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K Number
K973580
Device Name
INVOTEC CLEAN PAD
Manufacturer
INVOTEC INTERNATIONAL, INC.
Date Cleared
1997-12-10

(82 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

THE INVOTEC CLEAN PAD may be used during any surgical procedure as an instrument wipe.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Clean Pad." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory approval document and does not detail the technical or clinical performance studies that might have been conducted to support the 510(k submission. Therefore, I cannot provide the requested information based on the given input.

N/A