(194 days)
The Bipore PTA catheters are indicated for percutaneous transluminal angioplasty of the illac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
The Birgore, Inc. PTA Balloon Dilatation Catheter is also indicated for post-deployed stent expansion. Use of the Signe Dilatation Catheter for post-deployment sten expansion was demonstrated on the bench with the Cordi's Palmaz™ stent *.
All sterts must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.
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 sire 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.
This is a 510(k) premarket notification for a medical device (Bipore Balloon Dilatation Catheter), not an AI/ML device. Therefore, many of the requested categories regarding AI/ML performance, such as sample size for training data, ground truth establishment for training data, number of experts for ground truth, and MRMC studies, are not applicable.
However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate its safety and effectiveness based on the provided text.
Here's the breakdown:
Acceptance Criteria and Device Performance for Bipore Balloon Dilatation Catheter
1. Table of Acceptance Criteria and Reported Device Performance
The document describes in vitro functional tests and biocompatibility tests performed on the device. While specific quantitative acceptance criteria (e.g., "burst pressure must exceed X psi") are not explicitly listed in numerical form, the completion of these tests with acceptable results implies that the device met pre-defined performance standards for each. The document states that "it has been demonstrated that the Bipore Balloon Dilatation Catheter product line extensions are safe and effective for their intended use," which serves as the overall reported performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| In Vitro Functional Tests: | The following tests were performed and implicitly met acceptance criteria: |
| - Balloon Burst Strength | Performed |
| - Balloon Multiple Inflation Durability | Performed |
| - Balloon Compliance (Ability to expand predictably) | Performed |
| - Balloon Inflation/Deflation Time Efficiency | Performed |
| - Rated Burst Pressure within the Stent | Demonstrated on the bench within Cardis Palmaz™ stent. * |
| - Balloon Fatigue within the Stent | Demonstrated on the bench within Cardis Palmaz™ stent. * |
| Biocompatibility Tests: | The following tests were performed on the predicate device (Bipore Balloon Dilatation Catheter; 510(k) K961980) and implicitly met acceptance criteria, extending to the new product line due to the nature of the submission (line extensions): |
| - Systemic Toxicity | Performed |
| - Intracutaneous Toxicity | Performed |
| - Implantation Effects | Performed |
| - Hemolysis (Blood compatibility) | Performed |
| - Cytotoxicity (Cell compatibility) | Performed |
| - Sensitization (Allergic reaction potential) | Performed |
| Overall Safety and Effectiveness | "Safe and effective for their intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the functional and biocompatibility tests.
The provenance of the data is bench testing (in vitro) for functional tests and laboratory testing for biocompatibility, carried out by the manufacturer, Bipore, Inc. There is no indication of human subject data, retrospective or prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/ML device, and the "ground truth" for its performance is established through standard engineering and laboratory testing protocols rather than expert consensus on images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. This device is not an AI/ML device relying on human interpretation or adjudication for its performance evaluation. Performance is determined by objective physical and chemical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/ML device, and MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (balloon catheter), not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements and observations from validated in vitro functional tests and standard biocompatibility assessments. For instance, a balloon burst test has a physical burst pressure as its ground truth, not an expert's opinion. Similarly, biocompatibility is assessed against established biological response criteria.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is used for this physical device.
§ 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).