(131 days)
The Bausch & Lomb™ Stellaris Microsurgical System device is intended for the emulsification rno basion of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for use in both untonor und polonialion, bipolar, coaxial, and bipolar coagulation, vitrectorny, phaooomalions in ingaoval and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.
The Bausch & Lomb Stellaris Microsurgical System is an integrated ophthalmic microsurgical System designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrector vitrectorny. The Stellaris system is a next generation system based on the Millennium phacoemulsification System, and has been cleared under K063331 for anterior segment procedures including anterior vitreous (posterior). The modification to the current Stellaris system is to provide a pressurized infusion pump system for the bottle assembly which was heretofore placed on the IV provide a pressuntzed only requires a nouver connections assembly which was heretofore plac pole requires a power generated action to raise and lower the pole to gain appropriate pressure for the delivery of BSS saline during intraocular surgery. The pressurized infusion system alleviates this necessity by allowing the IV pole to remain stationary. A bottle hangar assembly is attached to the 1000.) by and might to Toman Stationaly. In bothe nangal assembly by line in the appropriate and desired in a claim to allow don't it in this from the non the nout by the all the intention and of the infraccular surgery procedure. The infusion system embedded in the integral part of the Stellaris system that has not been activated previously. The current Stellaris system incorporates both vacuum and flow-based fluidics system (peristallic The carrent of clians of commission of anterior and posterior procedures. The compressor pullip) to meet ourinn and fearly nechanical and pneumatic interfaces to the pressurized infusion system.
The Stellaris Microsurgical System by Bausch & Lomb is not a medical AI device, but rather an ophthalmic surgical system. Therefore, most of the requested information about acceptance criteria, study design for AI models, and human-in-the-loop performance is not applicable.
Here's a breakdown of the available information relevant to a non-AI medical device:
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the system will be manufactured in compliance with FDA and ISO quality systems and relevant standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with FDA and ISO quality systems and device-related international, domestic, and industry standards and requirements. | "System verification and validation will demonstrate that the functional requirements and system specifications will have been met prior to commercial release and distribution." (General statement, no specific data) |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is a hardware surgical system undergoing a 510(k) clearance based on substantial equivalence to a predicate device, not a software AI model tested on a dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Ground truth assessment by experts is for data-driven models, which this device is not.
4. Adjudication Method:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is for evaluating observer performance with and without an AI assistant, which is not relevant for this surgical system.
6. Standalone Performance:
The device's performance is inherently "standalone" in the sense that it operates independently as a surgical system. However, "standalone performance" in the context of AI usually refers to the algorithm's performance without human interaction in a diagnostic or screening task. For this surgical device, performance is evaluated through its functional capabilities for procedures like phacoemulsification and vitrectomy.
7. Type of Ground Truth Used:
For a hardware device like this, the "ground truth" is typically defined by its ability to perform its intended surgical functions safely and effectively, as demonstrated through design verification and validation tests and comparison to a predicate device. This is not about medical diagnoses or pathology results.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI model that undergoes a "training set." Its design is based on engineering principles and previous device generations.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the 510(k) Submission for the Bausch & Lomb Stellaris Microsurgical System (Pressurized Infusion Pump):
The 510(k) submission (K082473) for the Bausch & Lomb Stellaris Microsurgical System focused on adding a pressurized infusion pump system for the bottle assembly. This modification aimed to improve the convenience and stability of fluid delivery during intraocular surgery by allowing the IV pole to remain stationary, eliminating the need for manual adjustment to gain appropriate pressure.
The FDA cleared the device based on substantial equivalence to its predicate devices, specifically the Bausch & Lomb NGX Microsurgical System (K063331) and the Bausch & Lomb Premiere II Millennium Microsurgical System (K961310). The argument for substantial equivalence rested on the fact that the Stellaris system is a "next generation system" based on the Millennium, sharing similar core technology and fluidics systems, with the new pressurized infusion being an activation of an integral part of the system that was previously inactive.
The submission stated that clinical investigations were deemed not necessary due to the extensive clinical and surgical use of the previous generation Millennium Microsurgical System and the nature of the modification (an enhancement to fluidics rather than a fundamental change in surgical mechanism). "System verification and validation" (presumably engineering and functional testing) were stated to be conducted to ensure the device met functional requirements and specifications.
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Bausch& Lomb
JAN - 5 2009
510(k) Summary Statement Bausch & Lomb Stellaris Microsurgical System (Pressurized Infusion Pump)
Applicant's Name and Address
Bausch & Lomb. Inc. 1400 North Goodman Street Rochester, NY 14609
Contact Person
Ned L. Luce Director, Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 (585) 338-6368
1. Identification of device
Common Name:
Trade Name: Classification: ophthalmic surgical system for cataract and vitreo-retinal surgerv
Bausch & Lomb™ Stellaris Microsurgical System 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
2. Description of device
The Bausch & Lomb Stellaris Microsurgical System is an integrated ophthalmic microsurgical System designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrector vitrectorny.
The Stellaris system is a next generation system based on the Millennium phacoemulsification System, and has been cleared under K063331 for anterior segment procedures including anterior vitreous (posterior). The modification to the current Stellaris system is to provide a pressurized infusion pump system for the bottle assembly which was heretofore placed on the IV provide a pressuntzed
only requires a nouver connections assembly which was heretofore plac pole requires a power generated action to raise and lower the pole to gain appropriate pressure for the delivery of BSS saline during intraocular surgery. The pressurized infusion system alleviates this necessity by allowing the IV pole to remain stationary. A bottle hangar assembly is attached to the 1000.) by and might to Toman Stationaly. In bothe nangal assembly by line in the appropriate and desired in a claim to allow don't it in this from the non the nout by the all the intention and of the infraccular surgery procedure. The infusion system embedded in the integral part of the Stellaris system that has not been activated previously.
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The current Stellaris system incorporates both vacuum and flow-based fluidics system (peristallic The carrent of clians of commission of anterior and posterior procedures. The compressor pullip) to meet ourinn and fearly nechanical and pneumatic interfaces to the pressurized infusion system.
3. Intended use
The Bausch & Lomb™ Stellaris Microsurgical System device is intended for the emulsification rno basion of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for use in both untonor und polonialion, bipolar, coaxial, and bipolar coagulation, vitrectorny, phaooomalions in ingaoval 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 | 12/19/2006 | Bausch & Lomb NGXMicrosurgical System(Stellaris) |
| K961310 | 6/27/1996 | Bausch & Lomb Premiere IIMillennium MicrosurgicalSystem |
5. Technological Characteristics
The B&L Stellaris™ Microsurgical System utilizes the same technology as the Millennium™ System but with ergonomic, aesthetics, and reliability upgrades to the phaco hand-piece and system. The base unit contains all of the modules, however, the module area is not visible to the user. The fluidics systems for the Stellaris System are comprised of the same technology as the Millennium but have been upgraded for reliability and manufacturability. The pressurized influsion assembly of the Stellaris Microsurgical System is an integral part of the system however has not been active until now. The purpose of the pressurized infusion system serves to provide nav not boor as a min hemand to the accessory fluid bottle(s) which are placed onto the IV pole hangar assembly, and allows for the IV pole to be in a stationary position while providing the desired amount of pressure to the bottle by activation from the surgeon.
Perfomance Data: 6.
The Stellaris 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 validation will demonstrate that the functional requirements and system specifications will have been met prior to commercial release and distribution.
7. Packaging
The B&L Stellan's Microsurgical 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 pouches.
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8. Clinical data:
The B&L Stellaris Microsurgical System is the next generation of the Millennium Microsurgical System and as such provides for procedures and use of tools that have extensive clinical and surgical use. Clinical investigations were deemed as not necessary for the planned marketing of this system.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars above it, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bausch & Lomb. Inc. c/o Ned L. Luce Director, Global Regulatory Affairs 1400 North Goodman Street Rochester. NY, 14609
JAN - 5 2009
Re: K082473
Trade/Device Name: Stellaris Microsurgical System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC, HQE Dated: December 16, 2008 Received: December 18, 2008
Dear Mr. Luce:
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 Mav 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 such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egelston, m.d.
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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
5082473
Device Name:
Bausch & Lomb™ NGX Microsurgical System
Indication for Use
The Bausch & Lomb™ NGX Microsurgical System device is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectorny. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phaceemulsification, 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the -counter-use
510(k) Number KO86493
Rally
510(k) Number K082473
§ 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.