(200 days)
No
The device description and intended use clearly define a contact lens cleaning solution with no mention of AI/ML technology or related functionalities.
No.
The primary indication for this device is the cleaning, disinfection, and storage of contact lenses, not the treatment or prevention of a disease or condition in the human body.
No
Explanation: The device is a 'Multipurpose Solution' for cleaning and disinfecting contact lenses, not for diagnosing medical conditions. Its intended use focuses on maintenance of contact lenses rather than the detection, monitoring, or assessment of a disease or condition.
No
The device description clearly states it is a sterile, isotonic solution containing various chemical components, indicating it 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 for cleaning, disinfecting, and storing contact lenses. This is a direct interaction with a medical device (contact lenses) and not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the chemical composition of a solution used for contact lens care. It does not describe a device or reagent used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.
The device is clearly a solution for the care of contact lenses, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Clued Up Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses, as recommended by the eye care practitioner
Product codes
LPN
Device Description
Clued Up Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal.
Clued Up Multipurpose Solution remains unchanged from the previously approved product in K980147, except for the revised directions for use.
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
eye care practitioner
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
A clinical trial of 3 months usage of the Multipurpose Solution by 50 subjects, wearing soft (hydrophilic) contact lenses of either group II and IV, compared to 21 control subjects using to the AMO Complete Brand Multi-Purpose Solution - No Rub, showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use.
Key Metrics
Not Found
Predicate Device(s)
AMO Complete Brand Multi-Purpose Solution - No Rub
Reference Device(s)
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
MULTIPURPOSE SOLUTION 510(k)
K030910
21st March2003
7.0
510(k) SUMMARY
CLUED UP MULTIPURPOSE SOLUTION
- Clued Up Ltd 1. Submitted by: 135 High Street Egham Surrey TW20 9HL
| Official correspondent: | Jenny Kokshun, BSc Hons |
|---|---|
| Regulatory Affairs Officer |
2. Device name
| Common Name: | Multipurpose Solution |
|---|---|
| -------------- | ----------------------- |
Clued Up Multipurpose Solution Proprietary Name:
-
- Classification: Class II (Performance Standards) 21 CFR 886.5928 Soft (hydrophilic) contact lens solution
- The product is substantially equivalent to the currently 4. Substantial marketed Complete Brand Multi-Purpose Solution - No Equivalence: Rub
-
- Device Description: Clued Up Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal.
Clued Up Multipurpose Solution remains unchanged from the previously approved product in K980147, except for the revised directions for use.
- Clued Up Multipurpose Solution is indicated for use in 6. Intended use: the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage and soft (hydrophilic) contact lenses, as recommended by the eye care practitioner
1
7. Pre-clinical Testing
Solution compatibility
Details of the compatibility study on the Clued Up Multipurpose Solution are contained in K980147
Toxicology
The toxicological testing of Clued Up Multipurpose Solution is contained in K980147
CLUED UP MULTIPURPOSE SOLUTION CONTAINER
The Clued Up Multipurpose solution container components meet the requirements of the USP for containers and closures for ophthalmic preparations, and it has been confirmed by the appropriate tests (i.e the cytotoxicity, occular irritancy, and systemic toxicity tests).
Microbiology
Sterilitv
The Clued Up Multipurpose Solution meets the requirements of sterility testing as per K980147.
Preservative efficacy
The Clued Up Multipurpose Solution meets the requirements of the preservative efficacy test with rechallenge at 14 days as per K980147.
Disinfection Efficacy
The Clued Up Multipurpose Solution meets the requirements of both the stand-alone with organic load disinfection test and the regimen test.
8. Clinical Studies
A clinical trial of 3 months usage of the Multipurpose Solution by 50 subjects, wearing soft (hydrophilic) contact lenses of either group II and IV, compared to 21 control subjects using to the AMO Complete Brand Multi-Purpose Solution - No Rub, showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use.
9. Conclusions
The Clued Up Multipurpose Solution for use in a no rub regimen for lenses replaced in 30 days or less is substantially equivalent to the AMO Complete Brand Multi-Purpose Solution - No Rub.
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 an abstract symbol that resembles an eagle or bird in flight, with human profiles incorporated into the design.
Public Health Service
OCT 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Clued Up Limited c/o Ms. Azitta Jadalizadeh Regulatory Affairs Officer 135 High St. Egham. Surrey United Kindom TW20 9HL
Re: K030910
Trade/Device Name: Clued Up Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: September 18, 2003 Received: September 22, 2003
Dear Ms. Jadalizadeh:
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
Page 2 - Ms. Azitta Jadalizadeh
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. Rakyi Rosenthal
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
4
4-1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K030910
Device Name:
Indications For Use:
Clued Up Multipurpose Solution
The Clued Up Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses, as recommended by the eye care practitioner
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| OR | |
| Over-The Counter | X |
Daniel W. C. Brown Ph.D.
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
| 510(k) Number | K030270 K030910 |
|---|---|
| --------------- | ----------------------------------------------------------------------------------------------------------------- |