(120 days)
The Gallery™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery™ Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The Gallery™ Laminoplasty Fixation System consists of implantable plates and screws that will act as a buttress to maintain decompression after a laminoplasty procedure.
The provided document describes the "Gallery™ Laminoplasty Fixation System," a medical device intended for spinal fixation. It outlines the device's indications for use and a summary of mechanical testing conducted to establish substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test/Standard) | Reported Device Performance |
|---|---|
| Four-point bend test (ASTM F382-99) | Met all mechanical test requirements based on worst-case construct testing and engineering rationale. |
| Axial pullout test (ASTM F543-07) | Met all mechanical test requirements based on worst-case construct testing and engineering rationale. |
| Cantilever bend test | Met all mechanical test requirements based on worst-case construct testing and engineering rationale. |
| Dimensional Analysis | Detailed analysis comparing nominal dimensions to predicates, indicating similarity. |
| Substantial Equivalence | Determined to be substantially equivalent to predicate devices (Synthes ARCH Fixation System (K032534) and Blackstone Laminoplasty Fixation System (K043338)) in intended use, indications, technological characteristics, and principles of operation. No new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of a clinical study or AI model evaluation. The "performance data" refers to mechanical testing of the device itself.
- Sample Size: Not explicitly stated as a number of devices or iterations, but implied to be sufficient for mechanical testing according to the listed ASTM standards and worst-case construct testing.
- Data Provenance: The data is from mechanical testing performed on the device itself (Gallery™ Laminoplasty Fixation System) rather than human or animal subjects. No country of origin is mentioned for the data, as it is laboratory-based mechanical testing. The testing is assumed to be prospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
N/A. This information is not relevant as the study described is mechanical testing of a medical device, not a human reader or AI study where ground truth would be established by experts.
4. Adjudication Method for the Test Set:
N/A. This is not applicable to the mechanical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No MRMC comparative effectiveness study was mentioned. The document describes mechanical testing of a spinal fixation system, not an AI or human-reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No standalone algorithm performance study was mentioned. The device is a physical implantable system, not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" here refers to the established standards and specifications for material properties and mechanical performance of spinal fixation devices. These are implicitly defined by the ASTM standards (ASTM F382-99, ASTM F543-07) and engineering rationale for worst-case construct testing.
8. The Sample Size for the Training Set:
N/A. This device is a physical medical implant, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
N/A. This question is not applicable to the device described.
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JUL 2 Q 2010
K10 0005 Page 1/2
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Sponsor: | Biomet Spine100 Interpace ParkwayParsippany, NJ 07054 |
|---|---|
| Establishment Registration No: | 2242816 |
| Contact: | Vivian KellyRegulatory Affairs Project ManagerBiomet Spine100 Interpace ParkwayParsippany, NJ 07054Tel.: 973-299-9300, Ext. 2214Fax: 973-257-0232Email: Vivian.kelly@biomet.com |
| Date Prepared: | July 16, 2010 |
| Trade/Proprietary Name: | Gallery™ Laminoplasty Fixation System |
| Common/Usual Name: | Appliance, fixation, interlaminal |
| Classification Name: | Spinal interlaminal fixation orthosis |
| Device Classification: | 21 CFR §888.3050Product Code: NQW |
| Predicate Device: | Synthes ARCH Fixation System (K032534)Blackstone Laminoplasty Fixation System (K043338) |
| Device Description: | The Gallery™ Laminoplasty Fixation System consists ofimplantable plates and screws that will act as a buttress tomaintain decompression after a laminoplasty procedure. |
| Indications for Use: | The Gallery™ Laminoplasty Fixation System is intendedfor use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. TheGallery™ Laminoplasty Fixation System holds orbuttresses the allograft in place in order to prevent theallograft from expulsion or impinging on the spinal cord. |
| Summary of Technologies: | The technological characteristics of the implants andinstruments comprising the Laminoplasty FixationSystem are the same as or similar to the predicate devicecommercially distributed. |
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Performance Data:
Substantial Equivalence:
Conclusion:
The following mechanical testing was conducted: four point bend test per ASTM F382-99, axial pullout per ASTM F543-07, and cantilever bend test as well as a detailed dimensional analysis comparing the nominal dimensions of the subject plates to its predicates. The performance data verifies that the subject device is substantially equivalent to other spinal devices currently on the market and has met all mechanical test requirements based on the worst-case construct testing and the engineering rationale.
The Gallery Laminoplasty Fixation System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. Examples of predicates include the Synthes ARCH Fixation System (K032534) and Blackstone Laminoplasty Fixation System (K043338).
The subject device is substantially equivalent to its predicate devices when used as a spinal fixation device. The indications for use and fundamental technology of the device remain unchanged. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject device to the other laminoplasty fixation devices. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 0 2010
Biomet Spine % Ms. Vivian Kelly Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K100805
Trade/Device Name: Gallery™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: July 15, 2010 Received: July 16, 2010
Dear Ms. Kelly:
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
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Page 2 - Ms. Vivian Kelly
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.
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,
Barbara Buehrig
Mark N. Melkerso 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): K100805
Device Name: Gallery Laminoplasty Fixation System
Indications for Use:
The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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_ KI00805
Page 1 of 1
§ 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.