(97 days)
Not Found
No
The description focuses on mechanical and fluidic improvements for surgical efficiency and control, with no mention of AI or ML capabilities.
Yes.
The device is intended for the emulsification and removal of cataracts and vitrectomy, which are therapeutic surgical procedures.
No
Explanation: The device is described as a surgical system for emulsification and removal of cataracts, vitrectomy, and other ophthalmic surgical procedures, not for diagnosing conditions.
No
The device description clearly outlines a physical system with hardware components like handpieces, fluidics, and a phaco hand-piece, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System is a surgical system used directly on the patient's eye during procedures like cataract removal and vitrectomy. It performs physical actions like emulsification, aspiration, cutting, and fluid exchange.
- Intended Use: The intended use clearly describes surgical procedures performed in vivo (within the living body).
The device is a surgical instrument, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Bausch & Lomb™ 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 phacoemulsification (coaxial or bimanual), irrigation, bipolar diathermy, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb™ disposable packs and handpieces designated for use with the system.
Product codes
HQC, HQE
Device Description
The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination.
The Stellaris® PC™ Vision Enhancement system is the next generation Stellaris® NGX Microsurgical System. The new system is based on the technology and the performance platform of the existing Stellaris® NGX Microsurgical System and is designed to improve surgical efficiency, surgeon ergonomics, control of fluidics and aesthetics.
The system incorporates vacuum based fluidics to meet the needs of anterior and posterior procedures. The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency. The ultrasound lens removal system extends and improves upon existing technologies with new and improved designs in the phaco hand-piece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
System verification and validations have demonstrated that the functional requirements and system specifications have been met and are currently ready for commercial release and distribution. This submission contains all testing data and validation summaries supporting system function.
Key Metrics
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
510(k): K101325
Image /page/0/Picture/1 description: The image shows the logo for Bausch & Lomb. The text "Bausch&Lomb" is written in a bold, sans-serif font. There is a thick, black line above the text, which is angled slightly.
510(k) Summary Statement Bausch & Lomb Stellaris PC Vision Enhancement System
AUG 1 7 2010
July 26,2010
Applicant's Name and Address
| | 1400 North Goodman Street
Rochester, NY 14609 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ned Luce |
| | Director, Global Regulatory Affairs |
| | Bausch & Lomb, Inc. |
| | 1400 North Goodman Street |
| | Rochester, NY 14609
(585) 338-6368 |
| 1. Identification of device | |
| Common Name: | ophthalmic surgical system for cataract and vitreo-retinal
surgery |
| Trade Name: | Bausch & Lomb™ Stellaris PC Vision Enhancement
System |
| Classification: | Class II ophthalmic microsurgical system including:
-Phacofragmentation system (21 CFR 886.4670
-Vitreous Aspirating and Cutting Device (21 CFR
886.4150 |
| Device classification:
Pro Code: | Class II (21 CFR 886.4670 and 21 CFR 886.4150)
HQC, HQE |
| | |
Bausch & Lomb, Inc.
2. Description of device
The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination.
The Stellaris® PC™ Vision Enhancement system is the next generation Stellaris® NGX Microsurgical System. The new system is based on the technology and the performance platform of the existing Stellaris® NGX Microsurgical System and is designed to improve surgical efficiency, surgeon ergonomics, control of fluidics and aesthetics.
The system incorporates vacuum based fluidics to meet the needs of anterior and posterior procedures. The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency. The ultrasound lens removal system extends and improves upon existing technologies with new and improved designs in the phaco hand-piece.
1
1
3. Intended use
The Bausch & Lomb™ 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 phacoemulsification (coaxial or bimanual), irrigation, bipolar diathermy, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb™ disposable packs and handpieces designated for use with the system.
4. Substantial Equivalence
| 510(k) | Clearance Date | Device Description |
|---|---|---|
| K063331 | 12/14/2006 | Bausch & Lomb™ Stellaris® |
| NGX Microsurgical System | ||
| K961310 | 6/27/1996 | Bausch & Lomb™ Premiere II |
| Millennium® Microsurgical System | ||
| K082473 | 1/9/2009 | Bausch & Lomb™ Stellaris® |
| NGX System |
5. Technological Characteristics
The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System utilizes similar technology as the Stellaris® NGX Microsurgical System with similar ergonomic, aesthetics, and reliability upgrades. The base unit contains all of the modules, however, the module area is not visible to the user. The fluidics systems for the Stellaris® PC Vision Enhancement System are comprised of similar vacuum technology as the Premiere II Millennium® Microsurgical System. New modules for the Stellaris® PC™ Vision Enhancement System have been added or enhanced to provide posterior surgical functionalities such as endoillumination, viscous fluid injection/extraction, fluid/air exchange and high speed vitrectomy ..
6. Perfomance Data:
The Stellaris® PC™ Vision Enhancement System will be manufactured in compliance with FDA and ISO quality systems and device related international, domestic, and industry standards and requirements. System verification and validations have demonstrated that the functional requirements and system specifications have been met and are currently ready for commercial release and distribution. This submission contains all testing data and validation summaries supporting system function.
| # | Document Title | Version | Date |
|---|---|---|---|
| 1. | IEC 60601-1 Medical Electrical Equipment | ||
| Part 1: General Requirements for Safety; (Amd.1-1991) (CENELEC EN | |||
| 60601-1:1990) (Amd. 2-1995(Corrigendum-1995) - Also includes | |||
| requirements for enclosures covered in IEC 60529 | Ed: 2 | 1998/12/01 | |
| 2. | UL 60601-1 UL Standard for Safety Medical Electrical Equipment | ||
| Part 1: General Requirements for Safety; Includes CSA C22.2 NO. 601.1 | Edition | ||
| 1 | 2003/04/25 | ||
| 3. | IEC 60601-1-1:2000 Medical Electrical Equipment | ||
| Part 1: General Requirements for Safety - Collateral Standard: Safety | |||
| requirements for medical electrical systems | - | 2000/12/01 | |
| # | Document Title | Version | Date |
| 4. | EN60601-1-2:2001 Medical Electrical Equipment | ||
| Part 1: General Requirements for Safety |
- Collateral Standard: Electromagnetic Compatibility - Requirements and
tests, including Amendment A1:2006 | - | 2004/11/01 |
| 5. | IEC 60601-2-2
Medical Electrical Equipment
Part 2-2: Particular requirements for the safety of high frequency surgical
equipment | - | 2006/0701 |
| 6. | FCC Part 15 Part B and Part C
Radio Frequency Devices | - | Nov 5, 2004 |
| 7. | FCC Supplement C
Evaluating Compliance with FCC Guidelines for Human Exposure to
Radiofrequency Electromagnetic Fields | 01-01 | June 29, 2001 |
| 8. | FCC OET Bulletin 65
Evaluating Compliance with FCC Guidelines for Human Exposure to
Radiofrequency Electromagnetic Fields | 97-01 | Aug 1997 |
| 9. | EN 300 328
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Wideband transmission systems;
Data transmission equipment operating
in the 2,4 GHz ISM band and
using wide band modulation techniques;
Harmonized EN covering essential requirements
under article 3.2 of the R&TTE Directive | 1.5.1 | 2004-08 |
| 10. | EN 300 328-1
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Wideband Transmission systems;
Data transmission equipment operating
in the 2,4 GHz ISM band and using spread spectrum modulation techniques;
Part 1: Technical characteristics and test conditions | 1.3.1 | 2001-12 |
| 11. | EN 300 328-2
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Wideband Transmission systems;
Data transmission equipment operating
in the 2,4 GHz ISM band and
using spread spectrum modulation techniques;
Part 2: Harmonized EN covering essential requirements under article 3.2 of
the R&TTE Directive | 1.2.1 | 2001-12 |
| 12. | ARIB STD-T66 (Japan)
Radio Equipment for Second-generation Low-power Data Communications
Systems Radio Stations" and "Wireless LAN Systems' Equipment | 2.1 | March 2003 |
| # | Document Title | Version | Date |
| 13. | ISO 15004-2:2007
Ophthalmic Instruments Fundamental Requirements and Test Methods Part
2: Light Hazard Protection | 2 | 12/17/2007 |
| Transportation Standards | | | |
| # | Document Title | Version | Date |
| 14. | ISTA Schedule 3H "Products or Packaged-Products in Mechanically Handled
Bulk Transport Containers" for the completed system . | 2005 | 6/2005 |
| 15. | Service Modules: ISTA Project 3A, "Packaged-Products for Parcel Delivery
System Shipment, 150lbs. or Less (standard, small, flat or elongated)" | 2006 | 5/2006 |
| 16. | Disposable Packs: ASTM D4169 Standard Practice for Performance Testing
of Shipping Containers and Systems | Ed:08 | 08/01/2008 |
| Biocompatibility Standards | | | |
| # | Document Title | Version | Date |
| 17. | ISO 10993:2003 Biological Evaluation of Medical Devices-
Evaluation and Testing | 2003 | 09/08/2009 |
| 18. | ISO 10993-5:2009 Biological Evaluation of Medical Devices- Tests for in-vitro
cytotoxicity | 2009 | 09/08/2009 |
| 19. | ISO 10993-10:2002 Biological Evaluation of Medical Devices- Tests for
Irritation and Delayed Type hypersensitivity | 2002 | 09/08/2009 |
Non Clinical Testing for Performance Data (Standards Based)
2
3
7. Packaging
The Bausch &Lomb™ Stellaris® PC™ Vision Enhancement System is housed in a dedicated single free standing unit in which all major components are enclosed as an integrated system. Sterile accessory surgical packs are packaged separately in sealed Tyvek packaging.
8. Clinical data:
The Bausch &Lomb™ Stellaris® PC™ Vision Enhancement System is the next generation of the Stellaris® NGX Microsurgical System and as such provides for procedures and use of tools that have extensive clinical and surgical use. Modules for posterior surgical procedures have predicates from the Bausch & Lomb™ Premiere II® Millennium Microsurgical System with modifications and upgrades. Clinical investigations were deemed not necessary for the planned marketing of this system.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bausch & Lomb, Inc. c/o Mr. Daniel W. Lehtonen Senior Staff Engineer Intertek Testing Services NA, Inc. 2307 E. Aurora Rd. Unit B7 Twinsburg, OH 44087
AUG 1 7 2010
Re: K101325
Trade/Device Name: Stellaris PC Vision Enhancement System Regulation Number: 21 CFR 886,4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Codes: HOC, HOE Dated: July 30, 2010 Received: August 2, 2010
Dear Mr. Lehtonen:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm:
ia.2971/MedicalDevices/ResourceController.Tour/included/default.htm
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 4 : INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Bausch & Lomb ™ Stellaris PC Vision Enhancement System
Indication for Use
The Bausch & Lomb™ 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 phacofragmentation (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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X
Prescription Use
OR Over-the -counter-use
signature
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________