SOLO-CARE BRAND MULTI-PURPOSE SOLUTION

K983291 · Ciba Vision Corporation · MRC · Nov 25, 1998 · Ophthalmic

Device Facts

• Record ID: K983291
• Device Name: SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
• Applicant: Ciba Vision Corporation
• Product Code: MRC · Ophthalmic
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5918
• Device Class: Class 2

Intended Use

SOLO-Care ™ Brand Multi-Purpose Solution Is Indicated for use in daily cleaning, ninsing, chemical (not haat) disinfecting, protein removal and storing of soft (hydrophilic) or rigld gas permeable (fluoro sillcone acrylate and sillcone acrylate) lenses as recommended by your eye care precitioner.

Device Story

SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous chemical solution for contact lens care. Ingredients include sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, edetate disodium dihydrate (0.025%), and polyhexanide (0.0001%). The solution performs daily cleaning, protein removal, rinsing, chemical (non-heat) disinfection, and storage. It is intended for use by patients with soft (hydrophilic) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) lenses. The solution is supplied in a plastic bottle. Patients follow the regimen recommended by their eye care practitioner to maintain lens hygiene and safety.

Clinical Evidence

Preclinical and clinical studies were conducted to assess safety and effectiveness for soft (hydrophilic) contact lenses (P940042). Additional compatibility studies were performed for rigid gas permeable (fluoro silicone acrylate and silicone acrylate) lenses, comparing the subject device to the predicate (Boston Simplicity). Compatibility was also verified with Focus Lens Drops.

Technological Characteristics

Sterile aqueous solution; active ingredients: sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic; preservatives: edetate disodium dihydrate (0.025%) and polyhexanide (0.0001%). Form factor: plastic bottle. Chemical disinfection principle (non-heat).

Indications for Use

Indicated for daily cleaning, rinsing, chemical disinfecting, protein removal, and storage of soft (hydrophilic) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by an eye care practitioner.

Regulatory Classification

Identification

A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

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

• BOSTON Simplicity Multi-action Solution (P950010)

Reference Devices

• Focus Lens Drops (P860060/S02)

Submission Summary (Full Text)

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510(k) SUMMARY - K983291

## SUMMARY OF SAFETY AND EFFECTIVENESS FOR SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION

### Submitter Information 1.

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person; Steven Dowdley (Senior Regulatory Affairs Associate) 770-418-3897 Telephone No.

#### Device Name 2.

Classification Name: Proprietary Name:

Soft (hydrophilic) Contact Lens Solution SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION

#### Predicate Devices 3.

BOSTON Simplicity Multi-action Solution (P950010, June 9, 1995) has been selected as the predicate devices for SOLO-Care™ Brand MULTI-PURPOSE SOLUTION.

#### Description of the Devices 4.

SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%. SOLO-Care™ Brand Multi-Purpose Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, protein removal, rinsing, disinfecting, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

#### રું Indications for Use

SOLO-Care ™ Brand Multi-Purpose Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing of soft (hydrophilic) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) lenses as recommended by your eye care practitioner.

#### Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical studies have been conducted to assess and demonstrate the safety and effectiveness of SOLO-Care Brand Multi-Purpose Solution for soft (hydrophilic), contact lenses (P940042, April 25, 1996). In addition, SOLO-Care Brand Multi-Purpose Solution has been approved for a daily protein removal indication for soft contact lenses under K982168. Soft contact lenses represent worst case in terms of cleaning, protein removal, rinsing, disinfecting and storing of contact lenses. In addition, lens solution compatibility tests were conducted under the recommended care regimen, compared with the predicate device (Boston Simplicity) indicating that SOLO-Care Brand Multi-Purpose Solution is compatible with rigid gas permeable (flourosilicone and silicon acrylate) lenses. An addition compatibility study was also successfully conducted to determine the compatibility of SOLO-Care Brand Multipurpose Solution when used in conjunction with Focus Lens Drops. Focus Lens Drops was previously approved for use with rigid gas permeable lenses under P860060/S02 on March 28, 1990.

#### 7. Substantial Equivalence

SOLO-Care Brand Multi-Purpose Solution is substantially equivalent to BOSTON Simplicity Multi-Action Solution for daily cleaning, rinsing, disinfecting rigid gas permeable (fluoro silicone acrylate and silicone acrylate) lenses. In addition, SOLO-Care Brand Multi-Purpose Solution has been approved for a daily protein removal indication for soft contact lenses under K982168.

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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 1998

Mr. Steven Dowdley Senior Associate, Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097-1556

Re: K983291 Trade Name: SOLO-Care ™ Brand Multi-Purpose Solution (labeling change to allow for use with Soft and RGP Lenses) Regulatory Class: II Product Code: 86 MRC Dated: September 18, 1998 Received: September 21, 1998

Dear Mr. Dowdley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Steven Dowdley

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number: K983291

SOLO-Care ™ Brand Multi-Purpose Solution Device Name:

Indications for Use:

SOLO-Care ™ Brand Multi-Purpose Solution Is Indicated for use in daily cleaning, ninsing, chemical (not haat) disinfecting, protein removal and storing of soft (hydrophilic) or rigld gas permeable (fluoro sillcone acrylate and sillcone acrylate) lenses as recommended by your eye care precitioner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription Use:

Over-the-Counter: B

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(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K983291