(25 days)
The UltraScore Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, and stent grafts in the peripheral vasculature.
The ULTRASCORE™ Focused Force PTA Balloon consists of a flexible, over-the-wire (OTW) catheter shaft with a semi-compliant balloon fixed at the distal end. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. Two scoring wires, oriented 180° apart, provide focused force upon dilatation. The ULTRASCORE™ Focused Force PTA Balloon is compatible with 0.014" or 0.035" guidewires, as denoted by the product labeling. The distal portion of the 0.014" guidewire compatible catheters is hydrophilically coated. The proximal portion of the catheter includes a female luer lock hub connected to the catheter with a guidewire lumen and an inflation lumen. Packaged with every product is a protective sheath that is positioned over the balloon and must be removed prior to use. A stylet is placed into the tip of the catheter. These products are not made with natural rubber latex.
This document describes a 510(k) submission for the ULTRASCORE™ Focused Force PTA Balloon (K172571). The device is being submitted as substantially equivalent to a previously cleared device, also named ULTRASCORE™ Focused Force PTA Balloon (K163420).
Key Finding: This submission is for a device that is almost identical to its predicate, with the only change being a new formulation of PTFE on the scoring wires due to supplier discontinuance of the existing PTFE. Therefore, the "study" described is a series of non-clinical, in vitro tests to confirm the new formulation does not negatively impact performance or safety. There is no clinical study involving human participants described in this summary.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-Clinical Performance | |
| Reinsertion | Met All Predetermined Acceptance Criteria. (Specific criteria not detailed in this summary, but implies mechanical integrity and functionality after reinsertion.) |
| Sheath Compatibility | Met All Predetermined Acceptance Criteria. (Specific criteria not detailed, but implies the device can be safely and effectively used with specified introducer sheaths without damage or hindrance.) |
| Biocompatibility (ISO 10993-1:2009) | |
| Cytotoxicity | Met All Predetermined Acceptance Criteria. (Implies the device materials are not toxic to cells.) |
| Sensitization | Met All Predetermined Acceptance Criteria. (Implies the device materials do not cause allergic reactions.) |
| Intracutaneous Reactivity | Met All Predetermined Acceptance Criteria. (Implies the device materials do not cause irritation when in contact with tissue.) |
| Acute Systemic Toxicity | Met All Predetermined Acceptance Criteria. (Implies the device materials do not cause harmful effects via systemic exposure.) |
| Hemocompatibility | Met All Predetermined Acceptance Criteria. (Implies the device materials are compatible with blood and do not cause adverse blood reactions.) |
| Material Mediated Pyrogenicity | Met All Predetermined Acceptance Criteria. (Implies the device materials do not cause fever.) |
| Thrombogenicity | Met All Predetermined Acceptance Criteria. (Implies the device materials do not promote the formation of blood clots.) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of devices or samples used for each test. It refers to "the subject device" and its performance in various in vitro tests.
- Data Provenance: The tests are described as in vitro. No human or clinical data is mentioned, so there is no country of origin or retrospective/prospective designation in this context. The testing was conducted internally as part of design verification and validation by the manufacturer, C.R. Bard, Inc. (Tempe, Arizona, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this submission. The "ground truth" for these in vitro engineering and biocompatibility tests is based on established scientific principles, standardized test methods (e.g., ISO 10993-1:2009 for biocompatibility), and internal engineering specifications/risk assessments, not expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., image reading). The described tests are objective, measurable in vitro 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
- This question is not applicable. No MRMC study was performed as this is a medical device (PTA Balloon), not an AI-powered diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical and biocompatibility testing is based on:
- Applicable standards (e.g., ISO 10993-1:2009).
- FDA Guidance Documents on non-clinical testing.
- Internal Risk Assessment procedures.
- Predetermined acceptance criteria derived from these standards and assessments.
8. The sample size for the training set
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- This question is not applicable. No training set exists.
§ 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).