Who is the manufacturer of Accuject Refra Injector AR2900?

Medicel AG filed the 510(k) submission for Accuject Refra Injector AR2900 (K231106).

What is the FDA product code for Accuject Refra Injector AR2900?

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

What is the regulatory pathway for Accuject Refra Injector AR2900?

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

Who can help prepare an FDA 510(k) submission like Accuject Refra Injector AR2900?

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.

Accuject Refra Injector AR2900

Q: What are the predicate devices for Accuject Refra Injector AR2900?

Visian nanoPOINTTM 2.0 Injector (K101134).

K231106 · Medicel AG · MSS · Sep 19, 2023 · Ophthalmic

Device Facts

Record ID	K231106
Device Name	Accuject Refra Injector AR2900
Applicant	Medicel AG
Product Code	MSS · Ophthalmic
Decision Date	Sep 19, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4300
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The ACCUJECT™ REFRA Injector is a device intended to fold and insert STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye.

Device Story

Single-use, sterile injector system; facilitates loading, folding, and insertion of STAAR Surgical Collamer Phakic IOLs. Operated by ophthalmic surgeons in clinical settings. Principle of operation: IOL loaded into cartridge; plunger (push or twist mechanism) advances lens through tubular pathway into eye. Includes silicone buffer; no spring mechanism. Output is physical delivery of IOL into eye; assists surgeon in surgical implantation. Benefits patient by enabling minimally invasive IOL delivery.

Clinical Evidence

Bench testing only. Evaluated per ISO 11979-3:2012 (recovery of lens properties after folding/deformation) and ISO 10993-1:2018 (biocompatibility). Particulate testing also performed. All tests met acceptance criteria, demonstrating performance equivalent to predicate.

Technological Characteristics

Single-use, sterile (EtO) injector. Materials: Polyamide cartridge tip with Medicoat A, polypropylene loading chamber with Medicoat A, ABS injector body/plunger, silicone plunger tip, silicone buffer. No spring. Dimensions/form factor: Tubular pathway for IOL delivery. Manual operation (push/twist).

Indications for Use

Indicated for surgical placement of STAAR Surgical Collamer Phakic One Piece Intraocular Lenses (Model EVO/EVO+ VISIAN® Implantable Collamer® Lens) into the human eye.

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

Visian nanoPOINTTM 2.0 Injector (K101134)

Related Devices

K172228 — pioli IOL Delivery System · Ast Products, Inc. · Dec 15, 2017
K231838 — RxSight® Insertion Device (63002) · Rxsight, Inc. · Aug 15, 2023
K181401 — RxSight Insertion Device · Rxsight, Inc. · Jul 26, 2018
K152357 — MicroSTAAR Injector System Cartridges · STAAR Surgical Company · Oct 30, 2015
K252540 — ACCUJECT Injector Set 2.1-1P (LP604590) · Medicel AG · Sep 16, 2025

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. September 19, 2023 Medicel AG % Dan Lew Manager of Regulatory Affairs STAAR Surgical 1911 Walker Avenue Monrovia, California 91016 Re: K231106 Trade/Device Name: ACCUJECTTM REFRA Injector, Model AR2900 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, reserved Product Code: MSS Dated: August 9, 2023 Received: August 10, 2023 Dear Mr. Lew: 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, Bennett N. Digitally signed by Walker -S Date: 2023.09.19 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) K231106 Device Name ACCUJECT™ REFRA Injector (AR2900) Indications for Use (Describe) The ACCUJECT™ REFRA Injector is a device intended to fold and insert STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | X Research Use (Part 21 CFR 201.321(a)) | ☐ Over-The-Counter Use (21 CFR 201.66(c)(2)) | |------------------------------------------------------------------------------------------|----------------------------------------------| |------------------------------------------------------------------------------------------|----------------------------------------------| * | 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 | Date: | September 19, 2023 | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Medicel AG Dornierstrasse 11 9423 Altenrhein Switzerland | | Contact Person: | STAAR Surgical Company Dan Lew Manager of Regulatory Affairs Phone: 626-303-7902 Email: dlew@staar.com | | Trade name: | Medicel ACCUJECT™ REFRA Injector | | Regulation: | 21 CFR 886.4300 - Intraocular lens guide | | Product Code: | MSS | | Predicate Device: | Visian nanoPOINTTM 2.0 Injector (K101134) | | Device Description: | The Medicel ACCUJECT™ REFRA Injector System, Model AR2900 is to be used by an ophthalmic surgeon and is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye. The ACCUJECTTM REFRA is a single use device designed specifically to deliver the STAAR Surgical Implantable Collamer® Lenses. | | Indications for Use: | The ACCUJECT™ REFRA Injector is a device intended to fold and insert STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye. | | Comparative Analysis: | The ACCUJECT™ REFRA Injector has been demonstrated to be equivalent to the predicate device for their intended use. | | Functional Testing: | The ACCUJECT™ REFRA Injector have successfully completed functional testing and have been found to deliver Visian ICLs in conformance with the requirements in ISO 11979-3. | | Conclusion: | The ACCUJECT™ REFRA Injector is substantially equivalent to the predicate device. | {4}------------------------------------------------ | Characteristic | Predicate Device (K101134) | Subject Device (K231106) | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Visian nanoPOINT™ 2.0 Injector Model LP604430 | Proposed ACCUJECTTM REFRA Injector, Model AR2900 | | Product Description | This Injector and Cartridge System is a sterile, single-use device intended to fold and insert a STAAR Surgical Collamer phakic one piece intraocular lens through surgical procedure in a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of a phakic IOL into the human eye. | Same | | Intended use | The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic one-piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye. | Same (as modified to include update of new branding) The ACCUJECT™ REFRA Injector is a device intended to fold and insert STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ Visian® Implantable Collamer® Lens, for surgical placement in the human eye. | | Operating Principle | A phakic IOL is loaded into a cartridge, then pushed through the cartridge by pushing the plunger to deliver into a human eye. | A phakic IOL is loaded into a cartridge, then pushed through the cartridge by pushing or twisting the plunger to deliver into a human eye. | | Materials | Cartridge tip: Polypropylene | Cartridge tip: Polyamide coated with Medicoat A | | | Cartridge loading chamber: Polypropylene | Cartridge loading chamber: Polypropylene coated with Medicoat A | | | Injector body and finger flanges & Plunger body: ABS | Same | | | Plunger tip: Silicone | Same | | | Spring: stainless steel | No spring used | | | No buffer | Silicone buffer | | Sterile | Yes, EtO. | Same | | Packaging | Blister sealed with a Tyvek lid. 10-pack box. | Same | | Shelf life | 3 years | 1 year | | Manufacturer | Medicel AG | Same | {5}------------------------------------------------ The technological characteristics of the modified ACCUJECT™ REFRA Injector are substantially equivalent to the predicate nanoPOINT™ Injector, cleared in K101134. As demonstrated above, the ACCUJECT™ REFRA Injector and nanoPOINTTM Injector share the same intended use, indications, operating principle, design, and sterilization method. Brief Summary of Nonclinical Test and Results: Results from validation testing of the ACCUJECT™ REFRA Injector demonstrate that the injector functions as intended. In accordance with applicable tests in ISO 11979-3:2012 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods (i.e., Section 5, Recovery of Properties following simulated surgical manipulation), intraocular lenses recovered to specifications after being folded and deformed by the Injector. The ACCUJECT™ REFRA Injector has been tested for biocompatibility to ensure that the injector meets the requirements of ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Non-Clinical Study Results: | Study | Result | Is the Subject Device as safe and effective as the Predicate Device? | |------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Recovery of Properties | The change in injector design does not impact the performance characteristics of the injector cartridge or lens. | Yes | | Biocompatibility | The biocompatibility tests performed on the modified injector met all acceptance criteria. | Yes | | Particulate | The particulate testing performed on the modified injector met all acceptance criteria. | Yes | The data generated from the non-clinical studies of the subject device, ACCUJECT™ REFRA Injector, support the subject device substantial equivalence to the predicate device. The comparison of technical characteristics and data generated from the non-clinical studies demonstrate the substantial equivalence of the subject device and the predicate device.