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510(k) Data Aggregation
(196 days)
The Stryker® iVAS® Elite Inflatable Vertebral Augmentation 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. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The Stryker iVAS ® Elite Balloon Catheter is a bone tamp with an inflatable component at the distal end. The balloon is inflated to create a void within the vertebral body. It is used with various accessories during vertebral augmentation.
When the balloon is inflated with radiopaque fluid, the balloon expands axially and radially. Two radiopaque markers are fixed near the distal end of the balloon to show the location of the balloon during placement. The balloon is coated with silicone to assist with insertion of the catheter into the access needle.
The patient contacting components of the device such as the balloon, catheter, catheter coating, lubricant and radiopaque material are externally communicating tissue/bone/dentin-limited contact ≤24 hrs.
Associated Accessories include:
- Access cannula/stylet
- Syringe
- Inflator
- Hand Drill
- Coaxial Cement Tube
The provided text describes the acceptance criteria and supporting studies for the Stryker iVAS® Elite Balloon Catheter. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met all requirements of ISO 10993-1 and FDA Guidance (non-sensitizing, non-irritating, non-toxic). |
| Insertion and Retraction Force | Met all acceptance criteria. |
| Tensile Force Testing | Met all acceptance criteria. |
| Length to Diameter Testing | Met all acceptance criteria. |
| Unconstrained Burst | Met minimum open air inflation volume of 5 cc. |
| Constrained Burst | Met all acceptance criteria. |
| One-way Valve Torque | Met all acceptance criteria. |
| Accelerated Aging Testing | Met requirements for general use after 18 months accelerated aging. |
| Silicone Infrared Analysis | Demonstrated equivalence between subject and Stryker predicates. |
| Catheter Flexibility Testing | Met all acceptance criteria (time to deflate, force to bend). |
| Cold Age Testing | Met constrained and unconstrained requirements after conditioning. |
| Balloon inflation pressure | Demonstrated in cadaveric testing that pressures >700 psi are needed to create a void, implying the device can withstand and achieve this pressure. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a sample size for test sets in the traditional sense of a clinical or human performance study. The studies primarily involve bench testing and cadaveric testing.
- Bench Testing: The sample sizes for each specific bench test (e.g., insertion force, tensile force, burst tests) are not provided.
- Cadaveric Testing: The sample size (number of cadavers or vertebral segments) for cadaveric testing is not specified.
- Data Provenance: This information is not directly applicable to the type of testing performed (bench and cadaveric, not human data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The performance is assessed against engineering specifications, material properties, and physical capabilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There was no expert adjudication process as the testing involved physical and material properties rather than medical interpretations.
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
No. An MRMC comparative effectiveness study was not performed. This device is a medical instrument (balloon catheter), not an AI diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This concept is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by engineering specifications, material science standards, and mechanical testing results. For example, the "ground truth" for burst pressure is the specified pressure the balloon must withstand, and for biocompatibility, it's meeting the criteria of ISO 10993-1. Cadaveric testing provided practical validation of the device's ability to create a void in bone.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
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(44 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. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
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 document, K113477, is a 510(k) summary for the Stryker® iVAS Balloon Catheter, seeking clearance for a modification to a previously cleared device. As such, the study described is primarily focused on demonstrating substantial equivalence to predicate devices through functional and biocompatibility testing, rather than a clinical trial with acceptance criteria for disease detection or diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for each test or detailed performance metrics in a table format as might be seen for a diagnostic device. Instead, it makes a general statement of compliance and equivalence.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Testing (e.g., Insertion and Retraction Force, Force to Puncture, Burst, Simulated Use) | Meets specified performance characteristics and is substantially equivalent to predicate devices. (Implies meeting established engineering specifications for safety and effectiveness, and performing comparably to the predicate devices). | "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. The testing which was conducted included functional testing, such as insertion and retraction force, force to puncture, burst and simulated use." |
| Biocompatibility | Meets applicable requirements of FDA Blue Book Memorandum G95-1 and ISO-10993 Part -1. (Implies no unacceptable biological reactions and safe for contact with the body). | "Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing and are biocompatible." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the tests (functional or biocompatibility). It also does not discuss data provenance in terms of country of origin or whether it was retrospective or prospective, as these are typically not relevant for benchtop and biocompatibility testing for medical device clearance of this nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of testing described. The document pertains to engineering performance and biocompatibility of a medical device, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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. This is a medical device clearance for a physical catheter, not an AI or imaging diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used
For functional testing, the "ground truth" would be established engineering specifications, safety standards, and performance benchmarks derived from the predicate devices. For biocompatibility, the ground truth is defined by the requirements of the FDA Blue Book Memorandum G95-1 and ISO-10993.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not an AI/machine learning model that undergoes training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
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