The PROSBEN Contact Lens Cases are intended for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only; not to be used with heat.

Device Description

The PROSBEN Contact Lens Case is the subject of this 510(k) premarket notification. The Contact Lens Case is a lens care product to be used the contact lens wearer or practitioner for storing contact lenses while not being worn. The PROSBEN Contact Lens Cases are designed for use in chemical disinfection only; not to be used with heat. The PROSBEN Contact Lens Cases are not including the disinfection, only for shipping the cases in a dry state.

AI/ML Overview

The provided text describes the PROSBEN Contact Lens Cases and its 510(k) submission to the FDA. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device (i-Promotions Contact Lens Case, K042578) through safety data (biocompatibility tests) and a comparison of design and materials.

Crucially, the document does not describe a study involving a test set, expert ground truth, or statistical analysis of device performance against acceptance criteria in the manner typically expected for AI/algorithm-based devices. The "device" in this context is a physical product (contact lens cases), not a software algorithm that outputs a diagnostic or predictive result.

Therefore, many of the requested sections (2-9) are not applicable or cannot be extracted from the provided text because the nature of the device and its evaluation are different from what your prompt anticipates for an AI/algorithm.

Here's an attempt to answer based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility:
- Absence of in vitro cytotoxicity (ISO 10993-5)	- Complied with the biological and toxicology evaluation.
- Absence of irritation and skin sensitization (ISO 10993-10)	- Complied with the biological and toxicology evaluation.
- Absence of systemic toxicity (ISO 10993-11)	- Complied with the biological and toxicology evaluation.
Safety for Intended Use:	- Results of studies show that the Contact Lens Cases are safe for their intended use.
Material Composition Equivalence:	- Materials (PP or PE with color additives) are compared to predicate device's materials (Low density Polyethylene with five colorants), and deemed not relating to safety or effectiveness aspects, thus substantially equivalent.
Design Equivalence (functional):	- Designs (hinged caps or screw-top caps) are compared to predicate (adjoining wells with integral hinged caps), and deemed not relating to safety or effectiveness aspects, thus substantially equivalent.

Explanation of Acceptance Criteria:
The acceptance criteria are derived from the safety tests conducted per ISO 10993 standards for biological evaluation of medical devices. The "reported device performance" indicates that the PROSBEN Contact Lens Cases successfully met these criteria, concluding they are safe for their intended use. The substantial equivalence claim is also a key "acceptance criterion" met by demonstrating similar intended use, working principle, and technologies to a legally marketed predicate device, with differences not impacting safety or effectiveness.

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

Sample Size: Not specified for the biological evaluations. These tests are typically performed on samples of the manufactured material or final product.
Data Provenance: Not explicitly stated, but the tests were performed on the PROSBEN Contact Lens Cases themselves. The 510(k) summary is prepared in Taiwan (R.O.C.), implying the testing might have been conducted there or by affiliated labs. The data is internal to the manufacturer for regulatory submission.

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

Not applicable. For biological and material compatibility tests, the "ground truth" is established by the test protocols and objective measurements (e.g., cell viability, presence/absence of an irritation response) following international standards (ISO 10993). Expert interpretation would be involved in designing and analyzing results, but not in establishing a "ground truth" in the way it's done for diagnostic AI algorithms based on expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As above, the evaluation relies on standardized test methods and objective metrics rather than expert adjudication of cases/images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. This type of study is relevant for diagnostic imaging or similar interpretation tasks where human readers' performance is augmented by AI. The PROSBEN Contact Lens Case is a physical medical device for storage; therefore, an MRMC study is not applicable.

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

Not applicable. This device is a physical product, not a software algorithm.

7. The type of ground truth used

For the biological evaluations (cytotoxicity, irritation, systemic toxicity), the ground truth is based on standardized laboratory test results and established scientific criteria as defined by ISO 10993. For demonstrating substantial equivalence, the "ground truth" is the legally marketed status and characteristics of the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this physical device evaluation.

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

Not applicable. As no training set exists, no ground truth needed to be established for it.

Summary

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Image /page/0/Picture/0 description: This image contains the company information for PROSBEN INC. Their phone number is 886-2-2500 0586, and their fax number is 886-2-2500 0945. The company address is 11F, No.58, Ming Chuan East Road, Sec.3, Taipei 104, Taiwan. The image also contains the date MAY 31 2013.

II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)

2.1. General Information Establishment

. Manufacturer: PROSBEN INC.
Address: 11F., No.58, Sec. 3, Mingchaun East Road, Taipei, 10477, Taiwan, R.O.C. .
B Owner Number: 8022656

Contact Person:	Dr. Jen, Ke-Min E-mail: ceirs.jen@msa.hinet.net
	(Tel) +886-3-5208829 ; (Fax) +886-3-5209783

. Date Prepared: August 23, 2012

Device

Proprietary Name: PROSBEN Contact Lens Cases;

CA66-02, CA66-03WB, CA66-04T series

Common Name: . Contact Lens Case
. Case, Contact Lens Classification Name:
LRX, Class II, 886.5928 ● Product Code:

2.2. Safety and Effectiveness Information

. Predicate Device:

Claim of Substantial Equivalence (SE) is made to i-Promotions Contact Lens Case (K042578)

● Device Description:

Summary of Safety Data: ●

PROSBEN Contact Lens Cases completed the relevant test including:

1. ISO 10993-5 Biological evaluation of medical devices, part 5: Test for in vitro cytotoxicity;
1. ISO10993-10 Biological evaluation of medical devices, part 10: Test for irritation and skin sensitization;

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Image /page/1/Picture/0 description: The image shows the letterhead for PROSBEN INC. The letterhead includes the company's name, address, telephone number (886-2-2500 0586), and fax number (886-2-2500 0945). The address is 11F, No.58, Ming Chuan East Road, Sec. 3, Taipei 104, Taiwan. The letterhead also includes the phrase "NEW VISION BEGIN WITH".

1. ISO10993-11 Biological evaluation of medical devices, part 11: Test for system toxicity:
1. The materials are complied with the biological and toxicology evaluation and the results of these studies show that the Contact Lens Cases are safety for its intended use.

Intended Use: ●

. Substantial Equivalence (SE)

A claim of substantial equivalence is made to i-Promotions Contact Lens Case (K042578). Both of them have the same indications for use, working principle and technologies. The major differences of the two devices are due to the different designed for adjoining wells with integral hinged caps or screw-top caps, and used the different PP or PE material with different color additives; please refer to the below "Comparison Table". These are not relating to the safety or effectiveness aspects. Thus they are substantially equivalent.

ComparisonFeature	i-PromotionsContact Lens Case(K042578)	PROSBENContact Lens Cases series(K122700)
Design	Two adjoining wells withintegral hinged caps intowhich respective lenses areimmersed.	hinged caps: CA66-04T seriesscrew-top caps: CA66-02 andCA66-03WB series
Materials	Low density Polyethylene#9931 with five colorants.	PP (CAS# 9003-07-0): CA66-02 andCA66-03WB seriesPE (CAS# 9002-88-4): CA66-04Tseries with colorants:white, blue, green

Comparison Table

Ke. Minte

Dr. Jen, Ke-Min 510Kcorrespondent person for PROSBEN INC.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

May 31, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Dr. Jen, Ke-Min Prosben, Inc. 11F, No. 58, Sec. 3 Mingchaun East Road Taipei China (Taiwan) 104

Re: K122700

Trade/Device Name: Prosben Contact Lens Cases, CA66-02, CA66-03WB, and CA66-04T Series Regulation Number: 21 CFR 886.5928 Regulation Name: Case, Contact Lens Regulatory Class: Class II Product Code: LRX Dated: May 11, 2013 Received: May 22, 2013

Dear Dr. Jen:

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 interstatecommerce.prior to.May. 28, 1976, the enactment.date.of the Medical.Device. Amendments, or todevices 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Dr. Jen. Ke-Min

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia YAlexander -S

Center for Devices and Radiological Health

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation

Enclosure

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Indications for Use

510 (K) Number ( If Known ): K122700 Device Name: _ Contact Lens Cases; CA66-02, CA66-03WB, CA66-04T series

Indications for Use:

The PROSBEN Contact Lens Cases are intended for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses.

For use during chemical disinfection only; not to be used with heat.

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

V Over the Counter Use __ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Claudine H. Krayçzy 2013.05.30 13:27:3540

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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.”