(75 days)
The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
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.
This document is a 510(k) summary for the Boston Scientific Charger™ PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new performance claim. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not directly applicable or available in this submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or algorithm performance study with specific thresholds (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device (Mustang™ Balloon Dilatation Catheters, K103751) through comparison of technological characteristics and performance data. The "acceptance criteria" here are implicitly that the new device performs equivalently or comparably to the predicate device in various engineering and biological tests, without raising new safety or performance issues.
| Characteristic | Predicate Device (Mustang) Performance | Charger Device Performance (Implied Acceptance/Equivalence) |
|---|---|---|
| Technological Characteristics | ||
| Manifold | Same material. Different colorant. Same design serving same function | Same material. Different colorant. Same design serving same function. |
| Strain Relief | Same material. Same design serving same function | Same material. Same design serving same function. |
| Catheter Proximal Shaft / Distal Outer Cable | Same material. Different colorant/additive. Same design serving same function | Same material. Different colorant/additive. Same design serving same function. |
| Catheter Inner Shaft | Same material, different colorant/additive and serving same function | Same material, different colorant/additive and serving same function. |
| Bumper Tip | Same material. Different colorant. Same design serving same function | Same material. Different colorant. Same design serving same function. |
| Balloon | Same balloon material and design and serving same function and fundamental technology | Same balloon material and design and serving same function and fundamental technology. |
| Balloon Bonding Method | Same bonding method and function | Same bonding method and function. |
| Balloon Forming Process | Same forming method and function | Same forming method and function. |
| Marker Bands | Same component serving same function | Same component serving same function. |
| Coating | Same coating serving same function | Same coating serving same function. |
| Balloon Protector | Same material and similar design both serving same function. | Same material and similar design both serving same function. |
| Proximal Shaft Outer Diameter | Same shaft outer diameters | Same shaft outer diameters. |
| Balloon Diameters | Same balloon diameter range serving same function | Same balloon diameter range serving same function. |
| Balloon Lengths | Same balloon length ranges serving same function | Same balloon length ranges serving same function. |
| Rated Burst Pressure (RBP) | Similar rated burst pressure | Similar rated burst pressure. |
| Catheter Length | Same catheter length ranges serving same function | Same catheter length ranges serving same function. |
| Recommended Introducer Sheath Compatibility | Similar ranges and compatibilities | Similar ranges and compatibilities. |
| Recommended Guidewire | Same compatibility. | Same compatibility. |
| Sterilization Method | Same method. | Same method. |
| SAL | Same level of assurance | Same level of assurance. |
| Packaging Material and Configuration | Same design and function | Same design and function. |
| Biocompatibility Testing | Passed (implied in predicate) | Passed (MEM Elution / Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Rabbit Pyrogen, Hemolysis, Complement Activation, Partial Thromboplastin Time, Bacterial Mutagenicity, Mouse Lymphoma Assay, USP Physiochemical Latex) |
| In-vitro Performance Testing | Passed (implied in predicate) | Passed (Bond Tensile) |
The reported device performance for the Charger PTA Balloon Dilatation Catheter is that it "has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised during the testing." This implies the Charger device met the same or similar performance standards as the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and biocompatibility testing.
- Test Set Sample Size: Not explicitly stated for each test, but standard engineering and biological testing typically involve specific sample sizes per test article/batch. These are generally much smaller than clinical study sample sizes.
- Data Provenance: The tests are described as "Biocompatibility testing and bench testing were performed," implying these were conducted by Boston Scientific Corporation (USA, where the submitter is located) within a controlled laboratory setting. This would be considered prospective testing for the purpose of this submission.
- The comparison data for the predicate device (Mustang™) is inherent in its marketing clearance (K103751).
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)
This is not applicable to this type of submission. The ground truth for bench testing (e.g., tensile strength, burst pressure) and biocompatibility testing (e.g., cytotoxicity, pyrogenicity) is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) and laboratory protocols, rather than expert clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for diagnostic interpretation, which is not part of this device's performance evaluation for 510(k) clearance based on substantial equivalence. Performance is measured against engineering specifications and biological safety standards.
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 device is a Balloon Dilatation Catheter, a physical medical device, not an AI software or diagnostic imaging tool. Therefore, MRMC studies and the concept of human readers improving with/without AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. See point 5. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation in this 510(k) is based on:
- Engineering Specifications: Adherence to defined physical and mechanical properties (e.g., bond tensile strength, burst pressure, dimensions).
- Biological Safety Standards: Conformance to established limits for biocompatibility (e.g., non-cytotoxic, non-sensitizing, non-pyrogenic).
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (Mustang™) set the de facto standard for substantial equivalence.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).