(49 days)
Not Found
No
The device description and performance studies focus on the physical properties and basic functionality of a contact lens case, with no mention of AI or ML.
No
The device is described as a storage container for contact lenses during chemical disinfection, not as a device that directly treats a medical condition or ailment.
No
Explanation: The device is intended for the storage of contact lenses during chemical disinfection, not for diagnosing any medical condition.
No
The device description clearly outlines a physical product made of polypropylene and polyethylene, designed for storing contact lenses. It describes physical components (case body, lids, wells) and physical tests (biocompatibility, leak test, color fastness), indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment.
- Device Function: The Contact Lens Case is used for the storage of contact lenses during chemical disinfection. It does not analyze any biological specimens from the human body.
- Intended Use: The stated intended use is for the storage of contact lenses, not for diagnostic purposes.
The device description and performance studies focus on the physical properties and safety of the case itself, not on any diagnostic capabilities.
N/A
Intended Use / Indications for Use
The Contact Lens Case is a device intended for 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 Contact lens case is medical device for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lids. The case body based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing.
All the four variant models of this device have a capacity of 5.3 ml to allow contact lenses fully immersed into the well, and the well from these models accommodates all lenses currently being sold in the market. In addition, the contact lens case are made of polypropylene (96%) and Polyethylene (4%), which allow the same design principle with the same intended use.
Speaking of the labeling, the inner lids of the case are marked with L (left) or R (right), meanwhile the bottom of each well is also labeled with L (left) or R (right) to distinguish the left and right lenses. In addition, at the bottom of the case body, two sides of which have labeled REPLACE MONTHLY respectively to remind user to replace the contact lens case at least once every month.
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)
Non-Clinical Performance Data:
Biocompatibility Tests:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity. The test article is considered non-cytotoxic under the conditions of the test.
- ISO 10993-10 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin sensitization. Under the conditions of this study, the Contact Lens Cases were classified as non-irritating.
- ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity. The requirements of the ISO Acute Systemic Test have been met by the test article.
Leak Test:
To prove the sealing performance of the Contact Lens Case, the device has undergone the leakage testing. The water was put inside the box, natural be locked and sloshing around 180° for 0.5 h. The result is shown that the device has passed the test successfully.
Color Fastness Test:
The Contact Lens Case also has undergone the tests of color fastness to crocking (based on AATCC 116-2013) and color fastness to light (based on AATCC TM 16.3-2014), the result has indicate the good color fastness of our device to light and crocking.
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 symbol of three human profiles facing to the right, arranged in a cascading manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
E-Link Plastic & Metal Industrial Co.,Ltd % Long Yang COO Shenzhen Hlongmed Biotech Company 1002, 10th Floor, Zhongxing Administrative Building Zhongxing Industrial Zone, Chuangye Road, Nanshan Shenzhen, China 518054 Guangdong
Re: K171539
Trade/Device Name: Contact Lens Case Model: ELENS-001-001, ELENS-001-002, ELENS-001-003, ELENS-003-001 Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: May 15, 2017 Received: May 26, 2017
Dear Long Yang:
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,
Image /page/1/Picture/10 description: The image shows the name "Denise L. Hampton -S" in a large, sans-serif font. The text is black and appears to be the focus of the image. There is a light blue watermark in the background, but it is faint and does not obscure the text.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171539
Device Name
Contact Lens Case Model: ELENS-001-001, ELENS-001-002, ELENS-001-003, ELENS-003-001
Indications for Use (Describe)
The Contact Lens Case is a device intended for 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 Druq 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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
1. Submitter
E-Link Plastic & Metal Industrial Co.,Ltd.
No. 69-40, Hsing Shuh Rd., Hsing Chung Zone, New Taipei City, Taiwan, 24262.
2. Contact Person
2.1 Primary Contact Person
Long Yang (COO) Shenzhen Hlongmed Biotech Company 1002, 10th Floor, Zhongxing Administrative Building, Zhongxing Industrial Zone, Chuangye Road, Nanshan, Shenzhen, P.R.China, 518054 Tel: 0086-755-86664986 Fax: 0086-755-86664933 E-mail: yanglong@hlongmed.com
2.2 Secondary Contact Person
Mavis Lee Sales Manager E-Link Plastic & Metal Industrial Co.,Ltd. No. 69-40, Hsing Shuh Rd., Hsing Chung Zone, New Taipei City, Taiwan. Tel : +886-2-29011777 Fax: +886-2-29017517
3. Date Prepared: May 15, 2017
4
4. Proposed Device Information
Trade name: Contact Lens Case Model: ELENS-001-001, ELENS-001-002, ELENS-001-003, ELENS-003-001 Common name: Contact Lens Case Classification name: Soft (hydrophilic) contact lens care products Review Panel: Ophthalmic Product Code: LRX Regulation Class: II Regulation Number: 21 CFR 886.5928
5. Predicate Device Information
| Manufacturer | Device Name | 510(K) Number |
|---|---|---|
| Ningbo Lishunda | ||
| Electronics Co.,Ltd | “OWL Contact Lens Cases” and “DOG | |
| Contact Lens Case” ( or other clients | ||
| private labeling) | K130930 |
6. Device Description
The Contact lens case is medical device for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lids. The case body based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing.
All the four variant models of this device have a capacity of 5.3 ml to allow contact lenses fully immersed into the well, and the well from these models accommodates all lenses currently being sold in the market. In addition, the contact lens case are made of polypropylene (96%) and Polyethylene (4%), which allow the same design principle with the same intended use.
Speaking of the labeling, the inner lids of the case are marked with L (left) or R (right),
5
meanwhile the bottom of each well is also labeled with L (left) or R (right) to distinguish the left and right lenses. In addition, at the bottom of the case body, two sides of which have labeled REPLACE MONTHLY respectively to remind user to replace the contact lens case at least once every month.
7. Indications for use
The Contact Lens Case is a device intended for 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.
8. Comparison to Predicate Device
The contact lens case has the same intended use, similar design and materials as the following predicate device and is substantially equivalent with regards to safety and effectiveness.
"OWL Contact Lens Cases" and "DOG Contact Lens Case", (1) K130930 manufactured by Ningbo Lishundo Electronics Co., Ltd
The following table shows similarities and differences of technological characteristics between our device and the predicate devices.
| Item | Proposed Device | Predicate Devices |
|---|---|---|
| Trade Name | Contact Lens Case | "OWL Contact Lens Cases" and |
| "DOG Contact Lens Case" | ||
| Model | ELENS-001-001, | |
| ELENS-001-002, | ||
| ELENS-001-003, | ||
| ELENS-003-001 | -- | |
| 510(k) | ||
| Submitter | E-Link Plastic & Metal Industrial | |
| Co.,Ltd. | Ningbo Lishunda Electronics | |
| Co.,Ltd | ||
| 510(k) Number | Pending | K130930 |
| Classifications | 21 CFR 886.5928 Soft | |
| (hydrophilic) contact lens care | ||
| products (LRX) | 21 CFR 886.5928 Soft | |
| (hydrophilic) contact lens care | ||
| products (LRX) | ||
| Name & | ||
| Citations | ||
| Intended for | ||
| Use | Intended for 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. | 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 | Two adjoining wells with screw | |
| down lids | ||
| Materials | Polypropylene(96%) Polyethylene | |
| (4%) | Acrylonitrile-Butadiene-Styrene | |
| Copolymer (ABS) | ||
| Size | ||
| (length × width | ||
| × height ) | ELENS-001 series: | |
| 64.40×31.95 × 19.30 mm | ||
| ELENS-003-001: | ||
| 66.44 × 32.94 × 28.69 mm | OWL: | |
| 71 ×38.5 ×17 mm | ||
| DOG: | ||
| 69.5 x38 ×14 mm | ||
| Volume | 5.3 ml | 5.5ml (OWL) and 4.8 ml ( DOG) |
| Outer | ||
| Lid | ||
| Colors | Two | Three |
| Sterility | No | No |
| Disinfection | ||
| type | Chemical disinfection | |
| No heat-disinfection | Chemical disinfection | |
| No heat-disinfection | ||
| Cytotoxicity | ||
| (ISO 10993-5) | No cytotoxicity | No cytotoxicity |
| Irritation (1SO | ||
| 10993-10) | No irritation | No irritation |
| Systematic | ||
| Toxicity | ||
| (ISO 10993- |
- | No systematic toxicity | No systematic toxicity |
| Leakage Test | No leakage | No leakage |
6
Our device and the predicate device differ in the following areas.
(1) Our device is made from polypropylene (96%) and Polyethylene (4%), while the predicate devices "OWL Contact Lens Cases" and "DOG Contact Lens Case" are made from Acrylonitrile-Butadiene-Styrene Copolymer.
This difference does not affect the effectiveness and safety of our devices. Our device has
7
been tested for cytotoxicity, irritation, and systemic toxicity. All results show that material is not cytotoxic, causes no irritation, and has no systemic toxicity.
(2) Other minor difference that do not affect the safety and performance of our device: the predicate device "OWL Contact Lens Cases" and "DOG Contact Lens Case" have the plain tops, while our device (model: ELENS-003-001) have an animal shaped part on the top lid as well as ELENS-001 series have the plain tops. These differences of appearance would not affect the clinical use of the device. Besides, the volume of each chamber in our device is 5.3 ml (ELENS-001 series: 64.40×31.95×19.30 mm and ELENS-003-001 : 66.44 × 32.94 × 28.69 mm ), the volume of each chamber in "OWL Contact Lens Cases" and "DOG Contact Lens Case" are 5.5 ml and 4.8 ml . Although the volume of our device is different than the predicate, it is designed within the range of these acceptable volumes ( 4.4 ml ~5.5 ml), which any contact lens on the market can be fully immersed in the chambers due to the sizes of all contact lenses on the market are no larger than 1.4 cm diameter ×0.35 cm height.
9. Non-Clinical Performance Data
Biocompatibility Tests
The Contact Lens Case has been evaluated in accordance with Part 10993 of the International Standard Organization (ISO). Standard tests administered include:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity. The test article is considered non-cytotoxic under the conditions of the test.
- ISO 10993-10 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin sensitization. Under the conditions of this study, the Contact Lens Cases were classified as non-irritating.
- ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity. The requirements of the ISO Acute Systemic Test have been met by the test article.
Leak Test
To prove the sealing performance of the Contact Lens Case, the device has undergone the leakage testing. The water was put inside the box, natural be locked and sloshing around 180° for 0.5 h. The result is shown that the device has passed the test successfully.
Color Fastness Test
The Contact Lens Case also has undergone the tests of color fastness to crocking (based on AATCC 116-2013) and color fastness to light (based on AATCC TM 16.3-2014), the result has indicate the good color fastness of our device to light and crocking.
8
10. Substantial Equivalent Conclusions
Contact Lens Case has the same intended use, similar technological characteristics as the predicate device. Moreover, non-clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness.
In conclusion, Contact Lens Case is substantial equivalent to the predicate device.