(77 days)
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra-low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires.
The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire (OTW) catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guide wires 0.014 in or 0.018 in to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon.
The effective lengths of the balloon catheter are 90 cm and 150 cm. Markers on the 90 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 150 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The proximal portion of the catheter includes one female Luer-lock port connected to the inflation lumen, and one female Luer-lock port for guidewire lumen.
The balloon lengths are available in 20, 30, 40, 60, 200 and 220 mm sizes with diameters of 1.5, 2.0, 2.5, 3.0, 3.5 and 4.0 mm.
The provided text describes a 510(k) submission for the Sterling™ Over-the-Wire PTA Balloon Dilatation Catheter (K141112). This is a medical device, not an AI/ML device, therefore, many of the requested categories are not applicable.
Here's the analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
Since this is a traditional medical device (a balloon catheter), acceptance criteria are typically related to engineering specifications and performance in bench tests, rather than diagnostic accuracy metrics common for AI/ML devices. The "Performance Data" section states that "Bench testing was performed to support a determination of substantial equivalence." It does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it states that the tests "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "no new safety or performance issues were raised."
Therefore, specific numerical acceptance criteria and reported device performance (e.g., specific burst pressures, deflation times, crossing profiles) are not provided in this document. The document lists the types of tests performed.
| Acceptance Criteria Category (Implied by Test Type) | Reported Device Performance (Summary statement from document) |
|---|---|
| Balloon Compliance | Bench testing demonstrated conformance to requirements. |
| Balloon Nominal Diameter | Bench testing demonstrated conformance to requirements. |
| Balloon Rated Burst Pressure (RBP) | Bench testing demonstrated conformance to requirements. |
| Burst in a Stent | Bench testing demonstrated conformance to requirements. |
| Balloon Multiple Inflation | Bench testing demonstrated conformance to requirements. |
| Balloon Body Length | Bench testing demonstrated conformance to requirements. |
| Crossing Profile | Bench testing demonstrated conformance to requirements. |
| Guidewire Movement | Bench testing demonstrated conformance to requirements. |
| Full Catheter Tensile Extension and Deflation | Bench testing demonstrated conformance to requirements. |
| Sheath Withdrawal | Bench testing demonstrated conformance to requirements. |
| Balloon Multiple Inflation in a Stent | Bench testing demonstrated conformance to requirements. |
| Marker Band to Balloon Alignment | Bench testing demonstrated conformance to requirements. |
| Proximal Balloon Bond and Shaft Tensile Strength | Bench testing demonstrated conformance to requirements. |
| Deflation Time | Bench testing demonstrated conformance to requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in the provided document. The document only mentions "Bench testing."
- Data Provenance: Not specified. Bench testing typically involves laboratory-controlled environments and materials, not patient data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. For this type of medical device (catheter), ground truth is established through physical measurements and engineering specifications, often by qualified engineers and technicians, not clinical experts for diagnostic accuracy.
- Qualifications of Experts: Not applicable in the context of clinical "ground truth" establishment for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. This concept relates to resolving discrepancies among expert readers in diagnostic studies, which is not relevant for bench testing of a balloon catheter.
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:
- MRMC Study: No, this is not an AI/ML device, so an MRMC study is not relevant or performed.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The ground truth for this device is based on engineering specifications, material properties, and physical performance measurements against established industry standards and internal design requirements. For example, "Rated Burst Pressure" has a defined value that the device must meet during testing.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The device is designed, manufactured, and then tested against specifications.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth established for such a purpose.
§ 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).