The Applicant contact lens case is a lens care product to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.

Device Description

The applicant device of Contact Lens Case is a device intended to be used by the contact lens wearer or practitioner for storing contact lenses while not being worn. The applicant device is not sterile and not for heat-disinfection.
Applicant Device Variants: SL-295, SL-298, SL-326, SL-338, SL-316, SL-511, SL-800, SL-863, SL-884, SL-886, SL-869, SL-876, SL-880, SL-899
All the variant models as mention above follow the same design principle with the same intended use. The only difference is the dimension and appearance of each model, which do no effect on the usage and intended use and just for commercial purpose.
The applicant device of Contact Lens Case consists of 2 parts: case body and case cover. The case body is based with adjoining dual wells for the containment of fluid, and the cap is designed for screwing. All the variant models of the applicant device have a capacity of over 1.5 ml in each case well. And the inner height of the all well 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.
The applicant device of Contact Lens Case made of 2 types of material of Polypropylene (PP) and Acrylonitrile - butadiene - styrene copolymer (ABS) for each variant model.

AI/ML Overview

The provided 510(k) summary is for a Contact Lens Case, which is a medical device. The summary focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing efficacy through a traditional clinical study with acceptance criteria for device performance in terms of diagnostic accuracy or impact on human readers.

Therefore, many of the typical bullet points for AI/diagnostic device studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of device and submission.

Here's an analysis based on the information provided, tailored to a non-AI/diagnostic device and its substantial equivalence determination:

1. Table of Acceptance Criteria and the Reported Device Performance

For this type of device, "acceptance criteria" are primarily related to safety (biocompatibility) and functional equivalence, rather than a quantifiable performance metric like sensitivity or specificity. The "reported device performance" is framed in terms of meeting these safety standards and having comparable functionality to the predicate.

Acceptance Criteria (Safety/Functionality)	Reported Device Performance
Biocompatibility of Materials:
- In Vitro Cytotoxicity	- No Cytotoxicity (for Polypropylene, ABS, and PP with Carbazole violet)
- Delayed-type Hypersensitivity	- No delayed dermal contact sensitization (for Polypropylene, ABS, and PP with Carbazole violet)
- Eye Irritation / Intracutaneous Reactivity (for Systemic Toxicity test)	- No intracutaneous reactivity (for Polypropylene, ABS, and PP with Carbazole violet)
- Systemic Toxicity	- No systemic toxicity (for Polypropylene, ABS, and PP with Carbazole violet)
- Compliance with ISO 10993 "Biological Evaluation of Medical Devices"	- All conducted Biological Evaluation Tests are in compliance with ISO 10993. The compatibility of skin-contact component material meets biocompatibility requirements.
Functional Equivalence:
- Capacity of each case well	- Over 1.5 ml (stated to be sufficient for full immersion of contact lenses)
- Inner height of well	- Exceeds 8.5 mm (stated to be sufficient for full immersion given typical contact lens thickness)
- Intended Use	- The same as the predicate device: storing soft, rigid gas permeable, or hard contact lenses with chemical disinfection (not heat disinfection).
- Design	- Two adjoining wells, screwed with screw top (similar to the predicate's screwed with integral hinged cap, deemed similar for intended use).
- Disinfection Type	- Chemical Disinfection, Not Heat-Disinfection (same as predicate).
- Indications	- Storage and Disinfection of Soft, Rigid Gas Permeable or Hard Contact Lenses (same as predicate).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Specific sample sizes for the individual biocompatibility tests (e.g., number of test specimens for cytotoxicity, number of animals for sensitization/irritation) are not detailed in this summary. The summary states that representative samples (SL-884 for PP, SL-800 for ABS, and SL-295 for PP with colorant) were used for testing their respective material types.
Data Provenance: The origin of the raw test data is not explicitly stated beyond being "test results." Given the manufacturer's location in China, it is plausible the tests were conducted there or at labs compliant with ISO standards. This is a prospective assessment of newly manufactured materials/devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a safety and functional equivalence submission, not a diagnostic accuracy study relying on expert interpretation of images or patient data. The "ground truth" here is objective laboratory measurements for biocompatibility (e.g., cell viability, dermal reactions) and physical dimensions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no expert adjudication process for the types of tests conducted (biocompatibility, physical measurements). The results of these objective tests are generally interpreted against established criteria or controls.

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 is not an AI or diagnostic imaging device.

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

Not Applicable. This is not an algorithm or AI device. The tests performed are standalone evaluations of the physical device's characteristics and material safety.

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

The "ground truth" consists of objective laboratory measurements and internationally recognized standards. Specifically:

Biocompatibility: Results of tests (cytotoxicity, delayed-type hypersensitivity, eye irritation, systemic toxicity) are compared against established biological responses and compliance with ISO 10993 standards.
Physical Characteristics: Direct physical measurements (e.g., volume capacity, inner height) of the device.

8. The sample size for the training set

Not Applicable. This device uses standard materials and manufacturing processes; there is no "training set" in the context of machine learning or AI.

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

Not Applicable. As there is no training set for an AI model, this question does not apply. The safety and effectiveness are established through direct testing against recognized standards and comparison to a legally marketed predicate device.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The Assigned 510(k) Number is:

1. Date of Submission: Nov 28, 2006

Applicant Device Information 2.

Trade/Proprietary Name: Contact Lens Case (Multiple Brand Names) Common Name: Contact Lens Case Classification Name: Case, Contact Lens Device Class: Jly F Product Code: LRX Regulation Number: 886.5928

Intended Use:

The Applicant contact lens case is a fens care product to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.

3. Submitter Information

Manufacturer Name:

Ningbo Kaida Rubber & Plastic Technology Co., Ltd. No.1 Qinggang Industrial Park, Mou Shan Town, Yu Yao City, Zhejiang Province, China

Contact Person of the Submission:

Ms. Diana. Hong Mr. Eric. Chen Shanghai Mid-link Consulting Co., Ltd. Suite 8D, Zhongxin Zhongshan Building, Lane 999, Zhongshan No.2 Road (S), Shanghai 200030 China Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809

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Premarket Notification 510(k) Submission-510(k) Summary Report No.: A20060121

Email: Diana.hong@mid-link.net

Predicate Device 4.

The Legally Marketed Contact Lens Case as predicate devices is identified as followings:

i-Promotions Contact Lens Case (K042578) Manufactured by: i-Promotions, Inc. 9522 Gravois Rd. St. Louis, MO 63123

Device Description 5.

applicant device of Contact Lens Case is a device intended to be used The by the contact lens wearer or practitioner for storing contact lenses while not being worn. The applicant device is not sterile and not for heat-disinfection.

Applicant Device Variants: SL-295, SL-298, SL-326, SL-338, SL-316, SL-511, SL-800, SL-863, SL-884, SL-886, SL-869, SL-876, SL-880, SL-899

All the variant models as mention above follow the same design principle with the same intended use. The only difference is the dimension and appearance of each model, which do no effect on the usage and intended use and just for commercial purpose.

The applicant device of Contact Lens Case consists of 2 parts: case body and case cover. The case body is based with adjoining dual wells for the containment of fluid, and the cap is designed for screwing. All the variant models of the applicant device have a capacity of over 1.5 ml in each case well. And the inner height of the all well 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.

The applicant device of Contact Lens Case made of 2 types of material of Polypropylene (PP) and Acrylonitrile - butadiene - styrene copolymer (ABS) for each variant model.

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Premarket Notification 510(k) Submission—510(k) Summary
Report No.: A20060121

Substantially Equivalence Determination 6.

Comparison Table of the Applicant Device and Predicate Device of Single Lumen

Comparison Elements	Applicant Device	Predicated Device
Device Name	Multiple Brand Names	2) i-Promotions Contact Lens Case (K042578)
Classification Name	Contact Lens Case	Contact Lens Case
Product Code	LRX	LRX
Comparison Statement	The applicant device has same classification information as the predicate device.
Intended Use	The Applicant contact lens case is a lens care product to beused by the contact lens wearer or practitioner for storing contactlenses while not being worn. The applicant device is not designedfor heat disinfecting system. Use only with chemical disinfection.	i-Promotions Contact Lens Case is intended for storageduring disinfection of soft, rigid gas permeable or hardcontact lenses. Not to be used with heat disinfection. Useonly with chemical disinfection.
Indications	Storage and Disinfection of Soft, Rigid Gas Permeableor Hard	Storage and Disinfection of Soft, Rigid Gas Permeableor Hard
Comparison Statement	The applicant device has same indications and intended use as the predicate device.
Disinfection Type	Chemical DisinfectionNot Heat-Disinfection	Chemical DisinfectionNot Heat-Disinfection
Design	Two adjoining Wells Screwed with Screw Topinto Which	Two adjoining Wells Screwed with Integral Hinged Cap into WhichRespective Lenses are Immersed
Main Material	SK Corporation Polypropylene (PP) R370Y withcertificated quality	Dow Chemical Company Low Density Polyethene DowProduct
	Acrylonitrile - butadiene - styrene copolymer (ABS) PA -757K	#9931 See 510(k) (K993486)
	Carbazole violet (Pigment Violet 23) (CAS Reg. No.6358-30-1, Color Index No. 51319)
Comparison Statement		The applicant device has similar product design as the predicate device. The only difference is the ABS material

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	Effectiveness Elements
		Two adjoining Wells Screwed with Integral Hinged Cap into Which
		Respective Lenses are Immersed
Comparison Statement		The applicant device has same performance effectiveness as the predicate device.
Safety Elements		Polypropylene (PP) R370Y	Low Density Polyethene Dow Product #9931
	In Vitro Cyto-toxicity	No Cyto-toxicity	In Vitro Cyto-toxicity	No Cyto-toxicity
	Delayed-typeHypersensitivity	No delayed dermal contactsensitization	Delayed-type Hypersensitivity	No delayed dermal contact sensitization
	Eye Irritation	No intracutaneous reactivity	Eye Irritation	No intracutaneous reactivity
	Systemic Toxicity	No systemic toxicity	Systemic Toxicity	No systemic toxicity
		Acrylonitrile - butadiene - styrene copolymer (ABS)
		PA - 757K
	In Vitro Cyto-toxicity	No Cyto-toxicity
	Delayed-typeHypersensitivity	No delayed dermal contactsensitization
	Eye Irritation	No intracutaneous reactivity
	Systemic Toxicity	No systemic toxicity
		Polypropylene (PP) R370Y with colorant of Carbazole violet
	In Vitro Cyto-toxicity	No Cyto-toxicity
	Delayed-typeHypersensitivity	No delayed dermal contactsensitization
	Eye Irritation	No intracutaneous reactivity
	Systemic Toxicity	No systemic toxicity
Comparison Statement		The applicant device has same performance safety as the predicate device

Premarket Notification 510(k) Submission—510(k) Summary

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rket Notification 510(k) Submission-510(k) Summission-510(k) Summit No.: A20060121

SULT OF COMPARIS

same performano The applican device has same classion information, same intended use, similar product design,

Conclusion

The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore is applicant device in the spelicant device in the

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Effectiveness and Safety Considerations 7.

Effectiveness:

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

Safety Considerations:

The test results of biocompatibility of Polypropylene (PP) contact lens (SL-884 is sampled for the test) are presented as Table IV-5 for the consideration of Biological Specifications.

The test results of biocompatibility of Acrylonitrile - butadiene - styrene copolymer (ABS) contact for the test) are presented as Table IV-6 for the lens case (SL-800 is sampled consideration of Biological Specifications

The test results of biocompatibility Polypropylene (PP) contact lens case with colorant Carbazole is sampled for the test) are presented as (SL-295 vjolet (Pigment Violet 23) IV-7 for the consideration of Biological Specifications. Table

Per 21 CFR 73.3107, Carbazole violet (Pigment Violet 23) (CAS Reg. No. 6358-30-1, Color Index No. 51319) is exempt from the certification requirement of 721(c) of FD&C Act.

Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility

The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.

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Public Health Service

Image /page/6/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ningbo Kaida Rubber and Plastic Technology Co., Lt c/o Marc M. Mouser Underwriters Laboratories, Inc. Laboratory and Testing 2600 NW Lake Rd. Camas, WA 98607

MAY - I 2007

Re: K071081

Trade/Device Name: Contact Lens Case (Multiple Brand Names) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: March 1, 2007 Received: April 17, 2007

Dear Mr. Mouser:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 - Marc M. Mouser

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

M.B. Eichelman, M.D.

Malvina B. Evdelman, 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

ා දූ

Pending KO7/08) 510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: _Contact Lens Case

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)	√
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number	K071081	Page 1 of 1
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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.”