(126 days)
No
The device is a contact lens solution, and the description focuses on its chemical composition and intended use for cleaning and disinfecting lenses. There is no mention of AI or ML in the text.
No.
The product is a contact lens solution intended for cleaning, disinfecting, and storing contact lenses, not for treating or diagnosing a medical condition.
No
The device is a contact lens solution for cleaning, disinfecting, and storing contact lenses, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile, isotonic, buffered solution, which is a chemical product, 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 for the cleaning, disinfection, and storage of contact lenses. This is a direct interaction with a medical device (contact lenses) and not a test performed in vitro (outside the body) on a biological specimen to provide information about a disease or condition.
- Device Description: The description details a solution for cleaning and disinfecting contact lenses, not a reagent or instrument used for diagnostic testing.
- Lack of Diagnostic Claims: There are no claims or indications related to diagnosing, monitoring, or treating any disease or condition based on testing biological samples.
- Performance Studies: The performance studies focus on microbial efficacy, preservative effectiveness, toxicology, and clinical performance related to contact lens care, not diagnostic accuracy or performance on biological samples.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide diagnostic information. This device's function is entirely focused on the maintenance and care of contact lenses.
N/A
Intended Use / Indications for Use
The EYE SEE™ Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
The EYE SEE™ Multipurpose Contact Lens Solution is a sterile, isotonic, buffered, solution containing boric acid, sodium chloride, Hydroxypropyl Methylcellulose (HPMC) as a lubricant, poloxamer 407 as a surfactant, disodium edetate as chelating agent, purified water and preserved with polyhexanide.
The EYE SEE™ Multipurpose Contact Lens Solution 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
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)
Pre-Clinical Performance Data: Data to demonstrate all indications: daily cleaning, rinsing, chemical (not heat) disinfecting, and storage of soft (hydrophilic) contact lenses, of the EYE SEE™ Multipurpose, Contact Lens Solution can be referenced in Lapis Lazuli 510(k) K051104 which shows all results are satisfactory. Permission to reference 510(k) K051104 is included in this 510(k).
Chemistry Testing: Reference 510(k) K051104 for all of the following chemistry testing:
- Solution Compatibility
- Cleaning Effectiveness
- Stability
- Enzymatic Cleaning Studies
Microbial Testing: Microbiological studies were conducted to demonstrate the microbial efficacy of EYE SEE™ Multipurpose Contact Lens Solution for 10 Minute Express Disinfection. This testing concluded that the product met primary stand-alone criteria.
Preservative Effectiveness with Re-challenge was conducted and met requirements for the Preservative Efficacy Test for Multi-Dos Preserved Contact Lens Care Products. This data can be referenced in 510(k) K051104.
Toxicology Testing: A series of Toxicology studies were conducted to demonstrate the safety of EYE SEE™ Multipurpose Contact Lens Solution and to demonstrate the safety of the packaging system. Results of the testing demonstrated that EYE SEE™ Multipurpose Contact Lens Solution is non-toxic and is a non-irritant. Reference 510(k) K051104.
Clinical Study: A clinical study has been conducted, and results of this study can be referenced in the previously cleared 510(k) K051104.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051104, Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 2 4 2007
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K070767 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
Date Prepared:
July 5, 2007
Name: Lapis Lazuli International NV Address Damsluisweg 48 1332 ED Almer The Netherlands
Contact Person:
Phone number:
USA Consultant:
Phone number: Fax number: Email address:
MedVice Consulting, Inc. Mr. Martin Dalsing (970) 243-5490 (970) 243-5501 marty@FDApproval.com
Mr. Mark Berkouwer Executive Officer
+31 (0) 36 547 6020
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPN 886.5928 |
Classification Name: Accessories, soft lens products Soft (hydrophilic) contact lens care products
Trade Name:
EYE SEE™ Multipurpose, Contact Lens Solution
1
Purpose of 510(k) Submission:
Change in Directions for Use.
Change from 4 hour soak to a 10 Minute Express Disinfection, will be added to the Labeling and Directions for Use of Lapis Lazuli International's previously cleared 510(k) K051104~
Lapis Lazuli International NV Co. Ltd proposes to market and sell in United States interstate commerce, The EYE SEE™ Multipurpose Contact Lens Solution with a new directions for use, the change from 4 hour soak to a 10 minute express disinfection. Data supporting the 10-minute express disinfection is contained in this submission. The EYE SEE™ Multipurpose Contact Lens Solution is the same solution as cleared in 510(k) K051104. Equivalent Devices:
The EYE SEE™ Multipurpose Contact Lens Solution is substantially equivalent in terms of its actions and indications for use to the following predicate devices:
PREDICATE DEVICES ~
- The EYE SEE™ Multipurpose Contact Lens Solution Manufactured by Lapis . Lazuli International NV Co. Ltd.
- The Aquify® Multi-Purpose Solution Manufactured by Ciba Vision". .
The EYE SEE™ Multipurpose Contact Lens Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
Device Description:
The EYE SEE™ Multipurpose Contact Lens Solution is a sterile, isotonic, buffered, solution containing boric acid, sodium chloride, Hydroxypropyl Methylcellulose (HPMC) as a lubricant, poloxamer 407 as a surfactant, disodium edetate as chelating agent, purified water and preserved with polyhexanide.
The EYE SEE™ Multipurpose Contact Lens Solution is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
2
Intended Use:
The EYE SEE™ Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
Pre-Clinical Performance Data:
Data to demonstrate all indications: daily cleaning, rinsing, chemical (not heat) disinfecting, and storage of soft (hydrophilic) contact lenses, of the EYE SEE™ Multipurpose, Contact Lens Solution can be referenced in Lapis Lazuli 510(k) K051104 which shows all results are satisfactory. Permission to reference 510(k) K051104 is included in this 510(k).
Chemistry Testing: Reference 510(k) K051104 for all of the following chemistry testing:
-
- Solution Compatibility
-
- Cleaning Effectiveness
-
- Stability
-
- Enzymatic Cleaning Studies
Microbial Testing: Microbiological studies were conducted to demonstrate the microbial efficacy of EYE SEE™ Multipurpose Contact Lens Solution for 10 Minute Express Disinfection. This testing concluded that the product met primary stand-alone criteria.
Preservative Effectiveness with Re-challenge was conducted and met requirements for the Preservative Efficacy Test for Multi-Dos Preserved Contact Lens Care Products. This data can be referenced in 510(k) K051104.
Toxicology Testing: A series of Toxicology studies were conducted to demonstrate the safety of EYE SEE™ Multipurpose Contact Lens Solution and to demonstrate the safety of the packaging system. Results of the testing demonstrated that EYE SEE™ Multipurpose Contact Lens Solution is non-toxic and is a non-irritant. Reference 510(k) K051104
Clinical Study:
A clinical study has been conducted, and results of this study can be referenced in the previously cleared 510(k) K051104.
3
Substantial Equivalence:
The EYE SEE™ Multipurpose, Contact Lens Solution is substantially equivalent in terms of its actions and indications for use to the following predicate devices:
- The EYE SEE™ Multipurpose, Contact Lens Solution Manufactured by . Lapis Lazuli International NV Co. Ltd.
- The Aquify® Multi-Purpose Solution Manufactured by Ciba Vision®. .
4
SUBSTANTIAL EQUIVALENCY CHART
. . . .
| Substantial
Equivalency | EYE SEE™
MULTIPURPOSE
SOLUTION | The Aquify® Multi-
Purpose Solution |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | Lapis Lazuli International | Ciba Vision® |
| INTENDED
USE | The EYE SEE Multipurpose
Contact Lens Solution is
indicated for use in the daily
cleaning, removing protein
deposits, rinsing, chemical (not-
heat) disinfecting and storage of
soft (hydrophilic) contact
lenses, as recommended by your
eye care practitioner. | The Aquify® Multi-Purpose
Solution is indicated for the
care of soft hydrophilic contact
lenses. Use this product as
recommended by our eye care
practitioner to: Chemically
(NOT HEAT) Disinfect, Clean,
Rinse, Store, Remove Protein |
| Preservative | Polyhexanide 0.00015%, | Polyhexanide 0.00015%, |
| Chelating Agent | Disodium edetate | Disodium edetate |
| Lens Care
Regimen | Rub and Rinse
10 Minute Express | Rub and Rinse
5 Minute Express |
| Sterility Claim | Sterile | Sterile |
.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three flowing lines representing the body and head. The figure is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2007
Lapis Lazuli International, NV c/o Mr. Martin Dalsing Medvice Consulting, Inc. 2214 Sanford Drive Suite B7 Grand Junction, CO 81503
Re: K070767
Trade/Device Name: EYE SEE™ Multipurpose Contact Lens Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: July 5, 2007 Received: July 12, 2007
Dear Mr. Dalsing:
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.
6
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egerlums, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K070767". The characters are written in a simple, slightly uneven style, suggesting they were written quickly or without precise attention to detail. The contrast between the characters and the background is clear, making the string easily readable.
INDICATIONS FOR USE STATEMENT
K070767 510(k) Number:
Device Name: EYE SEE™ Multipurpose Contact Lens Solution
INDICATIONS FOR USE:
The EYE SEE™ Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Marc Roblay | ||
| (Division Sign-Off) | ||
| Division of Ophthalmic Ear, | ||
| Nose and Throat Devises | ||
| 510(k) Number | K070767 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | or | |
| (Optional Format 1-2-96) | Over-The-Counter Use X |