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K Number
K022752
Device Name
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
Manufacturer
HDC CORP.
Date Cleared
2003-09-09

(386 days)

Product Code
CAZ
Regulation Number
868.5140
Type
Traditional
Panel
AN
Reference & Predicate Devices
K021567,K831715,K994059
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pandin Continuous Nerve Stimulating Catheter permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.

Device Description

Not Found

AI/ML Overview

This document, K022752, is a 510(k) premarket notification for the Pandin Continuous Nerve Stimulating Catheter. It establishes substantial equivalence to predicate devices but does not contain acceptance criteria or a study proving that the device meets acceptance criteria.

The provided text focuses on the administrative aspects of the 510(k) submission, including:

  • Device Name: Pandin Continuous Nerve Stimulating Catheter
  • Common Name: Continuous Nerve Stimulating Catheter
  • Classification Name: Kit, Conduction Anesthetic
  • Intended Use: Permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques, indicated for use up to 72 hours.
  • Predicate Devices: StimuCath Continuous Nerve Block Set (K021567), Neurotrac (K831715), and CLA Kit (Nerve Block Infusion) (K994059).
  • Substantial Equivalence Argument: The Pandin device is single patient, single use, intended to facilitate placement of a Peripherally Inserted Conductive Catheter for regional nerve block procedures, similar to its predicates. It's used procedurally the same as the StimuCath™ and contains the identical Tuhoy needle used in the CLA™ kit.
  • FDA Response: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information (performance data, sample sizes, expert qualifications, ground truth details, MRMC studies, or training set information) from the provided text because it is not present in the document. The 510(k) summary for this device does not include details of performance testing or clinical studies for acceptance criteria.

§ 868.5140 Anesthesia conduction kit.

(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).