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K Number
K980985
Device Name
SCMD-1000
Manufacturer
HOWARD INSTRUMENTS, INC.
Date Cleared
1998-05-01

(45 days)

Product Code
HNO
Regulation Number
886.4370
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SCMD-1000 blades are to be used with the SCMD Microkeratome.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) letter for the SCMD-1000 device does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This document is a notification of substantial equivalence and does not detail the technical performance or validation studies of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.