The SonoScape S22 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), OB/Gyn and Urology.

Device Description

This SonoScape S22 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

AI/ML Overview

The SonoScape S22 Digital Color Doppler Ultrasound System is a diagnostic ultrasound system. Based on the provided FDA 510(k) summary (K142815), here's an analysis of its acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical targets and corresponding device performance metrics for the S22 system in the typical sense of a novel algorithm or AI device. Instead, the "acceptance criteria" are implied by the conformity to established medical device standards and the demonstration of substantial equivalence to predicate devices, particularly regarding safety and effectiveness.

However, the document does mention "design specifications" and that the system "met all design specifications." For the specific feature of Elastography, it states that "Elastography performance met design specifications, including accuracy and repeatability of strain-ratio measurement and etc."

Based on the information, a hypothetical table reflecting the mentioned information would look like this:

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1	System found to be compliant with IEC 60601-1.
Mechanical Safety	Design specifications met	System met all design specifications.
Thermal Safety	Compliance with IEC 60601-2-37	System found to be compliant with IEC 60601-2-37.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	System found to be compliant with IEC 60601-1-2.
Biocompatibility	Compliance with ISO 10993-5, ISO 10993-10	Probes found to be compliant with ISO 10993-5 and ISO 10993-10.
Acoustic Output	Compliance with UD2, UD3 and consistent with predicate devices	System found to be compliant with UD2 and UD3. Acoustic output levels are consistent with predicate devices, suggesting they are within safe and effective limits.
Elastography Performance	Met design specifications for accuracy and repeatability of strain-ratio measurement	Phantom test showed excellent performance for strain Elastography, meeting design specifications, including accuracy and repeatability of strain-ratio measurement. The function was found to be effective. (No specific numerical values provided in the summary, but stated as "met design specifications").
Overall Safety & Effectiveness	Substantially equivalent to predicate devices (SonoScape S30 K132527, Philips EPIQ K132304)	System demonstrated substantial equivalence to predicate devices regarding safety and effectiveness, indicating it performs as intended and is as safe and effective as devices already on the market.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical testing was required." Therefore, there is no test set of patient data of the type typically associated with outcome or diagnostic accuracy studies for this submission. The testing revolved around device standards and phantom studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no clinical testing involving patient data was required or performed, there were no experts used to establish ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring human interpretation, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The submission demonstrates substantial equivalence primarily through technical comparisons and compliance with established standards, not through studies showing human reader improvement with or without AI assistance.

6. If a Standalone Performance Study Was Done

While not a "standalone performance study" in the context of AI algorithm only without human-in-the-loop, the document describes laboratory tests and a phantom test for the S22 system's functions and performance.

Laboratory tests: These were conducted to verify that the system met all design specifications and conformed to applicable medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3). This essentially acts as a rigorous standalone check against engineering and safety criteria.
Phantom Test for Elastography: A specific phantom test was performed "to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain-ratio measurement and etc." This is a standalone evaluation of the Elastography feature's technical performance using a controlled phantom.

7. The Type of Ground Truth Used

For regulatory compliance and safety/performance standards (electrical, mechanical, thermal, EMC, biocompatibility, acoustic output), the "ground truth" is defined by the specifications within the cited international and national standards (e.g., IEC, ISO, UD2/UD3). The device's output and performance are measured against these established quantitative and qualitative criteria.
For the Elastography phantom test, the "ground truth" would be the known physical properties of the phantom material and the expected strain-ratio measurements, as defined by the phantom's design and engineering specifications.

8. The Sample Size for the Training Set

The S22 Digital Color Doppler Ultrasound System is described as an "integrated preprogrammed color ultrasound imaging system" and a "software controlled" system. While it uses complex algorithms for image processing and display (B-Mode, M-Mode, Color-Flow Doppler, etc., and features like Elastography), the document does not indicate that this specific device underwent a machine learning or AI training process that would require a "training set" of data to develop its core functionality. These systems typically rely on pre-programmed algorithms based on physics and signal processing, often optimized through extensive engineering rather than data-driven machine learning. Therefore, a "training set" of the kind used for AI development is not mentioned and likely not applicable to how this device's algorithms were developed or validated for this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

As no "training set" in the context of machine learning/AI development is indicated, the concept of establishing ground truth for such a set is not applicable to this 510(k) summary. The "ground truth" for the device's development and validation would instead stem from fundamental physics, engineering principles, and the specifications of the standards it adheres to.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 28, 2015

Sonoscape Company Limited % Mrs. Toki Wu Regulatory Affairs Manager Yizhe Building, Yuquan Road, Nanshan Shenzhen Guandong 518051 P.R. CHINA

Re: K142815

Trade/Device Name: S22 Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 29, 2014 Received: January 09, 2015

Dear Mrs. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142815

Device Name

S22 Digital Color Doppler Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Submitter [21 CFR807.92 (a) (1)]

Submitter:	SonoScape Company Limited
Address:	Yizhe Building, Yuquan Road, Nanshan, Shenzhen518051, P.R.China
Contact Person:	Toki Wu
Tel:	+86 755 26722890
Fax:	+86 755 26722850
Email:	wusq@sonoscape.net
Date Prepared	August 29, 2014

2. Device [21 CFR807.92 (a)(2)]

Trade Name:	S22 Digital Color Doppler Ultrasound System
Common Name:	Diagnostic Ultrasound System and Transducers

Classification Regulatory:

	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

Classification Panel: Radiology Device Class: ll

3. Predicate Device(s) [21 CFR 807.92(a) (3)]

The identified predicate devices within this submission are as follows:
SonoScape S30 Digital Color Doppler Ultrasound System	K132527
Philips EPIQ Diagnostic Ultrasound System	K132304

4. Device Description [21 CFR 807.92(a) (4)]

The basic principle is that system transmits ultrasonic energy into patient body and

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implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

5. Intended Use [21 CFR 807.92(a)(5)]

The SonoScape S22 system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal. Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), OB/Gyn and Urology.

6. Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]

S22 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate devices:

SonoScape S30 Digital Color Doppler Ultrasound System	K132527
Philips EPIQ Diagnostic Ultrasound System	K132304

Intended Use Comparison:

Compared with SonoScape S30 (K132527), the Subject Device S22 has the same intended uses.

Technical Characteristics Comparison:

The basic and main technical features of the subject device S22 are the same as the predicated device S30 (K132527), including Design, Operation Controls, Display Modes, Measurement Items, Cine Loop and Operating and Storage Condition.

For Operation Modes, Elastography is a special Operation Mode for the Subject Device S22, but already employed by many marketed devices and considered Substantially Equivalent to the Predicate Device Philips EPIQ (K132304) and detailed comparison analysis can be found in Substantial Equivalence Comparison.

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The detailed technical features comparison and analysis can be found in Substantial Equivalence Comparison and the detailed technical features can be found in General Device Descriptions of the submission.

Probes Comparison:

Subject device S22 has the similar probes as the predicated device SonoScape S30 (K132527).

Subject deviceSonoScape S22	Predicate DeviceSonoScape S30	Remark
C322 Micro-curved Array	C322 Micro-curved Array
C344 Curved Array	C344 Curved Array
C353 Curved Array	C353 Curved Array	SEAnalysis 1
C354 Curved Array	C362 Curved Array
C542 Curved Array	C542 Curved Array
VC6-2 Curved Array	VC6-2 Curved Array	Same
C613 Micro-curved Array	C611 Micro-curved ArrayC311 Micro-curved Array	SEAnalysis 1
2P1 Phased Array	2P1 Phased Array	Same
5P1 Phased Array	5P1 Phased Array
L741 Linear Array	L741 Linear Array
L742 Linear Array	L742 Linear Array
L752 Linear Array	L743 Linear ArrayL752 Linear Array	Same
10L1 Linear Array	10L1 Linear Array
6V1 Micro-curved Array	6V1 Micro-curved Array
6V3 Micro-curved Array	6V3 Micro-curved Array
EC9-5 Micro-curved Array	EC9-5 Micro-curved Array	Same
BCC9-5 Micro-curved Array	BCC9-5 Micro-curved Array
BCL10-5 Biplane (Micro-curved + Linear Array)	BCL10-5 Biplane (Micro-curved +Linear Array)
MPTEE Phased Array(Multi-plane)	MPTEE Phased Array(Multi-plane)	Same
MPTEE mini Phased Array(Multi-plane)	MPTEE mini Phased Array(Multi-plane)

Table 1 Probes Comparison

SE Analysis 1:

Compared with the predicate device, there are only two new probes (C354 and C613) for the subject device, but no new intended use. And the frequency and performance of C354 and C613 probes is the same as C353 and C611 respectively for predicate device.

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Moreover, compared with predicated devices, the subject device (S22) complies with the same regulation and safety standards and has the consistent acoustic output levels. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

7. Non-Clinical Tests [21 CFR 807.92(b) (1)]

The S22 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.

Laboratory tests were conducted to verify that the S22 system met all design specifications and the S22 system conformed to applicable medical device standards. Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strainratio measurement and etc.

The S22 system has been designed and manufactured to meet the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3.

8. Clinical Test [21 CFR 807.92(b) (2)]

No clinical testing was required.

9. Substantially Equivalent Conclusions [21 CFR 807.92(b) (3)]

In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S22 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.

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.