(119 days)
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.
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.
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:
- 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.
- Sample sized used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- 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.
- 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.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- 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).
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3365 Tree Court Industrial Blvd
St. Louis, MO USA 63122 6694
1 - 7 2000
SUMMARY OF SUBSTANTIAL EQUIVALENCE
BAUSCH
& LOMB
Surgical
Contact Person: Vanada Johnson, Regulatory Affairs Specialist Bausch & Lomb Surgical 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694 Phone (636)-226-3182 Fax (636) 226-3030
Date Prepared: September 10, 1999
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 Millennium ™ Viscous Fluid Injector System (K972664) is intended for the Stort viscous fluids and Balance Salt Solution (RSS) into to eye as well as aspiration of viscous fluids from the eye during ophthalmic posterior vitreoretinal and retinal translocation surgical procedures using the Bausch & Lomb Surgical's disposable, single-use accessories .
The only difference between the proposed vs. the predicate VFI system is the inclusion of administering Balanced Salt Solution used for retinal translocation procedures. The Millennium ™ Viscous Fluid Injector System (K972664), in and of itself, will remain unchanged in that there will be no changes to the design, functional characteristics, sterilization method(s), product specifications, or intended use.
Bausch & Lomb Surgical considers the VFI system to be substantially equivalent in design and intended use in comparison to the currently marketed Viscous Fluid Injection System covered by K972664. Further, Bausch & Lomb considers the VFI system similar to the following previously cleared Storz Millennium™ Microsurgical System Shillia Escalon® Viscous Fluid System (K963434), The Richard James Viscous Fluid Transfer System (K902835) and the Alcon Accurity, The Richard Summes Viscous F
Submitted by:
A
Vanada Johnson Regulatory Affairs
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2000
Ms. Vanada Johnson Regulatory Affairs Specialist Bausch & Lomb Surgical 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694
Re: K993039 Trade Name: Viscous Fluid Injector System Module Regulatory Class: II Product Code: 86 MRH Regulation: 880.5725 Dated: December 6, 1999 Received: December 7, 1999
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commence prior to May 18, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Coscil (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for vanual regustration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing mail a regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such, assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices nonder the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ARolph lorentthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K993039 510(K) Number -
Device Name: Storz Millennium Viscous Fluid System
Indications for 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. 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-the-Counter Use
(Division Sign-Off) Dennis L. McCarthy
510(k) Number K993039
Bausch & Lomb Surgical
§ 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).