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K Number
K991215
Device Name
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
Manufacturer
SYMTEX HEALTHCARE CORP.
Date Cleared
1999-06-11

(63 days)

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

THIS PRODUCT IS INTENDED TO BE USED BY:

  • SURGEONS
    • NURSES
    • LAB TECHNICIANS
    • I. V. TEAM
    FOR THE FOLLOWING PROCEDURES:
    • WOUND DRESSING
    • DEBRIDEMENT
    • CLEANING
    • PREPPING AND SCRUBBING
Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter for a medical device called "Symtex Gauze Pads and Symtex Gauze Sponges." It states that the FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.

Based on the provided text, there is no information available regarding acceptance criteria or the study that proves the device meets those criteria. This document is solely an FDA clearance letter, not a study report or a detailed device submission.

Here's why the requested information cannot be extracted:

  • Type of Device: The device is "Gauze Pads and Gauze Sponges." These are typically low-risk, well-established medical devices (Class I or II, often exempt from extensive clinical trials). The FDA's substantial equivalence determination for such devices often relies on comparison to existing, legally marketed predicate devices, rather than new performance studies with specific acceptance criteria.
  • Nature of Document: This is a regulatory clearance letter, which confirms the device's clearance for marketing. It summarizes the FDA's decision but does not include the detailed technical or clinical data that would have been part of the 510(k) submission itself.
  • Lack of Performance Data: The letter simply states "The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration." It does not mention any specific performance metrics, clinical outcomes, or study results.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone studies, or ground truth establishment, as this information is not present in the provided document.

N/A