(47 days)
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
FibroScan® system consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology, and is designed to perform non-invasive measurements of liver shear wave speed and estimates of tissue stiffness. The probe containing a mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness. The results are displayed on the system unit.
This 510(k) submission (K173034) by Echosens for its FibroScan® Family of Products primarily focuses on a revision of the Indications for Use (IFU), changing "an aid to clinical management" to "an aid to diagnosis and monitoring" for adult patients. The submission explicitly states that no new hardware or software elements were included, and therefore, no new performance data were required in support of the submission.
This means that the document does not contain a new study proving the device meets new acceptance criteria related to its diagnostic and monitoring capabilities. Instead, it relies on the safety record and broad clinical use of the already cleared devices.
Therefore, many of the requested details regarding acceptance criteria and a new study are not present in the provided text. I will extract the information that is available based on the request and clearly state what is not found.
Acceptance Criteria and Device Performance
Since this submission is a revision of the Indications for Use and states "No new performance data were required," there are no new acceptance criteria or reported device performance metrics presented in this document specifically for the revised IFU. The document implicitly relies on the performance proven during the clearance of the predicate device (K160524) and prior versions of the FibroScan systems.
Study Details (for a new study validating the "aid to diagnosis and monitoring" claim)
No new study is presented in this 510(k) submission to demonstrate that the device meets new acceptance criteria for the revised "aid to diagnosis and monitoring" claim. The submission explicitly states: "No new hardware or software elements were included in the submission. Therefore, no new performance data were required in support of the submission."
Based on this, the following information is not applicable or not found in the provided text:
- Sample size used for the test set and the data provenance: Not applicable, as no new performance study is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a standalone device, and no MRMC study for AI assistance is mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The FibroScan is inherently a "standalone" device in the sense that it provides measurements directly. However, the submission does not detail a new standalone performance study for the revised IFU. It relies on previously established performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study in this submission.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information from the document regarding studies and performance:
The basis for the revised Indications for Use (from "aid to clinical management" to "aid to diagnosis and monitoring") is stated as:
- "Its perfect safety record and broad clinical use as an aid to the diagnosis and monitoring of adult patients with liver disease support the revision of its indications for use."
- This suggests reliance on post-market surveillance, existing clinical practice, and prior clearance data rather than a new, specific clinical performance study for this particular change.
The submission focuses heavily on non-clinical testing to assure compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electromagnetic, and mechanical safety, conforming to applicable standards (listed in the "Recognized Consensus Standards Used" section). This indicates that the device's fundamental physical and safety performance was established previously and confirmed to meet current standards.
§ 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.