(68 days)
The CONTACT LENS CASE ROUND GLASSES is intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
The Contact Lens Case Round Glasses is leak-proof and made from durable plastic with secure, snap lids. Note: can be used with hard and soft contact lenses; for chemical disinfection only; rinse case thoroughly before initial use; replace contact case every 2 months. The secure snap lids are connected to the body by stainless steel hinges and securely close by use of the silicon seal within the plastic Each compartment has a capacity of 4,4ml and diameter of 26,5mm and an overall dimension of 76mm x 29mm x 17mm The Case body is in White Color and the Lids in Black Color with transparent windows. Contact lenses can be fully immersed in each compartment, and each compartment fit all standard lenses currently being sold in the market. The side of each compartment is marked with L (left) or R (right)
The document describes a contact lens case, not an AI device, so many of the requested criteria related to AI performance, such as MRMC studies, ground truth establishment, or training set size, are not applicable.
However, based on the provided text, I can extract the relevant information regarding the acceptance criteria and the study performed for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Anti-Leakage | None of the tested lens cases showed any leakage. All of the Leakage Test Passed Successfully. |
| Cytotoxicity | No cytotoxicity |
| Eye Irritation | No Eye Irritation |
| Systemic Toxicity | No systemic Toxicity |
2. Sample Size for Test Set and Data Provenance
- Anti-Leakage Test: 48 products (units of Contact Lens Case Round Glasses) were used. The provenance is internal testing performed by the manufacturer, FiftyTwoWavs Ltd, presumably in Hong Kong S.A.R. (based on their address). This appears to be a prospective test as it was performed on units of their product.
- Biocompatibility Tests (Cytotoxicity, Eye Irritation, Systemic Toxicity): The document states "All results show that the material is not cytotoxic, causes no eye irritation and has no systematic cytotoxic." However, it does not explicitly state the number of samples or the specific methodology/sample size used for these biocompatibility tests (ISO-10993-5, ISO 10993-10, ISO-10993-11). The results were submitted in the application.
3. Number of Experts and Qualifications
Not applicable for tests described (leakage, biocompatibility). These are laboratory/engineering tests, not expert-adjudicated clinical assessments.
4. Adjudication Method for Test Set
Not applicable. The tests performed are objective physical/chemical assessments (e.g., visual inspection for leakage, lab assays for biocompatibility).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a contact lens case, not an AI-assisted diagnostic or treatment device. No MRMC study was performed or is relevant. The submission explicitly states: "No Clinical Test Were Performed."
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical product (contact lens case), not an algorithm or software.
7. Type of Ground Truth Used
- Anti-Leakage: Empirical observation (visual inspection for liquid leakage).
- Biocompatibility: Established ISO standards (ISO-10993-5, ISO 10993-10, ISO-10993-11) for evaluating material safety. The "ground truth" is defined by the passing criteria of these standardized tests.
8. Sample Size for Training Set
Not applicable. This device is a physical product and does not involve AI/machine learning, therefore no training set is relevant.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2017
FiftyTwoWavs Ltd Jos Reinders Official Correspondent Unit 4, 7th Floor, Flat B, Grand Ind. Bldg, 159-165 Wo Yi Hop Rd, Kwai Chung, Hong Kong S.A.R
Re: K171163 Trade/Device Name: Contact Lens Case Round Glasses Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: April 4, 2017 Received: May 2, 2017
Dear Jos Reinders:
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.
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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); 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"
(21 CFR 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,
Denise L. Hampton -S
for Malvina 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)
Device Name
Contact Lens Case Round Glasses
Indications for Use (Describe)
The CONTACT LENS CASE ROUND GLASSES is intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
| 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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510 (k) summary
This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92
| Submitter & ForeignManufactureldentification | FiftyTwoWays LtdUnit 4, 7th Floor, Flat B, Grand Industrial Building159-165 Wo Yi Hop Road, Kwai ChungHONG KONGtel: +852 27352527E-mail: jos@fiftytwoways.comContact: Jos Jacob Reinders | |
|---|---|---|
| Date of Initial Summary: | 04.04.2017 | |
| Device Name:Proprietary Name:Trade Name:Common Name:Classification Name:Device Classification:Regulation Number:Panel:Product Code: | Contact Lens Case Round GlassesContact Lens Case Round GlassesContact Lens Case Round GlassesContact Lens CaseSoft (hydrophilic) contact lens care productsClass II21 CFR 886.5928OphthalmicLRX | |
| Predicate DeviceInformation: | K130930OWL Contact Lens Case, manufactured by Ningbo LishundaElectronics Co Ltd in Ningbo, CHINA | |
| Device Description: | The Contact Lens Case Round Glasses is leak-proof and made from durableplastic with secure, snap lids. Note: can be used with hard and soft contactlenses; for chemical disinfection only; rinse case thoroughly before initialuse; replace contact case every 2 months.The secure snap lids are connected to the body by stainless steel hinges andsecurely close by use of the silicon seal within the plasticEach compartment has a capacity of 4,4ml and diameter of 26,5mm and anoverall dimension of 76mm x 29mm x 17mmThe Case body is in White Color and the Lids in Black Color with transparentwindows.Contact lenses can be fully immersed in each compartment, and eachcompartment fit all standard lenses currently being sold in the market. Theside of each compartment is marked with L (left) or R (right) | |
| Materials Used:Hinge (Part 1):Glasses Frame (Part 2):Glasses (Part 3):Anti Water Layer (Part 4):Cups (Part 5):Holder/Backside (Part 6):Colorants: | Stainless SteelPC (Covestro 2805)PC (Covestro 2805)TPE (Zhongsuwang)ABS (Chi Mei 757)PC (Covestro 2805)Critsal Tiona | |
| Indications for Use: | The CONTACT LENS CASE ROUND GLASSES is intended for the storageof soft (hydrophilic), rigid gas permeable, and/or hard contact lenses.Used for storage during chemical disinfection only.Not for use during heat disinfection. | |
| Clinical Test | No Clinical Test Were Performed | |
| Anti Leakage: | Units of the Contact Lens Case Round Glasses have undergoneleakage testing. 48 products were filled to 2/3 with liquid. Each setwas turned upside down for 15 minutes and the test repeated for 4times. None of the tested lens cases showed any leakage and all ofthe Leakage Test Passed Successfully | |
| Comparison to Predicate Devices: | The Contact Lens Case Round Glasses is compared with the following predicate device in terms of intended use, design, material, specifications and performace* K130930 (Owl Contact Lens Case) |
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The following table shows similarities and differences of use, design, and materials between our device and the predicate device
| Table 1: Comparison ofIFU and technologicalcharacteristics | |||
|---|---|---|---|
| Indication forUse | Our Device | Predicate Device(K130930) | |
| The CONTACT LENS CASEROUND GLASSES isintended for the storageof soft (hydrophilic), rigidgas permeable, and/orhard contact lenses. Usedfor storage duringchemical disinfectiononly. Not for use duringheat disinfection. | The Owl Contact Lens Caseis intended for the storageof soft (hydrophilic), rigidgas permeable, and/orhard contact lens cases.Used for storage duringchemical disinfection only.Not for use during heatdisinfection | ||
| Materials: | PC (Covestro 2805), TPE(Zhongsuwang), ABS (ChiMei 757). Critsal Tiona | Acrylonitrile-ButadieneStyrene Copolymer | |
| Basic Design | Two adjoining wells withsnap lids | Two adjoining wells withscrew down lids | |
| Size | 76x29x17mm | 711x38,5x17mm | |
| Volume | 4.4ml | 5.5ml | |
| Colors | White. Black | Black. White. Blue |
Our design of Contact Lens Case Round Glasses are the same with the predicate device in indications for use and adding a fun design to the item. Although there are differences in the outlook they serve the same indication for use. Our device and the predicate device have some minor difference in material and color which are described in above table 1 and in the text below.
Table 2: Comparison of Biocompatibility
| Our Device | Predicate Device(K130930) | |
|---|---|---|
| Cytotoxicity(ISO-10993-5) | No cytotoxicity | No cytotoxicity |
| Eye Irritation(ISO 10993-10) | No Eye Irritation | No Eye Irritation |
| Systemic Toxicity (ISO-10993-11) | No systemic Toxicity | No systemic Toxicity |
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Our device and the predicate device differ in the following areas:
Our device is made from PC Bayer, ABS and TPE plastics and has two colors on the outside (black and white) and has snap lids, while the predicate device is made from Acrylonitrile-Butadiene-Styrene Copolymer and has three colors and screw lids.
The above mentioned differences do not affect the effectiveness and safety of our device. Our device has been tested for cytotoxicity, eye irritation and systematic cytotoxicity. All results show that the material is not cytotoxic, causes no eye irritation and has no systematic cytotoxic.
Above mentioned test results were submitted in the application to demonstrate that the device is safe and effective and meets all requirements
Substantial Equivalence Conclusions:
Based on above comparisons our device (Contact Lens Case Round Glasses) is substantially equivalent to its predicate devices.
§ 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.”