Eusol-C

K162013 · Al.Chi.Mi.A. S.R.L · LYX · Sep 15, 2016 · OP

Device Facts

• Record ID: K162013
• Device Name: Eusol-C
• Applicant: Al.Chi.Mi.A. S.R.L
• Product Code: LYX · OP
• Decision Date: Sep 15, 2016
• Decision: SESE
• Submission Type: Special
• Device Class: Class U

Intended 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.

Device Story

Eusol-C is a corneal storage medium used to preserve explanted corneas for up to 14 days prior to transplantation. It is utilized in eye bank settings by physicians or highly skilled personnel. The device functions as a chemical preservation solution to maintain corneal tissue viability during storage. It does not involve electronic inputs, software, or automated processing.

Technological Characteristics

Corneal storage medium solution. No electronic, software, or mechanical components.

Indications for Use

Indicated for storage of explanted corneas for up to 14 days. Intended for use by physicians or eye bank personnel.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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1. September 19. :

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| DEPARTMENT OF HEALTH AND HUMAN<br>SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below- |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

| Indications for use | |
|-----------------------------------|--|
| 510(k) Number ( <i>if known</i> ) | |
| K162013 | |
| Device name | |
| Eusol-C | |

| Indications for Use ( <i>Describe</i> ) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-.052z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 2h12v12H2V2z" fill="none" stroke="currentColor" stroke-width="2"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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