The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vireous humor, the lens, the iris, the anterior chamber, as well as other ocular structures during surgical procedures or consultation.

The endocular viewing lens is a passive device that is used to view the fundus of the eye by placing it on the cornea.

Device Description

The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices comprised of an endocular viewing lens and/or of a cornea support that allows for stabilization of this lens on the eye. This range allows one to view the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the "ENDOCULAR VIEWING LENSES AND SILICONE RING" device. Based on the provided text, the device is not an AI/ML medical device and therefore the concepts of acceptance criteria for an AI model, training/test sets, ground truth establishment by experts, adjudication, or MRMC studies, do not apply.

The device is a passive ophthalmic viewing lens classified as a Class II medical device. The 510(k) submission establishes substantial equivalence to legally marketed predicate devices, primarily based on the following:

Intended Use: The device is used to view ocular structures during surgical procedures or consultation, which is similar to the predicate devices.
Design: The device includes various types of viewing lenses and a silicone ring, comparable to the predicate devices.
Materials: The materials used (PMMA, OKP4 Polyester Optical Plastic, silicone) are similar to those used in predicate devices.
Mechanical Safety and Performance: No specific details are provided on performance metrics, but the claim of substantial equivalence implies comparable safety and performance.

Non-clinical tests performed:

ISO 10993-5 In vitro cytotoxicity
ISO 10993-10 Irritation
ISO 10993-10 Sensitization

Clinical tests:

No clinical studies were performed. The submission states: "No clinical studies were performed."

Therefore, the request for acceptance criteria and study details related to AI/ML performance is not applicable to this 510(k) submission.

Summary

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October 25, 2018

PHAKOS % J. D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K173944

Trade/Device Name: Endocular Viewing Lenses and Silicone Ring Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) Diagnostic Contact Lens Regulatory Class: Class II Product Code: HJK Dated: September 19, 2018 Received: September 25, 2018

Dear J. D. Webb:

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.

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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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "J. Angelo Green" in a large, bold font. The text is black and appears to be centered on a white background. The name is likely that of a person, and the image may be a title or heading.

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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Indications for Use

510(k) Number (if known) K173944

Device Name ENDOCULAR VIEWING LENSES AND SILICONE RING

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 201.326(a) and D) Over-The-Counter Use (21 CFR 201.326(c))
	Prescription Use (Part 21 CFR 201.326(a) and D) Over-The-Counter Use (21 CFR 201.326(c))

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: ENDOCULAR VIEWING LENSES AND SILICONE RING

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

Date Prepared	October 22, 2018
Submitted By	PHAKOS62 Rue Kléber93100 MontreuilFRANCE
Primary Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681 512-388-0199 Telee-mail: jdwebb@orthomedix.net
Trade Name	Endocular Viewing Lenses and Silicone Ring
Common Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Classification Name	Polymethylmethacrylate (PMMA) diagnostic contact lens
Class	ll
Product Code	HJK
CFR Section	21 CFR section 886.1385
Device Panel	Ophthalmic
Primary PredicateDevice	Disposable Vitrectomy Lens, OCULAR Instruments, Inc. (K012096)
Secondary PredicateDevices	Disposable Vitrectomy Lens, VOLK Optical, Inc. (K050623/ K151961)Family of Vitrectomy Lenses, SENSOR Medical Technology LLC (K140368/ K142715)
Device Description	The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devicescomprised of an endocular viewing lens and/or of a cornea support that allows forstabilization of this lens on the eye. This range allows one to view the retina, the vitreoushumor, the lens, the iris, the angle of the anterior chamber, as well as other ocularstructures during surgical procedures or consultation.
Materials	Conventional lens:PMMA polymethyl methacrylateHigh Resolution lens:OKP4 Polyester Optical PlasticFlexible removablering:MED 4035 siliconeSilicone ring (alone):MED 4035 silicone
Intended Use	The endocular viewing lens is a passive device that is used to view the fundus of the eyeby placing it on the cornea.

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K173944

SubstantialEquivalence Claimedto Predicate Devices	The Endocular Viewing Lenses and Silicone Ring is substantially equivalent to thepredicate devices in terms of intended use, design, materials used, mechanical safetyand performances.
Indications for Use	The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizationsof the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, aswell as other ocular structures during surgical procedures or consultation.
	Device	PHAKOS	OCULAR	VOLK	SENSOR
Summary of theTechnologicalCharacteristicsCompared toPredicate	Intended Use	The endocularviewing lens isa passivedevice that isused to viewthe fundus ofthe eye byplacing it on thecornea.	Allowvisualization ofthe ocularfundus,vitreous, andretinalstructuresduringvitrectomysurgery.	For use asdiagnosticlenses for eyefundusexaminationsand use in thetherapy ofintraocularabnormalities.	Used in theexamination ofthe eyefundus, retinaand irido-corneal andvitreousbodies
	Type ofLenses	- Vitrectomy- Gonioprism- PanoramicWide Field- 3-prism- Capsulotomy- Silicone Ring	- Vitrectomy- Gonioprism- PanoramicWide Field- 3-prism- Capsulotomy- Silicone Ring	- Vitrectomy- Gonioprism- PanoramicWide Field- 3-prism- Capsulotomy	- Vitrectomy- Gonioprism- PanoramicWide Field- 3-prism- Capsulotomy- Silicone Ring
	Comparison ofLenses	- All of the systems include the full range of Vitrectomy Lens, with theexception of the SENSOR not having a Wide-Angle Lens. TheSENSOR has no HR Vitrectomy Lens- All of the systems include Gonioprism Lens.- All systems include a Panoramic Wide Field Lens. All of the systemsinclude 3-prism Lens.- All systems include a Capsulotomy Lens.
	Material	- PMMA- OKP 4(acrylic)- silicone	- PMMA- Acrylic- Glass- Quartz	- PMMA- Acrylic- Glass	- PMMA
Non-clinical TestSummary	The following tests were performed:- ISO 10993-5 In vitro cytotoxicity- ISO 10993-10 Irritation- ISO 10993-10 Sensitization
Clinical TestSummary	No clinical studies were performed

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Conclusions:	PHAKOS considers the Endocular Viewing Lenses and Silicone Ring to be equivalent to
Non-	the predicate devices listed above. This conclusion is based upon the devices' similarities
clinical and Clinical	in principles of operation, technology, materials and indications for use

Regulation Number and Section

§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.