VITRECTOMY CUTTER AND ACCESSORIES

K081681 · Advanced Medical Optics, Inc. · MLZ · Oct 8, 2008 · Ophthalmic

Device Facts

• Record ID: K081681
• Device Name: VITRECTOMY CUTTER AND ACCESSORIES
• Applicant: Advanced Medical Optics, Inc.
• Product Code: MLZ · Ophthalmic
• Decision Date: Oct 8, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.

Device Story

The AMO 20GA Vitrectomy Cutter and Irrigation Sleeve are ophthalmic surgical instruments used to remove vitreous matter and provide irrigation during vitrectomy procedures. The device is designed for use with the Whitestar Signature System. During surgery, the cutter removes vitreous matter from the anterior or posterior segments of the eye, while the sleeve provides necessary irrigation. The device is operated by a surgeon in a clinical or surgical setting. By facilitating the removal of vitreous matter, the device assists in the treatment of ocular trauma, secondary intraocular lens implantation, and various posterior segment conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

20-gauge vitrectomy cutter and irrigation sleeve. Designed for use with the Whitestar Signature System. Manufactured in compliance with FDA QSR and ISO standards.

Indications for Use

Indicated for removal of vitreous matter from the eye during vitrectomy procedures, including anterior segment vitrectomy following trauma or during cataract surgery, and posterior segment vitrectomy for various conditions. For use with the Whitestar Signature™ System.

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

• UnuVit and 4422CE (Midlabs) (K950287)

Submission Summary (Full Text)

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# OCT 0 8 2008

K081861 Vitrectory Cutter/Aspiration Device and Irrigation Sleeve - Request for Information Advanced Medical Optics, Inc.

K081681

# 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the Medical Device Amendments of 1976, the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.

| The applicant is: | Advanced Medical Optics, Inc.<br>1700 E. St. Andrew Place<br>Santa Ana CA 92705, USA |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Est. Registration number: | 2020664 |
| The contact person is: | Evelyn De La Vega<br>Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone] |
| Date: | September 18, 2008 |
| Device Trade Name: | AMO™ 20GA Vitrectomy Cutter and<br>Irrigation Sleeve, AMO™ 20GA<br>Vitrectomy Cutter, AMO™ 20GA Irrigation<br>Sleeve. |
| Device Classification Name: | Vitreous Aspiration and Cutting Device, and<br>Irrigation Sleeve |
| Classification: | Class II, Tier II |

The devices to which substantial equivalence is claimed:

| 510(k) Number | Clearance Date | Device |
|---------------|----------------|-------------------|
| K950287 | March 3, 1995 | UnuVit and 4422CE |
| | | (Midlabs) |

### DEVICE DESCRIPTION

The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.

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K081861 Vitrectory Cutter/Aspiration Device and Irrigation Sleeve -- Request for Information Advanced Medical Optics, Inc.

The device has been placed in Class II under section 513 of the Federal Food, Drug, and Cosmetic Act. The device is a Tier II and the appropriate panel is the Ophthalmic devices Its classification maybe found in Part 886 of 21 CFR (Code of Federal Panel. Regulations); it's specifically identified under regulation number 886.4150.

#### INDICATIONS FOR USE

The Vitrectorny Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure.

#### SUMMARY

The physical and performance characteristics of the vitrectomy cutter and the irrigation sleeve are substantially equivalent to those of the predicate devices. The products will be manufactured in compliance with both FDA (QSR) and ISO standards and have demonstrated to be safe and effective for the indicated use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Medical Optics, Inc. c/o Evelyn De La Vega 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92705

Re: K081681

Trade/Device Name: AMOTM 20GA Vitrectomy Cutter and Irrigation Sleeve NGP0020, AMOTM 20GA Vitrectomy Cutter NGP0020A, AMOTM 20GA Irrigation Sleeve NGP0020B Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting instrument Regulatory Class: II Product Code: MLZ Dated: August 25, 2008 Received: August 26, 2008

Dear Evelyn De La Vega:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Madina B. Eggleston, M.D.

Malvina B. Eydelman, M.I 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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# INDICATION FOR USE STATEMENT

510(k) number (if known): K081681

Device Name: AMO™ 20GA Vitrectomy Cutter and Irrigation Sleeve,AMO™ 20GA Vitrectomy Cutter, AMO™ 20GA Irrigation Sleeve

Indication for Use:

The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

M. O'Connell
(Division Sign-Off)

Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K081681