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K Number
K962978
Device Name
CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
Manufacturer
JOHNSON & JOHNSON MEDICAL, INC.
Date Cleared
1997-01-07

(160 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CENTERMARK * Catheter Introducer Sheath with PROTECTIV* 2000 Needle Safety System is designed for percutaneous access for the introduction of catheters and guidewires. The PROTECTIV* 2000 Needle Safety System is designed to reduce needle sticks injuries.

Device Description

The introducer sheath portion of the system is the same product that is currently marketed by JJMI. The Safety system has passed all tests for safety and effectiveness (i.e. biocompatability, sterility and system performance).

AI/ML Overview

This document (K962978) is a 510(k) Summary of Safety and Effectiveness for a medical device. It does not contain the detailed study results, acceptance criteria, or performance metrics you are requesting.

The 510(k) summary is a high-level document intended to demonstrate substantial equivalence to a predicate device. It briefly states that the safety system "has passed all tests for safety and effectiveness (i.e. biocompatibility, sterility and system performance)," but it does not provide the specific data from those tests.

Therefore, I cannot provide the detailed information requested in your prompt based solely on the provided text. To get this information, you would need to access the full 510(k) submission, which is typically much more extensive and includes the actual test reports and data.

Here's why I cannot fulfill each point of your request based on the provided text:

  1. A table of acceptance criteria and the reported device performance: The document states the system "passed all tests," but it doesn't specify what those tests were, what the acceptance criteria for each test were, or the numerical performance results.
  2. Sample sizes used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth... and qualifications: Not mentioned. This type of device would likely not involve "ground truth" in the same way an AI diagnostic device would. Its performance would be assessed through engineering tests, biocompatibility studies, and sterility validation, not expert image review.
  4. Adjudication method: Not applicable/not mentioned for this type of device testing.
  5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is not an AI diagnostic device where human reader improvement with AI assistance would be studied.
  6. Standalone performance: The document states the system passed tests, implying standalone performance was evaluated, but no specific metrics are given.
  7. Type of ground truth used: Not explicitly relevant or described in the context of this device's testing. Its "performance" would relate to its physical function (e.g., ease of insertion, needle safety mechanism activation) and biological interactions (biocompatibility).
  8. Sample size for the training set: Not applicable for this type of device. There is no AI model being trained.
  9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary is far too brief to extract the detailed testing and performance data you are looking for.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).