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 Description

The Bausch + Lomb PreVue inserter for enVista preloaded is a sterile, single-use device used to fold and insert an intraocular lens (MX60PL) through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

AI/ML Overview

The provided text is a 510(k) summary for the Bausch + Lomb PreVue Inserter for enVista Preloaded. It describes the device, its intended use, and the non-clinical testing performed to establish its substantial equivalence to predicate devices.

However, the request asks about acceptance criteria and a study that proves a device meets those criteria. The provided document concerns a medical device accessory (an inserter for intraocular lenses), not an AI/algorithm-based diagnostic device where terms like "ground truth," "expert consensus," "MRMC study," "training set," or "test set" are typically relevant. The document focuses on showing the physical device's functional performance, biocompatibility, sterilization, and packaging validation, primarily through bench tests and laboratory evaluations.

Therefore, many of the requested points in the prompt (e.g., sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to the type of device and testing described in this 510(k) summary. The "study" proving the device meets acceptance criteria refers to the non-clinical functional and safety testing performed.

Here's an analysis based on the information available in the provided text, addressing the applicable points and explaining why others are not relevant:

Device: Bausch + Lomb PreVue Inserter for enVista Preloaded
Type of Device: Intraocular Lens (IOL) Inserter (Medical Device Accessory)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Pass" result for each test, indicating the device met the standards/requirements. Specific quantitative thresholds for "Pass" are not detailed in this summary but would be found in the full test reports.

Test Category / Type	Specific Test Performed	Standard / Guideline	Acceptance Criteria (Implied)	Reported Performance (Result)
Delivery Verification	Fold and recovery test	ISO 11979-3: 2012	Met standard requirements	Pass
	Dioptric Power and Image quality Post delivery	ISO 11979-2: 2012	Met standard requirements	Pass
	Lens Dimensions Post Delivery	ISO 11979-3: 2012	Met standard requirements	Pass
	Surface and Bulk Homogeneity	ISO 11979-3: 2012	Met standard requirements	Pass
	PreVue Inserter Cosmetic Inspection	N/A (Internal Specification)	Met internal specifications	Pass
	Coating transfer study	ISO 10993-1	No cytotoxic/irritant transfer	Pass
	Particle counting study	ISO 10993-1	Particle limits met	Pass
Biocompatibility & Stability	Biocompatibility and Baseline Stability	ISO 10993-1	Biologically safe	Pass
	Leachable Extractions	ISO 10993-18	Acceptable levels of leachables	Pass
Chemical Evaluation	Evaluation and rationale for inclusion in “family grouping” of similar devices	ANSI/AAMI/ISO 11135	Consistent with family grouping	Pass
Sterilization Validation	Product Adoption Analysis	EN ISO 11135:2014	Validated sterilization process	Pass
EO Residuals	ETO/ECH Transfer Engineering Study	ISO 10993-7: 2008	Residual limits met	Pass
Bacterial Endotoxin	Bacterial Endotoxin test	ANSI/AAMI ST72:2011/(R)2016	Endotoxin limits met	Pass
Packaging Verification	Injector Sealing Validation Report	ASTM F88-09 and ASTM F1929	Packaging integrity maintained	Pass

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the summary. For non-clinical bench testing of medical devices, sample sizes are typically determined by statistical rationale for validation, often involving multiple units per lot and multiple lots. The summary mentions "functional performance testing," but the exact number of devices or number of insertions is not provided.
Data Provenance: The data originates from internal Bausch & Lomb laboratory and bench testing. There is no mention of specific country of origin for the data beyond the company's location in St. Louis, MO, USA. The testing is prospective as it's performed for regulatory submission of a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical medical device accessory, not an AI or diagnostic algorithm requiring expert interpretation of images or data to establish ground truth. "Ground truth" in this context refers to meeting predefined engineering and biological safety specifications through physical and chemical testing. The "experts" involved would be engineers, chemists, and quality assurance personnel performing and verifying the tests, but their number and specific qualifications are not detailed as they would be for a clinical AI study.

4. Adjudication method for the test set:

Not Applicable. As per point 3, this is not an AI/diagnostic algorithm study using human readers. "Adjudication" usually refers to resolving disagreements among multiple human experts. For non-clinical bench testing, results are typically objective (e.g., pass/fail based on measurements) and verified by quality control procedures.

5. 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:

Not Applicable. MRMC studies are relevant for evaluating diagnostic accuracy or reader performance with AI assistance, which is not pertinent to an IOL inserter. No human readers or AI assistance are involved in the functional testing of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical mechanical device, not an algorithm. Therefore, "standalone" algorithm performance is irrelevant.

7. The type of ground truth used:

Engineering Specifications / ISO Standards: The "ground truth" for this device's performance is compliance with established engineering specifications, relevant ISO standards (e.g., ISO 11979-3 for IOLs and inserters, ISO 10993 for biocompatibility), and internal quality requirements. For example, "Fold and recovery test" and "Lens Dimensions Post Delivery" imply that the true "ground truth" is whether the IOL is inserted without damage and retains its proper form and function after insertion.

8. The sample size for the training set:

Not Applicable. This is not an AI device that requires a "training set." The device is manufactured based on design specifications and then tested.

9. How the ground truth for the training set was established:

Not Applicable. (See point 8).

Summary Rationale from the Document:
The document explicitly states: "No clinical testing was performed on the subject device." and "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." This reinforces that the "study" proving the device met acceptance criteria was entirely non-clinical, focusing on functional performance, material safety, and manufacturing quality. The conclusion emphasizes that "Device functional performance testing all passed and demonstrates equivalence to predicate device." and that all results support "substantial equivalence to the predicate devices."

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
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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.3365 Tree Court Industrial Blvd.St. Louis, MO 63122
Contact Person:	Rekha JanarthananRegulatory Affairs ManagerPhone: 636-226-3095Email: rekha.janarthanan@bausch.com
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)2. Bausch & Lomb Injector System, BLIS (K131958)
Device Description:	The Bausch + Lomb PreVue inserter for enVista preloaded is a sterile,single-use device used to fold and insert an intraocular lens (MX60PL)through surgical procedure into a human eye. The Inserter provides atubular pathway through an incision over the iris, allowing delivery of anIOL into the capsular bag.
Indications for Use:	The Bausch + Lomb PreVue inserter for enVista preloaded is indicated forfolding and inserting of enVista IOLs (Model MX60PL) and IOL modelsapproved for use with this IOL insertion device as indicated in the IOLapproved labeling.
Comparative Analysis:	The Bausch + Lomb IOL Inserters have been demonstrated to beequivalent to the predicate devices for their intended use.
Functional/Safety Testing:	The Bausch + Lomb IOL Inserters have successfully undergonefunctional testing and are found to deliver the Bausch + Lomb IOLs inconformance with the requirements set forth in ISO 11979-3.
Conclusion:	The Bausch + Lomb IOL Inserters are substantially equivalent to thepredicate devices.

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a.	Predicate - Bausch + LombIOL Injector, INJ100(K113852)	Predicate - Bausch + LombInjector System, BLIS(K131958)	Subject Device - Bausch +Lomb PreVue Inserter
Indications forUse	The Bausch + Lomb IOLInjector is indicated forfolding and injection ofBausch + Lomb IOLsapproved for use with thisinjector.	The BLIS Bausch + LombInjector System is indicatedfor the folding and insertionof Bausch + Lomb intraocularlenses cleared or approved foruse with this IOL Injectorsystem.	The Bausch +Lomb PreVueinserter for enVista preloaded isindicated for folding andinserting of enVista IOLs(Model MX60PL) and IOLmodels approved for use withthis IOL insertion device asindicated in the IOL approvedlabeling.
How device isused	The IOL is placed in theloading chamber. Aplunger pushes the IOLinto the tip, which foldsthe IOL. Pushing theplunger further advancesthe IOL out through the tipinto the eye.	The IOL is placed in theloading cartridge. Thecartridge is snapped into thehandpiece. The screw plungeradvances the IOL through thecartridge, which folds theIOL and advances it into theeye.	The preloaded IOL shuttle issnapped into loading chamberof the PreVueinserter. The screw plungeradvances the IOL through theshuttle into the cartridgewhich folds the IOL andadvances it into the eye.
Injector/InserterComponents	• ABS Body• ABS Plunger• Polyamide Cartridge• Medicoat A Coating	• Titanium Body• Stainless Steel Plunger Shaft• Titanium Plunger Tip• Polyamide Cartridge• Medicoat A Coating	• ABS Body• Polyamide Cartridge• ABS Thread Bushing• Polypthalamide Plunger(this uses AI- 28 aspredicate)• ABS Spindle• Medicoat A Coating
Single Use	Injector: YesCartridge: Yes	Injector: NoCartridge: Yes	Inserter: YesCartridge: Yes
SterilizationMethod	Ethylene Oxide	• Cartridge: StainlessSteel• Injector: Shipped Non-Sterile. Steam Sterilizedby User	Ethylene Oxide
Shelf Life	24 months	Cartridge: 24 monthsInjector: Reusable	12 months

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 “familygrouping” of similar devices	ANSI/AAMI/ISO11135	Pass
Sterilization ValidationAdoption	Product Adoption Analysis	EN ISO 11135:2014	Pass
EO Residuals	ETO/ECH Transfer Engineering Study– MVD00170164	ISO 10993-7: 2008	Pass
Bacterial Endotoxin	Bacterial Endotoxin test	ANSI/AAMIST72:2011/(R)2016	Pass
Packaging Verification	Injector Sealing Validation Report	ASTM F88-09 andASTM 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.

Regulation Number and Section

§ 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.