YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION

K980147 · Automatic Liquid Packaging, Inc. · LPN · Apr 13, 1998 · Ophthalmic

Device Facts

• Record ID: K980147
• Device Name: YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
• Applicant: Automatic Liquid Packaging, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Apr 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The STORE NAME Multi-Purpose Solution is indicated for use in cleaning, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact lenses.

Device Story

Sterile, isotonic, phosphate-buffered saline solution; contains polyoxyethylene polyoxypropylene block copolymer, 0.128% EDTA, and 0.0001% Cosmocil CQ (polyhexamethylene biguanide). Used by contact lens wearers for daily maintenance; cleans, loosens, and removes film, deposits, and debris from lens surfaces; destroys microorganisms; rinses, stores, and re-wets lenses. Applied by patient at home. Solution acts as chemical disinfectant; replaces heat disinfection methods. Benefits include improved lens hygiene, comfort, and reduced risk of ocular infection.

Clinical Evidence

Clinical study compared test solution against multipurpose and peroxide control solutions. Study involved 491 subjects (test group). Primary endpoints included visual acuity, slit lamp findings (edema, neovascularization, staining, hyperemia), and symptom reporting. Results showed 2,919/2,990 lenses were clinically clean. Adverse reactions were limited to 2 cases in the test group, both resolved without sequelae. Slit lamp findings and symptom profiles were comparable to control groups.

Technological Characteristics

Sterile, isotonic, phosphate-buffered saline solution. Ingredients: polyoxyethylene polyoxypropylene block copolymer, 0.128% EDTA, 0.0001% Cosmocil CQ (polyhexamethylene biguanide). Free of chlorhexidine and thimerosal. Chemical disinfection principle (non-heat).

Indications for Use

Indicated for cleaning, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.

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

Submission Summary (Full Text)

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# K980147

K980147 Summary

## 510(k) SUMMARY

Company: SUBMITTER 1. Address:

Automatic Liquid Packaging, Inc 2200 W. Lake Shore Dr Woodstock, IL 60098-7498

CONTACT PERSON 2. Address: John Brda 2200 W. Lake Shore Dr Woodstock, IL 60098-7498 [phone]

- DEVICE IDENTIFICATION તે જ Common Name Multipurpose Contact Leus Solution Store Name Multi-purpose Sciution Trade Name
CLASSIFICATION 4.

Class II (Performance Standards) 21 CFR 886,5928 Soft (hydrophilic) contact leas solution

#### PREMARKET NOTIFICATION NUMBER K980147 રે.

Telephone:

#### INDICATIONS FOR USE 6.

The STORE NAME Multi-Purpose Solution is indicated for use in cleaning, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact leases.

#### DEVICE DESCRIPTION 7.

A sterile isotatic, phosphate buffered saline solution containing polyoxyethylens polyoxypropylane block copolymer, preserved with 0.128% EDTA and 0.0001% Cosmocil CQ (polyhexamethylene biguanide).

Contains no chiorhaxidine or thimerosal.

Cleans, loosens and removes accurations of films, deposits and dabris from soft consist. Innissa, Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewels lenses before the lansas are placed on the eye.

#### SUBSTANTIAL EQUIVALENCE ಳು

This product is substantially equivalent to the currently marketed product, Complete brand Multi-Purpose Solution. The device has the same basic technological characteristics as the predicate

device, relative to design, packaging and composition.

Summary Page 1

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K980147 Summary

#### SAFETY AND EFFICACY ರಿ.

### A Chemistry

STORE NAME Multi-Purpose Solution is a starile isotonic, phosphate buffered saline s I OK Notaining polyonyethylene polyoxypropylene Block copolymer; preserved with 0.128% EDTA and 0.0001% Cosmocil CQ (polyhexamethylene bignanide).

The competibility of the Store Name Multi-purpose Solution was shown for cleaning, rinsing, disinfecting and storing soft hydrophilic contact leases.

a, eyeling

b. critical micalle concentration

#### B. Toxicology

The solution and bortle were shown to be non-loxic in all tests as listed balow.

- Agar Ovarlay Cytoloxicity (Direct Contact Autian/Oceas Method): ਕ non-cytoloxic
- Systemic Toxicity (USPASO Method): no difference, test/contro} ﺗﻘ
- Acute Oral Toxicity (FDA Draft Guidelines for Class III Sell Hydrophilic ப் Contact Lens Solutions, July 1985 revision): no acute oral toxicity.
- Acure Ocular Irritation (FDA Guidelines for Class III Introcular and Contact d. Lenses and Ophthalmic Solutions, Federal Register Volume 50, No. 183): no acute ocular irritation
- Full USP Class VI Testing for Coutainers for Ophthalmie Products. હ.

### C. Microbiology

- Sterility: Sterile ਕੇ.
- Preservative efficacy: passed challenge/rechallenge ت
- Disinfection Efficacy: passed stand-alone disinfection Lest d.
- d. Stability. to date, approximately one your

Summary Page 2

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…

#### ແມ່ນ ບຸນ 4

#### K980147 Summary

## 10. CLINICAL STUDIES

## A. Accountability

| | Test | Control | |
|--------------|------|--------------|----------|
| | | Multipurpose | Peroxide |
| Completed | 419* | 107 | 94 |
| Discontinued | 72 | 10 | 22 |
| Total | 491 | 117 | 116 |

*Number of cyer

## B. Final Visual Acuity

| | Test | Control | | |
|---------------------|------|--------------|----------|--|
| | | Multipurpose | Peroxide | |
| 20/15 | 30* | 7 | 8 | |
| 20/20 | 344 | 92 | 83 | |
| 20/25 | 74 | 13 | 17 | |
| 20/30 | 21 | 1 | 0 | |
| 20/40 | 5 | 1 | 0 | |
| 20/50 or<br>greater | 1 | 1 | 0 | |
| Not reported | 16 | 3 | 8 | |

*Number of eyes

#### ப் Adverse Reactions

2 adverse reactions in the test group, both resolved with no sequelac

## D. Slit Lamp Findings

| | Test | Control | |
|-----------|-----------|--------------|----------|
| | | Multipurpose | Peroxide |
| Edema | 5/2,990* | 6/750 | 4/672 |
| Neovas . | 102/2,990 | 48/750 | 62/672 |
| Stain | 85/2,990 | 119/750 | 60/672 |
| Hyperemia | 320/2,990 | 93/750 | 40/672 |
| Palpebral | 335/2,990 | 199/750 | 123/672 |
| Other | 16/2,990 | 7/750 | 3/672 |

· Number of reports/number of cyc cxaminations at scheduled visits

Summary Page 3

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……

۲ , 05/09

#### K980147 Sunmary

## E. Symptoms, Problems and Complaints

| | Test | Control | |
|----------------------|-------|--------------|----------|
| | | Multipurpose | Peroxide |
| Total Visits | 2,990 | 750 | 672 |
| No symptoms | 2,503 | 597 | 573 |
| 1.Discomfort | 88 | 26 | 24 |
| 2.Movement | 12 | 2 | 6 |
| 3.Tearing | 10 | 6 | 10 |
| 4.Photophobia | 17 | 4 | 4 |
| 5.Pain, etc | 61 | 22 | 18 |
| 6.Spectacle blur | 15 | 10 | 0 |
| 7.Secretions | 16 | 12 | 10 |
| 8.Lens awareness | 121 | 25 | 26 |
| 9.Blinking | 19 | 4 | 3 |
| 10.Variable vision | 46 | 34 | 11 |
| 11.Handling | 2 | 2 | 0 |
| 12.Poor dist. Vision | 25 | 19 | 2 |
| 13.Cleaning | 55 | 39 | 12 |
| 14.Reading problems | 7 | 2 | 5 |
| 15.Medications | 2 | 2 | 2 |
| 16.Sol'n sensitivity | 32 | 3 | 6 |
| 17.Other | 163 | 32 | 29 |
| Total symptoms | 691 | 244 | 168 |

## F. Lens Cleanliness

| | Test | Control | |
|------------------|-------------|--------------|----------|
| | | Multipurpose | Peroxide |
| Clinically clean | 2,919/2,990 | 695/750 | 630/672 |

Summary Page 4

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Image /page/4/Picture/0 description: The image shows the letterhead for the Department of Health & Human Services. The letterhead includes the department's logo, name, and the names of two of its agencies: the Public Health Service and the Food and Drug Administration. The address "9200 Corporate Boulevard" is also included on the letterhead.

JUL - 1 1998

Rockville MD 20850

Mr. John Brda Regulatory Affairs Manager Automatic Liquid Packaging 2200 Lake Shore Drive Woodstock, Illinois 60098-7498

Re: K980147

Trade Name: Store Name Multi-Purpose Soft (hydrophilic ) Contact Lens Solution Regulatory Class: II Product Code: 86 LPN Dated: January 14, 1998 Received: January 15,1998

Dear Mr. Brda:

This letter corrects our substantially equivalent letter of April 13, 1998 regarding the above referenced device to change the addressee.

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 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). 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 (2 remains 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will yerify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2- Mr. John Brda

action. In addition, the Food and Drug Administration (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.

This letter will allow you to begin marketing your device as described in your 510(k) I rail letter " " " 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

David M. Whipple

Sos A. Ralph Rosenthal Director Office of Device Evaluation Center for Devices and Radiological Health

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510(k) NUMBER (IF KNOWN) K980147

STORE NAME MULTI-PURPOSE SOLUTION DEVICE NAME

INDICATIONS FOR USE

STORE NAME Multi-Purpose Solution is indicated for use in cleaning, cinsing, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact lenses.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ 21 CFR 801.109)

(Per Over-The-Counter-Use _ OR (Optional Format 1-2-96)

.. . . . . . . . . . . . . .

Nira Smith

\$

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