(104 days)
The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma.
The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.
This K123942 submission for the Stryker® iVAS Balloon Catheter is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared devices rather than prove novel safety and effectiveness through extensive new clinical trials. Therefore, the information typically associated with acceptance criteria and a detailed study proving performance (like in a PMA submission) will be limited. This type of submission relies heavily on non-clinical testing and comparison to predicates.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, "acceptance criteria" are generally based on meeting the performance characteristics demonstrated by the legally marketed predicate devices through bench testing. The "reported device performance" refers to the results of the non-clinical tests that show the new device performs similarly.
| Acceptance Criterion (Based on Predicate Performance) | Reported Device Performance (Stryker® iVAS Balloon Catheter) |
|---|---|
| Material Properties: Equivalent to predicate devices. | Demonstrated through engineering testing, ensuring materials meet specified standards. |
| Functional Performance (Balloon Inflation/Void Creation): Capable of reducing fractures and creating a void in cancellous bone. | Achieved through bench testing, verifying the inflatable component's ability to inflate and create a void as intended. |
| Biocompatibility: Compliant with biocompatibility standards (implied by predicate equivalence). | Addressed in previous 510(k)s (K113477, K103807, K093419) and presumed to be met. |
| Sterility: Sterilized and maintained sterility (implied by predicate equivalence). | Addressed in previous 510(k)s and presumed to be met. |
| Durability/Reliability: Maintains integrity during intended use (implied by predicate equivalence). | Addressed in previous 510(k)s and presumed to be met. |
| Removal of Contraindication "Fractures in which more than 68% of vertebral height is lost": Bench testing to justify this specific change. | Bench testing performed to support the removal of this contraindication. Specific performance metrics are not detailed in this summary but would have been part of the full submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" for clinical evaluation because no clinical testing was deemed necessary for this submission. The "test set" would primarily refer to samples used in non-clinical bench testing. The document states: "Bench testing was performed for the removal of the contraindication 'Fractures in which more than 68% of vertebral height is lost.'" The specific number of devices or scenarios used for this bench testing is not provided in this summary.
- Data Provenance: The data provenance is primarily from non-clinical bench testing performed by Stryker Instruments. The country of origin for the data is implied to be the United States (Stryker Instruments is based in Kalamazoo, Michigan). The data is prospective in the sense that the bench tests were conducted specifically for this submission or its predicate submissions to demonstrate performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For a 510(k) based on substantial equivalence and non-clinical testing, expert-established "ground truth" derived from clinical data is not a primary component. The "ground truth" for non-clinical testing is typically defined by engineering specifications and objective measurements against those specifications.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since no clinical "test set" requiring expert review for ground truth was used, there was no adjudication method employed in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used to assess the impact of a device (often an AI-powered diagnostic tool) on human reader performance, which is not relevant for this medical device (an inflatable bone tamp).
- Effect Size: N/A, as no such study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The Stryker® iVAS Balloon Catheter is a physical medical device, not a standalone algorithm or software. Therefore, the concept of "standalone performance" in this context does not apply.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical testing, the "ground truth" would be established by engineering design specifications, material standards, and objective physical measurements (e.g., balloon inflation pressure, volume, tamp strength, void creation dimensions). For instance, if testing the removal of the contraindication regarding vertebral height loss, the ground truth would be the measurable performance of the device in various simulated fracture scenarios as defined by mechanical engineering principles.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. Since there is no training set, there is no ground truth to establish for it.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”