EyeGility™ Inserter for Preloaded enVista IOLs

K242389 · Bausch & Lomb, Incorporated · MSS · Oct 10, 2024 · Ophthalmic

Device Facts

• Record ID: K242389
• Device Name: EyeGility™ Inserter for Preloaded enVista IOLs
• Applicant: Bausch & Lomb, Incorporated
• Product Code: MSS · Ophthalmic
• Decision Date: Oct 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

Device Story

Sterile, single-use manual surgical instrument; used by ophthalmologists in clinical settings. Device consists of ABS body, Pebax cartridge, PPA plunger, and silicone soft tip. Operation: preloaded IOL shuttle snapped into loading chamber; push-type plunger advances IOL through shuttle into cartridge; cartridge folds IOL and delivers it through incision into capsular bag. Facilitates IOL implantation; reduces manual handling of lens; ensures proper folding and delivery. No electronic components or software.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including fold and recovery, dioptric power, image quality, lens dimensions, surface/bulk homogeneity, biocompatibility, EO sterilization validation, and transport stability.

Technological Characteristics

Materials: ABS body, Pebax cartridge (Medicoat A), PPA plunger, silicone soft tip. Manual push-type actuation. Sterile, single-use, ethylene oxide sterilized. Complies with ISO 11979-2, ISO 11979-3, ISO 10993-1/7/18, ISO 11135, ISO 11607-1, and ANSI/AAMI ST72.

Indications for Use

Indicated for folding and inserting of enVista IOL models approved for use with this device into the human eye during surgical procedures.

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 PreVue Inserter for enVista Preloaded (K192005)
• Bausch + Lomb IOL Injector, INJ 100 (K113852)

Submission Summary (Full Text)

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October 10, 2024

Bausch & Lomb Incorporated Renee Stoffel Associate Director, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609

## Re: K242389

Trade/Device Name: EyeGility™ Inserter for Preloaded enVista® IOLs Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, reserved Product Code: MSS Dated: August 12, 2024 Received: August 12, 2024

### Dear Renee Stoffel:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ginny Liu

For 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

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# Indications for Use

510(k) Number (if known) K242389

Device Name

EyeGility™ Inserter for Preloaded enVista® IOLs

Indications for Use (Describe)

The EyeGility Inserter for en Vista preloaded is indicated for folding and inserting of en Vista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

| Type of Use (Select <i>one or both</i> , as applicable) | |
|---------------------------------------------------------|--|
|---------------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Submitter: | Bausch & Lomb Incorporated<br>1400 North Goodman Street<br>Rochester, NY 14609 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Renee Stoffel<br>Associate Director, Regulatory Affairs<br>[phone] |
| Date Prepared: | September 20, 2024 |
| Trade Name: | EyeGility™ Inserter for Preloaded enVista® IOLs |
| Classification Name: | Intraocular lens guide (21 CFR 886.4300) |
| FDA Product Code: | MSS |
| Predicate Devices: | Primary Predicate Device<br>Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005) |
| | Predicate Device<br>Bausch + Lomb IOL Injector, INJ 100 (K113852) |
| Device Description: | The EyeGility Inserter is a sterile, single-use device used to fold and<br>insert an intraocular lens through surgical procedure into a human eye.<br>The Inserter provides a tubular pathway through an incision over the<br>iris, allowing delivery of an IOL into the capsular bag. |
| Indications for Use: | The EyeGility Inserter for enVista preloaded is indicated for folding<br>and inserting of enVista IOL models approved for use with this IOL<br>insertion device as indicated in the IOL approved labeling. |
| Summary of Performance<br>and Non-clinical Testing: | The EyeGility Inserter has successfully undergone functional testing in<br>conformance with the requirements set forth in ISO 11979-3.<br>Additional nonclinical testing information is provided in Table 1. All<br>acceptance criteria were met, demonstrating the subject device is<br>substantially equivalent to the predicate devices. |
| Clinical Testing: | No clinical testing was completed in support of the subject device. |
| Comparative Analysis: | The EyeGility Inserter has been demonstrated to be equivalent to the<br>predicate devices for its intended use. Table 2 includes a detailed<br>comparison of the subject and predicate devices. |
| Conclusion: | The EyeGility Inserter is substantially equivalent to the predicate<br>devices. |

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| Testing Category | Test | Standards | Results |
|-----------------------------------------------------------|---------------------------------------------------|------------------------------------------|---------|
| Delivery Verification<br>Testing and Stability<br>Testing | Fold and Recovery Test | ISO 11979-3 | Pass |
| | Dioptric Power and Image Quality Post<br>Delivery | ISO 11979-2 | Pass |
| | Lens Dimensions Post Delivery | ISO 11979-3 | Pass |
| | Surface and Bulk Homogeneity | ISO 11979-3 | Pass |
| | Cosmetic Inspection | N/A | Pass |
| Biocompatibility | Biocompatibility Assessment | ISO 10993-1 | Pass |
| | Particulate Study | ISO 10993-1 | Pass |
| | Coating Transfer Study | ISO 10993-1 | Pass |
| | Leachable Extractions | ISO 10993-18 | Pass |
| EO Sterilization | Validation Product Adoption Analysis | ISO 11135 | Pass |
| EO Residuals | ETO/ECH Transfer Engineering Study | ISO 10993-7 | Pass |
| Bacterial Endotoxin | Bacterial Endotoxin Test | ANSI/AAMI ST72 | Pass |
| Packaging | Transport Stability Testing | ISO 11607-1<br>ISO 11979-6<br>ASTM F2096 | Pass |

Table 1. Nonclinical Testing Summary

Table 2. Comparison of the subject and predicate device.

| Technological<br>Similarities | Subject Device – EyeGility<br>Inserter | Primary Predicate Device -<br>Bausch + Lomb PreVue<br>Inserter (K192005) | Predicate Device - Bausch +<br>Lomb IOL Injector, INJ100<br>(K113852) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | The EyeGility Inserter for<br>enVista preloaded is indicated<br>for folding and inserting of<br>enVista IOL models approved<br>for use with this IOL insertion<br>device as indicated in the IOL<br>approved labeling. | The Bausch +Lomb PreVue<br>inserter for en Vista preloaded<br>is indicated for folding and<br>inserting of enVista IOLs<br>(Model MX60PL) and IOL<br>models approved for use with<br>this IOL insertion device as<br>indicated in the IOL approved<br>labeling. | The Bausch + Lomb IOL<br>Injector is indicated for<br>folding and injection of<br>Bausch + Lomb IOLs<br>approved for use with this<br>injector |
| How device is<br>used | The preloaded IOL shuttle is<br>snapped into loading chamber<br>of the enVista inserter body.<br>The push-type plunger<br>advances the IOL through the<br>shuttle into the cartridge which<br>folds the IOL and advances it<br>into the eye. | The preloaded IOL shuttle is<br>snapped into loading chamber<br>of the PreVue inserter. The<br>screw plunger advances the<br>IOL through the shuttle into<br>the cartridge which folds the<br>IOL and advances it into the<br>eye. | The IOL is placed in the<br>loading chamber. A plunger<br>pushes the IOL into the tip,<br>which folds the IOL.<br>Pushing the plunger further<br>advances<br>the IOL out through the tip<br>into the eye. |

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| Technological<br>Similarities | Subject Device - EyeGility<br>Inserter | Primary Predicate Device -<br>Bausch + Lomb PreVue<br>Inserter (K192005) | Predicate Device - Bausch +<br>Lomb IOL Injector, INJ100<br>(K113852) |
|-------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Inserter<br>Components | ABS Body<br>Pebax Cartridge (Medicoat A)<br>PPA Plunger<br>Silicone Soft tip | ABS Body<br>Pebax Cartridge (Medicoat A)<br>PPA Plunger<br>ABS Thread Bushing and<br>Screw Spindle | ABS Body<br>ABS Plunger<br>Polyamide Cartridge<br>Medicoat A Coating |
| Single Use | Injector: Yes<br>Cartridge: Yes | Inserter: Yes<br>Cartridge: Yes | Inserter: Yes<br>Cartridge: Yes |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | 22 months | 36 months | 24 months |