(26 days)
The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.
The Bausch & Lomb (B&L) Phacoemulification Disposable Packs are an accessory to the Millennium, Premiere and Protege Microsurgical Systems for use in performing phacoemulification procedures. Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven handpiece which: 1) emulsifies the lens, 2) facilitates the irrigation of the anterior chamber and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eve
The provided text describes a 510(k) summary for Venturi Phaco Packs, which are accessories for microsurgical systems used in phacoemulsification procedures. This document aims to demonstrate substantial equivalence to previously marketed devices rather than presenting a study to prove performance against specific acceptance criteria for a new, distinct device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not available in the provided text.
The document primarily focuses on:
- Product Description: Venturi Phaco Packs are accessories for Bausch & Lomb microsurgical systems, used for ultrasonic disintegration of cataracts.
- Substantial Equivalence Claim: The redesigned DP4310 and new DP4305 Venturi Phaco Packs are claimed to be substantially equivalent to existing DP4310, DP4330, and DP4345 packs.
- Comparison Matrix: This table details component similarities (e.g., collection cassette, I/A tube set, sterilization method, intended use, sterility assurance level, single-use nature) between the currently marketed and proposed packs. The key differences noted are the quantity of some components (e.g., Test Chamber, Irrigation Sleeve) and the inclusion/exclusion of Phaco Needle and 2.5mm Slit Knife in specific packs.
- Intended Use: "The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery."
- Regulatory Clearance: The document includes the FDA's 510(k) clearance letter, indicating that the device is substantially equivalent to legally marketed predicate devices.
In summary, the provided text does not contain the detailed study information requested, as it is a 510(k) submission for substantial equivalence based on component comparison and intended use, rather than a de novo clinical performance study against specified acceptance criteria.
§ 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.