COLIBRI DISPOSABLE VITRECTOMY CUTTER

K033390 · Microworld Medical Instruments, Inc. · HQE · Nov 4, 2003 · Ophthalmic

Device Facts

• Record ID: K033390
• Device Name: COLIBRI DISPOSABLE VITRECTOMY CUTTER
• Applicant: Microworld Medical Instruments, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Nov 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The COLIBRI Disposable Vitrectomy Cutter is intended to be used for the removal of vitreous and vitreal membranes during ophthalmic surgery.

Device Story

COLIBRI Disposable Vitrectomy Cutter is a pneumatic guillotine-style handpiece for ophthalmic surgery. Device components include handle, diaphragm, inner spring, and stainless steel inner/outer cutters with attached tubing/connectors. Operates via connection to 20 psi or 30 psi ophthalmic surgical systems to provide cutting and aspiration of vitreous and vitreal membranes. Used by surgeons in clinical settings during anterior and posterior segment surgeries. Output is mechanical cutting/aspiration action controlled by the surgeon to facilitate tissue removal, aiding in surgical visualization and treatment of ocular conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pneumatic guillotine-style handpiece. Materials include stainless steel cutters, diaphragm, and spring. Dimensions/form factor: handheld. Energy source: pneumatic (20-30 psi). Connectivity: tubing/connectors to external surgical system. Sterilization: disposable/single-use.

Indications for Use

Indicated for removal of vitreous and vitreal membranes during ophthalmic surgery in patients undergoing anterior or posterior segment procedures.

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

• Bausch & Lomb Surgical MicroVit® Vitrectomy Cutter (K013488)
• M. Imonti and Associates Pro-Vit Vitrectomy Cutter
• D.O.R.C. Disposable Pneumatic Vitrectome

Submission Summary (Full Text)

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# K033390

## NOV = 4 2003

| | 510(k) Summary |
|--|----------------|
| | |

MicroWorld Medical Instruments, Inc. SUBMITTER: 4640 Malat Street Oakland, CA 94601 USA

CONTACT PERSON: Mr. Semvon Gambarin Chief Executive Officer Phone: [phone] Fax: [phone]

August 5, 2003 DATE PREPARED:

DEVICE TRADE NAME: COLIBRI Disposable Vitrectomy Cutter

COMMON/USUAL NAME: Vitrectomy Guillotine Cutter

CLASSIFICATION NAME: Vitreous Aspiration and Cutting Instrument

PREDICATE DEVICES: Bausch & Lomb Surgical MicroVit® Vitrectomy Cutter M. Imonti and Associates Pro-Vit Vitrectomy Cutter D.O.R.C. Disposable Pneumatic Vitrectome

### DEVICE DESCRIPTION:

The COLIBRI Disposable Vitrectomy Cutter is a quillotine-style pneumatic handbiece for use during ophthalmic surgery. TThe main components of the device are the handle, diaphragm, inner spring, stainless steel inner and outer cutters, and attached tubing and connectors. The device provides cutting and aspiration functions during removal of vitreous and vitreal membranes in anterior and posterior segment surgeries. It is designed to be used with 20 psi and 30 psi ophthalmic surgical systems.

### INDICATIONS FOR USE

The COLIBRI Disposable Vitrectomy Cutter is intended to be used for the removal of vitreous and vitreal membranes during ophthalmic surgery.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

This submission contains a comparison of the intended use and technical characteristics of the COLIBRI Disposable Vitrectomy Cutter to the predicate devices. The design and materials of the COLIBRI Disposable Vitrectomy Cutter are similar if not identical to those of ophthalmic guillotine cutters marketed today.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroWorld Medical Instruments, Inc. c/o Heinz-Joerg Steneberg TUV Rheinland of North America, Inc. 12 Commerce Road Newtown, CT 06470

NOV - 4 2003

Re: K033390

Trade/Device Name: COLIBRI Disposable Vitrectomy Cutter Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous aspiration and cutting instrument Regulatory Class: Class II Product Code: HQE Dated: October 22, 2003 Received: October 23, 2003

Dear Mr. Steneberg:

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 (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.

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Page 2 - Heinz-Joerg Steneberg

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

A. Karyi fore. That

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

Enclosure

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#### Indications For Use

510(k) Number (If known): K033390

Device Name:

COLIBRI Disposable Vitrectomy Cutter

Indications For Use:

The COLIBRI Disposable Vitrectomy Cutter is intended to be used for the removal of vitreous and vitreal membranes during ophthalmic surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Everett M. Been

510(k) Number K033390

Prescription Use /
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________