VIT ENHANCER

K992943 · Medical Instrument Development Laboratories, Inc. · HQE · Dec 10, 1999 · Ophthalmic

Device Facts

• Record ID: K992943
• Device Name: VIT ENHANCER
• Applicant: Medical Instrument Development Laboratories, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vit Enhancer in conjunction with standard vitrectomy equipment is used to remove vitreous and other intraocular tissue.

Device Story

Vit Enhancer is a standalone console box used with a high-speed vitreous cutter; functions as an accessory to standard vitrectomy machines. Device receives external pneumatic energy; uses an internal pressure regulator to control captured pneumatic energy; employs a solenoid valve to manage output. User interface on front panel allows setting and display of cutting frequency. Operated by surgeons in clinical settings during posterior segment ophthalmic surgery. Device transforms electronic signals into pneumatic pulses to drive guillotine-style vitreous cutters. Enables precise vitreous and tissue removal; assists in surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Standalone console box; pneumatic energy source; solenoid valve; electronic frequency control; guillotine-type vitreous cutter interface. No specific materials or software architecture details provided.

Indications for Use

Indicated for use in conjunction with standard vitrectomy equipment to remove vitreous and other intraocular tissue during ophthalmic surgery.

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 SupraVit® Vitreoretinal Surgical System (K932669)

Submission Summary (Full Text)

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K992943

DEC 1 0 1999

MID Labs Vit Enhancer Premarket Notification

## 510(k) Summary of Safety and Effectiveness

| Contact Person: | Linda Upton<br>MID Labs, Inc.<br>14477 Catalina Street<br>San Leandro, CA 94577<br>[phone] |
|----------------------|---------------------------------------------------------------------------------------------------|
| Date Prepared: | December 1, 1999 |
| Trade Name: | Vit Enhancer |
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument<br>(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<br>Description | Vit Enhancer | SupraVit |
|------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------|
| 510(k) Number | current | K932669 |
| Intended Use | vitreous cutting | posterior segment ophthalmic<br>surgery, including vitreous cutting |
| Vitreous Cutter<br>Type | guillotine | guillotine |
| User interface | Frequency setting and display on<br>front panel | Frequency setting and display on<br>front panel |
| Energy source | External input pneumatic energy | External input pneumatic energy |
| Internal pressure<br>control | Pressure regulator to control the<br>captured pneumatic energy | Pressure regulator to control the<br>captured pneumatic energy |
| Output valve<br>type | Solenoid valve | Solenoid valve |
| Output frequency<br>control | Electronic signal at user settable<br>frequencies | Electronic signal at user settable<br>frequencies |

Predicate Device Comparison Table

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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 .

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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 [phone]. Additionally, for questions on.the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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Enclosure II

K992943

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.

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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)