STELLARIS PC VISION ENHANCEMENT SYSTEM

K101325 · Bausch & Lomb, Inc. · HQC · Aug 17, 2010 · Ophthalmic

Device Facts

• Record ID: K101325
• Device Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Applicant: Bausch & Lomb, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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.

Device Story

Stellaris PC Vision Enhancement System is an integrated ophthalmic microsurgical system for anterior and posterior segment procedures. It functions as a next-generation evolution of the Stellaris NGX system, incorporating vacuum-based fluidics and enhanced phaco hand-piece designs. The system supports phacoemulsification, irrigation/aspiration, bipolar diathermy, vitrectomy, viscous fluid injection/removal, and air/fluid exchange. It is intended for use by surgeons in clinical settings. The device utilizes disposable packs and handpieces to maintain sterility and performance. By integrating anterior and posterior surgical capabilities into a single unit, the system aims to improve surgical efficiency, surgeon ergonomics, and fluidic control. Clinical decision-making is supported by the system's precise control over surgical parameters during cataract and vitreo-retinal procedures.

Clinical Evidence

No clinical data. The device is a next-generation evolution of the previously cleared Stellaris NGX system, utilizing established surgical tools and procedures. Substantial equivalence is supported by bench testing, system verification, and validation of functional requirements against international standards (IEC 60601 series, ISO 10993, etc.).

Technological Characteristics

Integrated ophthalmic microsurgical system. Features vacuum-based fluidics, phacoemulsification hand-piece, and modules for endoillumination, viscous fluid injection/extraction, and high-speed vitrectomy. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (high-frequency surgical equipment), and ISO 10993 (biocompatibility). Sterile disposable packs use Tyvek packaging. Connectivity includes radio frequency capabilities (FCC Part 15, EN 300 328).

Indications for Use

Indicated for patients requiring cataract emulsification and removal, or anterior and posterior segment vitrectomy. Designed for use in both anterior and posterior segment surgeries.

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™ Stellaris® NGX Microsurgical System (K063331)
• Bausch & Lomb™ Premiere II Millennium® Microsurgical System (K961310)
• Bausch & Lomb™ Stellaris® NGX System (K082473)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k): k101325

Image /page/0/Picture/1 description: The image shows the logo for Bausch & Lomb. The text "Bausch&Lomb" is written in a bold, sans-serif font. There is a thick, black line above the text, which is angled slightly.

# 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 Street<br>Rochester, NY 14609 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ned Luce |
| | Director, Global Regulatory Affairs |
| | Bausch & Lomb, Inc. |
| | 1400 North Goodman Street |
| | Rochester, NY 14609<br>[phone] |
| 1. Identification of device | |
| Common Name: | ophthalmic surgical system for cataract and vitreo-retinal<br>surgery |
| Trade Name: | Bausch & Lomb™ Stellaris PC Vision Enhancement<br>System |
| Classification: | Class II ophthalmic microsurgical system including:<br>-Phacofragmentation system (21 CFR 886.4670<br>-Vitreous Aspirating and Cutting Device (21 CFR<br>886.4150 |
| Device classification:<br>Pro Code: | Class II (21 CFR 886.4670 and 21 CFR 886.4150)<br>HQC, HQE |
| | |

Bausch & Lomb, Inc.

#### 2. Description of device

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.

1

{1}------------------------------------------------

#### 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®<br>NGX Microsurgical System |
| K961310 | 6/27/1996 | Bausch & Lomb™ Premiere II<br>Millennium® Microsurgical System |
| K082473 | 1/9/2009 | Bausch & Lomb™ Stellaris®<br>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 Equipment<br>Part 1: General Requirements for Safety; (Amd.1-1991) (CENELEC EN<br>60601-1:1990) (Amd. 2-1995(Corrigendum-1995) - Also includes<br>requirements for enclosures covered in IEC 60529 | Ed: 2 | 1998/12/01 |
| 2. | UL 60601-1 UL Standard for Safety Medical Electrical Equipment<br>Part 1: General Requirements for Safety; Includes CSA C22.2 NO. 601.1 | Edition<br>1 | 2003/04/25 |
| 3. | IEC 60601-1-1:2000 Medical Electrical Equipment<br>Part 1: General Requirements for Safety - Collateral Standard: Safety<br>requirements for medical electrical systems | - | 2000/12/01 |
| # | Document Title | Version | Date |
| 4. | EN60601-1-2:2001 Medical Electrical Equipment<br>Part 1: General Requirements for Safety<br>2. Collateral Standard: Electromagnetic Compatibility - Requirements and<br>tests, including Amendment A1:2006 | - | 2004/11/01 |
| 5. | IEC 60601-2-2<br>Medical Electrical Equipment<br>Part 2-2: Particular requirements for the safety of high frequency surgical<br>equipment | - | 2006/0701 |
| 6. | FCC Part 15 Part B and Part C<br>Radio Frequency Devices | - | Nov 5, 2004 |
| 7. | FCC Supplement C<br>Evaluating Compliance with FCC Guidelines for Human Exposure to<br>Radiofrequency Electromagnetic Fields | 01-01 | June 29, 2001 |
| 8. | FCC OET Bulletin 65<br>Evaluating Compliance with FCC Guidelines for Human Exposure to<br>Radiofrequency Electromagnetic Fields | 97-01 | Aug 1997 |
| 9. | EN 300 328<br>Electromagnetic compatibility<br>and Radio spectrum Matters (ERM);<br>Wideband transmission systems;<br>Data transmission equipment operating<br>in the 2,4 GHz ISM band and<br>using wide band modulation techniques;<br>Harmonized EN covering essential requirements<br>under article 3.2 of the R&TTE Directive | 1.5.1 | 2004-08 |
| 10. | EN 300 328-1<br>Electromagnetic compatibility<br>and Radio spectrum Matters (ERM);<br>Wideband Transmission systems;<br>Data transmission equipment operating<br>in the 2,4 GHz ISM band and using spread spectrum modulation techniques;<br>Part 1: Technical characteristics and test conditions | 1.3.1 | 2001-12 |
| 11. | EN 300 328-2<br>Electromagnetic compatibility<br>and Radio spectrum Matters (ERM);<br>Wideband Transmission systems;<br>Data transmission equipment operating<br>in the 2,4 GHz ISM band and<br>using spread spectrum modulation techniques;<br>Part 2: Harmonized EN covering essential requirements under article 3.2 of<br>the R&TTE Directive | 1.2.1 | 2001-12 |
| 12. | ARIB STD-T66 (Japan)<br>Radio Equipment for Second-generation Low-power Data Communications<br>Systems Radio Stations" and "Wireless LAN Systems' Equipment | 2.1 | March 2003 |
| # | Document Title | Version | Date |
| 13. | ISO 15004-2:2007<br>Ophthalmic Instruments Fundamental Requirements and Test Methods Part<br>2: Light Hazard Protection | 2 | 12/17/2007 |
| Transportation Standards | | | |
| # | Document Title | Version | Date |
| 14. | ISTA Schedule 3H "Products or Packaged-Products in Mechanically Handled<br>Bulk Transport Containers" for the completed system . | 2005 | 6/2005 |
| 15. | Service Modules: ISTA Project 3A, "Packaged-Products for Parcel Delivery<br>System Shipment, 150lbs. or Less (standard, small, flat or elongated)" | 2006 | 5/2006 |
| 16. | Disposable Packs: ASTM D4169 Standard Practice for Performance Testing<br>of Shipping Containers and Systems | Ed:08 | 08/01/2008 |
| Biocompatibility Standards | | | |
| # | Document Title | Version | Date |
| 17. | ISO 10993:2003 Biological Evaluation of Medical Devices-<br>Evaluation and Testing | 2003 | 09/08/2009 |
| 18. | ISO 10993-5:2009 Biological Evaluation of Medical Devices- Tests for in-vitro<br>cytotoxicity | 2009 | 09/08/2009 |
| 19. | ISO 10993-10:2002 Biological Evaluation of Medical Devices- Tests for<br>Irritation and Delayed Type hypersensitivity | 2002 | 09/08/2009 |

# Non Clinical Testing for Performance Data (Standards Based)

{2}------------------------------------------------

{3}------------------------------------------------

## 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.

{4}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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

{5}------------------------------------------------

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 [phone] or [phone] 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

{6}------------------------------------------------

# 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)

X

Prescription Use

OR Over-the -counter-use

signature

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________