The CorNeat EverPatch is a synthetic, tissue-integrating surgical matrix made of non-degradable polymer fibers. The EverPatch includes 6 bio-stitching holes which are intended to anchor the device by facilitating direct conjunctival adhesion to the sclera thus supporting its bio-integration. The holes at each corner can also be used to suture the device to the sclera.

AI/ML Overview

The FDA 510(k) summary for the CorNeat EverPatch focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed study results in the manner typically seen for novel efficacy claims. Therefore, some information, such as precise quantitative acceptance criteria or detailed effect sizes from MRMC studies, is not explicitly provided in this document because it's not required for a 510(k) submission based on substantial equivalence for this type of device.

However, I can extract the relevant information concerning characterization and performance testing that was performed to support the device's safety and bio-compatibility.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or a performance table as usually understood for diagnostic or interventional devices with quantifiable efficacy metrics. Instead, the performance is demonstrated through various bench testing and biocompatibility assessments, with the implicit "acceptance criterion" being that the results are acceptable for safe and effective use, and comparable to the predicate device where relevant.

Reported Device Performance (from "PERFORMANCE DATA" section):

Biocompatibility: Evaluated per ISO 10993 Biological Evaluation of Medical Devices Part 1, for externally communicating, blood contacting, permanent devices, and FDA Guidance. All listed tests (Cytotoxicity, Maximization Sensitization, Ocular Irritation, Acute Systemic Toxicity, Pyrogenicity, Implantation 13 weeks, Chemical Characterization, Subacute/Sub-chronic Toxicity, Subacute/Chronic Toxicity, Genotoxicity) were performed and presumably met their respective acceptance limits according to the standards.
Verification and Validation Tests: Performed in accordance with Design Controls (21 CFR §820.30).
- Dimensional Analysis: Performed.
- Cheese-wiring: Performed.
- Mechanical properties: Performed.
- Sterilization: Performed.
- Packaging Validation: Performed.
- Shelf-life: Performed.
- Pyrogenicity - Bacterial Endotoxin Test (LAL): Performed.
- Ocular implantation animal study: Performed.

The document implicitly states that these tests demonstrate the device "demonstrates the requirements and is substantially equivalent to the predicate."

2. Sample size used for the test set and the data provenance

The document mentions an "Ocular implantation animal study" as part of the performance data. However, the specific sample size (number of animals) for this study is not provided.
The provenance for the animal study (e.g., type of animal) is not specified.
For the other bench tests, "sample size" typically refers to the number of units tested, which is not specified in this summary.
Clinical data was not required to demonstrate substantial equivalence, so there is no human test set or data provenance from human subjects for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Since clinical data was not required and the performance evaluation focused on bench and animal studies (for biocompatibility and physical characteristics), there was no "ground truth" establishment by human experts in the context of clinical interpretation or diagnosis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As no human expert evaluation or clinical test set for diagnostic accuracy was part of this submission, there was no need for an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a passive implantable medical device (prosthesis, eyelid spacer/graft, polymer) not an AI-driven diagnostic or interpretative tool. Therefore, an MRMC study or AI assistance evaluation is irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. As mentioned above, this device is not an algorithm or AI system.

7. The type of ground truth used

For biocompatibility, the "ground truth" is established by relevant ISO standards (ISO 10993) and FDA guidance, which define acceptable biological responses and material properties.
For mechanical properties and physical dimensions, the "ground truth" is defined by engineering specifications and design requirements for the device, and assessed through standard engineering testing methodologies.
For the ocular implantation animal study, the ground truth would be based on histopathological examination and clinical observations derived from the animal models, interpreted by veterinary pathologists or researchers.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set for this device.

Summary

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June 2, 2023

CorNeat Vision Ltd. Gilad Litvin, M.D. Chief Medical Officer 4 Hasheyzaf St. Raanana, 4366411 Israel

Re: K223074

Trade/Device Name: CorNeat EverPatch Regulation Number: 21 CFR 886.3130 Regulation Name: Ophthalmic Conformer Regulatory Class: Class II Product Code: QWU Dated: May 5, 2023 Received: May 5, 2023

Dear Gilad Litvin, M.D.:

We have reviewed vour 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

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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 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,

Claudine H. Krawczyk -S

Claudine Krawczyk Acting 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

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Indications for Use

510(k) Number (if known) K223074

Device Name CorNeat EverPatch

Indications for Use (Describe)

The CorNeat EverPatch is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.

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

This 510(k) summary of safety and effectiveness information, provided on the following pages, is being submitted in accordance with the requirements of 21 CFR 807.92.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

APPLICANT:	CorNeat Vision, Ltd.4 Hasheizaf st. Raanana, Israel 4366411
OFFICIAL CORRESPONDENT:	Dr. Gilad LitvinChief Medical Officer
	+972 50-351-4057gilad@corneat.com
DATE SUMMARY PREPARED:	June 2, 2023
TRADE/MODEL NAME:	CorNeat EverPatch
COMMON NAME:	Prosthesis, eyelid spacer/graft, polymer
DEVICE CLASSIFICATION /CODE	21 CFR 886.3130, Class IIQWU
PREDICATE DEVICE:	KeraSys Bioengineered Lamellar Patch GraftK090078 (May 8, 2009)
REFERENCE DEVICES:	Neuro-Patch K960470 (May 10, 1996);
	PowerFlow™ Implantable Apheresis IV Port with 9.6Fr. ChronoFlex™ Catheter K163001 (April 17, 2017)

DEVICE DESCRIPTION

INDICATIONS FOR USE

The CorNeat EverPatch is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.

TECHNOLOGICAL CHARACTERISTICS COMPARISON

Both the subject device and predicate are intended to reinforce sclera and aid the physical

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reconstruction of the ocular surface. The subject and predicate devices are based on the following same technological elements: Intended use, placement technique and anatomical site, sterility, packaging, sterilization, and biocompatibility.

The differences between the subject device and cited predicate include:

. Dimensions: The CorNeat EverPatch is slightly thinner and smaller than the predicate device, the thickness is similar for its intended use. The CorNeat EverPatch is sized to be used as supplied and should not be trimmed.
Materials: The CorNeat EverPatch is comprised of aromatic poly(carbonate-urethane) which differs from the material used in the predicate. EverPatch material has demonstrated biocompatibility from testing conducted per ISO 10993-1 as the predicate device. Nondegradable, bio durable polymers have been used in the following reference devices for other applications for long-term intravascular catheters (K163001) and dura substitute in neurological procedures (K960470).

The following table shows a comparison of the technological characteristics between the CorNeat EverPatch and the cited predicate.

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TABLE 1
TECHNOLOGICAL COMPARISON OF THE CORNEAT EVERPATCH TO THE PREDICATE DEVICE

Characteristic	CorNeat EverPatch(Subject Device)	KeraSys Bioengineering Lamellar PatchGraft K090078(Predicate Device)	Comparison
Manufacturer	CorNeat Vision, Ltd.	IOP, Inc.	N/A
Regulation/Product Code	21 CFR 886.3130; QWU, Prosthesis, EyelidSpacer/Graft, polymer	21 CFR 886.3130; NXM, Prosthesis, EyelidSpacer/Graft	N/A
Intended use	To reinforce sclera and aid the physicalreconstruction of the ocular surface.	To reinforce sclera and aid the physicalreconstruction of the ocular surface.	Same
Target Population	Patients undergoing ocular surgery in needof scleral reinforcement	Patients undergoing ocular surgery in needof scleral reinforcement	Same
Indications for use	The EverPatch is intended for implantationto reinforce sclera and aid the physicalreconstruction of the ocular surface.	The KeraSys Bioengineered Lamellar PatchGraft is intended for implantation toreinforce sclera and aid the physicalreconstruction of the ocular surface.	Same
Anatomical Sites	Ocular Surface	Ocular Surface	Same
Use Environment	Surgical (Rx Only)	Surgical (Rx Only)	Same
Characteristics
Material	Aromatic Polycarbonate urethane	Processed porcine submucosa	Different butnot raisingdifferentquestions ofsafety andeffectiveness
Supplied	Sterile	Sterile	Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same
Recommended Usage	Single Use	Single Use	Same
Physical Dimensions	0.5 cm x 0.65 cm with 100 micronsthickness	1 cm x 1.5 cm with 150 microns thickness(hydrated)	Different butnot raisingdifferentquestions ofsafety andeffectiveness
Characteristic	CorNeat EverPatch(Subject Device)	KeraSys Bioengineering Lamellar PatchGraft K090078(Predicate Device)	Comparison
Fundamental Technology	Prefabricated material of fixed dimensionsto reinforce sclera and aid the physicalreconstruction of the ocular surface.	Prefabricated material of fixed dimensionsto reinforce sclera and aid the physicalreconstruction of the ocular surface.	Same
Fundamental Technology	The CorNeat EverPatch is sized to beused as supplied and should not betrimmed.	The device can be trimmed to size.	Different butnot raisingquestions ofsafety andeffectiveness.
Fundamental Technology	The device can be sutured in place withoutcheese-wiring.	The device can be sutured in place withoutcheese-wiring.	Same
Treatment PlanPrescription or OTC	Rx Only	Rx Only	Same

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PERFORMANCE DATA

Bench Testing

Biocompatibility evaluations were completed per ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, permanent devices and FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The following were evaluated:

Cytotoxicity ●
Maximization Sensitization ●
Ocular Irritation ●
. Acute Systemic Toxicity
. Pyrogenicity
. Implantation 13 weeks
Chemical Characterization ●
Subacute/ Sub-chronic Toxicity
Subacute/ Chronic Toxicity ●
. Genotoxicity

Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30.

The following tests were performed:

Dimensional Analysis
Cheese-wiring ●
Mechanical properties
Sterilization ●
Packaging Validation
Shelf-life ●
Pyrogenicity - Bacterial Endotoxin Test (LAL)
Ocular implantation animal study ●

Clinical Performance Evaluation

Clinical data is not required to demonstrate substantial equivalence.

CONCLUSION

The subject device, CorNeat EverPatch, has the same intended use as the cited predicate device. Testing performed on the subject device demonstrates the requirements and is substantially equivalent to the predicate.

Regulation Number and Section

§ 886.3130 Ophthalmic conformer.

(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.