The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Cephalic (adult), Peripheral Vessel, Carotid, Urology, FAST/EFAST, Lung, Ocular, Nerve, Cardiac (Pediatric and Adult) and Pediatric. The system provides diaging in B, Color Doppler, M, Power Doppler and Combined (B+M; B+CD ; B+PD) modes. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

Device Description

The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, Color Doppler mode, Power Doppler mode, PW mode or a combination of these modes.

The Apache Probe processes the ultrasound signal and transfers real-time scan image data to the Apache App through the wireless connection with the mobile device. The 64-channel beamforming architecture of the probe maximizes the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system. The Apache App provides the interface for mode/setting control and image display, acquisition, and storage functions. The Apache App is compatible with Android and iOS based mobile devices. Verified devices include Samsung Galaxy Tab S6, Samsung Galaxy Tab S6 Lite, Samsung Galaxy Tab S7, Samsung Galaxy Tab S7 FE, Samsung Galaxy Tab S8, Samsung Galaxy S10, Samsung Galaxy S21, Xiaomi Pad 5, Google Pixel 4, Google Pixel 6, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPhone 14, iPad Pro 11-inch (Gen2), iPad Air (Gen4), iPad Air (Gen5), iPad 9.

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

AI/ML Overview

This document describes the FDA clearance for the Aco Apache Ultrasound System, a portable color ultrasound imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device, the Clarius Ultrasound Scanner (K213436).

Here's an analysis of the provided information regarding acceptance criteria and study data:

Unfortunately, the provided FDA 510(k) summary does not contain details about specific acceptance criteria, reported device performance metrics, or a formal study that proves the device meets those criteria, especially in a comparative effectiveness context. The document primarily focuses on non-clinical testing and a claim of substantial equivalence to a predicate device based on similar intended use and technology.

Let's break down what information is available and what is missing based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
(Not explicitly defined in the document for clinical performance) The document states "The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance." This implies meeting safety and performance standards for ultrasound devices, but no quantifiable clinical performance metrics or thresholds are provided.	(No specific clinical performance metrics reported) The document lists compliance with various electrical, safety, usability, and biological evaluation standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62133-2, IEC 62366-1, ISO 10993 series, IEC 62304, ISO 14971, NEMA UD 2:2004). These are general compliance attestations, not specific performance outcomes against clinical acceptance criteria.

Acceptance Criteria

Reported Device Performance

(Not explicitly defined in the document for clinical performance) The document states "The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance." This implies meeting safety and performance standards for ultrasound devices, but no quantifiable clinical performance metrics or thresholds are provided.

(No specific clinical performance metrics reported) The document lists compliance with various electrical, safety, usability, and biological evaluation standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62133-2, IEC 62366-1, ISO 10993 series, IEC 62304, ISO 14971, NEMA UD 2:2004). These are general compliance attestations, not specific performance outcomes against clinical acceptance criteria.

Detailed breakdown of requested information:

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

No information provided. The document explicitly states: "Aco Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Ultrasound Scanner) that require clinical testing." This indicates that no separate clinical test set or study data, with specific sample sizes or provenance, was generated or presented for this 510(k) submission to demonstrate clinical performance.

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)

No information provided. As no clinical test set was presented or required, there was no need for experts to establish ground truth for a clinical study.

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

No information provided. No clinical test set or study requiring adjudication was conducted or 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 MRMC comparative effectiveness study was done or reported. The device is a general-purpose diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of providing automated readings or interpretations that would typically warrant an MRMC study. The comparison is primarily against a predicate device, not against human reader performance or human reader improvement with AI assistance.

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

Not applicable / No such study reported. The Aco Apache Ultrasound System is a diagnostic imaging device controlled by a human operator, not a standalone AI algorithm performing diagnoses. While it is software-controlled, its core function is to produce images for human interpretation.

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

No ground truth data from a clinical study is discussed. The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical verification against established engineering and safety standards.

8. The sample size for the training set

Not applicable / No information provided. The document does not describe the use of machine learning or AI models that would require a "training set" in the context of diagnostic interpretation. It is a general imaging system. While the device is software-controlled, the software development would adhere to IEC 62304 (Medical Device Software - Software Life Cycle Processes), which focuses on software quality and safety, not on training data for a diagnostic algorithm.

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

Not applicable / No information provided. As no training set for a diagnostic algorithm is indicated, the method of establishing its ground truth is not relevant or provided.

Summary of Device Verification Methods Presented:

The 510(k) submission for the Aco Apache Ultrasound System primarily relies on two pillars for demonstrating substantial equivalence:

Comparison to a legally marketed predicate device (Clarius Ultrasound Scanner K213436): The document highlights that the subject device has the same intended use, indications for use (with some minor variations in specific applications that are still covered by the predicate), product codes, regulation numbers, portability, power source, and fundamental imaging modes (B, M, Color Doppler, Power Doppler, PW Doppler, and combined modes) as the predicate.
Non-clinical performance testing and compliance with recognized standards: The document lists numerous international and national standards (e.g., electrical safety, EMC, usability, biological compatibility, acoustic output, software lifecycle, risk management) that the device complies with. These tests ensure the device's technical specifications, safety, and functionality meet established industry benchmarks.

The basis for clearance is that the new device does not introduce new technological characteristics or indications for use that would raise new questions of safety or effectiveness compared to the predicate device, thereby negating the need for de novo clinical studies for this 510(k) submission.

Summary

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October 24, 2023

Image /page/0/Picture/1 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, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Aco Healthcare Co., Ltd. % Henry Huang Manager of Product Marketing 1F, No.8-1, Nandong Rd., Pingzhen Dist. Taovuan City. 324 TAIWAN

Re: K231509

Trade/Device Name: Aco Apache 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: September 13, 2023 Received: September 21, 2023

Dear Henry Huang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Yanna S. Kang -S

Yanna Kang Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K231509

Device Name "Aco Apache" Ultrasound System

Indications for Use (Describe)

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

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K231509

510(K) Summary

Submitter:	Aco Healthcare Co., Ltd.Address: 1F, No.8-1, Nandong Rd., Pingzhen Dist.,Taoyuan City 324, TaiwanTel: +886-3-5820446
Official Contact:	Henry HuangAddress: 1F, No.8-1, Nandong Rd., Pingzhen Dist.,Taoyuan City 324, Taiwan
Email	Henry.huang@acohealthcare.com
Date Prepared:	May 12th, 2023
Device Name:	Aco Apache Ultrasound System
Regulation Number:	21 CFR 892.1550, 892.1560, 892.1570
Classification Name:	Ultrasonic Pulsed Doppler Imaging SystemUltrasonic Pulsed Echo Imaging SystemDiagnostic Ultrasonic Transducer
Regulation Class	Class II
Product Code:	IYN
Subsequent Product Code:	IYO, ITX
Intended Use	Diagnostic ultrasound imaging and fluid flow analysis
Indications for Use:	The Aco Apache Ultrasound System is intended fordiagnostic ultrasound imaging and fluid flow analysis inthe following applications: Abdominal, Fetal/Obstetric,Gynecological, Fetal Echo, Musculo-skeletal(conventional and superficial), Small Organ (includingbreast, scrotum, thyroid), Peripheral Vessel, Carotid,Urology, FAST/EFAST, Lung, Ocular, Cephalic (adult),Nerve, and Pediatric. The system provides diagnosticultrasound imaging in B, M, Color Doppler, PowerDoppler, PW Doppler and Combined (B+M; B+CD;B+PD) modes. The clinical environments where the system

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can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for for use in environments where healthcare is provided by trained healthcare professionals.

Device Description

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The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

Predicate Device

Equivalent devices are referred to as predicate devices in alignment with the FDA's standard terminology for comparable devices. The predicate device selected to demonstrate equivalence is the Clarius Ultrasound Scanner (K213436).

Determination of Substantial Equivalence

The subject device "Aco Apache Ultrasound System" is a Track 3 system that adopt the same fundamental scientific technology as the predicate device "Clarius Ultrasound Scanner (K213436)". All indications for use introduced by the Aco Apache Ultrasound System are same to at least one model of the predicate devices. Comparison between the predicate device and subject device is provided below:

Description	Subject Device	Predicate Device
	Aco Apache Ultrasound System	Clarius Ultrasound System (K213436)
Product Name	Apache Ultrasound System	Clarius Ultrasound Scanner
Prescription/OTC use	Prescription Use	Prescription Use
Regulation Number	21 CFR 892.155021 CFR 892.156021 CFR 892.1570	21 CFR 892.155021 CFR 892.156021 CFR 892.1570
Product Code	IYN, IYO, ITX	IYN, IYO, ITX
510(k) Track	Track 3	Track 3

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Intended Use	Diagnostic ultrasound imaging andfluid flow analysis	diagnostic ultrasound imaging andfluid flow analysis
Indications foruse	Ophthalmic	Ophthalmic
	FetalFetal------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
	Abdominal.	Abdominal
		Intraoperative (non-neurological)
	Pediatric------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Pediatric------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
	Small Organ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Small Organ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
	Cephalic (adult)	Cephalic (adult)
		Trans-rectal
		Trans-vaginal
	Musculo-skeletal (conventional)	Musculo-skeletal (conventional)
	Musculo-skeletal (Superficial)	Musculo-skeletal (Superficial)
	Urology	Urology
	Gynecology��	Gynecology
	Cardiac (Adult)	Cardiac (Adult)
	Cardiac (Pediatric)	Cardiac (Pediatric)
	Peripheral vessel��	Peripheral Vessel
	Carotid	Carotid
	Needle Guidance	Needle Guidance
Portability	Portable Ultrasound System	Portable Ultrasound System
Power Source	Li-Ion Battery	Li-Ion Battery
WirelessCommunication	Wireless communication via IEEEWireless communication via IEEE802.11g/n802.11g/n Bluetooth
Display andControl	Android or iOS mobile deviceAndroid or iOS mobile device

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Mode of operation
- B-Mode	- B-Mode
- M-Mode	- M-Mode
- Color Doppler	- Color Doppler
- Power Doppler	- Power Doppler
- PW Doppler	- PW Doppler
- Combined(B+M; B+CD; B+PD)	- Combined(B+M; B+CD; B+PD, B+PWD)

Non-Clinical Test

Non-clinical performance tests include measurement accuracy, system sensitivity, thermal, mechanical, electrical safety, patient-contact materials, cleaning and disinfection, software and acoustic output.

The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance.

Rec. Number	Standard	Title of Standard
19-4	ANSI/AAMI ES60601-1:2005/(R)2012 andA1:2012	Medical Electrical Equipment - Part 1: General Requirementsfor Basic Safety and Essential Performance
19-46	ANSI/AAMI ES60601-1:2005/(R)2012 andA1:2012 and AMD2:2021	Medical Electrical Equipment - Part 1: General Requirementsfor Basic Safety and Essential Performance
19-8	ANSI/AAMI IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic Capability -Requirements and tests.
19-36	ANSI/AAMI IEC 60601-1-2:2014+ AMD1:2020	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic Capability -Requirements and tests.
5-132	IEC 60601-1-6:2010+AMD1:2013+AMD2:2020	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance-Collateral standard: Usability
12-293	IEC 60601-2-37:2007+AMD1:2015	Medical electrical equipment - Part 2-37: Particularrequirements for the basic safety and essential performance ofultrasonic medical diagnostic and monitoring equipment.
19-33	IEC 62133-2:2017+AMD1:2021	Secondary Cells and Batteries Containing Alkaline or OtherNon-Acid Electrolytes - Safety Requirements for PortableSealed Secondary Cells, And for Batteries Made from Them,For Use in Portable Applications - Part 2: Lithium systems
5-129	IEC 62366-1:2015+AMD1:2020	Medical Devices - Part 1: Application of Usability Engineeringto Medical Devices
2-258	ISO 10993-1:2018	Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process
2-245	ISO 10993-5:2009	Biological Evaluation of Medical Devices - Part 5: Tests for In

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		Vitro Cytotoxicity
2-296	ISO 10993-10:2021	Biological Evaluation of Medical Devices - Part 10: Tests forIrritation and Skin Sensitization
2-289	ISO 10993-12:2021	Biological Evaluation of Medical Devices - Part 12: Samplepreparation and reference materials
2-291	ISO 10993-23:2021	Biological Evaluation of Medical Devices - Part 23: Tests forirritation
13-79	IEC 62304:2006+AMD1:2015	Medical Device Software - Software Life Cycle Processes
5-125	ISO 14971:2019	Medical Devices - Applications of Risk Management to MedicalDevices
N/A	NEMA UD 2:2004 (R2009)	Acoustic Output Measurement Standard for DiagnosticUltrasound Equipment

Quality assurance measures applied to the system design and development include, but were not limited to risk analysis, product specifications, design reviews and verification and validation.

Clinical Testing

Aco Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Ultrasound Scanner) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.

Conclusion

Aco Apache Ultrasound System is substantially equivalent to the predicate device. Aco Apache Ultrasound System function in a manner similar to and are intended for the same use as the predicate device. Based on the predicate device comparison of indications for use, labeling, acoustic output and general safety and effectiveness information, as well as the non-clinical performance test results, it is concluded that this device is as safe and effective as the predicate device for its intended use and performance and is substantially equivalent to the predicate device.

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.