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Pacel™ Flow Directed Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.

This catheter is designed to establish temporary right ventricular pacing with or without fluoroscopy guidance for placement. Catheters are depth marked as an aid in catheter placement under fluoroscopy. Electrodes at the catheter tip enable ECG monitoring and bipolar pacing. An inflatable balloon, located between two platinum electrodes, allows for flow directed positioning of the catheter in the right ventricle without fluoroscopy guidance. Once inflated, the balloon aids the operator in crossing the tricuspid valve. After the catheter has crossed the valve, the balloon is deflated and the catheter is advanced to the right ventricular apex in the usual manner. Electrograms are monitored to verify proper positioning in the right ventricular apex and pacing thresholds are obtained to confirm both proper location and reliable pacing. The catheters are available in two curve styles. The distal end of the catheter includes a platinum electrical connector ring and a tip electrode. The proximal end of the catheter includes a two pin electrical connector. The electrical signals can be transmitted to external equipment or from external equipment to the heart.

This document describes the 510(k) summary for the Pacel™ Flow Directed Pacing Catheters, which pertains to a change in the adhesive used to bond the latex balloon to the catheter and seal around the metal electrode ring edges. The submission aims to demonstrate substantial equivalence to a predicate device (Pacel™ Flow Directed Pacing Catheters K914185).

The information provided is not for a device that uses AI or performs any kind of diagnostic or analytical function that would require a study with acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. This submission is for a physical medical device (a catheter) and the studies are primarily engineering design verification tests and biocompatibility studies related to a material change (adhesive).

Therefore, I cannot fulfill the request to provide information about the acceptance criteria and study proving the device meets those criteria in the context of AI/diagnostic device performance. The provided text does not contain any of the following details required:

• Acceptance Criteria Table (related to performance metrics like accuracy, sensitivity, specificity): Not applicable for this type of device. The document mentions "passed all acceptance criteria per the DV requirements" for design verification, but these are related to physical properties of the catheter (e.g., surface appearance, inflation strength, inflation decay).
• Sample size for test set and data provenance: No "test set" in the context of image analysis or algorithm performance. The design verification and animal study would use sample sizes relevant to engineering and animal studies, not AI validation.
• Number of experts for ground truth, qualifications, adjudication method: This is irrelevant for a physical medical device and adhesive change.
• MRMC comparative effectiveness study: Not applicable as there is no "human reader" component or effect size from AI assistance.
• Standalone (algorithm only) performance: Not applicable as there is no algorithm.
• Type of ground truth: Not applicable in the context of diagnostic accuracy.
• Training set size and ground truth establishment for training set: Not applicable as there is no AI algorithm being trained.

The study described is focused on the physical and biological properties of the catheter due to a change in adhesive.

Summary of Stated Device Performance (from the document):

The document reports the following for the non-clinical testing:

1. Design Verification:

   • Acceptance Criteria: "show that the proposed device will meet Product Specification through the labelled Shelf Life of the device (T=18 mo)." and "passed all acceptance criteria per the DV requirements."
   • Reported Performance:
     • Surface Appearance: Adhesive on the balloon and electrodes. Results: Conforming
     • Balloon Repeat Inflation Strength. Results: Conforming
     • Inflation Decay. Results: Conforming
   • Specifics on sample size or individual performance values are not detailed in this summary.

2. Biocompatibility:

   • Acceptance Criteria: "demonstrated an acceptable biocompatibility profile." and "passed all acceptance criteria."
   • Reported Performance: "Biocompatibility testing was performed in accordance with ISO 10993. The proposed adhesive, Loctite 4311, used to secure the balloon to the catheter shaft demonstrated an acceptable biocompatibility profile."
   • Specifics on sample size or individual performance values are not detailed in this summary.

3. Chronic GLP Animal Study:

   • Acceptance Criteria: To demonstrate safety comparable to the control device, and that both devices are "substantially equivalent regarding clinical pathology, thrombogenicity and pathology/histopathology."
   • Reported Performance: "Both the test and control devices were considered substantially equivalent regarding clinical pathology, thrombogenicity and pathology/histopathology. The use of both devices was well tolerated. This data demonstrates that the proposed Pacel Flow Direct catheter's safety is comparable to the control device."
   • Specifics on sample size or individual performance values are not detailed in this summary.

In conclusion, the document's purpose is to demonstrate substantial equivalence of a physical medical device (catheter) after a manufacturing material change, not the performance of an AI/diagnostic algorithm.

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