(108 days)
Hypothermic (2-8°C) human corneal storage for 14 days
Cornea Cold® is a sterile hypothermic corneal storage medium intended for human corneal storage at 2-8°C, for up to 14 days. Corneas are directly placed in Cornea Cold storage medium after surgery, and stored in eye banks between +2°C for a maximum of 2 weeks. The shortest storage time is determined by the time needed to obtain serology results of the donor. It is for single use, to be used by physicians or highly skilled personnel such as bank operators. The device gets into direct contact with the patient by accumulation in the cornea graft.
The provided text describes the 510(k) submission for the Cornea Cold® device, a hypothermic corneal storage medium. The submission asserts substantial equivalence to a predicate device, Optisol-GS. However, the document does not contain specific acceptance criteria, detailed study results, or the other requested information for algorithm performance.
The document is a regulatory submission for a medical device that preserves biological material (corneas), not an AI/ML algorithm that analyzes data to produce performance metrics like sensitivity, specificity, or AUC. Therefore, a direct answer to the prompt's request for acceptance criteria and studies proving an algorithm's performance cannot be provided from this document.
The "Performance" section within the table comparing the device to the predicate device simply states "Substantially equivalent to predicate device." This indicates that the performance was deemed similar enough to the legally marketed predicate device to establish substantial equivalence, without providing specific metrics or a detailed study report.
In summary, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and performance studies of a device that uses an algorithm. It describes a medical device in the context of its regulatory clearance rather than its analytical or diagnostic performance metrics.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
Eurobio % Ms. Jessica Barrett International Medical 4733 Millrace Lane Murray, UT 84107
Re: K151061
Trade/Device Name: Cornea Cold® Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LYX Dated: June 2, 2015 Received: June 10, 2015
Dear Ms. Barrett:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -A
for 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) K151061
Device Name Cornea Cold
Indications for Use (Describe) Hypothermic (2-8°C) human corneal storage for 14 days
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) summary
Owner of the 510(K)
Company: Les Ulis City: Country: France Phone: +33--1 69 07 94 77 Fax: +33--1 69 07 95 34 E-mail: jm.carle@eurobio.fr
Preparer of 510(K)
Name: Marie-Claude Amoureux, PhD Tittle: Research and Development Manager Company: Eurobio Company. Zip Code: F-91953 City: Les Ulis Country:France Phone: +33--1 69 07 94 77 Fax: +33--1 69 07 95 34 E-mail:
USA correspondent/initial importer
Contact: Jessica Barrett Name of Agent's Company: International Medical Street address: 4733 Millrace Lane City, State, Zip Code: Murray, UT 84107-4061 Country: USA Phone: 801.652.6334 Fax: 801.284.5758 E-mail: Jessicabarrett3@gmail.com
Date prepared: July 29 2015.
Trade name: Cornea Cold®
Common name of the device: Hypothermic corneal storage media Product Code: LYX Device class: Unclassified
Substantial equivalence
The current device is substantially equivalent to Optisol-GS Corneal Storage Media from Chiron Intraoptics/Bausch& Laumb- 510(K) number: K924165
Description of the device
Functioning of the device: Cornea Cold® is a sterile hypothermic corneal storage medium intended for human corneal storage at 2-8°C, for up to 14 days. Corneas are directly placed in Cornea Cold storage
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medium after surgery, and stored in eye banks between +2°C for a maximum of 2 weeks. The shortest storage time is determined by the time needed to obtain serology results of the donor. It is for single use, to be used by physicians or highly skilled personnel such as bank operators. The device gets into direct contact with the patient by accumulation in the cornea graft.
Under aseptic conditions, the seal of the vial is broken and the cap loosened. The cap is lifted and place adjacent to sterile field with inner liner face up. The cornea is then transferred into the vial and submerged with liquid. The cap is tightened.
Scientific basis for the device: Cold storage of cornea is traditionally performed by keeping corneas in
a cold storage medium containing deswelling agent(s) between +2°C and +8°C. Cornea Cold hypothermic corneal storage media contains Dextran, an osmotic agent. The device contains the necessary components for preservation of cornea for grafting, with antibiotics to prevent microbiological contaminations, and other components (essential and non essential amino acids, energetic components, vitamins, pH indicator, inorganic salts) to maintain the cornea in healthy state for keratoplasty. Storage of cornea in these conditions can last up to 14 days.
Physical and performance characteristics:
Device design and Material used: Cornea Cold medium (28 mL/vial) is contained in a 30 ml type I glass vial and the cap has a seal to ensure the vial has not been opened. The device comes as single unit (Ref:
CMXCOLD4FB). Twelve individual Cornea Cold units are packaged in a box (Ref: CMXCOLD4FB-UN),
appropriately labeled with lot number and expiration date. Cornea Cold is ready to use and instructions for Use are included in the box.
Physical properties: Cornea Cold can be stored at 2-8°C until ready for use for up to 9 months. No defrosting of the medium is needed. pH is physiological and osmolarity are controlled. The red cherry color of the medium can be visually monitored in case of abnormal change in pH as indicated in Instruction for use package insert.
Intended use
Hypothermic (2-8°) human corneal storage for 14 days.
Technological characteristics compared to the predicate device
Cornea Cold® has the same technological characteristics as the predicate device, contains Dextran as deswelling agent. Like Optisol-GS, the medium is a sterile solution in a glass vial.
| Summary of substantial Equivalence highlighting similarities and differences | |||
|---|---|---|---|
| Feature | Optisol-GS (predicate deviceK924165) | Cornea Cold | Comment if differentfrom predicate device |
| Intended use | Hypothermic corneal storage | Hypothermic corneal storage | |
| Indications for use | Hypothermic (2-8°C) human cornealstorage for 14 days | Hypothermic (2-8°C) human cornealstorage for 14 days | |
| Target population | Cornea for keratoplasty | Cornea for keratoplasty | |
| Where used | Eye bank, hospital | Eye bank, hospital | |
| Energy used | Refrigeration 2-8°C | Refrigeration 2-8°C | |
| Design | Single use individual glass vials soldin a package of 12 | Single use individual glass vials soldin a package of 12 | |
| Performance | Substantially equivalent to predicate device | ||
| Standards | Sterile apyrogenic solution | Sterile apyrogenic solution |
Summary of substantial equivalence highlighting similarities and differences
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| Materials | Glass vial/ Dextran and chondroitin sulfate as osmotic agents/ gentamycin streptomycin antibiotics | Glass vial/Dextran as osmotic agent/penicillin streptomycin antibiotics | Cornea Cold. Dextran alone at 6% was found to be an efficient and safe deswelling agent. Penicillin and Streptomycin have been chosen for their abilities to have a broad spectrum of activity. |
|---|---|---|---|
| Biocompatibility | Full biocompatibility testing was done; interaction between container and content was negative; cornea in Cornea Cold were of as good or better quality than in Optisol-GS | ||
| Sterility | Sterile | Sterile | |
| Others (electrical, mechanical, chemical, thermal, radiation safety) | Not applicable | Not applicable |
Assessment of substantial equivalence
Non-clinical tests:
- Physicochemical tests (pH, osmolarity)
- Microbiological tests (endotoxins)
- Stability tests (physicochemical parameters) at temperature of storage and extreme temperatures
- Interaction container/content
- Biocompatibility
- . Cytotoxicity
- . Ocular irritation test
- . Sensitization test
- . Bacterial reverse mutation test (Ames test)
Clinical tests: Not required
Comparison with predicate device: Comparative analyses were performed on various typical morphological, structural and physiological parameters of paired, preserved eye bank corneas between the subject and predicate device.
Conclusion: Cornea Cold is substantially equivalent to the predicate device
N/A