(151 days)
Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the illac, femoral, iliofemoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Tri-Wedge PTA Scoring Balloon Dilatation Catheter is an over-the-wire (OTW) peripheral balloon dilatation catheter. The catheter working length is 50cm, 75cm, 90cm and 150cm. Balloon diameters range from 3.0mm to 8.0mm. The balloon is made of a minimally compliant material with rated burst pressure of 20atm for Ø3.0-6.0mm and 16atm for Ø7.0-8.0mm. A coaxial double lumen catheter for balloon inflation and guide wire insertion is bonded to a female luer connector to form the proximal shaft. The balloon and the coaxial double lumen are welded to compose the distal of the catheter surface is coated with hydrophilic coating from the tip to the distal shaft. A scoring element with three parallel struts wraps around the balloon has radiopaque markers for positioning the balloon relative to the stenosis. The guide wire lumen is compatible with a standard 0.018-inch or 0.035-inch guide wire that enters from the catheter and extends out from the hub. The catheter is sterilized with EO and for single use only.
The provided text describes a 510(k) summary for the Tri-Wedge PTA Scoring Balloon Dilatation Catheter, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results typical of drug approvals or novel device PMAs. The document focuses on bench testing and an animal study. Therefore, some of the requested information, particularly regarding human clinical trial data (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details for AI), is not applicable or available in this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "The test results met all acceptance criteria," but it does not provide a table detailing specific numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the types of tests performed.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Bench Testing): The document does not specify the exact sample sizes (N) for each individual bench test. It mentions that "Standard bench performance tests were conducted."
- Test Set (Animal Study): The document refers to "the test group and the control group" in the animal study, but the specific sample size (number of animals) for each group is not provided.
- Data Provenance: Not specified in the document. Likely refers to internal laboratory testing conducted by BrosMed Medical Co., Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The reported studies are bench tests and an animal study, which do not typically involve human expert adjudication for ground truth in the same way clinical trials for diagnostic devices do.
4. Adjudication Method for the Test Set
Not applicable for bench and animal studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a physical medical device (scoring balloon catheter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- Bench Testing: The "ground truth" would be established by the specifications and engineering requirements for the device. For example, a balloon's rated burst pressure is a predefined specification the device must meet.
- Animal Study: The "ground truth" for the animal study (safety evaluation) was based on histological examination for inflammation, injury, and endothelialization scores, as well as observations of device performance (passage, dilation, withdrawal, coordination).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Acceptance Criteria and Study Findings (Based on Provided Text):
The acceptance criteria for the Tri-Wedge PTA Scoring Balloon Dilatation Catheter were met through a series of bench tests and an animal study.
| Test Type | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Bench Testing | Adherence to FDA guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" and relevant ISO standards (e.g., ISO 10993-1). Device performance should be "same or similar to the predicate devices." | "The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Tri-Wedge PTA Scoring Balloon Dilatation Catheter design and construction are suitable for its intended use. The results also demonstrate that no new questions of safety or effectiveness are raised." |
| Dimensions | (Implied: Within specified ranges) | Met |
| Simulated Use | (Implied: Successful functionality) | Met |
| Balloon Rated Burst Pressure | (Implied: Meets specified pressure 16-20 atm) | Met |
| Balloon Fatigue & Compliance | (Implied: Meets durability and flexibility standards) | Met |
| Balloon Inflation and Deflation Time | (Implied: Within acceptable timeframes) | Met |
| Catheter Bond Strength | (Implied: Sufficient strength) | Met |
| Scoring Wire Bond Strength | (Implied: Sufficient strength) | Met |
| Tip Pull Strength | (Implied: Sufficient strength) | Met |
| Flexibility and Kinking | (Implied: Maintains structural integrity and navigability) | Met |
| Torque Strength | (Implied: Sufficient resistance to torsion) | Met |
| Radiopacity | (Implied: Visible under fluoroscopy) | Met |
| Scoring Performance | (Implied: Effective scoring) | Met |
| Coating Friction & Integrity | (Implied: Reduced friction, durable coating) | Met |
| Particulate Evaluation | (Implied: Within acceptable limits) | Met |
| Catheter Body Burst Pressure | (Implied: Sufficient pressure resistance) | Met |
| Biocompatibility Testing | In accordance with "ISO 10993-1, Biological Evaluation of Medical Devices" for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility (Hemolysis, Thrombosis, Complement Activation), and Pyrogenicity. | Met |
| Sterilization, Packaging, Shelf Life | (Implied: Maintained sterility and integrity over lifetime) | Met |
| Animal Study | Safety of the device with no significant difference in performance or histopathological findings compared to a control group. | "No significant difference between the test group and the control group in the performance of device passage, dilatation, withdrawal and coordination. Histopathological examination showed no difference between the test group and the control group in terms of inflammation score, injury score and endothelialization score." |
Conclusion from the document: The studies demonstrated that the Tri-Wedge PTA Scoring Balloon Dilatation Catheter met all acceptance criteria, showing substantial equivalence to the predicate device and raising no new questions of safety or effectiveness.
§ 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).