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K Number
K201676
Device Name
Barricaid Instrument Tray
Manufacturer
Intrinsic Therapeutics, Inc.
Date Cleared
2020-07-16

(27 days)

Product Code
QHG,OHG
Regulation Number
888.4510
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Intrinsic Therapeutics Defect Measurement Tool for the Barricaid® Annular Closure Device is intended to aid in determining if a patient meets the indications for the Barricaid® Annular Closure Device by assessing the defect size in the annulus fibrosus following limited discectory. This tool is indicated to only be used with the Intrinsic Therapeutics Barricaid® Annular Closure Device.

Device Description

The Barricaid® Instrument kit contains a number of manual surgical instruments as well as the Defect Measurement Tool. This kit is provided with all of the instruments with a sterilization tray. The Defect Measurement Tool is intended to measure the annular defect to determine if a patient meets the indications for use for the Barricaid® Annular Closure Device. All instruments are made from stainless steel. This kit is intended to be used only with the Intrinsic Therapeutics Barricaid® Annular Closure Device (ACD).

The purpose of this submission is to modify and reduce the size of the sterilization tray used to contain the reusable instruments necessary to surgically implant or remove the Barricaid® Annular closure device.

AI/ML Overview

The provided document is a 510(k) summary for the Barricaid® Instrument Tray and related instruments, not a submission for an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and studies for an AI/ML device.

The document describes a submission to modify and reduce the size of a sterilization tray for existing manual surgical instruments. It explicitly states:

  • "No new clinical testing was performed."
  • "No new biocompatibility testing was performed."

The performance data section only mentions "Scientific evaluation of sterilization validation and cleaning validation based on worst case" and "Scientific evaluation of shipping condition based on worst case and market history."

Consequently, I cannot provide the requested information for an AI/ML device, as the document pertains to a Class II manual surgical instrument and its sterilization tray.

N/A