K Number
K112832
Device Name
EYE CARE CURE CONTACT LENS CASE
Manufacturer
Date Cleared
2011-12-05

(67 days)

Product Code
Regulation Number
886.5928
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The storage and disinfection of soft, rigid gas permeable or hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
Device Description
The Eye Care and Cure Contact Lens Case consists of a lens case base with adjoining dual walls for the containment of fluid and separate integral hinged self-sealing caps. The Eye Care and Cure Contact Lens Case is polyethylene and consists of a two adjoining wells, with hinged self-sealing caps, in which contact lenses are immersed in fluid. The two adjoining wells of the Eye Care and Cure Contact Lens Case each have a capacity of 1.0ml. The inner height of the well measures 8mm. The Eye Care and Cure Contact Lens Case is made of Dow Chemical Company Low Density Polyethylene, Dow Product #9931. No colorant will be added.
More Information

Not Found

No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".

No
Explanation: A therapeutic device is one that treats or manages a disease or condition. This device is a contact lens case used for storage and disinfection, which does not directly treat a medical condition.

No
Explanation: The device is a contact lens case used for storage and disinfection, not for diagnosing medical conditions.

No

The device description clearly states it is a physical contact lens case made of polyethylene, which is a hardware component.

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 and disinfection of contact lenses. This is a physical process related to the care of a medical device (contact lenses), not a diagnostic test performed on a biological sample.
  • Device Description: The device is a simple container for holding contact lenses and fluid. It does not contain reagents, perform chemical reactions for diagnostic purposes, or analyze biological samples.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This contact lens case does not fit that description.

N/A

Intended Use / Indications for Use

The Eye Care and Cure Contact Lens Case is intended for storage during disinfection of soft, rigid gas permeable or hard contact lenses. It is to be used for chemical disinfection only. It is not intended to be use with heat disinfection.

The storage and disinfection of soft, rigid gas permeable or 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 Eye Care and Cure Contact Lens Case consists of a lens case base with adjoining dual walls for the containment of fluid and separate integral hinged self-sealing caps.

The Eye Care and Cure Contact Lens Case is to be used for the storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. The case is to be used during chemical disinfection only and is not to be used with heat disinfection devices.

The Eye Care and Cure Contact Lens Case is polyethylene and consists of a two adjoining wells, with hinged self-sealing caps, in which contact lenses are immersed in fluid. Rub and rinse your contact lenses as directed by your eye care professional. The two adjoining wells of the Eye Care and Cure Contact Lens Case each have a capacity of 1.0ml. This is sufficient capacity to fully immerse a contact lens when the well is filled with chemical under normal use conditions. The inner height of the well measures 8mm.

The Eye Care and Cure Contact Lens Case is made of Dow Chemical Company Low Density Polyethylene, Dow Product #9931. No colorant will be added.

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)

Not Found

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.

K042578, K030987

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

K112832

510(k) Summary

DEC - 5 2011

    1. Date of Preparation: September 21, 2011

2. Applicant Device Information:

Device Name: Eye Care and Cure Contact Lens Case

Common Name: Contact Lens Case

Classification Name: Case, Contact Lens

Device Class: Contact lens carrying cases are considered Class II Medical Devices by the FDA, although not formally classified at this time.

Recommended Classification Regulation Number: 21 CFR §886.5928

Product Code: LRX

Predicate Devices:

The following devices have been identified as the predicate devices for the Eye Care and Cure contact lens case:

Predicate Device: i-Promotions Contact Lens Case (K042578) i-Promotions, Inc. 9522 Gravois Rd. St. Louis, MO 63123

Predicate Device: Pelican Contact Lens Case (K030987) Pelican Products, Inc. 2248 Highway 43 North Pelhatchie, MS 39145

Non-Sterile:

The Eye Care and Cure Contact Lens Case is a non-sterile device.

Packaging/Labeling:

The contact cases will be sold in bags of 100, including 100 individual labels to be distributed by eye care professionals to contact lens case users together with the case.

1

Device Description and Intended Use:

The Eye Care and Cure Contact Lens Case consists of a lens case base with adjoining dual walls for the containment of fluid and separate integral hinged self-sealing caps.

The Eye Care and Cure Contact Lens Case is intended for storage during disinfection of soft, rigid gas permeable or hard contact lenses. It is to be used for chemical disinfection only. It is not intended to be use with heat disinfection.

Material:

Polyethylene 9931 Low Density (2380) is the same material used by predicate i-Promotions (K042578) with an established history of safe and effective use as a non body contacting, non implanted medical device for holding a contact lens.

3. Submitter Information

Manufacturer:

Eye Care and Cure Corporation 4646 S. Overland Dr. Tucson, AZ 85714 Establishment Registration: 2085143 Owner/Operator Number: 9044582

Contact Person for Submission:

Lindy van Dalen Regional Director Eye Care and Cure 4646 S. Overland Drive Tucson. AZ 85714 Phone: (520) 321-1262 Email: lindy.vandalen@eyecareandcure.com

5. Device Description

The Eye Care and Cure Contact Lens Case is to be used for the storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. The case is to be used during chemical disinfection only and is not to be used with heat disinfection devices.

The Eye Care and Cure Contact Lens Case is polyethylene and consists of a two adjoining wells, with hinged self-sealing caps, in which contact lenses are immersed in fluid. Rub and rinse your contact lenses as directed by your eye care professional. The two adjoining wells of the Eye Care and Cure Contact Lens Case each have a capacity of 1.0ml. This is sufficient capacity to fully immerse a contact lens when the well is filled with chemical under normal use conditions. The inner height of the well measures 8mm.

The Eye Care and Cure Contact Lens Case is made of Dow Chemical Company Low Density Polyethylene, Dow Product #9931. No colorant will be added.

2

6. Substantial Equivalence Determination

| | Applicant
Device | Predicate
Device | Predicate Device |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Classification | | | |
| Device Name | Eye Care and
Cure Contact
Lens Case | i-Promotions
Contact Lens Case
K042578 | Pelican Products,
Inc. #500/600
(deep well lens
case with integral
lids)
K030987 |
| Classification
Name | Case, Contact
Lens | Case, Contact
Lens | Case, Contact Lens |
| Product Code | LRX | LRX | LRX |
| Comparison
Statement | The applicant device has the same classification as
the predicate devices. | | |
| 2. Intended Use | | | |
| Intended Use | The applicant
device is to be
used for the
storage during
disinfection of
soft, rigid gas
permeable or
hard contact
lenses. The
case is to be
used during
chemical
disinfection
only and is not
to be used
with heat. | The predicate
device is intended
for storage during
disinfection of
soft, rigid gas
permeable or
hard contact
lenses. Not to be
used with heat
disinfection. Use
only with
chemical
disinfection. | The predicate
device is intended
for the storage of
soft
(hydrophilic)/rigid
gas permeable and
hard contact
lenses during
chemical
disinfection. Not to
be used for heat
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 | Storage of soft
(hydrophilic)/rigid
gas permeable and
hard contact
lenses during
chemical
disinfection |
| Comparison
Statement | The applicant device has the same intended use as
the predicate devices. | | |
| 3. Design/Material | | | |
| Design | Two adjoining
wells with | Two adjoining
wells with | Two adjoining
wells with integral |
| | | | |
| | integral
hinged caps,
into which
lenses are
immersed. | integral hinged
cap into which
respective lenses
are immersed. | lids into which
lenses are
immersed. |
| Material | Dow Chemical
Company Low
Density
Polyethylene,
Dow Product
#9931 | Dow Chemical
Company Low
Density
Polyethylene,
Dow Product
#9931 | |
| Comparison
Statement | The applicant device has a similar product design
and is made of the same material as the predicate
devices. | | |
| 4. Effectiveness | | | |
| Effectiveness | The applicant
device has two
adjoining
wells with
sufficient
capacity to
allow for a
contact lens to
be fully
immersed. | The predicate
device has two
adjoining wells
into which
respective lenses
are immersed. | The predicate
device has two
adjoining wells
into which lenses
are immersed |
| Comparison
Statement | The applicant device has the same performance
effectiveness as the predicate devices. | | |
| 5. Safety | Applicant | Predicate Device | |

3

page 4
KI12832

5. SafetyApplicant DevicePredicate Device
MaterialDow Chemical
Company Low
Density
Polyethylene,
Dow Product
#9931Dow Chemical
Company Low
Density
Polyethylene,
Dow Product
#9931
No tests
conducted as
material is the
same as the
material used
by the
predicate
device.1. In Vitro Cyto-
Toxicity: No
Cyto-toxicity
  1. Delayed-Type
    Hypersensitivity:
    No delayed
    dermal contact
    sensitization
  2. Eye Irritation:
    No
    intracutaneous
    reactivity
  3. Systemic
    Toxicity: No
    systemic toxicity |
    | Comparison
    Statement | The applicant device is made of the same material as the predicate device and therefore has the same performance safety as the predicate device. | |
    | 6. Labeling &
    Packaging | Applicant
    Device | Predicate Device |
    | | Refers to
    product as Eye
    Care and Cure
    contact lens
    case; instructs
    patients to
    clean lens case
    as
    recommended
    by the
    patient's eye
    care | Refers to product
    as
    i-Promotions
    contact lens case;
    instructs patients
    to clean lens case
    with disinfecting
    solution
    recommended for
    this purpose. |

4

Conclusion:

The applicant device has the same classification, same intended use and indications, similar product design, same materials, same performance effectiveness and the same performance safety as the predicate device. There are no new changes to raise new issues of safety and effectiveness. Therefore, therefore the applicant device is substantially equivalent to the predicate device.

5

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC - 5 2011

Eye Care and Cure Corp. c/o Lindy van Dalen Regional Director 4646 S. Overland Dr. Tucson, AZ 85714

Re: K112832

Trade/Device Name: Eye Care and Cure 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: September 21, 2011 Received: September 29, 2011

Dear Ms. van Dalen:

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 premaiket 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part

6

807); labeling (21 CFR Part 801); medical device 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.

Sincerely yours,

Kesia Alexander

Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510 (k) Number: ______________________________________________________________________________________________________________________________________________________________

Device Name: Eye Care and Cure Contact Lens Case

Indications for Use:

The storage and disinfection of soft, rigid gas permeable or hard contact lenses. For use during chemical disinfection only. Not to be used with heat.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE)

or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:_ (per 21 CFR 801.109) Over-The-Counter Use__


(Division Sign-Off)

Division of Ophthalmic, Neurological and ENT Devices 510(k) Number