(226 days)
The PTA balloon dilatation catheter is indicated for the percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, including the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The 0.0180" PTA balloon dilatation catheter is mainly composed of tip tube, inner tube, balloon, marker bands, outer tube, stress release tube and hub. Among them the balloon is the most important part of the catheter. In order to dilate different stenosis, the balloon should be dilated to difference dimension by inflating different pressure. The soft tip at the end of the balloon is to make the balloon catheter more easily to push to the stenosis position. The inner tubing which connects to the tip tubing is for guide wire passage and the pushing road. The two marker bands which wrapping on the inner tubing are for positioning the balloon location by cooperating in vitro monitoring equipment. The distal of the outer tube is connected with the balloon by a variable-diameter stretching structure, which can make the balloon get smaller winding diameter. The proximal of the outer tube is connected with the hub as the inflation passage and the pushing shaft. The hub is for connecting the outer pressure filling equipment. The stress release tubing is for protecting the outer tube from bending. The outer surface of the catheter is coated with a hydrophilic coating that ranges 400mm in length from the tip tube to the proximal end of the balloon, including part of the outer tube.
The provided text describes a 510(k) premarket notification for a PTA Balloon Dilatation Catheter. It outlines the device's characteristics, its comparison to a predicate device, and the performance data used to demonstrate substantial equivalence. However, it does not involve an AI/ML powered device, therefore no information about AI/ML specific aspects likes performance data, sample sizes for training/testing, ground truth establishment, or expert involvement for ground truth creation.
Here's the information based on the provided text, with "N/A" for criteria not applicable to this type of device submission:
Acceptance Criteria and Device Performance Study
The submission demonstrates substantial equivalence for the PTA Balloon Dilatation Catheter to a legally marketed predicate device (SABER .018 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter, K133843). The acceptance criteria are based on meeting performance standards primarily through bench testing and biocompatibility assessments, ensuring the device is suitable for its intended use and does not raise new questions of safety or effectiveness compared to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The general acceptance criteria are that the device's design and construction are suitable for its intended use, and its performance is equivalent to the predicate device, as recommended by the draft Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020). Specific acceptance criteria were applied to each bench test listed below.
| Acceptance Criterion (General) | Reported Device Performance |
|---|---|
| Device design and construction suitable for intended use, meeting relevant recommendations. | "The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use..." |
| Biocompatibility of body-contacting materials in accordance with ISO 10993-1 and FDA draft guidance. | "The results of the testing show that the subject device included in this submission met all acceptance criteria and the subject device is biocompatible." |
| Performance characteristics (e.g., burst pressure, flexibility, coating integrity) equivalent to or better than predicate, and safe for use. | See specific bench tests below. "The results met all acceptance criteria..." |
Specific Bench Tests Conducted:
- Visual inspection
- Dimensional verification
- Hydration test
- Leakage test
- Balloon inflation and deflation time
- Balloon fatigue
- Radiopacity
- Simulated use test/guidewire and introducer sheath compatibility test
- Tip pull strength
- Catheter bond strength
- Torque strength
- Balloon rated burst pressure
- Balloon compliance
- Catheter body burst pressure
- Flexibility and kinking
- Coating integrity
- Particulate evaluation
- Infusion flow rate
- Corrosion resistance test
- Packaging performance Test (Visual inspection, Sealing strength, Sealing integrity, Sterility)
- Shelf life testing
Specific Biocompatibility Tests Conducted:
- Cytotoxicity
- Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
- Hemocompatibility (hemolysis, partial thromboplastin time, complement activation, and in vivo thromboresistance)
- Material-mediated pyrogenicity
All these tests "met all acceptance criteria."
2. Sample size used for the test set and the data provenance
The document indicates that bench testing and biocompatibility testing were performed. However, it does not specify the exact sample sizes used for each of these tests.
Data Provenance: Not explicitly stated, but typically, these tests are conducted under controlled laboratory conditions by the manufacturer or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. Ground truth is established through physical and chemical testing against engineering specifications and industry standards, not expert annotation of data.
4. Adjudication method for the test set
N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. The "acceptance criteria" are based on quantitative measurements from bench and biocompatibility tests.
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
N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device is based on established engineering specifications, industry standards (e.g., ISO 10993-1 for biocompatibility), and performance benchmarks derived from the predicate device and relevant FDA guidance documents. This is determined through physical measurements, chemical analyses, and simulated use tests.
8. The sample size for the training set
N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device.
§ 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).