The Labat series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small organ (breast, thyroid, testes,etc.), neonatal cephalic, adult cephalic, trans-vaginal, trans-rectal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), trans-esoph.(cardiac), peripheral vessel and urology exams.

The operator for Labat series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics.

Modes of operation include: B-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging, Anatomic M and combined mode.

Device Description

The proposed Labat series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.

The Labat series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Nine models for the main units are included in this submission, that is Labat SE, Labat SP, Labat SG, Labat PE, Labat PG, Labat TE, Labat TG, Labat IE and Labat IG. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, Holo PW, Anatomic M (AMM), Tissue Doppler Imaging (TDI) and the combined modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.

The Labat series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG cables, gel warmer, magnetic cup, foot switch, barcode reader, laser marker. TEE( transesophageal echocardiography) architecture arm, etc.

Ten different models of probes are available for the Labat series, that is C6-1B-H, C8-3-H, L15-4WB-H, L15-4NB-H, L22-10-H, L15-6-H, LH15-6-H, SP5-1-H, EV11-3-H, P7-3T-H.

AI/ML Overview

The provided text describes the Labat series Diagnostic Ultrasound System (K210154). However, it does not contain information about acceptance criteria for device performance or a study that proves the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Mindray TE7/TE5 Diagnostic Ultrasound System, K180912) and conformity to various safety and performance standards. It explicitly states: "The subject of this premarket submission, Labat series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving specific performance metrics, as this information is not present in the provided text.

The closest information available that might relate to "acceptance criteria" and "performance" are the compliance with recognized standards for safety and acoustic output, but these are not diagnostic performance metrics.

I can, however, extract other requested information that is present in the document:

1. A table of acceptance criteria and the reported device performance:

Not applicable (N/A): The document does not specify acceptance criteria relating to diagnostic performance (e.g., sensitivity, specificity, accuracy) or report such performance for the Labat series Diagnostic Ultrasound System. It focuses on safety and technical compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

N/A: No clinical test set data is described, as the device "did not require clinical studies to support substantial equivalence." The performance data shared relates to engineering and biocompatibility testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

N/A: No clinical test set or ground truth determination by experts is mentioned, as no clinical studies were performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A: No clinical test set and thus no adjudication method is described.

5. 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:

No: No MRMC study was done, nor is there any mention of AI assistance in this device's description.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A: No standalone algorithm performance study was mentioned. The device is a diagnostic ultrasound system operated by professional clinical staff.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

N/A: No ground truth for clinical performance is mentioned, as no clinical studies were conducted to assess diagnostic accuracy.

8. The sample size for the training set:

N/A: The document does not describe any machine learning or AI components that would require a "training set" in the context of diagnostic accuracy. The software verification and validation are for the operational software of the device, not for a diagnostic algorithm with a training set.

9. How the ground truth for the training set was established:

N/A: As there is no mention of a training set for a diagnostic algorithm, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Shenzhen Wisonic Medical Technology Co.,Ltd. % Jiang Xiaosan Regulatory Manager 1st, 2nd, 5th & 6th Floor, NO.6 Building, Pingshan Technology Park, Taoyuan Street, Nanshan District Shenzhen, Guangdong 518055 CHINA

July 30, 2021

Re: K210154

Trade/Device Name: Labat series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 8, 2021 Received: June 21, 2021

Dear Jiang Xiaosan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210154

Device Name Labat series Diagnostic Ultrasound System

Indications for Use (Describe)

Modes of operation include: B-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging, Anatomic M and combined mode.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K210154

1. Submitter

Manufacturer:	Shenzhen Wisonic Medical Technology Co., Ltd.
Address:	1st, 2nd, 5th & 6th Floor, NO.6 Building, Pingshan Technology
	Park, Taoyuan Street, Nanshan District, Shenzhen. Guangdong,
	518055, P.R. CHINA
Contact person:	Name:	Jiang Xiaosan
	Phone:	+86-755-86007788
	Fax:	+86-755-86007799
Date prepared:	November 12, 2020
2. Device
Name of Device:	Labat series Diagnostic Ultrasound System
Models:	Labat SE, Labat SP, Labat SG, Labat PE, Labat PG, Labat
	TE, Labat TG, Labat IE and Labat IG.
Common/Usual Name:	Diagnostic Ultrasound System
Regulatory Class	II
Product Code:	IYN, IYO, ITX

3. Device Description

The Labat series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG cables, gel warmer, magnetic cup, foot switch, barcode reader, laser

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marker. TEE( transesophageal echocardiography) architecture arm, etc.

Ten different models of probes are available for the Labat series, that is C6-1B-H, C8-3-H, L15-4WB-H, L15-4NB-H, L22-10-H, L15-6-H, LH15-6-H, SP5-1-H, EV11-3-H, P7-3T-H.

Indications for Use

include: B-Mode, Modes of operation M-Mode, Color Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging, Anatomic M and combined mode.

510(k)Clearance	Trade Name	Manufacturer	Predicate Device
K180912	TE7/TE5 DiagnosticUltrasound System	Shenzhen MindrayBio-MedicalElectronics Co., Ltd	Predicate Device
K163712	Clover 50/Clover 60/Clover 70Diagnostic UltrasoundSystem	Shenzhen WisonicMedicalTechnology Co.,Ltd.	Reference device
K180461	Navi e/ Navi s/ Navi XDiagnostic UltrasoundSystem	Shenzhen WisonicMedicalTechnology Co.,Ltd.	Reference device
K201693	DC-90/ DC-90S/DC-90Q/ DC-95/DC-95S/ DC-88/	Shenzhen MindrayBio-MedicalElectronics Co.,Ltd	Reference device

Comparison of Technological Characteristics between Proposed Subject Device and Predicate Device

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	DC-88S/ DC-80A/
	DC-80AExp/ DC-80A
	Pro/ DC-8X/ DC-8Q/
	DC-81/ DC-82
	Diagnostic Ultrasound System

Labat series Diagnostic Ultrasound System has the same technology as the predicate device(K180912). The proposed device has the same intended uses and similar operation modes as the predicate device. All systems have the same capability in term of measurements and calculation functions .

The proposed device has the same intended uses and probe type as predicate device TE7/TE5(K180912);

The acoustic power levels of the proposed device are below the limits of FDA, which is the same as the predicate device (K180912);

The proposed device has similar operation modes as the predicate device TE7/TE5(K180912), except for Holo PW, AMM and TDI. For Holo PW and TDI, it has been cleared in reference device (K163712). For AMM mode, it can be considered same as reference device (K201693);

The proposed device has the same function, except for Needle Guide System(wiGuide), which detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. This function has similar operating principals and specifications as the reference device (K180461);

This difference in technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate device.

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Labat series Diagnostic Ultrasound System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk

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Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
Sensitization
Irritation or intracutaneous reactivity

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Labat series Diagnostic Ultrasound System. The system complies with the IEC 60601-1, IEC 60601-2-18 and IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "Moderate" level of concern.

Acoustic testing

Acoustic testing is conducted on the Labat series Diagnostic Ultrasound System in accordance with the NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.

Clinical study

The subject of this premarket submission, Labat series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence.

7. Conclusion

The differences between the Labat series Diagnostic Ultrasound System and its predicate device do not raise different questions of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Labat series Diagnostic Ultrasound System should perform as intended in the specified use conditions.

From the results of performance data described, Shenzhen Wisonic concludes that the Labat series Diagnostic Ultrasound System is as safe and as effective as the predicate devices.

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.