(269 days)
Not Found
No
The 510(k) summary describes a simple contact lens case for storage during chemical disinfection and does not mention any AI or ML capabilities.
No
The device is a contact lens case used for storage during chemical disinfection, not for treating any medical condition or directly benefiting health.
No
The device is a contact lens case used for storage and chemical disinfection, not for diagnosing medical conditions. Its intended use and description clearly state its function related to contact lens care.
No
The device is a physical contact lens case, not software. The description clearly indicates it is a tangible product for storing contact lenses.
Based on the provided information, the PROSBEN Contact Lens Cases are not an In Vitro Diagnostic (IVD) device.
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 reinforces that the cases are for storing lenses during chemical disinfection and are shipped dry. There is no mention of 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 diagnosis, monitoring, or prognosis of a disease or condition.
- Performance Studies: The performance studies focus on biological evaluation (cytotoxicity, irritation, systemic toxicity) and material compliance, which are relevant for a medical device that comes into contact with the body, but not specifically for an IVD.
Therefore, the PROSBEN Contact Lens Cases are classified as a medical device used for the care and maintenance of contact lenses, not an IVD.
N/A
Intended Use / Indications for Use
The PROSBEN Contact Lens Cases are intended for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses.
For use during chemical disinfection only; not to be used with heat.
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
The PROSBEN Contact Lens Case is the subject of this 510(k) premarket notification. The Contact Lens Case is a lens care product to be used the contact lens wearer or practitioner for storing contact lenses while not being worn. The PROSBEN Contact Lens Cases are designed for use in chemical disinfection only; not to be used with heat. The PROSBEN Contact Lens Cases are not including the disinfection, only for shipping the cases in a dry state.
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)
PROSBEN Contact Lens Cases completed the relevant test including:
- ISO 10993-5 Biological evaluation of medical devices, part 5: Test for in vitro cytotoxicity;
- ISO10993-10 Biological evaluation of medical devices, part 10: Test for irritation and skin sensitization;
- ISO10993-11 Biological evaluation of medical devices, part 11: Test for system toxicity:
- The materials are complied with the biological and toxicology evaluation and the results of these studies show that the Contact Lens Cases are safety for its intended use.
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/0 description: This image contains the company information for PROSBEN INC. Their phone number is 886-2-2500 0586, and their fax number is 886-2-2500 0945. The company address is 11F, No.58, Ming Chuan East Road, Sec.3, Taipei 104, Taiwan. The image also contains the date MAY 31 2013.
II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)
2.1. General Information Establishment
- . Manufacturer: PROSBEN INC.
- Address: 11F., No.58, Sec. 3, Mingchaun East Road, Taipei, 10477, Taiwan, R.O.C. .
- B Owner Number: 8022656
| Contact Person: | Dr. Jen, Ke-Min E-mail: ceirs.jen@msa.hinet.net |
|---|---|
| (Tel) +886-3-5208829 ; (Fax) +886-3-5209783 |
. Date Prepared: August 23, 2012
Device
- Proprietary Name: PROSBEN Contact Lens Cases;
CA66-02, CA66-03WB, CA66-04T series
- Common Name: . Contact Lens Case
- . Case, Contact Lens Classification Name:
- LRX, Class II, 886.5928 ● Product Code:
2.2. Safety and Effectiveness Information
. Predicate Device:
Claim of Substantial Equivalence (SE) is made to i-Promotions Contact Lens Case (K042578)
● Device Description:
The PROSBEN Contact Lens Case is the subject of this 510(k) premarket notification. The Contact Lens Case is a lens care product to be used the contact lens wearer or practitioner for storing contact lenses while not being worn. The PROSBEN Contact Lens Cases are designed for use in chemical disinfection only; not to be used with heat. The PROSBEN Contact Lens Cases are not including the disinfection, only for shipping the cases in a dry state.
Summary of Safety Data: ●
PROSBEN Contact Lens Cases completed the relevant test including:
-
- ISO 10993-5 Biological evaluation of medical devices, part 5: Test for in vitro cytotoxicity;
-
- ISO10993-10 Biological evaluation of medical devices, part 10: Test for irritation and skin sensitization;
1
Image /page/1/Picture/0 description: The image shows the letterhead for PROSBEN INC. The letterhead includes the company's name, address, telephone number (886-2-2500 0586), and fax number (886-2-2500 0945). The address is 11F, No.58, Ming Chuan East Road, Sec. 3, Taipei 104, Taiwan. The letterhead also includes the phrase "NEW VISION BEGIN WITH".
-
- ISO10993-11 Biological evaluation of medical devices, part 11: Test for system toxicity:
-
- The materials are complied with the biological and toxicology evaluation and the results of these studies show that the Contact Lens Cases are safety for its intended use.
Intended Use: ●
The PROSBEN Contact Lens Cases are intended for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only; not to be used with heat.
. Substantial Equivalence (SE)
A claim of substantial equivalence is made to i-Promotions Contact Lens Case (K042578). Both of them have the same indications for use, working principle and technologies. The major differences of the two devices are due to the different designed for adjoining wells with integral hinged caps or screw-top caps, and used the different PP or PE material with different color additives; please refer to the below "Comparison Table". These are not relating to the safety or effectiveness aspects. Thus they are substantially equivalent.
| Comparison
Feature | i-Promotions
Contact Lens Case
(K042578) | PROSBEN
Contact Lens Cases series
(K122700) |
|-----------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Design | Two adjoining wells with
integral hinged caps into
which respective lenses are
immersed. | hinged caps: CA66-04T series
screw-top caps: CA66-02 and
CA66-03WB series |
| Materials | Low density Polyethylene
#9931 with five colorants. | PP (CAS# 9003-07-0): CA66-02 and
CA66-03WB series
PE (CAS# 9002-88-4): CA66-04T
series with colorants:
white, blue, green |
Comparison Table
Ke. Minte
Dr. Jen, Ke-Min 510Kcorrespondent person for PROSBEN INC.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
May 31, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Dr. Jen, Ke-Min Prosben, Inc. 11F, No. 58, Sec. 3 Mingchaun East Road Taipei China (Taiwan) 104
Re: K122700
Trade/Device Name: Prosben Contact Lens Cases, CA66-02, CA66-03WB, and CA66-04T Series Regulation Number: 21 CFR 886.5928 Regulation Name: Case, Contact Lens Regulatory Class: Class II Product Code: LRX Dated: May 11, 2013 Received: May 22, 2013
Dear Dr. Jen:
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 interstatecommerce.prior to.May. 28, 1976, the enactment.date.of the Medical.Device. Amendments, or todevices 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
3
Page 2 - Dr. Jen. Ke-Min
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 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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia YAlexander -S
Center for Devices and Radiological Health
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation
Enclosure
4
Indications for Use
510 (K) Number ( If Known ): K122700 Device Name: _ Contact Lens Cases; CA66-02, CA66-03WB, CA66-04T series
Indications for Use:
The PROSBEN Contact Lens Cases are intended for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses.
For use during chemical disinfection only; not to be used with heat.
Prescription Use (21 CFR Part 801 Subpart D) AND/OR
V Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Claudine H. Krayçzy 2013.05.30 13:27:3540
Page_ 1 _of _1
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