Boston Advance ® Cleaner is indicated for use to clean fluoro silicone and silicone acrylate rigid gas permeable contact lenses after each removal and before conditioning (wetting, soaking, and disinfecting).

Device Description

Boston Advance® Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alky ether sulfate, ether sulfate, ethoxylated alkyl phenol, triquaternary cocoabased phospholipid, silica gel as cleaning agents; with titanium dioxide.

AI/ML Overview

This 510(k) summary describes a submission for a contact lens cleaner, Boston Advance® Cleaner. The primary goal of the submission is to demonstrate substantial equivalence to a previously marketed device. Therefore, the study focuses on showing comparable safety and efficacy rather than establishing novel performance criteria as might be expected for a new, unique device.

Here's an analysis of the provided information, structured around your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state distinct "acceptance criteria" with numerical thresholds for performance endpoints in the way you might see for an AI algorithm's accuracy or sensitivity. Instead, the "acceptance criteria" were implied by demonstrating substantial equivalence to the predicate device across various safety and efficacy parameters.

The "reported device performance" is a conclusion of "substantial equivalence" based on these tests.

Category	Implied "Acceptance Criteria" (Demonstrate Substantial Equivalence to Predicate)	Reported Device Performance (Summary)
Toxicology	No toxic effects when used with specified RGP contact lenses	"The results of these tests demonstrate that the product is not toxic."
Sterility	Product remains sterile according to USP standards.	Studies performed according to USP 23, 1995, Chapter 95, 1689 demonstrated sterility.
Antimicrobial Activity (Biostatic Efficacy)	Acceptable antimicrobial activity against USP-designated microorganisms over specified timeframes.	Samples inoculated with USP-designated microorganisms. Test samples assayed at 7 and 14 days, then continually every 7 days through 42 days, and every 2-3 weeks up to at least 98 days. The results imply acceptable biostatic efficacy.
Antimicrobial Activity (Preservative Efficacy)	Meets requirements for multi-dose preserved contact lens care products after storage.	"Results demonstrate that the modified Boston Advance® Cleaner meets the requirements for multi-dose preserved contact lens care products." "The results from these tests support that the product has acceptable antimicrobial activity."
Shelf Life	Product remains safe and effective over its stated shelf life.	Expiration dating established based on the Shelf-life Protocol testing in accordance with relevant Guidance Documents. The results support the claimed shelf life.
Lens/Solution Compatibility	Compatible with silicone acrylate and fluoro silicone acrylate RGP contact lenses.	"The results of these tests demonstrate the compatibility of the proposed regimens with silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses."
In-Vitro Cleaning	Cleaning efficacy equivalent to the predicate device, specifically demonstrated by surfactants being above critical micelle concentrations.	Critical micelle concentrations (CMC) of surfactants evaluated; found to be above CMC. "The results of these tests demonstrate that the cleaning efficacy of the product is equivalent to the predicate device."
Clinical Safety & Efficacy	Substantially equivalent in safety and efficacy to the currently marketed Boston Advance® Cleaner when used with RGP lens materials on a daily wear basis (no statistically significant difference).	"Based on these data, it is concluded that the modified Boston Advance® Cleaner (Test), is substantially equivalent in safety and efficacy to the currently marketed Boston Advance® Cleaner (Control)." (Detailed statistical findings for equivalence are not provided in this summary but are implied by the conclusion).

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

Clinical Study (In-vivo):
- Total Patients: 170 patients (340 eyes)
- Test Group (modified Boston Advance® Cleaner): 114 patients (228 eyes)
- Control Group (marketed Boston Advance® Cleaner): 54 patients (108 eyes)
- Completed Study: 151 patients
- Discontinued: 17 patients (none for safety or efficacy reasons)
- Data Provenance: The study involved 12 investigational sites. The document doesn't explicitly state the country of origin, but given the submission is to the U.S. FDA, it is highly likely that the investigational sites were in the United States. The study started in April 1997 and concluded in November 1997, making it a prospective clinical study.
In-vitro, Toxicology, Microbiology, Shelf Life, Lens/Solution Compatibility, In-Vitro Cleaning: These studies were conducted in laboratory settings as "pre-clinical" or in-vitro tests, not on human subjects. Sample sizes and provenance vary by test (e.g., "separate samples of three lots" for Biostatic Efficacy, unspecified numbers of lenses for compatibility). The provenance would be the testing laboratories, likely within the manufacturer's or contracted facilities.

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

This type of submission (for a contact lens care product) does not typically involve "experts establishing ground truth" in the way an AI diagnostic device would.

For the clinical study, the "ground truth" would be established through standard clinical examinations and patient reporting of symptoms by licensed eye care professionals (e.g., ophthalmologists, optometrists) at the 12 investigational sites. Their qualifications are not explicitly stated but are assumed to be appropriate for clinical trials involving contact lenses.
For the laboratory tests (toxicology, microbiology, cleaning efficacy, etc.), ground truth is established by following validated, standardized testing protocols (e.g., USP standards) and performing objective measurements. The "experts" would be the laboratory personnel qualified to conduct and interpret these specific assays, but they wouldn't be forming consensus "diagnoses" as for medical imaging.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (like 2+1 or 3+1 consensus) for the clinical test set. In clinical trials for equivalence, outcomes (e.g., adverse events, visual acuity, comfort levels) are typically assessed individually by the investigators at each site and then aggregated for statistical comparison between the test and control groups. It's not a diagnostic scenario requiring a consensus "ground truth" in the same way.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the performance of diagnostic devices or AI algorithms where multiple human readers interpret cases, often with and without AI assistance. This submission is for a contact lens cleaning solution and does not involve such an evaluation methodology.

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

This is not applicable as the device is a contact lens cleaning solution, not an algorithm or AI product. There is no algorithm to assess in a standalone manner.

7. The Type of Ground Truth Used

Clinical Study: The "ground truth" for the clinical study would be a combination of:
- Clinical Assessments: Objective findings from eye examinations (e.g., corneal staining, lens deposits) performed by eye care professionals.
- Patient-Reported Outcomes: Subjective feedback from patients regarding comfort, vision, and adverse events.
- Comparison against the predicate device's established safety and efficacy profile. The ultimate ground truth is "substantial equivalence" to the predicate.
Toxicology: Absence of biological reactivity (cell viability/response to extracts).
Microbiology: Absence of microbial growth (sterility) and reduction in microbial concentration (antimicrobial efficacy) based on standardized culture methods.
Shelf Life: Stability of the product's chemical and microbiological properties over time.
Lens/Solution Compatibility: Physical integrity and optical properties of lenses after exposure to the solution.
In-Vitro Cleaning: Objective measurement of surfactant properties (critical micelle concentration) and implied cleaning efficacy.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (contact lens cleaner) and does not involve an AI algorithm that requires a "training set." The clinical study performed functions as the "test set" to demonstrate equivalence.

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

Not applicable. As there is no AI algorithm, there is no training set and hence no ground truth establishment for a training set.

Summary

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K974466

FEB 1 9 1998

510(K) SUMMARY

Polymer Technology, Company Name: SUBMITTER: a division of Wilmington Partners, L.P. 1400 North Goodman Street Address: Rochester, NY 14692

CONTACT PERSON: 2.

Address:

Telephone No .: Fax No. E-mail Address: Douglas J. Fortunato Manager, Regulatory Affairs 1400 North Goodman Street Rochester, NY 14692 (716) 338-5477 (716) 338-0702 dfortunato@bausch.com

3. DEVICE IDENTIFICATION:

Trade Name:	Boston Advance® Cleaner
Common Name:	contact lens cleaner
Classification Name:	Rigid Gas Permeable contact lens care product

CLASSIFICATION NAME AND REFERENCE: 4. Class II Ophthalmic Device 21 CFR 886.5025 5918

PREMARKET NOTIFICATION NUMBER: છે.

ર્. INDICATION FOR USE:

The modified Boston Advance ® Cleaner is indicated for use to clean fluoro silicone and silicone acrylate rigid gas permeable contact lenses after each removal and before conditioning (wetting, soaking, and disinfecting).

7. DEVICE DESCRIPTION:

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8. STATEMENT OF EQUIVALENCE:

Boston Advance® Cleaner is substantially equivalent to the currently marketed Boston Advance® Cleaner, approved on May 3, 1990 under PMA, and Boston® Cleaner. The device has the same basic technological characteristics as the predicate devices relative to design, packaging and composition.

DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE: 9.

A series of in-vitro and in-vivo preclinical, toxicological, and microbiological studies were performed to assess the safety and effectiveness of Boston Advance @ Cleaner. Testing was carried out in accordance with Premarket Notification (510 (k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the Draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, April 1, 1996. A description of those tests can be found below.

Toxicology:

In vitro biological reactivity (Agar Diffusion, USP 23, 1995, Chapter 87, 1698) tests were conducted using Boston IV (silicone acrylate) and Boston ES (fluoro silicone acrylate) Rigid Gas Permeable Contact Lenses treated with a lens care regimen employing BOSTON ADVANCE Comfort Formula Conditioning Solution in conjunction with Boston Advance® Cleaner.

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

Microbiology:

Sterility:

Studies carried out in accordance with USP 23, 1995, Chapter 95, 1689, were performed to demonstrate the sterility of Boston Advance® Cleaner.

The antimicrobial activity of Boston Advance ® Cleaner was determined using a combination of two test methods. The Bacteriostasis Test Method and the Preservative Efficacy Test Method for Multi-Dose Preserved Contact Lens Care Products. Both methods are described in the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1 1997.

Biostatic Efficacy:

At the zero time point, separate samples of three lots of Boston® Liguid Enzyme Cleaner were each inoculated with one of the five USP-designated microorganisms to a final concentration of approximately 1x10 cfu/ml. Test samples were assayed at 7 and 14 days after inoculation to determine the concentrations of surviving microorganisms. Test samples were continually assayed every 7 days through 42 days after initial challenge, and were assayed every 2-3 weeks thereafter, up to at least 98 days.

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Preservative Efficacy:

After six months of storage at defined temperatures and humidity conditions samples from three lots were tested using the Preservative Efficacy of Multi-Dose Preserved Contact Lens Care Products method. Results demonstrate that the modified Boston Advance® Cleaner meets the requirements for multi-dose preserved contact lens care products.

The results from these tests support that the product has acceptable antimicrobial activity.

Shelf Life:

Expiration dating was established based on the Shelf-life Protocol testing in accord with the Premarket Notification (510 (k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the Draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. April 1, 1996.

Lens/Solution Compatibility:

The compatibility of Boston Advance @ Cleaner with silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses was determined using a test procedure that is based on the Solution Compatibility Test Protocol found in the Premarket Notification (510 (k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the Draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, April 1, 1996.

The results of these tests demonstrate the compatibility of the proposed regimens with silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses.

In-Vitro Cleaning:

The critical micelle concentrations (CMC) of the three surfactants used in the formulation were evaluated. This test is described in Premarket Notification (510 (k)) Guidance Document for Contact Lens Care Products, May 1, 1997. The critical micelle concentrations were calculated using the data collected. The concentration of each of the surfactants was found to be above the critical micelle concentration for each of the surfactants.

The results of these tests demonstrate that the cleaning efficacy of the product is equivalent to the predicate device.

10. _CLINICAL:

Purpose

The purpose of this study was to demonstrate that the investigational daily cleaner, the modified Boston Advance® Cleaner (test), is substantially equivalent in safety and efficacy when compared to the currently marketed Boston Advance® Cleaner (control), which was approved in May 3,1990 under PMA P890054, when used with currently marketed rigid gas permeable (RGP) contact lens materials on a daily wear basis. these lens materials include silicone acrylate and fluoro-silicone acrylate materials. The study started in April 1997,

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concluded in November 1997, and was carried out in accordance with the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997.

The study involved 12 investigational sites and 170 patients (340 eyes) for a period of three months. 114 patients (228 eyes) used modified Boston Advance® Cleaner, and 54 patients (108 eyes) used marketed Boston Advance® Cleaner.

Of the 168 subjects entered into the study, 151 completed the study. Seventeen subjects were discontinued from the study. None of the 17 discontinued patients, Test or Control, were discontinued for safety of efficacy reasons. Subjects recruited into the study ranged in age from 18 - 60 years of age with a mean age of 37.5. There were 132 females and 38 males.

Conclusion

Based on these data, the it is concluded that the modified Boston Advance @ Cleaner (Test), is substantially equivalent in safety and efficacy to the currently marketed Boston Advance® Cleaner (Control).

11. CONCLUSION:

The results from all non-clinical and clinical studies demonstrate that the Boston Advance® Cleaner is safe, effective, and is substantially equivalent to the predicate device.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1998

Mr. Douglas J. Fortunato Manager, Regulatory Affairs Polymer Technology Corporation 1400 N. Goodman Street Rochester, NY 14692

Re: K974466

Trade Name: Boston Advance ® Cleaner (new visibility tinted formula) Regulatory Class: II Product Code: 86 LPN Dated: November 25, 1997 Received: November 26, 1997

Dear Mr. Fortunato:

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 detormination-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 - Mr. Douglas J. Fortunato

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 at (301) 443-6597.

Sincerely yours,

AlrepL. Rosinttal

A. Ralph Rosenthal, M.D. 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

510(k) Number (if known):

K974466

Device Name:

Boston Advance @ Cleaner

Indications for Use:

Boston Advance ® Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-The-Counter-Use_

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(Division Sign-Off)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K 974466

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.”