(88 days)
The WILLOW PTA Balloon Dilatation Catheter is intended to dilate stenoses in the illac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Both the WILLOW and ELM are co-axial PTA Balloon Dilatation Catheters with a distal inflatable balloon. The lumen between the inner shaft is used for inflation of the balloon with contrast medium; the inner shaft lumen permits the use of a quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenoses.
The following materials are used in the WILLOW PTA Balloon Dilatation Catheter: Nylon 11, Polyethylene, Polycarbonate, and 90% Platinum/10% Iridium. The following materials are used in the ELM PTA Balloon Dilatation Catheter: Nylon 11, Pebax, Polycarbonate, Polyethylene, and 90% Platinum/10% Iridium. All materials in both devices were tested per ISO 10993-1 and determined to be biocompatible.
The provided document describes the Creagh Medical WILLOW and ELM PTA Balloon Dilatation Catheters, submitted for 510(k) clearance in 2010. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving de novo safety and effectiveness through clinical trials with specific acceptance criteria related to a disease state or imaging modality.
Therefore, the acceptance criteria and study detailed below relate to device performance characteristics intended to show that the new devices are as safe and effective as their legally marketed predecessors.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in a numerical or percentage format for all performance aspects, nor does it provide detailed quantitative results for every test. Instead, it broadly states that "performance testing demonstrated that the device performed as intended and in compliance with relevant consensus standards." However, for specific critical performance metrics, quantitative results are provided to support substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (WILLOW) | Reported Device Performance (ELM) |
|---|---|---|---|
| Rated Burst Pressure | 99.9% of product meets specification (with 95% confidence) | 99.9% of product meets specification (with 95% confidence) | 99.9% of product meets specification (with 95% confidence) |
| Compliance | 99.7% of product meets specification (with 95% confidence) | 99.7% of product meets specification (with 95% confidence) | 99.7% of product meets specification (with 95% confidence) |
| Biocompatibility | All materials tested per ISO 10993-1 and determined biocompatible | Achieved: All materials tested per ISO 10993-1 and determined biocompatible | Achieved: All materials tested per ISO 10993-1 and determined biocompatible |
| Sterilization | Validated | Achieved: Sterilization validated | Achieved: Sterilization validated |
| Shelf Life | Validated | Achieved: Shelf life validated | Achieved: Shelf life validated |
| Other V&V Tests* | Performed as intended & in compliance with standards | Achieved: Performed as intended & in compliance with standards | Achieved: Performed as intended & in compliance with standards |
*Other V&V Tests include: multiple inflation/fatigue and leak tight, balloon lengths and marker band position, inflation and deflation time, wire compatibility, catheter effective length, tensile strength, device profile/sheath compatibility, tip profile, radiopacity, simulated use including pushability and trackability and sheath compatibility, and manifold testing.
2. Sample Size for Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance testing. Instead, it refers to non-clinical design verification/validation tests and analyses.
- Sample Size: The document indicates that for rated burst pressure and compliance testing, the results are presented "with 95% confidence that 99.9% of the product meet the rated burst pressure specification" and "with 95% confidence that 99.7% of the product meets the compliance specification." While this phrasing suggests statistical sampling was used, the exact sample sizes (n) for each specific test are not reported.
- Data Provenance: This is a retrospective non-clinical study conducted by the manufacturer, Creagh Medical, whose address is in Ballinasloe, Co. Galway, Ireland. The data is from internal laboratory testing, not from patients or a specific country of origin in the clinical sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is a submission for a medical device (PTA balloon catheter) based on non-clinical engineering and performance testing, not an AI or diagnostic device that requires expert-established ground truth for image interpretation or disease diagnosis. The "ground truth" here is objective physical and mechanical measurements against established engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is non-clinical device testing, not a study involving human interpretation or adjudication of results. The "adjudication" would be performed by test engineers against predefined engineering specifications and regulatory standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a non-clinical submission for a physical medical device. MRMC studies are typically used for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers are involved in interpreting results.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on objective engineering specifications, performance standards (e.g., ISO, internal design documents), and comparison to the characteristics of the predicate devices. For example:
- Rated Burst Pressure: Ground truth is the specified pressure value the balloon must withstand.
- Compliance: Ground truth is the specified change in balloon diameter for a given pressure.
- Biocompatibility: Ground truth is compliance with ISO 10993-1.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set. The "training" for such devices would involve manufacturing process development and optimization, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set as this is not an AI/algorithmic 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).