(311 days)
Not Found
Not Found
No
The device description and performance studies focus on the chemical composition and sterility of a rewetting drop solution, with no mention of AI or ML technology.
No
The device is described as rewetting drops for contact lenses, providing lubrication and relief for irritation, not as a device for treating or curing a medical condition.
No
The device is described as rewetting drops for contact lenses to moisten, rehydrate, and relieve minor irritation, discomfort, and blurring. It does not mention diagnosis of any condition.
No
The device is a liquid solution packaged in a vial, which is a physical 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 to moisten and rehydrate contact lenses and relieve minor irritation while wearing them. This is a direct interaction with the contact lens and the eye, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a sterile solution for use with contact lenses. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD device.
The performance study described is a bacteriostasis study related to the sterility and shelf-life of the product in the reclosable vial, which is relevant to a contact lens care product, not an IVD.
N/A
Intended Use / Indications for Use
Use LENS PLUS® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.
Product codes
LPN
Device Description
Lens Plus® Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution containing sodium chloride and boric acid. The product is packaged in a plastic sterile reclosable vial which allows remaining drops can be used throughout the day (12 hours).
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A bacteriostasis study was conducted in accordance with Micro Appendix C of the Premarket Notification (510(K)) Guidance Document for contact Lens Care Products. The purpose of the study is to evaluate the ability of bacteria to survive in the reclosable vials containing Lens Plus® Rewetting Drops (unpreserved borate buffered saline). A neutralizer efficacy test was also performed to determine the most effective neutralizer recovery medium for the bacteriostasis testing. The results show that Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger have no significant growth and survive over the designed period. The data support the desired discard statement on label of up to 12 hours.
Key Metrics
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Predicate Device(s)
When used as directed, Lens Plus® (a)(3) Rewetting Drops with the sterile daily-use (12 hours) vial is substantially equivalent to the currently-marketed Lens Plus® Rewetting Drops with the single-use vial.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 9 2005
510(k) SUMMARY
Lens Plus® Rewetting Drops
This summary uses the format provided in 21 CFR 807.92:
| (a)(1) | Submitter: | Peter Xu
Regulatory Affairs Professional
Advanced Medical Optics
1700 E. St. Andrew Place
Santa Ana, CA 92799-5162 | |
|--------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | Phone: (714) 247-8592
Fax: (714) 247-8677
EMail: peter.xu@amo-inc.com | |
| (a)(2) | Summary Prepared:
Device Trade Name:
Device Common Name:
Device Classification/Panel:
Device Classification Names: | July 19, 2005
Lens Plus® Rewetting Drops
Soft (Hydrophilic) Contact Lens Solution
Class II (Special Controls)/Ophthalmic Device
Accessories to Contact Lens Solution (86LPN) | |
- Identification of Predicate Device: When used as directed, Lens Plus® (a)(3) Rewetting Drops with the sterile daily-use (12 hours) vial is substantially equivalent to the currently-marketed Lens Plus® Rewetting Drops with the single-use vial.
- Device Description: Lens Plus® Rewetting Drops is a sterile, preservative (a)(4) free, buffered, isotonic, aqueous solution containing sodium chloride and boric acid. The product is packaged in a plastic sterile reclosable vial which allows remaining drops can be used throughout the day (12 hours).
- Intended Use (Indications for Use): Use LENS PLUS® Rewetting Drops (a)(5) while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.
- of Technological Characteristics: The technological Comparison (a)(6) characteristics of the product remain the same.
1
Discussion of Nonclinical: (b)(1)
A bacteriostasis study was conducted in accordance with Micro Appendix C of the Premarket Notification (510(K)) Guidance Document for contact Lens Care Products. The purpose of the study is to evaluate the ability of bacteria to survive in the reclosable vials containing Lens Plus® Rewetting Drops (unpreserved borate buffered saline). A neutralizer efficacy test was also performed to determine the most effective neutralizer recovery medium for the bacteriostasis testing. The results show that Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger have no significant growth and survive over the designed period. The data support the desired discard statement on label of up to 12 hours.
Conclusions Drawn from Data Supporting Equivalence Determination: (b)(2)
The safety and performance of Lens Plus® Rewetting Drops packaged in a sterile daily-use (12 hours) vial is substantially equivalent to the Lens Plus® Rewetting Drops packaged in the single-use vial currently on the market.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2005
Advanced Medical Optics, Inc. c/o Mr. Peter Xu Regulatory Affairs Professional 1700 E. St. Andrew Place Santa Ana, CA 92799-5162
Re: K042562
Trade/Device Name: Lens Plus Rewetting Drops Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: June 9, 2005 Received: June 13, 2005
Dear Mr. Xu:
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.
3
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) 827-8910. 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/industry/support/index.html.
Sincerely yours.
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K042562
LENS PLUS® Rewetting Drops Device Name:
Indications For Use:
Use LENS PLUS® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hymn Smith
Page 1 of
(Division Sigh-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number _