(155 days)
No reference devices were used in this submission.
No
The device description and intended use are for a simple contact lens storage case, with no mention of any computational or analytical capabilities that would involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a contact lens case used for storing contact lenses, not for treating a disease or condition.
No
The device is a contact lens case used for storing contact lenses, not for diagnosing any condition. Its purpose is storage and chemical disinfection, not to identify or measure a medical condition.
No
The device description clearly states it is a physical product made of Polypropylene, designed for storing contact lenses.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "storing soft (hydrophilic) contact lenses while not being worn." This is a physical storage function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description reinforces the storage function and mentions the materials and design for holding contact lenses and chemical disinfection solution.
- Lack of Diagnostic Activity: There is no mention of analyzing a sample (like blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
- Performance Studies: The performance studies focus on leakage testing, which is relevant to the storage function, not diagnostic accuracy.
- Predicate Device: The predicate device is also a "Contact Lens Case," further indicating its classification as a storage device, not an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This contact lens case does not fit that description.
N/A
Intended Use / Indications for Use
Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.
Product codes
LRX
Device Description
Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. This device is not sterile and not for heat-disinfection. Use only with chemical disinfection.
There are two main series includes the variant model DC-2001, DC-3001 and DC-6001, the other includes DC-7001 and DC-8001. All these five variant models are made of Polypropylene, which follow the same design principle with the same intended use.
All the five variant models of this device have a capacity of over 1.5 ml in each case well. And the inner height of the all wells 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.
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
contact lens wearer or practitioner
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)
Summary of Non-Clinical Leakage Testing: Production units of Contact Lens Cases have undergone leakage testing. None of the tested lens cases Tests: showed any leakage and all of the Leakage Tests were passed successfully.
Summary of Clinical Tests: The subject of this premarket submission, Contact lens case did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or fabric. The profiles are arranged in a staggered formation, with the first profile being the largest and the third being the smallest. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2016
Danyang Chanxin Glasses Cases Factory c/o Mr. Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Co., Ltd Level 7, Jin Gui Business Center 982 Cunyun Road, Baiyun District, Guangzhou Guangdong, China 510420
Re: K160005
Trade/Device Name: Contact Lens Case (multiple brand names) Regulation Number: 21 CFR 886.5928 Regulation Name: Contact Lens Case Regulatory Class: Class II Product Code: LRX Dated: April 25, 2016 Received: April 28, 2016
Dear Mr. Gu:
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
1
Page 2 - Mr. Mike Gu
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" (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 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) K160005
Device Name Contact Lens Case
Indications for Use (Describe)
Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical 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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Image /page/3/Picture/1 description: The image shows a logo with a stylized flower-like design on the left and the text "诚欣 Chan Xin" on the right. The flower-like design is composed of overlapping petals in different colors, including blue, red, yellow, and cyan. The text "诚欣 Chan Xin" is written in a simple, sans-serif font, with the Chinese characters "诚欣" appearing above the English text "Chan Xin".
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
DANYANG CHANXIN GLASSES CASES FACTORY
HUADIAN CHUANGYE PARK, DANGUI ROAD, DEVELOPING ZONE, DANYANG CITY,
JIANGSUPROVINCE, CHINA
Phone: +86-511-86903193
Fax: +86-511-86903193
| Primary Contact Person: | Mike Gu |
|---|---|
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Lemon Chen |
| CEO | |
| DANYANG CHANXIN GLASSES CASES FACTORY | |
| Tel: +86-0511-86903193 | |
| Fax: +86- 0511-86903193 | |
| Email: lemon@jschanxin.com | |
| Preparing date: | 30 Dec 2015 |
| II. | |
| DEVICE | |
| Name of Device: | Contact Lens Case |
| Common/Usual Name: | Contact Lens Case |
| Classification Names: | Case, Contact Lens |
| Regulation Class: | II |
| Product Code: | LRX |
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Image /page/4/Picture/0 description: The image contains a logo with a stylized flower-like design on the left and the text "诚欣 Chan Xin" on the right. The flower-like design is composed of overlapping curved shapes in different colors, including blue, yellow, red, and black. The text "诚欣" is in Chinese characters, and "Chan Xin" is the corresponding English translation or transliteration, written in a smaller font size below the Chinese characters.
III. PREDICATE DEVICE
Contact Lens Case(K071081)
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. This device is not sterile and not for heat-disinfection. Use only with chemical disinfection.
There are two main series includes the variant model DC-2001, DC-3001 and DC-6001, the other includes DC-7001 and DC-8001. All these five variant models are made of Polypropylene, which follow the same design principle with the same intended use.
All the five variant models of this device have a capacity of over 1.5 ml in each case well. And the inner height of the all wells 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.
V. INDICATION FOR USE
Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.
VI. SUBSTANTIAL EQUIVALENCES
- Technology: The proposed device Contact lens case has similar product design as the predicate device. The major differences are due to the different design for adjoining wells with integral hinged caps or screw-top caps, the different dimension and appearance, made of the PP material with different color additives. These are not relating to the safety or effectiveness aspects. Thus they are substantially equivalent.
Summary of Non-Clinical Leakage Testing: Production units of Contact Lens Cases have
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Image /page/5/Picture/1 description: The image shows a logo with a stylized flower-like design on the left and Chinese characters along with the English words "Chan Xin" on the right. The flower-like design is composed of curved lines in various colors, including yellow, blue, red, and black. The Chinese characters are positioned above the English words, which are written in a simple, sans-serif font.
undergone leakage testing. None of the tested lens cases Tests: showed any leakage and all of the Leakage Tests were passed successfully.
Summary of Clinical Tests: The subject of this premarket submission, Contact lens case did not require clinical studies to support substantial equivalence.
The following comparison table identifies the similarities and differences of the proposed device Contact Lens Case to the legally marketed predicate device Contact Lens Case (K071081) to which substantial equivalency is claimed.
| Items | Predicate Device | Proposed Device | Discussion of
Differences |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | CONTACT LENS CASE | CONTACT LENS CASE | |
| | K071081 | | |
| Manufacturer | Ningbo Kaida Rubber &
Plastic Technology Co.,Ltd. | DANYANG
CHANXIN
GLASSES CASES FACTORY | --- |
| Device name | Multiple Brand Names | Contact Lens Case | --- |
| Classification Name | Contact Lens Case | Contact Lens Case | Identical |
| Product Code | LRX | LRX | Identical |
| Intended Use | The contact lens case is a
lens care product to be
used by the contact lens
wearer or practitioner for
storing contact lenses
while not being worn. The
device is not designed for
heat disinfecting system.
Use only with chemical
disinfection. | Contact Lens Case is a lens
care product to be used by
the contact lens wearer or
practitioner for storing
soft(hydrophilic) contact
lenses while not being
worn. Not designed for
heat disinfecting system.
Use only with chemical
disinfection. | Equivalent |
| Indications for Use | Storage and Disinfection of
Soft, Rigid Gas permeable
or Hard contact lenses
while not being worn | Storage and Disinfection of
Soft contact lenses while
not being worn | Equivalent |
| Disinfection Type | Chemical Disinfection
Not Heat-Disinfection | Chemical Disinfection
Not Heat-Disinfection | Identical |
| Items | Predicate Device | Proposed Device | Discussion of |
| | CONTACT LENS CASE | CONTACT LENS CASE | Differences |
| | K071081 | | |
| Design | Two adjoining Wells with
Screw-Top Caps | Two adjoining Wells with
Screw-Top Caps: DC-2001,
DC-3001 and DC-6001
Two adjoining Wells with
Integral-Hinged
Caps:
DC-7001 and DC-8001 | Equivalent |
| Main Materials | Polypropylene(PP) | Polypropylene(PP) | Equivalent |
| Dimension | Each case well has a
capacity of over 1.5 ml.
The inner height of the
wells exceeds 8.5mm. | Each case well has a
capacity of over 1.5 ml.
The inner height of the
wells exceeds 8.5mm. | Equivalent |
| Color | Purple | colorless, transparent
blue, transparent violet,
blue, violet, and white | Different,
the colors
of proposed
device have
been
demonstrat
ed to be
biocompati
ble safe. |
| Effectiveness | The capacity is sufficient
for contact lens to be fully
immersed
under
use
condition. | The capacity is sufficient
for contact lens to be fully
immersed
under
use
condition. | Identical |
| Safety | ISO 10993-5 Biological
evaluation of medical devices
-- Part 5: Tests for in vitro
cytotoxicity;
ISO 10993-10 Biological
evaluation of medical devices
-- Part 10: Tests for irritation
and skin sensitization
ISO 10993-11 Biological
evaluation of medical devices
-- Part 11: Tests for systemic
Toxicity. | ISO 10993-5 Biological
evaluation of medical devices
-- Part 5: Tests for in vitro
cytotoxicity;
ISO 10993-10 Biological
evaluation of medical devices
-- Part 10: Tests for irritation
and skin sensitization
ISO 10993-11 Biological
evaluation of medical devices
-- Part 11: Tests for systemic
Toxicity. | Identical |
| Sterility | No | No | Identical |
Comparison Table of Predicate device and Proposed Device
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Image /page/6/Picture/1 description: The image contains a logo with a stylized flower-like design on the left and the text "Chan Xin" in both Chinese and English on the right. The flower-like design is composed of four curved shapes in different colors: blue, yellow, red, and black. The text "Chan Xin" is written in a simple, sans-serif font, with the Chinese characters above the English text.
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Image /page/7/Picture/1 description: The image contains a logo with a stylized flower-like design on the left and the text "Chan Xin" on the right. The flower-like design is composed of overlapping curved lines in various colors, including blue, yellow, red, and teal. The text "Chan Xin" is written in a serif font, with the first word in a larger, bolder font than the second word.
VII. CONCLUSION
DANYANG CHANXIN GLASSES CASES FACTORY considers the Contact lens case to be as safe, as effective, and performance is substantially equivalent to the predicate device.