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, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, XBeam, Panoscope), and others (3D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).

Device Description

The SIUI Apogee 1000 series (Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W/ Apogee 1 series (Apogee 1T/ Apogee 1T/ Apogee 1G) Digital Color Ultrasound Imaging System is 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, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, THI, TDI, DPA, 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 1000 series / Apogee 1 series 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 document is a 510(k) summary for the SIUI Apogee 1000 series/Apogee 1 series Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and its comparison to a predicate device (SIUI Apogee 2300, K173000) to demonstrate substantial equivalence.

Based on the content, here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Device Performance

The document does not explicitly state specific, quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, or image quality metrics) for the device's performance. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Apogee 2300, K173000) through compliance with recognized standards and a comparison of technological characteristics.

The "device performance" reported is the demonstration that the subject device (Apogee 1000 series/Apogee 1 series) is comparable to the predicate device in terms of:

Intended Use: Both devices have the same intended use.
Technological Characteristics: They share the same PC module, digital signal processing module, and ultrasound front-end module. The overall user interface is substantially unchanged.
Functions: While some models of the subject device may lack the 4D imaging mode present in the predicate, they are similar in "other ultrasonic diagnostic functions, imaging modes, file storage management, compatible peripherals, measurement and calculation functions."
Safety and Effectiveness: Non-clinical tests demonstrate that the subject device performs as well as, and is substantially equivalent with respect to safety and effectiveness of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission for a diagnostic ultrasound system based on substantial equivalence, specific numerical acceptance criteria (like those for AI/CADe devices) are not typically presented in this format. The "acceptance criteria" here are implicitly meeting the regulatory requirements for substantial equivalence by demonstrating comparable technical characteristics and complying with relevant standards.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety: Device meets recognized safety standards.	Complies with IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (EMC), IEC 60601-2-37 (Ultrasonic medical diagnostic), ISO 14971 (Risk management), ISO 10993 (Biological evaluation), IEC 62304 (Software life cycle), IEC 60601-1-6 (Usability), IEC 62366-1 (Usability engineering), ISO 15223-1 (Symbols), ISO 13485 (Quality management systems).
Effectiveness: Device performs as intended.	The subject device performs "as well as" and is "substantially equivalent" to the predicate device (Apogee 2300, K173000) in terms of technical features, general functions, applications, and indications for use. Similarities include: shared PC, digital signal processing, and ultrasound front-end modules; substantially unchanged user interface; comparable ultrasonic diagnostic functions, imaging modes (with the exception of 4D imaging on some subject device models), file storage, peripherals, and measurement/calculation functions. The non-clinical tests confirmed compliance with relevant standards. These tests demonstrate the device's ability to function effectively for its intended diagnostic applications.
Substantial Equivalence: Device is equivalent to predicate.	Non-clinical tests demonstrate that the subject device is "as safe, as effective, and performs as well as the predicate." Differences (e.g., cosmetic design, no 4D mode on some models, new probe models) "have no impact on safety or efficacy" and "do not raise any new potential or increased safety risks."

Study Details

Sample size used for the test set and the data provenance:
- The document describes non-clinical testing to demonstrate compliance with various international standards (e.g., electrical safety, EMC, software lifecycle, biological evaluation).
- It does not mention a "test set" in the context of clinical image data or patient data. The evaluation is primarily based on engineering and performance standards applied to the device itself, rather than testing its diagnostic output against a specific dataset.
- Data provenance is not applicable as this is not a study involving clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of an external "test set" with ground truth established by experts. The "ground truth" implicitly comes from adherence to established engineering and medical device standards.
Adjudication method for the test set:
- Not applicable. No "test set" or adjudication process described.
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, an MRMC comparative effectiveness study was not done.
- This submission is for a general-purpose ultrasound imaging system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device designed to assist human readers or perform automated analysis. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done.
- This device is an imaging system, not an algorithm, and is intended for use by a "trained/qualified physician" (human-in-the-loop).
The type of ground truth used:
- For the non-clinical testing, the "ground truth" is implied by the technical specifications outlined in the international standards (e.g., electrical parameters, mechanical safety, software functionality, biocompatibility). It's not a clinical ground truth like pathology or patient outcomes.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. No training set is mentioned.

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" in a square and the words "U.S. Food & Drug Administration".

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

August 19, 2021

Re: K210317

Trade/Device Name: Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G 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 19, 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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) K210317

Device Name

Apogee 1000/ Apogee 1000Ned Apogee 1000Exp/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 10/ Apogee 1G 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: K210317

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 8, 2021

5.2 Device

Name of Device:

Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W/ Apogee 1U/ Apogee 1T/ Apogee 1G 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)

Regulatory Class: II

Product Code: IYN, IYO, ITX

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5.3 Predicate Device

Name of Predicate Device: Apogee 2300 (K173000)
510(k) holder: 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)
Regulatory Class: II
Product Code: IYN, IYO, ITX

5.4 Device Description

5.4.1 Description

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 1000 series / Apogee 1 series 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.

5.4.2 Comparisons of Apogee 1000 series and Apogee 1 series devices

Except for the cosmetic color, the Apogee 1000 series and Apogee 1 series are completely the same. Subject to market positioning, the Apogee 1000 series/ Apogee 1 series have different functional configurations. See the table below.

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SIUI Apogee 1000 series/ Apogee 1 series Digital Color Doppler Ultrasound Imaging System

	Apogee 1000 series				Apogee 1 series
	Apogee1000	Apogee1000Neo	Apogee1000Lite	Apogee1000Exp	Apogee1000B/W	Apogee1U	Apogee1T	Apogee1G
Photo		Image: Apogee 1000Lite				Image: Apogee 1U
Functionalconfiguration	ContinuousWaveDoppler (CW)	○	○	○	√	○	√	○
	Trapezoidal/ExtendedSector Imaging	○	○	√	○	√	○	√
	Panoscope	○	√	○	○	√	√	√

Note: "○" means "option configuration", "√" means "standard 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, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).

5.6 Comparison of Technological Characteristics with the Predicate Device

The Apogee 1000 series/Apogee 1 series Digital Color Doppler Ultrasound Imaging Systems is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and are substantially equivalent to predicate devices.

The comparison between the overall specifications of predicate device (Apogee 2300 (K173000)) and the subject device (Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W/ Apogee 1U/ Apogee 1T/ Apogee 1G) are as follows:

Compared with the predicate device Apogee 2300, the subject devices have the same intended 1) use.

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In cosmetic design, the subject device has a smaller and lighter structure and appearance. 2) Subject to cosmetic changes, the PCBAs in the system are adjusted in their size and layout, while the overall circuit principle is not changed. The subject device and the predicate device use the same PC module, digital signal processing module, and ultrasound front-end module. Compared with the predicate device, the overall user interface of the subject device has not changed substantially, and the position of the probe connector is adjusted to the side of the device according to the cosmetic structure. As the overall structure dimensions become smaller, the number of probe connectors is less than that of the predicate device by 1. Furthermore, the structure of the monitor is optimized, not only maintaining the up and down invert function of the predicate device, but also to achieve a 90-degree rotation left and right, which improves the user experience.
In terms of functions, compared with the predicate device, the subject device lacks the 4D 3) imaging mode, but both devices are the same in other ultrasonic diagnostic functions, imaging modes, file storage management, compatible peripherals, measurement and calculation functions.
In probe configuration, the subject device supports three new probe models: P5FN, ECBP-1 and 4) ECBP-2. The application range of the P5FN probe (of the subject device) is the same as that of the P3FN probe for the predicate device, and the application range of the ECBP-2 probes (of the subject device) is the same as that of the ECBN probe for the predicate device.
1. The subject device is similar in technological characteristics to the predicate device.

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 1000 series/ Apogee 1 series 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 Part 1-2: General requirements for basic ● safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
IEC 60601-2-37:2007+AMD1:2015 Medical electrical equipment — Part 2-37:Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

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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 device - 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 irritation and skin sensitization
IEC 62304:2006+AMD1:2015 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 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 subject 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 1000 series/ Apogee 1 series Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device.

5.9 Conclusion

The subject device SIUI Apogee 1000 series (Apogee 1000) Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W)/ Apogee 1 series (Apogee 1U/ Apogee 1T/ Apogee 1G) Digital Color Doppler Ultrasound Imaging System and the predicate device SIUI Apogee 2300 Digital Color Doppler Ultrasound Imaging System are comparable in terms of technical features, general functions, applications and indications for use.

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The nonclinical tests (discussed above) demonstrate that Apogee 1000 series (Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W// Apogee 1 series (Apogee 1U/ Apogee 1T/ Apogee 1G) Digital Color Doppler Ultrasound Imaging System performs as well as, and is substantially equivalent with respect to safety and effectiveness of the predicate device currently cleared for market.

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Appendix

Acronyms and full names of imaging modes

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

2. Equivalent Names of Subject Device

EquivalentNames ofSubjectDevice	Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee1000B/W/ Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color DopplerUltrasound Imaging System
	Apogee 1000 Digital Color Doppler Ultrasound Imaging System
	Apogee 1000Neo Digital Color Doppler Ultrasound Imaging System
	Apogee 1000Lite Digital Color Doppler Ultrasound Imaging System
	Apogee 1000Exp Digital Color Doppler Ultrasound Imaging System
	Apogee 1000B/W Digital Color Doppler Ultrasound Imaging System
	Apogee 1U Digital Color Doppler Ultrasound Imaging System
	Apogee 1T Digital Color Doppler Ultrasound Imaging System
	Apogee 1G Digital Color Doppler Ultrasound Imaging System
	Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee1000B/W/ Apogee 1U/ Apogee 1T/ Apogee 1G
	Apogee 1000 series (Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/Apogee 1000Exp/ Apogee 1000B/W)/ Apogee 1 series (Apogee 1U/ Apogee1T/ Apogee 1G) Digital Color Doppler Ultrasound Imaging System
	Apogee 1000 series/ Apogee 1 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.