(97 days)
The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System device 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 phacofragmentation (coaxial or bimanual), irrigation/aspiration, bipolar diathermy, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Uses only Bausch & Lomb™ disposable packs and handpieces designated for use with the system.
The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. The Stellaris® PC™ Vision Enhancement system is the next generation Stellaris® NGX Microsurgical System. The new system is based on the technology and the performance platform of the existing Stellaris® NGX Microsurgical System and is designed to improve surgical efficiency, surgeon ergonomics, control of fluidics and aesthetics. The system incorporates vacuum based fluidics to meet the needs of anterior and posterior procedures. The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency. The ultrasound lens removal system extends and improves upon existing technologies with new and improved designs in the phaco hand-piece.
The provided 510(k) K101325 describes the Bausch & Lomb™ Stellaris PC Vision Enhancement System, an ophthalmic microsurgical system. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the device's surgical functions. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and Electrical Standards Compliance: Meets international and domestic safety standards for medical electrical equipment, EMC, and specific requirements for high-frequency surgical equipment. (e.g., IEC 60601-1, UL 60601-1, IEC 60601-1-1, EN60601-1-2, IEC 60601-2-2). | The Stellaris PC Vision Enhancement System "will be manufactured in compliance with FDA and ISO quality systems and device related international, domestic, and industry standards and requirements." The document lists numerous standards it complies with, including various IEC, EN, UL, and FCC standards for electrical safety, EMC, and radio frequency devices. This statement, followed by the detailed list of standards, implies that the device successfully met the requirements of these standards during testing. |
| Biocompatibility: Materials in contact with patients are biocompatible. (e.g., ISO 10993 series). | The document lists compliance with ISO 10993:2003 (Biological Evaluation of Medical Devices - Evaluation and Testing), ISO 10993-5:2009 (Tests for in-vitro cytotoxicity), and ISO 10993-10:2002 (Tests for Irritation and Delayed Type hypersensitivity). This implies that relevant components of the device underwent and passed biocompatibility testing as per these standards. |
| Functional Equivalence: Performs the intended functions (phacoemulsification, vitrectomy, irrigation/aspiration, bipolar diathermy, viscous fluid injection/removal, air/fluid exchange) effectively and comparably to predicate devices. | "System verification and validations have demonstrated that the functional requirements and system specifications have been met and are currently ready for commercial release and distribution." The device is described as "the next generation Stellaris® NGX Microsurgical System" and "based on the technology and the performance platform of the existing Stellaris® NGX Microsurgical System." It states that it utilizes "similar technology as the Stellaris® NGX Microsurgical System" and "similar vacuum technology as the Premiere II Millennium® Microsurgical System." Modules for posterior surgical procedures have "predicates from the Bausch & Lomb™ Premiere II® Millennium Microsurgical System with modifications and upgrades." This indicates functional performance is considered equivalent due to its heritage and upgrades from existing, cleared devices. |
| Mechanical/Physical Performance and Transport Durability: Withstands transportation and maintains integrity. (e.g., ISTA, ASTM D4169). | Compliance with ISTA Schedule 3H, ISTA Project 3A, and ASTM D4169 for transportation standards for the completed system, service modules, and disposable packs, respectively, is stated. This implies the device and its packaging have undergone and passed these transport durability tests. |
| Light Hazard Protection (Ophthalmic Instruments): Complies with specific requirements for light hazard protection in ophthalmic instruments. (e.g., ISO 15004-2:2007). | Compliance with "ISO 15004-2:2007 Ophthalmic Instruments Fundamental Requirements and Test Methods Part 2: Light Hazard Protection" is listed. This indicates the device meets the safety standards for light emission during ophthalmic procedures. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes the submission as containing "all testing data and validation summaries supporting system function" derived from non-clinical testing (standards-based). It does not refer to a test set in the context of clinical images or patient data.
The testing is described as "System verification and validations," which likely involve engineering bench testing, simulated use, and compliance testing against the listed standards.
- No specific sample size for a "test set" of clinical data is mentioned because no clinical study was performed.
- Data provenance is not from patient data; rather, it appears to be from internal engineering and lab testing conducted by Bausch & Lomb, Inc. in the context of verifying compliance with international and domestic standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. Since no clinical study using patient data was conducted and no specific "ground truth" for diagnostic or intervention performance was established via expert review, this information is not provided. The "ground truth" for the non-clinical testing would be the specifications and requirements of the various listed standards.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set involving human judgment or interpretation was used. The compliance with technical standards is not typically adjudicated in this manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:
Not applicable. This device is an ophthalmic microsurgical system, not an AI-powered diagnostic or assistive tool for image interpretation by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a surgical system requiring human operation, not a standalone algorithm. Its "performance" refers to its mechanical, electrical, and fluidic functions, not algorithmic output.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the requirements and specifications defined by the numerous international and domestic standards (IEC, UL, EN, FCC, ISO, ISTA, ASTM D4169) for medical electrical equipment, biocompatibility, light hazard protection, and transportation. The device's performance was measured against these predefined technical benchmarks and safety parameters.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a "training set" of data. The "system verification and validations" would have involved testing of the manufactured system components and the integrated system based on engineering specifications.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set (in the context of AI/ML) was used. The "ground truth" for the device's design and engineering specifications was established through the design control process, incorporating regulatory requirements and engineering principles. The "ground truth" for validation was adherence to the various listed standards.
Summary Takeaway:
The K101325 submission for the Bausch & Lomb™ Stellaris PC Vision Enhancement System relies on demonstrating substantial equivalence to previously cleared predicate devices and compliance with a comprehensive set of international and domestic performance, safety, and quality standards. It is not a submission based on clinical efficacy data derived from a study comparing patient outcomes or diagnostic performance against a clinical ground truth. The device is an integrated surgical system, and its "performance" is evaluated through rigorous engineering, safety, and functional verification and validation processes against established technical standards, rather than through clinical studies with acceptance criteria for patient outcomes or diagnostic accuracy. The FDA's clearance letter confirms the substantial equivalence determination based on the provided data.
§ 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.