BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

Device Description

BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Contact Lenses are composed of fluoro silicone acrylate copolymers wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BOSTON® EQUALENS® and BOSTON® EQUALENS® II RGP Contact Lenses:

The information provided is a 510(k) summary for RGP contact lenses, focusing on the stability of the lenses when wet-shipped and stored in a specific conditioning solution. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the studies described are primarily performance and safety tests, not clinical efficacy trials in the typical sense for a new drug or high-risk device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Stability/Compatibility (Physical)	Average changes for diameter, base curve, and power compared to DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses - Part 1: Specifications for rigid corneal and scleral contact lenses.	After soaking for thirty days, the silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses were determined to be physically compatible with Boston Advance Comfort Formula Conditioning Solution.
Microbiology (Bioburden)	100 Colony Forming Units (CFU) per lens	Less than 10 Colony Forming Units (CFU) per lens (for both control and stored lenses).

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

Stability/Compatibility Test Set: The sample size is not explicitly stated. The text refers to "Silicone acrylate (SA) and fluorosilicone acrylate (FSA) tinted rigid gas permeable contact lenses" being subjected to the test.
Microbiology Test Set: The sample size is not explicitly stated, but it refers to "a set of test lenses" and "two sets of lenses" (one control, one stored).
Data Provenance: The studies were performed by "The applicant," Polymer Technology. The location of the testing is not specified, nor is whether the data is retrospective or prospective. Given the nature of a 510(k) submission for device approval, these would be prospective tests conducted specifically for the submission.

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

This information is not provided in the document. For these types of physical and microbiological performance tests, the "ground truth" is typically established by laboratory measurements against defined standards or protocols, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The tests described are objective laboratory measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the goal is to assess the impact of an AI algorithm on human reading performance. The described studies are physical and microbiological performance tests for contact lenses.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable in the context of this device. A standalone algorithm performance study refers to the evaluation of an AI algorithm's performance without any human intervention. The device in question is a contact lens, and the studies performed are physical and microbiological tests, not AI algorithm evaluations.

7. The Type of Ground Truth Used

Stability/Compatibility: The ground truth for physical compatibility (diameter, base curve, power changes) was established by comparison to the DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses - Part 1: Specifications for rigid corneal and scleral contact lenses. This is a recognized international standard for contact lens specifications.
Microbiology (Bioburden): The ground truth for microbial contamination was established by quantitative measurement of Colony Forming Units (CFU) per lens against a defined numerical acceptance criterion.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this device and study. Training sets are relevant for machine learning or AI models, which are not involved here.

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

This information is not applicable as there is no "training set" for this device.

Summary

{0}------------------------------------------------

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BOSTON® EQUALENS® and BOSTON® EQUALENS® II RGP Contact Lenses Wet Shipped In BOSTON® Advance® Comfort Formula Conditioning Solution And Stored For Up To 30 Days

SUBMITTER INFORMATION: 1.

Polymer Technology 1400 N. Goodman Street Rochester, New York 14603-0450

CONTACT PERSON: 2.

Address:

Fax No .:

1400 North Goodman Street P.O. Box 30450 Rochester, New York 14603-0450 (716) 338-8638 Telephone No .: (716) 338-0702 dketchum@bausch.com E-mail Address:

Manager, Regulatory Affairs

Debra Ketchum

3. Device Identification:

Rigid Gas Permeable (hydrophobic) Contact Classification Name: Lens Material BOSTON Contact Lens Materials Proprietary Name: fluoro silicone acrylate rigid gas permeable Common Name: contact lens material

PREDICATE DEVICE: 4.

BOSTON XO (hexafocon A) RGP Contact Lenses Wet Shipped and up to 30 day storage in Boston Advance Comfort Formula Conditioning Solution, 510(k) K002025 cleared on October 31, 2000.

DESCRIPTION OF THE DEVICE: 5.

{1}------------------------------------------------

INDICATIONS FOR USE: 6.

DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE: 7.

The applicant performed stability, compatibility, and microbiology testing on BOSTON EQUALENS and BOSTON EQUALENS II RGP Contact Lenses wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days.

Stability/Compatibility:

Silicone acrylate (SA) and fluorosilicone acrylate (FSA) tinted rigid gas permeable contact lenses were subjected to a thirty-day soak in Boston Advance Comfort Formula Conditioning Solution according to the lens compatibility protocol. The average changes for each parameter (diameter, base curve and power), relative to the initial measurements were determined and compared to the DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses- Part 1: Specifications for rigid corneal and scleral contact lenses.

After soaking in the contact lens carrying cases at room temperature for thirty days the silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses were determined to be physically compatible with Boston Advance Comfort Formula Conditioning Solution.

Microbiology

A bioburden study was completed. A set of test lenses was cleaned with Boston Laboratory Lens Cleaner and subjected to bioburden testing. In this test, two sets of lenses were tested to validate the storage in Boston Advance Comfort Formula after 30 days. One set was stored dry (control) and the other set was stored in Boston Advance Comfort Formula. This established the "cleanliness" of the test samples prior to entering the stability study. Testing showed that the colony forming units (CFU) per lens was less than 10. The acceptance criteria is 100 CFU per lens. Testing showed that the colony forming units (CFU) per lens was less than 10. The acceptance criteria is 100 CFU per lens.

{2}------------------------------------------------

SUBSTANTIAL EQUIVALENCE 8.

BOSTON EQUALENS and EQUALENS II RGP Contact Lenses wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days are substantially equivalent to the currently stored for up to of a oo areable Contact Lens Wet Shipped In markets a vance Comfort Formula Conditioning Solution and stored for up to 30 days, 510(k) Premarket Notification No. K002025.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

Food and Drug Administratio 200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2001

Polymer Technology c/o Ms. Debra Ketchum 1400 N. Goodman St. P.O. Box 30450 Rochester, NY 14603-0450

Re: K011945

Trade/Device Name: BOSTON® EQUALENS® (itafluorofocon A) and BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses (Wet Shipped and up to 30 day storage in Boston Advance Comfort Formula Conditioning Solution) Regulation Number: 21 CFR 886.5916 Regulatory Class: Class II Product Code: HQD Dated: June 20, 2001 Received: June 21, 2001

Dear Ms. Ketchum:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have here hear four becered the device is substantially equivalent (for the indications for use above and we nevelosure) to legally marketed predicate devices marketed in interstate commerce stated in the encrosary to tegars and date of the Medical Device Amendments, or to devices that pHor to May 26, 1776, the chactions atternent also be the Federal Food, Drug, and Cosmetic nave been reclassined in wefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, the rece. "The general consulacturing 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 Approval), it may be tound in the Code of Federal Regulations, Title 21, Parts 800 to 895. A your determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 mopononio, the I over regulation may result in regulatory action. In addition, FDA may comply with the GHF regulation in a since in the Federal Register. Please note: this publish larger announces 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.

{4}------------------------------------------------

Page 2 - Ms. Debra Ketchum

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his leter will allow you to begin mancally your device of your device to a legally marked on
notification. The FDA finding of substantial equivalence of your device to pro to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR-Part 801 and If you desire specific at nor ro diagnostic devices), please contact the Office of Compliance at (301) additional Addition Compress (201) 594-400 Aller planet (1) Arter please (1)
Strated in Armere (200) 394-400 Aller personal de metropomante metropomante metropomante mentalia

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

{5}------------------------------------------------

Polymer Technology 1400 North Goodman Street P.O. Box 30450 Rochester, NY 14603-0450

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

BOSTON® EQUALENS® (itafluorofocon A) RGP Contact Lens BOSTON® EQUALENS® II (oprifocon A) RGP Contact Lens

Indications for Use:

BOSTON EQUALENS (itafluorofocon A) and BOSTON EQUALENS II (oprifocon A) RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter-Use_

Myra Smith

ision Sign-Off) · Ision of Ophthalmic Devices . )/k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.