Boston® Enhanced Original Formula Conditioning Solution is indicated for use in wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

Device Description

The modified Boston® Enhanced Original Formula Conditioning Solution is a sterile conditioning solution used in the care of rigid gas permeable contact lenses and is indicated for the wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate contact lenses. This product is a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Boston® Enhanced Original Formula Conditioning Solution". This is a contact lens care product, not a medical device in the typical sense of providing diagnostic or therapeutic measurements based on algorithms. Therefore, many of the requested sections related to AI/algorithm performance (e.g., test set, training set, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable to this type of submission.

The acceptance criteria and study information provided focuses on demonstrating the safety and effectiveness of the conditioning solution for contact lenses, primarily through preclinical (toxicology, microbiology, solution compatibility, wetting angle) and clinical equivalence testing against a predicate device.

Here's the information that can be extracted from the provided text, structured according to your request, with a clear indication of non-applicable sections:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Acceptance Standard	Reported Device Performance
Toxicology	In-Vitro Cytotoxicity (USP Agar Diffusion)	Meets requirements of USP XXII for Agar Diffusion Test.	"The test article meets the requirements of the Agar Diffusion Test."
	Acute Ocular Irritation	No significant ocular irritation to laboratory animal tissues.	"Acute Ocular Irritation test was performed and produced no ocular irritation. The solution did not cause any significant irritation to the ocular tissues of the laboratory animals."
Microbiology	Preservative Effectiveness	Meets requirements of the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the ISO Draft Standard.	"The results of these tests demonstrate that the modified Boston® Enhanced Original Formula Conditioning Solution meets the requirements of the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. May 1, 1997 and the ISO Draft Standard."
	Disinfection Efficacy	Meets FDA performance criteria for regimen evaluation as described 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 this evaluation demonstrate that the product meets the FDA performance criteria for regimen evaluation as described 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."
Shelf Life	Expiration Dating	Established in accordance 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.	"Expiration dating will be established based on the Shelf-life Protocol in accordance 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." (Note: This is a protocol statement, implies that the protocol will ensure compliance to criteria, rather than stating measured performance.)
Solution Compatibility	Physical/Lens Parameters after Repeated Cycles	All physical and lens parameters tested within ISO specifications for rigid corneal and scleral contact lenses; no change in cosmetic appearance.	"After thirty repeated cycles with Boston Cleaner and the modified Boston® Enhanced Original Formula Conditioning Solution, all of the physical and lens parameters tested for BOSTON IV and BOSTON ES rigid gas permeable tinted contact lenses were within ISO specifications for rigid corneal and scleral contact lenses. There was no change in the cosmetic appearance."
Wetting Angle	Wettability Maintenance (Dynamic Contact Angle Analysis)	Modified solution should maintain wettability of the surface better than the currently marketed Boston Conditioning Solution.	"The results of the DCA testing indicate that the modified Boston® Enhanced Original Formula Conditioning Solution maintains the wettability of the surface better than the currently marketed Boston Conditioning Solution."
Clinical Equivalence	Safety and Efficacy compared to Predicate Device	No clinically significant differences between the Test (modified) and Control (predicate) groups. Substantially equivalent in safety and efficacy.	"Analysis of all data from this study showed no clinically significant differences between the Test and Control Groups. Based on these data, the Sponsor concludes that the modified Boston Enhanced Original Formula Conditioning Solution is substantially equivalent in safety and efficacy to the currently marketed Boston Original Conditioning Solution."

2. Sample size used for the test set and the data provenance

Sample Size (Clinical Study): 212 eyes (106 patients). 36 eyes (18 patients) were non-dispensed.
Data Provenance: The document does not explicitly state the country of origin, but the submission is to the U.S. FDA, and it mentions "laboratory animals" for acute ocular irritation, implying controlled laboratory and clinical studies rather than retrospective review of existing data. The clinical study was performed by "7 Investigators", which suggests a multi-site clinical trial. It is a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This submission is for a contact lens care solution, which does not involve "ground truth" derived from expert image interpretation or similar diagnostic tasks. The "ground truth" for preclinical and clinical studies is based on established laboratory testing methodologies and clinical observations by investigators (e.g., absence of irritation, meeting microbial reduction standards, no clinically significant differences).

4. Adjudication method for the test set

Not Applicable. As there is no "ground truth" established by experts in the sense of diagnostic interpretation, there is no need for an adjudication method. Clinical data was analyzed using "descriptive statistics, tests for normality, analysis of variance and/or t-tests where appropriate."

5. 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

Not Applicable. This type of study relates to AI in diagnostic imaging or similar scenarios requiring human reader interpretation, which is not relevant for a contact lens conditioning solution.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. There is no AI algorithm being evaluated in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Preclinical Studies: The "ground truth" for the preclinical tests (cytotoxicity, ocular irritation, preservative effectiveness, disinfection efficacy, solution compatibility, wetting angle) is derived from the results of standardized laboratory tests and measurements against predefined regulatory or international standards (e.g., USP XXII, 510(k) Guidance Document for Contact Lens Care Products, ISO Draft Standard, ISO specifications for RGP lenses).
Clinical Study: The "ground truth" (or outcome measure for equivalence) for the clinical study was based on observed clinical safety and efficacy parameters in human subjects, evaluated against the performance of the predicate device, with the goal of demonstrating 'no clinically significant differences'.

8. The sample size for the training set

Not Applicable. There is no AI algorithm and therefore no "training set" in the context of this submission. The "training" for the product refers to its formulation and testing to meet intended performance.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI algorithm, this question is not applicable.

Summary

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510(k) Premarket Notification Boston Conditioning Solution

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BOSTON® ENHANCED ORIGINAL FORMULA CONDITIONING SOLUTION

1. SUBMITTER INFORMATION:

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

2. CONTACT PERSON:

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

Debra Ketchum

3. Device Identification:

Classification Name:	Rigid Gas Permeable Contact Lens Solution
Proprietary Name:	Boston® Enhanced Original Formula Conditioning Solution
Common Name:	Contact Lens Conditioning Solution

4. PREDICATE DEVICE:

The currently marketed Boston® Conditioning Solution, approved under PMA P820070 on November 17, 1983, has been selected as the predicate device for the modified Boston® Enhanced Original Formula Conditioning Solution.

5. DESCRIPTION OF THE DEVICE:

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6. INDICATIONS FOR USE:

The modified Boston® Enhanced Original Formula Conditioning Solution is indicated for use in the wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

7. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE:

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the modified Boston® Enhanced Original Formula Conditioning Solution. A summary of the results from the preclinical tests 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. The solution did not cause any significant irritation to the ocular tissues of the laboratory animals.

Microbiology:

Preservative Effectiveness:

Studies were performed to evaluate the preservative efficacy of the modified Boston® Enhanced Original Formula Conditioning Solution in 1 oz. round containers and in 4 oz. oval containers. The results of these tests demonstrate that the modified Boston® Enhanced Original Formula Conditioning Solution meets the requirements of the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. May 1, 1997 and the ISO Draft Standard.

The results of all testing demonstrated that the safety and effectiveness of the modified Boston® Enhanced Original Formula Conditioning Solution is equivalent to the currently marketed Boston® Conditioning Solution.

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Disinfection Efficacy:

The ISO FDA Regimen Procedure for Disinfecting Regimens was performed to evaluate the disinfecting efficacy of the modified Boston® Enhanced Original Formula Conditioning Solution. The results of this evaluation demonstrate that the product meets the FDA performance criteria for regimen evaluation as described 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.

Shelf Life:

Expiration dating will be established based on the Shelf-life Protocol in accordance 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.

Solution Compatibility:

BOSTON IV (silicone acrylate) and BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses were subjected to thirty repeated cvcles with Boston Cleaner and the modified Boston® Enhanced Original Formula Conditioning Solution.

After thirty repeated cycles with Boston Cleaner and the modified Boston® Enhanced Original Formula Conditioning Solution, all of the physical and lens parameters tested for BOSTON IV and BOSTON ES rigid gas permeable tinted contact lenses were within ISO specifications for rigid corneal and scleral contact lenses. There was no change in the cosmetic appearance.

Wetting Angle:

This study evaluated the retention of the modified Boston® Enhanced Original Formula Conditioning Solution and the currently marketed Boston Conditioning Solution on two selected RGP lens materials. BOSTON IV (silicone acrylate) and BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses. Dynamic contact angle (DCA) analysis was the method chosen to measure the desorption of solution from the lens material surface. The results of the DCA testing indicate that the modified Boston® Enhanced Original Formula Conditioning Solution maintains the wettability of the surface better than the currently marketed Boston Conditioning Solution.

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8. SUBSTANTIAL EQUIVALENCE:

The modified Boston® Enhanced Original Formula Conditioning Solution is substantially equivalent to the currently marketed Boston Conditioning Solution, approved November 17, 1983 under PMA P820070, in that both products are formulated similarly, with the same indications, usage, and aspects of manufacturing.

9. CLINICAL:

The purpose of this study is to demonstrate that the modified Boston® Enhanced Original Formula Conditioning Solution is substantially equivalent in safety and efficacy to the currently marketed BOSTON Conditioning Solution when used with currently marketed silicone acrylate and fluoro-silicone acrylate rigid gas permeable contact lenses. This controlled clinical study was designed in accordance with the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Mav 1. 1997.

A total of 212 eyes (106 patients) were entered into the study by 7 Investigators. Of the 212 eves (106 patients) enrolled. 36 eves (18 patients) were non-dispensed.

The data from the study were examined using descriptive statistics. tests for normality, analysis of variance and/or t-tests where appropriate. Analysis of all data from this study showed no clinically significant differences between the Test and Control Groups.

Based on these data, the Sponsor concludes that the modified Boston Enhanced Original Formula Conditioning Solution is substantially equivalent in safety and efficacy to the currently marketed Boston Original Conditioning Solution.

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Ms. Debra Ketchum Manager, Regulatory Affairs Polymer Technology, a division of Wilmington Partners, L.P. 1400 North Goodman St. Rochester, New York 14692-0450

Re: K983836

Trade Name: Boston ® Enhanced Original Formula Conditioning Solution Regulatory Class: II Product Code: 86 MRC Dated: January 28, 1999 Received: January 29, 1999

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 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.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): ____________________________________________________________________________________________________________________________________________________ K983836

Device Name: Boston® Enhanced Original Formula Conditioning Solution

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_

Mgr. Smith

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K983836

APPX1.doc

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.”