to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) contact lenses.
to help relieve dryness, discomfort and irritation that may be associated with lens wear and,
to cushion lenses and ease insertion.

RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.

Device Description

TheraTears® brand Contact Lens Comfort Drops contains carmellose sodium in purified water as a lubricant. It is a sterile, hypotonic, borate buffered solution containing the following essential electrolytes found in natural tears: sodium chloride, potassium chloride, sodium chloride, sodium bicarbonate, calcium chloride, magnesium chloride, and sodium phosphate. The gentle patented preservative system consists of sodium perborate stabilized with phosphonic acid. This solution contains no chlorhexidine, no thimerosal and no other mercury-containing ingredients, and it contains no detergents.

AI/ML Overview

The provided text describes the 510(k) summary for TheraTears Contact Lens Comfort Drops, focusing on its safety and effectiveness. It outlines non-clinical and clinical testing performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it describes demonstrating "equivalence in performance, safety and efficacy" to a predicate device based on several qualitative and semi-quantitative metrics.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Relative frequency and severity of positive slit lamp findings	Equivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops
Stability of contact lens visual acuities	Equivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops
Stability of best spectacle-corrected visual acuities	Equivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops
Relative incidence and severity of symptoms, problems, and complaints	Equivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops
Lack of solution-associated complications	Equivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops

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

Sample Size: The document states "A one month clinical study was conducted," but it does not specify the sample size (i.e., number of participants) used in this clinical study.
Data Provenance: The document does not explicitly state the country of origin. Given the 510(k) submission to the US FDA, it is highly probable the data was collected in the United States. The study was a prospective clinical study conducted by the applicant.

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

The document does not provide information regarding the number of experts, if any, used to establish ground truth or their specific qualifications for this clinical study. The assessment of parameters like slit lamp findings, visual acuities, and patient-reported symptoms would typically involve trained ophthalmologists or optometrists, but details are not provided.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set data.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a contact lens comfort drop, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. This device is a physical product (contact lens drops), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was established by clinical assessment and comparison to a legally marketed predicate device (Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops). This involved:

Objective clinical observations (e.g., slit lamp findings, visual acuity measurements).
Subjective patient-reported outcomes (e.g., symptoms, problems, complaints).
Assessment of complications.

The aim was to show "equivalence in performance, safety and efficacy."

8. The Sample Size for the Training Set

The document does not mention a training set because this is a clinical trial for a medical device (eye drops), not an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no AI model or training set in the context of this device submission.

Summary

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NOV = 4 2003

Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K 032481", followed by the text "Page 1 of 2". The characters are written in a simple, clear font, and the text is smaller and positioned below the string of characters. The image appears to be a scan or photograph of a document.

510(k) Summary of Safety and Effectiveness

Applicant's Name and Address:	Advanced Vision Research, Inc.12 Alfred Street, Suite 200Woburn, MA 01801
Contact Person:	Jeffrey R. Gilbard, M.D.
Contact Person:	Jeffrey P. Gilbard, M.D.
	Phone (781) 932-8327
	Fax (781) 935-5075

October, 2003 Summary Prepared

Trade Name:

TheraTears Contact Lens Comfort Drops

Classification Name:

Soft (hydrophilic) contact lens care products (886.5928) Rigid gas permeable contact lens care products (886.5918)

Predicate Device:

Allergan Refresh Contacts™ (K992928) AQuify lens Comfort Drops (K013204)

Device Description:

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Indication for Use:

TheraTears Contact Lens Comfort Drops is indicated

to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) contact . lenses.
to help relieve dryness, discomfort and irritation that may be associated with lens . wear and,
to cushion lenses and ease insertion. .

RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.

Safety, Performance and Substantial Equivalence

Non-clinical Testing

The applicant performed stability, compatibility, toxicology and microbiology testing based the requirements of the May 1, 1997 Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. The results support the claim of substantial equivalence.

Clinical Testing

A one month clinical study was conducted to evaluate the safety and efficacy of TheraTears Contact Lens Comfort Drops. The results of the study demonstrate that TheraTears Contact Lens Comfort Drops is equivalent in performance, safety and efficacy to the Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops.

This conclusion is based upon and supported by:

The relative frequency and severity of positive slit lamp findings .
The stability of the contact lens visual acuities as well as the stability of the . best spectacle-corrected visual acuities
The relative incidence and severity of symptoms, problems and complaints .
. The lack of solution-associated complications

The claim of substantial equivalence to Allergan Refresh Contacts and AQuify lens Comfort Drops is based on the indication for use as a lubricating and rewetting solution for soft (hydrophilic) and RGP contact lenses. TheraTears Contact Lens Comfort Drops contains the same active ingredient as Allergan Refresh Contacts and the same preservative system as AQuify lens Comfort Drops.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 a stylized symbol resembling three abstract shapes that could be interpreted as human figures or abstract forms. The logo is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV = 4 2003

Advanced Vision Research, Inc. c/o Beverley D. Venuti, Ph.D. R.A.C. Foresight Regulatory Strategies 269A Ballardvale Street Wilmington, MA 01887

Re: K032481

Trade/Device Name: TheraTears Contact Lens Comfort Drops Regulation Number: 21 CFR 886.5928; 21 CFR 886.5918 Regulation Name: Soft (hydrophilic) contact lens care products; Rigid gas permeable contact lens care products Regulatory Class: Class II Product Code: LPN; MRC Dated: August 11, 2003 Received: August 12, 2003

Dear Dr. Venuti:

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. 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 (PMA), 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 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Beverley D. Venuti, Ph.D. R.A.C.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely vours,

A. Karyi korenthal.

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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Indications for Use

510(k) Number (if known):

Device Name: TheraTears Contact Lens Comfort Drops

Indications for Use:

TheraTears Contact Lens Comfort Drops is indicated

to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) . contact lenses,
to help relieve dryness, discomfort and irritation that may be associated with . lens wear and,
. to cushion lenses and ease insertion.

RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W. C. Brown Ph.D.

Ophthalmic Ear, roat Devises

510(k) Number K032481

OR Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use (Per 21 CFR 80.109)

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.”