(29 days)
The Peripheral Cutting Balloon catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
The 2cm PCB is an Over-The-Wire (OTW) catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The device consists of a double-lumen catheter with a non-compliant balloon attached at the distal tip. One of the lumens connects the Y-Adaptor to the proximal end of the outer shaft and the other connects the Y-Adaptor wire port extending from the wire lumen to the distal end of the balloon. The outer lumen is the balloon inflation lumen and is used to inflate and deflate the balloon during the procedure. The inner lumen is used to pass the catheter over a guidewire. The product is intended to pass a 0.018" (0.46 mm) guidewire. The catheter useable length (effective length) is measured from the distal end of the strain relief to the tip and is available in three sizes - 50 cm, 90 cm and 135 cm. Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. The device is coated with MDX 4-4159 silicone coating.
The provided document is a 510(k) Summary for the 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter (K151253) by Boston Scientific Corporation. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new clinical trial to establish new safety and effectiveness.
Therefore, the acceptance criteria and study information requested in the prompt (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are typically not found in a 510(k) summary for a medical device cleared based on substantial equivalence to existing predicate devices. Such details are usually associated with novel devices requiring clinical trials, de novo submissions, or Pre-Market Approval (PMA) applications, especially for AI/ML-driven devices.
This 510(k) submission primarily relies on bench testing and biocompatibility testing to demonstrate that the proposed device performs as intended and is as safe and effective as its predicate devices.
Here's a breakdown of the information that is available in the document related to performance and acceptance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative format for each test with corresponding performance metrics like one might find in a clinical study report. Instead, it states that the tests provide "reasonable assurance that the proposed device 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 indicates that the device met its internal design specifications and safety requirements, which effectively serve as the acceptance criteria for a 510(k) submission focusing on substantial equivalence.
| Test Type | Reported Device Performance/Conclusion |
|---|---|
| In-Vitro Performance Tests | All performed tests ensured conformance to requirements. (Specific quantitative results or pass/fail thresholds are not detailed in this summary, but the conclusion states "No new safety or performance issues were raised.") |
| Balloon Compliance | Met requirements |
| Balloon Rated Burst Pressure | Met requirements |
| Balloon Multiple Inflation | Met requirements |
| Balloon Deflation Time | Met requirements |
| Introducer Sheath Compatibility | Met requirements |
| Bond Strength | Met requirements |
| Crossing Profile | Met requirements |
| Freedom from Leakage | Met requirements |
| Blade Attach | Met requirements |
| Guide Catheter Compatibility | Met requirements |
| Particulate Release | Met requirements |
| Biocompatibility Tests | All performed tests demonstrated biocompatibility. (The conclusion implies these tests confirm the materials are safe for their intended use and are substantially equivalent to the predicate devices.) |
| In Vitro Cytotoxicity | Met requirements |
| Guinea Pig Maximization Sensitization | Met requirements |
| Intracutaneous Reactivity | Met requirements |
| Acute Systemic Injection | Met requirements |
| Materials Mediated Rabbit Pyrogen | Met requirements |
| Ames Mutagenicity | Met requirements |
| Mouse Lymphoma Assay | Met requirements |
| Direct Contact Hemolysis | Met requirements |
| Complement Activation C3a and SC5b-9 Assay | Met requirements |
| Indirect Extract Hemolysis | Met requirements |
| Partial Thromboplastin Time | Met requirements |
| In Vitro Hemocompatibility | Met requirements |
| USP Physicochemical | Met requirements |
| Natural Rubber Latex | Confirmed absence or acceptable levels for the device, given it's a critical material property for medical devices. (The summary doesn't state "absence" but lists it as a completed test for biocompatibility). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the 510(k) summary. For bench testing, sample sizes would typically be determined by engineering standards or internal quality procedures, but these specific numbers are not publicly disclosed in this type of document.
- Data Provenance: The tests are described as "Bench testing" and "biocompatibility tests," which are conducted in a laboratory setting. There is no mention of country of origin for data; it's assumed to be from Boston Scientific's internal testing facilities or contracted labs. The data is retrospective in the sense that it was generated prior to the submission, but it's not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is a physical medical device (catheter) and its substantial equivalence is demonstrated through engineering and material performance tests, not through interpretation of medical images or other data requiring clinical expert consensus for "ground truth." Ground truth, in this context, would be the known physical properties and performance characteristics of the predicate device, against which the new device is compared via testing.
4. Adjudication Method for the Test Set:
- Not Applicable. As noted above, this involves engineering and biocompatibility tests, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of outputs (e.g., radiologists reading images). This 510(k) is for a therapeutic catheter, not an AI/ML diagnostic aid.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not Applicable. This is a physical medical device, not a software algorithm or an AI/ML product.
7. The Type of Ground Truth Used:
- The "ground truth" for demonstrating substantial equivalence for this device would be:
- Predicate Device Performance: The established safety and performance characteristics of the legally marketed predicate devices (K041993 and K070951).
- Engineering Specifications/Standards: The device must meet predefined engineering specifications, design inputs, and relevant industry standards (e.g., ISO standards for medical devices, specific test methods for balloon catheters).
- Biocompatibility Standards: Compliance with established standards for biological evaluation of medical devices (e.g., ISO 10993 series).
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, no training set for an AI/ML algorithm is 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).