BOSTON EO (enflufocon B) Contact Lens Material is 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

The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49). The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Test Lens (BOSTON EO) Performance	Control Lens (BOSTON ES) Performance
Safety:
<= 15% difference in Grade 2 or greater slit lamp findings	Not significantly different from control	(Implied to be acceptable as predicate)
Efficacy:
<= 15% difference in visual acuity (20/40 or better)	Not significantly different from control	(Implied to be acceptable as predicate)
In-Vitro Cytotoxicity (USP Agar Diffusion)	Meets USP XXII requirements (Test article meets requirements)	Not directly reported, but predicate device is assumed compliant
Acute Ocular Irritation	No ocular irritation produced	Not directly reported, but predicate device is assumed compliant
Systemic Injection	Meets requirements, considered non-toxic	Not directly reported, but predicate device is assumed compliant
Solution Compatibility (after 30 cycles)	No significant changes to lens parameters (UV/vis, base curve, diameter, power, surface quality)	Not directly reported (Test performed on new device material)

2. Sample Size and Data Provenance

Sample Size (Clinical Test Set): 240 eyes (120 patients).
Data Provenance: The document does not explicitly state the country of origin.
Retrospective or Prospective: Prospective, as it describes a "clinical study carried out to evaluate the safety and efficacy" and mentions patient "entry into this study."

3. Number of Experts and Qualifications for Ground Truth

The document mentions "8 Investigators" for the clinical study. It does not provide specific qualifications for these investigators (e.g., ophthalmologists, optometrists, years of experience). Their role was likely to conduct the clinical assessments and collect data as per the protocol.
For preclinical tests (toxicology), the "ground truth" is based on established standards (e.g., USP XXII for cytotoxicity).

4. Adjudication Method

The document states the study utilized a "controlled, double masked design." This implies that both the patients and the investigators were unaware of whether they were using the test or control lens.
It does not specifically mention an independent adjudication method for clinical findings beyond the initial assessment by the investigators. The primary endpoints were defined as percentages of certain findings, implying a direct comparison of reported results.
For the preclinical tests, the "adjudication" is based on meeting the defined requirements of the specific test (e.g., "meets the requirements of the Agar Diffusion Test").

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
This study evaluates a contact lens material, not an AI or imaging device where human readers would interpret images. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) study was not done.
This submission is for a medical device (contact lens material), not an algorithm or AI system.

7. Type of Ground Truth Used

Clinical Study: The ground truth for safety was based on "Grade 2 or greater slit lamp findings" which are objective clinical observations made by the investigators. For efficacy, it was based on "lens visual acuities at the level of 20/40 or better," also an objective clinical measurement. These are considered expert clinical assessments/measurements.
Preclinical Tests (Toxicology): The ground truth was based on established standardized test criteria (e.g., USP XXII for cytotoxicity, defined parameters for ocular irritation and systemic injection).
Solution Compatibility: Ground truth was based on objective instrumental measurements of lens parameters (UV/vis spectra, base curve, diameter, power, surface quality) before and after cycles.

8. Sample Size for the Training Set

Not applicable. This is a clinical study for a physical medical device (contact lens material), not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device submission.

Summary

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510(k) Premarket Notification BOSTON EO Contact Lens Material

Image /page/0/Picture/1 description: The image shows a sequence of numbers and a letter. The sequence starts with the letter K, followed by the numbers 980741. The numbers are written in a bold, handwritten style, and there is a line underneath the sequence.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS MAY | | 1998

FOR

BOSTON EO

SUBMITTER INFORMATION: 1.

Polymer Technology, a division of Wilmington Partners, L.P. Global Vision Care 1400 N. Goodman Street Rochester, New York 14692-0450

CONTACT PERSON: 2.

Manager, Regulatory Affairs 1400 North Goodman Street Address: Rochester, New York 14692 (716) 338-8638 Telephone No .: (716) 338-0702 Fax No .: dketchum@bausch.com E-mail Address:

Debra Ketchum

3. DEVICE IDENTIFICATION:

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

4. PREDICATE DEVICE:

BOSTON ES (enflufocon A) has been selected as the predicate device for BOSTON EO (enflufocon B).

ડ. DESCRIPTION OF THE DEVICE:

The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49).

The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).

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INDICATIONS FOR USE: 6.

The BOSTON EO is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and notaphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfection system only.

DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE: 7.

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the BOSTON EO. The results of all testing demonstrated that the safety and effectiveness of the BOSTON EO is equivalent to the currently marketed BOSTON ES lens material. A summary of these results from the preclinical studies is presented below.

Toxicology:

In-Vitro Cytotoxicity:

USP Agar Diffusion Cytotoxicity was completed in accordance with USP XXII. The test article meets the requirements of the Agar Diffusion Test.

Acute Ocular Irritation:

Acute Ocular Irritation test was performed and produced no ocular irritation.

Systemic Injection

The lens material meets the requirements of the Systemic Injection Test and is considered non-toxic.

Shelf Life:

The BOSTON EO (enflufocon B) is a hydrophobic rigid gas permeable contact lens material with <1% water content. This material will be shipped dry. The data presented supports substantial equivalence of this BOSTON EO (enflufocon B) to the already marketed BOSTON ES (enflufocon A) lens material. Based on the Premarket Notification Guidance Document for Daily Wear contact Lenses, May 12, 1994, shelf-life studies are not required for clearance of this material.

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Solution Compatibility:

Studies were conducted on blue tinted lens material with the ultraviolet light absorber. Lenses were run through 30 cycles of cleaning and conditioning to establish the compatibility of the lens material with the recommended care regimen. The parameters of ultraviolet and visible light (UV/vis) spectra, base curve, lens diameter, power and surface quality were recorded prior to and upon completion of 30 cycles. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cycles.

Clinical Testing

Below is a summary of the clinical study carried out to evaluate the safety and efficacy of the BOSTON EO (enflufocon B) contact lens material when used as a daily wear contact lens for the correction of visual acuity.

The study utilized a controlled, double masked design. The predicate device, BOSTON ES rigid gas permeable lens, was used as the control material.

A total of 240 eyes (120 patients) were entered into the study by 8 Investigators. Prior to entry into this study, each patient was required to read and sign a Statement of Informed Consent.

The primary endpoints for this study were:

Safety: A difference of 15% in the proportion of total Grade 2 or greater . slit lamp findings, between the Test and Control lenses, will be considered clinically significant.
. Efficacy: A difference of 15% in the proportion of lens visual acuities at the level of 20/40 or better, between the Test and Control lenses, will be considered clinically significant.

Both the safety and efficacy endpoints, as defined in the study protocol, were achieved, and there were no significant differences seen between the Test and Control lens.

The sponsor concludes that BOSTON EO (enflufocon B) contact lens material is equivalent in safety and efficacy to the predicate device, BOSTON ES.

8. SUBSTANTIAL EQUIVALENCE

The BOSTON EO is substantially equivalent to the currently marketed BOSTON ES, which was cleared in 510(k) Premarket Notification No. K943177 on August 25, 1994. The difference between the two devices is a change in the component ratios.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a bird-like figure with three lines extending from its head. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 1998

Ms. Debra L.B. Ketchum Manager, Regulatory Affairs 1400 N. Goodman Street Rochester, New York 14692

Re: K980741 Trade Name: BOSTON EO Rigid Gas Permeable Contact Lens Material Regulatory Class: II Product Code: 86 HQD Dated: February 25, 1998 Received: February 26, 1998

Dear Ms. Ketchum:

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 (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 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 .

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Page 2 - Ms. Debra L.B. Ketchum

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. Ralph Rosenthal

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

Enclosure

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・・ Polymer Technology, a division of Wilmington Partners, L.P. 1400 North Goodman Street Rochester, NY 14692-0450

Indications for Use Statement

K980741 510(k) Number (if known):

Device Name: BOSTON EO

Indications for Use:

(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

Daniel W. Brown PHD.

ivision Sign-Off) Division of Ophthalmic Devices K980741 510(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.