(59 days)
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.
The EyeGility Inserter is a sterile, single-use device used to fold and insert an intraocular lens 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.
The provided text describes the EyeGility™ Inserter for Preloaded enVista® IOLs and its non-clinical testing to demonstrate substantial equivalence.
Here's the information broken down as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Category | Test | Standards | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|---|
| Delivery Verification Testing and Stability Testing | Fold and Recovery Test | ISO 11979-3 | Met established requirements | Pass |
| Dioptric Power and Image Quality Post Delivery | ISO 11979-2 | Met established requirements | Pass | |
| Lens Dimensions Post Delivery | ISO 11979-3 | Met established requirements | Pass | |
| Surface and Bulk Homogeneity | ISO 11979-3 | Met established requirements | Pass | |
| Cosmetic Inspection | N/A | Free from specified cosmetic defects | Pass | |
| Biocompatibility | Biocompatibility Assessment | ISO 10993-1 | Biocompatible | Pass |
| Particulate Study | ISO 10993-1 | Within acceptable particulate levels | Pass | |
| Coating Transfer Study | ISO 10993-1 | No unacceptable coating transfer | Pass | |
| Leachable Extractions | ISO 10993-18 | Within acceptable leachable limits | Pass | |
| EO Sterilization | Validation Product Adoption Analysis | ISO 11135 | Sterilization validated | Pass |
| EO Residuals | ETO/ECH Transfer Engineering Study | ISO 10993-7 | Within acceptable residual limits | Pass |
| Bacterial Endotoxin | Bacterial Endotoxin Test | ANSI/AAMI ST72 | Within acceptable endotoxin limits | Pass |
| Packaging | Transport Stability Testing | ISO 11607-1, ISO 11979-6, ASTM F2096 | Maintained integrity and sterility after transport | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test. It broadly mentions "functional testing" and "nonclinical testing." The data provenance is not mentioned, but given it's a premarket notification for the US market (FDA), such tests are typically conducted by the manufacturer in a controlled laboratory setting. The study is prospective in the sense that the device was designed and then tested against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is an inserter for Intraocular Lenses (IOLs) and the testing performed is non-clinical, focusing on the physical performance, biocompatibility, and sterility of the device against established standards (e.g., ISO standards). Ground truth, in the context of expert review, is typically relevant for interpretative devices (e.g., AI for medical imaging diagnosis), which is not the case here.
4. Adjudication Method for the Test Set
Not applicable, as this is a non-clinical device that is tested against objective, measurable performance standards rather than expert adjudication.
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
No. The provided text explicitly states: "No clinical testing was completed in support of the subject device." This implies no human readers or AI assistance was involved in a clinical comparative effectiveness study for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (an inserter) and does not involve an algorithm or AI.
7. The type of ground truth used
The "ground truth" for the non-clinical testing of this device is defined by the acceptance criteria established by international standards (e.g., ISO, ANSI/AAMI, ASTM) for medical devices and IOLs. These standards dictate acceptable performance for parameters like folding and recovery, optical quality, dimensions, biocompatibility, sterilization, and packaging integrity.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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 Incorporated1400 North Goodman StreetRochester, NY 14609 |
|---|---|
| Contact Person: | Renee StoffelAssociate Director, Regulatory Affairs(651) 392-4619 |
| 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 DeviceBausch + Lomb PreVue Inserter for enVista Preloaded (K192005) |
| Predicate DeviceBausch + Lomb IOL Injector, INJ 100 (K113852) | |
| Device Description: | The EyeGility Inserter is a sterile, single-use device used to fold andinsert an intraocular lens through surgical procedure into a human eye.The Inserter provides a tubular pathway through an incision over theiris, allowing delivery of an IOL into the capsular bag. |
| Indications for Use: | The EyeGility Inserter for enVista preloaded is indicated for foldingand inserting of enVista IOL models approved for use with this IOLinsertion device as indicated in the IOL approved labeling. |
| Summary of Performanceand Non-clinical Testing: | The EyeGility Inserter has successfully undergone functional testing inconformance with the requirements set forth in ISO 11979-3.Additional nonclinical testing information is provided in Table 1. Allacceptance criteria were met, demonstrating the subject device issubstantially 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 thepredicate devices for its intended use. Table 2 includes a detailedcomparison of the subject and predicate devices. |
| Conclusion: | The EyeGility Inserter is substantially equivalent to the predicatedevices. |
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| Testing Category | Test | Standards | Results |
|---|---|---|---|
| Delivery VerificationTesting and StabilityTesting | Fold and Recovery Test | ISO 11979-3 | Pass |
| Dioptric Power and Image Quality PostDelivery | 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 11607-1ISO 11979-6ASTM F2096 | Pass |
Table 1. Nonclinical Testing Summary
Table 2. Comparison of the subject and predicate device.
| TechnologicalSimilarities | Subject Device – EyeGilityInserter | Primary Predicate Device -Bausch + Lomb PreVueInserter (K192005) | Predicate Device - Bausch +Lomb IOL Injector, INJ100(K113852) |
|---|---|---|---|
| Indications ForUse | The EyeGility Inserter forenVista preloaded is indicatedfor folding and inserting ofenVista IOL models approvedfor use with this IOL insertiondevice as indicated in the IOLapproved labeling. | The Bausch +Lomb PreVueinserter for en Vista preloadedis indicated for folding andinserting of enVista IOLs(Model MX60PL) and IOLmodels approved for use withthis IOL insertion device asindicated in the IOL approvedlabeling. | The Bausch + Lomb IOLInjector is indicated forfolding and injection ofBausch + Lomb IOLsapproved for use with thisinjector |
| How device isused | The preloaded IOL shuttle issnapped into loading chamberof the enVista inserter body.The push-type plungeradvances the IOL through theshuttle into the cartridge whichfolds the IOL and advances itinto the eye. | The preloaded IOL shuttle issnapped into loading chamberof the PreVue inserter. Thescrew plunger advances theIOL through the shuttle intothe cartridge which folds theIOL and advances it into theeye. | The IOL is placed in theloading chamber. A plungerpushes the IOL into the tip,which folds the IOL.Pushing the plunger furtheradvancesthe IOL out through the tipinto the eye. |
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| TechnologicalSimilarities | Subject Device - EyeGilityInserter | Primary Predicate Device -Bausch + Lomb PreVueInserter (K192005) | Predicate Device - Bausch +Lomb IOL Injector, INJ100(K113852) |
|---|---|---|---|
| InserterComponents | ABS BodyPebax Cartridge (Medicoat A)PPA PlungerSilicone Soft tip | ABS BodyPebax Cartridge (Medicoat A)PPA PlungerABS Thread Bushing andScrew Spindle | ABS BodyABS PlungerPolyamide CartridgeMedicoat A Coating |
| Single Use | Injector: YesCartridge: Yes | Inserter: YesCartridge: Yes | Inserter: YesCartridge: Yes |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | 22 months | 36 months | 24 months |
§ 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.