EYE IRRIGATOR MODEL #2020

K980647 · Eye-Deal Ocular Safety Products, Inc. · KYG · May 15, 1998 · Ophthalmic

Device Facts

• Record ID: K980647
• Device Name: EYE IRRIGATOR MODEL #2020
• Applicant: Eye-Deal Ocular Safety Products, Inc.
• Product Code: KYG · Ophthalmic
• Decision Date: May 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4360
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eye irrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.

Device Story

The Eye-Deal Eye Irrigator is a plastic ocular irrigation device functioning like a shower-head to provide continuous irrigation under the upper eyelid. It features a lower speculum wire for positioning and an adhesive-backed frame for cheek stabilization. Designed for use with a standard saline bag, it provides approximately 20 minutes of irrigation. Used in emergency care settings by technicians or clinicians to treat ocular trauma, chemical exposure, or burns. The device facilitates the flushing of contaminants from the eye, aiding in clinical management of ocular injuries.

Clinical Evidence

Preliminary study comparing Eye Irrigator to Morgan Lens. Sample size: 6 patients (12 eyes). Endpoints: patient tolerance, ease of insertion, and efficacy in clearing fluorescein dye. Results indicated the device was well-tolerated and easy to use, with clear irrigation efficacy. Biocompatibility testing performed per ISO 10993-1 for surface/mucosal membrane contact; materials passed all assays.

Technological Characteristics

Plastic irrigation tube with shower-head design and lower speculum wire. Adhesive tape for stabilization. Sterilization via ethylene oxide gas (ANSI/AAMI/ISO 11135-1994) to a sterility assurance level of 10^-6. Materials pre-qualified for medical/food grade toxicity.

Indications for Use

Indicated for eye irrigation in patients with post-traumatic injury, chemical exposure, or burns. Suitable for irrigation of the eye and under the upper eyelid using sterile saline.

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.

Predicate Devices

• Morgan Lens (K821897)

Submission Summary (Full Text)

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SUBMITTER:

Submitted on behalf of:

| Company Name: | Eye-Deal Ocular Safety, Inc. | |
|------------------------|-----------------------------------------------------------------------------------------------|------------------------|
| Address: | 3620 Lake Mendota Drive<br>Madison, WI 53705 | |
| Telephone: | 608-238-9004 | |
| by: | Elaine Duncan<br>Paladin Medical®, Inc.<br>PO Box 560<br>Stillwater, MN 55082<br>715-549-6035 | Official Correspondent |
| CONTACT PERSON: | Elaine Duncan | |
| DATE SUMMARY PREPARED: | February 13, 1998: Revised 5-11-98 | |

Eye Irrigator, Ocular Irrigator TRADE NAME: Eye irrigator COMMON NAME:

SUBSTANTIALLY EQUIVALENT TO: The Eye Irrigator is substantially equivalent to the Morgan Lens, by Mortan, Inc., K821897

DESCRIPTION of the DEVICE: The Eye-Deal Eye Inigator, an ocular irrigator, consists of a plastic irrigation tube that works like a shower-head to irrigate continuously from under the upper eye-lid. The device is held in place with the lower speculum wire resting within the lower lid. The frame of the irrigator can be applied using adhesive tape provided, to the cheek of the patient, to stabilize the irrigator during the procedure. The device is designed to provide approximately 20 minutes of irigation using a standard saline bag.

INDICATIONS FOR USE: The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eye irrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.

CLINICAL INFORMATION and SAFETY and EFFECTIVENESS: A preliminary study was conducted to compare the efficacy of the irrigation of the Morgan lens, to evaluate the tolerance of the patient to the device and the ease of insertion of the emergency care provider. Six patients and 12 total eyes were compared, and although the study size was too small for statistically significant results, the trend was clear that the Eye Irrigator was well tolerated by the patient and easy to use by the technician. The Eye Irrigator was efficient in clearance of thorescein, an indicator dye commonly used as an indicating dye. A complete summary of the study is provided in the submission. In addition to the clinical testing, the materials used in the Eye Irrigator were pre-qualified by selecting materials with medical or food grade toxicity testing. In addition, the complete assembly (after sterilization) was tested for biocompatibility as indicated for surface devices/mucosal membrane/short-term ocular membrane contact by the Blue Book Memorandum for adoption of the ISO 10993-1 Part 1. Testing results indicated that the materials passed the required assays. Validation of the sterilization process that was conducted according to the procedures of ANSVAAMI/ISO 11135-1994 showed that the ethylene oxide gas cycle will reproducibly provide a sterility assurance level of 10-6 for processes meeting the specified cycle parameters.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a series of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | 5 1998

Eye-Deal Ocular Safety Products, Inc. c/o Ms. Elaine Duncan Paladin Medical Inc. P.O. Box 560 Stillwater, MN 55082-0560

Re: K980647 Trade Name: Eye-Deal Eye Irrigator Regulatory Class: I Product Code: 86 KYG Dated: February 13, 1998 Received: February 13, 1998

Dear Ms. Duncan:

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. Elaine Duncan

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl 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) _ K 980647

Eye-Deal EYE IRRIGATOR, Ocular Irrigator Device Name

## Indications for Use:

The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eyeirrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.

(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over -The-Counter Use

(Optional Format 1-2-96)

Musa Smith

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K980647