Silicone eye sphere implants 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 the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

Device Description

Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surqically remove the eye (enucleation), the contents of the eve sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis. Silicone eye spheres have been used for decades and still are. As for any implant, spheres are single use. Users are ophthalmologists who are very qualified to use eve spheres. Furthermore, we provide instructions for use with each device. These instructions include: Description, Appearance, Indications, Silicone sphere, Mode of action, Contra-indications, Adverse effects, Recommendation for use, Precautions for use. They are available by units in a wide range of sizes, from 12 to 22mm.

AI/ML Overview

This 510(k) premarket notification is for a Special 510(k), indicating a modification to an already cleared device, not a new device submission requiring extensive clinical studies to establish primary performance. The main change is the material grade and supplier for the silicone, along with labeling and packaging changes.

Therefore, the submission does not contain a traditional performance study comparing the device against acceptance criteria in the way a novel device might. Instead, the "study" demonstrating that the device meets the acceptance criteria is primarily biocompatibility testing to show the new material is equivalent to the old.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a material change, the "acceptance criteria" are primarily established by demonstrating equivalence to the predicate device and ensuring the new material does not introduce additional risks. The performance is largely implied as "same" or "equivalent" to the predicate, with specific biocompatibility tests performed.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance (New Device)
Biocompatibility	No additional risk compared to predicate device material; equivalent biocompatibility.	Equivalent. Silicone manufacturer performed same biocompatibility tests with same results. Additionally, 2 other tests performed on finished device.
Material Properties	Suitability for intended use (ophthalmic implant); inertness; documented solid-state properties.	Medical Grade (different grade but equivalent); Inert material (same as predicate); Well documented by manufacturers of silicone resins (same as predicate).
Sterility	"Non Sterile" at sale; withstand steam autoclave by user; provide detailed validated sterilization instructions.	Same. Must be sterilized by steam autoclave by the user. Detailed validated steam sterilization instructions provided.
Intended Use	Same as predicate.	Same. For enucleation, evisceration, or as secondary implant.
Target Population	Same as predicate.	Same. All ages.
Design	Same as predicate (Silicone elastomer Eye Sphere).	Same. Silicone elastomer Eye Sphere.
Performance Standards	No specific FDA performance standards applicable to "Sphere, Eye Implant".	Same. No performance standards applicable. Risk assessment performed against ISO 14971.
Safety (Mechanical/Chemical/Thermal/Radiation/Electrical)	Silicone in solid state well documented; inert material; can be autoclaved/gassed; no electricity/radiation involved.	Same for all categories.
Standards Met	None required for predicate.	ISO 14971 (New for the device, but not a performance standard for the implant itself, rather for risk management).

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

Sample Size: Not explicitly stated for the biocompatibility tests. It would typically involve a certain number of test specimens of the new silicone material.
Data Provenance: The biocompatibility tests were performed by the silicone manufacturer and by Oculoplastik on the finished device. The location of these labs (e.g., country) is not specified. The studies are most likely retrospective in the sense that they are laboratory tests on manufactured materials, not prospective patient studies.

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

Not Applicable. For a material change and biocompatibility testing, ground truth is established through standardized laboratory test protocols (e.g., ISO standards for biocompatibility), not through expert consensus on interpretation of, for example, medical images. The "ground truth" is the result of the physical/chemical/biological tests.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation studies where there is subjective human assessment. This submission concerns laboratory testing of material properties. The results of the biocompatibility tests would be considered objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is relevant for assessing human reader performance, particularly with AI assistance. This submission does not involve AI or human interpretation of medical cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This device is a passive silicone implant and does not involve any algorithm or software. The submission explicitly states "No software involved for this device."

7. The Type of Ground Truth Used

Laboratory Test Results (Biocompatibility): The "ground truth" for the new material's equivalence is established by the results of standardized biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity), which compare the new material's biological response to known safe materials or to the predicate device's material.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this device does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set.

Summary

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Premarket Notification (510k)

5- 510(k) Summary

SEP 1 5 2011

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

July 26th, 2011

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 modification - Special 510(k)

Device name: Requlation number: Regulatory Class: Product code: Establishment reg:

Silicone Eye sphere implants 21 CFR 886.3320 Class II HPZ 8022166

Contact person:

Sylvain Desrosiers, QM (514)381-3292 sdesrosiers@oculoplastik.com

This is a submission for a special 510(k) for our Silicone Eye sphere implants, which were previously cleared by FDA in 2004 (K040689). The basis for this submission is change of material grade and supplier, as the resin's manufacturer is discontinuing the current silicone grade. There is also a change for labeling and packaging. 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 material change does not affect the intended use, and does not alter the fundamental scientific technology of the device, therefore we are eligible to Special 510(k) approach.

We have determined that both silicone elastomers are equivalent and do not represent additional risk for the user.

Description of the device

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Intended use

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Silicone eye spheres have been used for decades and still are. As for any implant, spheres are single use. Users are ophthalmologists who are very qualified to use eve spheres. Furthermore, we provide instructions for use with each device. These instructions include:

· Description
· Appearance
· Indications
· Silicone sphere
· Mode of action
· Contra-indications
· Adverse effects
Recommendation for use
· Precautions for use

They are available by units in a wide range of sizes, from 12 to 22mm.

Radius	Vol.	Weight	Product no
12mm	0.9cc	1.0 g	11-212E
13mm	1.2cc	1.3 g	11-213E
14mm	1.4cc	1.7 g	11-214E
15mm	1.8cc	2.0 g	11-215E
16mm	2.1cc	2.5 g	11-216E
17mm	2.6cc	3.0 g	11-217E
18mm	3.1cc	3.5 g	11-218E
19mm	3.6cc	4.1 g	11-219E
20mm	4.2cc	4.8 g	11-220E
21mm	4.8cc	5.6 g	11-221E
22mm	5.6cc	6.4 g	11-222E

Intended use

Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac

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(evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

The new device is substantially equivalent to the predicate device. The comparison is established against our previous 510(k). The following comparison table shows similarities and differences between both devices.

	Predicate device	New device
510(k) number	K040689	K112176
FDA ProductClass	Class II	Same.
Indications foruse	For enucleation, evisceration,or as secondary implant.	Same.
Targetpopulation	All ages.	Same.
Design	Silicone elastomer EyeSphere	Same.
Material	Medical grade	Medical too but different grade
Performance	No performance standardsapplicable to SPHERE, EYEIMPLANT has been assignedby FDA.	Same.
Size Range	12, 13, 14, 15, 16, 17, 18 and19mm	12 to 22mm
Sterility	Non sterile.	Same. Must be sterilized by steamautoclave by the user.
Biocompatibility	The silicone manufacturerhas done manybiocompatibility tests on theirresin.	Equivalent. The silicone manufacturerhas done same biocompatibility testswith same results. In addition, we haveperformed 2 other tests on finisheddevice.
Mechanicalsafety	Silicone in its solid state iswell documented bymanufacturers of siliconresins, and well known byophthalmologists.	Same.
Chemicalsafety	Silicone is an inert material.	Same.
Anatomicalsites	Ocular globe replacement orfilling.	Same.
Human factors	Users are ophthalmologists.	Same.
Energy usedand/ordelivered	No energy involved for thistype of procedure.	Same.
Compatibilitywithenvironmentand otherdevices	In use for decades.	Same.
Where used	Operating rooms in hospitals.	Same.
Standards met	None.	ISO 14971
Electricalsafety	No electricity involved for thistype of procedure.	Same.
Thermal safety	Can be autoclaved or gassed(ETO)	Same. Highly resistant.
Radiationsafety	No radiation involved for thistype of procedure.	Same.
Color additives	Non applicable. No coloradditives used in themanufacturing process.	Same.
Software	Non applicable. No softwareinvolved for this device.	Same.

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No performance standards applicable to SPHERE, EYE IMPLANT has been assigned by FDA. However, a risk assessment has been performed against ISO 14971.

Sterility

Silicone spheres are sold «Non Sterile». The labels clearly mention that they are not sterilized. Sterilization of these implants is required before surgery.

Pyrogens

Non applicable. These devices are labeled as non-sterile and need to be sterilized by the user.

Sterilization by User

The standard accepted sterilization method is to be performed in the hospitals that will purchase the implants. We provide detailed validated steam sterilization instructions in our labeling for the silicone spheres.

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Image /page/4/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and elevation. Encircling the bird is text, which appears to be part of the logo's official branding. The text is arranged in a circular fashion, following the contour of the logo.

l ood and Dag Admin. Cahon 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Oculo -Plastik, Inc. c/o Mr. Sylvain Desrosiers Quality Manager 200 rue Sauvé ouest Montreal, Quebec H3L LY9 Canada

Re: K112176

Trade/Device Name: Silicone Spheres Regulation Number: 21 CFR 886.3320 Regulation Name: Eye Sphere Implant Regulatory Class: Class II Product Code: HPZ Dated: August 25, 2011 Received: September 6. 2011

ccp 15 2011

Dear Mr. Derosiers:

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 contractly and this 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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.html 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/ReportalProblem/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 Alexander

Image /page/5/Picture/7 description: The image shows a handwritten word, "for", in cursive script. The "f" is elongated with a loop extending below the baseline, and the "o" and "r" are connected with a smooth stroke. The writing appears to be done with a pen or fine-tipped marker, and the overall impression is one of casual, flowing handwriting.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological and Ear. Nose and Throat Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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K112176

4- Indication for use statement

510(k) Number (if known):

Device Name: Silicone Eye Sphere Implants

Indication for use

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denise Hampton

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112176

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.