Search Results

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

Note: The specific numerical thresholds for "acceptable" rates of complications are not provided in the document. The "Pass" implies these rates were deemed acceptable by the FDA for clearance.

2. Sample Size and Data Provenance

• Test Set Sample Size: 39 adult patients.
• Data Provenance: The study was a "prospective, non-randomized, single-arm clinical study." The country of origin of the data is not specified in the provided summary. No information is given about a separate test set in the context of an AI/algorithm-driven device, as this is a physical medical device. The "test set" here refers to the clinical study cohort.

3. Number of Experts and Qualifications for Ground Truth

• This device is a physical medical device (catheter introducer), not an AI algorithm. Therefore, the concept of establishing ground truth by "experts" for a test set in the way it applies to diagnostic algorithms (e.g., radiologists labeling images) is not directly applicable.
• The "ground truth" for the device's performance was established by direct observation and confirmation during the clinical procedures (e.g., guidewire access confirmed by X-ray technique, measurement of bleeding for perforations). Clinical outcomes were assessed by the physicians and medical staff conducting the study. The qualifications of these physicians are not detailed but would be assumed to be interventional electrophysiologists or cardiologists performing these complex procedures.

4. Adjudication Method for the Test Set

• As this is a physical device efficacy and safety study, not an AI diagnostic study relying on subjective interpretations, formal "adjudication" in the sense of multiple expert readers is not described.
• The study followed ISO 14155, which specifies requirements for clinical investigations of medical devices for human subjects. This standard would include methods for objective assessment and reporting of outcomes, rather than subjective adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not performed. This type of study is specifically relevant for diagnostic AI tools that assist human readers in interpreting medical images or data. The PeriCross™ Epicardial Access Kit is a physical surgical access device.
• The study was a "comparative effectiveness" study in the sense that it compared the device's performance to a "historical control of a Touhy needle," but this comparison was clinical outcome-based, not an MRMC study comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This concept is applicable to diagnostic algorithms performing without human intervention. The PeriCross™ Epicardial Access Kit is a physical device used by a human operator.

7. Type of Ground Truth Used

• The ground truth used was clinical outcomes and objective measurements observed during the procedures.
  • Efficacy: Guidewire access confirmed by standard X-ray technique.
  • Safety: Presence and severity of cardiac perforations (quantified by bleeding volume, and whether surgery was required). This is essentially outcomes data directly observed during the procedure.

8. Sample Size for the Training Set

• This question is not applicable as the PeriCross™ Epicardial Access Kit is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

9. How Ground Truth for the Training Set Was Established

• This question is not applicable for the same reason as above.

Ask a specific question about this device