(104 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 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 is a rebranding of the currently cleared Stellaris (K133242) Vision Enhancement System and Stellaris PC (K133486) Vision Enhancement System. The system is based on the technology and the performance of the existing Stellaris and Stellaris PC Vision Enhancement Systems, and this traditional 510(k) incorporates software and hardware revisions to support the introduction of the new Vitesse vitrectomy feature (including 2 new Vitesse handpieces and supporting accessories). The new Vitesse vitrectomy feature is available on the Stellaris Elite Vision Enhancement System based on the configuration matrix listed in Table 1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.
This document describes the Bausch + Lomb Stellaris Elite Vision Enhancement System, a device intended for surgical procedures related to cataracts and vitrectomy, and its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Stellaris Elite Vision Enhancement System are based on compliance with various international electrical and medical device standards, and successful functional, simulated use, environmental, and transport testing. The reported device performance is that it met all these criteria.
| Acceptance Criteria (Standards and Testing Goals) | Reported Device Performance |
|---|---|
| Electrical Safety Standards: | Compliance Demonstrated: |
| IEC 60601-1:2005 + C1(2006) + C2(2007) + AM1(2012) or IEC 60601-1:2012 (General requirements for basic safety and essential performance) | Passed all referenced testing. |
| IEC 60601-1-2 ed3.0 (2007) (Electromagnetic compatibility) | Passed all referenced testing. |
| IEC 60601-1-6:2010 (Usability) | Passed all referenced testing. |
| IEC 60601-2-2:2009 (Particular requirements for high frequency surgical equipment) | Passed all referenced testing. |
| IEC 60601-2-22:2007 (Particular requirements for diagnostic and therapeutic laser equipment) | Passed all referenced testing. |
| IEC 80601-2-58:2008 (Particular requirements for lens removal devices and vitrectomy devices) | Passed all referenced testing. |
| Functional, Simulated Use, Environmental & Transport Testing: Ensure the device performs as intended in various conditions and scenarios. | Successfully completed on representative units, demonstrating compliance and substantial equivalence to predicate devices. Functional requirements have been met. |
| Software Verification and Validation: Compliance with EN ISO IEC 62304:2006 (Medical device software life cycle processes) | Software changes were verified and validated in accordance with Bausch + Lomb's software quality procedures, which comply with EN ISO IEC 62304:2006. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or
clinical cases. The testing conducted was primarily hardware and software performance verification. The non-clinical tests involved "representative units" of the device. There is no information regarding country of origin of data or whether it was retrospective or prospective, as the testing described is not clinical in nature.
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 listed tests are engineering and compliance standards, not clinical studies requiring expert ground truth establishment for patient data. Expert involvement would be in the form of engineers, quality assurance personnel, and regulatory specialists ensuring compliance with the standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies when there's uncertainty about ground truth or disagreement among readers (e.g., radiologists). The testing described here is based on objective measurements against engineering and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technical characteristics and compliance with standards, not on comparing human reader performance with and without AI assistance. This device is not an AI-powered diagnostic tool, but a surgical system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the Stellaris Elite Vision Enhancement System. As a surgical system, it is inherently designed for human-in-the-loop operation. The "standalone" performance being assessed relates to the system's compliance with engineering and safety standards as an independent medical device, not as an algorithm performing a task without human intervention. The software verification and validation would be considered "standalone" in the sense of the software itself being tested, but in the context of contributing to the overall device's safety and functionality.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by its adherence and successful execution to various international engineering and medical device safety standards (e.g., IEC 60601 series, EN ISO IEC 62304). These standards define the acceptable performance, safety, and operational parameters for such medical equipment.
8. The Sample Size for the Training Set
This information is not applicable. This document describes a medical device, not an AI model that relies on training sets of data. The software within the device undergoes verification and validation, but this is distinct from machine learning model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no mention of a "training set" for an AI model in the context of this device's submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2017
Bausch + Lomb Mr. Dan Regan Director, Regulatory Affairs 3365 Tree Ct. Industrial Blvd St. Louis, MO 63122
Re: K170052
Trade/Device Name: Stellaris Elite Vision Enhancement System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HOC, HOE, HOF Dated: March 27, 2017 Received: March 28, 2017
Dear Mr. Dan Regan:
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. 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Denise L. Hampton -S
Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name 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 segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation, bipolar coagulation, vitrectomy, viscous fluid injection/removal, and air/fluid exchange operations. The 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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510(K) SUMMARY
General Information 1.
| Submitter: | Contact Person: |
|---|---|
| Bausch + Lomb Inc.3365 Tree Court Industrial Blvd.St. Louis MO 63122General Telephone: 636-226-3017 | Dan Regan3845 Corporate Centre DriveO'Fallon, MO 63368(636) 794-5013dan.regan@valeant.com |
Preparation Date: November 11, 2016
2. Names
| Device Name: | Stellaris Elite vision enhancement system |
|---|---|
| Classification Names: | Phacofragmentation Unit, Vitreous Aspiration and CuttingInstrument |
| Common Name: | Ophthalmic surgical system for cataract and vitreo-retinalsurgery |
| CFR References: | 21 CFR 886.4670, 21 CFR 886.4150, 21 CFR 886.4390 |
| Product Codes: | HQC, HQE, HQF |
Predicate Devices 3.
K133486 - Stellaris PC Vision Enhancement System, Bausch + Lomb K133242 - Stellaris Vision Enhancement System, Bausch + Lomb
Product Description 4.
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 is a rebranding of the currently cleared Stellaris (K133242) Vision Enhancement System and Stellaris PC (K133486) Vision Enhancement System. The system is based on the technology and the performance of the
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existing Stellaris and Stellaris PC Vision Enhancement Systems, and this traditional 510(k) incorporates software and hardware revisions to support the introduction of the new Vitesse vitrectomy feature (including 2 new Vitesse handpieces and supporting accessories). The new Vitesse vitrectomy feature is available on the Stellaris Elite Vision Enhancement System based on the configuration matrix listed in Table 1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.
| Configuration by SKU | |||
|---|---|---|---|
| Feature | BL11145 | BL14455 | BL15455 |
| Adaptive FluidicsFeature cleared under K162342 | Available | Available | Available |
| 2500 cpm vitrectomyFeature cleared under K162342 | Available | -- | -- |
| 7500 cpm vitrectomyFeature cleared under K162342 | -- | Available | Available |
| Laser moduleFeature cleared under K133486 | -- | -- | Available |
| Vitesse vitrectomy[new feature] | -- | Available | Available |
Table 1: Stellaris Elite Vision Enhancement System Configuration Table
Abbreviations: cpm = cuts per minute
--: Not available
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
Indications for Use 5.
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 Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
The above indication is a slightly reworded version of the already cleared indications for the Stellaris (K133242) and Stellaris PC (K133486) Vision Enhancement Systems. The rewording includes language regarding the rebranding of the product to Stellaris Elite Vision Enhancement System as well as clarification in regard to the laser module in the last sentence of the indications for use. The addition of the Vitesse vitrectomy feature did not further change the above indication for use statement.
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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 Elite VisionEnhancement System | K133486Stellaris PC VisionEnhancement System | K133242Stellaris VisionEnhancement System |
|---|---|---|---|
| Intended Use | Anterior/Posteriorophthalmic surgery | Same as subject device | Use in ophthalmicprocedures |
| Indications for Use | The Bausch + Lomb StellarisElite Vision EnhancementSystem is intended for theemulsification and removalof cataracts, anterior andposterior segment vitrectomy.The system is designed foruse in both anterior andposterior segment surgeries.It provides capabilities forphacoemulsification, coaxialand bimanualirrigation/aspiration, bipolarcoagulation, vitrectomy,viscous fluidinjection/removal andair/fluid exchange operations.The Stellaris Elite VisionEnhancement Systemconfigured with the lasermodule is additionallyintended for retinalphotocoagulation and lasertrabeculoplasty. | The Bausch + LombStellaris PC VisionEnhancement System isintended for theemulsification and removalof cataracts, anterior andposterior segmentvitrectomy. The system isdesigned for use in bothanterior and posteriorsegment surgeries. Itprovides capabilities forphacoemulsification,coaxial and bimanualirrigation/aspiration,bipolar coagulation,vitrectomy, viscous fluidinjection/removal andair/fluid exchangeoperations.The laser modes areintended for retinalphotocoagulation and lasertrabeculoplasty. | The Bausch + LombStellaris VisionEnhancement Systemdevice is intended for theemulsification and removalof cataracts, anterior andposterior segmentvitrectomy. The system isdesigned for use in bothanterior and posteriorsegment surgeries. Itprovides capabilities forphacoemulsification,irrigation/aspiration,bipolar, coaxial, andbipolar coagulation,vitrectomy, viscous fluidinjection/removal andair/fluid exchangeoperations. Use onlyBausch + Lomb disposablepacks and handpiecesdesignated for use with thesystem. |
| Laser capabilities | Yes | Same as subject device | No |
| User interface | LCD touch screen | Same as subject device | Same as subject device |
| Footswitch | Yes | Same as subject device | Same as subject device |
| ElectricalCharacteristics | 90 – 130 VAC, 50/60 Hz200 - 240 VAC, 50/60 Hz | Same as subject device | Same as subject device |
7. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Stellaris Elite Vision Enhancement System is substantially equivalent to the predicate devices and is safe and effective for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy.
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8. Brief Summary of Nonclinical Tests
Safety tests of the Stellaris Elite Vision Enhancement System have demonstrated its compliance with applicable requirements of the following electrical standards:
| IEC 60601-1:2005 + C1(2006) +C2(2007) + AM1(2012)or IEC 60601-1:2012 | Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance |
|---|---|
| IEC 60601-1-2 ed3.0 (2007) | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests |
| IEC 60601-1-6:2010 | Medical electrical equipment. Part 1-6: Generalrequirements for basic safety and essential performance.Collateral standard: Usability |
| IEC 60601-2-2:2009 | Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essential performanceof high frequency surgical equipment and high frequencysurgical accessories |
| IEC 60601-2-22:2007 | Medical electrical equipment - Part 2-22: Particularrequirements for the safety of diagnostic and therapeuticlaser equipment |
| IEC 80601-2-58:2008 | Medical electrical equipment - Part 2-58: Particularrequirements for the basic safety and essential performanceof lens removal devices and vitrectomy devices forophthalmic surgery |
Substantial equivalence is supported the successful tests for functional, simulated use, environmental and transport testing 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.
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 equivalent to the predicate devices.
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9. 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.