(122 days)
The PeriCross™ Epicardial Access Kit is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies in adult patients.
The PeriCross™ Epicardial Access Kit is designed to provide safe and reliable access to the epicardium. The kit is supplied sterile and is designed to deliver a .018" guidewire to the pericardial space.
The PeriCross™ Epicardial Access Kit consists of the following components:
- One (1) PeriCross™ Tunneler Assembly
- One (1) PeriCross™ Access Device
- One (1) Guidewire – 0.018" OD × 80cm Long
- One (1) Coaxial Introducer – 5F × 18cm
The PeriCross™ Tunneler assembly consists of a cannula and a removable blunt obturator that, together, create an atraumatic assembly, which is utilized to gain access to the pericardium via the subxiphoid approach. When the tip of the PeriCross™ Tunneler Assembly reaches the pericardial surface, the obturator is removed, leaving a path to the pericardial surface through the open cannula. The PeriCross™ Access Device is inserted into the cannula and secured via a snap connection. The PeriCross™ Access Device incorporates a thumb slide that deploys tines to engage and retract the pericardium away from the surface of the epicardium. The space created allows for the deployment of an integrated 21ga needle to puncture the pericardium in a location away from the heart. The PeriCross™ Access Device prevents inadvertent deployment of the needle and retraction of the tines via an interlock mechanism. A .018" guidewire can then be deployed through the PeriCross™ Access Device. A 5F x 18cm coaxial introducer is provided to allow for subsequent dilation and guidewire exchange to a .032" guidewire.
The provided FCC 510(k) clearance letter and summary for the PeriCross™ Epicardial Access Kit discuss its design, comparison to predicate devices, and general non-clinical and clinical testing performed to demonstrate substantial equivalence. However, it does not contain the specific details required to fully address all aspects of acceptance criteria and the study that proves the device meets them as requested in the prompt.
Specifically, the document states:
- "The primary efficacy endpoint of achieving guidewire access to the pericardial space using the PeriCross Epicardial Access Kit, confirmed by standard X-ray technique, was achieved in all subjects."
- "There were two non-serious cardiac perforations (≤ 80 mL of bleeding) and one serious cardiac perforation (≥ 80 mL of bleeding), with no surgery required for closure."
This information is related to the outcome of the study, but it does not provide a table of acceptance criteria (e.g., minimum success rate, maximum complication rate) or explicitly state how these specific results meet predefined acceptance criteria. It also lacks details about the test set, ground truth experts, adjudication, MRMC studies, or training set specifics.
Therefore, I will provide a response based on the inference of typical medical device study reporting and what might be implied by the passing results, acknowledging the limitations of the provided text.
Acceptance Criteria and Study Proving Device Performance: PeriCross™ Epicardial Access Kit
Based on the provided 510(k) summary, the primary efficacy endpoint for the PeriCross™ Epicardial Access Kit was the successful achievement of guidewire access to the pericardial space. Safety endpoints related to cardiac perforations were also assessed. While explicit numerical acceptance criteria are not detailed in the provided document, the successful clearance implies that the study results met the FDA's requirements for demonstrating substantial equivalence and safety/efficacy.
Inferring from the "Pass" results and the successful clearance, the implied acceptance criteria were met.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Efficacy: | |
| Guidewire access to the pericardial space achieved (primary efficacy endpoint) | Achieved in all subjects (39/39) |
| Safety: | |
| Acceptable rate of non-serious cardiac perforations ( |
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).