(86 days)
Not Found
No
The summary describes a pump system for injecting and aspirating viscous fluids during ophthalmic surgery and does not mention any AI or ML components or functionalities.
Yes
The device is described as assisting in posterior ophthalmic vitreoretinal surgery by injecting and aspirating viscous fluids that act as a tamponade in fixating retinal tears and detachments, which are therapeutic interventions.
No
The device is described as a system for injecting and aspirating viscous fluids during ophthalmic surgery, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states that the system consists of a "self-contained pump system" (CX5700 module) and a "disposable accessory pack" (CX5710), indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Storz Millennium™ Viscous Fluid System is used during surgery to inject and aspirate fluids directly into and out of the eye. This is an in vivo procedure (performed within the living body), not an in vitro test.
- Intended Use: The intended use clearly states it's for "injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery." This is a surgical tool, not a diagnostic test.
The device is a surgical instrument used to manipulate fluids within the eye during a surgical procedure. It does not perform any diagnostic testing on bodily samples.
N/A
Intended Use / Indications for Use
The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments.
The Storz Millennium™ Viscous Fluid System is a new device intended for the injection and aspiration of viscous fluids into and out of the eye during ophthalmic posterior vitreoretinal 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.
Product codes (comma separated list FDA assigned to the subject device)
MRH
Device Description
The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments. The Storz viscous fluid system consists of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack. The Storz CX5700 module is a self-contained pump system used as an individual module with the Storz Millennium™ Microsurgical System for the injection and aspiration of viscous fluids. The Storz CX5710 is the disposable accessory pack intended for single use to be used with the Storz viscous fluid module.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the word "storz" in white letters on a black background. The letters are stylized and bold. There is a registered trademark symbol in the upper right corner of the image. The background is a rounded rectangle.
Storz Millennium™ Viscous Fluid System Premarket Notification
0CT 1 0 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Patrick G. Balsmann, Regulatory Affairs Associate Storz, 3365 Tree Court Industrial Bldv., St. Louis, MO 63122-6694 Phone: (314) 225- 5051, ext. 5538.
Date Prepared: July 15, 1997
Proprietary Name: Storz Millennium™ Viscous Fluid System
Common/Usual Name: Viscous Fluid Injection/Aspiration System(s).
Classification Name: Infusion Pump, 86 MRH; 21CFR §880.5725.
Device Description/Intended Use: The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments. The Storz viscous fluid system consists of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack. The Storz CX5700 module is a self-contained pump system used as an individual module with the Storz Millennium™ Microsurgical System for the injection and aspiration of viscous fluids. The Storz CX5710 is the disposable accessory pack intended for single use to be used with the Storz viscous fluid module.
Predicate Device: The Storz CX5700 Millennium™ Viscous Fluid System Module is similar in design and function to the Storz Millennium™ Microsurgical System (K961310), Escalon® Viscous Fluid System (K963434), the Richard James Viscous Fluid Transfer System (K902835), and the Alcon Accurus™ Vitreoretinal Surgical System. The Storz CX5710 Viscous Fluid Injection Pack is similar in design, composition, and function to the Escalon® Fluid Delivery Pack (K963434.)
Predicate Comparison: A chart comparing characteristics of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack to those of the predicate devices is attached.
Submitted by:
Robert H. Johnson
Patrick G. Balsmann Regulatory Affairs
1 × 4
1
Storz CX5700 Millennium™ Viscous Fluid System Module Device Comparison Chart
(
(
| Device
Description | Storz CX5700
Viscous Fluid
System | Storz
Millennium™
Microsurgical
System | Alcon Accurus™
Vitreoretinal
Surgical System | Escalon® Viscous
Fluid System | Richard James
Viscous Fluid
Transfer System |
|----------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 510(k) | current | K961310 | unknown | K963434 | K902835 |
| Intended Use | Posterior segment
ophthalmic
surgery - injection
& aspiration of
viscous fluids. | Anterior & posterior
segment ophthalmic
surgery. | Posterior segment
ophthalmic surgery. | Posterior ophthalmic
surgery - injection
& aspiration of
viscous fluids. | Posterior ophthalmic
surgery - injection &
aspiration of viscous
fluids. |
| Modular
Design | Yes | Yes. | No. | No. | No. |
| Ophthalmic
Features | Viscous fluid
injection/
aspiration. | Irrigation/aspiration,
phacoemulsification/
fragmentation,
vitrectomy, scissors,
bipolar, illumination,
& IOP control. | Viscous fluid
injection/aspiration,
Irrigation/aspiration,
fragmentation,
vitrectomy, scissors,
bipolar, illumination,
& IOP control. | Viscous fluid
injection/aspiration. | Viscous fluid
injection/aspiration. |
| Programmable
For Multiple
Surgeons | Yes. | Yes. | Yes. | No. | No. |
| Device
Description | Storz CX5700
Viscous Fluid
System | Storz
MillenniumTM
Microsurgical
System | Alcon AccurusTM
Vitreoretinal
Surgical System | Escalon® Viscous
Fluid System | Richard James
Viscous Fluid
Transfer System |
| 510(k) | current | K961310 | unknown | K963434 | K902835 |
| Disposable
Accessories | Yes. | Yes. | Yes. | Yes. | Yes. |
| Viscous Fluid
User Interface | Foot pedal &
touch screen. | Foot pedal & touch
screen. | Foot pedal & touch
screen. | Foot pedal &
control knob. | Foot pedal & control
knob. |
| Foot
Controller -
Dual Linear | Yes | Yes. | No. | No. | No. |
| Viscous Fluid
Injection,
Pressure
Range | 0 - 70 PSI | Not Applicable. | 0 - 80 PSI. | 0 - 70 PSI. | 0 - 70 PSI. |
| Viscous Fluid
Injection,
Aspiration
Range | 0 - 600 mmHg. | Not Applicable. | 0 - 600 mmHg. | 0 - 600 mmHg. | 0 - 650 mmHg. |
ﻟ
2
Storz CX5700 Millennium™ Viscous Fluid System Module
Comparison
(
ﺴﺮ ﻣ
3
Storz CX5710 Viscous Fluid Injection Pack Device Comparison Chart
ﻟﻤﺴﺘﻌﻤﺎ
| Device Description | Storz CX5710 Viscous Fluid Injection Pack
Escalon® Fluid Delivery Pack |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | current
K963434 |
| Pack Components | Modified hose barb, tubing, male luer with locking nut, filter, 10cc syringe adaptor, 10cc modified piston, needle/cover assembly, 10cc standard piston, & 10cc syringe assembly.
Hose barb, tubing, male luer with locking nut, filter, 10cc syringe adaptor, 10cc modified piston, needle/cover assembly, 10cc standard piston, & 10cc syringe assembly. |
| Applicable Ophthalmic Surgical Unit | Storz Millennium™ Microsurgical System
Escalon® Viscous Fluid System |
| Provided Sterile | Yes.
Yes. |
| Labeled For Single Patient Use | Yes.
Yes. |
| Patient Contact Material | AISI 303 stainless steel.
AISI 303 stainless steel. |
| Packaging | Sealed Tyvek® pouches.
10 packs/box.
Sealed Tyvek® pouches.
10 packs/box. |
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
OCT 10 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick G. Balsmann Domestic Regulatory Affairs Associate Storz Instrument Company 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122-6694
Re: K972664
Trade Name: Storz Millennium™ Viscous Fluid System Regulatory Class: II Product Code: 86 MRH Dated: July 15, 1997 Received: July 16, 1997
Dear Mr. Balsmann:
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 commerce prior to May 28, 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 Cosmetic Act (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 annual registration, 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 major 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 under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Mr. Patrick G. Balsmann
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,
A. Roepke Rosenthal
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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Image /page/6/Picture/0 description: The image shows a logo for Storz. The logo is in black and white and features the word "storz" in a stylized font. The word is set against a black background with rounded corners. There is a registered trademark symbol to the right of the word.
Storz Millennium™ Viscous Fluid System Premarket Notification
INDICATIONS FOR USE
Device Name:
Storz Millennium™ Viscous Fluid System
Indications for Use:
The Storz Millennium™ Viscous Fluid System is a new device intended for the injection and aspiration of viscous fluids into and out of the eye during ophthalmic posterior vitreoretinal 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.
Enette TK Beers
ivision of Ophthalmic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
(114