(103 days)
Not Found
No
The summary describes a simple contact lens case with no mention of AI, ML, image processing, or any data-driven performance metrics.
No.
The device is a contact lens case used for storing and chemically disinfecting contact lenses, not for treating any medical condition or directly interacting with the body for therapeutic purposes.
No
Explanation: The device is a contact lens case used for storage and chemical disinfection of contact lenses. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical contact lens case with a base, wells, and screw-top caps, indicating it 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 storing contact lenses and chemical disinfection. This is a physical process for maintaining the cleanliness and safety of a medical device (contact lenses).
- Device Description: The device is a container for holding contact lenses and fluid. It does not perform any diagnostic testing on biological samples.
- Lack of IVD Characteristics: The description 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 treatment based on biological analysis.
The device is a medical device (specifically, an accessory to contact lenses), but it falls under a different regulatory category than IVDs. The predicate device listed (K071081) is also a contact lens case, further supporting that this is not classified as an IVD.
N/A
Intended Use / Indications for Use
The applicant contact case is to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not in use. Intended for chemical disinfection only. Not designed for heat disinfecting system.
Product codes
LRX
Device Description
The AC Branded Contact Lens Cases consists of a lens case base with dual adjoining wells for the containment of fluid. The case cover are two screw top caps. All the variant models have a capacity of over 3.0 ml in each case well, thus, any contact lens can be fully immersed 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 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)
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 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
510(k) Summary 807.92(c)
JUL 1 1 2012
| SPONSOR | 807.92(a)(1) |
|---|---|
| Company Name: | Arlington Contact Lens Services, Inc. |
| Company Address | 4265 Diplomacy Dr. Columbus, Ohio 43228 |
| Telephone: | 614-921-2522 |
| Contact Person: | Peter Clarkson |
Summary Preparation Date: March 13. 2012
| DEVICE NAME | 807.92(a)(2) |
|---|---|
| Trade Name: | Contact Lens Case (Multiple Brand Names) |
| Common/Usual Name: | Contact Lens Case |
| Classification Name: | Soft (hydrophilic) contact lens care products |
| Regulation Number: | 886.5928 |
| Product Code: | LRX |
| Device Class: | Class II |
PREDICATE DEVICE
Legally Marketed Equivalent Device
| Company | Device Name | K Number |
|---|---|---|
| Ningbo Kaida Rubber and Plastic | ||
| Technology Co., Ltd. | Contact Lens Case | K071081 |
DEVICE DESCRIPTION
The AC Branded Contact Lens Cases consists of a lens case base with dual adjoining wells for the containment of fluid. The case cover are two screw top caps. All the variant models have a capacity of over 3.0 ml in each case well, thus, any contact lens can be fully immersed into the chambers.
DEVICE INTENDED USE
The applicant contact case is to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not in use. Intended for chemical disinfection only. Not designed for heat disinfecting system.
| COMPARISON OF TECHNICAL CHARACTERISTICS | 807.92(a)(6) | ||
|---|---|---|---|
| Comparison Elements | |||
| Comments of the contract of the control of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the | |||
| Call College And Concellent College Collection College Company Come Company Come Company Come Comments of Children | AC Lens Applicant Device | Predicate Device | |
| Device Name | Multiple Brand Names | Multiple Brand Names | |
| (K071081) | |||
| Classification Name | Contact Lens Case | Contact Lens Case | |
| Product Code | LRX | LRX | |
| Comparison Statement | The applicant device has same classification information | ||
| as the predicate device. | |||
| Intended Use | The applicant contact case is | ||
| to be used by the contact lens | |||
| wearer or practitioner for | |||
| storing soft, rigid gas | |||
| permeable or hard contact | |||
| lenses while not in use. | |||
| Intended for chemical | |||
| disinfection only. Not | |||
| designed for heat | |||
| disinfecting system. | The Applicant 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 | |||
| applicant device is not | |||
| designed for heat | |||
| disinfecting system. Use | |||
| only with 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 wells with | ||
| screw top into which | |||
| respective lenses are | |||
| immersed | Two adjoining wells with | ||
| screw top into which | |||
| respective lenses are | |||
| immersed | |||
| Main Material | Polypropylene (PP) and | ||
| Acrylonitrile-Butadiene- | |||
| Styrene copolymer (ABS) | SK Corporation | ||
| Polypropylene (PP) R370Y | |||
| with certificated quality | |||
| Acrylonitrile-butadiene- | |||
| styrene copolymer (ABS) PA |
- 757K. | |
| Comparison Statement | The applicant device has a similar design and uses the
same materials as the predicate device. The only
difference is the colorant | | |
| Screw on Caps | Yes | Yes | |
| R/L indications on well
bottom and/or cap top | Yes | Yes | |
| Non-vented caps | Yes | Yes | |
807.92(a)(4)
807.92(a)(5)
Page 1 of 3
807.92(a)(3)
807.92(a)(1)
1
.
:
:
.
2
CONCLUSION
807.92(b)(3)
The applicant contact lens case is similar to the predicate device in
- . intended use,
- materials and ●
- design. .
The applicant contact lens case introduces no new questions concerning safety and efficacy.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arlington Contact Lens Services, Inc. c/o Christian Smith Consultant, Smith Associates, Inc. 1468 Harwell Ave Crofton, MD 21114
JUL 1 1 2012
Re: K120969
Trade/Device Name: AC Lens Branded 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: June 13, 2012 Received: June 14, 2012
Dear Mr. Smith:
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.
4
Page 2 - Mr. Christian Smith
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm
Sincerely yours,
R. D. Feldman, MD
Malvina B. Eydelman, MID Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K120969
Device Name: Contact Lens Case
Indications for Use:
The applicant contact case is to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not in use. Intended for chemical disinfection only. Not designed for heat disinfecting system.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K120969