REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

Device Description

REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%). The solution may also contain hydrochloric acid and/or sodium hydroxide to adjust pH. All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.

AI/ML Overview

This document is a 510(k) Summary for the REFRESH® RELIEVA™ FOR CONTACTS device. It describes the device, compares it to predicate devices, and summarizes testing performed to support its substantial equivalence. The document is a regulatory submission for a medical device and does not inherently describe a study that uses AI, nor does it provide detailed acceptance criteria related to AI performance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as this document pertains to a medical device (contact lens solution), not an AI/ML powered device.

However, I can extract the information relevant to the performance of the device as described in this document.

Device Name: REFRESH® RELIEVA™ FOR CONTACTS

Device Description: A sterile, buffered, isotonic, preserved solution containing carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%).

Indications for Use: To lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

Predicate Devices:

REFRESH® Contacts Lubricating and Rewetting Drops (K992028)
REFRESH OPTIVE CONTACTS Lubricating and Rewetting Drops (K083812)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, or similar metrics for an AI/ML device. Instead, the "acceptance criteria" are implied by the requirement for "substantial equivalence" to predicate devices, which the studies aimed to demonstrate. The performance is reported in terms of safety and efficacy.

Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance
Stability: Chemical, physical, and microbiological stability to support the claimed shelf-life and preservative effectiveness.	Demonstrated: Product showed chemical and physical stability for a 24-month shelf-life. Microbiology testing confirmed sterility maintenance and preservative effectiveness throughout the shelf-life.
Biocompatibility: Safety and effectiveness according to FDA guidance for contact lens care products.	Demonstrated: In-vitro and in-vivo studies, conducted per FDA guidance (Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products dated 1 May 1997), indicated physical, chemical, and microbiological properties are substantially equivalent to predicate devices.
Clinical Performance: Safety and efficacy for lubricating, rewetting, and cushioning contact lenses, comparable to marketed predicate devices.	Demonstrated: A 3-month clinical study showed substantial equivalence to REFRESH CONTACTS® for lubricating and rewetting during lens wear, and cushioning upon lens insertion.
Technological Characteristics: No new significant safety or effectiveness concerns compared to predicate devices.	Demonstrated: Components are not novel, similar concentrations to cleared products, no additional significant safety or effectiveness concerns identified. The intended use is identical to predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set:
- Clinical Study: The document states "A 3-month clinical study was conducted... in contact lens wearers." However, the exact number of participants (sample size) in this clinical study is not provided in the available text.
- Biocompatibility/Stability: Not applicable as these are bench/lab tests, not human test sets.
Data Provenance: Not explicitly stated (e.g., country of origin). The clinical study was conducted to evaluate the device against a marketed predicate, implying a controlled clinical trial setting. The studies are prospective as they were specifically performed to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable as the described studies are for a contact lens solution, not an AI/ML powered device where expert readers typically establish ground truth. Clinical endpoints in this context would likely be based on participant reporting of symptoms and potentially objective ophthalmological assessments, not "expert ground truth" for image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Clinical study endpoints would be collected and analyzed, but "adjudication" in the sense of resolving discrepancies between expert interpretations of data (as typically seen in AI/ML performance studies) is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This document describes the safety and effectiveness testing for a contact lens comfort solution, not an AI/ML diagnostic or assistive device. There are no "human readers" interpreting images with or without AI assistance in this context.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is a physical product (contact lens solution), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical study, the "ground truth" or primary endpoints would likely be based on:

Patient-reported outcomes (PROs): Subjective relief of dryness, discomfort, and irritation; comfort upon lens insertion.
Clinical assessments: Potentially objective measures of ocular surface health or lens-eye interaction, as assessed by an optometrist or ophthalmologist, though specific measures are not detailed in this summary.
The study aimed to demonstrate substantial equivalence in safety and efficacy compared to a predicate device, meaning its performance was judged against the established acceptable performance of the predicate.

For biocompatibility, the ground truth involves adherence to and successful completion of established test methods (e.g., cytotoxicity, irritation, sensitization) as per FDA guidance.

For stability, the ground truth involves chemical, physical, and microbiological specifications being met over time.

8. The sample size for the training set

This section is not applicable. The device is a contact lens solution, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the reasons stated above.

Summary

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August 8, 2019

Allergan, Inc. Emily Huang, MS Senior Manager, Global Regulatory Affairs 2525 Dupont Drive Irvine, CA 92623-9534

Re: K190674

Trade/Device Name: REFRESH® RELIEVA™ For CONTACTS Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: July 3. 2019 Received: July 5, 2019

Dear Ms. Huang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events)

(21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190674

Device Name REFRESH® RELIEVA™ FOR CONTACTS

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Applicant Information

Preparation Date:	07 August 2019
Applicant:	Allergan2525 Dupont DriveIrvine, CA 92623-9534
Contact Person:	Emily Huang, Senior Manager, Global Regulatory Affairs
Telephone Number:	(714) 246-2294
Fax Number:	(714) 796-3015
Email:	emily.huang@allergan.com
Device Information
Trade Name:	REFRESH® RELIEVA™ FOR CONTACTS
Common Name:	Soft (hydrophilic) Contact Lens Care Products and RigidGas Permeable Contact Lens Care Products
Classification Name:	Soft (hydrophilic) Contact Lens Care Products (21 CFR886.5928) and Rigid Gas Permeable Contact Lens CareProducts (21 CFR 886.5918)
Device Classification:	Class II
Product Code:	LPN and MRC

Predicate Device

The predicate devices are:

REFRESH® Contacts Lubricating and Rewetting Drops (K992028) .
. REFRESH OPTIVE CONTACTS Lubricating and Rewetting Drops (K083812)

Description of Device

All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.

Indications for Use

REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be

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associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

The indication for REFRESH® RELIEVA™ FOR CONTACTS is identical to the predicate devices. The modifications to the predicate devices do not change the intended use and the changes do not raise any additional significant safety or effectiveness concerns.

Comparison of Technological Characteristics with the Predicate Device

The intended use of REFRESH® RELIEVA™ FOR CONTACTS is identical to its predicate devices: For use with soft (hydrophilic) contact lenses and for use with rigid gas permeable (RGP) contact lenses. The components of the device are not novel and are included in already cleared contact lens lubrication and rewetting solutions with similar concentrations. The components of REFRESH® RELIEVA™ FOR CONTACTS and the predicate devices are provided in Table 1.

Devices
	Predicate 1:REFRESHCONTACTS (9329X)	Predicate 2:REFRESH OPTIVECONTACTS (9689X)	Proposed Device:REFRESH RELIEVAFOR CONTACTS(10077X)
Ingredient
Carboxymethylcellulose Sodium	X	X	X
Glycerin	-	X	X
Sodium Hyaluronate	-	-	X
Erythritol	-	X	X
Boric Acid	X	X	X
Sodium Borate Decahydrate	X	X	X
Sodium Citrate Dihydrate	X	X	X
Potassium Chloride	X	X	X
Calcium Chloride Dihydrate	X	X	X
Levocarnitine	-	X	-
Magnesium Chloride Hexahydrate	X	X	X
PURITE®, a stabilized oxychlorocomplex	X	X	X
Sodium Chloride	X	-	-
Sodium Hydroxide / HydrochloricAcid	X	X	X
Purified Water	X	X	X

Components of REFRESH® RELIEVA™ FOR CONTACTS and Predicate Table 1 Devices

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Allergan performed stability, biocompatibility and performance testing (bench, nonclinical, and clinical studies with this formulation to support the claim of substantial equivalence). A summary of the testing and studies is provided below.

Stability

The product demonstrated chemical and physical stability to support a 24-month shelf-life. Microbiology testing demonstrated the product's ability to maintain sterility and preservative effectiveness throughout the shelf-life.

Biocompatibility

In-vitro and in-vivo studies were performed to assess the safety and effectiveness of REFRESH® RELIEVA™ FOR CONTACTS. The tests were designed in accordance to FDA's Guidance for Industry - Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products dated 1 May 1997. The results of these studies indicate that the physical, chemical and microbiological properties of REFRESH® RELIEVA™ FOR CONTACTS are substantially equivalent to the predicate devices REFRESH CONTACTS and REFRESH OPTIVE CONTACTS.

Clinical Studies

A 3-month clinical study was conducted to evaluate the safety and efficacy of REFRESH® RELIEVA™ FOR CONTACTS to the marketed contact lens comfort drop, REFRESH CONTACTS® in contact lens wearers. The objective of this study was to provide evidence to support the claim that the performance of REFRESH® RELIEVA™ FOR CONTACTS is substantially equivalent to REFRESH CONTACTS for lubricating and rewetting during lens wear, and cushioning upon lens insertion. Results of the clinical study demonstrated substantial equivalence to REFRESH CONTACTS®.

Conclusion

Based on the stability, biocompatibility and performance testing (bench, nonclinical, and clinical studies) summarized above, the safety and effectiveness profile for REFRESH® RELIEVA™ FOR CONTACTS was substantially equivalent to the predicate devices for the same intended use.

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.”