EUSOL-C

K063617 · Al.Chi.Mi.A · LYX · Feb 8, 2007 · OP

Device Facts

• Record ID: K063617
• Device Name: EUSOL-C
• Applicant: Al.Chi.Mi.A
• Product Code: LYX · OP
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Special
• Device Class: Class U

Intended Use

Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4℃ for up to 14 days, to be used by physicians or highly skilled personnel.

Device Story

Eusol-C is a sterile medium designed for the hypothermic storage of explanted corneas at 4°C for up to 14 days. It is utilized by physicians or highly skilled personnel, such as Eye Bank operators, to maintain corneal viability prior to transplantation. The device is stored at 2-25°C until use and remains stable at peak temperatures up to 42°C. By providing a controlled environment for storage, the device facilitates the preservation of donor tissue, ensuring it remains suitable for clinical use.

Clinical Evidence

No clinical data. Bench testing only, including physical, microbiological, and biological assays.

Technological Characteristics

Sterile liquid medium for hypothermic corneal storage. Designed for storage at 4°C; stable at temperatures up to 42°C. Non-electronic, chemical/biological storage solution.

Indications for Use

Indicated for the storage of explanted corneas for up to 14 days. Intended for use by physicians or highly skilled personnel, such as Eye Bank operators.

Predicate Devices

• Eusol-C Corneal Storage Media (K032422)

Submission Summary (Full Text)

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## AL.CHI.MI.A. S.r.l Special 510(k) Submission EUSOL-C

#### 8 2007 FEB

### 510(k) Summary

(1) Submitter Information

Name: AL.CHI.MI.A. S.r.l.

Address:

Viale Austria, 14 Ponte San Nicolò (PD) ITALY

Telephone Number: 39-049-8962074

Contact Person:

Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: May 19, 2003

(2) Name of Device

Trade Name: Eusol-C Common Name: Sterile medium for hypothermic corneal storage Classification name: Not classified

(3) Equivalent legally-marketed devices.

Eusol-C Corneal Storage Media, K032422

(4) Description

Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4°C for up to 14 days, to be used by physicians or highly skilled personnel, such as Eye

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Bank operators. EUSOL-C can be stored at 2-25°C until ready for use. Based on stability studies, peak temperatures up to 42°C do not affect EUSOL-C parameters and performances.

(5) Intended Use

Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4℃ for up to 14 days, to be used by physicians or highly skilled personnel.

(6) Performance Data

(a) Non-clinical tests

The following tests have been done on Eusol-C:

1. Bench tests

- a) Physical Tests
- b) Microbiological Tests
- c) Biological Tests and Assays
- d) Performance tests

2. Clinical tests

Not required.

#### (6) Conclusions

Eusol-C is equivalent in safety and efficacy to the legally-marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Al.Chim.Mi.A S.R.L c/o Dr. George Myers Medsys, Inc. 377 Route 17 S. Hasbrouck Heights, NJ 07604

8 2007 FEB

Re: K063617

Trade/Device Name: EUSOL-C Corneal Storage Media Regulatory Class: Unclassified Product Code: LYX Dated: November 30, 2006 Received: January 12, 2007

Dear Dr. Myers:

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 indives 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, Insting 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 100-1050.

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Page 2 - Dr. George Myers

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eichler Si MD

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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Indications for Use

| 510(k) Number (if known): | K063617 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: EUSOL-C

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

K063617 510(k) Number ...

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(Posted November 13, 2003)