ML DISPOSABLE ALK TUBING

• K Number: K971173
• Device Name: ML DISPOSABLE ALK TUBING
• Manufacturer: MED-LOGICS, INC.
• Date Cleared: 1997-05-22 ( 52 days)
• Product Code: KYG
• Regulation Number: 886.4360
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For intermittent or continous irrigation, flushing, and cleansing of eyes

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "ML Disposable ALK Tubing". It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts.
• Information on adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used.
• Information about training sets or how their ground truth was established.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 1997

Mr. Glenn A. Dunki-Jacobs Director, Regulatory Affairs Med-Logics, Inc. 27071 Cabot Road, Suite 127 Laguna Hills, CA 92653

Re: K971173 Trade Name: ML Disposable ALK Tubing Regulatory Class: I Product Code: 86 KYG Dated: March 25, 1997 Received: March 31, 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Flectronic 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 at [phone].

Sincerely yours,

Aleph 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): K971173

ML Disposable ALK Tubing Device Name:

Indications For Use:

For intermittent or continous irrigation, flushing, and cleansing of eyes

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number	K971173
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Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 886.4360 Ocular surgery irrigation device.

(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.