ULTIMATE VIT ENHAMCER (UVE)

K102222 · Medical Instrument Development Laboratories, Inc. · HQE · Apr 8, 2011 · Ophthalmic

Device Facts

• Record ID: K102222
• Device Name: ULTIMATE VIT ENHAMCER (UVE)
• Applicant: Medical Instrument Development Laboratories, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Ultimate Vit Enhancer (UVE) is a standalone console box used with a MID Labs Vitreous Cutter and a host vitrectomy machine (e.g., phacoemulsification or vitreoretinal surgical equipment). The device receives pneumatic energy input and uses an electronic pressure regulator and solenoid valve to control the guillotine-style vitreous cutter. The user sets the frequency via the front panel; the UVE generates an electronic signal as a function of the host system frequency to drive the cutter. Used by surgeons in an operating room setting to facilitate vitreous and intraocular tissue removal. Benefits include precise control of cutting rates during ophthalmic procedures.

Clinical Evidence

Bench testing only. Evaluations included heat generation across a range of cut rates, cutter integrity (metal flaking) during extended use, and fluid dynamics (marker displacement in vitreous). All functional requirements and specifications were met.

Technological Characteristics

Standalone console box; guillotine-style vitreous cutter; electronic pressure regulator; solenoid valve; external pneumatic energy source; electronic frequency control interface; connects to host vitrectomy system.

Indications for Use

Indicated for removal of vitreous and intraocular tissue during ophthalmic surgery. Used in conjunction with a host vitrectomy machine.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MID Labs AVE (K020911)

Submission Summary (Full Text)

{0}------------------------------------------------

5io(k): k1022222

## 510(k) Summary of Safety and Effectiveness

## APR - 8 2011

| Contact Person: | Linda Upton<br>MID Labs, Inc.<br>557 McCormick Street<br>San Leandro, CA 94577<br>[phone] |
|----------------------|--------------------------------------------------------------------------------------------------|
| Date Prepared: | April 5, 2011 |
| Trade Name: | Ultimate Vit Enhancer (UVE) |
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument<br>(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<br>Description | UVE<br>Ultimate Vit Enhancer | AVE |
|---------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------|
| 510(k)<br>Number | Current | K020911 |
| Intended Use | Vitreous cutting | Vitreous cutting |
| Vitreous<br>Cutter Type | Guillotine | Guillotine |
| User interface | Frequency setting and display<br>on front panel | Frequency setting and display<br>on front panel |
| Energy source | External input pneumatic<br>energy | Internal input pneumatic<br>energy |
| Internal<br>pressure<br>control | Electronic pressure regulator | Pressure regulator to control<br>the pneumatic energy |
| Output valve<br>type | Solenoid valve | Solenoid valve |
| Output<br>frequency<br>control | Electronic signal at user<br>scalable function of Host<br>system frequency | Electronic signal at user<br>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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

11

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

{3}------------------------------------------------

## 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)

Ra

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

Page 1 of 1

510(k) Number k122222

Page 3 of 6