(28 days)
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI/ML terms or data-driven performance metrics.
No
The device is described as an implant system (plates and screws) used to hold allograft material in place after a laminoplasty procedure. Its function is structural support and stabilization, not the direct treatment or prevention of disease.
No
This device is a surgical implant designed to hold allograft material in place after laminoplasty procedures. It does not perform any diagnostic functions like detecting, monitoring, or predicting medical conditions.
No
The device description explicitly states that the system consists of titanium alloy plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Integra Laminoplasty System is described as titanium alloy plates and screws that are implanted into the spine. It is a surgical implant used to hold allograft material in place within the body.
- Intended Use: The intended use is to hold allograft material in place after a surgical procedure (laminoplasty) in the spine. This is a structural and mechanical function within the body, not a diagnostic test performed on a sample.
The description clearly indicates a surgically implanted device used for structural support, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Integra Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
Product codes
NQW
Device Description
The Integra Laminoplasty System consists of titanium alloy plates and screws that are attached to the lamina after a laminoplasty procedure. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage
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 to T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical Testing: The Integra Laminoplasty System demonstrated equivalent performance to the predicate systems through static testing per ASTM F2193.
Clinical Testing: No clinical testing was required to demonstrate equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with multiple overlapping faces suggesting a sense of community and interconnectedness.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2015
SeaSpine, Incoporated Ms. Michelle Willis Director, Regulatory Affairs 2302 La Mirada Drive Vista, California 92081
Re: K150469
Trade/Device Name: Integra® Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: February 17, 2015 Received: February 23, 2015
Dear Ms. Willis:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Michelle Willis
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Integra® Laminoplasty System
Indications for Use (Describe)
The Integra Laminoplasty System is intended for use in the lower thoracic spine (C3 to T3) for laminoplasty procedures. The Integra Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|| | Prescription Use (Part 21 CFR 801 Subpart D)
|__| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Contact Details
| Applicant Name: | SeaSpine, Inc. (A subsidiary of Integra LifeSciences Corporation) |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | 2302 La Mirada Drive, Vista, CA 92081 |
| (760) 216-5104 | |
| (760) 727-8891 | |
| Contact person: | |
| Email address: | Michelle Willis, - Director, Regulatory Affairs |
| michelle.willis@integralife.com | |
| Date Prepared: | February 17, 2015 |
2. Device Name
| Trade Name: | Integra® Laminoplasty System |
|---|---|
| Common Name: | Laminoplasty Plating System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050) |
| Product Code: NQW, Class II |
3. Legally Marketed Predicate Device(s)
| Predicate | 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|---|
| Primary | K130830 | NQW | Integra Laminoplasty System | SeaSpine, Inc. |
| Reference | K091623 | NQW | NuVasive (Leverage) | |
| Laminoplasty Fixation System | NuVasive, Inc. | |||
| Reference | K050082 | NQW | CENTERPIECETM Plate Fixation System | Medtronic Sofamor Danek |
| USA, Inc. |
4. Device Description
The Integra Laminoplasty System consists of titanium alloy plates and screws that are attached to the lamina after a laminoplasty procedure. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage
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5. Intended Use/Indications for use
The Integra Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
6. Substantial Equivalence Comparison
The Integra Laminoplasty System is substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
7. Non-clinical Testing
The Integra Laminoplasty System demonstrated equivalent performance to the predicate systems through static testing per ASTM F2193.
8. Clinical Testing
No clinical testing was required to demonstrate equivalence.
9. Conclusions
The submitted data demonstrate that the Integra Laminoplasty System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate devices.