The Boston® Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during simultaneous conditioning (wetting, soaking, and disinfecting) with Original Formula Boston® Conditioning Solution, Boston ADVANCE® Comfort Formula Conditioning Solution, or Boston SIMPLICITY® Multi-Action Solution.

Device Description

The Boston® Liquid Enzymatic Cleaner is a sterile, aqueous, buffered solution containing proteolytic enzyme (subtilisin) as the cleaning agent, and glycerol. Preservative-free.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Please note: This document is from 1997 and refers to guidance documents from that era. Modern regulatory submissions often have more detailed and quantitative acceptance criteria and study reporting.

Acceptance Criteria and Device Performance Study for Boston® Liquid Enzymatic Cleaner

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the acceptance criteria are largely implicit in the types of tests performed and the statement of "acceptable" or "substantially equivalent" results. Specific numerical performance targets are not explicitly stated in this high-level summary, which is common for 510(k) submissions of this vintage.

Criterium Category	Acceptance Criteria (Implicit from Testing)	Reported Device Performance (Summary)
Safety	Toxicology: Must not be toxic or ocular irritant.	"The results of these tests demonstrate that the product and packaging components are not toxic."
	Microbiology - Sterility: Must be sterile.	Studies demonstrated sterility.
	Microbiology - Biostatic Efficacy: Must demonstrate acceptable biostatic activity against specified microorganisms over time (up to 98+ days, with rechallenge).	"The biostatic activity of Boston® Liquid Enzymatic Cleaner was determined..." (Implies success as no negative findings reported).
	Microbiology - Disinfection Efficacy: Must meet disinfection efficacy requirements for a combination product.	"The results from these tests support that the product has acceptable antimicrobial activity."
	Lens/Solution Compatibility: Must be compatible with specified contact lens materials.	"The results of these tests demonstrate the compatibility of the proposed regimens with silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses."
Performance/Efficacy	In-Vitro Cleaning: Must demonstrate cleaning efficacy substantially equivalent to the predicate device.	"The results of these tests demonstrate that the cleaning efficacy of the product is substantially equivalent to the predicate device."
	Clinical Safety & Efficacy: Must be substantially equivalent in safety and efficacy to the predicate device in human use.	"The clinical study used to support this premarket notification was carried out to determine that the...Boston® Liquid Enzymatic Cleaner is substantially equivalent in safety and efficacy when compared to the currently marketed Alcon OPTI-ZYME Enzymatic Cleaner..."
Shelf Life	Must establish appropriate expiration dating based on stability testing.	Expiration dating was established.

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

Clinical Study Test Set:
- Total Patients: 103 (206 eyes)
- Boston® Liquid Enzymatic Cleaner Group: 69 patients (64 eyes)
- Alcon OPTI-ZYME® Enzymatic Cleaner Group (Predicate): 32 patients (64 eyes)
- Completed Study: 95 subjects
- Discontinued: 12 subjects (none due to adverse reactions)
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions are typically prospective and often multi-site within the US. The six investigational sites suggest a prospective, multi-center US study.

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

The document does not specify the number or qualifications of experts for establishing ground truth in the clinical study. It is a comparative study, implying that the clinical outcomes observed by the investigators (e.g., visual acuity, irritation) would be the "ground truth" for safety and efficacy comparison, rather than an independent expert panel interpreting data.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical study data or endpoints. Clinical studies for device approval rely on the observations and assessments of the participating investigators.

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

No, this was not an MRMC study. MRMC studies are typically used when multiple human readers interpret diagnostic images or data, and the device is an AI-powered diagnostic aid. This device is a contact lens cleaning solution, so an MRMC study design is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No, this concept (standalone algorithm performance) is not applicable to this medical device. This is a physical product (liquid cleaner) that is used by patients (human-in-the-loop activity, though not AI-assisted).

7. The Type of Ground Truth Used

For the Clinical Study: The "ground truth" was established through direct clinical observation and patient outcomes as assessed by the investigators over a three-month period. This would include parameters like visual acuity, ocular irritation, lens condition, and patient subjective experiences, compared between the investigational and predicate device groups.
For Pre-Clinical Studies:
- Toxicology: In vitro (cell culture reactivity) and in vivo (rabbit ocular irritation) tests with established biological reactivity and irritation scales/observations.
- Microbiology: Direct colony counting (cfu/mL) for biostatic and disinfection efficacy against specific challenge organisms, with defined reduction criteria.
- In-Vitro Cleaning: Protein level determination (likely quantitative protein assays on lenses) and Image Analysis to compare cleaning efficacy.
- Sterility, Shelf Life, Compatibility: Laboratory testing with defined pass/fail criteria based on accepted standards (e.g., USP).

8. The Sample Size for the Training Set

This is not applicable as the device is a chemical solution, not an AI/ML algorithm that requires a training set.

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

As mentioned above, this is not applicable for this type of medical device.

Summary

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510(K) SUMMARY

K973217

NOV 2 4 1997

1.	SUBMITTER:	Company Name:	Polymer Technology,a division of WilmingtonPartners, L.P.
		Address:	1400 North Goodman StreetRochester, NY 14692
2.	CONTACT PERSON:		Douglas J. FortunatoManager, Regulatory Affairs
		Address:	1400 North Goodman StreetRochester, NY 14692
		Telephone No.:	(716) 338-5477
		Fax No.	(716) 338-0702
		E-mail Address:	dfortunato@bausch.com

3. DEVICE IDENTIFICATION:

Trade Name:	Boston® Liquid Enzymatic 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 886.5925

PREMARKET NOTIFICATION NUMBER: ર્જ

INDICATION FOR USE: ર.

The Boston® Liquid Enzymatic Cleaner is indicated for weekly cazymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during simultaneous conditioning (wetting, soaking, and disinfecting) with Original Formula Boston® Conditioning Solution, Boston ADVANCE® Comfort Formula Conditioning Solution, or Boston SIMPLICITY® Multi-Action Solution.

DEVICE DESCRIPTION: 7.

The Boston® Liquid Enzymatic Cleaner is a sterile, aqueous, buffered solution containing proteolytic enzyme (subtilisin) as the cleaning agent, and glycerol. Preservative-free.

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8. STATEMENT OF EQUIVALENCE:

The Boston® Liguid Enzymatic Cleaner has the same indications for use as Alcon OPTI-ZYME® Enzymatic Cleaner, which was approved under PMA P820001. Substantial equivalence is also claimed with two other currently marketed enzymatic cleaner for rigid gas permeable contact leases. The first is Bausch & Lomb ReNu@ 1 Step14 Enzymatic Cleaner, which, like Boston® Liquid Enzymatic Cleaner, contains a proteolytic enzyme (subtilism) as the active cleaning agent. Bausch & Lomb ReNu® 1 StepTM Enzymatic Cleaner was approved under PMA P850093/S3. The second is Alcon OPTI-FREE® SupraCLENS Daily Protein Remover, which a also a liquid enzymatic cleaner that is indicated for use to clean fluoro silicone acrylate and sillcone acrylate rigid gas permeable contact lenses. OPTI-FREE® SupraCLENS was cleared under PMA No. P820001/S21.

ರಿ. PRE-CLINICAL:

A series of in-vitro and in-vivo preclinical chemical, toxicological, and microbiological studies were performed to assess the safety and effectivegess of Boston® Liquid Enzymatic Cleaner. Testing was carried out in accordance with Premarket Northcation (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:

An in vitro biological reactivity (Agar Diffusion, USP 23, 1995, Chapter 87, 1698) test was conducted using Boston IV (silicone scrylate) and Boston ES (fluoro silicone acrylate) Rigid Gas Permeable Contact Lenses treated with lens care regimens employing BOSTON Conditioning Solution, BOSTON ADVANCE Comfort Formula Conditioning Solution, or BOSTON SIMPLICITY Multi-Action Solution in conjunction with Boston® Liquid Enzymatic Cleaner,

A five day ocular irritation study was conducted in the rabbit to investigate the ocular irritation and toxicity potential of the Boston® Liquid Enzymatic Cleaner used in a lens care regimen employing BOSTON Cleaner and BOSTON Conditioning Solution with BOSTON ES Rigid Gas Permeable Contact Lenses.

A primary ocular irritation test was conducted using extracts from the red screw cap, red bulb cap, blue screw cap, and blue bulb cap packaging components for Boston® Liquid Enzymatic Cleaner to determine the potential for any extractable ocular irritants.

The results of these tests demonstrate that the product and packaging components are not toxic.

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Microbiology:

Sterility:

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

. : : :

Biostatic Efficacy:

The biostatic activity of Boston® Liquid Enzymatic Cleaner was determined using a combination of two test methods. One was the Bacteriostasis Test Method as described in the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. May 1 1997. The other was the Preservative Efficacy Test Method for Multi-Dose Preserved Contact Lons Care Products, is also described in the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. May 1 1997.

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 1x106 cfu/mL. Test microbes included bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, and Eschericia coli), yeast (Candida albicans), and mold (Aspergillus niger). Test samples were assaved at 7 and 14 days after inoculation to determine the concentrations of surviving microorganisms. Immediately after the 14-day assay, each test solution was rechallenged with a fresh inoculum of the same species of microorganisms. Test samples were continually assayed every 7 days through 42 days after initial challenge, and were assaved every 2-3 weeks thereafter, up to at least 98 days to establish the 90 day discard date.

Disinfection Efficacy:

The Baston® Liguid Enzymatic Cleaner/conditioning solution combination was tested in accordance with the disinfection efficacy requirements in the Premarket Notification (510 (k)) Guidance Document for Contact Lens Care, May 1, 1997 Products. BOSTON Conditioning Solution, BOSTON ADVANCE Comfort Formula Conditioning Solution and BOSTON SIMPLICITY Multi-Action Solution were tested for disinfection efficacy in combination with Boston® Liquid Enzymatic Cleaner.

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 competibility of Boston® Liquid Enzymatic Cleaner with silicone scrylate 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

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Nortfloation (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 cleaning efficacy of Boston® Liquid Enzymatic Cleaner dissolved in BOSTON Conditioning Solution, BOSTON ADVANCE Comfort Formula Conditioning Solution and BOSTON SIMPLICITY Multi-Action Solution compared to Alcon OPTI-ZYME Enzymatic Cleaner dissolved in Bausch & Lomb Sensitive Eyes Saline Solution was determined by Image Analysis

Human worn RGP leases were treated with both Boston® Liguid Enzymatic Cleaner and with Alcon OPTI-ZYME. The lenses were evaluated for protein level determination. This type of cleaning evaluation is suggested in the Premarket Notification (510(k) Guidance Document for Contact Lens Care Products, May 1, 1997.

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

10. CLINICAL:

The clinical study used to support this premarket notification was carried out to determine that the is the Boston® Liquid Enrymatic Cleaner is substantially equivalent in safety and efficacy when compared to the currently marketed Alcon OPTI-ZYME Enzymatic Cleaner, when used with currently marketed silicone acrylate and fluoro-silicone acrylate lens materials.

The study involved six investigational sites and 103 patients (206 eyes) for a period of three months. 69 Datients (64 eves) used Boston® Liquid Enomatic Cleaner. and 32 patients (64 eyes) used marketed Alcon OPTI-ZYME Enzymatic Cleaner.

Of the 103 subjects entered into the study, 95 subjects completed the study, Twelve subjects were discontinued from the study. No subjects were discontinued from the study for adverse reactions. Subjects recruited into the study ranged in age from 18 - 69, with a mean age of 43.2.

Completed and discontinued patients reported consistently good visual acuities with 95.1% of acuities reported for completed eyes at 20/30 or better. During the study the average lens wearing time for completed eyes was between 13.7 and 14.2 hours per day.

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11. CONCLUSION:

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

,:::

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Image /page/5/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1997

Mr. Douglas J. Fortunato Director, Regulatory Affairs Polymer Technology 1400 North Goodman Street Rochester, NY 14692

K973217 Re: Trade Name: Boston® Liquid Enzymatic Cleaner Regulatory Class: II Product Code: 86 LPN Dated: August 26, 1997 Received: August 27, 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 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 - 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 (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): ___K973217

Device Name: Boston® Lianid Enzymatic Cleaner

Indications for Use:

The Boston® Liquid Encymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during simultaneous conditioning (wetting, soaking, and disinfecting) with Original Formula Boston® Conditioning Solution, Boston ADVANCE® Comfort Formula Conditioning Solution, or Baston SIMPLICITY® Multi-Action Solution.

(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

Myra Smith

Sign-Off) f Ophthalmic Devices 510(k) Number_K973217

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

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