(132 days)
Not Found
No
The summary describes a sterile medium for corneal storage and does not mention any AI or ML components or functionalities.
No.
The device is a storage medium for corneas, not a device used to treat a condition or disease in a patient.
No
Explanation: The device is a storage medium for corneas and is not used to diagnose a medical condition. Its purpose is to preserve the cornea for transplantation.
No
The device description explicitly states "Eusol-C is sterile medium for hypothermic corneal storage," indicating it is a physical substance (a medium) and not solely software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. Eusol-C is a storage medium for donor corneas, which are tissues, not specimens being examined for diagnostic purposes.
- IVDs are used to provide information for diagnosis, monitoring, or treatment. Eusol-C's purpose is to preserve the viability of the cornea for transplantation, not to provide diagnostic information about a patient's condition.
- The intended use clearly states "corneal storage". This is a preservation function, not a diagnostic one.
The device is a medical device used in the process of corneal transplantation, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Eusol-C is indicated for corneal storage for up to 14 days.
Product codes
LYX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corneal
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
(a) Non-clinical tests
The following tests have been done on Eusol-C:
-
- Long-term stability and Accelerated aging
-
- Container closure test
-
- Performance characteristics
-
- Sterilization Validation
-
- 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.
- Comparison with Predicate Device
Key Metrics
Not Found
Predicate Device(s)
Optisol-GS Corneal Storage Media, K924165
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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:
-
- Long-term stability and Accelerated aging
-
- Container closure test
-
- Performance characteristics
-
- Sterilization Validation
-
- 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