EYE-CEPT STERILE SALINE SOLUTION

K110221 · Optics Laboratory, Inc. · LPN · Nov 1, 2011 · Ophthalmic

Device Facts

• Record ID: K110221
• Device Name: EYE-CEPT STERILE SALINE SOLUTION
• Applicant: Optics Laboratory, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Nov 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

Eye-Cept® Sterile Saline Solution is intended for use rinsing soft (hydrophilic) contact lens after cleaning and wetting before use after disinfection,

Device Story

Eye-Cept® Sterile Saline Solution is a preservative-free, sterile aqueous solution used for rinsing and wetting soft (hydrophilic) contact lenses. It is supplied in single-use 10 ml polyethylene bottles. The solution is used by the patient to remove debris and cleaning solution from lenses after cleaning and to wet lenses after disinfection. It is not a disinfectant and is not intended for use as eye drops. The device is discarded after a single use.

Clinical Evidence

Bench testing only. Studies included in vitro cytotoxicity of the solution and polyethylene container, acute ocular irritation, and antibacterial effectiveness, conducted in accordance with FDA guidance for contact lens care products.

Technological Characteristics

Sterile, preservative-free aqueous solution of sodium chloride, boric acid, and sodium borate. pH 7.2-7.8; tonicity 290-320 mOsm/kg. Provided in single-dose 10ml polyethylene containers.

Indications for Use

Indicated for rinsing soft (hydrophilic) contact lenses after cleaning and wetting soft contact lenses after disinfection before use. For OTC use.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Cachet Saline Solution (K093367)
• Alcon (formerly Cooper) Unisol® Saline Solution (P79001)

Submission Summary (Full Text)

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# 510(k) Summary for Eye-Cept® Sterile Saline Solution

### A. Sponsor

Optics Laboratory, Inc. 9480 Telstar Ave Ste 3 El Monte, CA 91731-2988

#### B. Contact

Patricia Chiu, CEO Optics Laboratory, Inc. Phone: [phone] Fax: [phone] Summary prepared October 2011

### C. Device Name

Trade Name: Eye-Cept® Sterile Saline Solution Common Name: Contact Lens Saline Solution Classification Name: Soft contact lens care products (21 CFR 886.5928, Product Code LPN)

# D. Predicate Device(s):

Cachet Saline Solution - K093367 Alcon (formerly Cooper) Unisol® Saline Solution - P79001 |

# E. Device Description:

Eye-Cept® Sterile Saline Solution is provided in single use, carry-on size bottles that are preservative free. It rinses loose debris and cleaning solution off soft (hydrophilic) contact lenses. It is only for use to rinse and wet soft contact lenses (a) after cleaning before disinfection and (b) after disinfection before using. It is not a disinfectant nor should it be used as eye drops. It is a clear solution and should not be used, if cloudy or discolored. The individual 10 ml bottle should not be kept once used; it should be discarded after opening. It should not be used after its labeled expiry date.

### F. Intended Use:

Eye-Cept® Sterile Saline Solution is intended for use rinsing soft (hydrophilic) contact lens after cleaning and wetting before use after disinfection,

# NOV - 1 900

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K110221

# G. Technological Characteristics:

Eye-Cept" Sterile Saline Solution is a sterile, preservative-free, aqueous solution of sodium chloride, boric acid, and sodium borate provided in single dose 10ml bottles. The sterile saline solution has pH of 7.2-7.8 and tonicity of 290- 320 mOsm/kg.

| Device Characteristic | Optics Laboratory<br>Eye-Cept® Sterile Saline<br>Solution | K093367 | P790011 |
|---------------------------------------|-----------------------------------------------------------|---------|---------|
| For hydrophilic contact lenses | Y | Y | Y |
| For rinsing and thermal disinfection | N | N | Y |
| Preservative-Free | Y | Y | Y |
| Sterile | Y | Y | Y |
| Aqueous solution of NaCl &<br>Borates | Y | Y | Y |
| pH balanced | Y | Y | Y |
| Multi-Dose Container | N | N | Y |
| Polyethylene Container | Y | Y | Y |
| Propellants | N | N | N |

# H. Substantial Equivalence:

A series of studies were completed to demonstrate the substantial equivalence of Eye-Cept Sterile Saline Solution to the predicate devices. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the solution is non-toxic, is comparable to other currently marketed soft contact lens solutions, and is substantially equivalent to legally marketed predicates. These studies followed the "Testing Matrix for Saline Solutions" of the "Guidance for Industry - Premarket Notification (510k) Guidance Document for Contact Lens Care Products, issued May 1, 1997" and included:

- l . in vitro cytotoxicity of both the saline solution and the polyethylene container
- 2. acute ocular irritation
- 3. antibacterial effectiveness

Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" a direct comparison of key characteristics demonstrates that the proposed saline solution is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance

characteristics. The proposed Optics Laboratory Eye-Cept® Sterile Saline Solution is as safe, as effective, and performs as well as the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Optics Laboratory, Inc. c/o Dr. George Samaras Official Correspondent Samaras & Associates, Inc. 7755 Soda Creek Road Pueblo County, CO 81005-9763

NOV = 1 2011

Re: K110221

Trade/Device Name: Eye-Cept® Sterile Saline Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: October 5, 2011 Received: October 14, 2011

Dear Dr. Samaras:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

6 Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

Indications for Use:

510(k) Number (if known):

K|1022|

Device Name:

Eye-Cept® Sterile Saline Solution

#### Indications for Use:

Eye-Cept® Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and for wetting soft contact lenses after disinfection before use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marc Robloz

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110622