MID LABS AUTONOMOUS VIT ENHANCER (AVE)

K020911 · Medical Instrument Development Laboratories, Inc. · HQE · Apr 29, 2002 · Ophthalmic

Device Facts

• Record ID: K020911
• Device Name: MID LABS AUTONOMOUS VIT ENHANCER (AVE)
• Applicant: Medical Instrument Development Laboratories, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Apr 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AVE is used in conjuction with ophthalmic surgical equipment (typically Pho AVE is assurent or vitreoretinal surgical equipment) to remove vitreous and intraocular tissue.

Device Story

Autonomous Vit Enhancer (AVE) is a standalone console box used with standard vitrectomy machines for vitreous cutting. Device utilizes internal pneumatic energy, controlled by a pressure regulator and solenoid valve, to drive a guillotine-style vitreous cutter. User interface on front panel allows setting and display of cutting frequency. Operated by surgeons in an OR setting. Device transforms electronic signals into pneumatic pulses to actuate the cutter, facilitating removal of vitreous and intraocular tissue during ophthalmic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Standalone console box; pneumatic energy source; guillotine-style vitreous cutter; electronic frequency control; solenoid valve output; front panel user interface for frequency setting/display.

Indications for Use

Indicated for use in conjunction with ophthalmic surgical equipment to remove vitreous and intraocular tissue during vitreoretinal 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 Vit Enhancer (K992943)
• MID Labs SupraVit Vitreoretinal Surgical System (K932669)

Submission Summary (Full Text)

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## APR 2 9 2002

MID Labs Autonomous 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 [phone]

Date Prepared:

| Trade Name: | Autonomous Vit Enhancer |
|----------------------|-------------------------------------------------------------------|
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument (86 HQE, 21CFR 886.4150) |

Device Description/ Intended Use: Autonomous Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting.

Predicate Device: MID Labs Vit Enhancer™, MID Labs SupraVit® Vitreoretinal Surgical System

Predicate Device Comparison Table

| Device | Autonomous Vit | Vit Enhancer | SupraVit |
|---------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------|
| Description | Enhancer | | |
| 510(k)<br>Number | current | K992943 | K932669 |
| Intended Use | vitreous cutting | vitreous cutting | Posterior segment<br>ophthalmic surgery,<br>including vitreous<br>cutting |
| Vitreous<br>Cutter Type | guillotine | guillotine | Guillotine |
| User interface | Frequency setting and<br>display on front panel | Frequency setting and<br>display on front panel | Frequency setting and<br>display on front panel |
| Energy source | Internal input<br>pneumatic energy | External input<br>pneumatic energy | Internal or external<br>input pneumatic energy |
| Internal<br>pressure<br>control | Pressure regulator to<br>control the captured<br>pneumatic energy | Pressure regulator to<br>control the captured<br>pneumatic energy | Pressure regulator to<br>control the captured<br>pneumatic energy |
| Output valve<br>type | Solenoid valve | Solenoid valve | Solenoid valve |
| Output<br>frequency<br>control | Electronic signal at user<br>settable frequencies | Electronic signal at user<br>settable frequencies | Electronic signal at user<br>settable frequencies |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name encircling the perimeter. Inside the circle, there is a stylized representation of three overlapping human figures, symbolizing health and human services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 9 2002

Medical Instrument Development Laboratories, Inc. c/o Linda M. Upton 14477 Catalina St. San Leandro, CA 94577

Re: K020911

Trade/Device Name: Autonomous Vit Enhancer Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration & Cutting Instrument Regulatory Class: Class II Product Code: HOE Dated: March 15, 2002 Received: March 20, 2002

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Linda M. Upton

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure II

Page 32 of 38

510(k) Number (if known):

Device Name: Autonomous Vit Enhancer (AVE)

Indications For Use:

The AVE is used in conjuction with ophthalmic surgical equipment (typically Pho AVE is assurent or vitreoretinal surgical equipment) to remove vitreous and intraocular tissue.

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

| (Division Sign-Off) | Huynh Hoang |
|-----------------------------------------------------|-------------|
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K020911 |

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)