K Number

Device Name

REFRESH CONTACTS LUBRICATING AND REWETTING DROPS

Manufacturer

ALLERGAN, INC.

Date Cleared

1999-10-07

(113 days)

Product Code

LPN

Regulation Number

886.5928

Intended Use

Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses). Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to help relieve dryness, discomfort and irritation that may be associated with lens wear. Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to cushion lenses by placing a drop on the lens prior to application on to the eye.

Device Description

REFRESH® CONTACTS™ Lubricating and Rewetting Drops is a sterile, buffered, isotonic preserved solution containing sodium carboxymethylcellulose as the demulcent and preserved with PURITE® (stabilized oxychloro complex 0.005%). Boric acid, sodium chloride, potassium chloride, calcium chloride and magnesium chloride act as buffering and tonicity agents. REFRESH® CONTACTS™ Lubricating and Rewetting Drops is supplied sterile, packaged in plastic bottles with controlled dropper tips and labeled with lot number and 24 month expiration date.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition and clinical safety/acceptability of a lubricating and rewetting solution, with no mention of AI or ML.

Therapeutic

No.
The device is used to lubricate and rewet contact lenses and relieve associated dryness and discomfort, which are not considered therapeutic actions.

Diagnostic

The device is a lubricating and rewetting drop for contact lenses, intended to relieve dryness and discomfort associated with lens wear, not to diagnose any condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a sterile, buffered, isotonic preserved solution, which is a liquid formulation, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is to lubricate and rewet contact lenses and relieve associated discomfort. This is a direct application to the contact lens and the eye, not a test performed on a sample taken from the body.
Device Description: The device is a sterile solution for direct application.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. The performance studies focus on the safety and acceptability of the solution for contact lens wearers, not on diagnostic accuracy.

Therefore, REFRESH® CONTACTS™ Lubricating and Rewetting Drops falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to lubricate and . rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses).
Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to help relieve . dryness, discomfort and irritation that may be associated with lens wear.
Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to cushion lenses . by placing a drop on the lens prior to application on to the eye.

Product codes (comma separated list FDA assigned to the subject device)

86 LPN

Device Description

REFRESH® CONTACTS™ Lubricating and Rewetting Drops is supplied sterile, packaged in plastic bottles with controlled dropper tips and labeled with lot number and 24 month expiration date.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A one month clinical study was conducted to evaluate the safety and acceptability of REFRESH® CONTACTS™ Lubricating and Rewetting Drops for both hydrogel and rigid gas permeable (RGP) contact lenses. The results of the study showed that the product is safe and acceptable for its intended use based on:

One month successful use by 100% of subjects- (25/25) hydrogel lens wearers and . (25/25) RGP lens wearers.
Safety comparable to COMPLETE® Lubricating and Rewerting Drops (hydrogel . lens wearers) or CLARIS® Rewetting Drops (RGP lens wearers) as measured by slit lamp findings.
Acceptability comparable to COMPLETE® Lubricating and Rewetting Drops . (hydrogel lens wearers) or CLARIS® Rewetting Drops (RGP lens wearers) as measured by symptoms of discomfort.

Results of the clinical study demonstrate the safety, acceptability and substantial equivalence of REFRESH® CONTACTS™ Lubricating and Rewetting Drops to the predicate devices for lubricating and rewetting both soft (hydrophilic) and RGP contact lenses.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

One month successful use by 100% of subjects- (25/25) hydrogel lens wearers and . (25/25) RGP lens wearers.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
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.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Summary

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS REFRESH® CONTACTS™ Lubricating and Rewetting Drops

1. Submitter Information:

Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534

Contact Person:	Paul J. Nowacki
Telephone:	Manager, Regulatory Affairs
	(714) 246-6761 (voice)
	(714) 246-5457 (fax)

2. Device Name:

| Common Name: | In-Eye Soft (Hydrophilic) Contact Lens and Rigid Gas
Permeable Contact Lens Lubricating and Rewetting
Solution |
|------------------------|----------------------------------------------------------------------------------------------------------------------|
| Trade Name: | REFRESH® CONTACTS™ Lubricating & Rewetting
Drops |
| Device Classification: | Accessories to Contact Lenses - Cleaning and Wetting
Agents (86LPN) |

3. Predicate Device:

The Allergan products, REFRESH® CL Lubricating and Rewetting Drops, COMPLETE® Lubricating and Rewetting Drops and CLARIS® Rewerting Drops were selected as the predicate device for REFRESH® CONTACTS™ Lubricating and Rewetting Drops.

4. Device Description:

REFRESH® CONTACTS™ Lubricating and Rewetting Drops is supplied sterile, packaged in plastic bottles with controlled dropper tips and labeled with lot number and 24 month expiration date.

5. Indications for Use:

Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to lubricate and . rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses).
Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to help relieve . dryness, discomfort and irritation that may be associated with lens wear.
Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to cushion lenses . by placing a drop on the lens prior to application on to the eye.

6. Description of Safety and Substantial Equivalence:

A series of preclinical tests and clinical testing was performed to demonstrate the safety and effectiveness of REFRESH® CONTACTSTM Lubricating and Rewetting Drops. The following is a summary of the test results.

Preclinical Testing

A series of in-vitro and in-vivo preclinical chemical, toxicological and microbiological studies were performed to assess the safety and effectiveness of REFRESH® CONTACTS™ Lubricating and Rewerting Drops. The tests were designed and performed 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.

The results of these studies indicate that the physical, chemical and microbiological properties of REFRESH® CONTACTS™ Lubricating and Rewetting Drops are substantially equivalent to the predicate devices REFRESH® CL Lubricating and Rewetting Drops, COMPLETE® Lubricating and Rewetting Drops and CLARIS® Rewetting Drops.

The solution is non-toxic to the ocular tissue as demonstrated by in-vivo preclinical testing in laboratory animals. In-vitro lens compatibility testing was conducted to establish product compatibility with both soft (hydrophilic) contact lenses and RGP contact lenses.

Clinical Testing

One month successful use by 100% of subjects- (25/25) hydrogel lens wearers and . (25/25) RGP lens wearers.
Safety comparable to COMPLETE® Lubricating and Rewerting Drops (hydrogel . lens wearers) or CLARIS® Rewetting Drops (RGP lens wearers) as measured by slit lamp findings.
Acceptability comparable to COMPLETE® Lubricating and Rewetting Drops . (hydrogel lens wearers) or CLARIS® Rewetting Drops (RGP lens wearers) as measured by symptoms of discomfort.

Substantial Equivalence

REFRESH® CONTACTS™ Lubricating and Rewetting Drops are substantially equivalent in terms of action, indications for use, safety and effectiveness to the predicate devices. REFRESH® CL Lubricating and Rewetting Drops (approved for marketing under PMA P960012), COMPLETE® Lubricating and Rewetting Drops (approved for marketing under P910075/S7) and CLARIS® Rewetting Drops (approved for marketing under P900047/S5). Any differences between the new device and its predicates do not effect the use of this product.

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1999

Mr. Paul J. Nowacki Manager, Regulatory Affairs Allergan 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534

Re: K992028

Trade Name: REFRESH® CONTACTS™ Lubricating and Rewetting Drops Regulatory Class: II Product Code: 86 LPN Dated: September 10, 1999 Received: September 13, 1999

Dear Mr. Nowacki:

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 .

Page 2 - Mr. Paul J. Nowacki

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl. forenthal

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

Enclosure

Indications for Use Statement

| 510(k)
Number

(if known)	K992028
Device Name	REFRESH ® CONTACTS TM Lubricating and Rewetting Drops
Indications
for Use	Use REFRESH® CONTACTSTM Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses).Use REFRESH® CONTACTSTM Lubricating and Rewetting Drops to help relieve dryness, discomfort and irritation that may be associated with lens wear.Use REFRESH® CONTACTSTM Lubricating and Rewetting Drops to cushion lenses by placing a drop on the lens prior to application on to the eye.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number	K992028

| Prescription Use

(Per 21 CFR 801.109	OR	Over-The-Counter Use ✓
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