(56 days)
Not Found
Not Found
No
The summary describes a storage solution for corneas and contains no mention of AI, ML, image processing, or any related concepts.
No
The device is used for storing explanted corneas and does not provide therapy to a patient.
No
The device, Eusol-C, is described as a storage solution for explanted corneas. Its function is to preserve corneas for transplantation, not to diagnose a condition or disease.
No
The 510(k) summary describes a solution for storing explanted corneas, which is a physical process involving a storage medium (Eusol-C). There is no mention of software as the primary or sole component of the device.
Based on the provided information, Eusol-C is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "store explanted corneas for up to 14 days." This describes a solution used for the preservation of biological tissue outside of the body, not for the diagnosis of a disease or condition.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide information about a patient's health status.
- Anatomical Site: While it involves corneas, the use is for storage, not for testing or analysis of the cornea itself for diagnostic purposes.
IVDs are typically used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. Eusol-C's function is purely for the preservation of tissue.
N/A
Intended Use / Indications for Use
Eusol-C is indicated when it is desired to store explanted corneas for up to 14 days. It is intended for use by physicians or highly skilled personnel, such as Eye Bank operators.
Product codes
LYX
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corneas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians or highly skilled personnel, such as Eye Bank operators.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
AL.CHI.MI.A. S.r.1. Ms. Elena Morozova US Agent 1416 Obispo Ave. Coral Gables, FL 33134
Re: K162013
Trade/Device Name: Eusol-C Regulation Number: 21 CFR N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LYX Dated: June 9, 2016 Received: August 17, 2016
Dear Ms. Morozova:
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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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3. Statement of Indications for Use
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- September 19. :
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| DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below- |
| ---------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
| Indications for use | |
|---|---|
| 510(k) Number ( if known ) | |
| K162013 | |
| Device name | |
| Eusol-C |
| Indications for Use ( Describe ) | |
|---|---|
| Eusol-C is indicated when it is desired to store explanted corneas for up to 14 days. It is intended for use by physicians or highly skilled personnel, such as Eye Bank operators. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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