EZYPOR® orbital implants are high density polyethylene (UHMWPE) implants designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation procedures. The polyethylene material has an open porosity structure of 40 to 60%. The implants are available in six diameter sizes, 12, 14, 16, 18, 20 and 22 mm. EZYPOR® orbital implants are supplied sterile and are sterilized by ethylene oxide.

AI/ML Overview

This is a 510(k) summary for the EZYPOR® orbital implant, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving the device meets specific performance criteria through clinical trials. Therefore, much of the requested information about acceptance criteria for device performance in a clinical context, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not applicable or available within this type of submission.

The document discusses non-clinical bench testing to ensure the device meets predefined specifications for its physical characteristics and biocompatibility.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicit for S.E. to Predicate)	Reported Device Performance
Non-Clinical Bench Testing
Diameter and Tunnel Dimensions	Within specified tolerance	Met acceptance criteria
Implant Mass	Within specified tolerance	Met acceptance criteria
Sphericity	Within specified tolerance	Met acceptance criteria
Open Porosity	40-60%	Met acceptance criteria
Resistance to Compression	Sufficient to withstand expected forces	Met acceptance criteria
Resistance to Traction	Sufficient to withstand expected forces	Met acceptance criteria
Biocompatibility
Chemical Characterization	No unacceptable leachables	Met acceptance criteria
Cytotoxicity	Non-cytotoxic	Met acceptance criteria
Sensitization	Non-sensitizing	Met acceptance criteria
Irritation	Non-irritating	Met acceptance criteria
Sterilization	Sterile (SAL 10^-6)	Sterilized by EO
Endotoxin	Meets endotoxin limits	Performed and met criteria
Shelf Life	5 years, maintained functional performance and package integrity	Established at 5 years

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

Sample Size: Not specified for non-clinical bench testing. Standard engineering and material testing practices would imply a sufficient number of units were tested to ensure consistency and meet statistical requirements for demonstrating product specifications.
Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by FCI S.A.S. (France Chirurgie Instrumentation SAS). The testing is non-clinical/bench-level, so concepts like "country of origin of the data" in a clinical sense or "retrospective/prospective" studies do not apply.

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

Not applicable. Ground truth for non-clinical bench testing is established by engineering specifications, material standards, and validated test methods.

4. Adjudication method for the test set:

Not applicable. Adjudication methods are typically for clinical studies where subjective interpretations might be involved. For bench testing, results are objectively measured against predefined specifications.

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 an orbital implant, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For non-clinical bench tests (diameter, mass, sphericity, porosity, resistance, biocompatibility, sterilization, shelf life), the "ground truth" is defined by pre-established engineering specifications, material standards (e.g., ISO standards), and validated test methodologies.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. No training set is used for this device.

Summary

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June 24, 2022

FCI (France Chirurgie Instrumentation) SAS % Barbara Fant, PharmD Principal Regulatory Consultant Clinical Research Consultants. Inc. 3308 Jefferson Avenue, Upper Level Cincinnati. Ohio 45220

Re: K212741

Trade/Device Name: EZYPOR Regulation Number: 21 CFR 886.3320 Regulation Name: Eye Sphere Implant Regulatory Class: Class II Product Code: HPZ Dated: May 12, 2022 Received: May 13, 2022

Dear Dr. Barbara Fant:

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

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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,

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

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Indications for Use

510(k) Number (if known) K212741

Device Name EZYPOR®

Indications for Use (Describe)

The EZYPOR® orbital implants are designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation.

Type of Use (Select one or both, as applicable)
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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 -- K212741

510(k) Owner:	France Chirurgie Instrumentation SAS (FCI S.A.S.)20-22 rue Louis Armand75015 Paris, France
Telephone:	+33 1 53 98 98 98
Facsimile:	+33 1 53 98 98 99

Barbara Fant, PharmD Contact Person: Clinical Research Consultants, Inc. 3308 Jefferson Avenue Upper Level Cincinnati, OH 45220 Phone: (513) 961-8200 Facsimile: (513) 961-2858

June 23, 2022 Date:

EZYPOR® Trade Name:

Common name: Orbital Implant

Classification Name: Implant, Eye, Sphere

Regulation Number: 886.3320

Product Code: HPZ

Identification of a Legally Marketed Predicate Device

EZYPOR® orbital implants are substantially equivalent to the MEDPOR® Plus SST™ Sphere (Smooth Surface Tunnel Sphere, 510(k) Premarket Notification Number K021357, FDA Product Code HPZ.

Identification of a Legally Marketed Reference Device

The MEDPOR® Sphere (K863943; Product Code HPZ) is a reference device for the technological characteristics of the 12 to 14 mm diameter porous, smooth spherical shape without a suture platform. The Silicone Orbital Implant (K911110) is a reference device for the technological characteristics of the 12 to 14 mm diameter spherical shape.

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General Description

EZYPOR® orbital implants are supplied sterile and are sterilized by ethylene oxide. A green indicator on the label shows that the product followed a sterilization cycle validated by FCI. The EZYPOR® orbital implants are sterilized in their final double-blister packaging, to make them easier to handle in aseptic conditions.

Indications for Use

The EZYPOR® orbital implants are designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation.

Sterilization

The EZYPOR® Orbital Implants are distributed as a packaged, sterile device. The EZYPOR® Orbital Implants are sterilized by ethylene oxide (EO) in the sealed packaging. EO is an established Category A Method, in accordance with ISO 11135-1:2014 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Endotoxin testing was performed as one of the assessments to evaluate sterility for the EZYPOR® Orbital Implants.

Brief Summary of Non-Clinical Tests and Results

Non-clinical bench testing for the EZYPOR® orbital implants included evaluation of diameter and tunnel dimensions, implant mass, sphericity and open porosity, implant resistance to compression, and implant resistance to traction. All nonclinical test results met the predetermined acceptance criteria for the device. In-process controls and final product quality controls, including finished product release testing and inspection, assure that EZYPOR® is manufactured within specifications.

Biocompatibility of the EZYPOR® orbital implants was established by a review of existing data and test results. The materials used in the implants and materials used in the manufacturing processes were reviewed for available toxicity and bioavailability data for each chemical component, and a justification for the tests conducted to evaluate all potential toxic end points was completed. Implant materials testing included a chemical characterization of materials (leachable test), cytotoxicity testing, sensitization and irritation. Biocompatibility testing was conducted in in accordance with:

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ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity ISO 10993-18:2020 Biological evaluation of medical devices -- Part 18: Chemical Characterization of Medical Device Materials in a Risk Management Process

Shelf life of the EZYPOR orbital implants has been established at five years based on accelerated aging and package integrity. The functional performance of the device as well as the package integrity have been verified through the tests conducted before and after the aging; the device transport testing was conducted in accordance with the standard ISTA 3A, and package integrity (visual integrity, dye penetration and bubble leak test) was conducted.

Basis of Substantial Equivalence

EZYPOR® orbital implants are substantially equivalent to the predicate MEDPOR® Plus SST™ Sphere (Smooth Surface Tunnel Sphere) cleared under K021357 as both devices have the same intended use and indications for use to fill the orbital cavity (void) following enucleation or evisceration of the eve. The EZYPOR® and MEDPOR® Plus SST™ Sphere orbital implants are both manufactured from porous polyethylene material that has the same pore size and porosity. The design of EZYPOR® and MEDPOR Plus SST™ predicate device are similar, with each having a spherical shaped body and available in diameters of 16 to 22 mm that have a suture platform which allows the device to be sutured to the muscularis. The EZYPOR® is also available in 12 mm and 14 mm diameter models that are designed without a suture platform. The EZYPOR® and MEDPOR devices are both sterilized by Ethylene Oxide.

The difference between the subject and predicate devices is that the EZYPOR® orbital implant is also available in 12 mm and 14 mm diameter sizes (without a suture platform), which is the same as the MEDPOR® Sphere; whereas the 16 mm is the smallable diameter of the predicate device. The 12 mm and 14 mm diameter sizes of the EZYPOR® are equivalent in size to Silicone Orbital Implants (K911110) manufactured and sold by FCI.

The similarities and differences between the EZYPOR® orbital implants and the predicate and reference devices are presented in the comparison table below. Based on this comparison, EZYPOR® orbital implants are substantially equivalent to the MEDPOR® Plus SST™ Sphere (Smooth Surface Tunnel Sphere, 510(k) predicate device (K021357).

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Comparison of EZYPOR®+and the Predicate Device and Reference Devices
	EZYPOR®	MEDPOR® PlusSST™ Sphere(Smooth SurfaceTunnel Sphere)K021357(Predicate Device)	MEDPOR® SphereK863943(Reference Device)	Silicone Orbital ImplantK911110(Reference Device)
FDAProductCode	HPZ	HPZ	HPZ	HPZ
Mfg.	FCI S.A.S.FCI SUD	Stryker	Stryker	FCI S.A.S.FCI SUD
Intendeduse	To fill the orbitalcavity followingenucleation orevisceration	Orbital volumereplacement implant	Orbital volumereplacement implant	To fill the orbital cavityfollowing enucleation orevisceration
Indicationsfor Use	The EZYPOR®orbital implants aredesigned to fill theorbital cavityfollowing enucleation,evisceration or duringsecondaryimplantation.	Void volumereplacement followingenucleation and/orevisceration of the eye.	For orbital reconstructionfollowing enucleation andevisceration procedures.	Fill the orbital cavityfollowing enucleation,evisceration
PatientContactMaterials	Porous, high-densitypolyethelene	Porous, high-densitypolyethylene	Porous, high-densitypolyethylene	Medical grade silicone
Pore Size	350-600 um	350-600 um	350-600 um	Not applicable
Porosity	40 - 60 %	40 - 60 %
Mfg.Process	Preformed shapes	Preformed shapes	Preformed shapes	Molded shape
Design	Image: white sphere	Image: white sphere	Image: multiple white spheres	Image: white sphere
AvailableDiameters	12, 14, 16, 18, 20, 22mm	16, 18, 20, 22 mm	14 mm to 23 mm diameters	12 mm to 22 mmdiameters
Single-UseOnly	Yes	Yes	Yes	Yes
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

Regulation Number and Section

§ 886.3320 Eye sphere implant.

(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.