(67 days)
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.
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.
The provided text is a 510(k) summary for a contact lens case, focusing on demonstrating substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria in the context of a new efficacy claim or a complex diagnostic algorithm.
Therefore, many of the requested categories are not applicable to this document. The submission aims to show that the new device is fundamentally similar to existing, legally marketed devices, and thus does not require extensive new studies or data to establish safety and effectiveness.
Here's an assessment based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: | Same intended use: storage during chemical disinfection of soft, rigid gas permeable, or hard contact lenses. Not for heat disinfection. |
| Design/Material Equivalence: | Similar product design: two adjoining wells with integral hinged caps. Same material: Dow Chemical Company Low Density Polyethylene, Dow Product #9931. |
| Effectiveness Equivalence: | Same performance effectiveness: two adjoining wells with sufficient capacity for full lens immersion. |
| Safety Equivalence: | Same material as predicate device (Dow Chemical Company Low Density Polyethylene, Dow Product #9931), which has established safety in predicate. |
| Labeling & Packaging Equivalence: | Similar: Refers to product as contact lens case; instructs cleaning as recommended by eye care professional (Predicate refers to disinfecting solution). |
Study Information (Based on provided text, most are Not Applicable for this type of submission):
This 510(k) submission establishes substantial equivalence to predicate devices, therefore, a traditional "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or performance study for a novel algorithm is not present. The demonstration of equivalence relies on comparing the applicant's device to already approved predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission did not involve a formal "test set" for performance evaluation in the typical sense of a diagnostic or therapeutic device. Substantial equivalence is established through comparison of specifications and existing data from predicate devices. The safety data referenced for the predicate (K042578) with biocompatibility tests (In Vitro Cyto-Toxicity, Delayed-Type Hypersensitivity, Eye Irritation, Systemic Toxicity) would have had their own sample sizes, but these are not for the applicant device and are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth establishment by experts for a test set is not relevant for this 510(k) submission, which focuses on material composition, design, and intended use equivalence to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in studies involving expert review of data, which is not the nature of this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a contact lens case, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical contact lens case, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Based on Equivalence: The "ground truth" here is the established safety and effectiveness of the identified predicate devices, particularly the i-Promotions Contact Lens Case (K042578). The applicant device's material is the same, and its design and function are deemed equivalent to these already approved devices. For the predicate device's safety, the ground truth would have been established by standard biocompatibility testing (cytotoxicity, hypersensitivity, irritation, systemic toxicity).
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this device.
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510(k) Summary
DEC - 5 2011
-
- 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.
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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.
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6. Substantial Equivalence Determination
| ApplicantDevice | PredicateDevice | Predicate Device | |
|---|---|---|---|
| 1. Classification | |||
| Device Name | Eye Care andCure ContactLens Case | i-PromotionsContact Lens CaseK042578 | Pelican Products,Inc. #500/600(deep well lenscase with integrallids)K030987 |
| ClassificationName | Case, ContactLens | Case, ContactLens | Case, Contact Lens |
| Product Code | LRX | LRX | LRX |
| ComparisonStatement | The applicant device has the same classification asthe predicate devices. | ||
| 2. Intended Use | |||
| Intended Use | The applicantdevice is to beused for thestorage duringdisinfection ofsoft, rigid gaspermeable orhard contactlenses. Thecase is to beused duringchemicaldisinfectiononly and is notto be usedwith heat. | The predicatedevice is intendedfor storage duringdisinfection ofsoft, rigid gaspermeable orhard contactlenses. Not to beused with heatdisinfection. Useonly withchemicaldisinfection. | The predicatedevice is intendedfor the storage ofsoft(hydrophilic)/rigidgas permeable andhard contactlenses duringchemicaldisinfection. Not tobe used for heatdisinfection. |
| Indications | Storage anddisinfection ofsoft, rigid gaspermeable orhard contactlenses | Storage anddisinfection ofsoft, rigid gaspermeable orhard contactlenses | Storage of soft(hydrophilic)/rigidgas permeable andhard contactlenses duringchemicaldisinfection |
| ComparisonStatement | The applicant device has the same intended use asthe predicate devices. | ||
| 3. Design/Material | |||
| Design | Two adjoiningwells with | Two adjoiningwells with | Two adjoiningwells with integral |
| integralhinged caps,into whichlenses areimmersed. | integral hingedcap into whichrespective lensesare immersed. | lids into whichlenses areimmersed. | |
| Material | Dow ChemicalCompany LowDensityPolyethylene,Dow Product#9931 | Dow ChemicalCompany LowDensityPolyethylene,Dow Product#9931 | |
| ComparisonStatement | The applicant device has a similar product designand is made of the same material as the predicatedevices. | ||
| 4. Effectiveness | |||
| Effectiveness | The applicantdevice has twoadjoiningwells withsufficientcapacity toallow for acontact lens tobe fullyimmersed. | The predicatedevice has twoadjoining wellsinto whichrespective lensesare immersed. | The predicatedevice has twoadjoining wellsinto which lensesare immersed |
| ComparisonStatement | The applicant device has the same performanceeffectiveness as the predicate devices. | ||
| 5. Safety | Applicant | Predicate Device |
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page 4
KI12832
| 5. Safety | Applicant Device | Predicate Device |
|---|---|---|
| Material | Dow ChemicalCompany LowDensityPolyethylene,Dow Product#9931 | Dow ChemicalCompany LowDensityPolyethylene,Dow Product#9931 |
| No testsconducted asmaterial is thesame as thematerial usedby thepredicatedevice. | 1. In Vitro Cyto-Toxicity: NoCyto-toxicity2. Delayed-TypeHypersensitivity:No delayeddermal contactsensitization3. Eye Irritation:Nointracutaneousreactivity4. SystemicToxicity: Nosystemic toxicity | |
| ComparisonStatement | 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 | ApplicantDevice | Predicate Device |
| Refers toproduct as EyeCare and Curecontact lenscase; instructspatients toclean lens caseasrecommendedby thepatient's eyecare | Refers to productasi-Promotionscontact lens case;instructs patientsto clean lens casewith disinfectingsolutionrecommended forthis purpose. |
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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.
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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
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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
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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
§ 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.”