(245 days)
No
The summary describes a synthetic surgical matrix and its physical properties and testing, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes.
The device is intended for implantation to reinforce the sclera and aid the physical reconstruction of the ocular surface, which falls under the definition of a therapeutic intervention.
No
The device is an implantable surgical matrix intended for physical reconstruction and reinforcement of the ocular sclera, not for diagnosing a condition.
No
The device description clearly states it is a "synthetic, tissue-integrating surgical matrix made of non-degradable polymer fibers," which is a physical hardware component, not software.
Based on the provided information, the CorNeat EverPatch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "implantation to reinforce sclera and aid the physical reconstruction of the ocular surface." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "synthetic, tissue-integrating surgical matrix" made of polymer fibers, designed for implantation and suturing. This is consistent with a medical device for surgical use, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The CorNeat EverPatch is a surgical implant used in vivo (within the body).
N/A
Intended Use / Indications for Use
The CorNeat EverPatch is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.
Product codes
QWU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular Surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical (Rx Only)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.
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
1
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 Litvin
Chief Medical Officer |
| | +972 50-351-4057
gilad@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 II
QWU |
| PREDICATE DEVICE: | KeraSys Bioengineered Lamellar Patch Graft
K090078 (May 8, 2009) |
| REFERENCE DEVICES: | Neuro-Patch K960470 (May 10, 1996); |
| | PowerFlow™ Implantable Apheresis IV Port with 9.6
Fr. ChronoFlex™ Catheter K163001 (April 17, 2017) |
DEVICE DESCRIPTION
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.
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
4
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 Patch
Graft K090078
(Predicate Device) | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Manufacturer | CorNeat Vision, Ltd. | IOP, Inc. | N/A |
| Regulation/Product Code | 21 CFR 886.3130; QWU, Prosthesis, Eyelid
Spacer/Graft, polymer | 21 CFR 886.3130; NXM, Prosthesis, Eyelid
Spacer/Graft | N/A |
| Intended use | To reinforce sclera and aid the physical
reconstruction of the ocular surface. | To reinforce sclera and aid the physical
reconstruction of the ocular surface. | Same |
| Target Population | Patients undergoing ocular surgery in need
of scleral reinforcement | Patients undergoing ocular surgery in need
of scleral reinforcement | Same |
| Indications for use | The EverPatch is intended for implantation
to reinforce sclera and aid the physical
reconstruction of the ocular surface. | The KeraSys Bioengineered Lamellar Patch
Graft is intended for implantation to
reinforce sclera and aid the physical
reconstruction 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 but
not raising
different
questions of
safety and
effectiveness |
| 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 microns
thickness | 1 cm x 1.5 cm with 150 microns thickness
(hydrated) | Different but
not raising
different
questions of
safety and
effectiveness |
| Characteristic | CorNeat EverPatch
(Subject Device) | KeraSys Bioengineering Lamellar Patch
Graft K090078
(Predicate Device) | Comparison |
| Fundamental Technology | Prefabricated material of fixed dimensions
to reinforce sclera and aid the physical
reconstruction of the ocular surface. | Prefabricated material of fixed dimensions
to reinforce sclera and aid the physical
reconstruction of the ocular surface. | Same |
| Fundamental Technology | The CorNeat EverPatch is sized to be
used as supplied and should not be
trimmed. | The device can be trimmed to size. | Different but
not raising
questions of
safety and
effectiveness. |
| Fundamental Technology | The device can be sutured in place without
cheese-wiring. | The device can be sutured in place without
cheese-wiring. | Same |
| Treatment Plan
Prescription or OTC | Rx Only | Rx Only | Same |
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7
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.