RxSight Contact Lens

K201909 · Rxsight, Inc. · HJK · Sep 10, 2020 · Ophthalmic

Device Facts

• Record ID: K201909
• Device Name: RxSight Contact Lens
• Applicant: Rxsight, Inc.
• Product Code: HJK · Ophthalmic
• Decision Date: Sep 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1385
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RxSight Contact Lens is indication and treatment in the anterior segment of the eye.

Device Story

Reusable diagnostic contact lens; used for intraocular visualization and therapy in anterior segment of eye. Device maintains corneal surface optical quality; provides lid stabilization to prevent blinking during therapeutic procedures requiring magnification. Composed of PMMA optical element housed in anodized aluminum cone. Used by clinicians in clinical settings during procedures. Provides magnification to enhance visualization of ocular structures; facilitates therapeutic interventions. Benefits patient by enabling stable, magnified view for precise treatment.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing: biocompatibility (ISO 10993-1, -5, -10), sterilization validation (ISO 10993-7, SAL 10^-6), and finished product performance testing meeting all acceptance criteria.

Technological Characteristics

PMMA optical element; anodized aluminum housing. Reusable; non-sterile. 15.0 mm contact diameter; 16.5 mm lens height; 1.30x image magnification. Biocompatibility per ISO 10993. Sterilization validation per ISO 10993-7.

Indications for Use

Indicated for visualization and treatment in the anterior segment of the eye.

Regulatory Classification

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.

Predicate Devices

• Ocular Instruments 12.5 mm Peyman Wide Field YAG Laser Lens (K872136)

Submission Summary (Full Text)

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September 10, 2020

Image /page/0/Picture/1 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

RxSight, Inc. Maureen O'Connell Vice President, Clinical/Regulatory Affairs 100 Colombia Aliso Viejo, California 92656

Re: K201909

Trade/Device Name: RxSight Contact Lens Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) Diagnostic Contact Lens Regulatory Class: Class II Product Code: HJK Dated: July 8, 2020 Received: July 9, 2020

Dear Maureen O'Connell:

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/cfpmp/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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Elvin Ng 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) K201909

Device Name RxSight Contact Lens

Indications for Use (Describe)

The RxSight Contact Lens is indication and treatment in the anterior segment of the eye.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

| APPLICANT: | RxSight, Inc.<br>100 Columbia<br>Aliso Viejo, CA 92656 |
|------------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Maureen O'Connell<br>Vice President, Clinical and Regulatory Affairs<br>[e-mail]<br>Tel: [phone] |
| DATE SUMMARY PREPARED: | September 4, 2020 |
| TRADE NAME: | RxSight Contact Lens |
| COMMON NAME: | Diagnostic Contact Lens |
| CLASSIFICATION NAME: | Polymethylmethacrylate (PMMA) Diagnostic Contact Lens |
| DEVICE CLASSIFICATION: | Class II; 21 CFR 886.1385 |
| PRODUCT CODE: | HJK |
| PREDICATE DEVICE: | Ocular Instruments 12.5 mm Peyman Wide Field YAG Laser Lens, K872136 |

### DEVICE DESCRIPTION

The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and therapy. The RxSight Contact Lens is used to maintain optical quality of the corneal surface and will provide lid stabilization to prevent blinking during therapeutic procedures that require magnification of the eye.

The RxSight Contact Lens is designed around the classic diagnostic contact lens with similar design including an optical element with a specific magnification to provide excellent visualization.

The optical component of the RxSight Contact Lens is made from polymethylmethacrylate (PMMA). The anodized aluminum cone houses the PMMA contact lens.

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## INDICATIONS FOR USE

The RxSight Contact Lens is indicated for visualization and treatment in the anterior segment of the eye.

## TECHNOLOGICAL CHARACTERISTICS COMPARISON

The technical features of the RxSight Contact Lens are as the features of the predicate device described in the table below. A comparison of the technological characteristics of the proposed and predicate devices is provided in the table below.

| | Proposed Device<br>RxSight Contact Lens | Ocular Instruments<br>12.5 mm Peyman Wide Field YAG<br>Laser Lens<br>(K872136) |
|---------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Product Code | HJK | HJK |
| Device Classification | 21 CFR 886.1385 | 21 CFR 886.1385 |
| Intended Use | Intended to aid in visualization and/or<br>therapy in the anterior segment of the<br>eye | Intended to aid in visualization and/or<br>therapy in the anterior segment of the<br>eye |
| Contact Material | PMMA | PMMA |
| Field of View | Wide angle | Wide Angle |
| Image Magnification | 1.30x | 1.40x |
| Laser Spot Magnification | 0.766x | 0.710x |
| Contact Diameter | 15.0 mm | 15.5 mm |
| Lens Height | 16.5 mm | 16.5 mm |
| How Supplied<br>(Reusable/Single Use) | Single lens packaging,<br>Non-sterile, Reusable | Single lens packaging,<br>Non-sterile, Reusable. |

### SUMMARY OF PERFORMANCE TEST RESULTS

Performance standards for contact lenses have not been issued. The descriptive characteristics of the RxSight Contact Lens are well-defined and adequate to ensure equivalence to the predicate device.

The following tests were successfully performed with the device components to establish substantial equivalence of the RxSight Contact Lens to the predicate device:

- Biocompatibility testing in accordance with ISO 10993-1 including ● Cytotoxicity (per ISO10993-5), Sensitization (per ISO10993-10), and Ocular Irritation (per ISO10993-10).
- . Sterilization validation was performed to confirm that recommended sterilization parameters for this device achieved a Sterility Assurance Level of 10-6, in accordance with ISO 10993-7.
- Finished product performance testing met all acceptance criteria. .

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The RxSight Contact Lens is substantially equivalent to the Ocular Instruments 12.5 mm Peyman Wide Field YAG Laser Lens cleared under K872136. These cleared devices are intended for use to enhance visualization and to aid in the treatment of the anterior segment of the eye. The predicate device is manufactured from the same materials, have the same technological characteristics and principles of operation as the RxSight Contact Lens. Any minor variation in specifications to the predicate devices do not impact safety or effectiveness of the lens during use.