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 only for 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the RxSight Insertion Device:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly list "acceptance criteria" with specific pass/fail thresholds. Instead, it describes the types of performance tests conducted and states that the device "meets all product design requirements and applicable standards."

Based on the summary, we can infer the following performance evaluations:

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary)
Biocompatibility	Evaluated and deemed adequate.
Sterilization (Cartridge)	Validated in accordance with ANSI/AAMI/ISO 11135 to ensure a sterilization assurance level (SAL) of 10-6.
Sterilization (Handpiece)	Validated via Autoclave cleaning/sterilization cycle in accordance with "Reprocessing Medical Devices..." guidance.
Cleaning (Handpiece)	Validated for both manual and automated processes as described in labeling.
Sterilization Residuals	Evaluated and deemed adequate.
Shipping and Handling	Evaluated and deemed adequate.
Mechanical Dimensions of IOL (Post-injection)	Verified after lens delivery and compared to pre-delivery measurements (per ISO 11979-3:2012). Implicitly meets standards.
Sagitta of IOL (Post-injection)	Verified after lens delivery and compared to pre-delivery measurements (per ISO 11979-3:2012). Implicitly meets standards.
Optical Properties (Overall Surface & Bulk Homogeneity of IOL - Pre/Post-injection)	Tested pre and post lens injection (per ISO 11979-2:2014). Implicitly meets standards.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document mentions "two IOLs" for the pre- and post-injection evaluation of mechanical and optical properties. This is an extremely small sample size for a performance test. It does not provide sample sizes for other tests like biocompatibility or sterilization.
Data Provenance: Not explicitly stated. These appear to be bench tests conducted by the manufacturer, but the location or specific context (e.g., in vivo, ex vivo, in vitro) is not detailed. There is no information about retrospective or prospective data collection from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests described are bench tests involving mechanical and optical measurements against ISO standards. There is no mention of expert-established ground truth or human readers involved in these performance tests.

4. Adjudication method for the test set

Not applicable. There is no mention of clinical endpoints or the need for adjudication as the tests are objective bench measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an IOL insertion device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical instrument, not an algorithm. Its performance is evaluated through its physical function and interaction with the IOL, not through an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests appears to be defined by international standards (ISO 11979-2:2014, ISO 11979-3:2012, ANSI/AAMI/ISO 11135). The device's performance (e.g., maintaining IOL dimensions, sagitta, optical properties) is compared against requirements or expected values specified by these standards for pre- and post-injection conditions.

8. The sample size for the training set

Not applicable. This device is a mechanical instrument and does not involve machine learning or a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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July 26, 2018

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

Re: K181401

Trade/Device Name: RxSight Insertion Device Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: May 25, 2018 Received: May 29, 2018

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Maureen O'Connell

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,

for

Malvina 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) K181401

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)

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1.0 510(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 ColumbiaAliso Viejo, CA 92656		RxSight Insertion DeviceProposed Device	Bausch + LombInjector SetK151102Predicate Device	AST Productspioli IOL Delivery SystemK172228Predicate Device
CONTACT PERSON:	Maureen O'ConnellVice President Clinical and Regulatorymoconnell@rxsight.comTel: (978) 207-1245	Product Code	MSS	MSS	MSS
DATE SUMMARYPREPARED:	July 17, 2018	Intended Use	Intraocular Lens Delivery	Intraocular Lens Delivery	Intraocular Lens Delivery
TRADE NAME:	RxSight Insertion Device	Indications for Use	The RxSight Insertion Deviceis indicated for the foldingand insertion of a 3-piecesilicone, intraocular lens intothe human eye through asurgical incision. TheRxSight Insertion Device isonly for the insertion of theBausch & Lomb LI61A0 andIOL models validated for usewith this device in IOLapproved labeling.	The Bausch + Lomb InjectorSystem is indicated for thefolding and insertion of theBausch + Lomb intraocularlenses cleared or approvedfor use with this IOLInjector system.	The pioli IOL Deliverysystem is a single-use, steriledevice intended to insert asingle-piece foldableintraocular lens (IOL) intothe human eye through asurgical procedure. Thesystem provides a tubularpathway for lens implantationthrough an incision. Thepioli IOL Delivery System isonly for the insertion of theLenstec Softec I IOL andIOL models validated for usewith this device as indicatedin the IOL approved labeling.
COMMON NAME:	IOL Injector	Operating Principle	IOL placed in loadingcartridge. Cartridge snappedinto the handpiece. Screwplunger advances the IOLthrough the cartridge whichfolds the IOL and advances itinto the eye.	IOL placed in loadingcartridge. Cartridge snappedinto the handpiece. Screwplunger advances the IOLthrough the cartridge whichfolds the IOL and advancesit into the eye.	Cartridge is back loaded intothe injection system thatdelivers the IOL through thecartridge and into the eye
CLASSIFICATION NAME:	Folders and Injectors, Intraocular Lens (IOL)	Pre-loaded IOL	No	No	No
DEVICE CLASSIFICATION:	Class I; 21 CFR 886.4300	Material (Injector)	Titanium	Titanium	Polypropylene
PRODUCT CODE:	MSS	Material (cartridge)	Polypropylene	Polyamide	LubriMATRIX™
PREDICATE DEVICES:	K151102, Bausch + Lomb Injector SystemK172228, pioli™ IOL Delivery System	Cartridge Coating	LubriMATRIX™	Hydrophilic coating(Medicoat A)	LubriMATRIX™
How Supplied(Reusable/Single Use)	Handpiece - ReusableCartridge - Single Use,supplied sterile	Handpiece - ReusableCartridge - Single Use,supplied sterile	Handpiece - Single Use,disposable, supplied sterileCartridge - Single Use,disposable, supplied sterile
Method of Sterilization	Handpiece - AutoclaveCartridge - Ethylene Oxide toSAL 10-6	Handpiece - AutoclaveCartridge - Ethylene Oxideto SAL 10-6	Ethylene Oxide to SAL 10-6

1.1 DEVICE DESCRIPTION

1.2 INDICATIONS FOR USE

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 only for the insertion of the Bausch & Lomb LI61A0 and IOL models validated for use with this device in IOL approved labeling.

1.3 TECHNOLOGICAL CHARACTERISTICS COMPARISON

The technical features of the RxSight Insertion Device and predicate devices are substantially equivalent. A comparison of the technological characteristics of these devices is provided in the table below.

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1.5 BRIEF SUMMARY OF PERFORMANCE TEST RESULTS

The descriptive characteristics are well-defined and adequate to ensure equivalence of the RxSight Insertion Device with the predicate device. Additionally, the proposed device was evaluated for biocompatibility, sterilization, cleaning, sterilization residuals, shipping and handling and performance bench testing. The cleaning and sterilization cycle was validated in accordance with "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" and covered both manual and automated cleaning processes described in the labeling for the RxSight Insertion Device. The EO sterilization cycle for the cartridge was validated in accordance with ANSI/AAMI/ISO 11135 to ensure a sterilization assurance level (SAL) of 10-6. The device will be labeled with an expiration date of 6 months from the date of sterilization.

Performance testing of the RxSight Insertion Device included pre- and post-injection evaluation of two IQLs in accordance with ISO 11979-3:2012 surgical manipulation - recovery of properties. Specifically, mechanical dimensions and sagitta were verified after the lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012. Similarly, optical properties overall surface and bulk homogeneity were tested pre and post lens injection per ISO 11979-2:2014.

1.6 CONCLUSION

The RxSight Insertion Device meets all product design requirements and applicable standards and embodies technological characteristics similar to the predicate devices and therefore has been shown to be substantially equivalent to the predicate device and is safe and effective for use.

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.