THE WAVE DIGITAL PHACO SYSTEM

K981989 · Circuit Tree · HQC · Aug 25, 1998 · Ophthalmic

Device Facts

• Record ID: K981989
• Device Name: THE WAVE DIGITAL PHACO SYSTEM
• Applicant: Circuit Tree
• Product Code: HQC · Ophthalmic
• Decision Date: Aug 25, 1998
• 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

The Wave Digital Phaco System is an ophthalmic surgical device used for the phacoemulsification of cataracts. It utilizes ultrasonic energy to emulsify cataractous lens tissue, allowing for aspiration and removal from the eye. The system is operated by ophthalmologists in a surgical setting. It provides precise control over irrigation, aspiration, and ultrasonic power parameters to facilitate lens extraction during cataract surgery. By enabling efficient emulsification, the device assists in the surgical treatment of cataracts, potentially improving patient visual outcomes.

Clinical Evidence

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

Technological Characteristics

Phacoemulsification system utilizing ultrasonic energy for lens emulsification. Includes irrigation and aspiration subsystems. Designed for ophthalmic surgical use.

Indications for Use

Indicated for phacoemulsification of cataracts in the human eye. Prescription use only.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1998

Circuit Tree Medical, Inc. Maurice Imonti c/o Imonti and Associates 25707 Compass Way San Juan Capistrano, CA 92675

Re: K981989 Trade Name: The Wave Digital Phaco System Regulatory Class: II Product Code: 86 HQC Dated: June 2, 1998 Received: June 5, 1998

Dear Mr. Imonti:

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. Maurice Imonti

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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510(k) Number (if known): K981989

Device Name: The WAVE Digital Phaco System

Hndications For Use: Phacoemulsification of cataracts in the human eye.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alegn L. Hoang, Scientific Reviewer

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K981989

Prescription Use_X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)