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K Number
K991222
Device Name
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
Manufacturer
JOHNSON & JOHNSON PROFESSIONALS, INC.
Date Cleared
1999-07-09

(88 days)

Product Code
GWM
Regulation Number
882.1620
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Use of the CODMAN® MICROSENSOR™ Ventricular Catheter Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid (CSF) drainage applications.

Device Description

The CODMAN® MICROSENSOR™ Ventricular Catheter Kit consists of the following components:

  • Ventricular Catheter Triple-lumen catheter with a center drainage lumen (1) and dedicated lumens for the stylet and MICROSENSOR™ ICP Sensor,
  • Stylet Preloaded stylet sued for catheter insertion and placement, (2)
  • MICROSENSOR™ ICP Sensor Intracranial pressure (ICP) sensor (3) embedded in a dedicated lumen with direct CSF access,
  • Y -Connector Connection component allowing the catheter to be either (4) connected to an external drainage system or capped,
  • (૨) Suture Clip - Catheter anchoring clip, and
  • Tunneling Trocar with TEFLON® Tubing Trocar with sheath designed (6) to allow the catheter to be tunneled under the scalp to the craniotomy site.
AI/ML Overview

The provided text is a 510(k) summary for the CODMAN® MICROSENSOR™ Ventricular Catheter Kit. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain information regarding acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical performance studies.

The section titled "Device Testing" only mentions:

  • Reliance on ISO 10993-1 for biological testing.
  • "Tripartite Biocompatibility Guidelines for Medical Devices."
  • Material characteristics of the silicone elastomer.
  • The general statement "All testing supports the device for its intended use."

This indicates that the testing primarily focused on biocompatibility and material properties, which are safety aspects, rather than a clinical performance study with specific acceptance criteria related to the device's functional performance (e.g., accuracy of ICP measurement, duration of function, success rate of CSF drainage).

Therefore, I cannot provide the requested information from the provided text. The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size for a test set or data provenance for a performance study.
  3. Number of experts or their qualifications for establishing ground truth in a performance study.
  4. Adjudication method for a performance study test set.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information on a standalone algorithm-only performance study.
  7. The type of ground truth used for performance (e.g., expert consensus, pathology, outcomes data).
  8. Sample size for a training set (as this is not an AI/algorithm-based device from the description).
  9. How ground truth was established for a training set.

This 510(k) summary relies on showing substantial equivalence to predicate devices based on similarities in intended use, materials, design, and principles of operation, along with biocompatibility testing, rather than a de novo clinical performance study with detailed acceptance criteria.

§ 882.1620 Intracranial pressure monitoring device.

(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).