(124 days)
The Bipore Balloon Dilatation Catheter is recommended for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployed stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*.
The Bipore Balloon Dilatation catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessel. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guide wire to locate the balloon at the site of stenosis. This submission adds two balloon sizes to the existing product line, as follows, and does not affect the safety or effectiveness of the device.
The document provided is a 510(k) premarket notification for a medical device, the Bipore Balloon Dilatation Catheter. It outlines the device's description, indications for use, and confirms substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results typically found in reports specifically designed to prove a device meets acceptance criteria for efficacy or performance in a clinical setting.
The "Testing included" section only mentions "Rated Burst pressure within the stent" and "Balloon Fatigue within the stent." These are likely engineering or bench tests for device integrity and durability, not clinical performance metrics.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the input:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Rated Burst pressure within the stent | Not specified in the provided document |
| Balloon Fatigue within the stent | Not specified in the provided document |
Explanation: The document only lists "Rated Burst pressure within the stent" and "Balloon Fatigue within the stent" under "Testing included." It does not provide the specific acceptance criteria (e.g., minimum burst pressure, number of cycles for fatigue) nor the actual performance results (e.g., "device achieved X burst pressure," "device endured Y fatigue cycles"). These details would typically be found in an engineering report or a full test report, which is not part of this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Cannot be determined from the provided document.
Explanation: The document refers to "bench" testing, implying laboratory-based engineering tests rather than clinical trials with patient data. As such, concepts like "test set," "data provenance," "country of origin," "retrospective," or "prospective" do not apply in the usual clinical sense. The sample size for the devices tested on the bench (e.g., number of catheters subjected to burst pressure or fatigue tests) is not mentioned.
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 / Cannot be determined from the provided document.
Explanation: This question pertains to studies involving human interpretation or assessment, often in diagnostic imaging or clinical outcomes. The mentioned "bench" testing does not involve human experts establishing ground truth in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Cannot be determined from the provided document.
Explanation: Adjudication methods are used in studies where multiple human readers or evaluators independently assess data, and a process is needed to resolve discrepancies. This is not relevant to the "bench" testing described.
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 MRMC comparative effectiveness study was mentioned or performed.
Explanation: The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
Explanation: The device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense for the described tests.
Explanation: For the "Rated Burst pressure" and "Balloon Fatigue" tests, the "ground truth" would be engineering specifications and physical properties measured against those specifications (e.g., a pressure gauge reading, a cycle counter). This isn't "expert consensus," "pathology," or "outcomes data" as typically used in medical device performance evaluation for clinical effectiveness.
8. The sample size for the training set
Not applicable (no training set mentioned).
Explanation: This question relates to machine learning models, which are not involved in the description of this physical medical device's testing.
9. How the ground truth for the training set was established
Not applicable (no training set mentioned).
Explanation: This question also relates to machine learning models, which are not involved.
§ 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).