(86 days)
Not Found
No
The device description and intended use clearly indicate a simple contact lens storage case made of plastic, with no mention of any computational or analytical capabilities.
No
The device is a contact lens case used for storage during chemical disinfection, not for treating any medical condition.
No
The device is a contact lens case intended for storage and chemical disinfection of contact lenses. Its purpose is not to diagnose any medical condition or disease.
No
The device description explicitly states it is made of polypropylene plastic and describes physical components (wells, caps), indicating it is a hardware device, not software only.
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 storage function, not a diagnostic test performed on a sample taken from the human body.
- Device Description: The device is a contact lens case made of plastic. It's a container for a medical device (contact lenses), not a diagnostic reagent, instrument, or system used to examine specimens.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on material safety (extraction and biocompatibility), which is relevant for a medical device accessory, but not for the analytical or clinical performance of a diagnostic test.
IVDs are used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This contact lens case does not perform any such function.
N/A
Intended Use / Indications for Use
Intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
The contact lens cases are designed for storage of contact lenses. The Color Case Contact Lens Case has 2 adjoining wells that have screw top caps. The Flip N Slide Contact Lens Case model has 2 adjoining wells with integral hinged, self-sealing caps in which contact lenses are immersed. The devices are not sterile and are not for heat disinfection. They are made of polypropylene plastic. The volume capacity is 5.91 ml on each well of both lens cases.
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 Testing: Extraction testing was conducted and demonstrated there were no leachable organic compounds above the pre-determined detection limit. Biocompatibility testing has been conducted on the materials and met acceptance criteria.
Clinical Testing Not Applicable
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.
Contact lens cases by Ningbo Kaida Rubber & Plastic Technology Co., LT (K071081)
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
K 130 75 3
8 510(k) Summary
| Submitter: | WatchDog Group, LC
7800 Forsyth Blvd 8th Floor
St. Louis, MO 63105 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Persons: | Primary Contact: John O'Hara
WatchDog Group, LC
7800 Forsyth Blvd 8th Floor, St. Louis, MO 63105
Phone: 314-721-5367; Fax: 314-725-5873, email: LensAlert@aol.com
Secondary Contact: Maggie Genovese (Same address as above)
Phone: 314-721-5367; Fax: 314-725-5873; email: MaggieLensAlert@aol.com |
| Date Prepared: | June 12, 2013 |
| Trade Names: | Color Case Contact Lens Case; Flip N Slide Contact Lens Case |
| Classification: | 21 CFR 886.5928; Soft (hydrophilic) contact lens care products, Class II |
| Product Code: | LRX |
| Predicate Device: | Contact lens cases by Ningbo Kaida Rubber & Plastic Technology Co., LT (K071081) |
| Device Description: | The contact lens cases are designed for storage of contact lenses. The Color
Case Contact Lens Case has 2 adjoining wells that have screw top caps. The
Flip N Slide Contact Lens Case model has 2 adjoining wells with integral
hinged, self-sealing caps in which contact lenses are immersed. The devices are
not sterile and are not for heat disinfection. They are made of polypropylene
plastic. The volume capacity is 5.91 ml on each well of both lens cases. |
| Intended Use: | Intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or
hard contact lenses during chemical disinfection. For use in storage during
chemical disinfection only. Do not use during heat disinfection. |
| Comparison of
Technological
Characteristics: | Similar to the predicate, both the Color Case Contact Lens Case and the Flip N
Slide Contact Lens Case have 2 adjoining wells with top caps designed to hold
contact lenses and their chemical disinfectant solutions. Similar to several of
the contact lens cases encompassed by the predicate premarket notification
(K071081), both the Color Case Contact Lens Case and the Flip N Slide Contact
Lens Case are composed of polypropylene plastic. The new Color Case Contact
Lens Case uses separate screw caps, as does the predicate. The Flip N Slide
Contact Lens Case model differs from the predicate in that it has integral, self-
sealing caps instead of separate screw top caps. This difference does not pose
new questions of safety and effectiveness, as the integral cap design achieves
the same outcome of securing the contact lenses and disinfectant solutions in the
wells. |
| Non-Clinical Testing: | Extraction testing was conducted and demonstrated there were no leachable
organic compounds above the pre-determined detection limit. Biocompatibility
testing has been conducted on the materials and met acceptance criteria. |
| Clinical Testing | Not Applicable |
| Conclusion: | The physical design, materials and intended use of the new devices are
substantially equivalent to those of the predicate device and any differences do |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is a common symbol associated with healthcare and medicine, and its presence in the logo signifies the department's role in promoting and protecting the health of Americans.
June 13, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Mr. John O'Hara President Watchdog Group, LC 7800 Forsyth Blvd., 8th Floor Clayton, MO 63105
Re: K130753
Trade/Device Name: Color Contact Lens Case; Flip n Slide Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Contact Lens Case Regulatory Class: Class II Product Code: LRX Dated: May 7, 2013 Received: May 10, 2013
Dear Mr. O'Hara:
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. Ilisting 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.
2
Page 2 - Mr. John O'Hara
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/Resourcesfor You/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 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 vours.
Kesia YAlexander -S
for Malvina Eydelman Director Division of Ophthalmic and Ear, Nose. and Throat Devices________________________________________________________________________________________________
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K130753
Device Names:
- · Color Contact Lens Case
· Flip N Slide Contact Lens Case
Indications for Use:
Intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.
| Prescription Use | |
|---|---|
| (part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | X |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Leoni 2013.06 04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:________________________________________________________________________________________________________________________________________________________________ K130753
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