STELLARIS VISION ENHANCEMENT SYSTEM

K133242 · Bausch & Lomb · HQC · Feb 14, 2014 · Ophthalmic

Device Facts

• Record ID: K133242
• Device Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Applicant: Bausch & Lomb
• Product Code: HQC · Ophthalmic
• Decision Date: Feb 14, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bausch & Lomb Stellaris® 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, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, 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 Vision Enhancement System is an integrated ophthalmic microsurgical platform for cataract and vitreo-retinal surgery. System performs phacoemulsification, irrigation/aspiration, coagulation, viscous fluid injection/removal, and air/fluid exchange. Operated by surgeons in clinical settings via LCD touch screen and footswitch. Device utilizes disposable packs and handpieces to manage fluidics and tissue removal. Output provides surgeons with precise control over surgical parameters to facilitate cataract removal and vitrectomy, improving surgical efficiency and patient outcomes. This 510(k) covers software revisions and minor hardware updates to the existing platform.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1 (General Safety) and IEC 60601-1-2 (EMC) standards confirmed. Software changes verified and validated per EN62304.

Technological Characteristics

Integrated ophthalmic microsurgical system. Features LCD touch screen interface and footswitch activation. Electrical requirements: 90-130 VAC or 200-240 VAC, 50/60 Hz. Utilizes proprietary disposable packs and handpieces. Software developed in compliance with EN62304.

Indications for Use

Indicated for patients requiring cataract emulsification and removal, or anterior and posterior segment vitrectomy. Used in ophthalmic surgical settings.

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

• Stellaris® Microsurgical System (K082473)
• Stellaris® Microsurgical System (K063331)
• Stellaris® PC Vision Enhancement System (K101325)

Submission Summary (Full Text)

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K133242

## BAUSCH + LOMB

See better. Live better.

Section 8-510(k) Summary

### 1. General Information

| Submitter: | Contact Person: |
|-----------------------------------------------|-----------------------------|
| Bausch & Lomb Inc. | Timothy W Capehart |
| 3365 Tree Court Industrial Blvd. | 636-226-3017 (Office) |
| St. Louis MO 63122 | 636-226-3245 (Fax) |
| General Telephone: [phone] | [e-mail] |
| Summary Preparation Date:<br>October 17, 2013 | |

2. Names

| Device Name(s): | Stellaris® 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 |
| Product Codes: | HQC, HQE |

### 3. Predicate Devices

- K082473 Stellaris® Microsurgical System .
- K063331 Stellaris ® Microsurgical System .
- K 101325 -- Stellaris ® PC Vision Enhancement System .

#### 4. Product Description

The Bausch & Lomb Stellaris® Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrectomy.

The system is based on the technology and the performance of the existing Stellaris® system, and this special 510(k) incorporates software revisions and minor hardware changes. There is no change in the intended use or indications for use of the system.

### 5. Indications for Use

### Indications for Use (same as K082473):

The Bausch & Lomb Stellaris® 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, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.

FEB 1 4 2014

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## BAUSCH + LOMB

See better. Live better.

#### 6. Summary of Technological Characteristics

The technological characteristics of the Stellaris Microsurgical system are substantially equivalent to those of the predicate device.

| Characteristic | Stellaris® Vision Enhancement System | K082473/K063331<br>Stellaris® Microsurgical System |
|----------------------------|-----------------------------------------------|----------------------------------------------------|
| Product Code | HQC, HQE | HQC, HQE |
| Regulation | 21 CFR 886.4670, 21 CFR 886.4150 | 21 CFR 886.4670, 21 CFR 886.4150 |
| Intended Use | Intended for use in ophthalmic<br>procedures | Intended for use in ophthalmic procedures |
| Indications for Use | Exactly the same as K082473 | See K082473 |
| User interface | LCD touch screen | LCD touch screen |
| Device<br>activation | footswitch | footswitch |
| Electrical<br>requirements | 90-130 VAC, 50/60 Hz<br>200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz<br>200-240 VAC, 50/60 Hz |

#### 7. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Stellaris® Vision Enhancement System is substantially equivalent to the predicate device and is safe and effective for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy.

#### Brief Summary of Nonclinical Tests and Results 8.

Safety tests of the Stellaris Vision Enhancement System have demonstrated its compliance with applicable requirements of the following standards:

- IEC 60601-1: Edition 3: 2007 Medical Electrical Equipment Part 1: General Requirements for . Safety
- . IEC 60601-1-2: Edition 3:2007-03 Medical Electrical Equipment - Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

Software changes were verified and validated in accordance with the Bausch & Lomb software quality procedures which comply with EN62304.

The Stellaris® 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.

### 9. Conclusion

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

February 14, 2014

Bausch & Lomb, Inc. % Mr. Timothy W. Capehart Manager of Regulatory Affairs, Equipment and Instruments 3365 Tree Court Industrial Blvd. St. Louis, MO 63122

Re: K133242

Trade/Device Name: Stellaris® Vision Enhancement System Regulation Number: 21 CFR 886.4670, 21 CFR886.4150 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Codes: HQC, HQE Dated: December 13, 2013 Received: December 16, 2013

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Igdustry/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/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/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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#### Indications for Use Statement

510(k) Number (if known): K133242

Device Name: Stellaris® Vision Enhancement System

Indications for Use :

The Bausch & Lomb Stellaris 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, 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.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Bradley S. Cunningham -S 2014.02.13 21:31:16 -05'00'