(214 days)
Not Found
No
The summary does not mention AI, ML, or related concepts like image processing or specific algorithms typically associated with AI/ML in medical devices. The described features like "Adaptive Fluidics" and "high speed vitrectomy" appear to be hardware and software revisions based on existing technology, not necessarily incorporating AI/ML for decision-making or analysis.
Yes.
The device is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy, and retinal photocoagulation and laser trabeculoplasty, which are all therapeutic procedures.
No
The device is described as a "Vision Enhancement System" intended for "emulsification and removal of cataracts, anterior and posterior segment vitrectomy," and various surgical operations. Its purpose is treatment, not diagnosis.
No
The device description explicitly states it is comprised of an "integrated ophthalmic microsurgical system" and mentions "software and hardware revisions" and "supporting accessories," indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device 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 patient (emulsification and removal of cataracts, vitrectomy, etc.). IVD devices are used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a microsurgical system with capabilities for phacofragmentation, vitreous aspiration and cutting, and endoillumination. These are all surgical functions, not diagnostic tests performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Bausch + Lomb Stellaris Elite Vision Enhancement System is a surgical device, not an IVD.
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 (comma separated list FDA assigned to the subject device)
HQC, HQE, HQF
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 system is based on the technology and the performance of the existing Stellaris and Stellaris PC Vision Enhancement Systems. This traditional 510(k) incorporates software and hardware revisions to support the introduction of new features including Adaptive Fluidics, high speed vitrectomy, and supporting accessories. The Stellaris Elite Vision Enhancement System is available in various configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior segment
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, IEC 60601-1-2 ed3.0 (2007), IEC 60601-1-6:2010, IEC 60601-2-2:2009, IEC 60601-2-22:2007, IEC 80601-2-58:2008.
Substantial equivalence is supported by successful test results for functional, simulated use, biocompatibility, shelf life, 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 applicable standards and functional testing. This testing demonstrates that the functional requirements have been met and that the modified device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 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
March 24, 2017
Bausch + Lomb Inc. Mr. Ken Nehmer Senior Manager, Regulatory Affairs 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122
Re: K162342
Trade/Device Name: Stellaris Elite Vision Enhancement System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC, HQE, HQF Dated: March 17, 2017 Received: March 20, 2017
Dear Mr. Nehmer:
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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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
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
2
Indications for Use
510(k) Number (if known) K162342
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 vitrectorny. 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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1. General Information
| Submitter: | Contact Person: |
|---|---|
| Bausch + Lomb Inc. | Ken Nehmer |
| 3365 Tree Court Industrial Blvd. | 351 Buena Vista Avenue E. |
| St. Louis MO 63122 | Unit 501E |
| General Telephone: 636-226-3017 | San Francisco, CA 94117 |
| 415-297-0408 (Cell) | |
| ken.nehmer@bausch.com | |
| Preparation Date: | |
| August 19, 2016 | |
| 2. Names | |
| Device Name(s): | Stellaris Elite Vision Enhancement System |
| Device Name(s): | Stellaris Elite 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, 21 CFR 886.4390 |
| Product Codes: | HQC, HQE, HQF |
3. Predicate Devices
- K133486 Stellaris PC Vision Enhancement System, Bausch + Lomb .
- K133242 Stellaris Vision Enhancement System, Bausch + Lomb ●
4. Product 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 system is based on the technology and the performance of the existing Stellaris and Stellaris PC Vision Enhancement Systems. This traditional 510(k) incorporates software and hardware revisions to support the introduction of new features including Adaptive Fluidics, high speed vitrectomy, and supporting accessories. The Stellaris Elite Vision Enhancement System is available in various configurations.
5. Indications for Use
The Bausch + Lomb Stellaris Elite Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior 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, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
4
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 Bausch + Lomb
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 |
5
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 as safe and effective as the predicate for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy.
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) | Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| or IEC 60601-1:2012 | |
| 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 by successful test results for functional, simulated use, biocompatibility, shelf life, 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 applicable standards and functional testing. This testing demonstrates that the functional requirements have been met and that the modified device is substantially equivalent to the predicate devices.
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.