The system is intended to be used by a trained qualified physician in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular, trans-rectal, obstetrics/ gynecology and urology applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, CWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).

Device Description

The SIUI Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Ultrasound Imaging System capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).

The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex, phased array and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

This system is a Track 3 device and the software used in Apogee 6500 / Apogee 6300/Apogee 6200 Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Level of Concern for the Ultrasound Software is Moderate.

AI/ML Overview

The provided text is a 510(k) summary for the Apogee 6500, Apogee 6300, and Apogee 6200 Digital Color Doppler Ultrasound Imaging Systems. This document aims to demonstrate substantial equivalence to a legally marketed predicate device (Apogee 5500).

Based on the provided information, the device is an ultrasound imaging system, not an AI/ML-driven device, and therefore the majority of the requested information (acceptance criteria, specific study details for AI/ML performance, ground truth, expert adjudication, MRMC studies) is not applicable or not provided in this type of regulatory document.

Here's an breakdown of the available information in response to your request, and why some parts cannot be answered from this document:

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

This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria for a novel AI/ML algorithm. The performance is assessed by comparison to the predicate device and compliance with relevant international standards.

Acceptance Criteria (Implied for Substantial Equivalence): The device is substantially equivalent if it has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate device.
Reported Device Performance:
- Intended Use: Same as the predicate device (Apogee 5500, K160853).
- Technical Characteristics: Basic and key technical features (Operation Principle, Operation Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management) are the same as the predicate.
- Acoustic Power Levels: Meet FDA limits, same as the predicate device.
- Materials of Probes: Same as the predicate device.
- Probes: Similar probes as the predicate, with two new transducers (P5FC and V6LF) whose applications fall within the predicate's indications for use.
- Safety and Efficacy: Differences between the new device and the predicate have no impact on safety or efficacy and do not raise new potential or increased safety risks. The new device is equivalent in performance to existing legally marketed devices.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. As this is an ultrasound imaging system (not an AI/ML diagnostic algorithm), the performance is assessed through engineering tests, compliance with safety standards, and comparison of technical specifications to the predicate device. There is no "test set" in the context of image classification or detection algorithms with associated ground truth labels to be tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. Ground truth establishment using expert review is relevant for AI/ML performance studies, which are not described in this 510(k) summary for an ultrasound imaging system.

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

Not applicable / Not provided. Adjudication is relevant for resolving discrepancies in expert labeling of imaging data for AI/ML algorithm development/testing, which is not the subject of this document.

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. The document explicitly states: "Clinical testing is not necessary for the Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." MRMC studies evaluating human reader performance with and without AI are not mentioned or required for this type of device clearance.

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

Not applicable / Not provided in the context of diagnostic performance. This device is an imaging system, not a diagnostic algorithm. Its "performance" is assessed by its imaging capabilities, safety, and compliance with standards, not a standalone diagnostic accuracy.

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

Not applicable / Not provided. The concept of "ground truth" as used in AI development is not relevant to the substantial equivalence demonstration for this general-purpose ultrasound system. Its performance evaluation relies on engineering verification, compliance with safety standards (e.g., IEC 60601 series), and direct comparison of specifications and intended use to the predicate device.

8. The sample size for the training set:

Not applicable / Not provided. This is not an AI/ML algorithm requiring a training set. The "software" mentioned (Ultrasound Software by SIUI) is based on the predicate device's software and its "Level of Concern" is Moderate, implying it was developed and validated through standard software engineering practices for medical devices (e.g., IEC 62304), not through machine learning training on a dataset.

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

Not applicable / Not provided. As there is no AI/ML training set, the establishment of ground truth for such a set is not relevant.

In summary, this 510(k) pertains to a new generation of an existing ultrasound imaging system, demonstrating its substantial equivalence to a previously cleared model. The evaluation focuses on hardware, software (system-level, not AI/ML), safety standards, and technical specifications, rather than clinical performance metrics typically associated with AI/ML-driven diagnostic aids.

Summary

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Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Flower Cai Liaison Manager 77 Jinsha Road Shantou. Guangdong 515041 CHINA

Re: K210318

Trade/Device Name: Apogee 6500, Apogee 6300, Apogee 6200 Digital Color Doppler Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 8, 2021 Received: July 12, 2021

August 18, 2021

Dear Flower Cai:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K210318

Device Name

Apogee 6500 Digital Color Doppler Ultrasound Imaging System Apogee 6300 Digital Color Doppler Ultrasound Imaging System Apogee 6200 Digital Color Doppler Ultrasound Imaging System

Indications for Use (Describe)

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

This summary of 510(k) safety and effectiveness information is provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

The assigned 510(k) number is: _ K210318

5.1 Submitter

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)

77 Jinsha Road, Shantou, Guangdong 515041, China

Tel: 86-754-88250150

Fax: 86-754-88251499

Contact Person: Flower Cai

Shantou Institute of Ultrasonic Instruments Co., Ltd.

77 Jinsha Road, Shantou, Guangdong 515041, China

Date Prepared: July 29, 2021

5.2 Device

Name of Device:

Apogee 6500 Digital Color Doppler Ultrasound Imaging System Apogee 6300 Digital Color Doppler Ultrasound Imaging System Apogee 6200 Digital Color Doppler Ultrasound Imaging System 510(k) submitter: SIUI

Classification Name:

Ultrasonic pulsed Doppler imaging system	90-IYN (per 21 CFR 892.1550)
Ultrasonic pulsed echo imaging system	90-IYO (per 21 CFR 892.1560)
Diagnostic ultrasonic transducer	90-ITX (per 21 CFR 892.1570)

TAB 2 Section 5

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Regulatory Class: II

Product Code: IYN, IYO, ITX

5.3 Predicate Device

Name of Predicate Device:

Apogee 5500 Digital Color Doppler Ultrasound Imaging System (K160853)

510(k) holder: SIUI

Regulatory Class: II

Product Code: IYN, IYO, ITX

Classification Name:

Ultrasonic pulsed Doppler imaging system	90-IYN	(per 21 CFR 892.1550)
Ultrasonic pulsed echo imaging system	90-IYO	(per 21 CFR 892.1560)
Diagnostic ultrasonic transducer	90-ITX	(per 21 CFR 892.1570)

5.4 Device Description

5.4.1 Description

This system is a Track 3 device and the software used in Apogee 6500 / Apogee 6300/Apogee 6200 Digital Color Ultrasound Imaging System is Ultrasound Software

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by SIUI and is based on the predicate device. The Level of Concern for the Ultrasound Software is Moderate.

5.4.2 Comparisons of Apogee 6500/Apogee 6300/Apogee 6200 devices

The Apogee 6500/ Apogee 6300/ Apogee 6200 use the same safe critical components, with the same circuit modules and working principles. The mechanical structure is designed for the market requirements of the devices according to the requirements of international general safety standard (IEC 60601-1). The hardware design is exactly the same for Apogee 6500/ Apogee 6300/ Apogee 6200. Subject to market positioning, the Apogee 6500/ Apogee 6300/Apogee 6200 have different software functional configurations. See the table below.

Product Model	Apogee 6500	Apogee 6300	Apogee 6200
Photo
Functionalconfiguration	XBeam✓	XBeam◯	XBeam✓
	Panoscope✓	Panoscope✓	Panoscope◯

Note: "y" means "standard configuration", "o" means "option configuration".

5.5 Indications for Use

The system is intended to be used by a trained/qualified physician in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular, trans-vaginal, trans-rectal, obstetrics/ gynecology and urology applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector

TAB 2 Section 5

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Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).

Comparison of Technological Characteristics with the Predicate Device 5.6

The Apogee 6500/Apogee 6300/Apogee 6200 Digital Color Doppler Ultrasound Imaging Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to the predicate device.

Type	Manufacturer	Device	510 (K) Number
Predicate device	SIUI	Apogee 5500 Digital ColorDoppler UltrasoundImaging System	K160853

For the intended use and technical specifications on the SIUI Apogee 6500/Apogee 6300/Apogee 6200, the claim of substantial equivalence to devices currently having FDA 510(k) clearance is SIUI Apogee 5500 Digital Color Doppler Ultrasound Imaging System (K160853).

For the transducers on the SIUI Apogee 6500/Apogee 6300/Apogee 6200, the claim of substantial equivalence to devices currently having FDA 510(k) clearance are SIUI Apogee 5500 Digital Color Doppler Ultrasound Imaging System (K160853).

Intended Use Comparison:

Compared with the predicate device Apogee 5500 (K160853), the Subject Devices have the same intended use.

Technical Characteristics Comparison:

The basic and key technical features of the subject Device are the same as the predicate device Apogee 5500 (K160853), including Operation Principle, Operation Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management.

Acoustic power levels Comparison:

The Acoustic power levels of subject devices meet the limits of FDA same as the predicate device Apogee 5500 (K160853)

Materials of probes Comparison:

The materials of probes with subject device are same as the predicate device of Apogee 5500 (K160853).

Probes Comparison:

Apogee 6500/Apogee 6300/Apogee 6200 has similar probes as the predicated device

TAB 2 Section 5

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of Apogee 5500. The proposed Apogee 6500/Apogee 6300/Apogee 6200 adds two new transducers P5FC and V6LF to the system. Applications for these probes are within the indications for use of the predicate system Apogee 5500 (K160853). The application range and probe type of the P5FC probe is the same as that of the P3FC probe for the predicate device Apogee 5500 (K160853). The application range of the V6LF probe is the same as that of the V6LC probe for the predicate device Apogee 5500 (K160853).

Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices.

5.7 Non-clinical Testing Summary

The Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System comply with and/or were tested in accordance with the following FDA guidance and International Standards:

. IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. IEC60601-1-2:2014 Medical electrical equipment requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
. 60601-2-37:2007+A1:2015 | Medical | electrical | equipment | - | Part IEC 2-37:Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
. IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
. ISO 14971:2019 Medical devices - Application of risk management to medical devices
ISO 10993-1:2018 Biological evaluation of medical devices Part1: Evaluation ● and testing within a risk management process
. ISO 10993-5:2009 Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10:Tests for .

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irritation and skin sensitization

IEC 62304:2006+A1:2015 Medical device software - Software life cycle processes
IEC 60601-1-6:2010+A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366-1:2015/COR1:2016 Medical devices – Part 1: Application of usability engineering to medical devices
ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
. ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
. Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

The subject device and the predicate device are comparable in terms of technical features, general functions, applications and intended uses. The test results showed compliance with the above standards. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate.

5.8 Clinical Testing

Clinical testing is not necessary for the Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device.

5.9 Conclusion

The subject device Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System and the predicate device SIUI Apogee 5500 Digital Color Doppler Ultrasound Imaging System are comparable in terms of technical features, general functions, applications and indications for use.

Therefore, SIUI Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System is substantially equivalent with respect to safety and effectiveness of the predicate device currently cleared for market.

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Appendix

Acronym	Full Name
CFM	Color Flow Map
CPA	Color Power Angio
DPA	Directional Power Angio
PWD	Pulsed Wave Doppler
CWD	Continuous Wave Doppler
THI	Tissue Harmonic Imaging
TDI	Tissue Doppler Imaging
MFI	Macro fidelity Imaging
VS Flow	Vector Space Flow

1. Acronyms and full names of imaging modes

2. Equivalent Names of Subject Device

EquivalentNames ofSubjectDevice	Apogee 6500 Digital Color Doppler Ultrasound Imaging SystemApogee 6300 Digital Color Doppler Ultrasound Imaging SystemApogee 6200 Digital Color Doppler Ultrasound Imaging System
	Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color UltrasoundImaging System
	Apogee 6500/ Apogee 6300/ Apogee 6200
	Apogee 6500 series

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.