Who is the manufacturer of RxSight Insertion Device?

Rxsight, Inc. filed the 510(k) submission for RxSight Insertion Device (K181401).

What is the FDA product code for RxSight Insertion Device?

MSS. It is classified under 21 CFR 886.4300 as a Class 1 device in the Ophthalmic panel.

What is the regulatory pathway for RxSight Insertion Device?

510(k) clearance (submission type: Traditional).

What are the predicate devices for RxSight Insertion Device?

Bausch + Lomb Injector System (K151102); pioli IOL Delivery System (K172228).

Who can help prepare an FDA 510(k) submission like RxSight Insertion Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RxSight Insertion Device

K181401 · Rxsight, Inc. · MSS · Jul 26, 2018 · Ophthalmic

Device Facts

Record ID	K181401
Device Name	RxSight Insertion Device
Applicant	Rxsight, Inc.
Product Code	MSS · Ophthalmic
Decision Date	Jul 26, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4300
Device Class	Class 1
Attributes	Therapeutic

Intended 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 Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.

Device Story

Two-part IOL injector system; reusable titanium handpiece; single-use disposable polypropylene cartridge. Surgeon loads IOL into cartridge; snaps cartridge into handpiece; screw plunger advances IOL through cartridge; cartridge folds IOL during advancement; IOL delivered into eye through small incision. Used in surgical settings by ophthalmologists. Output is physical delivery of IOL into eye; facilitates cataract surgery/lens replacement. Benefits include controlled, consistent lens insertion through small incision.

Clinical Evidence

Bench testing only. Evaluated per ISO 11979-3:2012 (mechanical dimensions/sagitta) and ISO 11979-2:2014 (optical properties/homogeneity) pre- and post-injection. Validated cleaning/sterilization per FDA guidance and ANSI/AAMI/ISO 11135 (SAL 10^-6). Biocompatibility, shipping, and handling testing performed.

Technological Characteristics

Handpiece: Titanium (reusable, autoclave). Cartridge: Polypropylene (single-use, EO sterilized to SAL 10^-6). Coating: LubriMATRIX. Mechanism: Screw plunger-driven folding and delivery. Dimensions/form factor: Manual handheld injector.

Indications for Use

Indicated for folding and insertion of 3-piece silicone intraocular lenses (IOLs) into the human eye via surgical incision. Limited to Bausch & Lomb LI61A0 and other IOL models validated for use in approved labeling.

Regulatory Classification

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.

Predicate Devices

Bausch + Lomb Injector System (K151102)
pioli IOL Delivery System (K172228)

Related Devices

K192926 — RxSight Insertion Device · Rxsight, Inc. · Jan 17, 2020
K131958 — BAUSCH & LOMB INJECTOR SYSTEM · Bausch & Lomb · Jan 9, 2014
K151102 — Bausch + Lomb Injector System · Bausch & Lomb, Inc. · May 22, 2015
K252540 — ACCUJECT Injector Set 2.1-1P (LP604590) · Medicel AG · Sep 16, 2025
K231466 — RxSight Insertion Device · Rxsight, Inc. · Jun 12, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and consists of a stylized caduceus symbol. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. 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); {1}------------------------------------------------ # 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181401 Device Name RxSIGHT Insertion Device Indications for Use (Describe) 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. | 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}------------------------------------------------ #### 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 Columbia Aliso Viejo, CA 92656 | | RxSight Insertion Device Proposed Device | Bausch + Lomb Injector Set K151102 Predicate Device | AST Products pioli IOL Delivery System K172228 Predicate Device | |---------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON: | Maureen O'Connell Vice President Clinical and Regulatory moconnell@rxsight.com Tel: (978) 207-1245 | Product Code | MSS | MSS | MSS | | DATE SUMMARY PREPARED: | 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 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. | The Bausch + Lomb Injector System is indicated for the folding and insertion of the Bausch + Lomb intraocular lenses cleared or approved for use with this IOL Injector system. | The pioli IOL Delivery system is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling. | | COMMON NAME: | IOL Injector | Operating Principle | IOL placed in loading cartridge. Cartridge snapped into the handpiece. Screw plunger advances the IOL through the cartridge which folds the IOL and advances it into the eye. | IOL placed in loading cartridge. Cartridge snapped into the handpiece. Screw plunger advances the IOL through the cartridge which folds the IOL and advances it into the eye. | Cartridge is back loaded into the injection system that delivers the IOL through the cartridge 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 System K172228, pioli™ IOL Delivery System | Cartridge Coating | LubriMATRIX™ | Hydrophilic coating (Medicoat A) | LubriMATRIX™ | | How Supplied (Reusable/Single Use) | Handpiece - Reusable Cartridge - Single Use, supplied sterile | Handpiece - Reusable Cartridge - Single Use, supplied sterile | Handpiece - Single Use, disposable, supplied sterile Cartridge - Single Use, disposable, supplied sterile | | | | Method of Sterilization | Handpiece - Autoclave Cartridge - Ethylene Oxide to SAL 10-6 | Handpiece - Autoclave Cartridge - Ethylene Oxide to SAL 10-6 | Ethylene Oxide to SAL 10-6 | | | #### 1.1 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. #### 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. {4}------------------------------------------------ {5}------------------------------------------------ #### 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.