(15 days)
Not Found
No
The device description and intended use are for simple contact lens storage cases, with no mention of any computational or analytical capabilities.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is intended for the storage of contact lenses during chemical disinfection, which is a maintenance function, not a therapeutic one.
No
The device is intended for the storage of contact lenses for chemical disinfection, not for diagnosing any medical condition.
No
The device description clearly describes physical contact lens cases, which are hardware, not software.
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 in vitro on biological samples.
- Device Description: The description details the physical design of the cases for holding contact lenses.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health.
- Performance Studies: The performance studies focus on biocompatibility and leak testing, which are relevant to the safety and functionality of a storage container, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This contact lens case does not fit that description.
N/A
Intended Use / Indications for Use
The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are 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
LRX
Device Description
The API Soft Grip Contact Lens Cases and Deluxe Contact Lens Cases are designed for storage of contact lenses with adjoining dual wells that have screw top caps. The cases are labeled with an 'R' or 'L' to distinguish right and left lenses. The Econo-Mate Contact Lens Cases have two adjoining wells with integral hinged, self-sealing caps in which respective contact lenses are immersed. The cases are also labeled with an 'R' or 'L' to distinguish right and left lenses. The cases are available in a variety colors. The applicant devices are not sterile and not for heat-disinfection.
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)
Biocompatibility testing performed by third party laboratories demonstrated the materials are safe for use in contact lens storage and disinfection.
The applicant contact lens cases were subjected to an 8 hour leak test to ensure devices are effective against leaking. All Soft Grip, Deluxe, and Econo-Mate contact lens cases meet leak test criteria per test plan and have demonstrated to be effective against leaking.
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.”
0
pothecary Products, Inc.°
JUL 1 4 2011
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 807.92 (c)
The assigned 510(k) number is: _K111856
| Applicant: | Apothecary Products, Inc.
11750 12th Avenue South
Burnsville, MN 55337 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | James Jenkins
Sr. Regulatory Affairs Specialist
Phone: 952.808.8364
Fax: 952.890.0418 |
| Date prepared: | March 11, 2011 |
| Name of Device: | Contact Lens Case, |
| | Model: Soft Grip Contact Lens Case; 68013, 68012 |
| | Model: Econo-Mate Contact Lens Case: K1010 |
| | Model: Deluxe Contact Lens Case; K1020 |
| Device Classification Name: | Soft (hydrophilic) contact lens care products |
| Common or usual name: | Contact Lens Case |
| Classification: | Class II, 21 CFR 886.5928 |
| Product Code: | LRX |
| Predicate Device information: | K093377; K991206; K042578 |
| Device Description: | The API Soft Grip Contact Lens Cases and Deluxe
Contact Lens Cases are designed for storage of
contact lenses with adjoining dual wells that have
screw top caps. The cases are labeled with an 'R' or
'L' to distinguish right and left lenses. The Econo-Mate
Contact Lens Cases have two adjoining wells with
integral hinged, self-sealing caps in which respective
contact lenses are immersed. The cases are also
labeled with an 'R' or 'L' to distinguish right and left
lenses. The cases are available in a variety colors. |
disinfection.
The applicant devices are not sterile and not for heat-
1
Image /page/1/Picture/0 description: The image shows the logo for Apothecary Products, Inc. The logo features a symbol resembling a mortar and pestle enclosed within a circle, followed by the text "Apothecary Products, Inc." The "Inc." is followed by the registered trademark symbol. The text is in a serif font and appears to be a professional logo design.
Intended Use: The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are 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 to Predicate Devices:
The API devices have the same intended use, similar design and materials as the predicate devices and are substantially equivalent with regards to safety and effectiveness.
Discussion of Non-Clinical Tests Performed in Determination of Substantial Equivalence:
Biocompatibility testing performed by third party laboratories demonstrated the materials are safe for use in contact lens storage and disinfection.
The applicant contact lens cases were subjected to an 8 hour leak test to ensure devices are effective against leaking. All Soft Grip, Deluxe, and Econo-Mate contact lens cases meet leak test criteria per test plan and have demonstrated to be effective against leaking.
| Attribute | API Contact Lens Case
Applicant Device; Soft Grip
Model 68012 & 68013 | Reliance Design & Mfg Corp,
Polaris Contact Lens Case,
Model #201 (K093377) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Contact Lens Case | Contact Lens Case |
| Intended Use | The API Soft Grip, 68012,
68013; Contact Lens Cases are
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. | Polaris Contact Lens Case is for
the storage of soft (hydrophilic),
rigid gas permeable or hard
contact lenses. It is to be used
with chemical disinfectants only.
It is not to be used in heat
disinfection. |
| Disinfection Type | Chemical
(Not Heat) | Chemical
(Not Heat) |
| Design | Two adjoining wells with screw
top caps into which respective
lenses are immersed. | Two adjoining wells screwed
with screw top into which
respective lenses are immersed. |
2
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Apothecary Products, Inc. c/o Mr. Bhavesh Sheth Intertek Testing Services 2307 East Aurora Road Unit B7 Twinsburg, OH 44087
JUL 1 4 2011
Re: K111856
Trade/Device Name: Soft Grip Contact Lens Case (Models 68012 and 68012); Deluxe Contact Lens Case (Model K1020), Econo-Mate Contact Lens Case (Model K1010) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: June 28, 2011 Received: June 29, 2011
Dear Mr. Sheth:
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
3
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.htm1.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and · Radiological Health
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Enclosure
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Indications for Use
510(k) Number (if known): KIII956
Device Name: Contact Lens Case
Indications for Use:
The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are 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)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
Denise Hayle
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111856