LogoFDA 510(k) Search
K Number
K964248
Device Name
HEARTPORT ENDOCORONARY SINUS CATHETR
Manufacturer
HEARTPORT, INC.
Date Cleared
1997-01-22

(90 days)

Product Code
DWF
Regulation Number
870.4210
Type
Traditional
Panel
CV
Reference & Predicate Devices
K961270
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the coronary sinus pressure during cardiopulmonary bypass.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Heartport Endocoronary Sinus Catheter) from 1996. It describes the device's intended use and comparison to a predicate device.

However, the text does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria. The summary is very high-level and only states:

  • "Performance testing has demonstrated with 95% confidence that the Endocoronary Sinus Catheter will meet or exceed Heartport's performance standards."
  • "Performance testing has demonstrated that the Endocoronary Sinus Catheter will function safely and effectively, while meeting the anticipated clinical requirements for the intended use."

It does not provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Information on experts, ground truth establishment, or adjudication methods.
  4. Details on multi-reader multi-case studies or standalone algorithm performance.
  5. Sample sizes or ground truth establishment for a training set.

Therefore, I cannot extract the requested information from the provided document. The summary focuses on regulatory approval based on equivalence and general performance claims, rather than a detailed breakdown of a specific study and its findings against defined acceptance criteria for an AI/algorithm-based device.

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).