(153 days)
No
The summary describes a mechanical injector device and does not mention any AI or ML components or capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is an injector designed to deliver an intraocular lens; it does not directly treat a medical condition.
No
The device is an injector used for surgical placement of intraocular lenses, rather than for diagnosing a condition.
No
The device description clearly states it is a "single use device designed specifically to deliver the STAAR Surgical Implantable Collamer® Lenses," indicating it is a physical injector, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to fold and insert an intraocular lens into the human eye for surgical placement. This is a surgical procedure performed in vivo (within a living organism).
- Device Description: The description reinforces its use by an ophthalmic surgeon to facilitate the loading, folding, and insertion of a lens into the human eye.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is clearly designed for a surgical procedure performed directly on the patient, not for testing samples outside the body.
N/A
Intended Use / 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.
Product codes
MSS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmic surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Recovery of Properties: The change in injector design does not impact the performance characteristics of the injector cartridge or lens.
Biocompatibility: The biocompatibility tests performed on the modified injector met all acceptance criteria.
Particulate: The particulate testing performed on the modified injector met all acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Visian nanoPOINTTM 2.0 Injector (K101134)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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 |
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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.