(63 days)
Not Found
No
The summary describes a physical diagnostic contact lens with an optical element and housing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on biocompatibility, sterilization, and physical performance, not algorithmic performance.
Yes
The device description states its intended use is for "intraocular visualization and therapy" and mentions it is used "during therapeutic procedures."
Yes
The Device Description explicitly states: "The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and therapy."
No
The device description explicitly states it is a physical contact lens made from PMMA and housed in an aluminum cone, indicating it is a hardware device.
Based on the provided information, the RxSight Contact Lens is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- RxSight Contact Lens Function: The description clearly states the device is a reusable diagnostic contact lens used for intraocular visualization and therapy in the anterior segment of the eye. It's used to maintain optical quality, provide lid stabilization, and offer magnification during therapeutic procedures.
- No Sample Analysis: The device does not analyze any samples taken from the body. It is a physical device applied to the eye for direct visualization and support during procedures.
Therefore, the RxSight Contact Lens falls under the category of a medical device used for visualization and procedural support, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The RxSight Contact Lens is indicated for visualization and treatment in the anterior segment of the eye.
Product codes (comma separated list FDA assigned to the subject device)
HJK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior segment of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.
100 Columbia
Aliso Viejo, CA 92656 |
|------------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Maureen O'Connell
Vice President, Clinical and Regulatory Affairs
moconnell@rxsight.com
Tel: (978) 207-1245 |
| 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
RxSight Contact Lens | Ocular Instruments
12.5 mm Peyman Wide Field YAG
Laser Lens
(K872136) |
|---------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Product Code | HJK | HJK |
| Device Classification | 21 CFR 886.1385 | 21 CFR 886.1385 |
| Intended Use | Intended to aid in visualization and/or
therapy in the anterior segment of the
eye | Intended to aid in visualization and/or
therapy in the anterior segment of the
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
(Reusable/Single Use) | Single lens packaging,
Non-sterile, Reusable | Single lens packaging,
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.