(57 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a simple contact lens case, with no mention of AI or ML capabilities.
No
The device is described as a simple container for storing contact lenses during chemical disinfection, not for treating any medical condition.
No
Explanation: The device is described as a contact lens case used for storage during chemical disinfection. Its purpose is to hold contact lenses and cleaning solution, not to diagnose a condition or disease. The performance studies focus on material biocompatibility and leakage, not diagnostic accuracy.
No
The device description explicitly states it is a physical object made of polypropylene and polyethylene, designed for storing contact lenses. It does not mention any software components.
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 on a biological sample.
- Device Description: The description clearly states it's a simple container for storing contact lenses and cleaning solution. It doesn't mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
- Performance Studies: The performance studies focus on biocompatibility and leakage, which are relevant to a container for contact lenses and cleaning solutions, but not to the performance of a diagnostic test.
In summary, the device is a container for contact lens care, not a diagnostic tool.
N/A
Intended Use / Indications for Use
For storage of soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
The Contact Lens Case is a simple device made with a polypropylene base and a polyethylene lid to store soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. This device is manufactured only for chemical disinfections with approved chemical cleaning agents to clean contact lenses.
The physical style is simple with a base volume of 4.8 milliliter and dimensions of 6.25 mm wide and 9.25 mm high. This provides sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately cover the lenses for cleaning.
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)
Biocompatibility testing was conducted as noted below:
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. The purpose of the test is to assess the potential cytotoxicity of test article Contact Lens Case in the In Vitro Cytotoxicity Test using L929 mouse fibroblast cells (From ATCC), which was sensitive to extractable cytotoxic articles. Under the conditions of this study, the test articles Contact Lens Case extract did not show potential toxicity to L-929 cells with polar and non-polar extracts.
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The test was designed to evaluate the potential of a test article extract to cause ocular irritation. According to what observed, the response of ocular on testing side does not exceed that on the control side. Thus, it is identified as grade 0. All animals were not found abnormal clinical symptoms. except ocular reactions. All animals were normal weight change. Under the conditions of this study, the test article extracts showed no significant evidence of causing ocular irritation.
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The purpose of this test is to evaluate the potential of a test article extract to cause skin sensitization in the guinea pig. All animals were not found abnormal clinical symptoms except skin reactions. All animals were normal weight change. The positive rate of all test group animals was 0%. The positive rate of all negative control animals was 0%. Under the conditions of this study, the test article extract showed no significant evidence of causing skin sensitization in the guinea pig.
ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. The purpose of this testing was to evaluate the potential of a test article extract to cause acute systemic toxicity in mouse. No animals were found with any abnormal clinical symptoms.
All animals had normal weight change. Under the conditions of this study, the test article extracts showed no significant evidence of causing acute systemic toxicity in the mice.
Leakage testing was conducted to the contact lens case samples. 240 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 contact lens cases showed any leakage and all passed the leakage tests successfully.
The test results show the Contact Lens Case complies with the requirement as defined.
No clinical tests were performed.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
Ningbo Yinzhou Zonghai Artware Co., Ltd. c/o Mr. Charles Mack IRC 7808 Rush Creek Drive Pasco. WA 99301
Re: K162869
Trade/Device Name: 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: September 28, 2016 Received: October 13, 2016
Dear Mr. Mack:
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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 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
2
Indications for Use
510(k) Number (if known) K162869
Device Name Contact Lens Case
Indications for Use (Describe)
For storage of soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.
| 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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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: September 30, 2016
- Company and Correspondent making the submission:
Name - Ningbo Yinzhou Zonghai Artware Co., Ltd. Address - Honglianchi, Guangsheng Village, Jishigang Town, Yinzhou District, Ningbo City Zhejiang Province, China 315172 Tel: +86-574-88003277 Fax: +86-574-88003255 Contact - Mr. Weng Changhai General Manager Email – : sales1@zonghai.net
US Correspondent Name- IRC, Charles Mack Address- 2091 Oak Drive, Lake Havasu City, Arizona 86406 Tel: 931-625-4938 Principal Engineer Email- charliemack@irc-us.com
-
- Device :
| Trade/proprietary name | : Contact Lens Case |
|---|---|
| Common Name | : Contact Lens Case |
| Classification Name | : case, contact lens |
-
- Predicate Devices :
| Manufacturer | Predicate Device | 510(k)
Number | Submitted Device |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------|-------------------|
| Ni Hau
Industrial Co.,
Ltd. | Cat Contact Lens Case
Sunglasses Contact Lens
Case
1st Contact Lens Case
Geeky Eye Contact Lens
Case | K142717 | Contact Lens Case |
-
- Classifications Names & Citations : 21CFR 886.5928, LRX, Contact Lens Case
4
- Description :
The Contact Lens Case is a simple device made with a polypropylene base and a polyethylene lid to store soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. This device is manufactured only for chemical disinfections with approved chemical cleaning agents to clean contact lenses.
The physical style is simple with a base volume of 4.8 milliliter and dimensions of 6.25 mm wide and 9.25 mm high. This provides sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately cover the lenses for cleaning.
6. Indication for use:
For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. Use for storage during chemical disinfections only. DO NOT USE WITH HEAT
7. Testing summary:
Biocompatibility testing was conducted as noted below:
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. The purpose of the test is to assess the potential cytotoxicity of test article Contact Lens Case in the In Vitro Cytotoxicity Test using L929 mouse fibroblast cells (From ATCC), which was sensitive to extractable cytotoxic articles. Under the conditions of this study, the test articles Contact Lens Case extract did not show potential toxicity to L-929 cells with polar and non-polar extracts.
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The test was designed to evaluate the potential of a test article extract to cause ocular irritation. According to what observed, the response of ocular on testing side does not exceed that on the control side. Thus, it is identified as grade 0. All animals were not found abnormal clinical symptoms. except ocular reactions. All animals were normal weight change. Under the conditions of this study, the test article extracts showed no significant evidence of causing ocular irritation.
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The purpose of this test is to evaluate the potential of a test article extract to cause skin sensitization in the guinea pig. All animals were not found abnormal clinical symptoms except skin reactions. All animals were normal weight change. The positive rate of all test group animals was 0%. The positive rate of all negative control animals was 0%. Under the conditions of this study, the test article extract showed no significant evidence of causing skin sensitization in the guinea pig.
5
ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. The purpose of this testing was to evaluate the potential of a test article extract to cause acute systemic toxicity in mouse. No animals were found with any abnormal clinical symptoms.
All animals had normal weight change. Under the conditions of this study, the test article extracts showed no significant evidence of causing acute systemic toxicity in the mice.
Leakage testing was conducted to the contact lens case samples. 240 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 contact lens cases showed any leakage and all passed the leakage tests successfully.
The test results show the Contact Lens Case complies with the requirement as defined.
- Comparison with predicate device:
Ningbo Yinzhou Zonghai Artware Co., Ltd. believes that the Contact Lens Case is substantially equivalent to the (K142717) Ni Hau Industrial Co., Ltd. Cat Contact Lens Case; Sunglasses Contact Lens Case; 1st Contact Lens Case; Geeky Eye Contact Lens Case.
6
| Element of
| comparison | Subject Device | Predict Device |
|---|---|---|
| Company | Ningbo Yinzhou Zonghai Artware | |
| Co., Ltd. | Ni Hau Industrial Co., Ltd. | |
| FDA510(K) Number | N/A | K142717 |
| Device Name | Contact Lens Case | Cat Contact Lens Case |
| Sunglasses Contact Lens Case | ||
| 1st Contact Lens Case | ||
| Geeky Eye Contact Lens Case | ||
| Classification | CFR 886.5928, Class II | CFR 886.5928, Class II |
| Product Code | LRX | LRX |
| Indications for Use | For storage of soft (hydrophilic), | |
| hard, and rigid gas permeable | ||
| contact lenses during chemical | ||
| disinfections. Use for storage | ||
| during chemical disinfections only. | ||
| DO NOT USE WITH HEAT | For storage of soft (hydrophilic), | |
| hard, and rigid gas permeable | ||
| contact lenses during chemical | ||
| disinfection. Use for storage during | ||
| chemical disinfections only. DO NOT | ||
| USE WITH HEAT. | ||
| Case Dimension | 63x32x16mm | Cat: 65 x 37 x 14mm |
| Sunglasses: 71 x 31 x 14mm | ||
| 1st Contact: 60 x 39.6 mm | ||
| Geeky eyes: 80 x 32 x 21mm | ||
| Single Well | ||
| Capacity Volume | 4.8ml | Cat: 3ml |
| Sunglasses: 2.5ml | ||
| 1st Contact: 3ml | ||
| Geeky eyes: 2.8ml | ||
| Device Material | BASE: Polypropylene(PP) | |
| LID: Polyethylene(PE) | Acrylonitrile Butadene Styrene(ABS) | |
| Device | ||
| Construction | Shaped base with two wells to hold | |
| the fluid and two screw lids for the | ||
| Left and Right eyes of contact | ||
| lenses. | Shaped base with two wells to hold | |
| the fluid and two screw lids for the | ||
| Left and Right eyes of contact | ||
| lenses. | ||
| Screw On Caps | Yes | Yes |
| R/L indications | ||
| on chamber bottoms | ||
| and/or top | Yes | Yes |
| Biocompatibility | Complying with ISO10993-1: |
- Cytotoxicity (ISO 10993-5)
- Skin sensitization (ISO10993-10)
- Ocular Irritation (ISO 10993-10)
-SystematicToxicity (ISO10993-11) | PASS the following test: - Cytotoxicity (ISO 10993-5)
- Eye Irritation (ISO 10993-10)
- Systematic Toxicity (ISO10993-11) |
| Disinfection Type | Chemical disinfection, not heat
disinfection. | Chemical disinfection, not heat
disinfection. |
| Sterilization | Not sold sterile | Not sold sterile |
7
9. Safety and Performance Data:
| Serial
| Number/Version | Standard and Description | Scope |
|---|---|---|
| Performance Standards | ||
| ISO10993-5: 2009 | Biological evaluation of medical devices -- Part 5: Tests | |
| for In Vitro cytotoxicity | Biocompatibility | |
| Testing | ||
| ISO10993-10: | Biological evaluation of medical devices - Part 10: Tests | |
| for irritation and skin sensitization | Biocompatibility | |
| Testing | ||
| ISO10993-10: | Biological evaluation of medical devices - Part 10: Tests | |
| for ocular irritation | Biocompatibility | |
| Testing | ||
| ISO10993-11: | Biological evaluation of medical devices - Part 11: Tests | |
| for systemic toxicity | Biocompatibility | |
| Testing |
-
- Clinical: No clinical tests were performed.
The basic design of the submitted device specifications is substantially the same 11. as the predicate, with differences in the aesthetic design and plastic material. Though the plastic material is different, biocompatibility testing has verified that the submitted device is safe for use.
- Clinical: No clinical tests were performed.
All the labeling and characteristics of the submitted OTC Contact Lens Case is the same as the predicate devices and most typical OTC contact lens cases currently on the market. The submitted device and predicate both are used for storage and disinfection by chemical solution of soft (hydrophilic), hard, and rigid gas permeable contact lenses.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Ningbo Yinzhou Zonghai Artware Co., Ltd. concludes that the Contact Lens Case is substantially equivalent to predicate devices as described herein.
- Conclusions:
END