LogoFDA 510(k) Search
K Number
K971173
Device Name
ML DISPOSABLE ALK TUBING
Manufacturer
MED-LOGICS, INC.
Date Cleared
1997-05-22

(52 days)

Product Code
KYG
Regulation Number
886.4360
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For intermittent or continous irrigation, flushing, and cleansing of eyes

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "ML Disposable ALK Tubing". It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

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

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, or the number/qualifications of experts.
  • Information on adjudication methods.
  • Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
  • The type of ground truth used.
  • Information about training sets or how their ground truth was established.

§ 886.4360 Ocular surgery irrigation device.

(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.