BAUSCH & LOMB NGX MICROSURGICAL SYSTEM

K063331 · Bausch & Lomb, Inc. · HQC · Dec 19, 2006 · Ophthalmic

Device Facts

• Record ID: K063331
• Device Name: BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
• Applicant: Bausch & Lomb, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Dec 19, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

The NGX Microsurgical System is an integrated ophthalmic surgical platform for anterior and posterior segment procedures. It functions as the next-generation successor to the Millennium system, incorporating both vacuum and flow-based fluidics (peristaltic pump) for improved IOP control and surgical efficiency. The system utilizes an ultrasound-based phacoemulsification handpiece for lens removal. It is operated by surgeons in a clinical or surgical setting to perform phacoemulsification, irrigation/aspiration, coagulation, vitrectomy, and fluid/air exchange. The system provides data collection capabilities and ergonomic improvements over its predecessor. It is designed to be used exclusively with Bausch & Lomb disposable packs and handpieces. The device assists the surgeon by providing precise control over fluidics and surgical tools, facilitating the removal of cataracts and vitreous tissue, thereby enabling ophthalmic surgical intervention.

Clinical Evidence

No clinical data. The device is an evolution of the existing Millennium Microsurgical System, which has extensive clinical and surgical history. Performance was established through bench testing, verification, and validation against functional requirements and system specifications, including compliance with relevant IEC, ISO, and ASTM standards.

Technological Characteristics

Integrated ophthalmic microsurgical system. Features vacuum and flow-based fluidics (peristaltic pump) and ultrasound phacoemulsification handpiece. System is a single free-standing unit. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 61847 (ultrasonics). Sterilization of accessories via radiation (ISO 11137). Software is a programmable electrical medical system (IEC 60601-1-4).

Indications for Use

Indicated for patients undergoing anterior or posterior segment ophthalmic surgeries, including cataract removal and vitrectomy.

Regulatory Classification

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.

Predicate Devices

• Bausch & Lomb Premiere II Millennium Microsurgical System (K961310)
• AMO Ophthalmic Surgical System (K060366)
• Alcon 2000 Legacy Microsurgical System (K952213)
• Alcon Infiniti Microsurgical System (K021566)

Submission Summary (Full Text)

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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 [phone] 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 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.

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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 II<br>Millennium Microsurgical<br>System |
| K060366 | 4/7/2006 | AMO Ophthalmic Surgical<br>System |
| K952213 | 8/9/1995 | Alcon 2000 Legacy<br>Microsurgical System |
| K021566 | 7/2/2002 | Alcon Infiniti Microsurgical<br>System |

#### 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 60601-1<br>Medical Electrical Equipment<br>Part 1: General Requirements for Safety, including Amendments<br>A1:1993, A11:1993, A12:1993, A2:1995<br>and A13:1996 | Second<br>Edition | October<br>1997 |
| IEC 60601-1-1:2000<br>Medical Electrical Equipment<br>Part 1: General Requirements for Safety- Collateral Standard:<br>Safety requirements for medical electrical systems | - | December<br>2000 |
| IEC 60601-1-2:2000 Medical Electrical Equipment<br>Part 1-2: General Requirements for Safety<br>Collateral Standard: Electromagnetic Compatibility - Requirements<br>and tests | Edition 2.1 | November<br>2004 |
| Document Title | Version | Date |
| IEC 60601-2-2 : 1998<br>Medical Electrical Equipment<br>Part 2-2: Particular requirements for the safety of high frequency<br>surgical equipment | - | September<br>1998 |
| IEC 61847 Ultrasonics - Surgical systems - Measurement and<br>declaration of the basic output characteristics | First edition | 1998-01 |
| UL-746C UL Standard for Safety Polymeric Materials - Use in<br>Electrical Equipment Evaluations | Sixth<br>Edition | 9/10/2004 |
| IEC 60529<br>Degrees of protection provided by enclosures (IP code) | 2.1 | 2001-02 |
| ASTM F1980-02 Standard Guide for Accelerated Aging of Sterile<br>Medical Device Packages | - | 1/10/2002 |
| ASTM D 4169-05 Standard Practice for Performance Testing of<br>Shipping Containers and Systems | - | 10/01/2005 |
| EN ISO 10993:2003 Biological Evaluation of Medical Devices -<br>Parts 1, 5, 10, 11 | - | 08/01/2003 |
| ISO 11737-1:2006 (E) Sterilization of medical devices -<br>Microbiological methods -Part 1: Determination of a population of<br>microorganisms on products | Second<br>Edition | 2006-04-01 |
| ISO 11607-1:2003 (E) Packaging for terminally sterilized medical<br>devices | Second<br>Edition | 02/15/2003 |
| ANSI/AAMI/ISO 11137:1994 Sterilization of Health care Products -<br>Requirements for validation and routine control - Radiation<br>sterilization | - | 1994 |
| EN 552:1994 Sterilization of medical devices - Validation and<br>routine control of sterilization by irradiation | - | 01/01/1994 |
| EN ISO 17664:2004 Sterilization of medical devices -Information to<br>be provided by the manufacturer for the processing of resterilizable<br>medical devices | First<br>Edition | 2004-03-01 |
| ISO/TS 15843 Sterilization of Health care Products - Radiation<br>sterilization - Product families and sampling plans for verification<br>dose experiments and sterilization dose audits, and frequency of<br>sterilization dose audits. | - | 02/21/2001 |
| MIL-STD-1472F (IV Pole) | F | August<br>1999 |
| NAVMAT-P-9492 "Random Vibration" | - | May 1979 |
| MIL-STD-202G, Method 213B, Test Condition C<br>"Mechanical<br>Shock" | G | Feb.8,<br>2002 |
| MIL-STD-810F, Method 514.4 "Transportation Vibration" | F | Jan 1,<br>2000 |
| NSTA Schedule 2A | - | |
| ISTA Project 2A | Version<br>date June,<br>1999 | June 29,<br>2000 |
| IEC 60601-1-4:1996/A1:1999<br>Medical Electrical Equipment<br>Part 1: General requirements for safety-<br>4. Collateral Standard: Programmable electrical medical systems. | Edition 1.1 | April 2000 |
| Guidance for the Content of Premarket Submissions for Software<br>Contained 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<br>- Requirements for Regulatory Purposes | - | July 31,<br>2003 |
| EN 980:2003 Graphical Symbols for Use in the Labeling of Medical<br>Devices | - | April 1,<br>2003 |
| ISO 15223:2004 Medical devices Symbols to be used with medical<br>device labels, labeling and information to be supplied-First Edition:<br>Amendment 1: 8/01/2002; Amendment 2: 02/15/2004 | - | 04/15/2000 |
| EN 1041:1998 Information Supplied By The Manufacturer with<br>Medical Devices | - | |
| IEC 60417 DB Graphical Symbols for Use on Equipment - Part 1:<br>Overview and Application-(DATABASE SNAPSHOTS:07/03/2006) | Third<br>edition | 05/21/2006 |
| EN ISO14971:2000/A1:2003 Medical Devices - Application of Risk<br>Management to Medical Devices-ISO 14971:2000 + A1:2003;<br>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 Electronic<br>Equipment (WEEE) | - | January<br>2003 |
| 2002/95/EC European Union Directive on the restriction of the use of<br>certain hazardous substances in electrical and electronic equipment | - | January<br>2003 |

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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 [phone]. 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 [phone] or [phone] 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

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.

#### (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