P3 UNIVERSAL PHACO HANDPIECE

K972253 · Odyssey Technologies, Inc. · HQC · Jul 29, 1997 · Ophthalmic

Device Facts

• Record ID: K972253
• Device Name: P3 UNIVERSAL PHACO HANDPIECE
• Applicant: Odyssey Technologies, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.

Device Story

The Odyssey Technologies P3 Universal Handpiece is a surgical instrument used during cataract surgery. It utilizes ultrasound energy to perform phacoemulsification, a process that disrupts and emulsifies the cataractous lens for subsequent extraction. The device is intended for use by ophthalmic surgeons in a clinical or surgical setting. It functions as a hand-held tool that delivers ultrasonic vibrations to the surgical site, allowing the surgeon to break down the lens material. The output is the physical disruption of the cataract, facilitating its removal from the eye. The device is designed to assist in the surgical treatment of cataracts, aiming to improve patient vision by enabling the removal of the clouded lens.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is an ultrasonic handpiece designed for phacoemulsification. It operates by converting electrical energy into ultrasonic mechanical vibrations to emulsify cataractous lens tissue. It is a Class II medical device (Product Code: 86 HQC).

Indications for Use

Indicated for patients undergoing cataract surgery requiring ultrasound emulsification and extraction of the cataract.

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 29 1997

Mr. Glenn A. Dunki-Jacobs . Official Correspondent Odyssey Technologies 9327 Blackley Street Temple City, CA 91780

Re: K972253 -- --Trade Name: Odyssey Technologies P3 Universal Handpiece Regulatory Class: II Product Code: 86 HQC Dated: May 31, 1997 Received: June 16, 1997

Dear Mr. Dunki-Jacobs:

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 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. Glenn A. Dunki-Jacobs

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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## ODYSSEY TECHNOLOGIES

26945 Cabot Road, Suite 113 Laguna Hills, CA 92653 Tel: [phone] - Fax: [phone]

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Odyssey Technologies P3 Universal . Handpiece

Indications For Use:

For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.

Dom/L Kaufmo

(Division Sign-Off) Division of Ophthalmic Devices 1972253 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)