(120 days)
Not Found
No
The device description and intended use clearly define a mechanical fixation system (plates and screws) for spinal surgery. There is no mention of software, image processing, AI, ML, or any data-driven decision-making components. The performance studies are mechanical tests, not algorithmic performance evaluations.
No
This device is a fixation system (plates and screws) used after a laminoplasty procedure to hold or buttress an allograft, preventing its expulsion or impingement on the spinal cord. It mechanically supports the spine rather than treating a disease or condition through a biological or pharmacological effect, which is characteristic of therapeutic devices.
No
Explanation: The device is a fixation system (plates and screws) used after a laminoplasty procedure to stabilize an allograft and prevent impingement on the spinal cord. It is a therapeutic/surgical device, not one that gathers or analyzes data to determine the nature or cause of a disease or condition.
No
The device description explicitly states it consists of "implantable plates and screws," which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in the lower cervical and upper thoracic spine after a laminoplasty procedure to hold or buttress an allograft. This is a surgical implant used in vivo (within the body).
- Device Description: The device is described as implantable plates and screws. These are physical components used in surgery, not reagents or instruments used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NQW
Device Description
The Gallery™ Laminoplasty Fixation System consists of implantable plates and screws that will act as a buttress to maintain decompression after a laminoplasty procedure.
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes ARCH Fixation System (K032534), Blackstone Laminoplasty Fixation System (K043338)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Spine
100 Interpace Parkway
Parsippany, NJ 07054 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No: | 2242816 |
| Contact: | Vivian Kelly
Regulatory Affairs Project Manager
Biomet Spine
100 Interpace Parkway
Parsippany, NJ 07054
Tel.: 973-299-9300, Ext. 2214
Fax: 973-257-0232
Email: 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 §888.3050
Product Code: NQW |
| Predicate Device: | Synthes ARCH Fixation System (K032534)
Blackstone Laminoplasty Fixation System (K043338) |
| Device Description: | The Gallery™ Laminoplasty Fixation System consists of
implantable plates and screws that will act as a buttress to
maintain decompression after a laminoplasty procedure. |
| 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. |
| Summary of Technologies: | The technological characteristics of the implants and
instruments comprising the Laminoplasty Fixation
System are the same as or similar to the predicate device
commercially distributed. |
1
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.
2
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
3
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
4
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