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

Intended Use

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

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use is simple irrigation.

Therapeutic

No
The device is used for irrigation, flushing, and cleansing of eyes, which are generally considered hygiene or maintenance activities rather than therapeutic interventions aimed at treating a disease or condition.

Diagnostic

No.
The intended use is for "irrigation, flushing, and cleansing of eyes," which are therapeutic or maintenance activities, not diagnostic ones. There is no mention of identifying a disease, condition, or anomaly.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The intended use describes a physical action (irrigation, flushing, cleansing), which typically involves hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "For intermittent or continuous irrigation, flushing, and cleansing of eyes." This describes a physical action performed directly on the body (the eyes) for therapeutic or cleansing purposes.
• Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
• Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, diagnostic testing, or any process that would fit the definition of an IVD.

Therefore, this device, used for irrigating and cleansing the eyes, falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

86 KYG

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eyes

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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)