(39 days)
Charger Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures.
The Boston Scientific Charger™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an over-the-wire (OTW) balloon catheter with a dual lumen shaft design. One lumen marked "WIRE" is used to pass the catheter over 0.035" (0.89mm) guidewires. The second lumen marked "BALLOON" communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are two radiopaque marker bands located under the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.
The Charger™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 200 mm and with shaft lengths of 40 cm, 75 cm, and 135 cm.
The provided text is a 510(k) summary for the Charger™ PTA Balloon Dilatation Catheters. This type of document is for a medical device seeking market clearance based on substantial equivalence to an existing predicate device, not for a novel diagnostic algorithm or AI. Therefore, much of the requested information regarding acceptance criteria and studies for AI/diagnostic devices (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) is not applicable to this submission.
The "acceptance criteria" in this context refer to the demonstration of substantial equivalence through comparison to a predicate device and performance testing relevant to the device's function and safety.
Here's the information that can be extracted from the provided text, structured as closely as possible to your request, with explicit notes about what is not applicable:
Acceptance Criteria and Device Performance for Charger™ PTA Balloon Dilatation Catheters
This submission is a 510(k) for a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter. The acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device (Mustang™ PTA Balloon Dilatation Catheters) and confirming that the device meets safety and performance requirements through biocompatibility and bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance/Outcome |
|---|---|---|
| I. Substantial Equivalence to Predicate Device | ||
| Technological Characteristics Comparison: |
- Manifold material & design
- Strain Relief material & design
- Catheter Proximal Shaft / Distal Outer material & design
- Catheter Inner Shaft material & design
- Bumper Tip material & design
- Balloon material, design, function, fundamental technology
- Balloon Bonding Method
- Balloon Forming Process
- Marker Bands
- Coating
- Balloon Protector material & design
- Proximal Shaft Outer Diameter
- Balloon Diameters - Balloon Lengths
- Rated Burst Pressure (RBP)
- Catheter Length
- Recommended Introducer Sheath Compatibility
- Recommended Guidewire
- Sterilization Method
- SAL
- Packaging Material and Configuration | Substantially Equivalent
- Most characteristics are "Same" or "Same material/design serving same function," though some material colorants/additives differ, these are considered not to impact substantial equivalence.
- RBP and Introducer Sheath Compatibility are "Similar."
- Guidewire compatibility is "Same." |
| II. Biocompatibility Testing | - MEM Elution / Cytotoxicity - Guinea Pig Maximization Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Materials Mediated Rabbit Pyrogen
- Hemolysis Direct Contact and Extract
- Complement Activation
- Partial Thromboplastin Time
- In Vitro Hemocompatibility
- Bacterial Mutagenicity (Ames Assay)
- Mouse Lymphoma Assay
- USP Physicochemical Latex | Passed. "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." |
| III. In-vitro Performance Testing | - Bond Tensile | Passed. "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This is a medical device 510(k) submission, not a study evaluating an AI/diagnostic algorithm using a test set of patient data. The "test set" here refers to the physical devices and materials undergoing bench and biocompatibility testing. The data provenance is internal laboratory testing and material characterization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. Ground truth, in the context of AI or diagnostic studies, is typically established by medical experts reviewing patient data. For medical device testing like this, the "ground truth" is adherence to established engineering standards, material specifications, and regulatory requirements, assessed by qualified engineers and scientists in laboratory settings.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple expert readers in diagnostic image interpretation studies. This is not relevant to the bench and biocompatibility testing performed for a PTA balloon catheter.
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. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is for a physical medical device (a catheter), not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical catheter, not a software algorithm.
7. The Type of Ground Truth Used
- For biocompatibility testing: Established biological safety standards (e.g., ISO 10993 series) and specific test methodologies (e.g., MEM Elution, Guinea Pig Maximization Sensitization).
- For in-vitro performance testing (Bond Tensile): Engineering specifications and validated test methods to ensure the device performs as intended and is safe.
- For substantial equivalence: Comparison against the predicate device's documented characteristics and performance specifications.
8. The Sample Size for the Training Set
- Not Applicable. Training sets are used for machine learning algorithms. This is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.