APLIO ARTIDA V2.0 SSH-880CV

• K Number: K090158
• Device Name: APLIO ARTIDA V2.0 SSH-880CV
• Manufacturer: TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
• Date Cleared: 2009-02-06 ( 15 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K080160 , K082119

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: cardiac, transesophageal, abdominal and peripheral vascular.

Device Description

This device is a mobile system is a Track 3 device that employs a wide range of probes that include flat linear array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Toshiba Aplio™ Artida (v2.0) SSH-880CV Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Instead, the document focuses on:

• Device Identification: Name, submitter, regulatory classifications.
• Predicate Devices: Lists previously cleared Toshiba ultrasound systems (K080160, K082119). The current device is considered substantially equivalent to these.
• Device Description: Mobile system, range of probes (flat linear array, sector array), frequency range (2.5 MHz to 7.5 MHz).
• Intended Use/Indications for Use: Specifies the types of studies the device is intended for (cardiac, transesophageal, abdominal, peripheral vascular) and indicates which clinical applications and modes of operation are "new" (N) or "previously cleared" (P) for various transducers (PST-25SX, PST-30BT, PST-30SBT, PST-50BT, PST-65AT, PLT-704SBT, PET-511BTM, PC-20M). The key new indication for the main system, as stated in the "Reason for Submission," is "abdominal."
• Declaration of Conformity: Lists the standards the device is designed and manufactured in conjunction with (e.g., IEC 60601-1, AIUM-NEMA UD2/UD3).
• FDA Clearance Letter: Confirms the FDA's determination of substantial equivalence based on the provided information.

Since the submission is for substantial equivalence, clinical performance data demonstrating specific acceptance criteria with detailed metrics is typically not required as it would be for a novel device or a Premarket Approval (PMA). The FDA determined substantial equivalence based on the device's technological characteristics, intended use, and adherence to relevant performance standards.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.