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K Number
K993190
Device Name
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
Manufacturer
SURGICAL INSTRUMENT SYSTEMS (SIS), LTD
Date Cleared
2000-02-10

(140 days)

Product Code
HNO
Regulation Number
886.4370
Type
Traditional
Panel
OP
Reference & Predicate Devices
K972808,K913697
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SIS, Ltd., ACCM microkeratome is a precision-manufactured instrument indicated for lamellar resection of the cornea.

Device Description

The SIS, Ltd ACCM Microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The design, material and operating principle are very similar to those of the predicate devices.

AI/ML Overview

The provided text does not contain detailed acceptance criteria, specific performance metrics, or a study design for a device. It primarily focuses on the submission of a 510(k) for a microkeratome and its substantial equivalence to predicate devices. Therefore, I cannot populate the table or answer the questions related to acceptance criteria and study details.

Here's a breakdown of what the document does include:

  • Device Name: Surgical Instrument Services (SIS), Ltd. Advanced Computer Controlled Microkeratome (ACCM)
  • Intended Use: Lamellar resection of the cornea.
  • Predicate Devices:
    • Bausch & Lomb Surgical: Hansatome Microkeratome (K972808)
    • Bausch & Lomb Surgical: Advance Corneal Shaper - ACS (K913697)
  • Technological Comparison (Table 1): This table outlines various technical characteristics of the SIS-ACCM and its predicate devices, demonstrating similarity in operating principle, intended use, blade material, and general features. This comparison is used to establish substantial equivalence.
  • Nonclinical Tests: The summary states that "The ACCM microkeratome has been designed and tested to applicable safety standards. Parameters related to lamellar resection were validated through extensive preclinical testing. The ACCM microkeratome does not raise any new issues of safety, effectiveness, or performance of the product." However, specific details of these tests, their results, or acceptance criteria are not provided.
  • FDA Clearance: The document includes the FDA's letter granting 510(k) clearance based on substantial equivalence, permitting the device to be marketed.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document. The document's purpose is to demonstrate substantial equivalence, not to present a detailed performance validation study with specific acceptance criteria and results.

§ 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.