(280 days)
P790011
No
The device is a sterile saline solution for contact lenses, and the description focuses on its chemical properties and intended use for rinsing and wetting. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The Eye-Cept Sterile Saline Solution is indicated only for rinsing and wetting soft contact lenses, not for direct therapeutic treatment of an ailment or disease.
No
Explanation: The device is a sterile saline solution for rinsing and wetting contact lenses, not for diagnosing medical conditions. Its described uses are limited to lens care and do not involve detecting, monitoring, or predicting diseases or health states.
No
The device is a sterile saline solution, which is a physical substance, not software. The description details its composition, packaging, and physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "rinsing soft contact lenses after cleaning and for wetting soft contact lenses after disinfection before use." This is a direct interaction with a medical device (contact lenses) and not a diagnostic test performed in vitro (outside the body) on biological specimens to diagnose a condition or provide information about a physiological state.
- Device Description: The description reinforces its function as a solution for cleaning and wetting contact lenses. It explicitly states it is "not a disinfectant nor should it be used as eye drops."
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on demonstrating the safety and equivalence of the saline solution for its intended use with contact lenses (cytotoxicity, ocular irritation, antibacterial effectiveness in vitro in the context of contact lens care). They do not involve diagnostic performance metrics like sensitivity, specificity, etc.
IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to provide information about a person's health. This device's function is solely related to the care and use of contact lenses.
N/A
Intended Use / Indications for Use
Eye-Cept® Sterile Saline Solution is intended for use rinsing soft (hydrophilic) contact lens after cleaning and wetting before use after disinfection,
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.
Product codes
LPN
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
-
- acute ocular irritation
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cachet Saline Solution - K093367
Reference Device(s)
P790011
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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:
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
1
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
Eye-Cept® Sterile Saline
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 &
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
-
- acute ocular irritation
-
- 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.
2
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.
3
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,
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
4
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