(158 days)
The icase™ Contact Lens Case is designed for storage of soft (hydrophilic) lenses during chemical disinfection.
Not Found
This document is a 510(k) clearance letter for a contact lens case, not a study report or clinical trial. Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth, or expert qualifications for AI/ML-based medical devices.
The document states that the "icase™ Contact Lens Case" is substantially equivalent to legally marketed predicate devices. This means that its safety and effectiveness were demonstrated by showing it is as safe and effective as a device already on the market, not through a study involving acceptance criteria and performance metrics as typically evaluated for AI/ML algorithms.
Here's why the requested information cannot be provided from this document:
- Table of acceptance criteria and reported device performance: This document does not describe performance metrics or acceptance criteria for the contact lens case itself. Its clearance is based on substantial equivalence.
- Sample size, data provenance: Not relevant for a substantial equivalence determination of a contact lens case. There's no "test set" in the context of an AI/ML study.
- Number of experts, qualifications: Not relevant. The review is by FDA staff based on regulatory requirements.
- Adjudication method: Not relevant.
- MRMC comparative effectiveness study: Not applicable as this is not an AI-assisted device.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
In summary, the provided text is a regulatory clearance letter for a physical medical device (contact lens case) based on substantial equivalence to a predicate device, and it does not contain information related to the rigorous testing and validation processes typically associated with AI/ML-based medical devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three lines forming the body and head, and two wavy lines below, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2002
ikeeps, Inc. TM c/o E.J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114
Re: K021248
Trade/Device Name: icase™ Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products (contact lens cases) Regulatory Class: Class II Product Code: LRX Dated: August 19, 2002 Received: August 21, 2002
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - E.J. Smith
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number: K021248
Device Name: icase™ Contact Lens Case
Classification Panel:
Indications for Use:
The icase™ Contact Lens Case is designed for storage of soft (hydrophilic) lenses during chemical disinfection.
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: 上海
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use: | |
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| Over-the-Counter Use: |
Ming-chuen Shi
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K021248 |
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| --------------- | --------- |
§ 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.”