AQUIFY LENS COMFORT DROPS

K042176 · Ciba Vision Corporation · LPN · Nov 3, 2004 · Ophthalmic

Device Facts

• Record ID: K042176
• Device Name: AQUIFY LENS COMFORT DROPS
• Applicant: Ciba Vision Corporation
• Product Code: LPN · Ophthalmic
• Decision Date: Nov 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing.

Device Story

AQuify Lens Comfort Drops is a sterile ophthalmic solution used by contact lens wearers to alleviate dryness and irritation. The solution contains sodium hyaluronate, sodium chloride, sodium phosphate, and sodium perborate (stabilized with phosphoric acid). It is applied topically to the eye while wearing contact lenses. The device functions as a lubricant and rewetting agent to improve comfort during lens wear. It is intended for over-the-counter use by patients.

Clinical Evidence

No new clinical data was generated for this submission. The application relies on clinical data previously provided in K013204 to support substantial equivalence.

Technological Characteristics

Sterile solution containing sodium hyaluronate, sodium chloride, sodium phosphate, and sodium perborate stabilized with phosphoric acid. No changes to product formulation.

Indications for Use

Indicated for contact lens wearers experiencing dryness and irritation to moisten, cushion, and refresh 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

• AMO Blink-N-Clean

Reference Devices

• AQuify Lens Comfort Drops (K013204)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2004

CIBA Vision Corporation c/o Steven Dowdley, RAC 11460 Johns Creek Parkway Duluth, GA 30097

Re: K042176 Trade/Device Name: AQuify Lens Comfort Drops Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: July 28, 2004 Received: August 23, 2004

Dear Mr. Dowdley:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) prematice is substantially equivalent (for the indications
referenced above and have determined the device is substantials in interstate referenced adove and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device Amendments for use stated in the encrosule) to regally manced promotions of the Federal Food. Device American Food Drug commerce prior to May 28, 1776, the enacement with the provisions of the Federal Food. Drug, devices that have been recassince in accerative while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, merelore, market the devreet, becjeer is the one of registration, listing of
general controls provisions of the Act include requirements for any interest wishrendin general controls provisions of the Fect merace required.
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 (PMA), it If your device is classified (SCC above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regal may be subject to such additional controls. Extrements, Lince 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additi be found in the Code of Pouchal Ingerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies . You must inal FDA has made a decemination that your cored by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal status and light or any Federal statutes and regulations damanistered or and limited to: registration and listing comply with all the Act s requirements, morating continenturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing dischlashes als (21 CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 Torth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Steven Dowdley, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k)
This and consistence and a TRA fieling of whiterstiol aquivalence of your device This letter will allow you to begin marketing your active of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your devi premarket notification. The FDA mailing of substantial equive 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), please
rs in the may on 12, 12, 1112 - Algo, please note the regulation entitled. If you desire specific advice for your device on on acoming the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation of contact the Office of Compliance at (301) 574 101.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Path 807.97). You may obtain "Misbranding by reference to prematici houried." (2) east from the Division of Small
other general information on your responsibilities under the Act from the Living of Small other general information on your responsionner assistancer at its toll-Erec number [phone] or
Manufacturers, International and Consumer Assistance at its toll-Erea ma Manufacturers, International and Consumer Assistance in
[phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.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

Enclosure

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### 510(k) SUMMARY .

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary In response to the requirements addressed by the Sales Moulser of the substantial equivalence determination is based.

## 510(k) SUMMARY FOR AQuify Lens Comfort Drops

#### Submitter Information 1.

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdley Telephone No. 678-415-3897

- Device Name 2. Classification Name: Proprietary Name:
Soft (hydrophilic ) Contact Lens Solution AQuify Lens Comfort Drops

- Predicate Devices 3. AMO Blink-N-Clean
#### Description of the Devices 4.

Description of the Donton is a sterile solution containing sodium hyaluronate, sodium chloride, sodium phosphate and sodium perborate stabilized with phosphoric acid as a preservative.

- 5. Indications for Use Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing.
### Description of Safety and Substantial Equivalence 6.

- Comparison of Technological Characteristics: The action section has been expanded. No . changes have been made to the current product formulation.
- Non- clinical: No new studies performed. Non-clinical data from K013204 should be I referenced.
- Discussion of Clinical Data: Clinical data .

### Conclusions Drawn form Data Supporting Equivalence Determination 7.

The purpose of this application is to provide a more descriptive "action to the package insert for AQuify Lens Comfort Drops. There were no changes to the product formulation. Application, K013204 has already established the substantial equivalence of the product. The clinical data provide in the application supports that AQuify Lens Comfort Drops is substantially equivalent to Complete Blink-N-Clean.

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PART III. INDICATIONS FOR USE STATEMENT OF KE - - 点寸型 男 和歌曲 (MS - 电影 (ST

510(k) Number:

This is a new 510 (k) Notification. (number to be assigned)

Device Name: AQuify Lens Comfort Drops

### Indications for Use:

Indications for Use:
Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness
in the Comfort be the sector the wearing Ose AQuily Echo Octated with contact lens wearing.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

or Over-the-Counter: ☑

*Daniel W.C. Brown, Ph.D.*

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

K042176 510(k) Number

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