(19 days)
The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
The PCB: small MR and OTW features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the PCB device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Angioplasty (PTA) with the PCB device allows dilatation of the target lesion with less pressure, minimizing barotrauma.
Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. The Rated Burst Pressure (RBP) is 12 atm. The devices are available in nominal balloon diameters from 2.0 mm to 4.0 mm and 1.5 cm length.
The OTW devices are attached to a Y-connector at one end; the MR is attached to a female luer. The catheter body for the PCB: small OTW has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire.
The proximal shaft for the PCB:small MR is a hypotube. This hypotube contains the balloon inflation lumen. The distal shaft is made of Pebax material and has a lumen for balloon inflation as well as a guidewire lumen. The guidewire lumen is colored green for case of guidewire insertion. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchange of the catheter. The PCB:small MR and OTW are coated with Bioslide BL at the distal section.
This document is a 510(k) summary for a medical device called the "Peripheral Cutting Balloon (PCB): small Monorail and Over-the-Wire Delivery systems". It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
The document does not describe the acceptance criteria and a study that proves the device meets specific acceptance criteria in the way you've outlined. Instead, it describes a submission seeking substantial equivalence to predicate devices based on bench testing and biocompatibility testing. This is a different regulatory pathway than proving performance against specific clinical efficacy or safety endpoints using a standalone or comparative effectiveness study.
Therefore, many of the requested fields cannot be directly extracted from this document, as the information is not present. Here's what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for a diagnostic or AI device. It mentions "Performance Testing" which consists of "Bench testing and biocompatibility testing" to support substantial equivalence. The specific results or defined acceptance criteria for these tests are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The submission is based on bench testing and biocompatibility testing, not a clinical test set with patient 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)
Not applicable. Ground truth as typically understood for diagnostic performance is not relevant to bench and biocompatibility testing of a physical medical device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic performance.
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 physical device (a catheter) and not an AI or diagnostic imaging device involved in human interpretation or a MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Performance Testing" mentioned (bench and biocompatibility), the "ground truth" would be established by standard engineering and biological testing protocols and criteria. Specific details are not provided in this summary.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary based on the document:
This document describes a 510(k) submission for a medical device (a peripheral cutting balloon catheter) seeking to establish substantial equivalence to legally marketed predicate devices.
- Acceptance Criteria & Device Performance: The document states that "Bench testing and biocompatibility testing support a determination of substantial equivalence." No specific quantitative acceptance criteria or performance metrics are provided in this summary. The device's performance is, implicitly, "substantially equivalent" to the predicate devices in terms of design, fundamental technology, and intended use.
- Study Type: The "study" mentioned for demonstrating equivalence involved "Bench testing and biocompatibility testing." These are laboratory-based evaluations rather than clinical trials with patient data.
- Purpose: The goal was to show that the new device is as safe and effective as pre-existing devices, not to establish novel efficacy or superior performance through clinical trials.
§ 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).