(202 days)
The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) for the purpose of improving myocardial perfusion.
The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of quidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.
The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.
The Boston Scientific Threader ™ Micro-Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a semi-compliant balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter (1.2 mm) and length (12 mm) at recommended pressures. The Threader™ Micro-Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There is a single radiopaque marker band located in the center of the balloon body to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.
Here's a breakdown of the acceptance criteria and the study information for the Threader™ Micro-Dilatation Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity Hemolysis (Direct Contact & Extract) | Tests completed; no new safety issues raised. |
| Sensitization | Tests completed; no new safety issues raised. | |
| Complement Activation | Tests completed; no new safety issues raised. | |
| Intracutaneous Reactivity | Tests completed; no new safety issues raised. | |
| Coagulation | Tests completed; no new safety issues raised. | |
| Acute Systemic Toxicity | Tests completed; no new safety issues raised. | |
| In Vitro Hemocompatibility | Tests completed; no new safety issues raised. | |
| Materials Mediated Pyrogenicity | Tests completed; no new safety issues raised. | |
| USP Physicochemical | Tests completed; no new safety issues raised. | |
| In-Vitro Performance | Effective Length | Tests completed; no new performance issues raised. |
| Catheter Bond Strength | Tests completed; no new performance issues raised. | |
| Shaft Inner and Outer Diameter | Tests completed; no new performance issues raised. | |
| Tip Pull Test | Tests completed; no new performance issues raised. | |
| Balloon Crossing Profile | Tests completed; no new performance issues raised. | |
| Flexibility and Kink | Tests completed; no new performance issues raised. | |
| Balloon Preparation, Deployment, and Retraction | Tests completed; no new performance issues raised. | |
| Torque Strength | Tests completed; no new performance issues raised. | |
| Withdrawal into a Guide Catheter | Tests completed; no new performance issues raised. | |
| Radiopacity | Tests completed; no new performance issues raised. | |
| Balloon Rated Burst Pressure | Tests completed; no new performance issues raised. | |
| Coating Integrity | Tests completed; no new performance issues raised. | |
| Balloon Fatigue (Repeat Inflations) | Tests completed; no new performance issues raised. | |
| Particulate Evaluation | Tests completed; no new performance issues raised. | |
| Balloon Compliance | Tests completed; no new performance issues raised. | |
| Catheter Body Burst Pressure | Tests completed; no new performance issues raised. | |
| Balloon Inflation/Deflation Time | Tests completed; no new performance issues raised. | |
| Contrast Media Flow Rate | Tests completed; no new performance issues raised. | |
| Overall Equivalence | Conformance to regulatory guidance | The device was subjected to testing according to the requirements of "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010." The results provide reasonable assurance of conformance and substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample sizes used for the biocompatibility or in-vitro performance tests. It only states that these tests were "completed."
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin. Given the nature of these tests (bench testing and biocompatibility), they are typically conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided in the 510(k) summary. The ground truth for device performance in this context is established through objective physical and chemical testing against engineering specifications and regulatory guidance, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of data (e.g., medical images) requires consensus. The tests described are objective, physical, and chemical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI with human readers, which is not relevant for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device (catheter), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Threader™ Micro-Dilatation Catheter is based on:
- Engineering Specifications: The device's design parameters (e.g., balloon diameter, length, bond strength) are inherent to its design and manufacturing.
- Regulatory Guidance: The "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" provides the established benchmarks and acceptance criteria for these types of devices.
- Predicate Device Performance: The device is compared to legally marketed predicate devices, implying that their established performance serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. "Training set" refers to data used to train AI algorithms, which is not relevant for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.