Bausch + Lomb PreVue Inserter for enVista Preloaded

K192005 · Bausch & Lomb, Inc. · MSS · Oct 4, 2019 · Ophthalmic

Device Facts

• Record ID: K192005
• Device Name: Bausch + Lomb PreVue Inserter for enVista Preloaded
• Applicant: Bausch & Lomb, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: Oct 4, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

The Bausch + Lomb PreVue inserter for enVista preloaded is indicated for folding and inserting of enVista IOLs (Model MX60PL) and IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

Device Story

The Bausch + Lomb PreVue Inserter is a sterile, single-use surgical instrument designed to fold and deliver an enVista intraocular lens (IOL) into the human eye. The device consists of an ABS body, polyamide cartridge, polypthalamide plunger, and ABS spindle, all treated with Medicoat A coating. During surgery, a preloaded IOL shuttle is snapped into the loading chamber. The surgeon operates a screw plunger to advance the IOL through the shuttle and cartridge; the cartridge geometry folds the lens as it is pushed through a tubular pathway into the capsular bag. Used in an OR setting by ophthalmologists, the device facilitates minimally invasive IOL implantation. By providing a controlled, preloaded delivery system, it reduces manual handling of the lens, potentially minimizing surgical time and tissue trauma. The device is sterilized via ethylene oxide.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including delivery verification (fold and recovery, dioptric power, image quality, lens dimensions, surface/bulk homogeneity), cosmetic inspection, coating transfer studies, particle counting, biocompatibility (ISO 10993-1, 10993-18), sterilization validation (EN ISO 11135), EO residual testing (ISO 10993-7), and packaging verification (ASTM F88-09, ASTM F1929).

Technological Characteristics

Materials: ABS body, polyamide cartridge, polypthalamide plunger, ABS spindle, Medicoat A coating. Principle: Mechanical screw-driven plunger for IOL folding and insertion. Single-use. Sterilization: Ethylene Oxide. Standards: ISO 11979-3 (delivery), ISO 10993 (biocompatibility), ISO 11135 (sterilization), ASTM F88-09/F1929 (packaging).

Indications for Use

Indicated for folding and inserting enVista IOLs (Model MX60PL) and other IOL models approved for use with this device in patients undergoing cataract surgery.

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 Injector System (K113852)
• Bausch & Lomb Injector System, BLIS (K131958)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

October 4, 2019

Bausch & Lomb, Inc Ms. Rekha Janarthanan Regulatory Affairs Manager 3365 Tree Court Industrial Blvd. St. Louis, MO 63122

Re: K192005

Trade/Device Name: Bausch + Lomb PreVue Inserter for enVista Preloaded Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: September 3, 2019 Received: September 4, 2019

Dear Ms. Janarthanan:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Tieuvi Nguyen, Ph.D. Acting Division 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) K192005

Device Name

Bausch + Lomb PreVue Inserter for enVista Preloaded

Indications for Use (Describe)

The Bausch + Lomb PreVue inserter for enVista preloaded is indicated for folding and inserting of enVista IOLs (Model MX60PL) and IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

| Type of Use (Select one or both, 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, Inc.<br>3365 Tree Court Industrial Blvd.<br>St. Louis, MO 63122 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rekha Janarthanan<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Trade name: | Bausch + Lomb PreVue Inserter for enVista preloaded |
| Classification Name: | Intraocular lens guide (21 CFR 886.4300) |
| FDA Product Code: | MSS |
| Predicate Devices: | 1. Bausch & Lomb Injector System (K113852)<br>2. Bausch & Lomb Injector System, BLIS (K131958) |
| Device Description: | The Bausch + Lomb PreVue inserter for enVista preloaded is a sterile,<br>single-use device used to fold and insert an intraocular lens (MX60PL)<br>through surgical procedure into a human eye. The Inserter provides a<br>tubular pathway through an incision over the iris, allowing delivery of an<br>IOL into the capsular bag. |
| Indications for Use: | The Bausch + Lomb PreVue inserter for enVista preloaded is indicated for<br>folding and inserting of enVista IOLs (Model MX60PL) and IOL models<br>approved for use with this IOL insertion device as indicated in the IOL<br>approved labeling. |
| Comparative Analysis: | The Bausch + Lomb IOL Inserters have been demonstrated to be<br>equivalent to the predicate devices for their intended use. |
| Functional/Safety Testing: | The Bausch + Lomb IOL Inserters have successfully undergone<br>functional testing and are found to deliver the Bausch + Lomb IOLs in<br>conformance with the requirements set forth in ISO 11979-3. |
| Conclusion: | The Bausch + Lomb IOL Inserters are substantially equivalent to the<br>predicate devices. |

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| a. | Technological<br>Similarities | Predicate - Bausch + Lomb<br>IOL Injector, INJ100<br>(K113852) | Predicate - Bausch + Lomb<br>Injector System, BLIS<br>(K131958) | Subject Device - Bausch +<br>Lomb PreVue Inserter |
|---------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | | 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. | The BLIS Bausch + Lomb<br>Injector System is indicated<br>for the folding and insertion<br>of Bausch + Lomb intraocular<br>lenses cleared or approved for<br>use with this IOL Injector<br>system. | The Bausch +Lomb PreVue<br>inserter for enVista preloaded is<br>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. |
| How device is<br>used | | The IOL is placed in the<br>loading chamber. A<br>plunger pushes the IOL<br>into the tip, which folds<br>the IOL. Pushing the<br>plunger further advances<br>the IOL out through the tip<br>into the eye. | The IOL is placed in the<br>loading cartridge. The<br>cartridge is snapped into the<br>handpiece. The screw plunger<br>advances the IOL through the<br>cartridge, which folds the<br>IOL and advances it into the<br>eye. | The preloaded IOL shuttle is<br>snapped into loading chamber<br>of the PreVue<br>inserter. The screw plunger<br>advances the IOL through the<br>shuttle into the cartridge<br>which folds the IOL and<br>advances it into the eye. |
| Injector/Inserter<br>Components | | • ABS Body<br>• ABS Plunger<br>• Polyamide Cartridge<br>• Medicoat A Coating | • Titanium Body<br>• Stainless Steel Plunger Shaft<br>• Titanium Plunger Tip<br>• Polyamide Cartridge<br>• Medicoat A Coating | • ABS Body<br>• Polyamide Cartridge<br>• ABS Thread Bushing<br>• Polypthalamide Plunger<br>(this uses AI- 28 as<br>predicate)<br>• ABS Spindle<br>• Medicoat A Coating |
| Single Use | | Injector: Yes<br>Cartridge: Yes | Injector: No<br>Cartridge: Yes | Inserter: Yes<br>Cartridge: Yes |
| Sterilization<br>Method | | Ethylene Oxide | • Cartridge: Stainless<br>Steel<br>• Injector: Shipped Non-<br>Sterile. Steam Sterilized<br>by User | Ethylene Oxide |
| Shelf Life | | 24 months | Cartridge: 24 months<br>Injector: Reusable | 12 months |

b.

| Non Clinical Testing | Test | Standards | Results |
|-----------------------|------------------------------------------------|-------------------|---------|
| Delivery Verification | Fold and recovery test | ISO 11979-3: 2012 | Pass |
| Delivery Verification | Dioptric Power and Image quality Post delivery | ISO 11979-2: 2012 | Pass |
| Delivery Verification | Lens Dimensions Post Delivery | ISO 11979-3: 2012 | Pass |
| Delivery Verification | Surface and Bulk Homogeneity | ISO 11979-3: 2012 | Pass |
| Delivery Verification | PreVue Inserter Cosmetic Inspection | N/A | Pass |
| Delivery Verification | Coating transfer study | ISO 10993-1 | Pass |
| Delivery Verification | Particle counting study | ISO 10993-1 | Pass |

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| | Biocompatibility and Baseline Stability | ISO 10993-1 | Pass |
|--------------------------------------|-----------------------------------------------------------------------------------|--------------------------------|------|
| | Leachable Extractions | ISO 10993-18 | Pass |
| Chemical Evaluation | Evaluation and rationale for inclusion in “family<br>grouping” of similar devices | ANSI/AAMI/ISO<br>11135 | Pass |
| Sterilization Validation<br>Adoption | Product Adoption Analysis | EN ISO 11135:2014 | Pass |
| EO Residuals | ETO/ECH Transfer Engineering Study– MVD<br>00170164 | ISO 10993-7: 2008 | Pass |
| Bacterial Endotoxin | Bacterial Endotoxin test | ANSI/AAMI<br>ST72:2011/(R)2016 | Pass |
| Packaging Verification | Injector Sealing Validation Report | ASTM F88-09 and<br>ASTM F1929 | Pass |

- No clinical testing was performed on the subject device. c.
#### Summary of Nonclinical tests and Results: d.

Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Pre Vue Inserter for enVista Preloaded. No animal or clinical testing was required for this submission.

Device functional performance testing all passed and demonstrates equivalence to predicate device. EO/ ECH residual transfer and Endotoxin validation testing passed. Sterilization evaluation, packaging verification, biocompatibility evaluation all met requirements and demonstrated equivalence to the predicate device. All results support the conclusion that the proposed device PreVue Inserter for enVista Preloaded demonstrates substantial equivalence to the predicate devices.

A risk analysis was conducted for the PreVue Inserter in accordance with EN ISO 14971: 2012. The Hazard and Risk Assessment follows a systematic approach by a cross-functional team to help prioritize problem prevention efforts for the PreVue, considering possible failures of components and subsystems of the product and the resulting effects. The technique employed used the bottom-up approach that is typical of Failure Mode and Effects Analysis (FMEA), while capturing all results in an FMEA table. The document is used in the design, development, and testing of PreVue to identify risks and track mitigation efforts.

Product safety risks are assessed in terms of probability that harm may occur, taking into consideration normal use and reasonably foreseeable misuse conditions. As well as, historical complaint data and applying other risk management elements as per EN ISO 14971. Each residual risk was evaluated for acceptability through a risk/benefit analysis. All identified foreseeable hazards and potential failure modes have been subjected to risk/ benefit analysis and it has been determined that the medical benefits of the intended use outweigh the overall residual risk.