(101 days)
Not Found
No
The summary describes a mechanical device for vitreous cutting and does not mention any AI or ML components or functionalities.
Yes
The device is used to remove vitreous and other intraocular tissue, which is a therapeutic intervention.
No
The device is described as "used to remove vitreous and other intraocular tissue" and "used in conjunction with a standard vitrectomy machine for vitreous cutting," which indicates a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly states it is a "stand alone console box with accessories," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove vitreous and other intraocular tissue" using surgical equipment. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting." This describes surgical equipment used for a physical intervention.
- Anatomical Site: The anatomical site is "intraocular," meaning inside the eye. This is a site within the living body.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a person's health. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Vit Enhancer in conjunction with standard vitrectomy equipment is used to remove vitreous and other intraocular tissue.
Product codes
86 HOE, 86 HQE
Device Description
Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. The High Speed Vitreous Cutter is used with the Vit Enhancer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraocular
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 0 1999
MID Labs Vit Enhancer Premarket Notification
510(k) Summary of Safety and Effectiveness
| Contact Person: | Linda Upton
MID Labs, Inc.
14477 Catalina Street
San Leandro, CA 94577
(510) 357-3952 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Date Prepared: | December 1, 1999 |
| Trade Name: | Vit Enhancer |
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument
(86 HOE, 21CFR 886.4150) |
Device Description/ Intended Use: Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. The High Speed Vitreous Cutter is used with the Vit Enhancer.
Predicate Device: MID Labs SupraVit® Vitreoretinal Surgical System
| Device
| Description | Vit Enhancer | SupraVit |
|---|---|---|
| 510(k) Number | current | K932669 |
| Intended Use | vitreous cutting | posterior segment ophthalmic |
| surgery, including vitreous cutting | ||
| Vitreous Cutter | ||
| Type | guillotine | guillotine |
| User interface | Frequency setting and display on | |
| front panel | Frequency setting and display on | |
| front panel | ||
| Energy source | External input pneumatic energy | External input pneumatic energy |
| Internal pressure | ||
| control | Pressure regulator to control the | |
| captured pneumatic energy | Pressure regulator to control the | |
| captured pneumatic energy | ||
| Output valve | ||
| type | Solenoid valve | Solenoid valve |
| Output frequency | ||
| control | Electronic signal at user settable | |
| frequencies | Electronic signal at user settable | |
| frequencies |
Predicate Device Comparison Table
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble water or fabric. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the central image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1999
Ms. Linda M. Upton Medical Instrument Development 14477 Catalina St. San Leandro, CA 94577
Re: K992943
Trade Name: Vit Enhancer Regulatory Class: II Product Code: 86 HQE Regulation: 886.4150 Dated: November 22, 1999 Received: November 30, 1999
Dear Ms. Upton:
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 .
2
Page 2 - Ms. Linda M. Upton
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.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Enclosure II
Page I of I
510(k) Number (if known): K992943
Device Name:_ Vit Enhancer
Indications For Use:
The Vit Enhancer in conjunction with standard vitrectomy equipment is used to remove vitreous and other intraocular tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic 510(k) Numb
(3-time 15-0 (3.00))
(Optional Format 3-10-98)