K Number
K102222
Device Name
ULTIMATE VIT ENHAMCER (UVE)
Date Cleared
2011-04-08

(245 days)

Product Code
Regulation Number
886.4150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).
Device Description
Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.
More Information

Not Found

No
The document describes a device for vitreous cutting and removal, focusing on mechanical function, heat generation, cutter integrity, and fluid dynamics. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications.

Yes.
The device is used to remove vitreous and intraocular tissue, which is a therapeutic intervention.

No

The device is described as a vitreous cutter used to remove vitreous and intraocular tissue, indicating a therapeutic or surgical function, not a diagnostic one.

No

The device description explicitly states it is a "standalone console box with accessories," indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the UVE and Vitreous Cutter are used to remove vitreous and intraocular tissue during surgery. They are not used to analyze samples taken from the body.
  • The device is a surgical tool. It is used in conjunction with ophthalmic surgical equipment as a "Host system" for vitreous cutting. This is a direct surgical intervention, not a diagnostic test performed on a sample.
  • There is no mention of analyzing biological samples. The description focuses on the mechanical function of cutting and removing tissue, fluid dynamics, and heat generation.

Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).

Product codes

HQE

Device Description

Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Testing and validations have demonstrated that the functional requirements and specifications have been met. Testing was conducted to measure heat generation in the vitreous cutter operated at a range of cut rates. Cutter integrity, including evaluation of the potential for metal flaking, was tested during extended exercising of the vitreous cutter at a range of cut rates. Fluid dynamics were evaluated by measuring displacement of a marker in vitreous at a range of cut rates. Requirements as outlined in the testing were met. Test data and documentation has been submitted to support system function.

Key Metrics

Not Found

Predicate Device(s)

K020911

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.

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5io(k): k1022222

510(k) Summary of Safety and Effectiveness

APR - 8 2011

| Contact Person: | Linda Upton
MID Labs, Inc.
557 McCormick Street
San Leandro, CA 94577
(510) 357-3952 |
|----------------------|--------------------------------------------------------------------------------------------------|
| Date Prepared: | April 5, 2011 |
| Trade Name: | Ultimate Vit Enhancer (UVE) |
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument
(86 HQE, 21CFR 886.4150) |

Device Description/ Intended Use: Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.

Predicate Device: MID Labs AVE

| Device
Description | UVE
Ultimate Vit Enhancer | AVE |
|---------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------|
| 510(k)
Number | Current | K020911 |
| Intended Use | Vitreous cutting | 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 | Internal input pneumatic
energy |
| Internal
pressure
control | Electronic pressure regulator | Pressure regulator to control
the pneumatic energy |
| Output valve
type | Solenoid valve | Solenoid valve |
| Output
frequency
control | Electronic signal at user
scalable function of Host
system frequency | Electronic signal at user
settable frequencies |

Predicate Device Comparison Table

Performance Data: Testing and validations have demonstrated that the functional requirements and specifications have been met. Testing was conducted to measure heat generation in the vitreous cutter operated at a range of cut rates. Cutter integrity, including evaluation of the potential for metal flaking, was tested during extended exercising of the vitreous cutter at a range of cut rates. Fluid dynamics were evaluated by measuring displacement of a marker in vitreous at a range of cut rates. Requirements as outlined in the testing were met. Test data and documentation has been submitted to support system function.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

APR - 8 2511

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medical Instrument Development Laboratories, Inc. c/o Ms. Linda Upton Vice President 557 McCormick Street San Leandro, CA 94577

Re: K102222

Trade/Device Name: MID Labs Ultimate Vit Enhancer Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: II Product Code: HQE Dated: March 23, 2011 Received: March 25, 2011

Dear Ms. Upton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

$

2

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K102222

Device name: Ultimate Vit Enhancer (UVE) MID Labs Vitreous Cutter labeled for use with the UVE

Indications For Use:

The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).

Prescription Use X (Part 21 CFR 801 SubpartD)

AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K122222

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