(42 days)
No
The summary describes a mechanical surgical system for vitrectomy and does not mention any AI or ML components or functionalities.
Yes
The device is used for the "removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery," which is a direct medical intervention to treat a condition.
No
Explanation: The device is intended for the removal of vitreous matter during ophthalmic vitrectomy surgery, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists hardware components: a module, a handpiece, and a single-use accessory pack.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description reinforces its use in a surgical setting for the aspiration of vitreous matter from the eye.
- Anatomical Site: The anatomical site is the posterior vitreous cavity, which is an internal part of the human body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on specimens.
This device is clearly a surgical instrument used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 sterile single use accessory pack.
Product codes (comma separated list FDA assigned to the subject device)
86 HQE
Device Description
The Storz Millennium™ High Speed Vitrectomy System is intended for the aspiration of vitreous matter from the eye during ophthalmic vitrectomy surgery. The system consists of the Storz CX5800 Millennium™ System High Speed Vitrectomy module used with the Storz Millennium™ Microsurgical System, Storz CX5810 High Speed Vitrectomy handpiece, and the Storz CX4804 High Speed Vitrectomy single use disposable pack.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior vitreous cavity
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
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
MAR 2 3 1998
Storz Millennium™ High Speed Vitrectomy System Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person:Gary Rauvola, Regulatory Affairs Group Manager Bausch & Lomb Surgical, Storz Products 3365 Tree Court Industrial Blvd. St. Louis. MO 63122-6694 Phone: (314) 225- 5051, ext. 5340.
Date Prepared: February 4, 1998
Proprietary Name: Storz Millennium™ High Speed Vitrectomy System
Common/Usual Name: Automated Vitrectomy Device
Classification Name: Vitreous Aspiration & Cutting Instrument, 86 HQE; 21CFR $886.4150.
Device Description/Intended Use: The Storz Millennium™ High Speed Vitrectomy System is intended for the aspiration of vitreous matter from the eye during ophthalmic vitrectomy surgery. The system consists of the Storz CX5800 Millennium™ System High Speed Vitrectomy module used with the Storz Millennium™ Microsurgical System, Storz CX5810 High Speed Vitrectomy handpiece, and the Storz CX4804 High Speed Vitrectomy single use disposable pack.
Predicate Devices: The Storz CX5800 Millennium™ System High Speed Vitrectomy module is substantially equivalent in design and function to the Storz Millennium™ Microsurgical System (K961310), Promex Vitrectomy System (K961078), Scieran Technologies VIT Commander System (K961738), and the Alcon Accurus™ Vitreoretinal Surgical System. The Storz CX5810 Millennium™ High Speed Vitrectomy handpiece is substantially equivalent to the Storz Micro Vit Vitrectomy Probe (K954816 and K961310), Promex Vitrectomy handpiece (K961078), Alcon Accurus InnoVit Probe, and the Scieran Vit Commander System handpiece (K961738). The Storz CX4804 High Speed Vitrectomy pack is similar in design, composition, and function to the Storz DP4801 Vitrectomy Probe pack (K954816 and K961310), the Promex vitrectomy cutter pack (K961078), and the Alcon Accurus Total Plus Pak.
Predicate Comparisons: Charts comparing characteristics of the Storz CX5800 Millennium™ High Speed Vitrectomy module, Storz CX5810 Millennium™ High Speed Vitrectomy handpiece, and the Storz CX4804 pack to those of the predicate devices are attached.
Submitted by:
Gary Rauvole
Gary Rauvola Regulatory Affairs Group Manager
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Image /page/1/Picture/0 description: The image is a black and white halftone pattern. The pattern is arranged in a semi-circular shape, with the dots becoming smaller and more sparse towards the edges of the semi-circle. The dots are densely packed in the center of the semi-circle, creating a darker area. The overall effect is a gradient from dark to light, with the darkest area in the center and the lightest areas at the edges.
Storz CX5800 Millennium™ High Speed Vitrectomy Module Device Comparison Chart
| Device
Description | Storz CX5800
High Speed
Vitrectomy
Module | Storz
MillenniumTM
Microsurgical
System | Alcon AccurusTM
Vitreoretinal
Surgical System | Promex
Vitrectomy System | Scieran Technologies Vit
Commander System | Device
Description | | Storz
MicroVit®
Vitrectomy
Probe | Alcon Accurus™
InnoVit™
Probe | Promex Vitrectomy
System | Scieran Technologies
Vit Commander
System |
|------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------|---------------------------------|--|-------------------------------------------|-------------------------------------|--------------------------------------------------|--------------------------------------------------|
| 510(k) | current | K961310 | unknown | K961078 | K961738 | 510(k) | | K954816
K961310 | unknown | K961078 | K961738 |
| Intended Use | Posterior segment
ophthalmic
surgery. | Anterior & posterior
segment ophthalmic
surgery. | Posterior segment
ophthalmic surgery. | Posterior segment
ophthalmic surgery. | Posterior segment ophthalmic
surgery. | Intended Use | | Posterior Vitreous
Removal | Posterior Vitreous
Removal | Posterior Vitreous
Removal | Posterior Vitreous
Removal |
| Modular
Design | Yes. | Yes. | No. | No. | Yes. | Cuts Per Minute | | 30 - 750 cpm | 100-1200 cpm | up to 2000 cpm | 400-2500 cpm |
| Ophthalmic
Features | Vitrectomy | 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. | Vitrectomy,
aspiration. | Irrigation/aspiration,
vitrectomy, bipolar. | Sterilization | | Single use
Disposable | Single use
Disposable | Autoclavable
handpiece with
disposable tip | Autoclavable
handpiece with
disposable tip |
| Programmable
For Multiple
Surgeons | Yes. | Yes. | Yes. | No. | No. | Handpiece Body | | Plastic | Plastic | Stainless steel and
aluminum | Titanium |
| Disposable
Accessories | Yes. | Yes. | Yes. | Yes. | Yes. | Type of
Handpiece Drive | | Pneumatic | Pneumatic | Electric | Electric |
| User Interface | Foot pedal &
touch screen. | Foot pedal & touch
screen. | Foot pedal & touch
screen. | Foot pedal & control
knobs. | Foot pedal & control knobs. | Associated
Aspiration system | | Venturi | Venturi | Venturi | Diaphragm |
| Foot
Controller -
Dual Linear | Yes. | Yes. | No. | No. | No. | Cutting Action | | Guillotine | Guillotine | Guillotine | Guillotine |
2
Storz CX5810 High Speed Vitrectomy Handpiece Device Comparison Chart
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3
Storz CX4804 High Speed Vit Cutter Pack Device Comparison Chart
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
| Device
Description | | Storz CX4804
High Speed
Vit Cutter
Pack | Storz
DP4801
Vitrectomy
Probe Pack | Alcon Accurus™ Total Plus™ Pak | Promex Pack |
|-------------------------------------------|--|------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| 510(k) | | current | K954816
K961310 | unknown | K961078 |
| Pack Components | | High speed vitrectomy
cutter with aspiration
tubing. | Vit cutter, aspiration
tubing, collection
cassette. | Cassette with drain bag, vitrectomy probe,
fiber optic illuminator probe, aspiration
tubing, infusion spike, infusion cannula. | High speed vitrectomy
cutter with aspiration
tubing. |
| Applicable
Ophthalmic
Surgical Unit | | Storz Millennium
Microsurgical System. | Storz Millennium
Microsurgical System.
Storz Premiere
Microsurgical System. | Alcon Accurus Vitreoretinal Surgical
System. | Promex Vitrectomy System. |
| Provided Sterile | | Yes. | Yes. | Yes. | Yes. |
| Labeled For
Single Patient Use | | Yes. | Yes. | Yes. | Yes. |
| Patient Contact
Material | | AISI 304 stainless steel
with anti-reflective steel | AISI 304 stainless
steel. | Stainless steel | AISI 304 stainless steel. |
| Packaging | | Sealed Tyvek trays.
Six trays/box. | Sealed Tyvek trays.
Six trays/box. | Unknown | Unknown |
ど .
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1998
Mr. Gary Rauvola Regulatory Affairs Group Manager Bausch & Lomb Surgical, Storz Products 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694
Re: K980488
Trade Name: Storz Millennium Microsurgical System High Speed Vitrectomy Regulatory Class: II Product Code: 86 HQE Dated: February 4, 1998 Received: February 9, 1998
Dear Mr. Rauvola:
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.
Image /page/4/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
5
Page 2 - Mr. Gary M. Rauvola
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 Ralph Rosenthal
A. Ralph Rosenthal, M.I Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Storz Millennium™High Speed Vitrectomy System Premarket Notification
INDICATIONS FOR USE
Device Name:
Storz Millennium™ High Speed Vitrectomy System
Indications for Use:
The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 sterile single use accessory pack.
Prescription USE ✓
Dennis L. McCarthy
vision Sign-Off)
L. vision of Ophthalmic Devices 510(k) Number_K 960 488 stice Cou