(116 days)
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.
The Bausch & Lomb Stellaris® Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrectomy. The system is based on the technology and the performance of the existing Stellaris® system, and this special 510(k) incorporates software revisions and minor hardware changes.
Here's an analysis of the provided text regarding the Bausch & Lomb Stellaris® Vision Enhancement System, structured to address your specific points:
Since this is a 510(k) submission for a medical device that has been updated with software revisions and minor hardware changes, and it's being compared to a predicate device, the "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence rather than a clinical study with primary performance endpoints. The "study" proving it meets acceptance criteria is the nonclinical testing showing compliance with applicable standards and verification/validation activities for software changes.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a modified device, the acceptance criteria are primarily about meeting safety standards and demonstrating equivalence to the predicate. Performance is generally shown by passing technical tests.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Safety Standards | Compliance with IEC 60601-1: Edition 3: 2007 (General Requirements for Safety) | The Stellaris® Vision Enhancement System "passed all of the above tests with no exceptions." |
| Compliance with IEC 60601-1-2: Edition 3:2007-03 (Electromagnetic Compatibility - Requirements and Tests) | The Stellaris® Vision Enhancement System "passed all of the above tests with no exceptions." | |
| Software Validation | Verification and validation of software changes in accordance with Bausch & Lomb software quality procedures (EN62304) | "Software changes were verified and validated in accordance with the Bausch & Lomb software quality procedures which comply with EN62304." Functional requirements met. |
| Functional Equivalence | Functional requirements of the modified device are equivalent to the predicate device. | "This testing demonstrates that the functional requirements have been met and that the modified device is equivalent to the predicate device." |
| Intended Use | Identical to predicate device (K082473). | "Exactly the same as K082473." Confirmed in "Indications for Use Statement." |
| Technological Equivalence | Substantially equivalent technological characteristics to predicate device. | "The technological characteristics of the Stellaris Microsurgical system are substantially equivalent to those of the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve patient data or a "test set" in the traditional sense of a clinical study evaluating diagnostic or treatment outcomes using patient samples. The "test set" here refers to the actual device and its components undergoing engineering and software verification/validation testing.
- Sample Size: Not applicable in terms of patient data. The "sample" is the medical device itself and its software. Testing would have been conducted on prototypes or production units of the Stellaris® Vision Enhancement System.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective patient data. The tests were performed internally by Bausch & Lomb and its designated testing facilities to meet international safety standards (IEC) and software development standards (EN62304).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission does not involve "experts" establishing a "ground truth" for a test set in the context of diagnostic accuracy or clinical outcomes. The "ground truth" for the engineering and software testing is defined by the technical specifications, international standards (IEC), and the functional requirements of the device and its predicate.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for subjective assessments, to resolve disagreements among multiple readers or experts. This is not relevant to the engineering and software testing described in this 510(k) summary.
- Adjudication Method: None.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a clinical study design used to assess the performance of diagnostic devices by comparing multiple readers' interpretations of multiple cases. This submission focuses on engineering and software substantial equivalence, not clinical diagnostic performance.
- Effect Size of Human Readers with/without AI: Not applicable, as this is not an AI-assisted diagnostic device or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is an ophthalmic surgical system, not an algorithm. Its operation inherently involves a human surgeon (human-in-the-loop).
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Technical Specifications and Design Requirements: The device's performance is compared against its own design specifications and the established performance of the predicate device.
- International Safety Standards: Adherence to standards like IEC 60601-1 and IEC 60601-1-2 constitutes a "ground truth" for electrical and electromagnetic safety.
- Software Quality Standards: Compliance with EN62304 for software development provides the "ground truth" for software functionality and safety.
8. The Sample Size for the Training Set
This submission does not involve a "training set" in the context of machine learning or AI algorithms. The device is a physical surgical system with software, not a system that learns from data.
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
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BAUSCH + LOMB
See better. Live better.
Section 8-510(k) Summary
1. General Information
| Submitter: | Contact Person: |
|---|---|
| Bausch & Lomb Inc. | Timothy W Capehart |
| 3365 Tree Court Industrial Blvd. | 636-226-3017 (Office) |
| St. Louis MO 63122 | 636-226-3245 (Fax) |
| General Telephone: 636-226-3017 | Timothy.Capehart@bausch.com |
| Summary Preparation Date:October 17, 2013 |
- Names
| Device Name(s): | Stellaris® 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 |
| Product Codes: | HQC, HQE |
3. Predicate Devices
- K082473 Stellaris® Microsurgical System .
- K063331 Stellaris ® Microsurgical System .
- K 101325 -- Stellaris ® PC Vision Enhancement System .
4. Product Description
The Bausch & Lomb Stellaris® Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrectomy.
The system is based on the technology and the performance of the existing Stellaris® system, and this special 510(k) incorporates software revisions and minor hardware changes. There is no change in the intended use or indications for use of the system.
5. Indications for Use
Indications for Use (same as K082473):
The Bausch & Lomb Stellaris® 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, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.
FEB 1 4 2014
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BAUSCH + LOMB
See better. Live better.
6. Summary of Technological Characteristics
The technological characteristics of the Stellaris Microsurgical system are substantially equivalent to those of the predicate device.
| Characteristic | Stellaris® Vision Enhancement System | K082473/K063331Stellaris® Microsurgical System |
|---|---|---|
| Product Code | HQC, HQE | HQC, HQE |
| Regulation | 21 CFR 886.4670, 21 CFR 886.4150 | 21 CFR 886.4670, 21 CFR 886.4150 |
| Intended Use | Intended for use in ophthalmicprocedures | Intended for use in ophthalmic procedures |
| Indications for Use | Exactly the same as K082473 | See K082473 |
| User interface | LCD touch screen | LCD touch screen |
| Deviceactivation | footswitch | footswitch |
| Electricalrequirements | 90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz |
7. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Stellaris® Vision Enhancement System is substantially equivalent to the predicate device and is safe and effective for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy.
Brief Summary of Nonclinical Tests and Results 8.
Safety tests of the Stellaris Vision Enhancement System have demonstrated its compliance with applicable requirements of the following standards:
- IEC 60601-1: Edition 3: 2007 Medical Electrical Equipment Part 1: General Requirements for . Safety
- . IEC 60601-1-2: Edition 3:2007-03 Medical Electrical Equipment - Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
Software changes were verified and validated in accordance with the Bausch & Lomb software quality procedures which comply with EN62304.
The Stellaris® 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.
9. Conclusion
The Stellaris® Vision Enhancement System shares identical indications for use, similar design features. and functional features with, and thus is substantially equivalent to, the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2014
Bausch & Lomb, Inc. % Mr. Timothy W. Capehart Manager of Regulatory Affairs, Equipment and Instruments 3365 Tree Court Industrial Blvd. St. Louis, MO 63122
Re: K133242
Trade/Device Name: Stellaris® Vision Enhancement System Regulation Number: 21 CFR 886.4670, 21 CFR886.4150 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Codes: HQC, HQE Dated: December 13, 2013 Received: December 16, 2013
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.
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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 (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 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/MedicalDevices/ResourcesforYou/Igdustry/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/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/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
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Indications for Use Statement
510(k) Number (if known): K133242
Device Name: Stellaris® Vision Enhancement System
Indications for Use :
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.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bradley S. Cunningham -S 2014.02.13 21:31:16 -05'00'
§ 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.