(153 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called the ACCUJECT™ REFRA Injector. This type of submission establishes substantial equivalence to a legally marketed predicate device, rather than proving performance against specific clinical acceptance criteria in the same way a de novo or PMA submission might.
Therefore, the information you've requested about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based diagnostic or prognostic devices, is largely not applicable to this 510(k) submission.
This submission focuses on demonstrating that the new injector device (ACCUJECT™ REFRA Injector) is as safe and effective as a previously cleared predicate device (Visian nanoPOINT™ 2.0 Injector) for the same intended use by comparing their technical characteristics and performing non-clinical (laboratory/bench) tests.
Here's a breakdown based on the information available:
-
A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Functional Performance (in accordance with ISO 11979-3:2012 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods, Section 5: Recovery of Properties following simulated surgical manipulation) Result: Intraocular lenses recovered to specifications after being folded and deformed by the Injector. Conclusion: "The change in injector design does not impact the performance characteristics of the injector cartridge or lens." (Implies meeting the recovery specifications, which are the acceptance criteria from ISO 11979-3). Biocompatibility (in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) Result: "The biocompatibility tests performed on the modified injector met all acceptance criteria." (Implies meeting the acceptance criteria defined by applying ISO 10993-1, which would involve various tests like cytotoxicity, sensitization, irritation depending on body contact and duration). Particulate Testing Result: "The particulate testing performed on the modified injector met all acceptance criteria." (Implies meeting acceptance criteria for particulate matter release, likely defined internally or by relevant standards to prevent complications in the eye). Substantial Equivalence to Predicate Device (K101134) Conclusion: "The ACCUJECT™ REFRA Injector is substantially equivalent to the predicate device." This is the overarching "performance" reported from the comparative analysis and non-clinical testing, meaning it performs as safely and effectively as the predicate for its intended use, despite minor technological differences (e.g., changes in materials, absence of a spring, presence of a silicone buffer, operating principle including twisting). -
Sample size used for the test set and the data provenance:
- The document does not explicitly state "sample size" in terms of number of devices or number of lenses tested for each functional, biocompatibility, or particulate test.
- The study is a non-clinical (bench/laboratory) study, not a clinical study involving human patients or real-world data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the typical sense. The testing was conducted in a controlled laboratory environment.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The ground truth is established by objective measurements and standardized test methods (e.g., ISO standards) for mechanical performance, biocompatibility, and particulate matter. There isn't a "ground truth" established by human experts in the context of interpreting images or clinical outcomes for this type of device submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant for subjective human assessments, especially in clinical trials or studies involving expert consensus on diagnostic interpretations. This submission relies on objective, quantifiable non-clinical testing.
-
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:
- This is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic devices in a clinical setting with human readers. The ACCUJECT™ REFRA Injector is a surgical instrument for delivering an intraocular lens, not an AI diagnostic device. There is no AI component or human reader interaction with AI.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As explained above, this product is a mechanical medical device, not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is established by:
- Standardized specifications: For functional recovery, the specifications would likely be derived from the requirements of ISO 11979-3.
- Standardized biological safety criteria: For biocompatibility, the criteria are defined by ISO 10993-1 and related sub-parts.
- Pre-defined acceptance limits: For particulate matter, specific limits for particle size and count would be established, often based on internal specifications, industry standards, or regulatory guidance for sterile medical devices.
- The "ground truth" for the non-clinical tests is established by:
-
The sample size for the training set:
- This is not applicable. There is no "training set" as this device does not involve machine learning or AI.
-
How the ground truth for the training set was established:
- This is not applicable. As there is no training set.
{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 AGDornierstrasse 119423 AltenrheinSwitzerland |
| Contact Person: | STAAR Surgical CompanyDan LewManager of Regulatory AffairsPhone: 626-303-7902Email: 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, ModelAR2900 is to be used by an ophthalmic surgeon and is intended tofacilitate the loading, folding and insertion of the STAAR SurgicalCollamer Phakic One Piece Intraocular Lenses, ModelEVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgicalplacement in the human eye. The ACCUJECTTM REFRA is asingle use device designed specifically to deliver the STAARSurgical Implantable Collamer® Lenses. |
| Indications for Use: | The ACCUJECT™ REFRA Injector is a device intended to foldand insert STAAR Surgical Collamer Phakic One Piece IntraocularLenses, Model EVO/EVO+ VISIAN® Implantable Collamer®Lens, for surgical placement in the human eye. |
| Comparative Analysis: | The ACCUJECT™ REFRA Injector has been demonstrated to beequivalent to the predicate device for their intended use. |
| Functional Testing: | The ACCUJECT™ REFRA Injector have successfully completedfunctional testing and have been found to deliver Visian ICLs inconformance with the requirements in ISO 11979-3. |
| Conclusion: | The ACCUJECT™ REFRA Injector is substantially equivalent tothe predicate device. |
{4}------------------------------------------------
| Characteristic | Predicate Device (K101134) | Subject Device (K231106) |
|---|---|---|
| Visian nanoPOINT™ 2.0 Injector ModelLP604430 | Proposed ACCUJECTTM REFRA Injector,Model AR2900 | |
| ProductDescription | This Injector and Cartridge System is asterile, single-use device intended to foldand insert a STAAR Surgical Collamerphakic one piece intraocular lens throughsurgical procedure in a human eye. Thesystem provides a tubular pathway throughan incision over the iris, allowing deliveryof a phakic IOL into the human eye. | Same |
| Intended use | The Visian® nanoPOINT™ 2.0 InjectorSystem is a device intended to fold andinsert STAAR Surgical Collamer® Phakicone-piece Intraocular Lenses, ModelVisian® ICL, for surgical placement in thehuman eye. | Same (as modified to include update of newbranding)The ACCUJECT™ REFRA Injector is a deviceintended to fold and insert STAAR SurgicalCollamer Phakic One Piece Intraocular Lenses,Model EVO/EVO+ Visian® ImplantableCollamer® Lens, for surgical placement in thehuman eye. |
| OperatingPrinciple | A phakic IOL is loaded into a cartridge,then pushed through the cartridge bypushing the plunger to deliver into a humaneye. | A phakic IOL is loaded into a cartridge, thenpushed through the cartridge by pushing ortwisting 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: Polypropylenecoated with Medicoat A | |
| Injector body and finger flanges & Plungerbody: 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-packbox. | 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 assafe and effective as thePredicate Device? |
|---|---|---|
| Recovery of Properties | The change in injector design doesnot impact the performancecharacteristics of the injectorcartridge or lens. | Yes |
| Biocompatibility | The biocompatibility tests performedon the modified injector met allacceptance criteria. | Yes |
| Particulate | The particulate testing performed onthe modified injector met all acceptancecriteria. | 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.
§ 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.