(228 days)
The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite™ vision enhancement system was initially cleared under K 162342 which included the introduction of an Adaptive Fluidics feature as well as increase in vitrectomy cut rate. The Vitesse vitrectomy handpiece was introduced and cleared for use on the Stellaris Elite™ vision enhancement system under K170052.
A selection of disposable single-use procedure packs is available for use with this system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to/from the patient as well as a selection of components (cannulas, cutters, probes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. Additional Stellaris Elite™ vision enhancement system procedure packs have been made available and these packs contain components that have been used in previously available procedure packs. Some of these Stellaris Elite™ vision enhancement system procedure packs now include the BiBlade vitrectomy cutter produced by Medical Instruments Development Lab (separately cleared via K153168).
The previously cleared Stellaris Elite™ vision enhancement system introduced new feature sets that are not available on the legacy Stellaris PC systems previously cleared under K133242/K133486 respectively. A summary of these additional feature sets for the Stellaris Elite™ vision enhancement system are listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.
The most recent clearance to the Stellaris Elite™ vision enhancement system introduced the Vitesse vitrectomy feature and was cleared via K170052 on April 19, 2017.
This traditional 510(k) incorporates updates to User Interface Computer System on Module (SOM) with an introduction of a new replacement Congatec SOM. In addition. the Stellaris Software platform is updated to Windows 10, since the current Stellaris software platform Windows XP is obsolete/incompatible with the new Congatec SOM.
The features remain the same as the previously approved Stellaris Elite™ vision enhancement system. The configuration matrix is listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.
The provided document is a 510(k) Summary for the Bausch + Lomb Stellaris Elite™ vision enhancement system. It primarily focuses on demonstrating substantial equivalence to a predicate device after software and hardware updates, rather than presenting a study proving a device meets specific acceptance criteria for performance.
Therefore, many of the requested categories cannot be fully addressed in the traditional sense of a clinical or performance study aimed at defining and meeting specific analytical or clinical performance metrics. The document describes how substantial equivalence was demonstrated, which involves various types of testing, but not a study designed to prove new performance claims against defined acceptance criteria.
Below is the information extracted and interpreted based on the context of this 510(k) submission, highlighting what is available and what is not.
Acceptance Criteria and Device Performance Study for K232084
This 510(k) submission (K232084) is for updates to the Bausch + Lomb Stellaris Elite™ vision enhancement system, not for a new device making novel performance claims. The primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170052 Stellaris Elite™ vision enhancement system) after changes to the User Interface Computer System on Module (SOM) and an update to the operating system from Windows XP to Windows 10. Consequently, the "acceptance criteria" and "device performance" are framed in terms of meeting regulatory standards and maintaining performance equivalent to the predicate device, rather than achieving specific performance thresholds for a novel diagnostic or therapeutic claim.
1. A table of acceptance criteria and the reported device performance
Given the nature of this 510(k) for system updates, the "acceptance criteria" are regulatory compliance and maintained functionality, rather than specific numerical performance metrics for a clinical task.
| Acceptance Criteria Category | Reported Device Performance / Assessment |
|---|---|
| Biocompatibility | Not required; device does not contain direct or indirect patient-contacting materials. |
| Electrical Safety | Complies with IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-1-6:2020, IEC 60601-2-2:2017, IEC 60601-2-22:2019, IEC 80601-2-58:2016. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2020. |
| Software Verification & Validation | Functional, simulated use, environmental, and transport testing performed. Software changes verified and validated per Bausch + Lomb software quality procedures, complying with EN ISO IEC 623304:2006. All testing passed. |
| Mechanical Testing | No specific mechanical testing performed to support this premarket notification for substantial equivalence (implied that existing mechanical performance is assumed to be equivalent). |
| Acoustical Testing | No specific acoustical testing performed to support this premarket notification for substantial equivalence. |
| Overall Functional Equivalence | The Stellaris Elite™ vision enhancement system features remain the same as the previously approved system and are described as substantially equivalent to the predicate (K170052). |
| Maximum vacuum | Subject Device: 660 mmHg. Predicate (K170052): 600 mmHg (This is listed as an "incremental improvement" since the predicate of K170052, indicating a specific performance change that was assessed). |
| Operating System | Subject Device: Windows 10. Predicate (K170052): Windows XP. (Functional equivalence demonstrated via software V&V). |
| User Interface SOM | Subject Device: Congatec. Predicate (K170052): Kontron. (Functional equivalence demonstrated via software V&V and system testing). |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a dataset for AI or clinical study. Instead, it refers to "representative units" for hardware testing (electrical safety, EMC) and software verification/validation.
- Test Set Sample Size: Not applicable in the context of an AI-driven clinical test set. Testing was performed on the device itself and its software.
- Data Provenance: Not applicable as no patient data or image data was used for a test set. This submission is for hardware/software updates to an ophthalmic surgical system. The standards cited (IEC standards for electrical safety, EMC, software lifecycle) are international regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set (e.g., diagnostic labels, disease states) was established by experts in this submission, as it's not a diagnostic AI device.
4. Adjudication method for the test set
Not applicable. There was no test set requiring 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
Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ophthalmic surgical system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study. For software and hardware validation, the "ground truth" would be the functional requirements and established performance specifications of the predicate device and relevant international standards.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the sense of machine learning for interpretation or diagnosis.
9. How the ground truth for the training set was established
Not applicable.
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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 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.
February 26, 2024
Bausch + Lomb Ken Nehmer Director, Regulatory Affairs 3365 Tree Court Industrial Blvd. St. Louis, Missouri 63122
Re: K232084
Trade/Device Name: Stellaris Elite™ vision enhancement system Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC, HQE, HQF Dated: January 26, 2024 Received: January 29, 2024
Dear Ken Nehmer:
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.
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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).
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 QS 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.
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 medical devices and radiation-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,
Claudine H. Krawczyk -S
Claudine Krawczyk 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) K232084
Device Name
Bausch + Lomb Stellaris Elite™ vision enhancement system
Indications for Use (Describe)
The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image displays the logo for Bausch + Lomb, a company specializing in eye health products. The logo features the company name in a bold, sans-serif font, with a plus sign in a lighter shade of teal connecting the two words. Below the logo, the tagline "See better. Live better." is written in a smaller, softer font, emphasizing the company's mission to improve people's vision and quality of life.
K232084-510(k) Summary
8. 510(K) SUMMARY
8.1 General Information
| Submitter: | Contact Person: |
|---|---|
| Bausch + Lomb Inc.3365 Tree Court Industrial Blvd.St. Louis MO 63122General Telephone: 636-226-3017 | Ken Nehmer3365 Tree Court Industrial Blvd.St. Louis MO 63122Telephone: 415-297-0408ken.nehmer@bausch.com |
| Preparation Date: | February 26, 2024 |
| 8.2 Names | |
| Device Name: | Stellaris EliteTM vision enhancement system |
| Classification Names: | Phacofragmentation Unit, Vitreous Aspiration and Cutting Instrument |
| Common Name: | Ophthalmic surgical system for cataract and vitreo-retinal surgery |
| CFR References: | 21 CFR 886.4670, 21 CFR 886.4150, 21 CFR 886.4390 |
| Product Codes: | HQC, HQE, HQF |
8.3 Predicate Device
K170052 - Stellaris Elite™ vision enhancement system, Bausch + Lomb
8.4 Product Description
The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite™ vision enhancement system was initially cleared under K 162342 which included the introduction of an Adaptive Fluidics feature as well as increase in vitrectomy cut rate. The Vitesse vitrectomy handpiece was introduced and cleared for use on the Stellaris Elite™ vision enhancement system under K170052.
A selection of disposable single-use procedure packs is available for use with this system. These packs contain the necessary tubing to facilitate delivery and removal of air
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BAUSCH + LOMB
See better. Live better.
K232084-510(k) Summary
and fluids to/from the patient as well as a selection of components (cannulas, cutters, probes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. Additional Stellaris Elite™ vision enhancement system procedure packs have been made available and these packs contain components that have been used in previously available procedure packs. Some of these Stellaris Elite™ vision enhancement system procedure packs now include the BiBlade vitrectomy cutter produced by Medical Instruments Development Lab (separately cleared via K153168).
The previously cleared Stellaris Elite™ vision enhancement system introduced new feature sets that are not available on the legacy Stellaris PC systems previously cleared under K133242/K133486 respectively. A summary of these additional feature sets for the Stellaris Elite™ vision enhancement system are listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.
The most recent clearance to the Stellaris Elite™ vision enhancement system introduced the Vitesse vitrectomy feature and was cleared via K170052 on April 19, 2017.
This traditional 510(k) incorporates updates to User Interface Computer System on Module (SOM) with an introduction of a new replacement Congatec SOM. In addition. the Stellaris Software platform is updated to Windows 10, since the current Stellaris software platform Windows XP is obsolete/incompatible with the new Congatec SOM.
The features remain the same as the previously approved Stellaris Elite™ vision enhancement system. The configuration matrix is listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.
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BAUSCH + LOMB
See better. Live better.
K232084–510(k) Summary
| Table 8-1: Stellaris Elite™ vision enhancement system Configuration Table | |||
|---|---|---|---|
| Configuration by SKU | |||
| Feature | BL11145 | BL14455 | BL15455 |
| 2500 cpm vitrectomyInitially cleared via K162342 – no substantialchanges to the feature since initial clearance | Available | Not Available | Not Available |
| 7500 cpm vitrectomyInitially cleared via K162342 – no substantialchanges to the feature since initial clearance | Not Available | Available | Available |
| Vitesse vitrectomyInitially cleared via K170052 | Not Available | Available | Available |
| Adaptive FluidicsInitially cleared via K162342 for use in the anteriorsegment of the eye | Available | Available | Available |
| Laser moduleInitially cleared via K133486 – no substantialchanges to the feature since initial clearance | Not Available | Not Available | Available |
Abbreviations: cpm = cuts per minute
BL11145: formerly the Stellaris Anterior Vision Enhancement System
BL14455: formerly the Stellaris PC Vision Enhancement System
BL15455: formerly the Stellaris PC Vision Enhancement System with laser
| The Stellaris Elite™ vision enhancement system is composed of the following: | |||
|---|---|---|---|
| Module/Assembly | Description |
|---|---|
| ElectromechanicalBase (EMB) | The EMB is intended to act as the central frameincluding the outer skin through which all systemmodules attach or receive power. The EMB also servesas the attachment point for all external electrical cordsand fluid lines. |
| Computer Unit | Consists of a standard personal computer (PC)customized to include the computer user interface withthe Stellaris Elite vision enhancement system. |
| User InterfaceModule | Provides user control of operation of the Stellaris Elitevision enhancement system. It provides a touch screendisplay with user input controls to command the systeminto its various modes and controls activation offunctions within each mode. |
| Power SupplyModule | Provides electrical power to all parts of the Stellaris Elitevision enhancement system integral to the EMB. |
| DeviceRelationshipManagement(DRM) | Designed to interact with an external managementsystem to monitor specific activities of the Stellaris Elitevision enhancement system and to provide Bausch +Lomb with a tool to monitor certain system metadata (nopatient identifiable data is collected) |
| Anterior Module(Phaco) | The Anterior Module contains all anterior segmentconnections, circuits, and operating hardware andfirmware necessary for anterior segment procedures. Itenables ultrasound for continuous, burst, and modulatedmodes, bimanual phacoemulsification, and bipolarcoagulation capability. |
| PosteriorIlluminationModule(ConfigurationsBL14455 andBL15455 only) | The Stellaris Elite vision enhancement systemIllumination Module has two light outputs from twoseparate light bulbs. The module is designed to supportthe use of Xenon or Mercury light bulbs. One of thelight outputs has a built-in switchable filter to producetinted Green, Amber or Yellow lights. Lights aretransmitted through fiber optics of varying gauge sizes. |
| CompressorModule | The Compressor Module provides the necessary pressureto drive the 2 fluidics modes available for operation ofthe system vacuum pumps and accessories that requireexternal assistance as drivers for fluid delivery andexchange. This module is the source of bottle infusionand also provides Adaptive Fluidics functionality. Itprovides pressure to vitrectomy and pinch valves. |
| Fluidics Module | This module is designed for use with anterior andposterior surgical procedures. The module providesvacuum control. The vacuum control is done by thesoftware via a transducer located inside the FluidicsModule. The Fluidics Module provides the electronics,pneumatic actuators, and mechanisms necessary tointerface and control the fluidics of the cartridge. TheFluidics Module also monitors the fluid level. Apneumatic vitrectomy cutter control and interface isincluded. |
| Automated IVPole | The unit contains electrical sensors to place the pole atpre-ordained positions via screen generated touch controlcommands for height requirements in delivery of fluidsat certain pressures. |
| Surgical InstrumentTray | The tray is ergonomically located within the base unitand set at a height useful to the surgeon and theassistant. The tray is capable of tilting, and is removablefor autoclave sterilization. The tray accommodates asurgical drape. The tray is retractable within the unitwhen not in use. |
| Foot Controller | The foot controller allows the user to control variousfeatures of the system. |
| Remote Control | The remote control unit mimics the GUI functions. Thedevice can control operation of IV pole height, vacuumpressure, ultrasound power, and bipolar power. |
| Digital MediaSystem (option) | Provides a microscope overlay capability. The DMS isused to overlay the surgical parameters output from theStellaris Elite to the video image of the surgical sitecaptured by the operating microscope camera. Thecombined image is output to a video monitor and/or avideo recorder. |
| Phaco Handpiece | Electrically powered hand-held instrument for anteriorsegment surgery. There are threecapabilities: Generation of ultrasonic energy fordisruption of lens tissue; provision for an aspiration pathfor disrupted tissue from the eye, and the delivery ofsaline irrigation fluid to the eye for standard, burst, orpulsed phacoemulsification. A phacofragmentation(posterior) handpiece is also available and has twofunctions: generation of ultrasonic energy for disruptionof lens tissue and aspiration path for disrupted tissuefrom the eye for standard, burst, or pulsedphacofragmentation. |
| Laser Module(ConfigurationBL15455 only) | The laser module uses an off the shelf 2 Watt 532 nmdiode pumped frequency doubled solid state lasercoupled coaxially with an off the shelf diode sourced 0.8mW 635 nm red aiming beam. These are enclosed in aseparate box located inside the system. The laser module |
| can be driven in either single shot, continuous or pulsed | |
| mode. The user may control treatment power, duty | |
| cycle, repetition rate, and aiming beam power. | |
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BAUSCH+LOMB See better. Live better.
K232084–510(k) Summary
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BAUSCH+LOMB See better. Live better.
K232084–510(k) Summary
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BAUSCH + LOMB
See better. Live better.
K232084-510(k) Summary
8.5 Indications for Use
The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
8.6 Summary of Technological Characteristics
The technological characteristics of the Stellaris Elite™ vision enhancement system are substantially equivalent to those of the predicate devices.
| Characteristic | Subject Device:Stellaris EliteTM visionenhancement system | K170052Stellaris PC Vision Enhancement System |
|---|---|---|
| Intended Use | Anterior/Posterior ophthalmicsurgery | Same as subject device |
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BAUSCH+LOMB See better. Live better.
K232084–510(k) Summary
| Indications forUse | The Bausch + Lomb Stellaris Elite™vision enhancement system isintended for the emulsification andremoval of cataracts, anterior andposterior segment vitrectomy. Thesystem is designed for use in bothanterior and posterior segmentsurgeries. It provides capabilities forphacoemulsification, coaxial andbimanual irrigation/ aspiration,bipolar coagulation, vitrectomy,viscous fluid injection/removal andair/fluid exchange operations. TheBausch + Lomb Stellaris Elite™vision enhancement systemconfigured with the laser module isadditionally intended for retinalphotocoagulation and lasertrabeculoplasty. | The Bausch + Lomb Stellaris PC VisionEnhancement System is intended for theemulsification and removal of cataracts,anterior and posterior segment vitrectomy.The system is designed for use in bothanterior and posterior segment surgeries. Itprovides capabilities forphacoemulsification, coaxial and bimanualirrigation/aspiration, bipolar coagulation,vitrectomy, viscous fluid injection/removaland air/fluid exchange operations.The laser modes are intended for retinalphotocoagulation and laser trabeculoplasty. |
|---|---|---|
| Laser capabilities | Yes | Same as subject device |
| User interface | LCD touch screen | Same as subject device |
| Footswitch | Yes | Same as subject device |
| ElectricalCharacteristics | 90 - 130 VAC, 50/60 Hz200 - 240 VAC, 50/60 Hz | Same as subject device |
| User InterfaceSOM (System onModule) | Congatec | Kontron |
| Operating System | Windows 10 | Windows XP |
| Maximum vacuum | 660 mmHg* | 600 mmHg |
| eyeTELLIGENCE | Available* | Available |
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BAUSC TT KOMB See better. Live better.
K232084-510(k) Summary
| Vitesse revisions including: | Available* | Available |
|---|---|---|
| a. Introduction of Vitesse procedure pack BL5631TD | ||
| b. Vitesse handpiece manufacturing process revisions | ||
| c. Firmware update to introduce Vitesse auto tune |
- incremental improvements introduced since the predicate of K170052
Performance Data
Biocompatibility testing
Biocompatibility assessment is not required to support the premarket notification. The Stellaris Elite™ vision enhancement systems do not contain direct or indirect patient contacting materials.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety tests of the Stellaris Elite™ vision enhancement system have demonstrated its compliance with applicable requirements of the following electrical standards:
| IEC 60601-1:2020 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance |
|---|---|
| IEC 60601-1-2:2020 | Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-6:2020 | Medical electrical equipment. Part 1-6: General requirementsfor basic safety and essential performance. Collateral standard:Usability |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essential performance ofhigh frequency surgical equipment and high frequency surgicalaccessories |
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K232084-510(k) Summary
| IEC 60601-2-22:2019 | Medical electrical equipment - Part 2-22: Particularrequirements for the safety of diagnostic and therapeutic laserequipment |
|---|---|
| IEC 80601-2-58:2016 | Medical electrical equipment - Part 2-58: Particularrequirements for the basic safety and essential performance oflens removal devices and vitrectomy devices for ophthalmicsurgery |
Details of the electromagnetic compatibility and safety standard testing can be found in Section 17.
Software Verification and Validation Testing
Functional, simulated use, environmental and transport testing were also performed on representative units. Software changes were verified and validated in accordance with the Bausch + Lomb software quality procedures which comply with EN ISO IEC 62304:2006 Medical device software -- Software life cycle processes. Refer to Section 16 for additional details on the specifications and reports.
The Stellaris Elite™ vision enhancement system passed all of the above referenced testing. This testing demonstrates that the functional requirements have been met and that the modified device is substantially equivalent to the predicate devices.
Mechanical and acoustic testing
There was no mechanical or acoustical testing performed to support substantial equivalence of this premarket notification.
Animal Study
There was no animal study performed to support substantial equivalence of this premarket notification.
Non-Clinical Performance Data
Non-clinical performance testing was conducted to establish substantial equivalence between the predicate device and the revisions as identified within this premarket notification.
Clinical Studies
There was no clinical study performed to support substantial equivalence of this premarket notification.
8.7 Conclusion
The Stellaris Elite™ vision enhancement system shares the same indications for use, design features, and functional features with, and thus is substantially equivalent to, the predicate devices. Non-clinical test results demonstrate that the Stellaris Elite™ vision enhancement system is substantially equivalent to the predicate devices and no new issues of safety or effectiveness have been raised.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.