The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Durette ocular implant (K123764):

Summary of Device and Context:
This 510(k) submission (K123764) is for a Durette ocular implant, a Class II device (21 CFR 886.3320). The submission is not for a new device concept but rather for changes to a previously cleared device (K073293). The primary changes are:

Welding process: Moving from laser welding (which used a liquid that left a dry residue) to ultrasonic welding (which uses PMMA only).
Packaging: Simplified and clearer.
Labeling: Revised instructions for use.

The submission explicitly states: "This change does not affect the indication for use, and does not alter the fundamental scientific technology of the device." Since the device is 100% acrylic, biocompatibility issues from the material itself are considered clear. The new welding process was validated for safety and effectiveness over a long period.

No clinical or comparative effectiveness study involving human readers or AI was performed or required for this 510(k) submission. The core of the submission revolves around demonstrating that the changes to the manufacturing process and packaging do not negatively impact the performance of the device, which is already established as substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for manufacturing and labeling changes to an existing, predicate device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity, specificity, or accuracy for an AI system. Instead, they relate to standard manufacturing, sterilization, and material safety parameters to ensure the modified device remains as safe and effective as the predicate.

The table below reflects the relevant parameters explicitly mentioned and the "reported performance" indicates how the new device aligns with these implicit or explicit criteria.

Acceptance Criteria (Implicit/Explicit)	Reported Device Performance (K123764)
Material Composition
- Biocompatible materials	- PMMA is 100% biocompatible.
- Absence of non-biocompatible additives (especially from welding)	- Ultrasonic welding uses PMMA only; no liquid welding component.
Welding Process
- Ensures safety and effectiveness over long term	- "This new welding process has been validated to ensure safety and effectiveness over a long period of time."
Sterility
- Instructions for non-sterile product processing	- Device is sold non-sterile; includes instructions for patient-ready processing via Ethylene Oxide (EO) sterilization.
- Sterilization validation of recommended method	- Sterilization parameters conform with AAMI TIR12:2010. Sterilization validation for Durette implant by EO.
Product Specifications (e.g., bioburden, endotoxin)	- Manufacturing process yields product within specifications.
Packaging
- Simpler and clearer for the user	- Proposed packaging is simpler and clearer for the user. (No specific performance metric mentioned, but implies improved usability/clarity over predicate packaging).
Labeling/Instructions for Use (IFU)
- Revised to minimize risk for the user	- IFU revised to minimize risk. (Implies improved safety communication over predicate labeling).
Substantial Equivalence to Predicate Device
- No change in intended use, indications for use, anatomical sites, or target population	- "Same" across all these categories for new device vs. predicate.
- Compatibility with environment and other devices	- "Same" as predicate (Compatible).
- Human factors (used by Ophthalmologists, permanent and safe implants)	- "Same" as predicate (Used by Ophthalmologists. Permanent and safe implants).
- Performance (effective and safe)	- "Same" as predicate (Effective and safe. No performance standards applicable to SPHERE, EYE IMPLANT has been assigned by FDA).
- Mechanical safety (solid devices)	- "Same" (Solid devices).
- Chemical safety (PMMA well documented)	- "Same" (PMMA is well documented in ophthalmology).
- Compliance with relevant standards	- New device meets ISO 10993-5, ISO 10993-7, ISO 11135-1, ISO 14971, ISO 15223-1, AAMI ST72, AAMI ST81. (Note: The predicate didn't list explicit standards, reinforcing the idea that these are new validations for the modified process rather than comparative performance metrics).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a distinct "test set" in the context of clinical performance data. The nonclinical tests (bioburden, endotoxin, sterilization validation) would have involved samples from manufacturing batches. The document does not specify the number of units tested for these validations.
Data Provenance: The studies are nonclinical manufacturing and sterilization validation tests conducted by the manufacturer, Oculo Plastik, in Montreal, Quebec, Canada. These are retrospective in the sense that they are validations conducted on the redesigned product before market release.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This submission does not involve clinical studies requiring expert-established ground truth for a diagnostic or AI device. The "ground truth" here is compliance with engineering, material, and sterilization standards.

4. Adjudication Method for the Test Set

Not Applicable. No human adjudication of clinical data was performed as part of this 510(k) submission.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not done. This device is an ocular implant, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, comparing human reader performance with and without AI assistance is irrelevant and was not performed.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical medical implant made of PMMA, not a software algorithm. Therefore, no "standalone" algorithm performance study was done.

7. Type of Ground Truth Used

The "ground truth" in this context is based on:

Biocompatibility Standards: PMMA's established biocompatibility in ophthalmology.
Sterilization Standards: Compliance with recognized international and national standards (ISO 11135-1, AAMI ST72, AAMI TIR12:2010 for Ethylene Oxide sterilization).
Quality Control Metrics: Bioburden and endotoxin specifications for manufactured products.
Material Safety Standards: ISO 10993-5, ISO 10993-7.
Risk Management Standards: ISO 14971.

8. Sample Size for the Training Set

Not Applicable. This is not an AI or machine learning device. 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, there is no ground truth established for it.

Summary

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K123764

page lot 4

5- 510(k) Summary

JAN 3 1 2013

OCULOPLASTIK

200, rue Sauvé ouest, Montreal, Quebec H3L 1Y9 Canada Tel (514) 381-3292 Fax (514) 381-1164 Toll-free Tel (888) 381-3292 Fax (800) 879-1849

Jan-16, 2013

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 USA

RE: Premarket notification -- Traditional 510(k)

Device name: Regulation number: Regulatory Class: Product code: Establishment reg: Contact person:

Durette ocular implant 21 CFR 886.3320 Class II HPZ 8022166 Sylvain Desrosiers, QM (514) 381-3292 sdesrosiers@oculoplastik.com

To the reviewer:

This is a submission for a 510(k) for the Durette Implant, which were previously cleared by FDA in 2008 (K073293). The basis for this submission is change of welding process, packaging, and labeling. The predicate device was welded using a liquid that was remaining in a dry form after welding; the new process does not require that liquid anymore. The proposed packaging is simpler and clearer for the user. The instructions for use (labeling) has been revised to minimize risk for the user. According to guidance "Deciding When to submit a 510(k) for a Change to an Existing Device" (CDRH, 1997), we determined that this change must be submitted to FDA prior to market in USA (paragraph C3). This change does not affect the indication for use, and does not alter the fundamental scientific technology of the device.

As there is no addition of any other component, the Durette implant is 100% made of acrylic clearing any possible biocompatibility issue. The previous 510(k) submission K073293 was cleared based on our own implants made of the same material grade.

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This new welding process has been validated to ensure safety and effectiveness over a long period of time.

Indication for use

Description

The Durette implant is a quasi-spherical ocular implant made in 4 models for variations in anterior surface. Each has a permanent smooth surface and many tunnels to allow direct suturing of the muscles. These 20 interconnected tunnels, all situated in the anterior 3rd of the implant, allow tissue integration or ingrowth to help stabilize the implant. Each has an off-center elongation. Please refer to Article published in the Journal of Ophthalmic Prosthetics and AAO_ASO Joint Scientific Session for more complete explanations on the Durette implant.

Areas	Predicate Durette implant (laser welding)	Durette implant (ultrasonic welding)
510(k) number	K073293	K123764
FDA Product Class	Class II	Same
Intended use	Enucleation, evisceration and secondary implantation	Same
Indications for use	Birth defects and diseases (cancer, glaucoma, retinaldetachment, Etc.) or trauma and ocular socketcomplications.	Same
Target population	Total population	Same
Anatomical sites	Ocular	Same
Where used	Hospitals and clinics	Same
Compatibility with theenvironment and otherdevices	Compatible.	Same
Human factors	Used by Ophthalmologists. Permanent and safeimplants	Same
Materials	PMMA and liquid for welding	PMMA only.

Device comparison table identifying relevant similarities and differences

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1123764

page 3 of 4

Design	Image: Durette 1, Durette 2, Durette 3, Durette 4	Same
Biocompatibility	PMMA is biocompatible. The liquid for welding isdocumented biocompatible.	PMMA isbiocompatible. Noother component.
Sterility	Sold non-sterile	Same
Performance	Effective and safe. No performance standardsapplicable to SPHERE, EYE IMPLANT has beenassigned by FDA.	Same
Size Range	4 models (1, 2, 3, 4)6 sizes (16, 18, 19, 20, 21, 22 mm)	4 models (1, 2, 3, 4)1 size (20 mm)
Chemical safety	PMMA is well documented in ophthalmology	Same
Mechanical safety	Solid devices	Same
Energy used and/ordelivered	No energy involved for this type of procedure.	Same
Standards met	None	ISO 10993-5ISO 10993-7ISO 11135-1ISO 14971ISO 15223-1AAMI ST72AAMI ST81
Electrical safety	No electricity involved for this type of procedure.	Same
Thermal safety	Not applicable	Same
Radiation safety	No radiation involved for this type of procedure.	Same
Color additives	Non applicable. No color additives used in themanufacturing process.	Same
Software	Non applicable. No software involved for this device.	Same

Discussion of the nonclinical tests submitted

We are providing assurance that our manufacturing process yields a product within specifications (e.g., bioburden, endotoxin) by the tests performed on the finished product. The device (Durette implant) is a single use device sold Non Sterile. Since it is new and sold non sterile, we include instructions as to how it should be processed to become patient ready (handling and sterilization).

The IFU recommends only sterilization by ethylene oxide (EO), and are based on sterilization

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validation for Durette implant. Selected parameters conform with AAMI TIR12:2010.

Conclusion

Based on the proposed changes and results of nonclinical tests, this device has been determined as substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is enclosed in a circle, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

January 31, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Oculo Plastik, Inc. % Mr. Sylvain Desrosiers Quality Manager 200, Rue Sauvé Ouest Montréal, Québec Canada H3L 1Y9

Re: K123764

Trade/Device Name: Durette Implant Regulation Number: 21 CFR 886.3320 Regulation Name: Sphere, Eye Implant Regulatory Class: Class II Product Code: HPZ Dated: December 4, 2012 Received: December 7, 2012

Dear Mr. Desrosiers:

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. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kesia Y. Alexander -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KI23764

4- Indications for Use

510(k) Number (if known):

Device Name: Durette Implant

AND/OR Over-The-Counter Use Prescription Use _ X _ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Ophthalmic and Ear, Nose
and Throat Devices
510(k) Number K123764

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.