← Product Code LYX · K032422 # EUSOL-C (K032422) _Al.Chi.Mi.A · LYX · Dec 15, 2003 · OP · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K032422 ## Device Facts - **Applicant:** Al.Chi.Mi.A - **Product Code:** LYX - **Decision Date:** Dec 15, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OP ## Intended Use Eusol-C is indicated for the storage of donor corneas for up to 14 days. ## Device Story Eusol-C is a sterile medium for hypothermic corneal storage. It is used by physicians or Eye Bank operators to store donor corneas at 4°C for up to 14 days prior to transplantation. The device functions as a chemical preservation environment to maintain corneal tissue viability during the storage period. It is a standalone chemical product. ## Clinical Evidence No clinical data. Bench testing only, including long-term stability, accelerated aging, container closure testing, and performance characteristics. ## Technological Characteristics Sterile liquid medium for hypothermic storage of corneal tissue. Designed for storage at 4°C. Non-electronic, chemical device. ## Predicate Devices - Optisol-GS Corneal Storage Media ([K924165](/device/K924165.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K032422 # DEC 1 5 2003 Alchimia 510(k) Page A2 Corrected AL.CHI.MI.A. S.r.1 510(k) Submission EUSOL-C ### 510(k) Summary #### (1) Submitter Information Name: AL.CHI.MI.A. S.r.l. Address: Viale Europa 12/A 35020 Ponte San Nicolò (PD) ITALY Telephone Number: 39-049-8962074/64 Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708 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. Optisol-GS Corneal Storage Media, K924165 ### (4) Description {1}------------------------------------------------ Alchimia 510(k) Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4℃ for up to 14 days. It is to be used by physicians or highly skilled personnel, such as Eye Bank operators. - (5) Intended Use Eusol-C is indicated for corneal storage for up to 14 days. ### (6) Performance Data (a) Non-clinical tests The following tests have been done on Eusol-C: - 1. Long-term stability and Accelerated aging - 2. Container closure test - 3. Performance characteristics - 4. Sterilization Validation - 5. Comparison with Predicate Device - (b) Clinical tests Not required. (c) Conclusions Eusol-C is equivalent in safety and efficacy to the legally-marketed predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 5 2003 AL.CHI.MI.A. S.r.l c/o George Myers, Ph.D. Medsys, Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Re: K032422 Trade Name: Eusol-C Regulation Number: Unclassified Product Code: LYX Dated: November 5, 2003 Received: November 6, 2003 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 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. {3}------------------------------------------------ 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, A Luigi lorentthal 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 Enclosure {4}------------------------------------------------ Alchimia Eusol C Page 8 Corrected Page _ 1______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Indications for Use Form Device Name: Eusol-C Indications for Use: Eusol-C is indicated for the storage of donor corneas for up to 14 days. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Raul Carraza (Division Sign Off) Throat De 510(k) Number K032422 --- **Source:** [https://fda.innolitics.com/device/K032422](https://fda.innolitics.com/device/K032422) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com