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510(k) Data Aggregation
(91 days)
The RX VIATRAC™ 18 Peripheral Dilatation Catheter is intended:
- To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries)
- For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae.
- For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).
The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended:
- . To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries)
- For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae.
- For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).
The RX VIATRACTM 18 and the OTW VIATRACTM 18 Peripheral Dilatation Catheters were developed in parallel as two platforms, a Rapid Exchange (RX) platform and an Over-the-Wire (OTW) platform. The distal 20 cm of both catheters are identical however, the proximal portions are modified to accommodate either the RX or OTW platform.
The RX catheter is a rapid exchange catheter with an integrated shaft system. The design is based upon the RX VIATRACTM 14 Peripheral Dilatation Catheter, manufactured by Guidant (K983055, 12/30/98). The RX VIATRAC™ 18 Peripheral Dilatation Catheter has catheter lengths of 75 and 135 cm, with balloon diameters of 6.0, 7.0, 8.0, 9.0 and 10.0 mm.
The OTW platform is an over-the-wire, coaxial design catheter that is similar to that of the RX catheter. However, the OTW catheter has an inner member extending the entire length of the catheter, and therefore has no mid-catheter junction. The OTW VIATRAC™ 18 Peripheral Dilatation Catheter has catheter lengths of 75 and 135 cm, with balloon diameters of 6.0, 7.0, 8.0, 9.0 and 10.0 mm.
The XCELON™ balloon, which is identical on both RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of know diameter and length at specific pressures.
The provided text describes the performance data and acceptance criteria for the RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters through bench testing. It does not contain information about a study involving human readers, AI, or specific details for training sets.
Here's an analysis based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accelerated Aging Testing | Not explicitly stated, implied to ensure device integrity over time. | Met acceptance criteria and performed similar to predicate devices. |
| Catheter Preparation Test | Not explicitly stated, implied to assess ease and safety of preparation. | Met acceptance criteria and performed similar to predicate devices. |
| Crossing Profile/Collapsed Profile | Not explicitly stated, implied to assess lubricity and ability to navigate vessels. | Met acceptance criteria and performed similar to predicate devices. |
| Balloon Compliance Test | Not explicitly stated, implied to ensure balloon expands to known diameter and length at specific pressures. | Met acceptance criteria and performed similar to predicate devices. |
| Balloon Inflation/Deflation Times | Not explicitly stated, implied to ensure efficient operation. | Met acceptance criteria and performed similar to predicate devices. |
| Balloon Fatigue Test | Not explicitly stated, implied to ensure durability under repeated inflation/deflation cycles. | Met acceptance criteria and performed similar to predicate devices. |
| Balloon Rupture Test | Not explicitly stated, implied to ensure balloon integrity at specified pressures. | Met acceptance criteria and performed similar to predicate devices. |
| Catheter Soft Tip Tensile Test | Not explicitly stated, implied to ensure tip integrity and prevent detachment. | Met acceptance criteria and performed similar to predicate devices. |
| Catheter Tensile Test | Not explicitly stated, implied to ensure overall catheter shaft integrity. | Met acceptance criteria and performed similar to predicate devices. |
| Catheter Bend Integrity Test | Not explicitly stated, implied to ensure the catheter can navigate tortuous anatomy without kinking. | Met acceptance criteria and performed similar to predicate devices. |
| Catheter Shaft Pressure Test | Not explicitly stated, implied to assess pressure resistance of the shaft. | Met acceptance criteria and performed similar to predicate devices. |
| Inner Member Collapse Test | Not explicitly stated, implied to ensure the inner member remains patent. | Met acceptance criteria and performed similar to predicate devices. |
| Catheter Wall/Mandrel Penetration Test | Not explicitly stated, implied to ensure no unintended penetration. | Met acceptance criteria and performed similar to predicate devices. |
| Support Mandrel Pull Test | Not explicitly stated, implied to assess integrity of support elements. | Met acceptance criteria and performed similar to predicate devices. |
| In-Stent Balloon Rupture Test | Not explicitly stated, implied to ensure safe operation within a stent. | Met acceptance criteria and performed similar to predicate devices. |
| In-Stent Balloon Fatigue Test | Not explicitly stated, implied to ensure durability when expanded within a stent. | Met acceptance criteria and performed similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes bench testing, not a clinical study involving human patients or real-world data. Therefore, the concept of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data is not applicable here. The tests were performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device (a catheter) is established through engineering and material science specifications, not through expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. This was bench testing against predetermined engineering specifications, not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The provided text describes bench testing of a physical medical device (catheter), not a comparative effectiveness study involving human readers, AI, or diagnostic performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm or AI device; it is a physical medical device. The "performance" described is the device's mechanical and material properties.
7. The Type of Ground Truth Used
The ground truth used for these tests would be the engineering specifications and performance characteristics of the device, with comparison to the predicate devices. For example, a balloon must inflate to a specific diameter at a given pressure, or the catheter shaft must withstand a certain tensile load. These are measurable, objective criteria.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is bench testing of a physical device, not an AI or algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set. The "ground truth" for the device's design and performance would have been established during its engineering and manufacturing process based on established standards and clinical needs.
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(118 days)
The Cordis PERFLEX Stainless Steel Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Cordis PERFLEX Stainless Steel Stent and Delivery System consists of the following components:
- The balloon-expandable PERFLEX Stainless Steel Stent; .
- A delivery balloon catheter (either the Cordis PowerFlex or OPTA 5 Balloon . Catheter, depending on the stent size); and,
- . An insertion tool.
The Cordis PERFLEX Stainless Steel Stent and Delivery System features a balloonexpandable, stainless steel, welded wire stent that is delivered by a balloon catheter. The stent is provided premounted upon its associated balloon catheter. The Cordis PowerFlex and OPTA 5 Balloon Catheters are used for the delivery of the PERFLEX Stainless Steel Stents. The Cordis PERFLEX Stainless Steel Stent and Delivery System is advanced over a guidewire through a sheath lumen to an obstruction site in the biliary tree where the balloon is inflated to expand the stent. The balloon is then deflated and removed.
Also included with the Cordis PERFLEX Stainless Steel Stent and Delivery System is a stainless steel insertion tool that can be placed within the hemostatic valve of a commercially available introducer sheath to protect the stent / balloon catheter assembly during its insertion. Once the stent/balloon assembly passes through the valve, the insertion tool is removed.
The Cordis PERFLEX Stainless Steel Stent and Delivery System is provided sterile and is intended for single use only.
This document, a 510(k) summary for the Cordis PERFLEX Stainless Steel Stent and Delivery System, focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness criteria through a new clinical study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific study design, and performance metrics is not present in this submission.
Here's a breakdown of what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary for the Cordis PERFLEX Stainless Steel Stent and Delivery System states: "The safety and effectiveness of the Cordis PERFLEX Stainless Steel Stent and Delivery System have been demonstrated via data collected from nonclinical tests and analyses." It does not provide specific acceptance criteria or reported device performance metrics from a clinical study. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the established safety and effectiveness of those predicates are sufficient.
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 provided in the document. The submission references "nonclinical tests and analyses," which are typically bench tests or animal studies, not human clinical trials. Thus, there is no "test set" in the context of human data.
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 provided in the document. As there is no human "test set" or clinical study with ground truth established by experts, this is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Not applicable as there is no human test set requiring adjudication.
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 provided in the document. MRMC studies are typically for AI/diagnostic imaging devices. This device is a medical implant (stent), and its approval process does not involve MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document. This is not an AI algorithm but a physical medical device; therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document beyond the mention of "nonclinical tests and analyses." For a physical device like a stent, ground truth in nonclinical tests would likely involve engineering specifications, materials testing results, and potentially animal model outcomes demonstrating mechanical integrity, patency, and biocompatibility, as compared to predicate devices.
8. The sample size for the training set
This information is not provided in the document. There is no mention of a "training set" in the context of machine learning or AI. For nonclinical tests, the "sample size" would refer to the number of devices tested, but this detail is not given.
9. How the ground truth for the training set was established
This information is not provided in the document. Not applicable, as there is no training set in the context of AI. For nonclinical tests, the "ground truth" would be established by validated measurement techniques and adherence to engineering standards.
Summary of the Document's Approach to Demonstrating Safety and Effectiveness:
The document leverages the concept of substantial equivalence to predicate devices. This means that instead of conducting a new clinical study with specific acceptance criteria, and reporting performance against those criteria, the manufacturer is arguing that their new device is fundamentally similar in design, materials, components, method of delivery, and intended use to devices already cleared by the FDA. The "performance data" mentioned refers to nonclinical tests that confirm the new device's characteristics align with those of the predicate devices and meet established engineering and biocompatibility standards. The FDA's clearance (K980653) confirms that they found the device to be substantially equivalent.
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