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510(k) Data Aggregation
(233 days)
The Advance Biliary Balloon Catheter is indicated for laparoscopic and general surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.
The Advance Biliary Balloon Catheter is a sterile, one-time use, device. The device is a doublelumen catheter manufactured with a nylon shaft. The distal tip of the catheter consists of a nylon balloon and is available in diameters of 6 and 8 millimeters, and a length of 4.0 centimeters. The Advance Biliary Balloon Catheter accepts a 0.035-inch diameter wire guide.
This document pertains to a 510(k) premarket notification for a medical device called the "Advance Biliary Balloon Catheter," not an AI/ML device or software. Therefore, the questions related to AI/ML device performance metrics, such as ground truth, expert adjudication, training/test sets, and AI assistance effects on human readers, are not applicable to the information provided in this document.
The document discusses the substantial equivalence of the Advance Biliary Balloon Catheter to a predicate device (Taut Biliary Balloon Catheter) based on engineering performance tests and biocompatibility, not on a study proving diagnostic or clinical performance determined by an algorithm.
Here's what can be extracted from the provided text regarding acceptance criteria and device performance for this specific medical device:
1. A table of acceptance criteria and the reported device performance:
The document describes several performance tests conducted to ensure the device meets its design input requirements. While it doesn't present these in a formal "acceptance criteria vs. reported performance" table with precise numerical values, it states that the test results "indicated an acceptable" or "appropriate" outcome for each criterion.
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility | Leveraged data from previously cleared devices (K033875, K091527) to mitigate biocompatibility concerns. Demonstrated safety for intended use and duration. |
| Balloon Burst Pressure | Test results indicated an acceptable balloon burst pressure. |
| Balloon Compliance | Test results indicated acceptable balloon compliance. |
| Tensile of Distal Bond of Balloon to Catheter Shaft | Test results indicated that the bond strength is appropriate. |
| Fatigue Test (Balloon stability) | Test results indicate that the balloon fatigue is appropriate. |
| Tensile Test of Hub-to-Shaft Bond | Test results indicated that the bond strength is appropriate. |
| Tensile Test of Proximal Bond of Balloon to Catheter Shaft | Test results indicated that the bond strength is appropriate. |
| Tensile Test of Tip-to-Shaft Bond | Test results indicated that the bond strength is appropriate. |
| Tensile Test of Soft Tip Bond | Test results indicated that the bond strength is appropriate. |
The following questions are not applicable as the document describes a traditional medical device (catheter) and its physical and mechanical performance testing, not an AI/ML diagnostic or predictive device:
- Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g., 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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(311 days)
The Advance® Enforcer™ 35 Focal Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.
The Advance® Enforcer™ 35 Focal Force PTA Balloon Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 6, 8, 10, 12 millimeters and a balloon length of 4 centimeters. The balloon includes four polymer elements, which provide focal force upon inflation. These elements will aid in opening lesions. The catheters are 5.2 French, dependent upon device specification, and will be available in lengths of 50, 80, or 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be supplied sterile and are intended for one-time use.
The provided document describes the mechanical and performance testing of the Advance® Enforcer™ 35 Focal Force PTA Balloon Catheter to demonstrate its substantial equivalence to a predicate device. This is a medical device, and the evaluation is based on engineering and material science tests, not artificial intelligence. Therefore, many of the requested fields related to AI/expert ground truth/etc. are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Balloon Compliance Testing | Labeled diameter at nominal pressure under simulated body temperature. | Each balloon met its labeled diameter at the nominal pressure. The acceptance criterion was met. |
| Balloon Profile Testing | Diameters less than maximum outside diameter for intended sheath size. | Diameters for each catheter were less than the maximum outside diameter appropriate for the intended sheath size. The acceptance criterion was met. |
| Fatigue Testing | From leakage and damage on inflation after 10 cycles of inflation/deflation (ISO 10555-4). | Balloons were free from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation. Conformed to ISO 10555-4. The acceptance criterion was met. |
| Balloon Burst Testing | Burst at or above minimum rated burst pressure, with all failure modes being linear tears. | Balloons burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The acceptance criteria were met. |
| Balloon Inflation/Deflation Testing | Inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. | Balloons inflated to rated burst pressure within 60 seconds and fully deflated within 60 seconds. The acceptance criteria were met. |
| Sheath Compatibility Testing | Capable of being inserted and retracted from an appropriately sized sheath without excessive resistance. | Catheters were capable of being inserted and retracted from an appropriately sized sheath without experiencing excessive resistance. The acceptance criterion was met. |
| Tensile Strength Testing | Peak load values in accordance with applicable values of ISO 10555-1. | Under proper clinical use of the device, the peak load values were in accordance with the applicable values of ISO 10555-1. The acceptance criteria were met. |
| Soft Tip Integrity Testing | Soft tip did not separate, kink, accordion, deform, or show other anomalies after clinically relevant model passage. | Soft tip did not separate from the catheter, kink, accordion, deform, or show any other anomalies after passage through a clinically relevant model. The acceptance criterion was met. |
| Balloon Working Length Testing | Matched labeled length within expected tolerance. | Balloon working length for the catheters was matched the labeled length within the expected tolerance. The acceptance criterion was met. |
| Simulated Use Testing | Adequate or better performance for preparation, introduction, pushability, trackability, inflatability, deflatability, and interaction with supporting devices. | Devices were adequate or better in terms of preparation, introduction, pushability, trackability, inflatability, deflatability, and interaction with supporting devices. |
| Torque Strength | Withstood at least two rotations before failure. | Balloon catheters withstood at least two rotations before failure. The acceptance criterion was met. |
| Dimensional Verification Testing | Catheter inner diameter, catheter length, and catheter profile are all within acceptable tolerances. | Catheter inner diameter, catheter length, and catheter profile were all within acceptable tolerances. The acceptance criteria were met. |
| Element Effectiveness Testing | Applied at least 20% greater stress in a simulated model than a standard PTA balloon (the predicate PTA5) at a given pressure. | Balloons applied at least 20% greater stress in a simulated model than a standard PTA balloon (the predicate PTA5) at a given pressure. The acceptance criterion was met. |
| Animal Testing | Adequate or better performance for preparation, introduction, pushability, trackability, flexibility, radiopacity, inflatability, deflatability, interaction with supporting devices, and inspection after use. No significant differences in arterial impact relative to the predicate device. | Devices were adequate or better in terms of preparation, introduction, pushability, trackability, flexibility, radiopacity, inflatability, deflatability, interaction with supporting devices, and inspection after use. No significant differences in arterial impact relative to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each test beyond indicating "each balloon" or "balloons" and "catheters". The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. These are engineering performance tests, typically performed in a controlled laboratory environment.
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. This is a medical device based on physical and mechanical properties, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as described above.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the engineering tests, the "ground truth" is defined by the physical specifications, industry standards (e.g., ISO 10555-1, ISO 10555-4), and internal design requirements of the device. For animal testing, it involves direct observation of performance and arterial impact.
8. The sample size for the training set
Not applicable. This device does not use an AI training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an AI training set.
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