Who is the manufacturer of RxSight Insertion Device?

Rxsight, Inc. filed the 510(k) submission for RxSight Insertion Device (K192926).

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).

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

Q: What are the predicate devices for RxSight Insertion Device?

RxSight Insertion Device (K181401).

K192926 · Rxsight, Inc. · MSS · Jan 17, 2020 · Ophthalmic

Device Facts

Record ID	K192926
Device Name	RxSight Insertion Device
Applicant	Rxsight, Inc.
Product Code	MSS · Ophthalmic
Decision Date	Jan 17, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4300
Device Class	Class 1

Intended Use

The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, 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 consisting of reusable titanium handpiece and single-use polypropylene cartridge. Surgeon places IOL into cartridge; cartridge snaps into handpiece. Screw plunger mechanism advances IOL through cartridge, which folds lens for delivery through small surgical incision into eye. Used in ophthalmic surgery settings by surgeons. Device facilitates safe IOL implantation, minimizing trauma to ocular tissues during insertion.

Clinical Evidence

Prospective clinical study evaluated corneal endothelial cell density (ECD) safety. Compared ECD changes in eyes implanted with RxLAL using subject device versus eyes implanted with monofocal control IOL and associated injector. Results showed similar rates of ECD loss between groups, supporting safety of the insertion device.

Technological Characteristics

Two-part injector: reusable titanium handpiece, single-use polypropylene cartridge. Cartridge features LubriMATRIX™ coating. Manual screw plunger actuation. Sterilization: Autoclave (handpiece), Ethylene Oxide (cartridge, SAL 10^-6). Complies with ISO 11979-3:2012 (mechanical properties) and ISO 11979-2:2014 (optical properties).

Indications for Use

Indicated for folding and insertion of 3-piece silicone intraocular lenses (IOLs) into the human eye via surgical incision. Compatible with RxSight Light Adjustable Lens, Bausch & Lomb LI61A0, and other IOL models validated for use with this device.

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

RxSight Insertion Device (K181401)

Related Devices

K231466 — RxSight Insertion Device · Rxsight, Inc. · Jun 12, 2023
K151102 — Bausch + Lomb Injector System · Bausch & Lomb, Inc. · May 22, 2015
K181401 — RxSight Insertion Device · Rxsight, Inc. · Jul 26, 2018
K073010 — ROYALE AE 9036 LSP INJECTOR · Asico, LLC · Nov 7, 2007
K191949 — UNFOLDER Vitan Inserter · Johnson & Johnson Surgical Vision, Inc. · Sep 13, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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. RxSight, Inc. Maureen O'Connell Vice President, Clinical/Regulatory Affairs 100 Columbia Aliso Viejo, California 92656 Re: K192926 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: December 21, 2019 Received: December 23, 2019 Dear Ms. 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 {1}------------------------------------------------ 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 (OS) 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, for Tieuvi Nguyen, Ph.D. 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) K192926 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, into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, 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 | |---------------------------|---------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON: | Maureen O'Connell Vice President Clinical and Regulatory Affairs moconnell@rxsight.com Tel: (978) 207-1245 | | DATE SUMMARY PREPARED: | January 10, 2020 | | 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. K181401 | #### 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 intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling. {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 510(k) Premarket Notification. A comparison of the technological characteristics of the proposed and predicate devices is provided in the table below. | | RxSight Insertion Device Proposed Device | RxSight Insertion Device Predicate Device (K181401) | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | MSS | MSS | | 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 intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling. | 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 IOL and IOL models validated for use with this device in IOL approved labeling | | Operating Principle | An IOL is placed in a 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. | An IOL is placed in a 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. | | Pre-loaded IOL | No | No | | Material (Injector) | Titanium | Titanium | | Material (cartridge) | Polypropylene | Polypropylene | | Cartridge Coating | LubriMATRIX™ | LubriMATRIX™ | | How Supplied (Reusable/Single Use) | Handpiece - Reusable Cartridge - Single Use, supplied sterile | Handpiece - Reusable Cartridge - Single Use, supplied sterile | | Method of Sterilization | Handpiece - Autoclave Cartridge - Ethylene Oxide to SAL 10-6 | Handpiece - Autoclave Cartridge - Ethylene Oxide to SAL 10-6 | #### 1.4 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. Non-clinical performance testing included simulated surgical manipulation and recovery of properties including both pre- and post-injection evaluation of aged IOLs in accordance with ISO 11979-3:2012 in support of the proposed 1 year shelf-life. Specifically, mechanical dimensions and sagitta were verified following lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012. Optical properties including overall surface and bulk homogeneity were tested pre- and post-lens injection per ISO 11979-2:2014. {5}------------------------------------------------ Additionally, a particulate analysis was performed on aged product to demonstrate coating stability of the sterile insertion device coating following shelf-life aging. ## Endothelial Cell Density Clinical Data To evaluate whether the RxSight insertion device (with associated insertion methods) presents a significant risk to the corneal endothelium, post-operative endothelial cell density (ECD) data was collected in a prospective clinical study. This study compared the ECD changes following cataract surgery between eyes implanted with the RxLAL using the RxSight insertion device and eyes implanted with a commercially available monofocal control IOL and associated insertion device. The analysis presented in the 510(k) shows similar rates of ECD loss in eyes implanted with either device, supporting the safety of insertion of the LAL with the RxSight Insertion device. ## 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. Performance data support the conclusion that the proposed RxSight Insertion Device is substantially equivalent to the predicate device.