(110 days)
No
The document describes a corneal storage solution and its performance studies, with no mention of AI or ML technology.
No.
The device is a storage solution for corneas intended for transplant, not a device used in the direct treatment or diagnosis of a condition in a patient.
No
Explanation: This device is a corneal storage solution, meaning it is used to preserve human corneas for transplantation. It does not perform any diagnostic function, such as detecting or identifying a disease or condition.
No
The device is a corneal storage solution, which is a physical substance (liquid medium) and not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the storage of human corneas for transplantation. It is a preservation solution, not a device used to perform a diagnostic test on a sample taken from the human body.
- Device Description: The description reinforces that it's a storage medium.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample, detect a condition, or provide diagnostic information. The performance studies focus on the preservation quality of the cornea, not on diagnosing anything.
- Testing: The testing described is related to the efficacy of the storage solution in maintaining the viability and integrity of the cornea, not on its ability to perform a diagnostic test.
IVDs are typically used to examine specimens (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment. This device's function is entirely focused on preserving a biological tissue for later use in a surgical procedure.
N/A
Intended Use / Indications for Use
Cornisol is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).
Product codes
LYX
Device Description
Cornisol is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8℃ for up to 14 days. Cornisol is for single use and to be used only by physicians or highly skilled personnel such as eye bank operators. Corneas are directly placed in Cornisol medium after surgery with a storage time based on the time needed to obtain serology results of the donor but for a period of time of no more than 14 days.
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.
CORNISOL is a sterile, buffered corneal preservation medium comprised of the ingredients shown in Table 1. It is supplied ready to use with a volume of 20 mL in a 20 mL type 1 glass vial with a polyethylene cap and PVC shrink wrap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians or highly skilled personnel such as eye bank operators. Eye bank, hospital
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
Cornisol has undergone various testing including physicochemical testing, microbiological testing, sterilization validation, stability (shelf-life), packaging integrity testing as well as biocompatibility and in vitro testing.
The Cornisol formulation was tested in two in vitro studies. The first was a prospective, in vitro, randomized study using paired donor corneas was performed. The assessments to determine equivalent performance were endothelial cell loss, endothelial cell density (ECD), coefficient of variance, and percentage hexagonality on days 3, 7, 10, and 14. The results indicated that Cornisol adequately preserved the cornea for up to 14 days in storage. The second study was on donor corneas to compare the structural and functional integrity of the donor corneas following storage in Cornisol or Optisol-GS. Corneas were immunostained for markers of structural integrity (ZO-1, Phalloidin) and functionality (Na+/K+ ATPase). The results indicated that Cornisol had similar performance in preserving cell structural integrity and functionality.
Key Metrics
Not Found
Predicate Device(s)
Optisol-GS Corneal Storage Media (Product Code: LYX Media, Corneal K924165 Storage; Regulation: Unclassified)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 5, 2022
Aurolab % Sean Griffin President Allied Regulatory Consulting 1540 Keller Parkway, Suite 108 #170 Keller, Texas 76248
Re: K221759
Trade/Device Name: Cornisol Regulatory Class: Unclassified Product Code: LYX Dated: July 6, 2022 Received: July 11, 2022
Dear Sean Griffin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221759
Device Name Cornisol
Indications for Use (Describe)
Cornisol is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) summary has been prepared in accordance with 21 CFR 807.92.
Submitter
- Aurolab No.1, Sivagangai Main Road Veerapanjan Madurai, 625020 Tamil Nadu India Registration Number: 9710098 FEI Number: 3002957101
Application Correspondent:
Sean Griffin President Allied Regulatory Consulting 1540 Keller Parkway, Suite 108 #170 Keller, TX 76248 Phone: (817) 805-8392
Date Prepared: September 30, 2022
Device
Device Subject to this 510(k):
| Trade Name: | Cornisol |
|---|---|
| Common Name: | Hypothermic corneal storage media |
| Product Code: | LYX (Media, Corneal Storage) |
| Classification: | Unclassified |
Predicate Device
- Optisol-GS Corneal Storage Media (Product Code: LYX Media, Corneal K924165 Storage; Regulation: Unclassified)
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K221759 / PAGE 2 OF 6
Device Description
Cornisol is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8℃ for up to 14 days. Cornisol is for single use and to be used only by physicians or highly skilled personnel such as eye bank operators. Corneas are directly placed in Cornisol medium after surgery with a storage time based on the time needed to obtain serology results of the donor but for a period of time of no more than 14 days.
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.
Indications for Use
CORNISOL is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).
Physical and Performance Characteristics
CORNISOL is a sterile, buffered corneal preservation medium comprised of the ingredients shown in Table 1. It is supplied ready to use with a volume of 20 mL in a 20 mL type 1 glass vial with a polyethylene cap and PVC shrink wrap.
| Ingredient | Function |
|---|---|
| Chondroitin Sulphate | Osmotic agent/membrane stabilizer |
| Dextran 40 | Osmotic agent |
| HEPES Buffer | To maintain pH |
| Sodium Pyruvate | Energy source for endothelial cell |
| viability | |
| Gentamycin | Antibiotic |
| Streptomycin | Antibiotic |
| Sodium Bicarbonate | pH adjustment |
| Medium 199 | Nutrient and electrolyte |
| Minimum Essential Medium | Nutrient and electrolyte |
| Glutamax i200 | Energy production and helps prevent |
| degradation | |
| Vitamin B12 | Cofactor for enzymatic reactions and |
| membrane stabilizing agent | |
| Phenol Red Indicator | pH indicator |
| Recombinant Human Insulin | Cell metabolism enhancer |
| Purified Water IP | Vehicle |
Table 1: Cornisol ingredients and their function
5
Comparison of Technological Characteristics with the Predicate Device
Cornisol has similar technological characteristics as the predicate device (Table 2). Cornisol and the predicate device use Dextran as a deswelling agent. Cornisol and its predicate are provided sterile, are intended for single use and are provided in glass vials.
| Features and
Characteristics | Proposed Device
Cornisol | Predicate
Optisol-GS
(K924165) | Comparison of
Proposed Device
and Predicate
Features |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Hypothermic corneal
storage | Hypothermic corneal
storage | Same |
| Indications for
use | CORNISOL is a corneal
storage solution for
storage of human cornea
suitable for keratoplasty
for up to 14 days under
refrigeration (2-8°C). | OPTISOL is a
biocompatible, enhanced
tissue culture media for
storage of human corneas
suitable for keratoplasty
for up to 14 days under
refrigeration (2 - 8°C). | Same |
| Description | Sterile solution | Sterile solution | Both are sterile
solutions |
| Target
Population | Cornea for keratoplasty | Cornea for
keratoplasty | Same |
| Where used | Eye bank, hospital | Eye bank, hospital | Same |
| Energy used | Refrigeration at 2 to 8°C | Refrigeration at 2 to 8°C | Same |
| Design | Single use glass vials | Single use glass vials | Similar design
(single use vials) |
| Packaging/
How Supplied | Glass vial with screw
cap top | Glass vial with screw cap
top | Similar packaging
(glass vial with
screw top cap) |
| Key Ingredients | Dextran and chondroitin
sulfate as osmotic agents
and gentamycin and
streptomycin as
antibiotics | Dextran and chondroitin
sulfate as osmotic agents
and gentamycin and
streptomycin as
antibiotics | Both contain dextran
and chondroitin
sulfate as osmotic
agents and
gentamycin and
streptomycin as
antibiotics |
| Sterility | Sterile | Sterile | Both are provided
sterile |
| Performance | Demonstrated to be
equivalent to predicate
device at storing corneas
for up to 14 days when
stored at 2 to 8°C | 510(k) cleared for the
storage of corneas for up
to 14 days when stored at
2 to 8°C | Substantially
equivalent to
predicate device |
Table 2: Comparison between Cornisol and Predicate Device
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K221759 / PAGE 4 OF 6
Performance Data
Cornisol has undergone various testing including physicochemical testing, microbiological testing, sterilization validation, stability (shelf-life), packaging integrity testing as well as biocompatibility and in vitro testing.
Chemical characterization to assess the biocompatibility profile of the corneal storage media and primary packaging was conducted. The selected ingredients are commonly used in corneal storage media and no novel ingredients were selected. Cornisol is a buffered corneal preservation medium that includes additives like buffering agents, osmotic agents and pH adjusters/indicators, and there are no residues and process contaminants present in the solution. In addition, Cornisol does not contain polymers, ceramics and metals in the formulation that would produce degradation products of this nature.
Cornisol is a solution that is manufactured and sterilized by sterile filtration using 0.2 micron polyether sulphone membrane filters. The filters have been validated for aqueous extracts to exhibit . A finished product endotoxin specification for Cornisol of 5 EU/device has been established and batch results confirm that Cornisol conforms with this specification.
Although Cornisol solution is sterilized by sterile filtration, the vial caps are sterilized by ethylene oxide (EO). The average daily exposure of EO to a patient shall not exceed 1.25 ug/device for EO and 5 µg/device for ECH (4 times EO limit), in compliance with the limits for IOLs in the ANSI/AAMI/ISO 10993-7:2008(R)2012 (Table C.1 in Annex C) standard. The shelf life for Cornisol is 12 months when stored at 2℃ to 8℃.
Package integrity testing is performed on every batch of packaging components (vial and caps) for Cornisol by dye ingress/egress vacuum testing to ensure that the components can maintain the sterile barrier. In addition, each batch of Cornisol finished product is also tested using inverted vacuum challenge testing. Representative samples of packaging components have been tested and these results confirm ability to maintain the sterile barrier.
In addition, biocompatibility testing of Cornisol has been conducted.
- Cytotoxicity in accordance with ISO 10993-5 .
7
- Sensitization in accordance with ISO 10993-10 .
- . Acute ocular irritation testing in accordance with ISO 10993-10
The Cornisol formulation was tested in two in vitro studies. The first was a prospective, in vitro, randomized study using paired donor corneas was performed. The assessments to determine equivalent performance were endothelial cell loss, endothelial cell density (ECD), coefficient of variance, and percentage hexagonality on days 3, 7, 10, and 14. The results indicated that Cornisol adequately preserved the cornea for up to 14 days in storage. The second study was on donor corneas to compare the structural and functional integrity of the donor corneas following storage in Cornisol or Optisol-GS. Corneas were immunostained for markers of structural integrity (ZO-1, Phalloidin) and functionality (Na+/K+ ATPase). The results indicated that Cornisol had similar performance in preserving cell structural integrity and functionality.
Conclusion
Cornisol is substantially equivalent to the predicate device, Optisol-GS. There are not different questions of safety and effectiveness with respect to the intended use and technologically characteristics between Cornisol and the predicate device.