BONASSE CONTACT LENS CASE

K991206 · Bonasse Ent. Co., Ltd. · LRX · Jun 6, 2000 · Ophthalmic

Device Facts

• Record ID: K991206
• Device Name: BONASSE CONTACT LENS CASE
• Applicant: Bonasse Ent. Co., Ltd.
• Product Code: LRX · Ophthalmic
• Decision Date: Jun 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.

Device Story

Bonasse contact lens cases are molded plastic storage containers; available in flat bed (Model SC 106) or non-vented barrel styles (Models BC 760-1-2-3, BC-793). Barrel models include lens basket for holding lenses. Devices used by patients for contact lens storage during chemical disinfection. Cases feature screw-top lids; R/L markings for lens orientation. No electronic or mechanical components; purely passive storage vessels.

Clinical Evidence

No clinical data. Biocompatibility testing performed by a third-party laboratory demonstrated that materials are safe for contact lens storage and disinfection.

Technological Characteristics

Molded plastic construction; flat bed or barrel form factor; screw-top lids; non-vented; includes lens baskets in barrel models; R/L markings for orientation. Passive device; no energy source or software.

Indications for Use

Indicated for storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection. Contraindicated for use with hydrogen peroxide disinfection systems.

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

• Alcon Opti-Free contact lens case (K991206)

Reference Devices

• Ciba Vision disposable cup

Submission Summary (Full Text)

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# JUN - 6 2000

## 510(K) SUMMARY

This summary of 5l0(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: K991206

#### Submitter's Identification: 1.

### Sponsor:

Bonasse Enterprises Company, Ltd. No. 7 Lane 16 Yuon-An South Rd., Sec. 2 Luchou City, Taipei, Taiwan

### Submitted by:

Carolann Kotula mdi Consultants Phone: [phone] Fax: [e-mail]

Date Summary Prepared: May 30, 2000

#### 2. Name of the Device:

The subject devices for this submission are the following:

Bonasse Flat Bed Soaking case, Model SC 106 White case and caps

Bonasse Non-Vented Barrel Style Contact Lens Case. Models BC 760-1-2-3; BC-793. White cap, lens holder, lens basket Clear Barrel

#### 3. Predicate Device Information:

The Bonasse Contact Lens cases are substantially equivalent in design, materials, and intended use to the Alcon Opti-Free contact lens case.

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#### Device Description: 4.

The Bonasse contact lens cases are molded plastic, flat or barrel style cases with screw top lids, similar in design to currently marketed products. The barrel styles include a lens basket used for holding the lens during storage.

#### ક. intended Use:

The Bonasse Flat Bed and non-vented barrel style of Contact Lens Cases are For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection.

2007年07月26日 10時間 2007 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

| | Alcon Opti-Free<br>Contact Lens<br>Case | Bonasse Flat Bed<br>Soaking Case | Bonasse Non<br>Vented Barrel<br>Case |
|--------------|-----------------------------------------|-----------------------------------------|------------------------------------------------------------------------|
| Intended Use | Storage and<br>chemical<br>disinfection | Storage and<br>chemical<br>disinfection | Storage and<br>chemical<br>disinfection |
| Materials | Similar | Similar | Similar to Ciba<br>Vision disposable<br>cup (see below) |
| Design | Similar | Similar | Similar |
| | Flat bed case with<br>screw on caps. | Flat bed case with<br>screw on caps. | Clear Barrel,<br>White (screw on)<br>cap; lens holder,<br>lens basket. |
| | R/L embossed on<br>caps. | R/L embossed on<br>caps. | R/L marked on<br>lens baskets. |
| | R/L cap<br>contrasting colors | R/L cap same<br>color | Non-vented cap |
| | Non-vented caps | Non-vented caps. | |
| Labeling | Similar | Similar | Similar, extra<br>precautions added |

#### Comparison to Predicate Device: 6.

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### Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence is as follows:

Biocompatibility testing by a third party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.

#### Discussion of Clinical Tests Performed: 8.

No clinical test were performed

#### න් Conclusions:

The Bonasse Contact Lens cases are safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 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 in flight, composed of three curved lines.

JUN - 6 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bonasse Enterprise Co., Ltd. c/o Ms. Carolann Kotula MDI Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021

Re: K991206 Trade Name: Bonasse Flat Bed Soaking Case Model SC 106 (white: case and caps) Bonasse Non-Vented Barrel Style Contact Lens Case onasse Non- Vol. Vol. 1-2-3; BC-793 (white: cap, lens holder, and lens basket; clear: barrel) Regulatory Class: Unclassified Product Code: 86 LRX Dated: April 21, 2000 Received: April 25, 2000

Dear Mr. Beneke:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your boomen be device is substantially equivalent (for the indications for above and we have determined thices marketed in interstate commerce prior to May 28, 1976, use stated in the enereday) volical Device Amendments, or to devices that have been the chactified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act 1 coulsment in accordino ", market the device, subject to the general controls provisions of the (Icc. The general controls provisions of the Act include requirements for annual registration, I sting 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 (1 remained iffecting 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 earrent Good Manazonical Devices: General regulation (21 CFR Part 820) and that, through rogations (QS) inspections, the Food and Drug Administration (FDA) will verify such perfoule (Q) inspections 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 ally Selectronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Ralph H. Larsen

This letter will allow you to begin marketing your device as described in your 510(k) premarket I has letter will are your finding of substantial equivalence of your device to a legally marketed notication: "The PDF intentig of cation 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 11 you desire openite an were diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please 571 0115. Traditional), and Compliance at [phone]. Also, please note the regulation entitled, eonation by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers on your respendents and are and or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Attachment 3

Page 1 of 1

### 510(k) Number (if known): K991206

- Device Name: Bonasse Flat Bed Soaking case, Model SC 106 White caps and case
Bonasse Non-Vented Barrel Style Contact Lens Case. Models BC 760-1-2-3, BC-793. White cap, lens holder, lens basket Clear barrel

### Indications for Use:

For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="signature" src="signature.png"/> |
|--------------------------------|--------------------------------------------|
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |

| 510(k) Number | K 991206 |
|---------------|----------|
|---------------|----------|

| Prescription Use | Over-The-Counter Use <img alt="checkmark" src="checkmark.png"/> |
|----------------------|-----------------------------------------------------------------|
| (Per 21 CFR 801.109) | OR |

(Optional Format 1-2-96)