ML UNIVERSAL TUBING by MED-LOGICS, INC.

The provided document is a 510(k) premarket notification letter from the FDA regarding Med-Logics, Inc.'s Administration Set, Drainage Bag, and Universal Tubing. This document is a regulatory letter approving a medical device based on its substantial equivalence to pre-existing devices. It does not contain information about acceptance criteria or study results in the context of device performance, algorithm evaluation, or clinical trials which are typically found in design validation reports or clinical study summaries.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval rather than technical performance data or study methodologies.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 1998

Ms. Betty Ross President Med-Logics, Inc. 30251 Golden Lantern Suite E-207 Laguna Niguel, CA 92677

Re: K983448

Trade Names: Med-Logics, Inc. Administration Set, Med-Logics, Inc. Drainage Bag, and Med-Logics, Inc. Universal Tubing Regulatory Class: II Product Code: 86 MSR Dated: September 28, 1998 Received: September 30, 1998

Dear Ms. Ross:

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 (OS) 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 ~Ms. Betty Ross, President

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. Ralph L. 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): K983448

Device Name:

Med-Logics, Inc., Administration Set (UT 3004) Med-Logics, Inc., Drainage Bag (UT 3002) Med-Logics, Inc., Universal Tubing Set (UT 3000)

Indication For Use:

Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Ro hickolas

(Division Sign-Off) Division of Ophthalmic Devices Division of Opidian K983448

OR

Prescription Use
Per 21 CFR 801.109

Over-The-Counter Use ...

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.