CLUED UP MULTIPURPOSE SOLUTION- NO RUB

K030910 · Clued UP Limited · LPN · Oct 10, 2003 · Ophthalmic

Device Facts

• Record ID: K030910
• Device Name: CLUED UP MULTIPURPOSE SOLUTION- NO RUB
• Applicant: Clued UP Limited
• Product Code: LPN · Ophthalmic
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended 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

Device Story

Clued Up Multipurpose Solution is a sterile, isotonic chemical solution for soft (hydrophilic) contact lens care. Ingredients include poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate, preserved with 0.0001% polyhexanide. It functions as a no-rub regimen for daily cleaning, rinsing, disinfection, and storage. Used by patients at home; prescribed or recommended by eye care practitioners. The solution removes proteins and disinfects lenses without heat. It is packaged in containers meeting USP<661> standards for ophthalmic preparations.

Clinical Evidence

Clinical trial of 3 months duration with 50 subjects wearing group II and IV soft contact lenses compared to 21 control subjects using the predicate device. Study evaluated safety and acceptability, confirming substantial equivalence.

Technological Characteristics

Sterile, isotonic solution. Ingredients: poloxamer, sodium phosphate buffer, sodium chloride, disodium edetate, 0.0001% polyhexanide. Free of chlorohexidine and thimerosal. Container meets USP<661> requirements for ophthalmic preparations. Chemical disinfection principle (non-heat).

Indications for Use

Indicated for daily cleaning, rinsing, chemical disinfection, protein removal, and storage of soft (hydrophilic) contact lenses as recommended by an eye care practitioner.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Complete Brand Multi-Purpose Solution - No Rub

Submission Summary (Full Text)

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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:

- 3. 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
- 5. 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

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#### 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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<br>(Per 21 CFR 801.109) | |
|------------------------------------------|---------------------------------------------------|
| OR | |
| Over-The Counter | <span style="text-decoration: overline;">X</span> |

Daniel W. C. Brown Ph.D.

(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

| 510(k) Number | <span style="text-decoration: overline;">K030270</span> <span style="text-decoration: overline;">K030910</span> |
|---------------|-----------------------------------------------------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------------------------------------------------|