(103 days)
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 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.
The provided document is a 510(k) premarket notification for a contact lens case, not a device that would typically have performance metrics measured like AI/ML algorithms or diagnostic devices. A contact lens case is typically evaluated based on its materials, design, and adherence to established standards for storing and chemically disinfecting contact lenses. The 510(k) essentially argues that the new device is "substantially equivalent" to an already legally marketed device (predicate device).
As such, the detailed information requested in your prompt (e.g., acceptance criteria with reported device performance in specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this type of medical device submission.
However, I can extract the relevant information regarding the equivalence argument, which serves as the "study" for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (contact lens case), the "acceptance criteria" are essentially the characteristics of the predicate device, and the "reported device performance" is the demonstration that the applicant's device matches these characteristics, thereby establishing substantial equivalence.
| Acceptance Criteria (Predicate Device Characteristics) | Reported Device Performance (AC Lens Applicant Device) |
|---|---|
| Intended Use: 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. | Intended Use: 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. |
| Indications: Storage and Disinfection of Soft, Rigid Gas Permeable or Hard Contact Lenses. | Indications: Storage and Disinfection of Soft, Rigid Gas Permeable or Hard Contact Lenses. |
| Disinfection Type: Chemical Disinfection, Not Heat Disinfection | Disinfection Type: Chemical Disinfection, Not Heat Disinfection |
| Design: Two adjoining wells with screw top into which respective lenses are immersed. | Design: Two adjoining wells with screw top into which respective lenses are immersed. |
| Main Material: Polypropylene (PP) and Acrylonitrile-Butadiene-Styrene copolymer (ABS). | Main Material: Polypropylene (PP) and Acrylonitrile-Butadiene-Styrene copolymer (ABS). |
| Screw on Caps: Yes | Screw on Caps: Yes |
| R/L indications on well bottom and/or cap top: Yes | R/L indications on well bottom and/or cap top: Yes |
| Non-vented caps: Yes | Non-vented caps: Yes |
Conclusion of Equivalence: The applicant device has the same classification information, uses the same materials (with only a colorant difference noted explicitly), and has a similar design as the predicate device.
The following points are Not Applicable (N/A) for this 510(k) submission of a contact lens case:
2. Sample size used for the test set and the data provenance: N/A. There isn't a "test set" in the traditional sense for performance evaluation like in AI/ML. The "test" is a comparison of product specifications and features.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth in this context refers to the established standards and specifications for contact lens cases, not an assessment by human experts on individual cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. No adjudication method for a test set is described or relevant for this type of device.
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: N/A. This is a contact lens case, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" used for this submission is the established regulatory requirements for contact lens cases and the characteristics of the legally marketed predicate device. The claim is one of substantial equivalence based on identical intended use, materials, and design.
8. The sample size for the training set: N/A. There is no training set mentioned or relevant for this type of device.
9. How the ground truth for the training set was established: N/A. There is no training set for this type of device.
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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 PlasticTechnology 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 ElementsComments 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 theCall 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 informationas the predicate device. | ||
| Intended Use | The applicant contact case isto be used by the contact lenswearer or practitioner forstoring soft, rigid gaspermeable or hard contactlenses while not in use.Intended for chemicaldisinfection only. Notdesigned for heatdisinfecting system. | The Applicant contact lenscase is a lens care product tobe used by the contact lenswearer or practitioner forstoring contact lenses whilenot being worn. Theapplicant device is notdesigned for heatdisinfecting system. Useonly with chemicaldisinfection. | |
| Indications | Storage and Disinfection ofSoft, Rigid Gas Permeable orHard Contact Lenses. | Storage and Disinfection ofSoft, Rigid Gas Permeable orHard Contact Lenses. | |
| Disinfection Type | Chemical Disinfection, NotHeat Disinfection | Chemical Disinfection, NotHeat Disinfection | |
| Design | Two adjoining wells withscrew top into whichrespective lenses areimmersed | Two adjoining wells withscrew top into whichrespective lenses areimmersed | |
| Main Material | Polypropylene (PP) andAcrylonitrile-Butadiene-Styrene copolymer (ABS) | SK CorporationPolypropylene (PP) R370Ywith certificated qualityAcrylonitrile-butadiene-styrene copolymer (ABS) PA- 757K. | |
| Comparison Statement | The applicant device has a similar design and uses thesame materials as the predicate device. The onlydifference is the colorant | ||
| Screw on Caps | Yes | Yes | |
| R/L indications on wellbottom 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)
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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.
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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.
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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
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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
§ 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.”