(56 days)
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.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device called "Eusol-C" which is intended for storing explanted corneas. However, the document does not contain any information regarding acceptance criteria, device performance, study details (sample size, provenance, expert details, adjudication methods), or training set information.
The document is primarily an FDA clearance letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements.
Therefore, I cannot provide the requested information based on the given text.
{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.
{1}------------------------------------------------
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
{2}------------------------------------------------
3. Statement of Indications for Use
.
a seem a comments of the comments of
1 .
a marka mana mana mana marka masa mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara
- September 19. :
.
| DEPARTMENT OF HEALTH AND HUMANSERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time
to review instructions, search existing data sources, gather and maintain the data needed, and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this collection of information, including suggestion for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
.
.
N/A