(214 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 system is based on the technology and the performance of the existing Stellaris and Stellaris PC Vision Enhancement Systems. This traditional 510(k) incorporates software and hardware revisions to support the introduction of new features including Adaptive Fluidics, high speed vitrectomy, and supporting accessories. The Stellaris Elite Vision Enhancement System is available in various configurations.
This document is a 510(k) premarket notification for the "Stellaris Elite Vision Enhancement System" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving performance against specific acceptance criteria in the manner one might expect for an AI/ML-based device.
Therefore, many of the requested sections (including specific acceptance criteria, sample sizes for test sets, expert consensus details, MRMC studies, standalone performance, and details on training sets) are not provided in this document. The document describes a traditional medical device (a surgical system that enhances vision), not an AI/ML product.
Here's a breakdown based on the information provided in the document:
1. Table of acceptance criteria and the reported device performance:
The document does not present a table of specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) for the device's clinical performance. Instead, it demonstrates compliance with recognized electrical and medical device safety standards and verifies functional performance to support substantial equivalence.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety Standards | Complies with: - IEC 60601-1:2005 + C1(2006) + C2(2007) + AM1(2012) or IEC 60601-1:2012 (General requirements for basic safety and essential performance) - IEC 60601-1-2 ed3.0 (2007) (Electromagnetic compatibility) - IEC 60601-1-6:2010 (Usability) - IEC 60601-2-2:2009 (High frequency surgical equipment) |
| Laser Safety Standards | Complies with: - IEC 60601-2-22:2007 (Diagnostic and therapeutic laser equipment) |
| Device-Specific Standards | Complies with: - IEC 80601-2-58:2008 (Lens removal and vitrectomy devices) |
| Functional Performance | Successful test results for functional, simulated use, biocompatibility, shelf life, and transport testing. |
| Software Quality | Software changes verified and validated in accordance with Bausch + Lomb software quality procedures, complying with EN ISO IEC 62304:2006 (Medical device software life cycle processes). |
| Clinical Equivalence | Demonstrated substantial equivalence in indications for use, design features, and functional features to predicate devices (K133486 Stellaris PC Vision Enhancement System, K133242 Stellaris Vision Enhancement System). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide details on specific sample sizes for test sets in a clinical performance study involving patient data. The "test sets" mentioned would refer to units of the device or its components for engineering and performance validation rather than patient data for AI model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. There is no mention of expert-established ground truth for a test set of medical cases. The assessment is based on compliance with standards and functional testing by engineers/testers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set requiring adjudication is described.
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 therapeutic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a surgical system operated by a human surgeon. It is not an algorithm performing a task autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device (a surgical system), the "ground truth" for its performance is typically defined by:
- Compliance with validated international and national standards (e.g., IEC standards for electrical safety, electromagnetic compatibility, usability, and device-specific requirements).
- Successful completion of functional and simulated use testing to ensure the device operates as intended (e.g., proper phacoemulsification, vitrectomy, fluidics).
- Biocompatibility testing of materials.
- Shelf-life and transport testing to ensure product integrity.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model that undergoes "training" on a dataset. The software development follows traditional software life cycle processes (EN ISO IEC 62304:2006).
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of an AI/ML model. Software validation involves verification against requirements and pre-defined test cases, not ground truth labeling for machine learning.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
Bausch + Lomb Inc. Mr. Ken Nehmer Senior Manager, Regulatory Affairs 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122
Re: K162342
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: March 17, 2017 Received: March 20, 2017
Dear Mr. 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 (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.
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 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) 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
for Malvina B. 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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Indications for Use
510(k) Number (if known) K162342
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 vitrectorny. 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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1. General Information
| Submitter: | Contact Person: |
|---|---|
| Bausch + Lomb Inc. | Ken Nehmer |
| 3365 Tree Court Industrial Blvd. | 351 Buena Vista Avenue E. |
| St. Louis MO 63122 | Unit 501E |
| General Telephone: 636-226-3017 | San Francisco, CA 94117 |
| 415-297-0408 (Cell) | |
| ken.nehmer@bausch.com | |
| Preparation Date:August 19, 2016 | |
| 2. Names | |
| Device Name(s): | Stellaris Elite Vision Enhancement System |
| Device Name(s): | Stellaris Elite Vision Enhancement System |
| Classification Name(s): | 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 |
3. Predicate Devices
- K133486 Stellaris PC Vision Enhancement System, Bausch + Lomb .
- K133242 Stellaris Vision Enhancement System, Bausch + Lomb ●
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 system is based on the technology and the performance of the existing Stellaris and Stellaris PC Vision Enhancement Systems. This traditional 510(k) incorporates software and hardware revisions to support the introduction of new features including Adaptive Fluidics, high speed vitrectomy, and supporting accessories. The Stellaris Elite Vision Enhancement System is available in various configurations.
5. Indications for Use
The Bausch + Lomb Stellaris Elite Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior 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.
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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 DeviceStellaris 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 + LombStellaris Elite VisionEnhancement System isintended for theemulsification andremoval of cataracts,anterior and posteriorsegment vitrectomy. Thesystem is designed for usein both anterior andposterior segmentsurgeries. It providescapabilities forphacoemulsification,coaxial and bimanualirrigation/aspiration,bipolar coagulation,vitrectomy, viscous fluidinjection/removal andair/fluid exchangeoperations.The Bausch + LombStellaris Elite VisionEnhancement Systemconfigured with the lasermodule is additionallyintended for retinalphotocoagulation and lasertrabeculoplasty. | The Bausch + LombStellaris PC VisionEnhancement System isintended for theemulsification andremoval of cataracts,anterior and posteriorsegment vitrectomy. Thesystem is designed for usein both anterior andposterior segmentsurgeries. It providescapabilities 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 andremoval of cataracts,anterior and posteriorsegment vitrectomy. Thesystem is designed for usein both anterior andposterior segmentsurgeries. It providescapabilities 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 |
| Electrical Characteristics | 90 - 130 VAC, 50/60 Hz200 - 240 VAC, 50/60 Hz | Same as subject device | Same as subject device |
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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 as safe and effective as the predicate for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy.
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) | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance |
|---|---|
| or IEC 60601-1:2012 | |
| IEC 60601-1-2 ed3.0 (2007) | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-6:2010 | Medical electrical equipment. Part 1-6: General requirements forbasic safety and essential performance. Collateral standard:Usability |
| IEC 60601-2-2:2009 | Medical electrical equipment - Part 2-2: Particular requirements forthe basic safety and essential performance of high frequencysurgical equipment and high frequency surgical accessories |
| IEC 60601-2-22:2007 | Medical electrical equipment - Part 2-22: Particular requirementsfor the safety of diagnostic and therapeutic laser equipment |
| IEC 80601-2-58:2008 | Medical electrical equipment - Part 2-58: Particular requirementsfor the basic safety and essential performance of lens removaldevices and vitrectomy devices for ophthalmic surgery |
Substantial equivalence is supported by successful test results for functional, simulated use, biocompatibility, shelf life, 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 applicable standards and functional testing. This testing demonstrates that the functional requirements have been met and that the modified device is substantially equivalent to the predicate devices.
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.