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K Number
K991601
Device Name
DUAL LUMEN CATHETER, MODEL DL-35-90
Manufacturer
ENDOLOGIX, INC.
Date Cleared
1999-10-28

(171 days)

Product Code
DQY
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use during a two guidewire procedure

Device Description

Dual Lumen Catheter

AI/ML Overview

I am sorry, but the provided text does not contain acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Dual Lumen Catheter," indicating that the device is substantially equivalent to a predicate device and can be marketed.

It references the general controls provisions of the Act, including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. However, it does not detail specific performance-based acceptance criteria for the device itself or any study data that would demonstrate compliance with such criteria.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).