PORTASCAN BLADDER SCANNER, MODEL PA00146

• K Number: K033906
• Device Name: PORTASCAN BLADDER SCANNER, MODEL PA00146
• Manufacturer: MEDIWATCH PLC
• Date Cleared: 2003-12-24 ( 7 days)
• Product Code: IYO
• Regulation Number: 892.1560
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K020112
• Predicate For: K143493

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal (new indication)

Device Description

Portascan Bladder Scanner; Portascan Probe (3.5 MHz/5.0 MHz Transabdominal & Bladder)

AI/ML Overview

This looks like an FDA 510(k) clearance letter for the Portascan Bladder Scanner, not a study document. It establishes substantial equivalence to a predicate device and gives permission to market the device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It doesn't describe the performance of the device, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The provided text only contains:

• Regulatory Information: Device name, regulation numbers, product codes, and the FDA's determination of substantial equivalence.
• Intended Use: The clinical applications for which the device is cleared, specifically for "Abdominal" imaging (indicated by 'N' for new indication in the first table of the "Diagnostic Ultrasound Indications for Use Form" for the "Portascan System"). The second table identifies the "Portascan Probe" manufactured by Pie Medical with a previous 510(k) number as the system.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report from the 510(k) submission.

Regulation Number and Section

§ 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.