The Bausch & Lomb StellarisPC Vision Enhancement System is intended for the emulsification and removal of catarior and posterior segment virectory. The system is designed for use in both anterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimigation, bipolar coagulation, virectory, viscous fluid injection/removal and sir/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laster trabeculaplasty.

Device Description

The Bausch + Lomb Stellaris PC Vision Enhancement System is 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, this model includes an optional 532nm laser module for photocoagulation.

The system is based on the technology and the performance of the existing Stellaris PC Vision Enhancement System, and this traditional 510(k) incorporates software revisions, a hardware revision to the power supply, and the additional of an optional laser photocoagulation module.

The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency.

AI/ML Overview

This submission describes the Bausch + Lomb Stellaris® PC Vision Enhancement System, an integrated ophthalmic microsurgical system. The submission focuses on demonstrating the substantial equivalence of the updated device to previously cleared predicate devices, rather than establishing de novo acceptance criteria for a novel device. Therefore, the information provided does not align with a typical AI/ML device submission that would include acceptance criteria and a study proving those criteria were met through performance metrics like sensitivity, specificity, etc.

However, based on the provided documents, I can extract the relevant information pertaining to the "acceptance criteria" (understood here as compliance with standards and functional requirements for safety and performance) and the "study" (referring to the nonclinical tests conducted) that "proves" (demonstrates compliance) the device meets these.

Here’s an interpretation of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Bausch + Lomb Stellaris® PC Vision Enhancement System are primarily met through compliance with established electrical, safety, usability, and software standards, as well as successful functional, simulated use, environmental, and transport testing. The "reported device performance" is essentially that the device passed all these tests and demonstrated substantial equivalence to predicate devices, thus fulfilling its intended use.

Acceptance Criterion Type	Specific Standard / Test	Reported Device Performance
Electrical Safety & Performance	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 tests with no exceptions.
	IEC 80601-2-58:2008 (Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices)	Passed all tests with no exceptions.
	IEC 60601-2-2:2009 (Particular requirements for basic safety and essential performance of high frequency surgical equipment)	Passed all tests with no exceptions.
	IEC 60601-2-22:2007 (Particular requirements for the safety of diagnostic and therapeutic laser equipment)	Passed all tests with no exceptions.
	IEC 60825-1:2007 (Safety of laser products - Equipment classification and requirements)	Passed all tests with no exceptions.
Usability	IEC 60601-1-6:2010 (Usability)	Passed all tests with no exceptions.
	IEC 62366:2007 (Application of usability engineering to medical devices)	Passed all tests with no exceptions.
Software Quality	EN ISO IEC 62304:2006 (Medical device software -- Software life cycle processes)	Software changes verified and validated in accordance with Bausch & Lomb software quality procedures. Passed all tests with no exceptions.
Functional & Environmental	Functional, simulated use, environmental, and transport testing	Passed all tests with no exceptions, demonstrating functional requirements met.
Substantial Equivalence	Comparison to predicate devices (K101325, K022760, K071687) for indications for use, design, and functional features.	Determined to be substantially equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This submission is for a traditional surgical system, not an AI/ML device in the modern sense. Therefore, the concept of a "test set" for performance evaluation in terms of AI model predictions (e.g., images for classification or detection) is not applicable. The "tests" performed were nonclinical engineering and functional tests on representative units of the device.

Sample Size for Test Set: "Representative units" of the Stellaris PC Vision Enhancement System were used for functional, simulated use, environmental, and transport testing. Specific numbers are not provided in this summary but would be detailed in the full test reports.
Data Provenance: Not applicable in the context of an AI/ML device where "data provenance" typically refers to the origin of training or test data (e.g., patient demographics, clinical sites, geographical distribution). The testing here relates to the engineering performance and safety of the physical device and its software.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This request is not directly applicable to the type of device and submission.

Number of Experts: Not applicable. Ground truth, in the context of this device, refers to the established standards and specifications that the device must meet, verified through engineering and functional tests.
Qualifications of Experts: The "experts" involved would be the Bausch + Lomb engineers and testers responsible for performing and evaluating the nonclinical tests, ensuring compliance with the cited regulatory standards. Their qualifications would be in engineering, quality assurance, and regulatory compliance for medical devices.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable. There was no "test set" requiring expert adjudication in the context of AI/ML evaluation. The evaluation was based on passing predefined engineering and performance metrics against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This type of study is typically used for diagnostic or screening AI/ML devices where reader performance is a key metric. The Stellaris PC Vision Enhancement System is a surgical system, and its evaluation focuses on safety, functional performance, and substantial equivalence, not human reader improvement with AI assistance.
Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only)

Was a standalone study done? No. This device is a surgical system; it does not feature a standalone algorithm that performs a diagnostic or prognostic task without human-in-the-loop performance in the way an AI/ML-based diagnostic device would. Its "performance" is integrated into its function during surgery.

7. Type of Ground Truth Used

The "ground truth" for this submission is implicitly defined by:

International Standards: Compliance with electrical safety (IEC 60601 series), usability (IEC 60601-1-6, IEC 62366), software quality (EN ISO IEC 62304), and laser safety (IEC 60825-1) standards.
Functional Specifications: The device's ability to perform its intended functions (e.g., phacoemulsification, vitrectomy, laser photocoagulation) as designed and specified, verified through functional and simulated use testing.
Predicate Device Performance: The established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use an AI/ML model that would require a "training set" of data in the typical sense. Any software development would follow standard software engineering practices, with internal testing and validation, but not "training" on a dataset for algorithmic prediction.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set was Established: Not applicable. As there is no AI/ML training set in this context, the concept of establishing ground truth for it does not apply.

Summary of Device and Acceptance:

The Bausch + Lomb Stellaris® PC Vision Enhancement System obtained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices (K101325, K022760, K071687). The "acceptance criteria" are the regulatory and engineering standards that the device must meet to ensure safety and effectiveness, and the "study" comprises a series of nonclinical tests (electrical, functional, simulated use, environmental, transport, and software verification/validation) that demonstrated the device's compliance with these standards and its ability to perform its intended functions. The FDA's letter (K133486) confirms this substantial equivalence based on the provided data.

Summary

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BAUSCH + LOMB

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1. General Information

Section 8-510(k) Summary

Submitter:	Contact Person:
Bausch + Lomb Inc.3365 Tree Court Industrial Blvd.St. Louis MO 63122General Telephone: 636-226-3017	Timothy W Capehart636-226-3017 (Office)636-226-3245 (Fax)Timothy.Capehart@bausch.com
Preparation Date: November 6, 2013

Names

Device Name(s):	Stellaris® PC 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

K101325 Stellaris PC Vision Enhancement System, Bausch & Lomb .
K022760 Millenium Microsurgical System, Bausch & Lomb .
K071687 Family of IRIDEX IQ Laser Systems (1Q532, 1Q577, IQ 630-670, 1Q8 10) & . Delivery Device Accessories

4. Product Description

The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency.

5. Indications for Use

The Bausch & Lomb Stellaris PC 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 laser modes are intended for retinal photocoagulation and laser trabeculaplasty.

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Section 8-510(k) Summary

6. Summary of Technological Characteristics

The technological characteristics of the Stellaris PC Vision Enhancement System are substantially equivalent to those of the predicate device.

Characteristic	Subject DeviceStellaris®PC VisionEnhancement System	K101325Stellaris®PC VisionEnhancementSystem	K022760Millennium LaserPhotocoagulatorSystem	K071687Iridex IQLaserFamily
Intended Use	Anterior/Posteriorophthalmic surgery	Anterior/Posteriorophthalmic surgery	Intended for use inophthalmicprocedures	Intended foruse inophthalmicanddermatological procedures(Ophthalmic532nm only)
Indications for Use	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 lasermodes are intended forretinal photocoagulationand laser trabeculaplasty.	The Bausch &LombTM Stellaris®PC VisionEnhancement Systemdevice is intended forthe emulsificationand removal ofcataracts, anteriorand posteriorsegment vitrectomy.The system isdesigned for use inboth anterior andposterior segmentsurgeries. It providescapabilities forphaco fragmentation(coaxial orbimanual),irrigation/aspiration,bipolar diathermy,vitrectomy, viscousfluidinjection/removaland air/fluidexchange operations.Uses only Bausch &Lomb disposablepacks and handpiecesdesignated for usewith the system-	The laser modesare intended forretinalphotocoagulationand lasertrabeculaplasty.Delivery devicesavailable are theEndoprobe forintraocularendolaser surgery,and the LaserIndirectOphthalmoscopePlus (LIO+) fortranspupillary laserdelivery forpatients in thesupine position.	Indicated forretinalphotocoagulation, lasertrabeculoplasty, iridotomy,iridoplastyincluding:• Retinalphotocoagulation (RPC)for thetreatment of> Diabeticretinopathy,including:Nonproliferativeretinopathy- Macularedema-Proliferativeretinopathy> Retinaltears anddetachments> Latticedegeneration> Age-relatedmaculardegeneration(AMD)> Retinopathyof
Characteristic	Subject DeviceStellaris®PC VisionEnhancement System	K101325Stellaris®PC VisionEnhancementSystem	K022760Millennium LaserPhotocoagulatorSystem	K071687Iridex IQLaserFamily
				prematurity> Sub-retinal(choroidal)neovascularization> Central andbranch retinalveinocclusion· Lasertrabeculoplasty, iridotomy, iridoplastyfor thetreatment ofglaucoma,including> Primaryopenangle/Closedangle
Laser capabilities	Yes	No	Yes	Yes
User interface	LCD touch screen	LCD touch screen	NA	LCDtouchscreen
Footswitch	Yes	Yes	Yes	Yes
ElectricalCharacteristics	90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz	90-130 VAC,50/60 Hz200-240 VAC,50/60 Hz	90-130 VAC,50/60 Hz200-240 VAC,50/60 Hz	90-130VAC, 50/60Hz200-240VAC, 50/60Hz

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Section 8 -510(k) Summary

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BAUSCH + LOMB

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7. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Stellaris PC 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 .

8. Brief Summary of Nonclinical Tests and Results

Safety tests of the Stellaris PC 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 requirementsfor basic safety and essential performance
or IEC 60601-1:2012
IEC 80601-2-58:2008	Medical electrical equipment - Part 2-58: Particularrequirements for the basic safety and essential performance oflens removal devices and vitrectomy devices for ophthalmicsurgery
IEC 60601-1-6:2010	Medical electrical equipment. Part 1-6: General requirementsfor basic safety and essential performance. Collateralstandard. Usability
IEC 62366:2007	Medical devices - Application of usability engineering tomedical devices
IEC 60601-2-2:2009	Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essential performance ofhigh 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 therapeutic laserequipment
IEC 60825-1:2007	Safety of laser products - Part 1: Equipment classification andrequirements

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.

The Stellaris PC Vision Enhancement System passed all of the above tests with no exceptions. This testing demonstrates that the functional requirements have been met and that the modified device is equivalent to the predicate device.

Premarket Notification Traditional 510(k) Bausch + Lomb Stellaris®PC Vision Enhancement System

Section 8-510(k) Summary

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Section 8 -- 510(k) Summary

9. Conclusion

The Stellaris®PC Vision Enhancement System shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G109 Silver Spring, MD 20993-0002

March 12, 2014

Bausch + Lomb, Inc. % Mr. Timothy W. Capehart Manger Regulatory Affairs. Equipment and Instruments 3365 Tree Court Industrial Boulevard Saint Louis, MO 63122

Re: K133486

Trade/Device Name: Stellaris PC Vision Enhancement System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system. Regulatory Class: Class II Product Code: HQC, HQE, HQF Dated: February 5, 2014 Received: February 7, 2014

Dear Mr. Capehart:

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.

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Page 2 - Mr. Timothy W. Capehart

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133486

Device Name

Stellaris®PC Vision Enhancement System

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

SE SERVER SELLER SECTION FOR FOR FOR FOR FOR FOR FOR FOR FOR SECTION OF CONSEL Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Rahul K. Ram -S (A 2014.03.11 17:38:33

FORM FDA 3881 (9/13)

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.