SAUFLON MULTIPURPOSE SOLUTION

K130734 · Sauflon Pharmaceuticals, Ltd. · LPN · May 15, 2013 · Ophthalmic

Device Facts

• Record ID: K130734
• Device Name: SAUFLON MULTIPURPOSE SOLUTION
• Applicant: Sauflon Pharmaceuticals, Ltd.
• Product Code: LPN · Ophthalmic
• Decision Date: May 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner.

Device Story

Sauflon Multipurpose Solution is a sterile, isotonic chemical solution for contact lens care. It functions by cleaning, rinsing, disinfecting, and conditioning soft (hydrophilic) contact lenses, including silicone hydrogel types. The solution contains poloxamer 188, sodium phosphate buffer, sodium chloride, and disodium edetate, preserved with polyhexanide 0.0001%. It is used by patients at home for daily lens maintenance. The solution removes proteins and provides disinfection without the need for heat. By maintaining lens hygiene, it supports comfortable lens wear and reduces the risk of ocular irritation or infection associated with contaminated lenses.

Clinical Evidence

Clinical trial of ~250 subjects conducted over two months. Evaluated Sauflon Multipurpose Solution with four silicone hydrogel lens brands and one conventional hydrogel control lens, compared against Ciba Vision Aquify Multi-Purpose Solution. Results demonstrated safety, acceptability, and substantial equivalence to the predicate. Pre-clinical data included successful microbiological disinfection/preservative efficacy testing and non-toxic results in cytotoxicity, systemic toxicity, and ocular irritation studies.

Technological Characteristics

Sterile, isotonic aqueous solution. Ingredients: Poloxamer 188 (surfactant), sodium phosphate buffer, sodium chloride (tonicity agent), disodium edetate (chelating agent), and polyhexanide 0.0001% (preservative). Free of chlorohexidine and thimerosal. Chemical disinfection principle. Compatible with soft (hydrophilic) contact lenses, including silicone hydrogel lenses.

Indications for Use

Indicated for daily cleaning, rinsing, disinfection, protein removal, storage, and conditioning of soft (hydrophilic) contact lenses, including silicone hydrogel lenses, for patients 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

• Aquify Multipurpose Disinfecting Solution (K050250/K033608)

Submission Summary (Full Text)

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### SAUFLON MULTIPURPOSE SOLUTION 510(k) Date of Revision 15th May 2013

## 510(k) SUMMARY

# MAY 1 5 2013

#### SAUFLON MULTIPURPOSE SOLUTION

Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner. The Sauflon Multipurpose Solution is identical to that cleared in K974485 and K030278. The purpose of this submission is to add the indication for use with Silicone Hydrogel Lenses.

| 1. Submitted by: | Sauflon Pharmaceuticals Ltd<br>49-53 York Street<br>Twickenham<br>TW1 3LP<br>UK |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Official correspondent: | Christopher Smejkal (BSc, PhD)<br>Strategic Technical Projects Manager<br>[phone]<br>[e-mail] |
| 2. Device name | |
| Common Name: | Multipurpose Solution |

Proprietary Name: Sauflon Multipurpose Solution

3. Classification: Class II (Performance Standards) 21 CFR 886.5928 Soft (hydrophilic) contact lens solution

- 4. Substantial The product is substantial equivalent to the currently marketed Aquify Multipurpose Disinfecting Solution Equivalence: (K050250/K033608)
- 5. Device Description: Sauflon 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.

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K130734
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#### SAUFLON MULTIPURPOSE SOLUTION 510(k) Date of Revision 15th May 2013

- 6. Indications for use: Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner
#### 7. Pre-clinical Testing

### Silicone Hydrogel lens compatibility

A series of compatibility studies were conducted assessing the Sauflon Multipurpose Solution with currently marketed Silicone Hydrogel lenses. The results of these studies confirm that the Sauflon Multipurpose Solution is compatible with Silicone Hydrogel lenses.

### Toxicology

Sauflon Multipurpose Solution was shown to be non-toxic in all cytotoxicity, systemic toxicity and ocular irritation testing.

### Microbiology

A series of microbiological studies were conducted to demonstrate the disinfection efficacy, preservative efficacy and thus safety of the Sauflon Multipurpose Solution. The Sauflon Multipurpose Solution met the requirements of this testing.

#### 8. Clinical Studies

A clinical trial of circa 250 subjects, using the Sauflon Multipurpose Solution with four different silicone hydrogel contact lens brands and one conventional hydrogel control lens was conducted over a period of two months, with a control group using Ciba Vision Aquify Multi- Purpose Solution. The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use.

#### 9. Technological Characteristics

The sponsor considers Sauflon Multipurpose Solution to be substantially equivalent to the current marketed product Aquify Multi- Purpose Solution. The following table shows a comparison of the Sauflon Multipurpose Solution to the predicate device, Aquify.

Sauflon Multipurpose solution is also identical to the currently marketed Sauflon Multipurpose solution which has already been previously reviewed by the FDA under 510(k)'s K974485 and K030278. The purpose of this submission is to add the indication for use with Silicone Hydrogel Lenses.

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K130734
Page 3 of 3

# SAUFLON MULTIPURPOSE SOLUTION 510(k) Date of Revision 15th May 2013

| Indications for use | SAUFLON MULTIPURPOSE<br>SOLUTION | AQUIFY MULTI-PURPOSE<br>SOLUTION |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sauflon Multipurpose Solution is<br>indicated for use in the daily<br>cleaning, rinsing, chemical (not heat)<br>disinfection, removal of proteins,<br>storage and conditioning of soft<br>(hydrophilic) contact lenses<br>(including Silicone Hydrogel Lenses)<br>replaced in 30 days or less, as<br>recommended by the eye care<br>practitioner. | Aquify Multi-Purpose Solution is<br>indicated for use in the daily<br>cleaning, rinsing, chemical (not heat)<br>disinfection, removal of proteins,<br>storage and conditioning of soft<br>(hydrophilic) contact lenses<br>(including Silicone Hydrogel Lenses)<br>replaced in 30 days or less, as<br>recommended by the eye care<br>practitioner. |
| Product description | | |
| | Sauflon Multipurpose Solution is a<br>sterile, isotonic solution that contains<br>poloxamer 188, sodium phosphate<br>buffer, sodium chloride, and<br>disodium edetate; preserved with<br>polyhexanide 0.0001%. Contains no<br>chlorohexidine or thimerosal. | Aquify Multi-Purpose Solution is a<br>sterile, aqueous solution that contains<br>sorbitol, tromethamine, pluronic<br>F127, sodium phosphate dihydrogen,<br>Dexpant 5 (dexpanthenol) and<br>edetate disodium dihydrate;<br>preserved with polyhexanide<br>0.0001%. Contains no<br>chlorohexidine or thimerosal. |
| Product Characteristics | | |
| Active ingredient/preservative | Polyhexamethylene biguanide | Polyhexamethylene biguanide |
| Chelating agent | Disodium edetate | edetate disodium dihydrate |
| Tonicity agent | Sodium Chloride | Sorbitol |
| Surfactant cleaner | Poloxamer 188 | Pluronic F127 |
| Lubricant | N/A | N/A |
| Sterility | Sterile | Sterile |
| Performance | | |
| Compatibility | Compatible with soft (hydrophilic)<br>contact lenses, groups 1 and 4 as per<br>510(k) K974485/ K030278 and with<br>4 representative marketed silicone<br>hydrogel lenses. | Compatible with soft (hydrophilic)<br>contact lenses and silicone hydrogel<br>lenses. |
| Clinical | Substantially equivalent to Aquify | |
| Toxicology | Non-toxic in all cytotoxicity and<br>ocular irritation tests. | |

#### Conclusions 10.

The data provided in this 510k submission concludes that Sauflon Multipurpose Solution for use in soft contact lenses including silicone hydrogel lenses is substantially equivalent to the Aquify Multi-Purpose Disinfecting Solution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 resembling an eagle or bird-like figure with three stylized wings or feathers.

May 15. 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Sauflon Pharmaceuticals Ltd % Dr. Christopher Smeikal Strategic Technical Projects Manager 49-53 York Street Twickenham, Middlesex TW1 3LP England

Re: K130734

Trade/Device Name: Sauflon Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: March 25, 2013 Received: March 29, 2013

Dear Dr. Smejkal:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Dr. Christopher Smeikal

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia YAlexander -S

for 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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# SAUFLON MULTIPURPOSE SOLUTION 510(k)

# INDICATIONS FOR USE

| 510(k) Number (if known): | K130734 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sauflon Multipurpose Solution |
| Indications For Use: | Sauflon Multipurpose Solution is indicated for use in<br>the daily cleaning, rinsing, disinfection, removal of<br>proteins, storage and conditioning of soft (hydrophilic)<br>contact lenses including silicone hydrogel lenses, as<br>recommended by the eye care practitioner |

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) ಳ

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

J Angelo Green హెక్టార్లు
2013.05.14 16:06:18 04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number_