(86 days)
The provided text does not contain any K/DEN numbers. The section "Predicate Device(s)" states "Not Found".
Not Found
No
The device is a lubricant eye drop solution, and the description and performance studies focus on its chemical composition, compatibility with contact lenses, and clinical safety and efficacy as a lubricant, with no mention of AI or ML.
Yes
The device is intended to relieve dryness, irritation, and discomfort associated with lens wear, which are therapeutic effects.
No
The device is described as a lubricant eye drop intended to relieve dryness and discomfort associated with contact lens wear, not to diagnose or detect any medical condition.
No
The device description clearly states it is a sterile, isotonic, buffered solution packaged in plastic bottles with controlled dropper tips, indicating it is a physical product (eye drops) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to lubricate and rewet contact lenses and relieve eye discomfort associated with lens wear. This is a direct application to the eye and contact lenses, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a sterile solution for direct application to the eye and contact lenses. It doesn't describe reagents, test kits, or equipment used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease or condition, or providing information about a patient's health status based on in vitro testing.
The device is clearly intended for direct use on the eye and contact lenses to alleviate symptoms, which falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Use blink™ CL Lubricant Eye Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses; to help relieve dryness, irritation and discomfort that may be associated with lens wear; and to cushion lenses by placing a drop on the lens prior to application on the eye.
Product codes
LPN, MRC
Device Description
blink™ CL Lubricant Eye Drops is a sterile, isotonic, buffered solution containing a lubricant, a preservative, buffers, tonicity agents, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye
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
Lens Compatibility: In vitro lens compatibility testing was conducted to establish product compatibility with both soft (hydrophilic) and RGP contact lenses. The results show that the product is compatible with soft (hydrophilic) and RGP contact lenses and substantially equivalent to the control.
Solution Compatibility: A study was conducted to evaluate the compatibility of blink™ CL Lubricant Eye Drops when used with leading contact lens care products on the market. The results indicate that the product is compatible with these leading contact lens care products.
Preservative Uptake and Release: A study was conducted with soft (hydrophilic) and RGP contact lenses to determine the uptake and release of the preservative in blink™ CL Lubricant Eye Drops. The results show that there is very little, if any, uptake of the preservative in or onto soft or RGP lenses. Any amounts taken up are quickly released. The results indicate that the product is compatible and acceptable for use with soft (hydrophilic) and RGP contact lenses.
Contact Lens Wetting Anqle: A wetting angle study was conducted to assess the effectiveness of blink™ CL Lubricant Eye Drops in enhancing the wettability of RGP lenses compared with predicate lubricating and rewetting products. The results indicate that blink™ CL Lubricant Eye Drops is substantially equivalent in wetting properties to the predicate devices.
Microbiological Studies: The product was evaluated for preservative efficacy and sterility: The product meets the acceptance criteria for Preservative Effectiveness . Testing as outlined in ISO 14730:2000(E), "Ophthalmic optics – Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date." The product meets USP Sterility test requirements.
Stability: Accelerated testing predicts that the product will remain stable for the labeled shelf-life.
Toxicology: The safety of blink™ CL Lubricant Eye Drops was evaluated using cytotoxicity and acute ocular toxicity tests. The results of the testing demonstrate that blink™ CL Lubricant Eye Drops is non-cytotoxic, non-irritating and well-tolerated.
Clinical Data: AMO conducted a multi-center, double-masked, randomized, parallel-group, one-month evaluation to assess the safety and acceptability of blink™ CL Lubricant Eye Drops. The results of this study indicate that the investigational formulation is safe, acceptable, and substantially equivalent to the control.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
SEP 2 5 2003
(Biomatrix).
Image /page/0/Picture/1 description: The image shows the logo for Advanced Medical Optics (AMO). The logo features the letters "AMO" in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words "ADVANCED MEDICAL OPTICS" are written in a smaller, sans-serif font. The logo is simple and professional, and it conveys the company's focus on medical optics.
510(k) SUMMARY
blink™ CL Lubricant Eye Drops
This summary uses the format provided in 21 CFR 807.92:
| (a)(1) | Submitter: | Paul J. Nowacki
Manager
Regulatory Affairs
Advanced Medical Optics
1700 E. St. Andrew Place
Santa Ana, CA 92799-5162 |
|--------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Phone: (714) 247-8601
Fax: (714) 247-8677
EMail: paul.nowacki@amo-inc.com |
| | Summary Prepared: | June 30, 2003 |
| (a)(2) | Device Trade Name: | blink ™ CL Lubricant Eye Drops |
| | Device Common Name: | Soft (Hydrophilic) and Rigid Gas Permeable
Contact Lens Lubricating and Rewetting
Solution |
| | Device Classification/Panel: | Class II (Special Controls)/Ophthalmic Device |
| | Device Classification Names: | Accessories to Contact Lenses - Cleaning and
Wetting Agents |
| (a)(3) | Identification of Predicate Device: | blink ™ CL Lubricant Eye Drops is
substantially equivalent to other lubricating and rewetting solutions currently
marketed or cleared for commercial distribution in the U.S. These include
REFRESH® CONTACTS™ Lubricating and Rewetting Drops (Allergan), AQuify
Lens Comfort Drops (CIBA Vision) and Hylashield® CL Lubricating Eye Drop |
- (a)(4) Device Description: blink™ CL Lubricant Eye Drops is a sterile, isotonic, buffered solution containing a lubricant, a preservative, buffers, tonicity agents, and purified water.
The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
1
- Intended Use (Indications for Use): Use blink™ CL Lubricant Eye Drops to (a)(5) lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, irritation and discomfort that maybe associated with lens wear, and to cushion lenses by placing a drop on the lens prior to application on the eve. The intended use is comparable to that of the predicate devices.
- Comparison of Technological Characteristics: blink™ CL Lubricant Eye (a)(6) Drops has the same intended use and the same technological characteristics as the predicate lubricants/rewetters. The lubricant and preservative are materials which are used in the predicate lubricants/rewetters but not in combination in any one product. The ophthalmic demulcent, while not listed in 21 CFR 349.12, is used in one of the three predicate lubricants/rewetters in which we are requesting a determination of substantial equivalence. Additionally, a chemically similar lubricant is used in another one of the predicate lubricants/rewetters. Both of these lubricants have been cleared for commercial distribution in the U.S. All excipients are commonly recognized and used in ophthalmic and contact lens care products, including the predicate lubricants/rewetters.
Description of Safety and Substantial Equivalence
Nonclinical and clinical studies were performed to demonstrate the substantial equivalence of blink™ CL Lubricant Eye Drops to the predicate device(s). Testing was conducted in accordance with and in conformance to applicable device requlations. The following is a discussion of the study results.
Discussion of Nonclinical: (b)(1)
Lens Compatibility: In vitro lens compatibility testing was conducted to establish product compatibility with both soft (hydrophilic) and RGP contact lenses. The results show that the product is compatible with soft (hydrophilic) and RGP contact lenses and substantially equivalent to the control.
Solution Compatibility: A study was conducted to evaluate the compatibility of blink™ CL Lubricant Eye Drops when used with leading contact lens care products on the market. The results indicate that the product is compatible with these leading contact lens care products.
Preservative Uptake and Release: A study was conducted with soft (hydrophilic) and RGP contact lenses to determine the uptake and release of the preservative in blink™ CL Lubricant Eye Drops. The results show that there is very little, if any, uptake of the preservative in or onto soft or RGP lenses. Any amounts taken up are quickly released. The results indicate that the product is compatible and acceptable for use with soft (hydrophilic) and RGP contact lenses.
2
Discussion of Nonclinical (Continued): (b)(1)
Contact Lens Wetting Anqle: A wetting angle study was conducted to assess the effectiveness of blink™ CL Lubricant Eye Drops in enhancing the wettability of RGP lenses compared with predicate lubricating and rewetting products. The results indicate that blink™ CL Lubricant Eye Drops is substantially equivalent in wetting properties to the predicate devices.
Microbiological Studies: The product was evaluated for preservative efficacy and sterility:
- The product meets the acceptance criteria for Preservative Effectiveness . Testing as outlined in ISO 14730:2000(E), "Ophthalmic optics – Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date."
- . The product meets USP Sterility test requirements.
Stability: Accelerated testing predicts that the product will remain stable for the labeled shelf-life.
Toxicology: The safety of blink™ CL Lubricant Eye Drops was evaluated using cytotoxicity and acute ocular toxicity tests. The results of the testing demonstrate that blink™ CL Lubricant Eye Drops is non-cytotoxic, non-irritating and well-tolerated.
Discussion of Clinical Data: (b)(2)
AMO conducted a multi-center, double-masked, randomized, parallel-group, one-month evaluation to assess the safety and acceptability of blink™ CL Lubricant Eye Drops. The results of this study indicate that the investigational formulation is safe, acceptable, and substantially equivalent to the control.
- (b)(3) Conclusions Drawn from Data Supporting Equivalence Determination: It is concluded that the safety, efficacy and performance of blink™ CL Lubricant Eye Drops is substantially equivalent to the predicate products currently on the market or cleared for commercial distribution in the U.S.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
SEP 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Optics. Inc c/o Paul J. Nowacki 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92799
Re: K032030
Trade/Device Name: blink™ CL Lubricant Eye Drops Regulation Number: 21 CFR 886.5928; 21 CFR 886.5918 Regulation Name: Soft (hydrophilic) contact lens care products; Rigid gas permeable contact lens care products Regulatory Class: Class II Product Code: LPN; MRC Dated: June 30, 2003 Received: July 1, 2003
Dear Mr. Nowacki:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A kalgi forentthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K032030
510(k) NUMBER: (IF KNOWN):
DEVICE NAME:
blink™ CL Lubricant Eye Drops
INDICATIONS FOR USE:
- Use blink™ CL Lubricant Eye Drops to lubricate and rewet soft and rigid gas permeable . (RGP) contact lenses; to help relieve dryness, irritation and discomfort that may be associated with lens wear; and to cushion lenses by placing a drop on the lens prior to application on the eye.
(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
Over-The-Counter-Use __X
(Optional Format 1-2-96)
Daniel W. Brown
(Division Sign-Off)
OR
Division of Ophthalmic Ear, Nose and Throat Devises
K032030 510(k) Number _