(429 days)
Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to the 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)
- spinal tumor
The device is not intended for stand-alone use.
The Integra Spinous Process System consists of an implantable spacer featuring plates of varying lengths with fixed hub diameters and set screws in order to clamp bilaterally to the spinous processes. It is a multicomponent device consisting of two plates coupled by a central hub and locked by a set screw. Each plate contains spikes for fixation to the spinous process to aid in resisting rotation after implantation. The device is available in a range of sizes to accommodate variations in patient pathology and anatomy. It is manufactured from Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and is single use only. The complete system, including insertion and accessory instrumentation for implantation, is packaged in a tray for transportation, cleaning and sterilization.
The Integra Spinous Process System is a medical device and as such, the concept of "acceptance criteria" and "device performance" as it might apply to an AI/ML model's diagnostic accuracy is not directly applicable.
Instead, the provided text describes the device's substantial equivalence to predicate devices based on technological characteristics and performance testing.
Here's an breakdown of the information that is available, structured to align with your request where possible:
(1) A table of acceptance criteria and the reported device performance
For a medical device like the Integra Spinous Process System, "acceptance criteria" are typically related to meeting established mechanical and material standards and demonstrating equivalence to legally marketed predicate devices. "Device performance" is then evaluated against these established standards and predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Devices | The Integra Spinous Process device has the same technological characteristics as the referenced predicate devices, including: composed of two clamping plates, a locking set screw, various hub diameters, and manufactured from Ti-6AL-4V per ASTM F136. |
| Mechanical Performance Requirements (ASTM F1717 & ASTM F1798) | Performance testing (compression bending and torsion) was conducted in accordance with ASTM F1717 and ASTM F1798 standards. Analysis and interpretation of the test results and device comparisons demonstrate that the Integra device is substantially equivalent to the predicate devices. (Specific quantitative performance metrics are not provided in this summary, but the conclusion is that they meet the acceptance criteria by being equivalent to predicates.) |
(2) Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a physical medical device (implant) and not an AI/ML diagnostic system. The "test set" here refers to mechanical testing of the device itself, not clinical data or patient samples. The provenance of such mechanical testing is typically the testing lab.
(3) Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth, in the context of device performance, would be defined by the technical specifications outlined in the ASTM standards (F1717 and F1798) and the performance of the predicate devices. The "experts" would be the engineers and scientists who conducted and interpreted the mechanical tests.
(4) Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth from human expert opinions. For mechanical device testing, the results are typically objectively measured against pre-defined engineering standards.
(5) If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This device is an implantable surgical system, not an AI-assisted diagnostic tool.
(6) If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device.
(7) The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on:
- Established mechanical testing standards: Specifically, ASTM F1717 and ASTM F1798, which define methods for evaluating the mechanical properties of spinal implants.
- Performance of legally marketed predicate devices: The Integra Spinous Process System's performance was compared to the performance of predicate devices (Life Spine Interspinous Fixation System, NuVasive® Spinous Process Plate System, Lanx Spinous Process Fusion Plate (SPFP), and Medtronic CD Horizon Spinous Process Plate) to demonstrate substantial equivalence.
(8) The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML model.
(9) How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI/ML model.
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Integra Spinous Process System Premarket Notification
K121924
Page 1 of 2
.
510(k) Summary
| Company Name: | SeaSpine, Inc.An Integra Life Sciences Company2302 La Mirada DriveVista, CA 92081 |
|---|---|
| Contact Information: | Nicholas M. Cordaro, Director of EngineeringE-mail: Nick.Cordaro@integralife.comPhone: (760) 727-8399, Fax: (760) 477-8260 |
| Michelle Willis, Director of Regulatory AffairsEmail: Michelle.Willis@integralife.comPhone: (760) 216-5104, Fax: (760) 727-8891 | |
| Date Prepared: | August 23, 2013 |
| Trade Name:Common Name:Classification Name:Classification:Product Codes: | Integra Spinous Process SystemSpinous Process SystemSpinal Interlaminal Fixation Orthosis21 CFR 888.3050, Class IIPEK |
| Device Description: | The Integra Spinous Process System consists of an implantable spacer featuringplates of varying lengths with fixed hub diameters and set screws in order toclamp bilaterally to the spinous processes. It is a multicomponent deviceconsisting of two plates coupled by a central hub and locked by a set screw.Each plate contains spikes for fixation to the spinous process to aid in resistingrotation after implantation. The device is available in a range of sizes toaccommodate variations in patient pathology and anatomy. It is manufacturedfrom Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and issingle use only. The complete system, including insertion and accessoryinstrumentation for implantation, is packaged in a tray for transportation,cleaning and sterilization. |
| Intended Use: | Integra Spinous Process System is a posterior non-pedicle supplementalfixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to the spinous processes forthe purpose 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)- spinal tumor |
| The device is not intended for stand-alone use. | |
| • Predicate Devices: | Integra Spinous Process System is substantially equivalent, in whole or in part,to the following commercially available predicate devices in design, materials,indications and performance: |
| Life Spine Interspinous Fixation System K100407NuVasive® Spinous Process Plate System K073278 |
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510(k) Summary
Page 2 of 2
4
Lanx Spinous Process Fusion Plate (SPFP) K090252; K083581; K043484 Medtronic CD Horizon Spinous Process Plate K032037
The technological characteristics of the Integra Spinous Process device are the Technological same as the referenced devices in that it is composed of two clamping plates, a Characteristics: locking set screw, various hub diameters and Ti-6AL-4V per ASTM F136.
Performance testing and a detailed engineering analysis were provided to Testing Summary: demonstrate substantial equivalence with respect to compression bending and torsion. Test standards referenced were ASTM F1717 and ASTM F1798. Analysis and interpretation of the test results and device comparisons demonstrate that the Integra device is substantially equivalent to the predicate devices.
The information submitted in this premarket notification supports a Conclusions: determination that the Integra Spinous Process System is substantially equivalent in technological characteristics and intended use to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 04, 2013
SeaSpine, Incorporated Mr. Nicholas M. Cordaro Director of Engineering 2302 La Mirada Drive Vista, California 92081
Re: K121924
Trade/Device Name: Integra Spinous Process System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: August 27, 2013 Received: August 28, 2013
Dear Mr. Cordaro:
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
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Page 2 - Mr. Nicholas M. Cordaro
forth in the quality systems (OS) regulation (2) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH is Office of Surveillance and Biometries/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 Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121924
Device Name: Integra Spinous Process System
Indications for Use:
Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- degenerative disc disease (defined as back pain of discogenic origin with . confirmed by history and radiographic studies) degeneration of the disc
- . spondylolisthesis
- trauma (i.e., fracture or dislocation) .
- . spinal tumor
The device is not intended for stand-alone use.
Prescription Use __ ਮ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121924.
§ 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.