(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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).