Who is the manufacturer of Stellaris Elite vision enhancement system?

Bausch+Lomb filed the 510(k) submission for Stellaris Elite vision enhancement system (K170052).

What is the FDA product code for Stellaris Elite vision enhancement system?

HQC. It is classified under 21 CFR 886.4670 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for Stellaris Elite vision enhancement system?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Stellaris Elite vision enhancement system?

Stellaris PC Vision Enhancement System (K133486); Stellaris Vision Enhancement System (K133242).

Who can help prepare an FDA 510(k) submission like Stellaris Elite vision enhancement system?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Stellaris Elite vision enhancement system

K170052 · Bausch+Lomb · HQC · Apr 19, 2017 · Ophthalmic

Device Facts

Record ID	K170052
Device Name	Stellaris Elite vision enhancement system
Applicant	Bausch+Lomb
Product Code	HQC · Ophthalmic
Decision Date	Apr 19, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Bausch + Lomb Stellaris Elite 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, vitrectomy, viscous fluid injection/removal, and air/fluid exchange operations. The Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

Device Story

Integrated ophthalmic microsurgical system for anterior/posterior segment surgery; performs phacoemulsification, vitrectomy, irrigation/aspiration, bipolar coagulation, viscous fluid injection/removal, and air/fluid exchange. Optional 532 nm laser module for photocoagulation and trabeculoplasty. Operated by surgeons in clinical settings via LCD touch screen and footswitch. System incorporates Vitesse vitrectomy feature; supports adaptive fluidics. Provides real-time surgical control; output includes mechanical tissue removal and laser energy delivery. Benefits include enhanced surgical flexibility and precision for cataract and vitreo-retinal procedures.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2, IEC 60601-2-22, and IEC 80601-2-58. Successful functional, simulated use, environmental, and transport testing performed. Software verified and validated per EN ISO IEC 62304.

Technological Characteristics

Ophthalmic microsurgical system; LCD touch screen interface; footswitch control. Electrical: 90–130 VAC or 200–240 VAC, 50/60 Hz. Features phacoemulsification, vitrectomy (including Vitesse), and optional 532 nm laser. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-2, 60601-2-22, 80601-2-58. Software lifecycle per EN ISO IEC 62304.

Indications for Use

Indicated for patients undergoing cataract removal, anterior or posterior segment vitrectomy, retinal photocoagulation, or laser trabeculoplasty.

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 PC Vision Enhancement System (K133486)
Stellaris Vision Enhancement System (K133242)

Related Devices

K162342 — Stellaris Elite Vision Enhancement System · Bausch+Lomb · Mar 24, 2017
K133486 — STELLARIS PC VISION ENHANCEMENT SYSTEM · Bausch & Lomb · Mar 12, 2014
K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) · Bausch and Lomb, Incorporated · Mar 25, 2026
K232084 — Stellaris Elite vision enhancement system · Bausch and Lomb · Feb 26, 2024
K142877 — EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) · Dutch Ophthalmic Research Center International BV · Mar 13, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 19, 2017 Bausch + Lomb Mr. Dan Regan Director, Regulatory Affairs 3365 Tree Ct. Industrial Blvd St. Louis, MO 63122 Re: K170052 Trade/Device Name: Stellaris Elite Vision Enhancement System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HOC, HOE, HOF Dated: March 27, 2017 Received: March 28, 2017 Dear Mr. Dan Regan: 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. {1}------------------------------------------------ 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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, # Denise L. Hampton -S Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K170052 Device Name Stellaris Elite vision enhancement system #### Indications for Use (Describe) The Bausch + Lomb Stellaris Elite 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 segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation, bipolar coagulation, vitrectomy, viscous fluid injection/removal, and air/fluid exchange operations. The Stellaris Elite vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. | 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(K) SUMMARY #### General Information 1. | Submitter: | Contact Person: | |-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Bausch + Lomb Inc. 3365 Tree Court Industrial Blvd. St. Louis MO 63122 General Telephone: 636-226-3017 | Dan Regan 3845 Corporate Centre Drive O'Fallon, MO 63368 (636) 794-5013 dan.regan@valeant.com | Preparation Date: November 11, 2016 #### 2. Names | Device Name: | Stellaris Elite vision enhancement system | |-----------------------|------------------------------------------------------------------------| | Classification Names: | 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 | #### Predicate Devices 3. K133486 - Stellaris PC Vision Enhancement System, Bausch + Lomb K133242 - Stellaris Vision Enhancement System, Bausch + Lomb #### Product Description 4. The Bausch + Lomb Stellaris Elite Vision Enhancement System is comprised of 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, the Stellaris Elite Vision Enhancement System may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite Vision Enhancement System is a rebranding of the currently cleared Stellaris (K133242) Vision Enhancement System and Stellaris PC (K133486) Vision Enhancement System. The system is based on the technology and the performance of the {4}------------------------------------------------ existing Stellaris and Stellaris PC Vision Enhancement Systems, and this traditional 510(k) incorporates software and hardware revisions to support the introduction of the new Vitesse vitrectomy feature (including 2 new Vitesse handpieces and supporting accessories). The new Vitesse vitrectomy feature is available on the Stellaris Elite Vision Enhancement System based on the configuration matrix listed in Table 1. The various available system configurations allow for system feature flexibility and are made available for physician convenience. | | Configuration by SKU | | | |------------------------------------------------------|----------------------|-----------|-----------| | Feature | BL11145 | BL14455 | BL15455 | | Adaptive Fluidics Feature cleared under K162342 | Available | Available | Available | | 2500 cpm vitrectomy Feature cleared under K162342 | Available | -- | -- | | 7500 cpm vitrectomy Feature cleared under K162342 | -- | Available | Available | | Laser module Feature cleared under K133486 | -- | -- | Available | | Vitesse vitrectomy [new feature] | -- | Available | Available | Table 1: Stellaris Elite Vision Enhancement System Configuration Table Abbreviations: cpm = cuts per minute --: Not available BL11145: formerly the Stellaris Anterior Vision Enhancement System BL14455: formerly the Stellaris PC Vision Enhancement System BL15455: formerly the Stellaris PC Vision Enhancement System with laser #### Indications for Use 5. The Bausch + Lomb Stellaris Elite 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, vitrectomy, viscous fluid injection/removal, and air/fluid exchange operations. The Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The above indication is a slightly reworded version of the already cleared indications for the Stellaris (K133242) and Stellaris PC (K133486) Vision Enhancement Systems. The rewording includes language regarding the rebranding of the product to Stellaris Elite Vision Enhancement System as well as clarification in regard to the laser module in the last sentence of the indications for use. The addition of the Vitesse vitrectomy feature did not further change the above indication for use statement. {5}------------------------------------------------ #### 6. Summary of Technological Characteristics The technological characteristics of the Stellaris Elite Vision Enhancement System are substantially equivalent to those of the predicate devices. | Characteristic | Subject Device: Stellaris Elite Vision Enhancement System | K133486 Stellaris PC Vision Enhancement System | K133242 Stellaris Vision Enhancement System | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Anterior/Posterior ophthalmic surgery | Same as subject device | Use in ophthalmic procedures | | Indications for Use | The Bausch + Lomb Stellaris Elite 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, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. | 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, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculoplasty. | 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. | | Laser capabilities | Yes | Same as subject device | No | | User interface | LCD touch screen | Same as subject device | Same as subject device | | Footswitch | Yes | Same as subject device | Same as subject device | | Electrical Characteristics | 90 – 130 VAC, 50/60 Hz 200 - 240 VAC, 50/60 Hz | Same as subject device | Same as subject device | #### 7. Safety and Effectiveness Information The review of the indications for use and technical characteristics provided demonstrates that the Stellaris Elite 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. {6}------------------------------------------------ #### 8. Brief Summary of Nonclinical Tests Safety tests of the Stellaris Elite 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) or IEC 60601-1:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | |------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-2 ed3.0 (2007) | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | | IEC 60601-1-6:2010 | Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance. Collateral standard: Usability | | IEC 60601-2-2:2009 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | | IEC 60601-2-22:2007 | Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment | | IEC 80601-2-58:2008 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery | Substantial equivalence is supported the successful tests for functional, simulated use, environmental and transport testing 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 Elite Vision Enhancement System passed all of the above referenced testing. This testing demonstrates that the functional requirements have been met and that the modified device is equivalent to the predicate devices. {7}------------------------------------------------ #### 9. Conclusion The Stellaris Elite Vision Enhancement System shares the same indications for use, design features, and functional features with, and thus is substantially equivalent to, the predicate devices. Non-clinical test results demonstrate that the Stellaris Elite Vision Enhancement System is substantially equivalent to the predicate devices and no new issues of safety or effectiveness have been raised.