(164 days)
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is a 6.3 Fr (2.08 mm) diameter, single-lumen, metal alloy hypotube shaft, a proximal polymer outer jacket and a balloon expandable scoring element at the distal tip. Designed to work with a standard PTA balloon catheter. The XO Score catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at its distal end. It is available in various catheter lengths (65cm, 125cm), and longitudinal scoring element lengths (5cm, and 7cm).
The provided text describes the "XO Score Percutaneous Transluminal Angioplasty Scoring Catheter" and its substantial equivalence to predicate devices, without directly presenting acceptance criteria in a table format with reported performance. However, it does state that "All necessary verification steps met pre-determined acceptance criteria to support substantial equivalence." and "All data met pre-determined acceptance criteria." It also mentions "The XO Score catheter met all acceptance criteria to support substantial equivalence."
Based on the information provided, here's an attempt to infer and structure the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of quantitative acceptance criteria alongside specific reported performance values for each criterion. Instead, it generally states that the device met "pre-determined acceptance criteria" and demonstrated "substantially equivalent" performance to the predicate devices.
However, based on the "Functional Testing" and "Comparative Analysis" sections, we can infer areas where performance was assessed and accepted:
| Acceptance Criteria Category | Reported Device Performance (Implicitly Met) |
|---|---|
| Design Verification | Met or exceeded Transit Scientific's in-house requirements and ISO 10555-1 requirements. |
| Packaging Integrity | Validated in conjunction with sterilization studies. |
| Biocompatibility | Verified according to ISO 10993-1 and FDA guidance for external communicating device with limited exposure ( |
§ 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).