The RxSight® Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.

Device Description

The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.

AI/ML Overview

The provided text is a 510(k) summary for the RxSight® Insertion Device. This document evaluates the device's substantial equivalence to a legally marketed predicate device, rather than proving that it meets specific, novel acceptance criteria through a new clinical study.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this particular document. The device is a Class I medical device (Intraocular Lens Guide), which typically relies on demonstrating equivalence to existing devices rather than extensive new clinical trials for market approval.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of quantitative acceptance criteria and corresponding performance metrics for a new study. Instead, it demonstrates substantial equivalence to a predicate device. This means the "acceptance criteria" are implicitly that the proposed device performs comparably to the predicate device for its intended use, without raising new questions of safety or effectiveness.

The document states:

"The descriptive characteristics are well-defined and adequate to ensure substantial equivalence of the RxSight Insertion Device with the predicate device."
"The RxSight Insertion Device has the same intended use as the legally marketed predicate devices identified in this 510(k) premarket notification and other IOL injectors regulated under 21 CFR 886.4300."
"This device continues to meet all product design requirements and applicable standards and embodies technological characteristics similar to the predicate device."

The comparison table provided in the document highlights the identical characteristics between the proposed device and its predicate (K192926):

Characteristic	RxSight Insertion Device (Proposed Device)	RxSight Insertion Device (Predicate Device - K192926)	Performance/Acceptance Detail (Implied)
Product Code	MSS	MSS	Same classification, indicating no change in regulatory requirements.
Indications for Use	Folding and insertion of 3-piece silicone IOLs into the human eye through a surgical incision, for specific IOL models (RxSight LAL, LAL+, Bausch & Lomb LI61A0, and other validated models).	Identical phrasing, indicating no change in clinical purpose or target population.
Operating Principle	IOL placed in loading cartridge, cartridge snapped into handpiece, screw plunger advances IOL through cartridge (folds IOL, advances into eye).	Identical, indicating identical mechanism of action.
Pre-loaded IOL	No	No	Same non-preloaded design.
Material (Injector)	Titanium	Titanium	Same biocompatible material.
Material (Cartridge)	Polypropylene	Polypropylene	Same biocompatible material.
Cartridge Coating	LubriMATRIX™	LubriMATRIX™	Same coating for lubrication.
How Supplied (Reusable/Single Use)	Handpiece - Reusable; Cartridge - Single Use, supplied sterile	Handpiece - Reusable; Cartridge - Single Use, supplied sterile	Same supply and use model.
Method of Sterilization	Handpiece - Autoclave; Cartridge - Ethylene Oxide to SAL 10-6	Handpiece - Autoclave; Cartridge - Ethylene Oxide to SAL 10-6	Same validated sterilization methods.

The "performance" documented here is the sameness or equivalence across all these characteristics, leading to the conclusion that the device performs as expected based on its predicate.

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

This information is not applicable and not provided in the document. This is not a study that involved a "test set" in the context of clinical or algorithmic performance evaluation. The submission relies on comparing the technical characteristics and intended use to a previously cleared device.

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

This information is not applicable and not provided. Ground truth establishment by experts is typically relevant for studies evaluating diagnostic accuracy, image interpretation, or treatment outcomes, which is not the nature of this 510(k) submission.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods are used in studies involving multiple readers or complex endpoints, which is not the case here.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI on human reader performance, which is not relevant for this device (an IOL insertion tool).

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

No, a standalone algorithm performance study was not done. This device is a manual surgical tool, not an AI algorithm.

7. The Type of Ground Truth Used:

Ground truth, in the sense of expert consensus, pathology, or outcomes data, was not used for this 510(k) submission. The "truth" being established is the substantial equivalence of the proposed device to its predicate, based on its identical design, materials, manufacturing, indications for use, and operating principle. The ground truth, in a broader sense, is the already established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. There is no "training set" as this is not an AI or machine learning device.

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

This information is not applicable and not provided.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 12, 2023

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

Re: K231466

Trade/Device Name: RxSight® Insertion Device Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, reserved Product Code: MSS Dated: May 19, 2023 Received: May 19, 2023

Dear Ms. 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/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.

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

{1}------------------------------------------------

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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

Bennett	Digitally signed
N. Walker	by Bennett N. Walker -S
-S	Date: 2023.06.1212:44:19 -04'00'

Bennett Walker, Ph.D. 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K231466

Device Name RxSight® Insertion Device

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92(a).

APPLICANT:	RxSight, Inc.100 ColumbiaAliso Viejo, CA 92656
CONTACT PERSON:	Maureen O'ConnellSenior Vice President Clinical and Regulatory Affairsmoconnell@rxsight.comTel: (978) 207-1245
DATE SUMMARYPREPARED:	June 8, 2023
TRADE NAME:	RxSight® Insertion Device
COMMON NAME:	IOL Injector
CLASSIFICATION NAME:	Folders and Injectors, Intraocular Lens (IOL)
DEVICE CLASSIFICATION:	Class I; 21 CFR 886.4300
PRODUCT CODE:	MSS
PREDICATE DEVICE:	RxSight® Insertion Device, K192926

1.1 DEVICE DESCRIPTION

1.2 INDICATIONS FOR USE

{4}------------------------------------------------

1.3 TECHNOLOGICAL CHARACTERISTICS COMPARISON

The technical features of the RxSight Insertion Device, both predicate and proposed, are the same as no modifications to these features are proposed in this Special 510(k) Premarket Notification. A comparison of the technological characteristics of the proposed and predicate devices is provided in the table below.

	RxSight Insertion DeviceProposed Device	RxSight Insertion DevicePredicate Device(K192926)
Product Code	MSS	MSS
Indications for Use	The RxSight® Insertion Device is indicatedfor the folding and insertion of a 3-piecesilicone, intraocular lens into the human eyethrough a surgical incision. The RxSightInsertion Device is intended for theinsertion of the RxSight Light AdjustableLens®, RxSight Light Adjustable Lens+,the Bausch & Lomb LI61A0 IOL and IOLmodels validated for use with this device inIOL approved labeling.	The RxSight Insertion Device is indicatedfor the folding and insertion of a 3-piecesilicone, intraocular lens into the humaneye through a surgical incision. TheRxSight Insertion Device is intended forthe insertion of the RxSight LightAdjustable Lens, the Bausch & LombLI61A0 IOL and IOL models validated foruse with this device in IOL approvedlabeling.
Operating Principle	An IOL is placed in a loading cartridge.Cartridge snapped into the handpiece.Screw plunger advances the IOL throughthe cartridge which folds the IOL andadvances it into the eye.	An IOL is placed in a loading cartridge.Cartridge snapped into the handpiece.Screw plunger advances the IOL throughthe cartridge which folds the IOL andadvances it into the eye.
Pre-loaded IOL	No	No
Material (Injector)	Titanium	Titanium
Material (cartridge)	Polypropylene	Polypropylene
Cartridge Coating	LubriMATRIX™	LubriMATRIX™
How Supplied(Reusable/Single Use)	Handpiece - ReusableCartridge - Single Use, supplied sterile	Handpiece - ReusableCartridge - Single Use, supplied sterile
Method ofSterilization	Handpiece - AutoclaveCartridge - Ethylene Oxide to SAL 10-6	Handpiece - AutoclaveCartridge - Ethylene Oxide to SAL 10-6

SUMMARY OF PERFORMANCE TEST RESULTS 1.4

The descriptive characteristics are well-defined and adequate to ensure substantial equivalence of the RxSight Insertion Device with the predicate device.

{5}------------------------------------------------

Conclusion

The RxSight Insertion Device has the same intended use as the legally marketed predicate devices identified in this 510(k) premarket notification and other IOL injectors regulated under 21 CFR 886.4300. This device continues to meet all product design requirements and applicable standards and embodies technological characteristics similar to the predicate device.

Regulation Number and Section

§ 886.4300 Intraocular lens guide.

(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.