Data indicate that lens cases are a significant source of microbial contamination. The ProGuard Lens Case is a contact lens storage case that is infused with silver to help minimize contamination on the lens case surface. Laboratory testing showed that the silver ions reduce bacterial growth of Pseudomonas aeruginosa and Citrobacter amalonaticus on the case surface after 24 hours. No significant reduction was observed in the ProGuard lens case with S.epidermidis, S. aureus, P. mirabilis and S. marcescens (2 isolates).

AI/ML Overview

The provided text describes the "ProGuard Lens Case" and its performance in various studies. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" isn't explicitly defined with numerical thresholds in the document. Instead, the studies aim to demonstrate "substantial equivalence" to a predicate device and "significant reduction" in bacterial contamination. Based on the reported findings, here's a table summarizing the performance:

Category	Acceptance Criteria (Implied)	Reported Device Performance
Microbiology
Direct Microbial Challenge	Significant reduction of bacterial growth compared to regular lens cases.	After 24 hours:
Clinical Study #1 (Bacterial Contamination)	Statistically significantly lower degree of bacterial contamination compared to control lens cases.	ProGuard Lens Case: 26% bacterial contamination
Clinical Study #2 (Bacterial Contamination)	Statistically significantly lower degree of bacterial contamination compared to control lens cases.	ProGuard Lens Case: 38% bacterial contamination
Biocompatibility	Non-toxic, non-irritant, non-cytotoxic, comparable to predicate devices.
Cytotoxicity (USP Elution/Direct Contact)	Reactivity Grade of zero (0).	Reactivity Grade of zero (0) for all components and lens groups/solution combinations.
ISO Ocular Irritation	Negative ocular scores.	Negative ocular scores for all test and control eyes at 1, 24, 48, and 72 hours for lens case base and caps (Aqua & White).
Systemic Toxicity	No evidence of systemic toxicity.	No evidence of systemic toxicity observed for lens case base and caps (Aqua & White).
Silver Leaching	Minimal silver concentration in soaking solution and lenses.	Average amount of silver in lens case cycled with AQuify MPS: approx. 30 ppb.

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

Direct Microbial Challenge Studies:
- Sample Size:
  - 8 bacteria isolates were tested.
  - ProGuard lens cases and "regular lens cases" were exposed, but the exact number of cases per group isn't specified (e.g., how many ProGuard cases vs. how many regular cases were used for each isolate).
- Data Provenance: Retrospective (laboratory testing). No country of origin is specified, but given the submitter's location (Georgia, USA), it's likely U.S. based.
Clinical Study #1:
- Sample Size: 39 subjects. Each subject used one ProGuard bowl and one control case bowl.
- Data Provenance: Prospective (one-month clinical trial). No country of origin is specified, but again, likely U.S. based due to the submitter.
Clinical Study #2:
- Sample Size: 40 subjects. Each subject used one ProGuard bowl and one control lens case bowl.
- Data Provenance: Prospective (one-month clinical trial). No country of origin is specified, but likely U.S. based.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets.

For the microbiology studies, ground truth was established by laboratory methods (culturing and counting bacteria), not by human expert opinion.
For the biocompatibility studies, ground truth was established by standardized tests (USP, ISO) with measurable endpoints (e.g., reactivity grade, ocular scores) which typically don't involve subjective expert consensus for "ground truth."
For the clinical studies, the "ground truth" was the measured bacterial contamination level determined by laboratory analysis of the collected cases, not by expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method for the test set.

The studies described rely on objective laboratory measurements (bacterial counts, silver concentration, reactivity grades, ocular scores) or statistical comparisons of these measurements. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., imaging studies where multiple readers interpret images and a tie-breaker is needed).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC for AI assistance) is not relevant to this device, which is a contact lens case, not an AI-powered diagnostic or interpretive tool. There is no AI component involved, nor are human readers interpreting data.

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

This question is not applicable as the device (ProGuard Lens Case) is a physical medical device, not an algorithm. Therefore, there is no "standalone algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used in these studies varied by the type of non-clinical and clinical evaluation:

Microbiology Studies (Direct Challenge & Clinical):
- Bacterial Counts/Contamination Levels: Determined by laboratory methods (culturing, enumeration), which is a form of laboratory-confirmed outcome or direct measurement.
Biocompatibility Studies (Cytotoxicity, Ocular Irritation, Systemic Toxicity):
- Standardized Test Results: Based on established protocols like USP and ISO, yielding objective measurements like Reactivity Grade, Ocular Scores, and observations of systemic toxicity. This is a form of objective measurement against established standards.
Silver Determination:
- Concentration Measurement: Determined by Atomic Absorption (AA) spectroscopy, which is a direct analytical measurement.

8. The Sample Size for the Training Set

Not Applicable. The ProGuard Lens Case is a physical medical device. It is not an AI algorithm that requires a "training set" in the machine learning sense. The testing performed involved demonstrating safety and effectiveness directly through non-clinical and clinical studies, not by training a model.

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

Not Applicable (as explained in point 8).

Summary

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SEP = 9 2005

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.

K041820

0(k) Summary for the ProGuard Lens Case

1. Submitter Information

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097

Contact Person: Steven Dowdley Telephone No. 678-415-3897

2. Device Name

Classification Name: Soft (hydrophilic) contact lens care products Proprietary Name: ProGuard Lens Case

3. Predicate Devices

Contact Lens Case (K943183)

4. Description of the Devices

5. Indications for Use

The ProGuard Lens Case is indicated for storage of soft (hydrophilic) contact lenses.

6. Description of Safety and Substantial Equivalence

Non-clinical Studies

A series of nonclinical studies were completed to demonstrate the substantial equivalence of the ProGuard Lens Case to the predicate device. All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the lens case is non-toxic and biocompatible, and is comparable to other currently marketed contact lens cases. Results from all tests demonstrate the substantial equivalence of the case to other to previously FDA cleared devices.

Microbiology

Direct Microbial Challenge Studies

In a series of direct microbial challenge studies, ProGuard lens cases and regular lens cases were exposed to saline suspensions of 8 bacteria isolates and incubated at room temperature. After 4 hours there was no difference between the ProGuard lens case and the regular lens cases. After 24 hours the ProGuard lens cases showed significant reduction of 3 of the 8 bacteria isolates tested (P. aeruginosa GSU3, P. aeruginosa ATCC 9027, C. amalonaticus). There was no

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significant reduction difference between the ProGuard lens case and the regular lens case for S.epidermidis, S. aureus, P. mirabilis and S. marcescens (2 isolates).

AA Determination of Silver in the Lens Case & Lenses

In this study, atomic absorption was used to determine the concentration of silver found in the soaking solution of a ProGuard Lens Case and lenses exposed to the lens case. Under the conditions of the study, the results demonstrated that the average amount of silver found in a lens case cycled with AQuify MPS was approximately 30ppb. Lenses cycled in the same solution demonstrated a silver concentration ranging from 0.001 to 0.010µg/lens.

Cytotoxicity

A series of cytotoxicity studies were conducted to demonstrate the safety and substantial equivalence of the ProGuard Lens Case . Results of the testing demonstrated that the lenses case is non-cytotoxic and is a non-irritant.

USP Elution Test of Extracts of Case and Lid - A Reactivity Grade of zero (0) was observed for components of the ProGuard Lens Case .

USP Direct Contact Test of Extracts of Case and Lid - A Reactivity Grade of zero (0) was observed for the components of the ProGuard Lens Case .

USP Direct Contact with Karats & Test Lens Case (Group 1, IV & Silicone Hydrogels) - All lens groups/solution combinations tested produced a Reactivity Grade of zero (0) and exhibited no biological reactivity according to the USP Direct Contact Test.

USP Elution Test of with Karats MPS - A Reactivity Grade of zero (0) was observed for AQuify Multipurpose Solution stored in the ProGuard Lens Case .

ISO Ocular Irritation Test of Lens Case Base - ProGuard Lens Case bases were evaluated according to ISO 10993-10 for ocular irritation in the rabbit using saline and cottonseed oil extracts. Ocular scores were neqative for all test and control eves at 1, 24, 48 and 72 hours.

ISO Ocular Irritation Test of Aqua Lens Case Caps - ProGuard Lens Case caps were evaluated according to ISO 10993-10 for ocular irritation in the rabbit using saline and cottonseed oil extracts. Ocular scores were negative for all test and control eves at 1. 24. 48 and 72 hours.

ISO Ocular Irritation Test of White Lens Case Caps - ProGuard Lens Case caps were evaluated according to ISO 10993-10 for ocular irritation in the rabbit using saline and cottonseed oil extracts. Ocular scores were negative for all test and control eves at 1, 24, 48 and 72 hours.

Systemic Toxicity of Test Extracts of Lens Case - ProGuard Lens Case bases were evaluated according to USP and ISO 10993-11 for systemic toxicity in the mouse, using saline and cottonseed oil extracts. No evidence of systemic toxicity was observed.

Systemic Toxicity of Test Extracts of Aqua Lens Case Caps - ProGuard Lens Case caps were evaluated according to USP and ISO 10993-11 for systemic toxicity in the mouse. using saline and cottonseed oil extracts. No evidence of systemic toxicity was observed.

Systemic Toxicity of Test Extracts of White Lens Case Caps - ProGuard Lens Case caps were evaluated according to USP and ISO 10993-11 for systemic toxicity in the mouse, using saline and cottonseed oil extracts. No evidence of systemic toxicity was observed.

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Clinical Study

Two clinical studies were conducted to evaluate the performance of the ProGuard Lens Case versus a standard control lens case.

Clinical Study #1

This study was one month clinical trial with 39 subjects using AQuify MPS. Each subject in the trial used one bowl of a ProGuard Lens Case and one bowl of a control case to store their lenses. For the control lens cases, after disinfection, subjects were instructed follow the case care instructions for the control case (e.g., empty the solution, rinse with fresh AQuify MPS and leave open to air dry). For the test case, the subjects followed one of the following case care regimen:

Test Case Regimen 1 - the case was emptied rinse with AQuify MPS, then re-capped Test Case Regimen 2 - the case was emptied, rinse and re-filled with fresh Aquify MPS.

At the conclusion of the study, the ProGuard Lens Cases had a statistically significantly lower degree of bacterial contamination than the control lens cases - 26% (test case) versus 67% (control case). This study also demonstrated that recapping the ProGuard Lens Case an increase the microbial contamination of the case.

Clinical Study #2

This study was a one month clinical trial with 40 subjects using AQuify MPS with their lenses stored in one bowl of the ProGuard Lens Case and one bowl of the control lens case. After disinfection, the subjects were instructed to empty the cases, rinse with AQuify MPS and then re-cap the cases. In this study, the ProGuard Lens Cases had a statistically significantly lower degree of bacterial contamination than the control lens cases - 38% (test case) versus 63% (control case).

7. Substantial Equivalence

The date provided in this 510(k) submission concludes that the ProGuard Lens Case is substantially equivalent to the predicate lens case for storage of soft (hydrophilic contact lenses.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

JUL 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jerry Land, O.D. Head, Regulatory Affairs - Americas Global Clinical and Regulatory Affairs CIBA Vision Corp. 11460 Johns Creek Parkway Duluth. GA 30097

Re: K041820

Trade/Device Name: ProGuard™ Lens Case Regulation Number: CFR886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: II Product Code: LRX Dated: September 9, 2005 Received: July 19, 2004

Dear Dr. Land:

This letter corrects our substantially equivalent letter of September 9, 2005.

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 (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 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 - Jerry Land, O.D.

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 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. Egleston, und

Malvina B. Eydelman, M 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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Indications for Use

510(k) Number: K041820

ProGuard™ Lens Case Device Name:

Indications For Use:

The ProGuard™ Lens Case is indicated for storage of soft (hydrophilic) contact lenses with AQuify® Multipurpose Solution.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quyuh Hoang
Division Sign-Off

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

510(k) Number K041820

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.”