(314 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and functionality of a contact lens storage case, with no mention of software, algorithms, or data processing.
No
The device is intended for the storage of contact lenses for disinfection, not for treating a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that the device is intended for "the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses" and "for storage during chemical disinfection only." It does not mention any diagnostic purpose.
No
The device description clearly outlines physical components (case body, case lid, wells) made of ABS material, and the performance studies involve physical testing (leakage, biocompatibility). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the storage of contact lenses during chemical disinfection. This is a physical process related to the care and maintenance of a medical device (contact lenses), not a diagnostic test performed in vitro on biological samples.
- Device Description: The description details the physical characteristics and materials of a container designed to hold contact lenses and fluid. It does not describe any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical integrity (leakage) and biocompatibility of the case, which are relevant to a device that comes into contact with contact lenses and disinfection solutions, but not to an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This contact lens case does not perform any such function.
N/A
Intended Use / Indications for Use
The "OWL Contact Lens Case" and "DOG Contact Lens Cases" in this application are a device 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 (comma separated list FDA assigned to the subject device)
LRX
Device Description
The "OWL Contact Lens Case" and "DOG Contact Lens Case" are medical device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lid. The case body is based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing.
"OWL Contact Lens Case" has a well diameter of 27 mm, well capacity of 5.5 mL, and overall dimension of 71 x 38.5 x 17 mm (length x width x height). The case body is in blue color and case lids are in white and black colors. Inside of the lid has only white color and has no black color.
"DOG Contact Lens Case" has a well diameter of 25 mm, well capacity of 4.8 mL, and dimension of 69.5 x 38 x 14 mm (length x width x height). The case body is in blue color and case lids are in blue, black and white color. Inside of the lid has only blue color and has no white and black color.
Contact lenses can be fully immersed into the well from both models accommodates all lenses currently being sold in the market. The bottom of each well is marked with L (left) or R (right).
The applicant device of Contact Lens Case is made of Acrylonitrile - butadiene - styrene copolymer (ABS).
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)
Leakage Testing: Production units of both OWL Contact Lens Cases and DOG Contact Lens Cases have undergone leakage testing. 128 combinations of different tops and bottoms were filled to 2/3 with liquid. Each set was turned upside down for 15 minutes and the tests were repeated 3 times. None of the tested lens cases showed any leakage and all of the Leakage Tests passed successfully.
Biocompatibility Testing: Tests were conducted following the recommended procedures outlined in the respective consensus standards.
- Cytotoxicity (ISO 10993-5): No cytotoxicity
- Eye Irritation (ISO 10993-10): No Eye irritation
- Systematic Toxicity (ISO 10993-11): No systematic toxicity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
0
FEB 1 2 2014
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 Identification
Ningbo Lishunda Electronics Co., Ltd. 13 Lishan Guangming Road Yuyao, Zhejiang Province, China Tel: 86- 574-62240910 Submitter's FDA Registration Number: N/A
US Agent and Contact Person
Charles Shen Manton Business and Technology Services 853 Dorchester LN, Unit-B Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: January 3, 2014
| Device Name: | |
|---|---|
| Proprietary Name: | "OWL Contact Lens Cases" and "DOG Contact Lens |
| Case" (or other clients private labeling) | |
| Common Name: | Contact Lens Case |
| Classification Name: | Soft (Hydrophilic) Contact Lens Care Products |
| Device Classification: | 2 |
| Regulation Number: | 21 CFR 886.5928 |
| Panel: General | Ophthalmic |
| Product Code: | LRX |
Predicate Device Information:
- (1) K120904. "The Polaris Dial-a-Date Contact Lens Case", manufactured by "Reliance Design & Manufacture Corp." in Tainan, Taiwan
Device description:
The "OWL Contact Lens Case" and "DOG Contact Lens Case" are medical device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lid. The case body
1
is based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing.
"OWL Contact Lens Case" has a well diameter of 27 mm, well capacity of 5.5 mL, and overall dimension of 71 x 38.5 x 17 mm (length x width x height). The case body is in blue color and case lids are in white and black colors. Inside of the lid has only white color and has no black color.
"DOG Contact Lens Case" has a well diameter of 25 mm, well capacity of 4.8 mL, and dimension of 69.5 x 38 x 14 mm (length x width x height). The case body is in blue color and case lids are in blue, black and white color. Inside of the lid has only blue color and has no white and black color.
Contact lenses can be fully immersed into the well from both models accommodates all lenses currently being sold in the market. The bottom of each well is marked with L (left) or R (right).
The applicant device of Contact Lens Case is made of Acrylonitrile - butadiene - styrene copolymer (ABS).
Intended Use:
The "OWL Contact Lens Case" and "DOG Contact Lens Cases" in this application are a device 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.
Comparison to Predicate Devices
The "OWL Contact Lens Case" and "DOG Contact Lens Cases" are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- K120904, "The Polaris Dial-a-Date Contact Lens Case", manufactured by (1) "Reliance Design & Manufacture Corp." in Tainan, Taiwan
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
2
| Description | Our Device | Predicate Device (K120904) |
|---|---|---|
| Indication for | ||
| Use | The "OWL Contact Lens Case" and "DOG | |
| Contact Lens Cases" in this application are a | ||
| device 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 Polaris Dial-a-Date Contact Lens | |
| Case 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. | ||
| Basic Design | Two adjoining wells with screw down lids | Same |
| Materials | Acrylonitrile-Butadiene-Styrene Copolymer | Polypropylene and other polymer |
| mixture | ||
| Size | OWL: 71 x 38.5 x 17 mm (length x width x | |
| height) | ||
| DOG: 69.5 x 38 x 14 mm (length x width x | ||
| height) | 68 x 32 x 21.5 mm (length x width x | |
| height) | ||
| Volume | 5.5 mL (OWL) and 4.8 (DOG) | 4.4 mL |
| Colors | Three outer lid colors (white, black and blue) | Four outer lid colors |
Table 5.1: Comparison of Intended Use, Design, and Material
Our device of OWL and DOG Contact Lens Cases are the same with the predicate device in indications for use and basic design, similar to predicate devices in geometry and dimension. Our device and the predicate device have some minor differences in material and color, which will be discussed below.
The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results met all relevant requirements in the test standards, and are comparable to the predicate device.
| Description | Our Device | Predicate Device (K120904) |
|---|---|---|
| Cytotoxicity (ISO 10993-5) | No cytotoxicity | No cytotoxicity |
| Eye Irritation (ISO 10993-10) | No Eye irritation | No Eye irritation |
| Systematic Toxicity (ISO 10993-11) | No systematic toxicity | No systematic toxicity |
| Leakage Test | No leakage | No leakage |
Table 5.2: Comparison of Biocompatibility and Performance Testing
3
Our device and the predicate device differ in the following three areas
-
(1) Our device is made from Acrylonitrile-Butadiene-Styrene Copolymer and has two colors on the outer lid, while the predicate device is made from polypropylene (95%) and other unspecified polymer mixtures (5%).
This difference does not affect the effectiveness and safety of our devices. Our device has been tested for cytotoxicity, eye irritation, and systemic toxicity. All results show that the material is not cytotoxic, causes no ocular irritation, and has no systemtic toxicity. -
(2) Our device has three colors on the outer lid, while the predicate device has four colors on the outer lid.
This difference does not affect the effectiveness and safety of our devices. The color additives we use are medical grade. Additionally, the device (with the color additives) has been tested for biocompatibility, and results show that the material is not cytotoxic, causes no sensitization and irritation, and has no systematic toxicity. -
(3) Other minor differences that do not affect the safety and performance: the predicate device has a moveable part on the top lid to set a reminder while our device has a plain top.
A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:
Leakage Testing: Production units of both OWL Contact Lens Cases and DOG Contact Lens Cases have undergone leakage testing. 128 combinations of different tops and bottoms were filled to 2/3 with liquid. Each set was turned upside down for 15 minutes and the tests were repeated 3 times.
None of the tested lens cases showed any leakage and all of the Leakage Tests passed successfully.
A brief discussion of the clinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Clinical data is typically not needed for contact lens case.
Substantial Equivalent Conclusions
Based on the comparison of intended use, design, materials, and performance, both OWL Contact Lens Cases and DOG Contact Lens Cases are substantial equivalent to its predicate devices.
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using only black and white, and is designed to be easily recognizable.
February 12, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ningbo Lishunda Electronics Co. Ltd. % Mr. Charles Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534
Re: K130930
Trade/Device Name: OWL Contact Lens Case DOG Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: January 8, 2014 Received: January 9, 2014
Dear Mr. Shen:
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. Ilisting 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 or any Federal statutes and regulations administered by other Federal agencies.
5
Page 2 - Mr. Charles Shen
・・・
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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for 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
6
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K 130930
Device Name
OWL Contact Lens Case; DOG Contact Lens Case
Indications for Use (Describe)
The "OWL Contact Lens Case" and "DOG Contact Lens Cases" are a device intended for the storage of soft (hydrophilio), 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)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ..............................................................................................................................................................................
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Leonid Livshitz 2014.02.10 17
7
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."