CYBERCASES BY BAUSCH & LOMB

K013232 · Bausch & Lomb, Inc. · LRX · Nov 20, 2001 · Ophthalmic

Device Facts

• Record ID: K013232
• Device Name: CYBERCASES BY BAUSCH & LOMB
• Applicant: Bausch & Lomb, Inc.
• Product Code: LRX · Ophthalmic
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

CyberCases by Bausch & Lomb are indicated for use in the storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection

Device Story

CyberCases are contact lens storage containers consisting of a polypropylene cap and body. Used for holding hard, rigid gas permeable, and soft contact lenses during chemical disinfection. Device is a passive storage accessory; no electronic or mechanical components. Used by patients at home.

Clinical Evidence

Bench testing only. In-vitro toxicological and chemical studies performed in accordance with FDA's May 1, 1997 Guidance for Industry - Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.

Technological Characteristics

Materials: Polypropylene. Form factor: Contact lens case (cap and body). No energy source, connectivity, or software.

Indications for Use

Indicated for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.

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

• Bausch & Lomb Sight Savers Contact Lens Case (K852384)

Submission Summary (Full Text)

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## K013232

# NOV 2 0 2001

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# CyberCases™ by BAUSCH & LOMB

#### 1. Submitter Information:

Bausch & Lomb Incorporated 1 400 North Goodman Street P.O. Box 30450 Rochester, New York 14603-0450

| Contact Person: | Kim S. DeVitto |
|-----------------|-----------------------------|
| | Manager, Regulatory Affairs |
| Telephone No.: | 716-338-6401 |
| Fax No.: | 716-338-0702 |

#### 2. Device Name:

Classification Name: Contact Lens Cases

Proprietary Name: CyberCases™ by Bausch & Lomb

#### Predicate Device: 3.

The Bausch & Lomb® Sight Savers® Contact Lens Case was selected as the predicate device for the CyberCases by Bausch & Lomb.

#### 4. Description of the Device

CyberCases by Bausch & Lomb consist of a polypropylene cap and polypropylene body for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.

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#### ડ. Indications for Use:

CyberCases by Bausch & Lomb are indicated for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.

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

A series of in-vitro toxicological and chemical studies were performed to assess the safety and effectiveness of the CyberCases by Bausch & Lomb in accordance with the guidelines set forth in FDA's May 1, 1997 Guidance for Industry - Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. All studies were conducted in compliance with the Good Laboratory Practice Regulation for Nonclinical Laboratory Studies.

Results of the testing demonstrate that the safety and effectiveness of the CyberCases by Bausch & Lomb is equivalent to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case.

#### 7. Substantial Equivalence

CyberCases by Bausch & Lomb are substantially equivalent in terms of indications for use, safety and effectiveness to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case, cleared for marketing under 510(k) Notification #K852384 on 7/31/1985. The addition of different colorants to the lens case does not effect the use of this product.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

Bausch & Lomb, Inc. c/o Kim S. DeVitto Manager, Regulatory Affairs 1400 N Goodman Street P.O. Box 30450 Rochester, NY 14603

Re: K013232

Trade/Device Name: CyberCases™ by Bausch & Lomb® Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products (contact lens cases) Regulatory Class: Class II Product Code: LRX Dated: September 26, 2001 Received: September 27, 2001

Dear De Vitto:

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 (QS) 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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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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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

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K013232

NOV 2 0 2001

Bausch & Lomb Incorporated 1400 North Goodman Street P.O. Box 30450 Rochester, NY 14603-0450

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

N/A

Device Name:

CyberCases™ by Bausch & Lomb

Indications for Use:

CyberCases by Bausch & Lomb are indicated for use in the storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use Use (Per 21 CFR 801.109) | |
|-------------------------------------------|--|
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| | OR | Over-The-Counter |
|--|-------------------------------------------------------------------------------|------------------|
| | <div> <p>(Division Sign-Off)</p> <p>Division of Ophthalmic Devices</p> </div> | |

| 510(k) Number | K013232 |
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