PHACOPAK by PARADIGM MEDICAL INDUSTRIES, INC.

This document is a 510(k) clearance letter from the FDA for a device called "Phacopak" (also referred to as "Phaco Tip"). It explicitly states that the device is substantially equivalent to legally marketed predicate devices.

However, this document DOES NOT contain any information regarding acceptance criteria, device performance, sample sizes for testing, ground truth establishment, expert qualifications, adjudication methods, or results from any studies (standalone or MRMC comparative effectiveness).

The letter is a regulatory approval document and focuses on the administrative aspects of substantial equivalence, not the detailed technical data that would be found in a study report.

Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided text. The requested information is simply not present in these documents.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

.JAN 20 1998

Mr. Richard Dirkson Regulatory/ Quality Affairs Paradigm Medical Industries, Inc. 1772 West 2300 South Salt Lake City, Ut. 84119

Re: K974719/S1 Trade Name: Phacopak Regulatory Class: II Product Code: 86 HQC Dated: December 16, 1997 Received: December 18, 1997

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 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Raeyl 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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Page 1 of 2

510(K) Number K974719

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Device Name: Phaco Tip

Indications For Use:

: 上

The Paradigm Phaco Tip is intended to be used in conjunction with an ultrasonic handpiece for ophthalmic surgery to remove cataract tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division Sign-Off
Division of Ophthalmic Devices
510(k) Number	K974719

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
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.(b)
Classification. Class II.