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The Multifire Clip Applier is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The device is intended for use on vessels, which in the opinion of the surgeon, require a small ligating clip. The Multifire Clip Applier may be used during endoscopic procedures such as the endoscopic harvesting of the Internal Mammary Artery.

The Heartport Multifire Clip Applier is a sterile, use disposable device containing 15 small Titanium ligating clips. The device is designed to automatically deliver small hemostatic clips for ligation of blood vessels.

This document is a 510(k) summary for the Heartport Multifire Clip Applier, submitted in 1996. It details the device's classification, intended use, and comparison to predicate devices, but it heavily lacks the specific information requested in your prompt regarding acceptance criteria and a structured study.

Here's a breakdown of why this document cannot fulfill your request comprehensively:

Missing Information:

• Acceptance Criteria Table: The document states the device "was safe and effective" and "meeting the anticipated clinical requirements," but it does not provide any quantitative acceptance criteria (e.g., success rates, force measurements, specific closure percentages) or numerical performance data to fill a table.
• Detailed Study Information:
  • Sample size for the test set: Not specified beyond "in vitro" and "in vivo studies."
  • Data provenance: Not mentioned (country of origin, retrospective/prospective).
  • Number of experts and qualifications: Not mentioned.
  • Adjudication method: Not mentioned.
  • MRMC comparative effectiveness study: Not mentioned.
  • Standalone algorithm performance: This is a physical device, so "standalone algorithm" doesn't apply in the typical sense of AI software. The performance here refers to the device itself.
  • Type of ground truth: Not explicitly stated, though "clip feeding and clip closure" are the performance elements observed.
  • Sample size for the training set: Not applicable for a physical device where "training" isn't a discrete software development phase.
  • How ground truth for the training set was established: Not applicable.

What can be extracted (and why it's limited):

The document broadly mentions performance testing and biocompatibility.

• Performance: "The Multifire Clip Applier was evaluated in vitro for clip feeding and clip closure In addition, the Clip Applier was evaluated during in vivo studies. functions. Performance testing demonstrated that the Heartport Multifire Clip Applier was safe and effective, while meeting the anticipated clinical requirements for its intended use."
• Biocompatibility: "The patient contacting materials used in the Multifire Clip Applier are identical to those used in the Pilling Weck - Hemoclip S15 Automatic Applier."

Conclusion:

This 1996 510(k) summary is very high-level and focused on demonstrating substantial equivalence to already approved predicate devices. It does not contain the detailed, quantitative acceptance criteria or a structured study description that would be required to complete your request. The standards for regulatory submissions, especially for device performance studies, have evolved significantly since 1996, and a modern submission would likely include much more of this specific information.

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