family of posterior, non-pedicle, supplemental fixation devices that are manufactured from Titanium alloy (per ASTM F136). More specifically, these devices are interspinous process implants that are offered in a variety of diameters and lengths and are clamped to two consecutive non-cervical spinous processes. The system is to be implanted from the posterior approach.
The SureFix Interspinous Fusion System is a medical device for spinal interlaminal fixation. The provided text outlines its characteristics, indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices, but it does not describe an AI medical device or a study involving AI. Therefore, I am unable to provide information on acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, or MRMC studies as these are not relevant to the provided content.
The provided text focuses on the mechanical and material properties of a physical spinal implant device, not a software algorithm or AI.
Summary of the Device's Performance and Basis for Substantial Equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in terms of pass/fail thresholds for specific quantitative metrics that are then reported. Instead, it states that testing was done "according to ASTM F1717-11" and "ASTM F543-07," which are general standards for spinal implant testing. The reported performance is a qualitative statement of "substantial equivalence" to predicate devices rather than numerical results against a pre-defined acceptance criterion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance according to ASTM F1717-11 (construct static compression bending, static torsion, dynamic compression bending) | Testing was performed for these parameters. The device was found "substantially equivalent" to the predicate devices (Lanx Spinal System K100935 and Axle Interspinous Fusion System K101471). |
| Performance according to ASTM F543-07 (component level testing) | Testing was performed for this parameter. The device was found "substantially equivalent" to the predicate devices. |
| Demonstrates safety and effectiveness | The device is reported as both a "safe and effective device" based on testing and comparison with predicate devices. |
| Similarities in Indications for Use, technological characteristics, and materials to predicate devices | The device has the "same 'Indications for Use'," "share similar technological characteristics," and "Materials of manufacture are also similar" to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The study involves mechanical testing of physical medical devices, not a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI study, and "ground truth" as typically understood in AI/medical imaging is not relevant here. The evaluation is based on engineering standards and comparison to previously cleared devices.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided text describes mechanical testing of a physical implant, not a study evaluating human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate devices and the compliance with established ASTM standards for mechanical properties. The substantial equivalence is established by demonstrating that the new device performs similarly or equivalently to these benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is not an AI study involving a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI study.
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Section 5 - 510(k) Summary
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| APPLICANT: | JG Spine, LLC |
|---|---|
| Contact Person: | Greg Smith, Manager309 N Sea Lake LanePonte Vedra Beach, FL 32082Tel: (904) 509-6030 |
| Application Correspondent: | Kapstone Medical, LLC100 E. South Main St.P.O. Box 1458Waxhaw, NC 28173 |
| Contact Person: | John Kapitan, President, Kapstone Medical LLCTel: (704) 843-7852Fax: (704) 831-5316Email: jkapitan@kapstonemedical.com |
| AUG 09 2013 | |
| PROPOSED TRADE NAME: | SureFix Interspinous Fusion System |
| PREPARATION DATE: | 08/08/13 |
| DEVICE CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Spinal Interlaminal Fixation Orthosis |
| REGULATION NUMBER: | 888.3050 |
| PRODUCT CODE: | PEK |
| DEVICE DESCRIPTION: | The JG Spine SureFix Interspinous Fusion System device is a family of posterior,non-pedicle, supplemental fixation devices that are manufactured from Titaniumalloy (per ASTM F136). More specifically, these devices are interspinous processimplants that are offered in a variety of diameters and lengths and are clamped totwo consecutive non-cervical spinous processes. The system is to be implantedfrom the posterior approach. |
| INDICATIONS FOR USE: | The SureFix Interspinous Fusion System is a posterior, non-pedicle supplementalfixation device, intended for use at a single level in the non-cervical spine (T1-S1inclusive). It is intended for plate fixation/attachment to spinous processes for thepurpose of achieving supplemental fusion in the following conditions:degenerative disc disease (defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies);spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SureFixInterspinous Fusion System is intended for use with bone graft material, and notfor stand-alone use. |
| MATERIALS: | Medical grade Titanium alloy. |
| PREDICATE DEVICES: | Lanx Spinal System (K100935)Axle Interspinous Fusion System (K101471) |
| TECHNOLOGICCHARACTERISTICS: | The fundamental scientific principles and technological characteristics of theSureFix Interspinous Fusion System, including the intended use, general design,and sizes of the devices are the same as, or similar to, the predicate devices listed |
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above.
Testing of the SureFix Interspinous Fusion System to demonstrate substantial PERFORMANCE DATA: equivalence included construct static compression bending, static torsion and dynamic compression bending according to ASTM F1717-11, and component level testing according to ASTM F543-07. SAFETY & EFFECTIVENESS: The JG Spine SureFix Interspinous Fusion System is substantially equivalent to the predicate Lanx device (K100935) and X-Spine device (K101471). The devices have the same "Indications for Use", share similar technological characteristics, are
CONCLUSION:
available by prescription only, and are provided non-sterile for single-use only. Materials of manufacture are also similar. Performance testing has shown that the SureFix Interspinous Fusion System is substantially equivalent to the predicate devices.
The SureFix Interspinous Fusion System is both a safe and effective device and is substantially equivalent to the predicate devices based on testing and comparison.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 9, 2013
JG Spine, LLC John Kapitan 100 E. South Main St. Waxhaw, NC 28173 US
Re: K124014
Trade/Device Name: SureFix Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: July 8, 2013 Received: July 12, 2013
Dear Mr. Kapitan:
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);
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Page 2 - Mr. John Kapitan
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.htmfor 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Division Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use Statement
Device Name: SureFix Interspinous Fusion System
The SureFix Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (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); and/or tumor. The SureFix Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
× Over-The-Counter Use __ Prescription Use _____________________________________________________________________________________________________________________________________________________________ or
(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)
Colin O'Neill
for RPJ
(Division Sign-Off) Division or Orthopedic Devices 510(k) Number: K124014
§ 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.