(266 days)
The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures.
The LANDMARK REBOA Catheter consists of five elements:
- . Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
- Catheter Handle (PA 12)
- Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
- Occluder Balloon (polyurethane)
- Guide J-tip (stainless steel, nitinol, acrylic) ●
The provided text is a 510(k) summary for the LANDMARK REBOA Catheter. While it outlines non-clinical testing performed to establish substantial equivalence to a predicate device, it does not contain information about studies involving human readers, AI assistance, or the use of expert consensus for ground truth. This device, a physical medical catheter, is evaluated based on its physical performance characteristics and biocompatibility, not on diagnostic accuracy derived from image analysis or human interpretation.
Therefore, many of the requested points regarding acceptance criteria and studies would not be applicable in this context. The document focuses on demonstrating that the new device performs comparably to a legally marketed predicate device through bench testing and an animal model, rather than validating a diagnostic algorithm's performance.
Here's an attempt to answer the applicable points based on the provided text, with an explanation for the missing information:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a specific table of "acceptance criteria" with quantitative performance metrics for each test in the way one might for a diagnostic AI. Instead, it states that "Performance bench testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system."
The tests performed and implicitly, the criteria for passing them, are:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Balloon Burst Testing: Withstand pressure without bursting. | Met applicable design and performance requirements. |
| Balloon Inflation/Deflation Testing: Inflate and deflate correctly. | Met applicable design and performance requirements. |
| Balloon Diameter to Inflation Volume Testing: Consistent diameter for given inflation volume. | Met applicable design and performance requirements. |
| Occlusion Time Testing: Achieve and maintain occlusion for specified time. | Met applicable design and performance requirements. |
| Torque Testing: Withstand torsional forces. | Met applicable design and performance requirements. |
| Kink Diameter Testing: Resist kinking at specific diameters. | Met applicable design and performance requirements. |
| Fatigue Testing: Withstand repeated stress cycles. | Met applicable design and performance requirements. |
| Freedom From Leakage Testing: No leaks. | Met applicable design and performance requirements. |
| Tensile Strength Testing: Withstand pulling forces. | Met applicable design and performance requirements. |
| Dimensional Testing: Adhere to specified dimensions. | Met applicable design and performance requirements. |
| Maximum Inflation Volume Testing: Achieve specified max inflation volume. | Met applicable design and performance requirements. |
| Shelf-Life Testing: Maintain performance over specified shelf life (12 months). | Demonstrated to meet requirements throughout its shelf life. |
| Simulated Use: Clinically safe for prescription use. | Supported conclusion of clinical safety through simulated use results and risk analysis (ISO 14971:2019). |
| Biocompatibility (ISO 10993): Safe for patient contact. | Fulfilled requirements for External Communicating Device, Circulating Blood, A-Limited ( |
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).