(119 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional surgical system components and software revisions.
Yes
The device is described as an ophthalmic microsurgical system intended for procedures such as the emulsification and removal of cataracts, posterior segment vitrectomy, phacoemulsification, bipolar coagulation, and retinal photocoagulation, all of which are therapeutic interventions.
No
The device is described as an ophthalmic microsurgical system intended for therapeutic procedures (emulsification, removal, coagulation, vitrectomy, etc.) rather than for diagnosis.
No
The device description explicitly states it is an "integrated ophthalmic microsurgical system" and includes hardware revisions (power supply) and an optional laser module, indicating it is a physical device with software components, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on the eye (emulsification and removal of cataracts, posterior segment vitrectomy, phacoemulsification, etc.). IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a microsurgical system with tools for cutting, aspirating, and illuminating within the eye. This is consistent with a surgical device, not a diagnostic device that analyzes samples.
- No mention of analyzing biological samples: The text does not mention the device being used to analyze any biological specimens.
Therefore, the Bausch & Lomb StellarisPC Vision Enhancement System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bausch & Lomb StellarisPC Vision Enhancement System is intended for the emulsification and removal of catarior and posterior segment virectory. The system is designed for use in both anterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimigation, bipolar coagulation, virectory, viscous fluid injection/removal and sir/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laster trabeculaplasty.
Product codes
HQC, HQE, HQF
Device Description
The Bausch + Lomb Stellaris PC Vision Enhancement System is 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, this model includes an optional 532nm laser module for photocoagulation.
The system is based on the technology and the performance of the existing Stellaris PC Vision Enhancement System, and this traditional 510(k) incorporates software revisions, a hardware revision to the power supply, and the additional of an optional laser photocoagulation module.
The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior segment surgeries (ophthalmic)
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 PC 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 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
- IEC 60601-1-6:2010: Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance. Collateral standard. Usability
- IEC 62366:2007: Medical devices - Application of usability engineering to medical devices
- 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 60825-1:2007: Safety of laser products - Part 1: Equipment classification and requirements
Functional, simulated use, environmental and transport testing were also 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 PC 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.
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.
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1. General Information
Section 8-510(k) Summary
| Submitter: | Contact Person: |
|---|---|
| Bausch + Lomb Inc. | |
| 3365 Tree Court Industrial Blvd. | |
| St. Louis MO 63122 | |
| General Telephone: 636-226-3017 | Timothy W Capehart |
| 636-226-3017 (Office) | |
| 636-226-3245 (Fax) | |
| Timothy.Capehart@bausch.com | |
| Preparation Date: November 6, 2013 |
- Names
| Device Name(s): | Stellaris® PC 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
- K101325 Stellaris PC Vision Enhancement System, Bausch & Lomb .
- K022760 Millenium Microsurgical System, Bausch & Lomb .
- K071687 Family of IRIDEX IQ Laser Systems (1Q532, 1Q577, IQ 630-670, 1Q8 10) & . Delivery Device Accessories
4. Product Description
The Bausch + Lomb Stellaris PC Vision Enhancement System is 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, this model includes an optional 532nm laser module for photocoagulation.
The system is based on the technology and the performance of the existing Stellaris PC Vision Enhancement System, and this traditional 510(k) incorporates software revisions, a hardware revision to the power supply, and the additional of an optional laser photocoagulation module.
The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency.
5. Indications for Use
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, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculaplasty.
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Section 8-510(k) Summary
6. Summary of Technological Characteristics
The technological characteristics of the Stellaris PC Vision Enhancement System are substantially equivalent to those of the predicate device.
| Characteristic | Subject Device
Stellaris®PC Vision
Enhancement System | K101325
Stellaris®PC Vision
Enhancement
System | K022760
Millennium Laser
Photocoagulator
System | K071687
Iridex IQ
Laser
Family |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Anterior/Posterior
ophthalmic surgery | Anterior/Posterior
ophthalmic surgery | Intended for use in
ophthalmic
procedures | Intended for
use in
ophthalmic
and
dermatologic
al procedures
(Ophthalmic
532nm only) |
| Indications for Use | 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 trabeculaplasty. | The Bausch &
LombTM 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
phaco fragmentation
(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- | The laser modes
are intended for
retinal
photocoagulation
and laser
trabeculaplasty.
Delivery devices
available are the
Endoprobe for
intraocular
endolaser surgery,
and the Laser
Indirect
Ophthalmoscope
Plus (LIO+) for
transpupillary laser
delivery for
patients in the
supine position. | Indicated for
retinal
photocoagula
tion, laser
trabeculoplast
y, iridotomy,
iridoplasty
including:
• Retinal
photocoagula
tion (RPC)
for the
treatment of
Diabetic
retinopathy,
including:
Nonproliferat
ive
retinopathy
- Macular
edema
-Proliferative
retinopathy
Retinal
tears and
detachments
Lattice
degeneration
Age-related
macular
degeneration
(AMD)
Retinopathy
of |
| Characteristic | Subject Device
Stellaris®PC Vision
Enhancement System | K101325
Stellaris®PC Vision
Enhancement
System | K022760
Millennium Laser
Photocoagulator
System | K071687
Iridex IQ
Laser
Family |
| | | | | prematurity
Sub-retinal
(choroidal)
neovascularization
Central and
branch retinal
vein
occlusion
· Laser
trabeculoplasty, iridotomy, iridoplasty
for the
treatment of
glaucoma,
including
Primary
open
angle/Closed
angle |
| Laser capabilities | Yes | No | Yes | Yes |
| User interface | LCD touch screen | LCD touch screen | NA | LCD
touchscreen |
| Footswitch | Yes | Yes | Yes | Yes |
| Electrical
Characteristics | 90-130 VAC, 50/60 Hz
200-240 VAC, 50/60 Hz | 90-130 VAC,
50/60 Hz
200-240 VAC,
50/60 Hz | 90-130 VAC,
50/60 Hz
200-240 VAC,
50/60 Hz | 90-130
VAC, 50/60
Hz
200-240
VAC, 50/60
Hz |
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Section 8 -510(k) Summary
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7. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Stellaris PC 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 .
8. Brief Summary of Nonclinical Tests and Results
Safety tests of the Stellaris PC 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 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 |
| IEC 60601-1-6:2010 | Medical electrical equipment. Part 1-6: General requirements
for basic safety and essential performance. Collateral
standard. Usability |
| IEC 62366:2007 | Medical devices - Application of usability engineering to
medical devices |
| 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 60825-1:2007 | Safety of laser products - Part 1: Equipment classification and
requirements |
Functional, simulated use, environmental and transport testing were also 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 PC 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.
Premarket Notification Traditional 510(k) Bausch + Lomb Stellaris®PC Vision Enhancement System
Section 8-510(k) Summary
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Section 8 -- 510(k) Summary
9. Conclusion
The Stellaris®PC Vision Enhancement System shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
5
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G109 Silver Spring, MD 20993-0002
March 12, 2014
Bausch + Lomb, Inc. % Mr. Timothy W. Capehart Manger Regulatory Affairs. Equipment and Instruments 3365 Tree Court Industrial Boulevard Saint Louis, MO 63122
Re: K133486
Trade/Device Name: Stellaris PC Vision Enhancement System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system. Regulatory Class: Class II Product Code: HQC, HQE, HQF Dated: February 5, 2014 Received: February 7, 2014
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.
6
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K133486
Device Name
Stellaris®PC Vision Enhancement System
Indications for Use (Describe)
The Bausch & Lomb StellarisPC Vision Enhancement System is intended for the emulsification and removal of catarior and posterior segment virectory. The system is designed for use in both anterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimigation, bipolar coagulation, virectory, viscous fluid injection/removal and sir/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laster trabeculaplasty.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
SE SERVER SELLER SECTION FOR FOR FOR FOR FOR FOR FOR FOR FOR SECTION OF CONSEL Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Rahul K. Ram -S (A 2014.03.11 17:38:33
FORM FDA 3881 (9/13)