The Acclarix AX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:

Abdominal
Gynecology
Obstetric
Cardiac
Small parts
Urology
Musculoskeletal
Peripheral vascular
Adult Cephalic

Device Description

Acclarix AX3 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Acclarix AX3 Series Diagnostic Ultrasound System:

Based on the provided FDA 510(k) summary, the device in question, the Acclarix AX3 Series Diagnostic Ultrasound System, is a diagnostic ultrasound system. For this type of device, the "acceptance criteria" and "device performance" in the context of FDA clearance typically refer to compliance with recognized performance standards and safety requirements rather than a specific algorithmic performance metric. Similarly, "proving the device meets acceptance criteria" is primarily demonstrated through non-clinical testing.

The document explicitly states: "Clinical testing is not required." This is a critical piece of information. Since no clinical testing was performed for the purpose of this 510(k) clearance, many of the requested bullet points, particularly those related to human readers, ground truth establishment, and training/test set details for AI-based performance, are not applicable.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Electrical Safety	Compliance with ANSI/AAMI ES60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.
Basic Safety & Essential Performance	Compliance with IEC 60601-2-37 (Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment).
Acoustic Output	Acoustic output testing conducted as per the guideline "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated June 27, 2019. The summary states that acoustic output values are "below the limits of FDA." This implies the device met the safety limits for acoustic output.
Biocompatibility of Patient-Contacting Parts	Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process), ISO 10993-5 (Tests for in vitro cytotoxicity), and ISO 10993-10 (Tests for irritation and skin sensitization).
Substantial Equivalence	The overall acceptance criterion for 510(k) clearance is demonstrating substantial equivalence to legally marketed predicate devices. The non-clinical performance testing (listed above) concluded that "the subject devices are as safe and as effective as the predicate devices." Key similarities to the primary predicate (Acclarix AX4, K171900) include: Intended Use/Indications for Use, Mode of Operations, Transducer Types, and Acoustic Output. Differences identified (lack of Intra-operative, Pediatric and Neonatal applications; no 3D/4D; different transducer models) were deemed not to raise different questions of safety or effectiveness.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- No test set for clinical performance was used as clinical testing was not required.
- For non-clinical performance (electrical safety, EMC, acoustic output, biocompatibility), the "sample size" would refer to the number of devices or components tested. This specific number is not provided in the summary, but it would typically involve a statistically relevant sample or a representative unit for each test.
- Data Provenance: Not applicable in the context of clinical data for performance evaluation. For non-clinical testing, the testing was conducted by Edan Instruments, Inc. as part of their verification and validation process (implied by "Verification and validation testing has been conducted").
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as clinical testing (which would involve expert review for ground truth) was not required for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication was used.
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 device is a diagnostic ultrasound system, not an AI-assisted interpretation device in the context of this 510(k) submission. This type of study is not relevant to its clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware-based diagnostic imaging system, not an AI algorithm requiring standalone performance evaluation in the typical sense.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" would be established by the specifications defined in the relevant international standards (e.g., electrical safety limits in ANSI/AAMI ES60601-1, acoustic output limits as per FDA guidelines). Compliance with these standards serves as the "ground truth" for safe and effective operation.
The sample size for the training set:
- Not applicable as no AI training set was used for this device for the purpose of 510(k) clearance.
How the ground truth for the training set was established:
- Not applicable as no AI training set was used.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 27, 2019

Edan Instruments, Inc. % Stella Guo Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 CHINA

Re: K192791

Trade/Device Name: Acclarix AX3 Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO. ITX. IYN Dated: September 25, 2019 Received: September 30, 2019

Dear Stella Guo:

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

{1}------------------------------------------------

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 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,

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192791

Device Name

Acclarix AX3 Series Diagnostic Ultrasound System (including Acclarix AX3 Exp/Acclarix AX3 Super/Acclarix AX25/Acclarix AX28/Acclarix AX2/Acclarix AX2 Exp/Acclarix AX2 Super/Acclarix AX15/Acclarix AX18)

Indications for Use (Describe)

□ Abdominal
□ Gynecology
Obstetric
Cardiac
□ Small parts
□ Urology
□ Musculoskeletal
□ Peripheral vascular
□ Adult Cephalic

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

	510(k) Summary	K192791
	Prepared in accordance with the requirements of 21 CFR Part 807.92
1. Submitter:	Edan Instruments, Inc.#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.Tel: +86-755-2685 8736	Fax: +86-755-2689 8330
Contact person:	Stella Guo
Preparing date:	September 25, 2019
2. Device name andclassification:	Device Name: Diagnostic Ultrasound System
	Model: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix
	AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 SuperAcclarix AX15, Acclarix AX18
	Classification Name/ Product code:
	21 CFR 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic / IYN
	21 CFR 892.1560, Ultrasonic, Pulsed echo, Imaging / IYO
	21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic / ITX
	Regulatory Class: Class II
3.Premarket NotificationClass III Certificationand Summary	Not applicable, the subject device is Class II.
4. Predicate Device(s):	1) Edan Instruments, Acclarix AX4 Diagnostic Ultrasound System, clearedunder K171900 (Primary)
	2) Edan Instruments, Acclarix U50 Diagnostic Ultrasound System, clearedunder K173003 (Reference)
	3) Edan Instruments, Acclarix AX8 Diagnostic Ultrasound System, clearedunder K180862 (Reference)
5. Reason forSubmission	By submission of the Traditional 510(k), Edan Instruments is requestingclearance for new devices Acclarix AX3 Series Diagnostic Ultrasound System
6.Pre-Submission	Not applicable, there is no pre-submission.

IDE

{4}------------------------------------------------

1. Device Description: Acclarix AX3 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.
1. Indication for Use The Acclarix AX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics. General clinical applications include:
- Abdominal ●
- . Gynecology
- Obstetric ●
- Cardiac ●
- Small Parts ●
- Urology
- . Musculoskeletal
- Peripheral Vascular ●
- Adult Cephalic ●

9. Predicate Device Comparison

The subject device Acclarix AX3 Series is same as the primary predicated device Acclarix AX4 (K171900) in items such as:

1. Intended Use/ Indications for Use;
1. Mode of Operations;
1. Transducer Types
1. Acoustic Output, which are below the limits of FDA;

The differences of subject device Acclarix AX3 Series with the predicated devices are described as below:

1. The subject device Acclarix AX3 Series is not intended to do Intra-operative. Pediatric and Neonatal clinical ultrasound evaluation, which are already cleared in the primary predicated device Acclarix AX4 (K171900).

{5}------------------------------------------------

1. The subject device Acclarix AX3 Series does not support 3D/4D, which are already cleared in the primary predicated device Acclarix AX4 (K171900).
1. The subject device does not support four transducers that are already cleared in the primary predicated device Acclarix AX4 (K171900)
1. The subject device additionally support two new transducers L17-7HO and L17-70. L17-7HO is already cleared in the reference predicate device Acclarix AX8 (K180862). And L17-70 is modified from the transducer L15-7b cleared by the reference predicate device U50 (K173003) by only changing the shape of the transducer connector.

The subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

10. Performance Data:

Clinical test:

Clinical testing is not required.

Non-clinical test:

The Acclarix AX3 Series Diagnostic Ultrasound System comply with:

(1) ANSI/AAMI ES60601-1 Electrical Safety

(2) IEC 60601-1-2 Electromagnetic Compatibility

(3) IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

(4) Acoustic output testing as per the guideline "Marketing Clearance of Diagnostic Ultrasound Systems and

Transducers" dated June 27, 2019.

The following biocompatibility standards are conducted on the subject device:

(5) ISO 10993-1, ISO 10993-5 and ISO 10993-10

The tests were selected to show substantial equivalence between the subject device and the predicate.

The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate devices.

11. Conclusion

Verification and validation testing has been conducted on the Acclarix AX3 Series Diagnostic Ultrasound System. This premarket notification submission demonstrates that Acclarix AX3 Series Diagnostic Ultrasound System are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.