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K Number
K081225
Device Name
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
Manufacturer
CARDICA, INC.
Date Cleared
2008-09-05

(128 days)

Product Code
FZP
Regulation Number
878.4300
Type
Traditional
Panel
SU
Reference & Predicate Devices
K003446
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PAS•Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.

Device Description

The Cardica® PAS•Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS•Port® Proximal Anastomosis System consists of a connector and a delivery system.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Cardica® PAS•Port® Proximal Anastomosis System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets such criteria.

The document states:
"All necessary in vitro and in vivo testing has been performed on the PAS-Port™ Proximal Anastomosis System and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device."

This statement confirms that testing was done, but it does not provide details about:

  1. A table of acceptance criteria and reported device performance: No such table is present.
  2. Sample size used for the test set and data provenance: Not mentioned.
  3. Number of experts and their qualifications for ground truth: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool.
  6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable.
  7. Type of ground truth used: Not mentioned.
  8. Sample size for the training set: Not applicable (not an AI/ML algorithm).
  9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device (St. Jude Medical Aortic Connector System). This process typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through comparisons of materials, design, and general in vitro/in vivo testing, but it doesn't usually present detailed acceptance criteria and performance data in the way requested for an AI/ML product.

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.