(115 days)
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which shares the similar technological characteristics as the predicate, Powerflex Pro PTA Catheter. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate crossing of tight stenoses. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI). The SABER™ .035" Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has similar device/component constructions as the predicate. Powerflex Pro PTA Catheter. Same as the predicate, the balloon of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement, when under fluoroscopy. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a guide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.
The provided text describes the 510(k) submission for the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. A 510(k) submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not for establishing novel performance criteria or conducting studies that prove efficacy or an AI's performance against human readers. Therefore, the document does not contain the information required to answer most of the questions related to acceptance criteria, AI performance, multi-reader multi-case studies, or detailed ground truth establishment.
The document focuses on showing that the new device (SABER™) is as safe and effective as a previously cleared predicate device (Powerflex™ Pro). This is primarily achieved through:
- Comparison of technological characteristics: demonstrating similarity in design, materials, and operation.
- Biocompatibility testing: ensuring the materials are safe for human contact.
- Design Verification and Validation (DV&V) testing: confirming the device meets pre-determined engineering requirements and performance specifications (e.g., inflation/deflation, burst pressure, kink resistance).
- Sterilization and packaging validation: ensuring the device is sterile and remains so until use.
Here's what can be extracted from the provided text, and where the information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not present a single table of acceptance criteria with corresponding performance data. Instead, it states that "Design Verification and Validation (DV&V) testing were performed to verify that the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter meets the pre-determined design verification and validation requirements." It also states that tests were completed "with favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards pertaining to evaluations of PTA Catheters" and that "favorable results... show that no new questions of safety or effectiveness are raised."
The specific performance tests conducted are listed under "Design Verification Performance Testing":
| Acceptance Criteria (Implied: Conformance to ISO standards and pre-determined design requirements) | Reported Device Performance |
|---|---|
| CSI Withdrawal | Favorable test results |
| Guide Wire Compatibility | Favorable test results |
| Usable catheter length | Favorable test results |
| Kink diameter | Favorable test results |
| Visual coating integrity | Favorable test results |
| Particulate Count Testing | Favorable test results |
| Outer surface lubricity | Favorable test results |
| Marker Band Locations | Favorable test results |
| Inflation / Deflation | Favorable test results |
| No Leakage | Favorable test results |
| Connector compatibility | Favorable test results |
| Hub-Catheter tensile test | Favorable test results |
| Balloon proximal tensile test | Favorable test results |
| Balloon Distal Tip tensile test | Favorable test results |
| Catheter Body Burst (Inflation Lumen) | Favorable test results |
| Catheter Body Burst (Guide Wire Lumen) | Favorable test results |
| Torque-ability | Favorable test results |
| Balloon Working Length | Favorable test results |
| Balloon Diameter | Favorable test results |
| Balloon compliance | Favorable test results |
| Balloon Burst | Favorable test results |
| System Fatigue | Favorable test results |
Note: The document confirms "favorable test results" for all listed tests, indicating they met their respective acceptance criteria. However, explicit numerical thresholds for these criteria are not provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of the number of devices tested for each performance characteristic. The document refers to "samples" being tested (e.g., "T=0 Baseline Sample Testing and T=3 Years Accelerated Aging Testing of Finished Devices").
- Data Provenance: Not specified for the performance testing if it refers to patient data. This is a device performance study, not a clinical study involving patients. Biocompatibility testing was conducted at a "US testing laboratory." The physical manufacturer of the device is Confluent Medical Technologies.
- Retrospective/Prospective: Not applicable in the context of device performance testing.
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)
Not applicable. This submission pertains to a medical device (catheter), not an AI algorithm or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" here is based on engineering specifications, physical measurements, and compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to a process for resolving discrepancies in expert interpretations, which is not relevant for the type of device performance testing described.
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 physical catheter, not an AI or imaging software. Therefore, an MRMC study related to human reader improvement with AI assistance was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to an AI algorithm; the device is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- Engineering Specifications: Pre-determined design requirements and measurable performance parameters (e.g., specific dimensions, burst pressures, tensile strengths).
- Recognized Consensus Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility, ISO 14971 for risk management) and FDA's recognized consensus standards for PTA Catheters.
- Physical Measurements and Laboratory Tests: Direct measurement of device characteristics (e.g., usable catheter length, balloon diameter) and tests under controlled conditions (e.g., inflation/deflation, burst, fatigue).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device. This term is relevant for machine learning models.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, this question is not relevant.
§ 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).