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510(k) Data Aggregation
(266 days)
INJECTION PIN (KIP(02031-02061) (03031-03061))
The Injection Pin, is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F200) for the treatment of fractures caused by trauma, osteoporosis, or turnors in the thoracic/lumbar spine from T9-L5.
The Injection Pin is a single piece of Titanium alloy (Ti 6Al 4V) that complies with ISO 5832-3 and ASTM F136. It is a fenestrated screw that is cannulated along its entire length, with lateral holes along the body that do not interfere or affect the threads. The spherical head of the screw has an internal hexagon for firm coupling with the insertion screwdriver (REF IPST0007).
The Injection Pin implant is a medical device to be placed in the thoracolumbar region through a minimally invasive procedure. This device being cannulated and fenestrated permits the use, when applicable, for the introduction of approved PMMA (Teknimed F20®). It is available in both 5 and 6mm diameters and in lengths 31-61mm in 3mm increments.
The Injection Pin is easily seen Intra-Operatively as well as post-Op with good visualization.
The SLK Ortho LLC Injection Pin (K221697) is a fenestrated screw made of Titanium alloy (Ti 6Al 4V) intended for use in combination with PMMA bone cement (Teknimed F20®) to treat fractures in the thoracic/lumbar spine (T9-L5) caused by severe osteoporosis, trauma, or tumors. The device's substantial equivalence to the predicate device, Hyprevention SAS V-STRUT© (K191709), was established through various performance tests.
Here's an analysis of the acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" in a numerical or pass/fail format for the Injection Pin device. However, the performance data presented is used to demonstrate substantial equivalence to the predicate device, V-STRUT©. The implicit acceptance criterion is that the Injection Pin exhibits substantially equivalent safety, effectiveness, and performance to the predicate device.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance (Injection Pin) |
|---|---|---|
| Biomechanical | Demonstrates substantially equivalent biomechanical behavior to the predicate device (V-STRUT©). | Mechanical testing (bending and torsional tests) was performed at the Polytechnic University of Milan, Dept. of Structural Engineering, applying worst-case loading scenarios. Bone cement injection testing was conducted to verify compatibility and delivery capability with Teknimed F20® cement under worst-case conditions. In silico simulations at Politecnico di Milano were validated and performed for 4 different scenarios, comparing the Injection Pin with the predicate V-STRUT©. The in-silico approach was consistent with the biomechanical behavior of an osteoporotic vertebra after augmentation (force-displacement curves, stiffness, maximum forces). Result: The Injection Pin device demonstrated substantially equivalent biomechanical behavior to the predicate V-strut device. |
| Biocompatibility | Non-cytotoxic, non-pyrogenic, and residuals from sterilization within acceptable limits. | Tested to be non-cytotoxic according to ISO 10993-1 – PART 5. Tested to be non-pyrogenic according to ISO 10993-1. ETO and ECH residuals were performed after EO sterilization process. Comparison with "marketed device" Miniars Screws (K143596) was used to demonstrate the safety of the manufacturing process. |
| Sterility | STERILE with a sterility assurance level (SAL) of 10-6. | Provided STERILE to the end user. Sterilized by Ethylene Oxide in accordance with ISO 11135-1 with a SAL of 10-6. Single use only. |
| Shelf-life | Maintain integrity and sterility for a specified shelf-life. | Released with a maximum shelf-life of 5 years from the date of sterilization. Validation performed in compliance with UNI EN ISO 11607-1:2009, UNI EN ISO 11607-2:2006, UNI EN 868:2009 (relevant sections), ASTM F 1980-07:2011, ASTM F 1608-00, ASTM F 1929-98, ASTM F 1886/ F 1886-M. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Biomechanical and Biocompatibility): The document does not specify a numerical sample size for the mechanical testing or in silico simulations beyond mentioning "worst-case loading scenario" and "4 different scenarios." For biocompatibility, it states "Injection Pin was tested" indicating that testing was performed on representative samples of the device.
- Data Provenance:
- Biomechanical: Testing was conducted at the Polytechnic University of Milan, Dept. of Structural Engineering. In silico simulations were conducted in Labs of Politecnico di Milano.
- Biocompatibility: Testing performed on the Injection Pin device, likely in a laboratory setting.
- Retrospective or Prospective: The testing described appears to be prospective, specifically designed to evaluate the performance of the Injection Pin device for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is generally not applicable to the non-clinical performance studies (biomechanical, biocompatibility, sterility, shelf-life) used for the Injection Pin. These studies evaluate the physical and biological characteristics of the device itself rather than interpretation of clinical images or patient data by human experts. The "ground truth" for these tests is based on established scientific principles, engineering standards (e.g., ISO, ASTM), and laboratory methodologies.
4. Adjudication Method for the Test Set
Not applicable, as this refers to adjudication by experts for clinical data interpretation, which is not described here. The evaluation involves laboratory testing against established specifications and comparison to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance data (biomechanical, biocompatibility, sterility, shelf-life) in comparison to a predicate device, rather than a clinical trial involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies conducted (biomechanical, biocompatibility, sterility, shelf-life) are essentially "standalone" in nature, as they evaluate the device itself and its intrinsic properties without human-in-the-loop performance in a clinical setting. The in silico simulations are also a form of standalone evaluation.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical studies is:
- Biomechanical: Defined by established engineering principles, material science properties, mechanical loads, and the performance characteristics of the legally marketed predicate device (V-STRUT©).
- Biocompatibility: Based on established international standards (ISO 10993-1 parts 5 and ETO/ECH residual limits) and comparisons to a marketed device (Miniars Screws K143596).
- Sterility: Defined by a Sterility Assurance Level (SAL) of 10-6 and adherence to ISO 11135-1.
- Shelf-life: Defined by compliance with packaging and aging standards (e.g., UNI EN ISO 11607, ASTM F 1980-07).
8. The Sample Size for the Training Set
Not applicable. There is no information about a "training set" as this device assessment relies on non-clinical performance testing and in silico simulation for substantial equivalence, not machine learning or AI algorithm development that would involve training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set described in the provided document.
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