(557 days)
The Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels following reconstructive microvascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for onetime use.
The Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for one-time use. The device is supplied sterile and is intended for one-Reasonable assurance of biocompatibility of time use. the materials comprising the Swartz Doppler Flow Probe is provided by their established history of use in medical product manufacturing.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for the Swartz Doppler Flow Probe and Monitor System (K964001).
The 510(k) summary outlines the device description, its intended use, and claims substantial equivalence to predicate devices based on indications for use, materials, and physical construction. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.
However, neither document includes the specific details requested in your prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- Method for establishing ground truth for the training set.
The FDA clearance for this device, which was approved in 1998, relies on substantial equivalence to predicate devices rather than requiring extensive clinical performance studies as might be seen for novel or high-risk devices today. The closest information related to performance assessment is the requirement for a "postclearance special report" with "acoustic output measurements based on production line devices," but this is an engineering requirement, not a clinical performance study against acceptance criteria.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.