(65 days)
No
The document describes a sterile medium for corneal storage and does not mention any AI or ML components or functionalities.
No.
This device is a storage medium for corneas, not a device used to treat a disease or condition in a patient.
No
Explanation: The device is a sterile medium for hypothermic corneal storage, used to preserve corneas for transplantation. It does not perform any diagnostic function.
No
The device is a sterile medium for hypothermic corneal storage, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the storage of explanted corneas. This is a preservation function for a biological tissue, not a diagnostic test performed on a sample from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description reinforces that it's a storage medium.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample, detecting a substance, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical, microbiological, biological, and performance characteristics of the storage medium itself, not on its ability to diagnose a condition.
IVDs are typically used to test blood, urine, tissue, or other bodily fluids to detect diseases, conditions, or markers. This device's function is to maintain the viability of a tissue outside the body for later transplantation.
N/A
Intended Use / Indications for 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.
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.
Product codes
LYX
Device 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corneas
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests:
- Bench tests
a) Physical Tests
b) Microbiological Tests
c) Biological Tests and Assays
d) Performance tests - Clinical tests: Not required.
Conclusions: Eusol-C is equivalent in safety and efficacy to the legally-marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 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.
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
1
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:
- Bench tests
- a) Physical Tests
- b) Microbiological Tests
- c) Biological Tests and Assays
- d) Performance tests
- Clinical tests
Not required.
(6) 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 & 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.
3
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 (240) 276-0115. 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 (240) 276-3150 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
4
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
K063617 510(k) Number ...
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(Posted November 13, 2003)