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

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.

AI/ML Overview

The provided text describes a 510(k) submission for the "Clued Up Multipurpose Solution", a soft contact lens solution. It details pre-clinical testing and a clinical study to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, formatted as requested:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for its pre-clinical or clinical studies. Instead, it states that the device "meets the requirements" or demonstrates "substantial equivalence." For the purpose of this response, I will interpret the "acceptance criteria" as meeting the regulatory requirements for various tests and then report the finding as the "reported device performance."

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Pre-clinical Testing
Solution Compatibility	Compatibility with contact lenses	Details of compatibility study are contained in K980147 (implicitly, it met requirements as K030910 was approved).
Toxicology	Safety profile	Toxicological testing is contained in K980147 (implicitly, it met requirements as K030910 was approved).
Container Requirements	USP<661> for ophthalmic preparations	Container components meet the requirements of USP<661> for containers and closures for ophthalmic preparations, confirmed by cytotoxicity, ocular irritancy, and systemic toxicity tests.
Microbiology - Sterility	Sterility testing requirements	Meets the requirements of sterility testing as per K980147.
Microbiology - Preservative Efficacy	Preservative efficacy test with rechallenge at 14 days	Meets the requirements of the preservative efficacy test with rechallenge at 14 days as per K980147.
Microbiology - Disinfection Efficacy	Stand-alone with organic load disinfection test	Meets the requirements of the stand-alone with organic load disinfection test.
Microbiology - Disinfection Efficacy	Regimen test	Meets the requirements of the regimen test.
Clinical Studies
Safety and Acceptability	Safety, acceptability, and substantial equivalence to predicate device for intended use (3-month usage)	Demonstrated safety, acceptability, and substantial equivalence to the AMO Complete Brand Multi-Purpose Solution - No Rub (predicate device) in a 3-month clinical trial.
Overall Conclusion	Substantial Equivalence to Predicate Device	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. The FDA's 510(k) clearance confirms this finding ["device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices"].

Study Details

2. Sample size used for the test set and the data provenance

Test Set Sample Size: 50 subjects for the test device (Clued Up Multipurpose Solution) and 21 control subjects for the predicate device (AMO Complete Brand Multi-Purpose Solution - No Rub).
Data Provenance: The document does not explicitly state the country of origin. Given the submitting company's address (Egham, Surrey, UK) and the regulatory body (FDA, USA), it's likely a multinational study or initiated from the UK for US market approval. The study was prospective, as it involved "3 months usage of the Multipurpose Solution by 50 subjects... compared to 21 control subjects."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. The assessment of "safety, acceptability and substantial equivalence" would typically involve eye care practitioners, but the specific details are not provided.

4. Adjudication method for the test set

The document does not specify an adjudication method for the clinical study's test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Was an MRMC study done? No. This device is a contact lens solution, not an AI-powered diagnostic or imaging device.
Effect size of human readers with/without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Was a standalone performance study done? Yes, in a sense. The pre-clinical tests (Microbiology - Disinfection Efficacy, Preservative Efficacy, Sterility, etc.) evaluate the solution's performance as an "algorithm only" in a controlled environment, without human intervention in the efficacy measurement itself. These tests demonstrate the inherent functional capabilities of the solution.

7. The type of ground truth used

For pre-clinical microbiology tests (disinfection, sterility, preservative efficacy): Ground truth is established by microbiological standards and quantitative measurements of microbial reduction/elimination against defined challenge organisms and accepted performance thresholds within the specified test protocols.
For the clinical study: Ground truth for safety and acceptability would be based on clinical observations, patient reported outcomes, and examinations by eye care practitioners, likely against established clinical endpoints for ocular health and contact lens wear. The "substantial equivalence" is the primary ground truth, meaning its performance metrics (implicitly safety and effectiveness) were comparable to a legally marketed predicate device.

8. The sample size for the training set

The document does not mention or imply a training set. This is not an AI/ML device where a separate training set would be defined. The information provided describes a traditional medical device (contact lens solution) and its evaluation.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of medical device submission.

Summary

{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:

1. 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
1. 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<661> 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

(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
---------------	-----------------------------------------------------------------------------------------------------------------

Regulation Number and Section

§ 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.”