(375 days)
Inion Spinal Graft Containment System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Inion Spinal Graft Containment System includes plates, meshes and screws which are made of degradable polylactic acid copolymers, P(L/DL)LA. Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The plates and screws include tantalum spheres for postoperative radiographic imaging. The implants are offered in different shapes and sizes suitable for this application. Inion Spinal Graft Containment System implants are provided sterile to the user and are noncollagenous. The shelf life of the device is 3 years.
The provided text is a 510(k) summary for the Inion Spinal Graft Containment System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a de novo study. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment (as would be found in a performance study for a novel device or a device requiring clinical evidence) is not present in this type of submission.
Here's a breakdown of what can be extracted and what is not applicable/provided:
1. Table of acceptance criteria and the reported device performance
- Not applicable/provided. This 510(k) summary is not a report of a performance study against specific acceptance criteria. Its purpose is to demonstrate substantial equivalence to existing devices. The "performance data" mentioned refers to mechanical and degradation characteristics that show it behaves similarly to predicates, not metrics against pre-defined clinical acceptance criteria.
2. Sample size used for the test set and the data provenance
- Not applicable/provided. There is no "test set" in the context of a clinical or performance study as usually understood for AI/diagnostic devices. The submission relies on a comparison of material properties and intended use with predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/provided. Ground truth establishment is not relevant in this type of regulatory submission, as it doesn't involve subjective interpretations (e.g., image-reading by experts).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/provided. Adjudication is not relevant here.
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
- Not applicable/provided. This device is a physical implant, not an AI or diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/provided. Ground truth, in the context of clinical or diagnostic device performance, is not established for this type of submission. The "truth" here relates to material properties and bio-compatibility, which are assessed through engineering and biological testing, not expert consensus or pathology data in a clinical trial.
8. The sample size for the training set
- Not applicable/provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/provided. Not an AI/machine learning device; thus, no training set or ground truth for it.
Summary based on the provided document:
The 510(k) summary for the Inion Spinal Graft Containment System demonstrates substantial equivalence to legally marketed predicate devices, rather than meeting specific performance acceptance criteria from a novel study. The key arguments for substantial equivalence are based on:
- Intended use: Both the Inion system and predicates are used in spinal fusion procedures to maintain the position of weak bony tissue (allografts or autografts) in conjunction with rigid fixation, and are not intended for load-bearing.
- Material composition and scientific technology: The components are made of degradable polylactic acid copolymers, P(L/DL)LA, similar to the predicate devices.
- Degradation profile: The implants retain most strength for 16 weeks and resorb within 2-4 years, which is compared to predicates.
- Mechanical properties: These are considered equivalent, although specific data points are not included in this summary.
- Radiographic markers: The inclusion of tantalum spheres for post-operative imaging is deemed equivalent to the Biomet Tantalum Beads predicate.
The FDA's decision to clear the device is based on this demonstration of substantial equivalence, with the added limitation that the device's "safety and effectiveness... when used without rigid supplemental internal fixation has not been established. This device is not designed to withstand physiologic loads when used by itself." This limitation highlights a critical aspect of how the device must be used, reinforcing that its performance is tied to its use as an adjunct rather than a standalone load-bearing implant.
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510(k) SUMMARY
Image /page/0/Picture/1 description: The image shows the word "INION" in large, bold, white letters against a green background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, sans-serif font, also in white. The overall design is simple and clean, with a focus on the company name and its tagline.
Inion Spinal Graft Containment System
Manufacturer and submitter Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND
Contact Person
Kati Marttinen, Regulatory Affairs Specialist Phone: +358 10 830 6600 Fax: +358 10 830 6691 kati.marttinen@inion.com
Establishment registration number 9710629
Trade name of the device Inion Spinal Graft Containment System
Device classification and product code
Class II Classification Panel: Orthopedic Product Code: KWQ Common name: Appliance, fixation, spinal intervertebral body Regulation number: 21 CFR 888.3060
Predicate devices
Macropore OS SpineTM System (K010911) MacroPore HydrosorbTM Spine System (K041105) Inion S-1 1M Biodegradable Anterior Cervical Fusion System (K051821) Biomet Tantalum Beads - Radiographic Marker (K010348)
Device description and principles of operation
Inion Spinal Graft Containment System includes plates, meshes and screws which are made of degradable polylactic acid copolymers, P(L/DL)LA. Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The plates and screws include tantalum spheres for postoperative radiographic imaging.
The implants are offered in different shapes and sizes suitable for this application. Inion Spinal Graft Containment System implants are provided sterile to the user and are noncollagenous. The shelf life of the device is 3 years.
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510(k) SUMMARY
Inion Spinal Graft Containment System
Image /page/1/Picture/2 description: The image shows the word "INION" in large, white, sans-serif font against a green background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, white, sans-serif font. The background is a textured green pattern.
Indications for use
Inion Spinal Graft Containment System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Substantial equivalence to marketed products
Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion Spinal Graft Containment System are substantially equivalent with the predicate devices Macropore OS Spine™ System (K010911), MacroPore Hydrosorb™ Spine System (K041105) and Inion S-17M Biodegradable Anterior Cervical Fusion System (K051821), and additionally in regard to radiographic marker, with Biomet Tantalum Beads - Radiographic Marker (K010348).
Inion Spinal Graft Containment System is substantially equivalent to predicate Class II devices when used, in conjunction with traditional rigid fixation, in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, because the differences between Inion Spinal Graft Containment System and the predicate devices do not raise new questions of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
JUL 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Laakarinkatu 2 Tampere Finland 33520
K071810 Trade/Device Name: Inion Spinal Graft Containment System Regulation Number: 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: OJB Dated: April 21, 2008 Received: April 24, 2008
Dear Ms. Marttinen:
Re:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings section of the device's labeling:
"The safety and effectiveness of this device, as an adjunct to fusion, when used without rigid supplemental internal fixation has not been established. This device is not designed to withstand physiologic loads when used by itself."
Furthermore, the indication for graft containment use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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Page 2 - Ms. Kati Marttinen
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
DaGrell
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K071810
Device Name:
Inion Spinal Graft Containment System
Indications For Use:
Inion Spinal Graft Containment System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
V. Garten
Page 1 of
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.