BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyocia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only.

BOSTON IV (itafocon B), BOSTON II (itafocon A) RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia, hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.

Device Description

BOSTON RGP Contact Lenses are composed of silicone acrylate or fluoro silicone acrylate copolymers wet shipped in Boston SIMPLUS® Multi-Action Solution and stored up to 30 days.

BOSTON SIMPLUS® Multi-Action Solution, a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalky phosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with polyaminopropyl biguanide (0.0005%), chlorhexidine gluconate (0.003%).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Bausch & Lomb BOSTON RGP Lenses wet-shipped in BOSTON SIMPLUS® Multi-Action Solution:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Stability of physical and optical properties	Testing demonstrated stability as to physical and optical properties in accordance with ISO 11987:1997 Ophthalmic Optics - Determination of Shelf-life and WI0523 GP Lens Wet Packaging Qualification Procedures. Results support a 30-day shelf-life.
Bioburden levels	Bioburden levels were below the required minimum cfu values (<100 cfu / lens) at day 30, as determined by internal procedures.

Study Details

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: The document mentions "examples of SA and FSA lenses" for bioburden testing and "The representative FSA lens was the Boston Equalens II RGP Contact Lens. The representative SA lens was the BOSTON IV RGP Contact Lens" for shelf-life testing. However, specific numerical sample sizes are not explicitly stated in the provided text.
- Data Provenance: The studies appear to be retrospective laboratory studies conducted by the applicant, Bausch & Lomb, Inc., without specific mention of external sites or data origin.
Number of experts used to establish the ground truth for the test set and their qualifications:
- The document does not mention using experts to establish ground truth for the test set. The ground truth for biophysical and microbiological parameters would typically be established by standardized laboratory testing methods and accredited personnel, not necessarily "experts" in the clinical sense mentioned in the question.
Adjudication method for the test set:
- Not applicable. This concept typically applies to studies involving human subjective evaluation or image interpretation where multiple raters' opinions need to be reconciled. The studies described are objective laboratory tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not performed. This device is a contact lens, and the studies focused on its physical, optical, and microbiological stability, not on human reader performance or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in the sense that the tests were objective laboratory tests of the device itself. The performance evaluations were for the contact lenses and their storage solution, not an algorithm. The "standalone" performance here refers to the device's intrinsic characteristics as measured in controlled conditions.
The type of ground truth used:
- Laboratory test results against established ISO standards and internal procedures.
  - For physical and optical properties, the ground truth was determined by measurements conforming to ISO 11987:1997 Ophthalmic Optics - Determination of Shelf-life; WI0523 GP Lens Wet Packaging Qualification Procedures.
  - For bioburden levels, the ground truth was determined by measurements against a specified minimum cfu value (<100 cfu / lens) using internal procedures.
The sample size for the training set:
- Not applicable. This device is a physical product (contact lens and solution), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply.

Summary

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FEB 21 _ 12

Bausch&Lomb

510(k) Summary Statement BOSTON RGP Lenses Wet Shipped in Boston SIMPLUS® Multi-Action Solution and Stored for up to 30 Days

Applicant's Name and Address	Bausch & Lomb, Inc.1400 North Goodman StreetRochester, NY 14609
Contact Person	Debra KetchumManager, Regulatory AffairsBausch & Lomb, Inc.1400 North Goodman StreetRochester, NY 14609(585) 338-8638Debra_Ketchum@bausch.com
1. Identification of device

Common Name: flouro silicone acrylate and silicone acrylate rigid gas permeable contact lens materials BOSTON Contact Lens Materials Trade Name: Classification Name: Rigid Gas Permeable (hydrophobic) Contact Lens Material Device classification: Class II 886.5916 Pro Code: HQD

2. Description of device

BOSTON RGP Contact Lenses are composed of silicone acrylate or fluoro silicone acrylate copolymers wet shipped in Boston SIMPLUS® Multi-Action Solution and stored up to 30 days.

3. Intended use

BOSTON IV (itafocon B), BOSTON II (itafocon A) RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia,

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hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.

4. Substantial Equivalence

510(k)	Clearance Date	Device Description
K002025	10/31/2000	BOSTON RGP Lenses WetShipped in Boston AdvanceComfort Formula ConditioningSolution and Stored for Up to30 Days

BOSTON RGP Lenses Wet Shipped in Boston Advance Comfort Formula Conditioning Solution and Stored for up to 30 Days has been selected as the predicate device for the Bausch & Lomb BOSTON RGP Lenses to be labeled and stored in BOSTON SIMPLUS® Multi-Action Solution for up to 30 days in which the predicate and substantially equivalent clearance was made under K002025 on 10/31/2000. All identified BOSTON RGP contact lenses are included for labeling with wet storage using BOSTON SIMPLUS® Multi-Action Solution and there is no change in indication for use, nor a change in manufacturing.

5. Safety and Perfomance Testing:

Performance Testing- Microbiology:

Shelf-Life Testing: Determination of shelf-life for the recommended period of 30 days for storage of Boston fluorcsilicone acrylate (FSA) and silicone acrylate (SA) classes of gas permeable lenses as stored in Boston SIMPLUS® Multi-Action Solution was conducted. The representative FSA lens was the Boston Equalens II RGP Contact Lens. The representative SA lens was the BOSTON IV RGP Contact Lens. Testing demonstrated stability as to physical and optical properties in accordance with testing conducted under ISO 11987: 1997 Ophthalmic Optics- Determination of Shelf-life; WI0523 GP Lens Wet Packaging Qualification Procedures. Results support a wet packaging shelf-life of 30 days for SA and FSA GP lenses.

Bioburden Testing: Testing was conducted in accordance with internal procedures to compare bioburden levels of examples of SA and FSA lenses at day 30 as stored at ambient temperatures. Results indicated that bioburden levels were below the required minimum cfu values (<100 cfu / lens).

ర్. Packaging

Bausch & Lomb BOSTON SIMPLUS® Multi-Action Solution will be placed in the lens packages for wet shipping and storaqe from the laboratory with accompanying labeling instructions with each shipment.

Clinical Data: 7.

Clinical data is not necessary to support the wet shipment of silicone acrylate (SA) and fluoro silicone acrylate (FSA) GP lenses. Testing has been conducted to demonstrate

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that lenses shipped wet maintain their optical and physical parameters within their that leness of ipped won the maintained well within the acceptable bioburden limit.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a globe, suggesting the department's mission of protecting and promoting the health and well-being of people.

FEB 21 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bausch & Lomb, Inc. c/o Debra Ketchum 1400 North Goodman Street Rochester NY 14609-3547

Re: K073184

Trade/Device Name: Boston RGP Lenses Wet Shipped in SIMPLUS® Multi-Action Solution and Stored for up to 30 Days Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: November 8, 2007 Received: November 13, 2007

Dear Ms. Ketchum:

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 -Debra Ketchum

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 premiumer nedicate 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Epler, and

Malvina B. Eydelman, M.I 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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510(K) Bausch & Lomb, Inc. BOSTON SIMPLUS Multi-Action Solution

Indication for Use

SECTION 4 : INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Ko73184

BOSTON RGP Lenses Wet Shipped in BOSTON SIMPLUS® Device Name: Multi-Action Solution and Stored for Up To 30 Days.

Indication for Use

Prescription Use _

BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, are indicated for daily would in aphakic and not-aphakic persons with non-diseased assigmation), and probe disinfected using a chemical disinfecting system only.

BOSTON IV (itafocon B), BOSTON II (itafocon A) RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia, daily wear for the och our of the correction of corneal astigmatism up to 4.00 risperopia, or Kerator disinfected using a chemical (not heat) disinfection system recommended in the labeling.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-the-counter-use_

(Divisign Sign off)

(Division Sign-off)
Division of Ophthalmic Devices

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.