(104 days)
Not Found
No
The document describes a surgical system for ophthalmology and mentions software and hardware revisions, but there is no mention of AI or ML capabilities, image processing, or data sets for training or testing.
Yes
The device is described as "intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy" and provides capabilities for various surgical procedures, which are forms of therapy.
No
This device is an ophthalmic microsurgical system intended for therapeutic procedures like cataract removal, vitrectomy, and photocoagulation. It is not described as diagnosing conditions.
No
The device description explicitly states it is comprised of an "integrated ophthalmic microsurgical system" and mentions "software and hardware revisions" and "new Vitesse handpieces and supporting accessories," indicating it is a hardware-based system with software components, not a software-only device.
Based on the provided information, the Bausch + Lomb Stellaris Elite vision enhancement system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system for performing procedures on the eye (emulsification and removal of cataracts, vitrectomy, etc.). IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Description: The description details a microsurgical system with various tools for performing surgery. This aligns with a surgical device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory tests.
The Stellaris Elite is a surgical device used during a procedure, not a diagnostic device used to analyze samples in vitro.
N/A
Intended Use / 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 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.
Product codes
HOC, HOE, HOF
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior segment surgeries (eyes)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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) |
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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.
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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.