FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 6/Resona 5/Resona 57/ Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.

Device Description

The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, TDI mode, Color M, Strain Elastography, 3D/4D mode, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array. Phased array and convex array.

AI/ML Overview

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Resona 6/Resona diagnostic ultrasound system. It indicates that the device has been evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices, and no clinical studies were deemed necessary or performed to support this submission.

Therefore, I cannot provide details on acceptance criteria and a study that proves the device meets those criteria from the given text, as no such clinical study was conducted. The information provided heavily emphasizes non-clinical testing and comparison to predicate devices, which is typical for 510(k) submissions demonstrating substantial equivalence rather than novel device performance.

However, based on the information implicitly stating that non-clinical tests were sufficient to demonstrate substantial equivalence to predicate devices, we can infer the "acceptance criteria" are compliance with established regulatory standards and the performance of the predicate device.

Here's an analysis of what would be relevant if a clinical study had been performed, and how the available information relates to the request:

Based on the provided document, no clinical study was conducted to prove the device meets specific acceptance criteria in a clinical setting. The submission relies on non-clinical tests and comparison to a legally marketed predicate device (Mindray Resona 7, K171233) to demonstrate substantial equivalence.

Therefore, the following points in your request cannot be directly answered from the provided text:

Table of acceptance criteria and reported device performance (from a clinical study): Not available. The document states "Non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device." The acceptance criteria are implicitly that the device performs equivalently to the predicate and meets safety standards, as demonstrated by non-clinical means.
Sample size used for the test set and data provenance: No clinical test set.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable as there was no clinical test set/ground truth established in a clinical setting.
Adjudication method 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 device is an ultrasound system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the established performance metrics and safety standards.
The sample size for the training set: Not applicable as no AI/machine learning model is described.
How the ground truth for the training set was established: Not applicable.

What the document does indicate regarding demonstration of equivalence (which serves as the basis for "acceptance"):

Acceptance Criteria (Implicit - based on Substantial Equivalence): The device is accepted if it is "substantially equivalent" to legally marketed predicate devices. This means it must:

Have the same intended uses.
Have the same technological characteristics, or if different, the differences do not raise new questions of safety and effectiveness and are demonstrated to be as safe and effective as the predicate.
Perform comparably in key safety and effectiveness features.

Reported Device Performance (as demonstrated through non-clinical testing and comparison to predicate):

The document states:

"Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes."
"All systems transmit ultrasonic energy into patients, perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations."
It has the "same intended uses" as the predicate device Resona 7 (K171233).
"The patient contact materials of the transducers are tested under ISO 10993-1."
"The acoustic power levels... are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)."
"designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)."
"has the same imaging modes as the predicated devices."
"All of the functions... are the same as the predicated devices."
"has similar transducers with the predicated devices."

Summary of "Acceptance Criteria" and "Device Performance" as inferred from the 510(k) summary:

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as per 510(k) Summary)
1. Same Intended Use as Predicate: Applicable for adults, pregnant women, pediatric patients, and neonates; for use in fetal, abdominal, pediatric, small organ, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.	The subject device has the "same intended uses and basic operating modes" as the predicate device Resona 7 (K171233). Specific applications listed match the predicate.
2. Same Technological Characteristics (or equivalent safety/effectiveness): Utilizing B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape, TDI, Color M, Strain Elastography, 3D/4D, Contrast imaging (Liver/LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ, and combined modes.	The subject device "has the same technological characteristics," "same imaging modes," "all of the functions... are the same," and "similar transducers" as the predicate devices.
3. Safety Standards Compliance:	"The acoustic power levels... are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)."

"designed in compliance with the FDA recognized electrical and physical safety standards," specifically:

NEMA UD 2-2004 (R2009) (Acoustic Output)
AAMI/ANSI ES60601-1:2005/(R)2012 (Basic Safety & Essential Performance)
AAMI/ANSI/IEC 60601-1-2:2007/(R)2012 (EMC)
IEC 60601-1-6 Ed. 3.1 (Usability)
IEC 60601-2-37 Ed. 2.0 (Specific Ultrasound Safety)
ISO 14971 (Risk Management)
AAMI/ANSI/ISO 10993-1:2009/(R)2013 (Biocompatibility)
AAMI/ANSI/IEC 62304:2006 (Software Life Cycle)
AAMI/ANSI/IEC 62366:2007/(R)2013 (Usability Engineering) |
| 4. Biocompatibility: Patient contact materials meet safety standards. | "The patient contact materials of the transducers are tested under ISO 10993-1." |
| 5. Cleaning and Disinfection Effectiveness. | "evaluated for... cleaning and disinfection effectiveness" (no specific results provided, but compliance is stated). |
| 6. Thermal, Electrical, and Mechanical Safety. | "evaluated for... thermal, electrical and mechanical safety" (no specific results provided, but compliance is stated). |

In conclusion, the document explicitly states that no clinical studies were conducted for this 510(k) submission. The device's acceptance is based on demonstrating substantial equivalence to a predicate device through comprehensive non-clinical testing and adherence to recognized safety and performance standards.

Summary

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.