ML-DISPOSABLE PAK

• K Number: K972522
• Device Name: ML-DISPOSABLE PAK
• Manufacturer: MED-LOGICS, INC.
• Date Cleared: 1997-09-30 ( 85 days)
• Product Code: MSR
• Regulation Number: 886.4150
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For use in cataract surgery to irrigate and aspirate cataract material.

Device Description

Not Found

AI/ML Overview

I apologize, but this document contains general regulatory correspondence from the FDA regarding a 510(k) submission for a medical device called "ML-Disposable Pak." It explicitly states that this is an "Indications For Use Statement" for a device used in cataract surgery to irrigate and aspirate cataract material.

This document DOES NOT contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or any of the other specific items you've requested.

Therefore, I cannot provide the requested table and information based on the text provided.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with its wings spread, formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K972522 Re: Trade Name: ML-Disposable Pak Regulatory Class: II Product Code: 86 HQC Dated: June 9, 1997 Received: July 7, 1997

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 (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.

SEP 3 0 1997

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Page 2 - Ms. Betty Ross

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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MED-LOGICS, INC.

27071 Cabot Road, Suite 127 Laguna Hills, CA 92653 Tel: [phone] - Fax: [phone]

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	K972522
Device Name:	Med-Logics Disposable Pak --
Indications For Use:	For use in cataract surgery to irrigate and aspirate cataract material.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)
Division of Ophthalmic Devices
(50k) Number	K972522

Prescription Use ✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.