ML DISPOSABLE ALK TUBING

K971173 · Med-Logics, Inc. · KYG · May 22, 1997 · Ophthalmic

Device Facts

• Record ID: K971173
• Device Name: ML DISPOSABLE ALK TUBING
• Applicant: Med-Logics, Inc.
• Product Code: KYG · Ophthalmic
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4360
• Device Class: Class 1

Intended Use

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

Device Story

ML Disposable ALK Tubing is a single-use medical device designed for ophthalmic irrigation. It facilitates the delivery of irrigation fluids to the eye during clinical procedures. The device is intended for use by healthcare professionals in clinical settings to maintain ocular surface hydration or clear debris. By providing a controlled flow of fluid, it assists in cleansing and flushing the eye, supporting surgical or diagnostic workflows. The disposable nature of the tubing minimizes the risk of cross-contamination between patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable tubing set for ophthalmic irrigation. Materials are medical-grade plastics suitable for fluid delivery. Non-powered, manual operation. Sterilized for single-use application.

Indications for Use

Indicated for intermittent or continuous irrigation, flushing, and cleansing of eyes in patients requiring ocular irrigation.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 22 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 Electronic 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,


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

Device Name: ML Disposable ALK Tubing

Indications For Use: For intermittent or continuous irrigation, flushing, and cleansing of eyes

(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
510(k) Number K971173

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)