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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Eye-Cept® Sterile Saline Solution.

Important Note: The provided document is a 510(k) Summary for a contact lens care product, not a medical device in the typical sense of AI/CADe systems that require clinical studies with human readers. Therefore, many of the requested elements (like sample sizes for test sets, number of experts, MRMC studies, standalone performance for AI, etc.) are not applicable to this type of submission. The "study" here refers to pre-clinical and laboratory testing to demonstrate safety and effectiveness for a chemical solution.

Acceptance Criteria and Reported Device Performance for Eye-Cept® Sterile Saline Solution

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "Eye-Cept® Sterile Saline Solution" are primarily based on demonstrating substantial equivalence to predicate devices and conformance to specified physicochemical properties and safety/effectiveness standards outlined in FDA guidance documents for contact lens care products.

Characteristic / Acceptance Criterion	Eye-Cept® Sterile Saline Solution Performance	Reference/Standard
Intended Use Equivalence	Matches predicate devices’ intended use for rinsing soft (hydrophilic) contact lenses after cleaning and wetting before use after disinfection.	Substantial Equivalence to K093367, P790011
Preservative-Free	Yes	K093367, P790011
Sterile	Yes	K093367, P790011
Aqueous solution of NaCl & Borates	Yes	K093367, P790011
pH balanced	Yes (pH 7.2-7.8)	K093367, P790011
Tonicity	290-320 mOsm/kg	-
Container Material	Polyethylene	K093367, P790011
Propellants	None	K093367, P790011
In vitro cytotoxicity	Non-toxic solution and polyethylene container	FDA Guidance Document
Acute Ocular Irritation	No acute ocular irritation	FDA Guidance Document
Antibacterial Effectiveness	Effective (as saline, not a disinfectant)	FDA Guidance Document
Overall Safety & Effectiveness	As safe, effective, and performs as well as predicate devices.	Substantial Equivalence

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify exact sample sizes for the in vitro cytotoxicity, acute ocular irritation, or antibacterial effectiveness tests. For these types of tests, sample sizes are typically determined by established laboratory protocols and standards for chemical testing, rather than patient-based test sets used for AI/CADe.
Data Provenance: The studies were conducted by Optics Laboratory, Inc. to support their 510(k) submission. The data is internal to the manufacturer, as is standard for pre-market submissions of this nature. The country of origin for the data is implicitly the USA, where the sponsor is located and where the FDA operates. The studies are described as having been completed "to demonstrate the substantial equivalence," implying they were specifically conducted for this submission (prospective in that sense, but not a prospective clinical trial).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this type of device. "Ground truth" in the context of diagnostic devices typically refers to expert consensus, pathology, or clinical outcomes for patient data. For a sterile saline solution, the "ground truth" is established by laboratory measurements (e.g., pH meters, osmometers, cytotoxicity assays) and standardized animal or in vitro tests for irritation and antimicrobial properties. These are measured by laboratory technicians and scientists following established protocols, rather than medical experts forming a consensus.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers interpret medical images or perform clinical assessments, and disagreement needs to be resolved. For laboratory-based chemical and safety testing, the results are typically quantitative measurements or qualitative observations directly interpreted by trained laboratory personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable. An MRMC study is relevant for AI/CADe diagnostic devices that assist human readers in interpreting medical data. The Eye-Cept® Sterile Saline Solution is a chemical solution, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This device is a chemical solution, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:
- Physicochemical Measurements: Direct measurements of properties like pH (7.2-7.8) and tonicity (290-320 mOsm/kg).
- In vitro Laboratory Assays: Tests for cytotoxicity (evaluating non-toxicity of the solution and container).
- Animal Testing: Acute ocular irritation studies (demonstrating no irritation).
- Microbiological Testing: Antibacterial effectiveness (to ensure it does not promote microbial growth, though it is not a disinfectant).
- Substantial Equivalence: Demonstrating that its characteristics and performance are comparable to legally marketed predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. The concept of a "training set" and "test set" applies to machine learning algorithms. For a chemical solution, there is no "training set" in this context. The manufacturing process is developed and validated, but this is distinct from training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons above.

Summary

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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: 1-626-350-1926 Fax: 1-626-350-1906 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:

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 LaboratoryEye-Cept® Sterile SalineSolution	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 &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
1. acute ocular irritation
1. 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another, represented by three curved lines.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

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