OCUSYSTEM ART ADVANTAGE, MODEL 995

K991852 · Surgical Design Corp. · HQC · Jul 7, 1999 · Ophthalmic

Device Facts

• Record ID: K991852
• Device Name: OCUSYSTEM ART ADVANTAGE, MODEL 995
• Applicant: Surgical Design Corp.
• Product Code: HQC · Ophthalmic
• Decision Date: Jul 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Phacoemulsification of cataracts in the human eye.

Device Story

Ocusystem Art Advantage is a phacoemulsification system used by ophthalmologists in surgical settings to treat cataracts. The device utilizes ultrasonic energy to emulsify the cataractous lens, allowing for its aspiration from the eye. It functions as a surgical tool to facilitate lens removal during cataract surgery, improving visual outcomes for patients. The system is operated by a surgeon during the procedure.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Phacoemulsification system; utilizes ultrasonic energy for lens emulsification and aspiration. Class II device (Product Code: 86 HQC).

Indications for Use

Indicated for phacoemulsification of cataracts in the human eye.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 1999

Mr. Wayne H Matelski C/O Arent Fox Surgical Design Corp. 1050 Connecticut Avenue, NW Washington, DC 20036-5339

Re: K991852 Trade Name: Ocusystem Art Advantage® Regulatory Class: II Product Code: 86 HQC Dated: May 28, 1999 Received: June 1, 1999

Dear Mr. Matelski:

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 - Mr. Wayne H. Matelski

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/dsma/dsmamain.html".

Sincerely yours,

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

Enclosures: Indications for Use Paradigm Attachment Letter

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510(k) Nunber (if known): _ K991852

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Phacoemulsification of cataracts in the human eye.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daryl L. Kaufman

Division of Ophthalmic Devices K991852 510(k) Number.

?rescription Use
Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)