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K Number
K030439
Device Name
HEADFIX
Manufacturer
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
Date Cleared
2003-05-08

(86 days)

Product Code
IYE
Regulation Number
892.5050
Type
Traditional
Panel
RA
Reference & Predicate Devices
K893707,K984365,K980201
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Positioning and repositioning of the patient's head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets

Device Description

The VBH HeadFIX™ is a fixation device for cranial stereotactic radiotherapy and radiosurgery. The major parts of the system include the Vacuum Pump, Vacuum Cushion, Target Positioner Screens and Baseplate, Post Set, and Cranial Localizer.

AI/ML Overview

The provided submission for K030439, concerning the VBH HeadFIX™, explicitly states that no performance data was required or requested by the Food and Drug Administration (Office of Device Evaluation) for this Class II device.

Therefore, the following information, which requires specific performance study data, cannot be extracted from the given text:

  1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported performance data is provided.
  2. Sample sized used for the test set and the data provenance: No test set information is available.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
  4. Adjudication method for the test set: No adjudication method is described.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was conducted or reported. The device is a physical fixation device, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No such study was conducted or reported. The device is a physical fixation device, not an algorithm.
  7. The type of ground truth used: No ground truth information is available as no performance testing was required.
  8. The sample size for the training set: No training set information is available.
  9. How the ground truth for the training set was established: No ground truth establishment for a training set is described.

The submission relies on a database search for adverse effects of similar, currently marketed devices rather than prospective performance testing of the VBH HeadFIX™.

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.