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K Number
K993039
Device Name
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
Manufacturer
BAUSCH & LOMB, INC.
Date Cleared
2000-01-07

(119 days)

Product Code
MRH
Regulation Number
880.5725
Type
Traditional
Panel
OP
Reference & Predicate Devices
K961310,K972664,K963434,K902835
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Storz Millennium™ Viscous Fluid System is intended for the injection of viscous fluids and Balance Salt Solution (BSS) into to eye as well as aspiration of viscous fluids from the eye during ophthalmic posterior vitreoretinal and retinal translocation surgery.

Device Description

The Storz Millennium Viscous Fluid Injector system (VFI) is a Class II device in accordance with 21 CFR Section 880.5725. Further, the VFI and its accessories was previously cleared, via the Premarket Notification process and was assigned 510(k) file number K972664 and Classification Code 86 MRH. The VFI system module (CX5700) is a self-contained pump system used in conjunction with the Storz Millennium™ Microsurgical System (K961310). The Storz viscous fluid system consists of the Storz CX5700 module to be used with the Storz Millennium™ Microsurgical System and the Storz CX5710 sterile single-use accessory pack consisting of an infusion tube set, a syringe, a Cannula and instructions for use.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and does not contain information from a clinical study with acceptance criteria and reported device performance. It is a regulatory submission to demonstrate substantial equivalence to a previously cleared device. Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance based on this document.

Here's why and what information can be extracted:

  • No Clinical Study Details: This document explicitly states that the device (Storz Millennium Viscous Fluid Injector system, VFI) remains "unchanged in that there will be no changes to the design, functional characteristics, sterilization method(s), product specifications, or intended use" compared to its predicate device (K972664), except for the addition of administering Balanced Salt Solution for retinal translocation procedures. This suggests that extensive new performance testing or clinical studies were likely not performed for this 510(k) submission, as the goal is to demonstrate substantial equivalence, not novel performance.
  • Focus on Substantial Equivalence: The entire document revolves around demonstrating that the new VFI system is "substantially equivalent in design and intended use" to previously cleared devices. This is a regulatory pathway that often relies on existing data, design similarities, and sometimes limited bench testing, rather than new, large-scale clinical trials with specific acceptance criteria as you'd find for novel devices.

Information that can be extracted from the provided text, but not in the context of a performance study:

  1. Acceptance Criteria and Reported Device Performance: Not applicable as no new performance study is described. The acceptance criterion for this submission was "substantial equivalence" to a predicate device.
  2. Sample sized used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical medical device, not an AI algorithm.
  7. The type of ground truth used: Not applicable for a performance study. For the 510(k) submission, the "ground truth" was the existing regulatory clearance and established performance of the predicate device.
  8. The sample size for the training set: Not applicable. This is not an AI/ML device.
  9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The submission itself serves as the "study" for regulatory clearance, where the primary objective is to demonstrate substantial equivalence to an already legally marketed device. The "acceptance criteria" were met by showing that the differences between the proposed device and the predicate device (K972664, and others like K963434, K902835) did not raise new questions of safety or effectiveness. The key "performance" reported is its intended use, which is identical to the predicate except for the additional capability of administering Balanced Salt Solution for retinal translocation procedures. No specific quantitative performance metrics from a new study are presented in this 510(k).

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).