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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k): K101325

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510(k) Summary Statement Bausch & Lomb Stellaris PC Vision Enhancement System

AUG 1 7 2010

July 26,2010

Applicant's Name and Address

	1400 North Goodman StreetRochester, NY 14609
Contact Person	Ned Luce
	Director, Global Regulatory Affairs
	Bausch & Lomb, Inc.
	1400 North Goodman Street
	Rochester, NY 14609(585) 338-6368
1. Identification of device
Common Name:	ophthalmic surgical system for cataract and vitreo-retinalsurgery
Trade Name:	Bausch & Lomb™ Stellaris PC Vision EnhancementSystem
Classification:	Class II ophthalmic microsurgical system including:-Phacofragmentation system (21 CFR 886.4670-Vitreous Aspirating and Cutting Device (21 CFR886.4150
Device classification:Pro Code:	Class II (21 CFR 886.4670 and 21 CFR 886.4150)HQC, HQE

Bausch & Lomb, Inc.

2. Description of device

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.

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3. Intended use

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 phacoemulsification (coaxial or bimanual), irrigation, bipolar diathermy, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb™ disposable packs and handpieces designated for use with the system.

4. Substantial Equivalence

510(k)	Clearance Date	Device Description
K063331	12/14/2006	Bausch & Lomb™ Stellaris®NGX Microsurgical System
K961310	6/27/1996	Bausch & Lomb™ Premiere IIMillennium® Microsurgical System
K082473	1/9/2009	Bausch & Lomb™ Stellaris®NGX System

5. Technological Characteristics

The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System utilizes similar technology as the Stellaris® NGX Microsurgical System with similar ergonomic, aesthetics, and reliability upgrades. The base unit contains all of the modules, however, the module area is not visible to the user. The fluidics systems for the Stellaris® PC Vision Enhancement System are comprised of similar vacuum technology as the Premiere II Millennium® Microsurgical System. New modules for the Stellaris® PC™ Vision Enhancement System have been added or enhanced to provide posterior surgical functionalities such as endoillumination, viscous fluid injection/extraction, fluid/air exchange and high speed vitrectomy ..

6. Perfomance Data:

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. 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. This submission contains all testing data and validation summaries supporting system function.

#	Document Title	Version	Date
1.	IEC 60601-1 Medical Electrical EquipmentPart 1: General Requirements for Safety; (Amd.1-1991) (CENELEC EN60601-1:1990) (Amd. 2-1995(Corrigendum-1995) - Also includesrequirements for enclosures covered in IEC 60529	Ed: 2	1998/12/01
2.	UL 60601-1 UL Standard for Safety Medical Electrical EquipmentPart 1: General Requirements for Safety; Includes CSA C22.2 NO. 601.1	Edition1	2003/04/25
3.	IEC 60601-1-1:2000 Medical Electrical EquipmentPart 1: General Requirements for Safety - Collateral Standard: Safetyrequirements for medical electrical systems	-	2000/12/01
#	Document Title	Version	Date
4.	EN60601-1-2:2001 Medical Electrical EquipmentPart 1: General Requirements for Safety2. Collateral Standard: Electromagnetic Compatibility - Requirements andtests, including Amendment A1:2006	-	2004/11/01
5.	IEC 60601-2-2Medical Electrical EquipmentPart 2-2: Particular requirements for the safety of high frequency surgicalequipment	-	2006/0701
6.	FCC Part 15 Part B and Part CRadio Frequency Devices	-	Nov 5, 2004
7.	FCC Supplement CEvaluating Compliance with FCC Guidelines for Human Exposure toRadiofrequency Electromagnetic Fields	01-01	June 29, 2001
8.	FCC OET Bulletin 65Evaluating Compliance with FCC Guidelines for Human Exposure toRadiofrequency Electromagnetic Fields	97-01	Aug 1997
9.	EN 300 328Electromagnetic compatibilityand Radio spectrum Matters (ERM);Wideband transmission systems;Data transmission equipment operatingin the 2,4 GHz ISM band andusing wide band modulation techniques;Harmonized EN covering essential requirementsunder article 3.2 of the R&TTE Directive	1.5.1	2004-08
10.	EN 300 328-1Electromagnetic compatibilityand Radio spectrum Matters (ERM);Wideband Transmission systems;Data transmission equipment operatingin the 2,4 GHz ISM band and using spread spectrum modulation techniques;Part 1: Technical characteristics and test conditions	1.3.1	2001-12
11.	EN 300 328-2Electromagnetic compatibilityand Radio spectrum Matters (ERM);Wideband Transmission systems;Data transmission equipment operatingin the 2,4 GHz ISM band andusing spread spectrum modulation techniques;Part 2: Harmonized EN covering essential requirements under article 3.2 ofthe R&TTE Directive	1.2.1	2001-12
12.	ARIB STD-T66 (Japan)Radio Equipment for Second-generation Low-power Data CommunicationsSystems Radio Stations" and "Wireless LAN Systems' Equipment	2.1	March 2003
#	Document Title	Version	Date
13.	ISO 15004-2:2007Ophthalmic Instruments Fundamental Requirements and Test Methods Part2: Light Hazard Protection	2	12/17/2007
Transportation Standards
#	Document Title	Version	Date
14.	ISTA Schedule 3H "Products or Packaged-Products in Mechanically HandledBulk Transport Containers" for the completed system .	2005	6/2005
15.	Service Modules: ISTA Project 3A, "Packaged-Products for Parcel DeliverySystem Shipment, 150lbs. or Less (standard, small, flat or elongated)"	2006	5/2006
16.	Disposable Packs: ASTM D4169 Standard Practice for Performance Testingof Shipping Containers and Systems	Ed:08	08/01/2008
Biocompatibility Standards
#	Document Title	Version	Date
17.	ISO 10993:2003 Biological Evaluation of Medical Devices-Evaluation and Testing	2003	09/08/2009
18.	ISO 10993-5:2009 Biological Evaluation of Medical Devices- Tests for in-vitrocytotoxicity	2009	09/08/2009
19.	ISO 10993-10:2002 Biological Evaluation of Medical Devices- Tests forIrritation and Delayed Type hypersensitivity	2002	09/08/2009

Non Clinical Testing for Performance Data (Standards Based)

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7. Packaging

The Bausch &Lomb™ Stellaris® PC™ Vision Enhancement System is housed in a dedicated single free standing unit in which all major components are enclosed as an integrated system. Sterile accessory surgical packs are packaged separately in sealed Tyvek packaging.

8. Clinical data:

The Bausch &Lomb™ Stellaris® PC™ Vision Enhancement System is the next generation of the Stellaris® NGX Microsurgical System and as such provides for procedures and use of tools that have extensive clinical and surgical use. Modules for posterior surgical procedures have predicates from the Bausch & Lomb™ Premiere II® Millennium Microsurgical System with modifications and upgrades. Clinical investigations were deemed not necessary for the planned marketing of this system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Bausch & Lomb, Inc. c/o Mr. Daniel W. Lehtonen Senior Staff Engineer Intertek Testing Services NA, Inc. 2307 E. Aurora Rd. Unit B7 Twinsburg, OH 44087

AUG 1 7 2010

Re: K101325

Trade/Device Name: Stellaris PC Vision Enhancement System Regulation Number: 21 CFR 886,4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Codes: HOC, HOE Dated: July 30, 2010 Received: August 2, 2010

Dear Mr. Lehtonen:

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.

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 (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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm:

ia.2971/MedicalDevices/ResourceController.Tour/included/default.htm

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 : INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Bausch & Lomb ™ Stellaris PC Vision Enhancement System

Indication for Use

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-the -counter-use

signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.