Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.

Device Description

Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. This device is not sterile and not for heat-disinfection. Use only with chemical disinfection.

There are two main series includes the variant model DC-2001, DC-3001 and DC-6001, the other includes DC-7001 and DC-8001. All these five variant models are made of Polypropylene, which follow the same design principle with the same intended use.

All the five variant models of this device have a capacity of over 1.5 ml in each case well. And the inner height of the all wells exceeds 8.5 mm. With regard to the Center Thickness of the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, the capacity is sufficient for contact lens to be fully immersed under use condition.

AI/ML Overview

This document is a 510(k) premarket notification for a Contact Lens Case. It does not describe a study that uses a machine learning algorithm or AI. Therefore, I cannot provide the requested information about acceptance criteria for an AI device.

The document primarily focuses on establishing substantial equivalence to a predicate device (K071081) for a physical product (contact lens case). The "tests" mentioned are non-clinical leakage testing and biological evaluation for safety.

Here's a breakdown of why the requested information cannot be extracted:

No AI/Machine Learning Device: The device in question is a "Contact Lens Case," a physical product for storing contact lenses. There is no mention of any AI or machine learning component.
No Acceptance Criteria for AI Performance: Since it's a physical product, the acceptance criteria are related to its physical properties, safety, and functionality (e.g., lack of leakage, biocompatibility, sufficient capacity for lenses), not performance metrics like sensitivity, specificity, or AUC for an AI algorithm.
No Study for AI Performance: The document explicitly states, "The subject of this premarket submission, Contact lens case did not require clinical studies to support substantial equivalence." The "Summary of Non-Clinical Leakage Testing" is a performance test for the physical case, not an AI study.
No Ground Truth, Training Set, Experts, etc.: These concepts are relevant to AI/machine learning studies, not to the approval process for a simple medical device like a contact lens case.

Therefore, I cannot populate the table or answer the specific questions related to AI studies.

Summary

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

June 7, 2016

Danyang Chanxin Glasses Cases Factory c/o Mr. Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Co., Ltd Level 7, Jin Gui Business Center 982 Cunyun Road, Baiyun District, Guangzhou Guangdong, China 510420

Re: K160005

Trade/Device Name: Contact Lens Case (multiple brand names) Regulation Number: 21 CFR 886.5928 Regulation Name: Contact Lens Case Regulatory Class: Class II Product Code: LRX Dated: April 25, 2016 Received: April 28, 2016

Dear Mr. Gu:

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 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 - Mr. Mike Gu

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 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or 301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. 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 (if known) K160005

Device Name Contact Lens Case

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows a logo with a stylized flower-like design on the left and the text "诚欣 Chan Xin" on the right. The flower-like design is composed of overlapping petals in different colors, including blue, red, yellow, and cyan. The text "诚欣 Chan Xin" is written in a simple, sans-serif font, with the Chinese characters "诚欣" appearing above the English text "Chan Xin".

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

l. SUBMITTER

DANYANG CHANXIN GLASSES CASES FACTORY

HUADIAN CHUANGYE PARK, DANGUI ROAD, DEVELOPING ZONE, DANYANG CITY,

JIANGSUPROVINCE, CHINA

Phone: +86-511-86903193

Fax: +86-511-86903193

Primary Contact Person:	Mike Gu
	Regulatory Affairs Manager
	OSMUNDA Medical Device Consulting Co., Ltd
	Tel: (+86) 20-6232 1333
	Fax: (+86) 20-8633 0253
Secondary Contact Person:	Lemon Chen
	CEO
	DANYANG CHANXIN GLASSES CASES FACTORY
	Tel: +86-0511-86903193
	Fax: +86- 0511-86903193
	Email: lemon@jschanxin.com
Preparing date:	30 Dec 2015
II.
DEVICE
Name of Device:	Contact Lens Case
Common/Usual Name:	Contact Lens Case
Classification Names:	Case, Contact Lens
Regulation Class:	II
Product Code:	LRX

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Image /page/4/Picture/0 description: The image contains a logo with a stylized flower-like design on the left and the text "诚欣 Chan Xin" on the right. The flower-like design is composed of overlapping curved shapes in different colors, including blue, yellow, red, and black. The text "诚欣" is in Chinese characters, and "Chan Xin" is the corresponding English translation or transliteration, written in a smaller font size below the Chinese characters.

III. PREDICATE DEVICE

Contact Lens Case(K071081)

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATION FOR USE

Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.

VI. SUBSTANTIAL EQUIVALENCES

Technology: The proposed device Contact lens case has similar product design as the predicate device. The major differences are due to the different design for adjoining wells with integral hinged caps or screw-top caps, the different dimension and appearance, made of the PP material with different color additives. These are not relating to the safety or effectiveness aspects. Thus they are substantially equivalent.
Summary of Non-Clinical Leakage Testing: Production units of Contact Lens Cases have

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Image /page/5/Picture/1 description: The image shows a logo with a stylized flower-like design on the left and Chinese characters along with the English words "Chan Xin" on the right. The flower-like design is composed of curved lines in various colors, including yellow, blue, red, and black. The Chinese characters are positioned above the English words, which are written in a simple, sans-serif font.

undergone leakage testing. None of the tested lens cases Tests: showed any leakage and all of the Leakage Tests were passed successfully.

Summary of Clinical Tests: The subject of this premarket submission, Contact lens case did not require clinical studies to support substantial equivalence.

The following comparison table identifies the similarities and differences of the proposed device Contact Lens Case to the legally marketed predicate device Contact Lens Case (K071081) to which substantial equivalency is claimed.

Items	Predicate Device	Proposed Device	Discussion ofDifferences
	CONTACT LENS CASE	CONTACT LENS CASE
	K071081
Manufacturer	Ningbo Kaida Rubber &Plastic Technology Co.,Ltd.	DANYANGCHANXINGLASSES CASES FACTORY	---
Device name	Multiple Brand Names	Contact Lens Case	---
Classification Name	Contact Lens Case	Contact Lens Case	Identical
Product Code	LRX	LRX	Identical
Intended Use	The contact lens case is alens care product to beused by the contact lenswearer or practitioner forstoring contact lenseswhile not being worn. Thedevice is not designed forheat disinfecting system.Use only with chemicaldisinfection.	Contact Lens Case is a lenscare product to be used bythe contact lens wearer orpractitioner for storingsoft(hydrophilic) contactlenses while not beingworn. Not designed forheat disinfecting system.Use only with chemicaldisinfection.	Equivalent
Indications for Use	Storage and Disinfection ofSoft, Rigid Gas permeableor Hard contact lenseswhile not being worn	Storage and Disinfection ofSoft contact lenses whilenot being worn	Equivalent
Disinfection Type	Chemical DisinfectionNot Heat-Disinfection	Chemical DisinfectionNot Heat-Disinfection	Identical
Items	Predicate Device	Proposed Device	Discussion of
	CONTACT LENS CASE	CONTACT LENS CASE	Differences
	K071081
Design	Two adjoining Wells withScrew-Top Caps	Two adjoining Wells withScrew-Top Caps: DC-2001,DC-3001 and DC-6001Two adjoining Wells withIntegral-HingedCaps:DC-7001 and DC-8001	Equivalent
Main Materials	Polypropylene(PP)	Polypropylene(PP)	Equivalent
Dimension	Each case well has acapacity of over 1.5 ml.The inner height of thewells exceeds 8.5mm.	Each case well has acapacity of over 1.5 ml.The inner height of thewells exceeds 8.5mm.	Equivalent
Color	Purple	colorless, transparentblue, transparent violet,blue, violet, and white	Different,the colorsof proposeddevice havebeendemonstrated to bebiocompatible safe.
Effectiveness	The capacity is sufficientfor contact lens to be fullyimmersedunderusecondition.	The capacity is sufficientfor contact lens to be fullyimmersedunderusecondition.	Identical
Safety	ISO 10993-5 Biologicalevaluation of medical devices-- Part 5: Tests for in vitrocytotoxicity;ISO 10993-10 Biologicalevaluation of medical devices-- Part 10: Tests for irritationand skin sensitizationISO 10993-11 Biologicalevaluation of medical devices-- Part 11: Tests for systemicToxicity.	ISO 10993-5 Biologicalevaluation of medical devices-- Part 5: Tests for in vitrocytotoxicity;ISO 10993-10 Biologicalevaluation of medical devices-- Part 10: Tests for irritationand skin sensitizationISO 10993-11 Biologicalevaluation of medical devices-- Part 11: Tests for systemicToxicity.	Identical
Sterility	No	No	Identical

Comparison Table of Predicate device and Proposed Device

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Image /page/6/Picture/1 description: The image contains a logo with a stylized flower-like design on the left and the text "Chan Xin" in both Chinese and English on the right. The flower-like design is composed of four curved shapes in different colors: blue, yellow, red, and black. The text "Chan Xin" is written in a simple, sans-serif font, with the Chinese characters above the English text.

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Image /page/7/Picture/1 description: The image contains a logo with a stylized flower-like design on the left and the text "Chan Xin" on the right. The flower-like design is composed of overlapping curved lines in various colors, including blue, yellow, red, and teal. The text "Chan Xin" is written in a serif font, with the first word in a larger, bolder font than the second word.

VII. CONCLUSION

DANYANG CHANXIN GLASSES CASES FACTORY considers the Contact lens case to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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.”