(119 days)
No
The document describes a pump system for injecting and aspirating fluids during ophthalmic surgery and makes no mention of AI or ML.
No
The device is used for injecting and aspirating fluids during ophthalmic surgery, which is a procedural function, not a therapeutic treatment itself.
No
The device is described as a system for injecting and aspirating viscous fluids during ophthalmic surgery, which is a therapeutic/surgical function, not a diagnostic one.
No
The device description explicitly states it is a "self-contained pump system" and includes physical accessories like an infusion tube set, syringe, and cannula, indicating it is a hardware device with associated software, not a software-only device.
Based on the provided information, the Storz Millennium™ Viscous Fluid System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the injection and aspiration of fluids into and from the eye during surgical procedures. This is a direct interaction with the patient's body during surgery, not a test performed on a sample taken from the body.
- Device Description: The device is described as a pump system used in conjunction with a microsurgical system. This aligns with surgical equipment, not diagnostic equipment.
- Classification: The device is classified as a Class II device under 21 CFR Section 880.5725, which is for Ophthalmic surgical instruments. IVD devices are typically classified under different sections of the CFR related to in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on testing.
Therefore, the Storz Millennium™ Viscous Fluid System is a surgical device used in ophthalmic procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
86 MRH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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 .
2
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
3
Page 1 of 1
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