(65 days)
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.
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.
This document is a 510(k) summary for Eusol-C, a sterile medium for hypothermic corneal storage. It describes the device, its intended use, and indicates that it is substantially equivalent to a legally marketed predicate device (Eusol-C Corneal Storage Media, K032422).
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical targets or thresholds for device performance. Instead, it states that "The following tests have been done on Eusol-C:" and lists general categories of tests. The overall conclusion is that "Eusol-C is equivalent in safety and efficacy to the legally-marketed predicate device."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Tests | Done |
| - Physical Tests | Done |
| - Microbiological Tests | Done |
| - Biological Tests and Assays | Done |
| - Performance tests | Done |
| Clinical Tests | Not required |
| Overall Conclusion | Equivalent in safety and efficacy to legally-marketed predicate device. |
| Stability | Can be stored at 2-25°C. Peak temperatures up to 42°C do not affect EUSOL-C parameters and performances. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench tests" and "Performance tests" but does not specify the sample size for these tests. It also does not provide details on data provenance (e.g., country of origin, retrospective or prospective) for any of the non-clinical tests. Clinical tests were "Not required."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that clinical tests were not required, it's unlikely that "experts" in the traditional sense (e.g., radiologists) were used to establish ground truth for a clinical test set. The non-clinical tests would rely on established laboratory testing methodologies and standards.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable since clinical tests requiring adjudication were not conducted according to the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document states "Clinical tests: Not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
This question is not applicable as the device (Eusol-C) is a sterile medium for corneal storage, not an algorithm or AI-based diagnostic tool. Therefore, an "algorithm only" or "standalone" performance study in the context of AI is not relevant.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" would have been established through a combination of:
- Standard laboratory assays and measurements: For physical, microbiological, and biological tests.
- Established performance specifications: For "Performance tests," likely comparing against a predicate device or pre-defined benchmarks for corneal viability/integrity after storage in Eusol-C.
- The document implies comparison to a predicate device for equivalence, suggesting the predicate's performance served as a de-facto ground truth or benchmark.
8. The Sample Size for the Training Set
This question is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is not an AI/ML algorithm that requires a training set.
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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 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
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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:
- 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.
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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 (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
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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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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)
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