QUITETIP

K981109 · Paradigm Medical Industries, Inc. · HQC · Jun 9, 1998 · Ophthalmic

Device Facts

• Record ID: K981109
• Device Name: QUITETIP
• Applicant: Paradigm Medical Industries, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Jun 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The QuiteTip™ I/A handpiece and tips are used in ophthalmic surgery to provide controlled aspiration of lens tissue while maintaining anterior chamber shape by replacing aspirated fluids with BSS.

Device Story

QuiteTip™ I/A handpiece and tips used during ophthalmic surgery; device facilitates controlled aspiration of lens tissue; maintains anterior chamber shape by replacing aspirated fluids with balanced salt solution (BSS). Operated by ophthalmic surgeons in clinical settings. Device provides mechanical aspiration functionality; assists in cataract or lens-related surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ophthalmic irrigation/aspiration (I/A) handpiece and tips; manual surgical instrument; utilizes BSS for fluid replacement; non-powered mechanical device.

Indications for Use

Indicated for use in ophthalmic surgery for controlled aspiration of lens tissue and maintenance of anterior chamber shape via fluid replacement with BSS.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0 1998 JUN

Mr. Richard Dirkson Regulatory/Quality Affairs Paradigm Medical Industries, Inc. 1127 West 2320 South, Suite A Salt Lake City, UT 94119

Re: K981109 Trade Name: Quite Tip™ I/A Handpiece and Tips Regulatory Class: II Product Code: 86 HOC Dated: March 26, 1998 Received: March 27, 1998

Dear : Mr. Dirkson:

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. Richard Dirkson

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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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March 26, 1998 510(K) Notification Paradigm Medical Industries, Inc., I/A Handpiece and Tips

510(K) Number K981109

Device Name: I/A Handpiece and Tips

## Indications For Use:

The QuiteTip™ I/A handpiece and tips are used in ophthalmic surgery to provide controlled aspiration of lens tissue while maintaining anterior chamber shape by replacing aspirated fluids with BSS.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daryl L. Kautz

Division Sion-Off Division of Ophthalmic Device

510(K) Number K981109

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)