Boston SIMPLUS Multi-Action Solution is for cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

Device Description

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies for the Boston SIMPLUS Multi-Action Solution, as extracted from the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria	Reported Device Performance
Toxicology	No evidence of cell lysis (ISO 10993-5); no significant ocular irritation (ISO 10993-10).	ISO Agarose Overlay Tests: No evidence of cell lysis for Boston SIMPLUS Multi-Action Solution, cycled fluoro silicone acrylate lenses, and cycled silicone acrylate lenses. All test requirements met. ISO Ocular Irritation Tests: Test solution did not produce significant ocular irritation for Boston SIMPLUS Multi-Action Solution, extracts of cycled fluoro silicone acrylate lenses, and extracts of cycled silicone acrylate lenses. All test requirements met.
Stability/Sterility	Meets specifications regarding physical, microbiological, and chemical properties over time.	All data to date indicates the test product meets its specifications. Studies are ongoing.
Cleaning Efficacy	Cleans equvalently to or better than controls (protein and lipid deposition model); cleans better than controls (tenacious protein deposition model). Substantially equivalent lens cleanliness to control in clinical study.	Protein and Lipid Mixture Deposition Model: Cleans equivalently to or better than positive and negative controls. Tenacious Protein Deposition Model: Cleans better than positive and negative controls. Clinical Lens Cleanliness: Lenses used with Boston SIMPLUS Multi-Action Solution found to be substantially equivalent in cleanliness to those used with Boston Simplicity Multi-Action Solution.
Lens Compatibility	Physical lens parameters remain within specifications; cosmetic appearance equivalent to controls.	Physical lens parameters tested within specifications. Cosmetic appearance of both lens materials tested equivalent to their respective controls.
Microbiological Efficacy	Meets FDA/ISO requirements for preservative efficacy, disinfection efficacy (stand-alone and with organic soil), and regimen test.	All results are satisfactory and indicate that the product meets FDA/ISO requirements for Preservative Efficacy with Rechallenge, Disinfection Efficacy-Stand Alone, Disinfection Efficacy-Stand Alone with Organic Soil, and Regimen Test.
Clinical Safety	No statistically significant difference in the incidence rate of any Grade 2 or greater slit lamp findings between test and control.	The safety endpoint of no statistically significant difference in the incidence rate of any Grade 2 or greater slit lamp findings between the Test (Boston SIMPLUS) and Control (Boston Simplicity) was satisfied.
Clinical Efficacy	Statistical equivalence in the proportion of lens visual acuities at the level of 20/40 or better.	The efficacy endpoint of statistical equivalence in the proportion of lens visual acuities at the level of 20/40 or better was met.

Study Details

Sample size used for the test set and the data provenance:
- Toxicology: Not explicitly stated as a numerical sample size but involved testing Boston SIMPLUS Multi-Action Solution, fluoro silicone acrylate lenses cycled in the solution, and silicone acrylate lenses cycled in the solution. Provenance: Not specified, but generally in-vitro lab studies.
- Cleaning Studies (in-vitro): Not explicitly stated as numerical sample sizes for the deposition models. Provenance: Lab studies. For the clinical lens cleanliness evaluation, it's tied to the clinical study.
- Lens Compatibility Studies: Not explicitly stated as numerical sample sizes. Provenance: Lab studies.
- Microbiology Studies: Not explicitly stated as numerical sample sizes, but involved conducting various efficacy tests with microorganisms. Provenance: Lab studies.
- Clinical Studies: The number of patients in the multi-site randomized controlled clinical study is not explicitly stated. It involved patients wearing lenses daily. Provenance: Multi-site clinical study (prospective, as patients were instructed on use and evaluated). Country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Toxicology, Cleaning (in-vitro), Lens Compatibility, Microbiology: These are laboratory-based tests with objective endpoints (e.g., cell lysis, cleaning scores, microbial kill rates). Ground truth is established by standard laboratory protocols and measurements, not subjective expert assessment in the same way clinical diagnoses are made.
- Clinical Studies: Evaluations included "visual acuity, lens surface characteristics, and physiological response." The interpretation of "Grade 2 or greater slit lamp findings" likely involved clinicians (e.g., ophthalmologists, optometrists), but the specific number and qualifications of these experts are not provided. Similarly, visual acuity measurements are objective (Snellen chart equivalent), but the assessment of "lens surface characteristics" and "physiological response" by clinicians would constitute the ground truth for these clinical endpoints.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For the laboratory-based studies (toxicology, cleaning, lens compatibility, microbiology), the ground truth relies on direct experimental results and measurements against predefined standards. Adjudication in the sense of multiple human readers resolving disagreements is not applicable or described.
- For the clinical study, while evaluations were performed, the document does not specify any adjudication method for resolving discrepancies if individual evaluators differed in their assessments of slit lamp findings or lens surface characteristics.
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 submission describes the evaluation of a contact lens care solution, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study involving AI assistance for human readers was performed or is relevant to this device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm. It is a chemical solution for contact lens care. Therefore, no standalone algorithm performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Toxicology: In-vitro cellular responses (absence of lysis, absence of irritation).
- Cleaning Studies: Laboratory measurement of protein/lipid removal, visual/image analysis of lens cleanliness.
- Lens Compatibility: Measurement of physical lens parameters and cosmetic appearance.
- Microbiology Studies: Quantitative microbial reduction based on standardized methods.
- Clinical Studies: Clinical assessments by healthcare professionals (for slit lamp findings, lens surface characteristics, physiological response) and objective measurements (visual acuity). The safety and efficacy endpoints relied on aggregated clinical data and statistical comparisons.
The sample size for the training set:
- This is for a contact lens care solution, not a machine learning model. Therefore, the concept of a "training set" in the context of AI is not applicable. The development of the solution involved chemical formulation and iterative testing, which is a different paradigm from training an AI model.
How the ground truth for the training set was established:
- Again, as this is not an AI device, the concept of a training set and its associated ground truth establishment is not applicable.

Summary

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K024289

510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

Boston SIMPLUS Multi-Action Solution

Submitter Information 1.

Polymer Technology A Bausch & Lomb company 1400 North Goodman Street Rochester, New York 14609

Contact Person:	Jennifer B. Murray
	Global Regulatory Affairs

Telephone Number: 585-338-8460

2. Device Name

Classification Name: Rigid Gas Permeable Contact Lens Care Product

Proprietary Name: Boston® SIMPLUS Multi-Action Solution

3. Predicate Devices

Boston Simplicity® Multi-Action Solution, Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution and Alcon Unique pH were selected as the predicate devices for Boston SIMPLUS Multi-Action Solution.

4. Description of the Device

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ર્ડ Indications for Use

Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical studies were completed on Boston SIMPLUS Multi-Action Solution. The results indicate that this product is safe, efficacious, and substantially equivalent to the predicate devices identified in Section 3 of this summary.

Toxicology

A series of in-vitro biological reactivity test were performed to determine the toxicity of Boston SIMPLUS Multi-Action Solution.

ISO Agarose Overlay Tests of Boston SIMPLUS Multi-Action Solution, Fluoro Silicone Acrylate Lenses Cycled in Boston SIMPLUS Multi-Action Solution and Silicone Acrylate Lenses Cycled in Boston SIMPLUS Multi-Action Solution were conducted in accordance with the requirements of ISO 10993-5. The negative and positive controls performed as anticipated. The test articles demonstrated no evidence of cell lysis. All test requirements were met.

ISO Ocular Irritation Tests of Boston SIMPLUS Multi-Action Solution, extracts of fluoro silicone acrylate lenses cycled in Boston SIMPLUS Multi-Action Solution and extracts of silicone acrylate lenses cycled in Boston SIMPLUS Multi-Action Solution were conducted in accordance with the requirements of ISO 10993; Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization. The test solution did not produce significant ocular irritation. All test requirements were met.

The results of these tests demonstrate that the product is not toxic.

Stability/Sterility

Stability studies were performed to evaluate the effects of various temperatures on the physical, microbiological and chemical properties of various lots of Boston SIMPLUS Multi-Action Solution. These studies are on-going. To date, all data indicates that the test product meets its specifications.

Cleaning Studies

The cleaning efficacy of Boston SIMPLUS Multi-Action Solution was determined by a series of in-vitro studies. In addition, the returned clinical lenses were evaluated for cleanliness.

The Critical Micelle Concentration of the surfactant in Boston SIMPLUS Multi-Action Solution was evaluated and found acceptable.

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Testing was performed to determine the cleaning ability of Boston SIMPLUS Multi-Action Solution on rigid gas permeable contact lenses. The first model employed a protein and lipid mixture deposition. The results of this model indicate that the test solution cleans equivalently to or better than the positive and negative controls. A second model employed a tenacious deposition of protein. The results of this model indicate that the test solution cleans better than the positive and negative controls.

Lens compatibility studies were performed to determine the average changes observed in the physical lens parameters of rigid gas permeable contact lenses when subjected to repeated cleaning cycles with Boston SIMPLUS Multi-Action Solution. The physical lens parameters tested within the specifications. The cosmetic appearance of both lens materials tested equivalent to their respected controls.

Lenses returned from the clinical study that were used with either the Test (Boston SIMPLUS Multi-Action Solution) or Control (Boston Simplicity Multi-Action Solution) regimens have been examined by Image Analysis for lens cleanliness and found to be substantially equivalent.

Microbiology Studies

A series of studies as provided in the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products were completed to demonstrate the microbiological efficacy of Boston SIMPLUS Multi-Action Solution.

Microbiology testing included Preservative Efficacy with Rechallenge. Disinfection Efficacy-Stand Alone, Disinfection Efficacy-Stand Alone with Organic Soil and a Regimen Test. All results are satisfactory and indicate that the product meets FDA/ISO requirements.

Clinical Studies

A multi-site randomized, controlled clinical study was conducted to evaluate the safery and efficacy of Boston SIMPLUS Multi-Action Solution employing a regimen that requires the user to rub lenses after the disinfection cycle. The Control solution was Boston Simplicity Multi-Action Solution traditional rub and rinse steps.

Patients were instructed to wear their lenses on a daily wear basis with no scheduled replacements and to clean and disinfect them in accordance with the provided directions for use. Evaluations included visual acuity, lens surface characteristics, and physiological response. The safety endpoint of no statistically significant difference in the incidence rate of any Grade 2 or greater slit lamp findings between the Test and Control was satisfied. The efficacy endpoint of statistical equivalence in the proportion of lens visual acuities at the level of 20/40 or better was met.

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Both solutions demonstrated clinically acceptable lens cleanliness. Safety and efficacy were demonstrated. Boston SIMPLUS Multi-Action Solution is substantially equivalent to Boston Simplicity Multi-Action Solution.

Substantial Equivalence

Boston SIMPLUS Multi-Action Solution for use with rigid gas permeable contact lenses is substantially equivalent to Boston Simplicity Multi-Action Solution, Bausch & Lomb ReNu Multi-Purpose Solution and Alcon Unique pH Solution.

Boston SIMPLUS Multi-Action Solution will be sold in plastic bottles as a sterile solution; each bottle will be marked by a lot number and expiration date.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Bausch & Lomb Incorporated c/o Jennifer B. Murray Associate Manager 1400 N. Goodman Street Rochester, NY 14609

Re: K024289

Trade/Device Name: Boston SIMPLUS Multi-Action Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid gas permeable contact lens care products Regulatory Class: Class II Product Code: MRC Dated: April 21, 2003 Received: April 22, 2003

Dear Ms. Murray:

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 - Jennifer B. Murray

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/cdrh/dsma/dsmamain.html

Sincerely yours,

A. helyi kirendbal

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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Polymer Technology a Bausch & Lomb company 1400 North Goodman Street Rochester, NY 14609

Indications for Use Statement

510(k) Number (if known): K024289

Device Name: Boston® SIMPLUS Multi-Action Solution

Indications for Use:

Boston SIMPLUS Multi-Action Solution is indicated for use in cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

(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

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

April

510(k) Number K024289

Regulation Number and Section

§ 886.5918 Rigid gas permeable contact lens care products.

(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”