(68 days)
No
The device description and performance studies focus on the physical properties and functionality of a contact lens case, with no mention of AI or ML.
No
The device is a contact lens case used for storage and chemical disinfection of contact lenses, which does not provide a therapeutic effect on the body but rather maintains the sterility of the contact lenses.
No
The device is a contact lens case intended for storage and chemical disinfection of contact lenses, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical contact lens case made of plastic with lids and hinges, and the performance studies focus on physical properties like leakage and biocompatibility. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Contact Lens Case Round Glasses is designed for the storage of contact lenses during chemical disinfection. It does not perform any diagnostic testing on biological samples.
- Intended Use: The intended use clearly states "for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only." This is a storage and disinfection aid, not a diagnostic tool.
The information provided about the device's materials, dimensions, leakage testing, and biocompatibility are all relevant to its function as a contact lens storage case, not as an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
LRX
Device Description
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).
Materials Used:
Hinge (Part 1): Stainless Steel
Glasses Frame (Part 2): PC (Covestro 2805)
Glasses (Part 3): PC (Covestro 2805)
Anti Water Layer (Part 4): TPE (Zhongsuwang)
Cups (Part 5): ABS (Chi Mei 757)
Holder/Backside (Part 6): PC (Covestro 2805)
Colorants: Critsal Tiona
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test: No Clinical Test Were Performd
Anti Leakage: Units of the Contact Lens Case Round Glasses have undergone leakage testing. 48 products were filled to 2/3 with liquid. Each set was turned upside down for 15 minutes and the test repeated for 4 times. None of the tested lens cases showed any leakage and all of the Leakage Test Passed Successfully.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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.
1
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 & Foreign
Manufacture
ldentification | FiftyTwoWays Ltd
Unit 4, 7th Floor, Flat B, Grand Industrial Building
159-165 Wo Yi Hop Road, Kwai Chung
HONG KONG
tel: +852 27352527
E-mail: jos@fiftytwoways.com
Contact: 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 Glasses
Contact Lens Case Round Glasses
Contact Lens Case Round Glasses
Contact Lens Case
Soft (hydrophilic) contact lens care products
Class II
21 CFR 886.5928
Ophthalmic
LRX | |
| Predicate Device
Information: | K130930
OWL Contact Lens Case, manufactured by Ningbo Lishunda
Electronics Co Ltd in Ningbo, CHINA | |
| Device Description: | 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) | |
| | 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 Steel
PC (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 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. | |
| Clinical Test | No Clinical Test Were Performed | |
| Anti Leakage: | Units of the Contact Lens Case Round Glasses have undergone
leakage testing. 48 products were filled to 2/3 with liquid. Each set
was turned upside down for 15 minutes and the test repeated for 4
times. None of the tested lens cases showed any leakage and all of
the 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 of
IFU and technological
| characteristics | |||
|---|---|---|---|
| Indication for | |||
| Use | Our Device | Predicate Device | |
| (K130930) | |||
| 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 Owl Contact Lens Case | ||
| is intended for the storage | |||
| of soft (hydrophilic), rigid | |||
| gas permeable, and/or | |||
| hard contact lens cases. | |||
| Used for storage during | |||
| chemical disinfection only. | |||
| Not for use during heat | |||
| disinfection | |||
| Materials: | PC (Covestro 2805), TPE | ||
| (Zhongsuwang), ABS (Chi | |||
| Mei 757). Critsal Tiona | Acrylonitrile-Butadiene | ||
| Styrene Copolymer | |||
| Basic Design | Two adjoining wells with | ||
| snap lids | Two adjoining wells with | ||
| screw 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.