(269 days)
The swiftPro™ System is a surface based device intended for the coagulation of soft tissue during non-invasive procedures.
The swiftProTM System is not indicated for use in cardiac procedures.
The swiftPro® system is a hand-held microwave generator intended to provide the functionality of the Swift® microwave treatment system in a compact and portable package. The system comprises a hand-held microwave generator and an applicator tip assembly. The generator produces microwave energy at a frequency of 8 GHz with a maximum output power of 6 Watts, the output power is restricted depending on the applicator tip attached, which delivers the microwave energy to the tissue to effect thermal heating, The swiftPro® System interface is intuitive with a quick setup for setting treatment; output power level & treatment duration (seconds). The applicator tip and the handheld generator have been designed to be only connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. The SwiftPro® applicator tips have been designed to prevent re-use to mitigate the risk of cross-contamination.
The SwiftPro® system compromises of the following components:
- SwiftPro® Handheld Generator
- SwiftPro® Cradle
- SwiftPro® URT Applicator tip (non-sterile, single use)
- SwiftPro® LRT Applicator tip (non-sterile, single use)
The provided text describes a medical device called the swiftPro™ System and its comparison to a predicate device, the Swift® System, to demonstrate substantial equivalence for FDA clearance. However, the document does not contain information about acceptance criteria, reported device performance in the context of clinical or diagnostic accuracy, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as typically apply to AI/ML powered devices.
The document focuses on the engineering and safety aspects of an electrosurgical cutting and coagulation device. The "performance data" section refers to:
- Biocompatibility testing
- Electrical safety and electromagnetic compatibility (EMC)
- Software verification and validation testing
- Cybersecurity
- Human Factors and Usability Engineering
- Bench Testing (thermal effects analysis in ex-vivo porcine skin, bovine liver, porcine kidney, and porcine muscle)
These are technical performance characteristics of the device itself and not related to diagnostic accuracy or clinical effectiveness in a way that would require the typical AI/ML study details requested in the prompt.
Therefore, I cannot populate the requested table and information based on the provided text, as the nature of the device and its evaluation for FDA clearance (as described here) do not involve those types of criteria or studies. The device is for "coagulation of soft tissue," which is a direct physical action, not a diagnostic or AI-assisted interpretation task.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.