The Bausch & Lomb™ NGX Microsurgical System device is intended for the emulsification and removal of cataracts, anterior segment vitrectorny. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.

Device Description

The Bausch & Lomb NGX Microsurgical System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrectomy. The NGX system is the next generation Millennium phacoemulsification system. The new system is based on the technology and the performance of the existing Millennium system and is designed to improve surgical efficiency, surgeon ergonomics, more reliable control of fluidics, which will help IOP control, better data collection capability, and improved aesthetics. The system incorporates both vacuum and flow-based fluidics system (peristaltic pump) to meet current and future needs of anterior and posterior procedures. This enhances the ability to perform as one combined 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

This document describes the Bausch & Lomb NGX Microsurgical System, an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgeries, including phacofragmentation, vitreous aspirating, and cutting.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision, flow rates, vacuum levels) with corresponding target values. Instead, it states a general acceptance criterion related to compliance with standards and functional requirements.

Acceptance Criterion	Reported Device Performance
System manufactured in compliance with FDA and ISO quality systems and device-related international, domestic, and industry standards and requirements.	The NGX System "will be manufactured in compliance with FDA and ISO quality systems and device related international, domestic, and industry standards and requirements."
Functional requirements and system specifications met prior to commercial release and distribution.	"System verification and validation will demonstrate that the functional requirements and system specifications will have been met prior to commercial release and distribution."

2. Sample Size and Data Provenance

The submission primarily focuses on non-clinical testing against various standards rather than clinical studies with patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the traditional sense of a clinical performance study involving patient data.

The "test set" in this context refers to the device itself and its components undergoing engineering and safety tests against various standards. No patient data or clinical samples were used for performance evaluation in this specific submission.

3. Number of Experts and Qualifications for Ground Truth

Given that clinical data and patient samples were not used for performance evaluation, the concept of "ground truth established by experts" for a test set is not applicable. The ground truth for the non-clinical tests would be the specifications and requirements of the various international and domestic standards listed.

4. Adjudication Method

Since no clinical studies with human readers or assessments of a test set are reported, an adjudication method for such a test set is not applicable.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The device is a surgical system, not an AI diagnostic tool, so such a study comparing human readers with and without AI assistance is not relevant to its premarket notification.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The Bausch & Lomb NGX Microsurgical System is a physical surgical device, not an algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The system is designed for use by surgeons.

7. Type of Ground Truth Used

The primary ground truth for the performance evaluation in this submission is the compliance with established international, domestic, and industry standards and requirements for medical devices, electrical safety, biocompatibility, packaging, and software. This is demonstrated through "System verification and validation" against these standards.

8. Sample Size for the Training Set

Since this submission concerns a physical microsurgical system and not a machine learning algorithm, the concept of a "training set" and its sample size is not applicable.

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

As there is no training set for a machine learning algorithm, this question is not applicable.

Summary of Device Performance Study:

The primary study type reported is non-clinical testing for performance data (standards-based). The device's performance is demonstrated through its compliance with a comprehensive list of international and domestic standards (e.g., IEC, ISO, ASTM, UL, MIL-STD, EN). These standards cover aspects such as electrical safety, electromagnetic compatibility, biocompatibility, sterilization, packaging, and software development. The submission states that "System verification and validation will demonstrate that the functional requirements and system specifications will have been met prior to commercial release and distribution."

Clinical Data:

The submission explicitly states that "Clinical investigations were deemed as not necessary for the planned marketing of this system." This decision is based on the fact that the NGX Microsurgical System is considered "the next generation of the Millennium Microsurgical System," implying substantial equivalence to a predicate device with extensive clinical and surgical use.

Summary

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K063331

Image /page/0/Picture/1 description: The image shows the logo for Bausch & Lomb. The logo consists of the company name in a bold, sans-serif font. Above the name is a black graphic element that appears to be a stylized representation of light or optics, possibly alluding to the company's focus on eye care and vision products. The text is clear and legible, indicating a professional and established brand identity.

510(k) Summary Statement Bausch & Lomb NGX Microsurgical System

Applicant's Name and Address

DEC 1 9 2006

Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609

Lisa Graney Contact Person Manager Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 (585) 338-6612 1. Identification of device ophthalmic surgical system for cataract and vitreo-retinal Common Name: surgerv Bausch & Lomb™ NGX Microsurgical System Trade Name: Class II ophthalmic microsurgical system including: Classification: -Phacofragmentation system (21 CFR 886.4670 - Vitreous Aspirating and Cutting Device (21 CFR 886.4150

Class II (21 CFR 886.4670 and 21 CFR 886.4150) HQC, HQE

2. Description of device

Device classification:

Pro Code:

The NGX system is the next generation Millennium phacoemulsification system. The new system is based on the technology and the performance of the existing Millennium system and is designed to improve surgical efficiency, surgeon ergonomics, more reliable control of fluidics, which will help IOP control, better data collection capability, and improved aesthetics.

The system incorporates both vacuum and flow-based fluidics system (peristaltic pump) to meet current and future needs of anterior and posterior procedures. This enhances the ability to perform as one combined 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™ NGX Microsurgical System device is intended for the emulsification and The Badoon and posterior segment vitrectorny. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, 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
K961310	6/27/1996	Bausch & Lomb Premiere IIMillennium MicrosurgicalSystem
K060366	4/7/2006	AMO Ophthalmic SurgicalSystem
K952213	8/9/1995	Alcon 2000 LegacyMicrosurgical System
K021566	7/2/2002	Alcon Infiniti MicrosurgicalSystem

5. Technological Characteristics

The B&L NGX Microsurgical System utilizes the same technology as the Millennium System but with ergonomic, aesthetics, and reliability upgrades to the phaco hand-piece and system. The base unit contains all of the modules, however, the module area is not visible to the user. The fluidics systems for the NGX System are comprised of the same technology as the Millennium but have been upgraded for reliability and manufacturability.

Perfomance Data: 6.

The NGX 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 validation will demonstrate that the functional requirements and system specifications will have been met prior to commercial release and distribution.

Non Clinical Testing for Performance Data (Standards Based)

Document Title	Version	Date
IEC 60601-1Medical Electrical EquipmentPart 1: General Requirements for Safety, including AmendmentsA1:1993, A11:1993, A12:1993, A2:1995and A13:1996	SecondEdition	October1997
IEC 60601-1-1:2000Medical Electrical EquipmentPart 1: General Requirements for Safety- Collateral Standard:Safety requirements for medical electrical systems	-	December2000
IEC 60601-1-2:2000 Medical Electrical EquipmentPart 1-2: General Requirements for SafetyCollateral Standard: Electromagnetic Compatibility - Requirementsand tests	Edition 2.1	November2004
Document Title	Version	Date
IEC 60601-2-2 : 1998Medical Electrical EquipmentPart 2-2: Particular requirements for the safety of high frequencysurgical equipment	-	September1998
IEC 61847 Ultrasonics - Surgical systems - Measurement anddeclaration of the basic output characteristics	First edition	1998-01
UL-746C UL Standard for Safety Polymeric Materials - Use inElectrical Equipment Evaluations	SixthEdition	9/10/2004
IEC 60529Degrees of protection provided by enclosures (IP code)	2.1	2001-02
ASTM F1980-02 Standard Guide for Accelerated Aging of SterileMedical Device Packages	-	1/10/2002
ASTM D 4169-05 Standard Practice for Performance Testing ofShipping Containers and Systems	-	10/01/2005
EN ISO 10993:2003 Biological Evaluation of Medical Devices -Parts 1, 5, 10, 11	-	08/01/2003
ISO 11737-1:2006 (E) Sterilization of medical devices -Microbiological methods -Part 1: Determination of a population ofmicroorganisms on products	SecondEdition	2006-04-01
ISO 11607-1:2003 (E) Packaging for terminally sterilized medicaldevices	SecondEdition	02/15/2003
ANSI/AAMI/ISO 11137:1994 Sterilization of Health care Products -Requirements for validation and routine control - Radiationsterilization	-	1994
EN 552:1994 Sterilization of medical devices - Validation androutine control of sterilization by irradiation	-	01/01/1994
EN ISO 17664:2004 Sterilization of medical devices -Information tobe provided by the manufacturer for the processing of resterilizablemedical devices	FirstEdition	2004-03-01
ISO/TS 15843 Sterilization of Health care Products - Radiationsterilization - Product families and sampling plans for verificationdose experiments and sterilization dose audits, and frequency ofsterilization dose audits.	-	02/21/2001
MIL-STD-1472F (IV Pole)	F	August1999
NAVMAT-P-9492 "Random Vibration"	-	May 1979
MIL-STD-202G, Method 213B, Test Condition C"MechanicalShock"	G	Feb.8,2002
MIL-STD-810F, Method 514.4 "Transportation Vibration"	F	Jan 1,2000
NSTA Schedule 2A	-
ISTA Project 2A	Versiondate June,1999	June 29,2000
IEC 60601-1-4:1996/A1:1999Medical Electrical EquipmentPart 1: General requirements for safety-4. Collateral Standard: Programmable electrical medical systems.	Edition 1.1	April 2000
Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices	-	05/11/2005
Document Title	Version	Date
IEEE 1012, Standard for Software Verification and Validation	-	12/08/2004
EN ISO 13485:2003 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes	-	July 31,2003
EN 980:2003 Graphical Symbols for Use in the Labeling of MedicalDevices	-	April 1,2003
ISO 15223:2004 Medical devices Symbols to be used with medicaldevice labels, labeling and information to be supplied-First Edition:Amendment 1: 8/01/2002; Amendment 2: 02/15/2004	-	04/15/2000
EN 1041:1998 Information Supplied By The Manufacturer withMedical Devices	-
IEC 60417 DB Graphical Symbols for Use on Equipment - Part 1:Overview and Application-(DATABASE SNAPSHOTS:07/03/2006)	Thirdedition	05/21/2006
EN ISO14971:2000/A1:2003 Medical Devices - Application of RiskManagement to Medical Devices-ISO 14971:2000 + A1:2003;Amendment A1: March 2003	-	12/01/2000
93/42/EEC, European Union Medical Device Directive	-	July 1993
2002/96/EC European Union Waste Electrical and ElectronicEquipment (WEEE)	-	January2003
2002/95/EC European Union Directive on the restriction of the use ofcertain hazardous substances in electrical and electronic equipment	-	January2003

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7. Packaging

The B&L NGX Microsurgical System is housed in a dedicated single free standing unit in which all major components are enclosed as an integrated system. Sterile accessory surgical mindial an packaged separately in sealed Tyvek pouches.

8. Clinical data:

The B&L NGX Microsurgical System is the next generation of the Millennium Microsurgical System and as such provides for procedures and use of tools that have extensive clinical and surgical use. Clinical investigations were deemed as not nevessary for the planned marketing of this system.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bauch & Lomb, Inc. c/o Ms. Lisa Graney 1400 North Goodman Street Rochester. NY 14609

DEC 1 9 2006

Re: K063331

Trade/Device Name: Bausch & Lomb™ NGX Microsurgical System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HQC, HQE Dated: November 3, 2006 Received: November 6, 2006

Dear Ms. Graney:

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 such 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); 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.

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Page 2 - Ms. Lisa Graney

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychler-Siwd

Malvina B. Evdelman, 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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Bausch & Lomb, Inc.

SECTION 4

INDICATION FOR USE STATEMENT

SECTION 4 : INDICATIONS FOR USE STATEMENT

K063333 510(k) Number (if known):

Bausch & Lomb™ NGX Microsurgical System Device Name:

Indication for Use

(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

Denis L. McCarthy

(Division Sign-off)
Division of Ophthalmic Devices

510(k) Numl

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.