(228 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Intra-luminal (B Mode)
Endoscopically Deliverable Ultrasound Point Probe System (SP-701) with transducers PL-1726-20, PL-1726-15, PL-1726-12, PL-1926-20, PL-1926-15, PL-1926-12, PL-2226-20, PL-2226-15, PL-2226-12.
The provided text is a 510(k) premarket notification letter from the FDA to Fuginon, Inc. regarding their Endoscopically Deliverable Ultrasound Point Probe System (SP-701). This document approves the device for marketing based on substantial equivalence to previously marketed devices. However, it does not contain a study that proves the device meets acceptance criteria. Instead, it outlines the regulatory classification and general controls, and importantly, requires a post-clearance special report with acoustic output measurements based on production line devices. This means the specific performance data for acceptance criteria would be generated after this clearance, not before this document was issued.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
- Standalone (algorithm only) performance study results
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on the regulatory clearance process rather than detailed performance study results. The closest information related to performance acceptance is the requirement for a post-clearance special report containing acoustic output measurements, which implicitly suggests that certain acoustic output levels would need to be met for the production units to be considered compliant.
Summary of available information:
- Device: Endoscopically Deliverable Ultrasound Point Probe System (SP-701) with various transducers.
- Regulatory Status: Substantially equivalent to previously marketed devices (K971528).
- Key Requirement Post-Clearance: Submission of a "post-clearance special report" including "complete information, including acoustic output measurements based on production line devices." This indicates that performance data, specifically acoustic output, is a critical aspect for ensuring compliance after initial clearance.
- Intended Use: Diagnostic ultrasound imaging or Doppler analysis of the human body, specifically for Intra-luminal applications across all listed transducers (PL-1726-20, PL-1726-15, PL-1726-12, PL-1926-20, PL-1926-15, PL-1926-12, PL-2226-20, PL-2226-15, PL-2226-12). For transducers PL-2220-20 and SP-701 Transducer P1-1926-12, they state only "Intra-luminal" (not A or B mode).
No study details are provided in this document regarding how the device initially met any acceptance criteria to establish substantial equivalence, other than the general statement of "reviewed your section 510(k) notification...and we have determined the device is substantially equivalent."
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.