← Product Code LYX · K221759 # Cornisol (K221759) _Aurolab · LYX · Oct 5, 2022 · OP · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K221759 ## Device Facts - **Applicant:** Aurolab - **Product Code:** LYX - **Decision Date:** Oct 5, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OP ## Intended 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). ## Device Story Cornisol is a sterile, hypothermic corneal storage medium used in eye banks and hospitals by physicians or skilled personnel. It functions as a preservative solution for human corneas awaiting keratoplasty. The device consists of a buffered solution containing osmotic agents (dextran, chondroitin sulphate), nutrients (Medium 199, MEM), energy sources (sodium pyruvate, Glutamax i200), antibiotics (gentamycin, streptomycin), and stabilizers. Corneas are submerged in the solution within a glass vial and stored at 2-8°C. The medium maintains endothelial cell viability, structural integrity, and functionality during the storage period. By preserving donor tissue quality, the device ensures the cornea remains suitable for transplantation, potentially improving surgical outcomes for patients requiring keratoplasty. ## Clinical Evidence Bench testing only. Includes physicochemical, microbiological, sterilization validation, shelf-life, and packaging integrity testing. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10. Two in vitro studies conducted: 1) Prospective, randomized study using paired donor corneas evaluated endothelial cell loss, density, coefficient of variance, and hexagonality at days 3, 7, 10, and 14, showing adequate preservation. 2) Comparative study against Optisol-GS using immunostaining for structural (ZO-1, Phalloidin) and functional (Na+/K+ ATPase) markers, confirming similar performance. ## Technological Characteristics Sterile, buffered hypothermic storage medium. Ingredients: Chondroitin Sulphate, Dextran 40, HEPES, Sodium Pyruvate, Gentamycin, Streptomycin, Sodium Bicarbonate, Medium 199, MEM, Glutamax i200, Vitamin B12, Phenol Red, Recombinant Human Insulin. Supplied in 20 mL Type 1 glass vials with polyethylene caps. Sterilization: Sterile filtration (0.2 micron PES membrane) for solution; Ethylene Oxide (EO) for caps. Complies with ANSI/AAMI/ISO 10993-7:2008(R)2012 for EO/ECH residuals. Shelf life: 12 months at 2-8°C. ## Predicate Devices - Optisol-GS Corneal Storage Media ([K924165](/device/K924165.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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) {4}------------------------------------------------ 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 {6}------------------------------------------------ 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 < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) testing per USP<85>. 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. --- **Source:** [https://fda.innolitics.com/device/K221759](https://fda.innolitics.com/device/K221759) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com