(195 days)
None
No
The 510(k) summary describes a simple contact lens case with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is described as a contact lens case for storage during chemical disinfections, which is not a therapeutic function. It is a container for another product that performs the therapeutic action (chemical disinfection).
No
This device is a contact lens case used for storage during chemical disinfection, not for diagnosing any medical condition.
No
The device description clearly states it is a physical contact lens case, which is a hardware device. There is no mention of software functionality.
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 device is a physical container for contact lenses and fluid. It does not involve any reagents, assays, or procedures for analyzing biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a contact lens accessory used for the proper storage and disinfection of contact lenses. The predicate device listed (K120969; Contact Lens Case) further supports this classification as a non-IVD device.
N/A
Intended Use / 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 heat disinfection.
Product codes
LRX
Device Description
Our contact lens case will consist of a lens base with dual adjoining wells for the containment of fluid. The case covers are two screw top caps. The contact lens case has a capacity of over 3.0 ml, therefore, any contact lens can be submerged into the chambers.
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 wearers or practitioners
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logo for the U.S. Department of Health and Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. In the center of the circle is a stylized image of three 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
September 10, 2014
Maca Plastics, Inc. Mr. Jesse F. Grooms Assistant Quality Manager 3455 Cross Road Winchester, Ohio 45697
K140488 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: July 23, 2014 Received: August 1, 2014
Dear Mr. Grooms:
Re:
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
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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 yours,
Kesia Y. Alexander -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
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Indications for Use
510(k) Number (if known) K140488
Device Name Contact Lens Case
Indications for Use (Describe)
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 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)
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SPONSOR
Company Name: | MACA Plastics Inc |
---|---|
Company Address: | 3455 Cross Road |
West Union, Ohio 45693 | |
Telephone: | (937) 544-8618 |
Contact Person: | Jesse Grooms |
Contact Email: | jgrooms@macaplastics.com |
Summary Preparation Date: 04/10/2014
DEVICE NAME | 807.92 | |
---|---|---|
Trade Name: | Contact Lens Case | |
Common/Usual Name: | Contact Lens Case | |
Classification Name: | Soft (hydrophilic) contact lens care products | |
Regulation Number: | 886.5928 | |
Product Code: | LRX |
PREDICATE DEVICE
Legally Marked Equivalent Device
Company | Device Name | K Number |
---|---|---|
Arlington Contact Lens Service, | ||
Inc. | Contact Lens Case | K120969 |
DEVICE DESCRIPTION
807.92(a) (4)
Our contact lens case will consist of a lens base with dual adjoining wells for the containment of fluid. The case covers are two screw top caps. The contact lens case has a capacity of over 3.0 ml, therefore, any contact lens can be submerged into the chambers.
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DEVICE INTENDED USE
The applicant contact lens case is intended for use by contact wearers or practitioners for storing soft, rigid gas permeable or hard contact lenses. This particular contact lens case is not designed for heat disinfection. It is only designed for chemical disinfection.
Comparison Elements | MACA Contact Lens | Predicate Device |
---|---|---|
Device Name | Multiple Brand Names | Multiple Brand Names |
Classification Name | Contact Lens Case | Contact Lens Case |
Product Code | LRX | LRX |
Comparison Statement | The applicant device has same classification information as predicate device. | |
Intended Use | The applicant contact lens case is intended for use by contact wearers or practitioners for storing soft, rigid gas permeable or hard contact lenses. This particular contact lens case is not designed for heat disinfection. It is only designed for chemical disinfection. | The predicate contact lens case is to be used by the contact wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses. This particular contact lens case is not designed for heat disinfection. It is only designed for chemical disinfection. |
Indications | Storage and disinfection of soft, rigid gas permeable or hard contact lenses. | Storage and disinfection of soft, rigid gas permeable or hard contact lenses. |
Disinfection Type | Chemical disinfection, not heat disinfection. | Chemical disinfection, not heat disinfection. |
Design | Two adjoining chambers with screw top into which contact lenses are immersed. | Two adjoining chambers with screw top into which contact lenses are immersed. |
Main Material | Polypropylene (PP) and Acrylonitrile-Butadiene-Styrene copolymer (ABS) | Polypropylene (PP) and Acrylonitrile-Butadiene-Styrene copolymer (ABS) |
Comparison Statement | The applicant device has a similar design and uses the same materials as the predicate. | |
Screw On Caps | Yes | Yes |
R/L indications on chamber bottoms and/or top | Yes | Yes |
Non-vented caps | Yes | Yes |
COMPARISON OF TECHINICAL CHARACTER
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CONCLUSION
807.92(b) (3)
The applicant contact lens case is similar to the predicate device in
- . Intended use
- . Materials
- . Design
The applicant contact lens case introduces no new questions concerning safety and efficacy.