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K Number
K031885
Device Name
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
Manufacturer
IMAGE-GUIDED NEUROLOGICS, INC.
Date Cleared
2003-08-21

(64 days)

Product Code
HBL
Regulation Number
882.4460
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intended Use: The Navigus Passive Head Restraint System is intended for use in neurosurgical procedures.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Navigus Passive Head Restraint System." This document does not contain information about acceptance criteria, study details, or device performance metrics. It primarily serves as an approval letter, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any tests.
  3. Number or qualifications of experts.
  4. Adjudication methods.
  5. Information about MRMC comparative effectiveness studies.
  6. Details about standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 882.4460 Neurosurgical head holder (skull clamp).

(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).