(18 days)
The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and.for the treatment of lomoral, popilisal, mostive or synthetic arteriovenous dialysis fistulae.
The Cordis AMIIA PTA catheter has a shaft with a distal inflatable balloon. The Cordis I Info I I T I causs indicate the dilatation section of the balloon description I wo facilopaque marker bands the balloon dimensions are indicated on the and ald in banoon pracements eter configuration has two proximal shaft nub 1D band. The 112 cm cm from the distal tip to indicate the relative markers at 90 cm and 100 on fistal end of the guiding catheter. An additional position of the catheror to the dist. exit and aids in locating the exit location of the guide wire. the guide wire. A flushing needle is packaged with the catheter as an accessory for flushing A husining necure is packaged with use as indicated in the Instructions for Use
The provided text does not contain information about acceptance criteria or a study proving that the Cordis AMIIA .014" PTA Balloon Catheter meets specific acceptance criteria. The document is a 510(k) summary primarily focused on establishing substantial equivalence to predicate devices (Cordis AVIATOR and Cordis M3 PTA Balloon Catheters).
However, it does mention some general information related to device validation:
- Device performance: The "Safety and Performance Data" section states that the safety and effectiveness were "demonstrated via data collected from non-clinical design verification tests and analyses." It also states that "all materials used in this modified device have been verified according to the 1993-Part 1 and were found biocompatible."
- Intended Use: The device is intended to "dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae."
- Substantial Equivalence: The primary "proof" of the device's market readiness is its substantial equivalence to previously approved predicate devices, not through a separate study against established performance acceptance criteria.
Therefore, I cannot populate the requested table or answer most of the questions because the document does not provide this specific information. It focuses on demonstrating equivalence rather than detailed performance metrics against specific acceptance criteria.
Summary of what cannot be provided from the text:
- Table of acceptance criteria and reported device performance: Not present.
- Sample size and data provenance for test set: Not present. The testing mentioned is "non-clinical design verification tests and analyses."
- Number and qualifications of experts for ground truth: Not applicable/present.
- Adjudication method for test set: Not applicable/present.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone algorithm performance: Not applicable (this is a physical medical device, not an AI algorithm).
- Type of ground truth used: Not applicable in the context requested. The "ground truth" for this device would be its physical properties and biocompatibility, verified against standards.
- Sample size for training set: Not applicable (not an AI algorithm).
- How ground truth for training set was established: Not applicable.
§ 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).