Acclarix LX8 Diagnostic Ultrasound System by EDAN INSTRUMENTS INC

The Edan Acclarix LX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

Abdominal
Gynecology (including endovaginal)
Obstetric
Cardiac
Small parts (Breast, Testes, Thyroid, etc.)
Urology
Musculoskeletal
Peripheral vascular
Intra-operative
Pediatric
Neonatal (including abdominal and cephalic).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Device Description

The Edan Acclarix LX8 Diagnostic Ultrasound system consists of a main system along with associated transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The Acclarix LX8 Diagnostic Ultrasound system then analyzes the returned signal to generate an image or conduct Doppler processing. The Acclarix LX8 Diagnostic Ultrasound system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides both touch screen and hard buttons for the User Interface.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Acclarix LX8 Diagnostic Ultrasound System. It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices. The document does not describe acceptance criteria or a study that proves the device meets specific performance acceptance criteria beyond regulatory safety and performance standards. It primarily focuses on comparing the new device's features and safety compliance with predicate devices to establish substantial equivalence.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for a diagnostic task) or clinical performance metrics. Instead, it outlines regulatory compliance and feature equivalence as the basis for substantial equivalence.

The "reported device performance" is essentially that the device complies with various safety and performance standards and offers similar or expanded features compared to its predicates.

Category	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Must be the same or similar to predicate devices.	Same as predicate devices (Diagnostic ultrasound imaging or fluid flow analysis of the human body).
Indications for Use	Must be the same or similar to predicate devices. The document notes "Difference" but implies the differences are acceptable and don't raise new questions of safety/effectiveness, as they are mostly additions of previously cleared applications marked "N" (new indication) or already "P" (previously cleared by FDA) on specific transducers.	Similar, with additions for certain transducers (e.g., new "N" indications cleared).
Product Design	Similar to predicate devices.	Similar to predicate devices.
Performance Effectiveness	Similar to predicate devices, demonstrated through technical specifications and compliance with standards.	Same as predicate devices (in terms of modes of operation, acoustic output, transducer frequency, display).
Performance Safety	Similar to predicate devices, demonstrated through compliance with recognized consensus standards.	Same as predicate devices. Complies with IEC 60601-1, -1-2, -2-37, ISO 10993 series, NEMA UD 2, UD3.
Features	Similar or enhanced compared to predicate devices, without raising new questions for safety/effectiveness. Some features (e.g., Auto IMT) are noted as having "Difference" but are considered not to affect basic design principles, usage, effectiveness, or safety.	Similar, with some feature differences and additions.

2. Sample Size Used for the Test Set and the Data Provenance:

The document explicitly states: "Clinical test: Clinical testing is not required."
Therefore, there is no test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective). The assessment for substantial equivalence relies on non-clinical tests and comparisons to predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:

Since no clinical testing was performed, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document states "Clinical test: Clinical testing is not required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. The device is a diagnostic ultrasound system, not an AI algorithm for standalone performance evaluation in the context of this submission. The "algorithm" here refers to the internal signal processing of the ultrasound system itself, which is evaluated through technical performance standards rather than clinical algorithm performance studies.

7. The Type of Ground Truth Used:

For the demonstration of substantial equivalence, the "ground truth" primarily refers to:

Compliance with recognized consensus standards (e.g., IEC 60601 series for electrical safety and electromagnetic compatibility, ISO 10993 series for biocompatibility, NEMA UD for acoustic output). These standards define technical performance requirements.
Equivalence to predicate devices based on their previously cleared performance and safety profiles.

8. The Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (ultrasound system) submission, not an AI/Machine Learning device that undergoes a training phase with a specific dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 31, 2017

Edan Instruments, Inc. % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Avenue, Suite 200 SUNNYVALE CA 94089

Re: K162055

Trade/Device Name: Acclarix LX8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 23, 2016 Received: December 30, 2016

Dear Mr. Worth:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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)

K162055

Device Name

Acclarix LX8 Diagnostic Ultrasound System

Indications for Use (Describe)

The Edan Acclarix LX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

· Abdominal
· Gynecology (including endovaginal)
Obstetric
· Cardiac
· Small parts (Breast, Testes, Thyroid, etc.)
· Urology
· Musculoskeletal
· Peripheral vascular
· Intra-operative
· Pediatric
· Neonatal (including abdominal and cephalic)

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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Acclarix LX8 Diagnostic Ultrasound System

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify)[2]3

Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)	P	P	P		P	P	P
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Specify) *	P	P	P		P	P	P
FetalImaging& Other	Neonatal Cephalic	N	N	N		N	N	N
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac	P	P	P	P	P	P	P
	Pediatric Cardiac	P	P	P	P	P	P	P
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	P	P	P		P	P	P
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication: P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDVDPDI, B+Color+PW, B+PDI/DPDI +PW, B+CW, B+Color+CW, B+PDI/DPDI+CW,

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology and Neonatal adbdominal

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance .

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)

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Acclarix LX8 with L10-4D Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P		P	P	P
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	P	P	P		P	P	P
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast.

** Other use includes Urology, Gynecology.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)

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Acclarix LX8 with E8-4D Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Acclarix LX8 with L17-7HD Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined (Specify) [1]	Other (Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P		P	P	P
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	P	P	P		P	P	P
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Acclarix LX8 with C5-2XD Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined (Specify) [1]	Other (Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)

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Acclarix LX8 with P5-1XD Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac	P	P	P	P	P	P	P
	Pediatric Cardiac	P	P	P	P	P	P	P
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication: P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+CW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW, B+Color+CW, B+PDI/DPDI+CW

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Acclarix LX8 with L17-7SD Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)	P	P	P		P	P	P
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
FetalImaging	Neonatal Cephalic
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Acclarix LX8 with C5-2MD Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify)[2]3
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology Gynecology

Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
4: 3D/4D

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Acclarix LX8 with C5-2D Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	N	N	N	N	N	N	N
	Abdominal	N	N	N	N	N	N	N
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
FetalImaging	Neonatal Cephalic
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N
	Musculo-skeletal (Superficial)	N	N	N	N	N	N	N
	Intravascular
	Other (Specify) **	N	N	N	N	N	N	N
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix LX8 with L12-5D Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	N	N	N		N	N	N
Fetal	Neonatal Cephalic
Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	N	N	N		N	N	N
	Musculo-skeletal (Superficial)	N	N	N		N	N	N
	Intravascular
	Other (Specify) **	N	N	N		N	N	N
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	N	N	N		N	N	N
vascular	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast.

** Other use includes Urology.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix LX8 with MC8-4D Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Specify) *
FetalImaging& Other	Neonatal Cephalic	N	N	N		N	N	N
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	N	N	N		N	N	N
	Musculo-skeletal (Superficial)	N	N	N		N	N	N
	Intravascular
	Other (Specify) **	N	N	N		N	N	N
	Adult Cardiac
Cardiac	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	N	N	N		N	N	N
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast. Note

** Other use includes Neonatal adbdominal.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Edan Instruments, Inc.3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen, 518067 P.R. ChinaTel.: (0755) 26858736Fax: +1 (408) 418-4059
Contact Person:	Alice Yang
Date prepared:	July 21 2016
2. Device nameand classification:	Device Name: Acclarix LX8 Diagnostic Ultrasound SystemModel: Acclarix LX8 Diagnostic Ultrasound SystemClassification Name:892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN892.1560 Ultrasonic, Pulsed echo, Imaging Product code: IYO892.1570 Transducer, Ultrasonic, Diagnostic Product code: ITXRegulatory Class: Class II
3.PremarketNotification ClassIII Certificationand Summary	Not applicable, the subject device is Class II.
4. PredicateDevice(s):	1. Acclarix LX8 Diagnostic Ultrasound System/ K160790/Edan Instruments, Inc.2. DC-8 Diagnostic Ultrasound System/ K150080/ ShenzhenMindray Bio-Medical Electronics Co., Ltd.3. Acclarix AX8 Diagnostic Ultrasound System/ K161300/Edan Instruments, Inc.,
5. Reason forSubmission	Modification for previous cleared product DiagnosticUltrasound system, model Acclarix LX8.
6. Pre-Submission,IDE	Not applicable, there is no prior submission.
7. DeviceDescription:	The Edan Acclarix LX8 Diagnostic Ultrasound systemconsists of a main system along with associated transducers.
	The system circuitry generates an electronic voltage pulse,which is transmitted to the transducer. In the transducer, a piezoelectric array converts the electronic pulse into an ultrasonicpressure wave. When coupled to the body, the pressure wavetransmits through body tissues. The waves are then reflectedwithin the body and detected by the transducer, which thenconverts back to an electrical signal. The Acclarix LX8Diagnostic Ultrasound system then analyzes the returned signalto generate an image or conduct Doppler processing.
	The Acclarix LX8 Diagnostic Ultrasoundsystem gives theoperator the ability to measure anatomical structures, andoffers analysis packages that provide information used bycompetent health care professionals to make a diagnosis.
	The system provides both touch screen and hard buttons for theUser Interface.
8. Intended Use:	The Acclarix LX8 Diagnostic Ultrasound System is intendedfor use by a qualified physician or sonographer for ultrasoundevaluation. Clinical applications include: Abdominal,Gynecology (including endovaginal), Obstetric, Cardiac, Smallparts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal,Peripheral vascular, Intra-operative, Pediatric and Neonatal(including abdominal and cephalic).

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9. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table:

Item	Acclarix LX8 r1.21 DiagnosticUltrasound System(Edan Instruments)	Acclarix LX8 r1.1 DiagnosticUltrasound System(Edan Instruments)	ComparisonResult
510(k) Number	Current Submission	K160790	-
Intended Use	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Same
Indications forUse	The Acclarix LX8 DiagnosticUltrasound System is intended foruse by a qualified physician or	The Acclarix LX8 DiagnosticUltrasound System is intended foruse by a qualified physician or	Difference

Table 9-1: Comparison between the subject Acclarix LX8 and the previous cleared Acclarix LX8

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	sonographer for ultrasound evaluation. Clinical applications include: Abdominal, Gynecology (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric and Neonatal (including abdominal and cephalic).
	Installation andUse	Trolley Mobile Equipment	Trolley Mobile Equipment
	SafetyStandards	IEC 60601-1	IEC 60601-1
		IEC 60601-1-2	IEC 60601-1-2
		IEC 60601-2-37	IEC 60601-2-37
		ISO 10993-1, -5, -10, -12	ISO 10993-1, -5, -10, -12
		AIUM, NEMA UD 2, UD3	AIUM, NEMA UD 2, UD3
	Patient ContactMaterials	Complies with ISO 10993	Complies with ISO 10993
	Mode ofOperationsMeasurements	B-Mode, M-Mode, Color,PDI/DPDI, PW, CW, 3D/4D	B-Mode, M-Mode, Color,PDI/DPDI, PW, CW, 3D/4D
		B-Mode: Distance, Circ/Area,Angle, Volume, Stenosis ratio	B-Mode: Distance, Circ/Area,Angle, Volume, Stenosis ratio
		M-Mode: Distance, Time, Slope andHeart Rate	M-Mode: Distance, Time, Slope andHeart Rate
	D-Mode: Velocity, RI, Time, PI,Heart Rate, Auto Trace, PG, S/D,△V, Acceleration, PHT, VTI	D-Mode: Velocity, RI, Time, PI,Heart Rate, Auto Trace, PG, S/D,△V, Acceleration, PHT, VTI
Principle ofOperation	Applying high voltage burst to thePiezoelectric material in thetransducer and detect reflected echoto construct diagnostic image	Applying high voltage burst to thePiezoelectric material in thetransducer and detect reflected echoto construct diagnostic image	Same
AcousticOutput	Track 3: MI, TIS, TIC, TIB(TIRange 0-6.0)	Track 3: MI, TIS, TIC, TIB(TIRange 0-6.0)	Same
	Derated ISPTA: 720 W/cm²	Derated ISPTA: 720 W/cm²
	maximum, Mechanic Index ≤1.9	maximum, Mechanic Index ≤1.9
	maximum or Derated ISPPA 190W/cm² max	maximum or Derated ISPPA 190W/cm² max

TransducerTypes	Convex Array	Convex Array	Difference
	Linear Array	Linear Array
	Endocavity-Micro Convex Array	Endocavity-Micro Convex Array
	Phased Array	Phased Array
	Micro Convex Array
TransducerFrequency	1-17.0 MHz	1-17.0 MHz	Same
PrimaryDisplay	Primary Screen: 21.5 inch(1920 x 1080)	Primary Screen: 21.5 inch(1920 x 1080)	Same
TransducerPorts	Dimensions/	Multi-Transducer Port (Four)	Height: 53 - 70 in (1355-1780mm)	Multi-Transducer Port (Four)	Height: 53 - 70 in (1355-1780mm)	Same	Same

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Weight	Width: 23 in (585mm)Depth: 36.6 in (930mm)Weight: 111 Kg(no peripherals)	Width: 23 in (585mm)Depth: 36.6 in (930mm)Weight: 111 Kg(no peripherals)
PowerRequirements	100-240V, 50/60Hz, 2.5A max	100-240V, 50/60Hz, 2.5A max	Same
Features	3D/4D, CW, HPRF, Dual screendisplay, Panorama, SpatialCompounding Imaging, FrequencyCompounding Imaging,Multi-Beam-Forming, SpeckleResistance Imaging(eSRI),One-Key-Optimization, B-Steer,Digital Zoom, Needle Visualization, Auto IMT	3D/4D, CW, HPRF, Dual screendisplay, Panorama, SpatialCompounding Imaging, FrequencyCompounding Imaging,Multi-Beam-Forming, SpeckleResistance Imaging(eSRI),One-Key-Optimization, B-Steer,Digital Zoom, Needle Visualization	Difference

Table 9-2: Comparison between the subject Acclarix LX8 and DC-8

Item	Acclarix LX8 r1.21 DiagnosticUltrasound System(Edan Instruments)	DC-8 Diagnostic Ultrasound System(Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.)	ComparisonResult
510(k) Number	Current Submission	K150080
Intended Use	Diagnostic ultrasound imaging or fluidflow analysis of the human body	Diagnostic ultrasound imaging or fluidflow analysis of the human body	Same
Indications forUse	The Acclarix LX8 DiagnosticUltrasound System is intended foruse by a qualified physician orsonographer for ultrasoundevaluation. Clinical applicationsinclude: Abdominal, Gynecology(including endovaginal), Obstetric,Cardiac, Small parts (Breast, Testes,Thyroid, etc.), Urology,Musculoskeletal, Peripheral vascular,Intra-operative, Pediatric andNeonatal (including abdominal andcephalic).	The DC-8 diagnostic ultrasoundsystem is applicable for adults,pregnant women, pediatric patientsand neonates. It is intended for use infetal, abdominal, pediatric, smallorgan (breast, thyroid, testes),neonatal cephalic, adult cephalic,trans-rectal, trans-vaginal,musculo-skeletal (conventional,superficial), cardiac adult, cardiacpediatric, peripheral vessel, urologyand transesophageal (Cardiac) exams.	Difference
Transducer Type	Convex ArrayLinear ArrayEndocavity-Micro Convex ArrayPhased ArrayMicro-Convex Array	Convex ArrayLinear ArrayEndocavity-Micro Convex ArrayPhased ArrayMicro-Convex Array	Same
SafetyStandards	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10, -12AIUM, NEMA UD 2, UD 3	IEC 60601-1IEC 60601-1-2IEC 60601-2-37AIUM, NEMA UD 2, UD 3ISO 10993-1, -5, -10, -12	Same
3D/4D feature	Static 3D4D (Real-time 3D)	Static 3D4D ( Real-time 3D )	Same
Auto IMT	Automatic detection of IMT when ROIis setSupport CCA, ICA, BIFSupport Far Intima and Near Intima	Automatic detection of IMT when ROIis setSupport CCA, ICA, ECA, Bulb IMTSupport Near wall and far walldetection	Difference

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Item	Acclarix LX8 r1.21 DiagnosticUltrasound System(Edan Instruments)	Acclarix AX8 Diagnostic UltrasoundSystem(Edan Instruments)	ComparisonResult
510(k) Number	Current Submission	K161300	-
Intended Use	Diagnostic ultrasound imaging or fluidflow analysis of the human body	Diagnostic ultrasound imaging or fluidflow analysis of the human body	Same
Indications forUse	The Acclarix LX8 DiagnosticUltrasound System is intended foruse by a qualified physician orsonographer for ultrasoundevaluation. Clinical applicationsinclude: Abdominal, Gynecology(including endovaginal), Obstetric,Cardiac, Small parts (Breast, Testes,Thyroid, etc.), Urology,Musculoskeletal, Peripheral vascular,Intra-operative, Pediatric andNeonatal (including abdominal andcephalic).	The Edan Acclarix AX8 UltrasoundSystem is intended for use by aqualified physician or allied healthprofessional for ultrasoundevaluations. Specific clinicalapplications include: Abdominal,Gynecology (including endovaginal),Obstetric, Cardiac, Small parts(Breast, Testes, Thyroid, etc.),Urology, Musculoskeletal, Peripheralvascular, and Intra-operative.	Difference
SafetyStandards	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10, -12AIUM, NEMA UD 2, UD 3	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10, -12AIUM, NEMA UD 2, UD 3	Same
TransducerNeedle Guideadaptors	Mechanical Needle guide adaptorswhich clip on transducer to provide afixed angle of insertion for needle.	Mechanical Needle guide adaptorswhich clip on transducer to provide afixed angle of insertion for needle.	Same

Tahle 9-3: . Comparison between the subject Acclarix I X8 and Acclarix AX8

The subject device has same intended use, similar product design, same performance effectiveness, and performance safety as the predicate device.

The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

10. Effectiveness and Safety Considerations:

Clinical test:

Clinical testing is not required.

Non-clinical test:

The Acclarix LX8 Diagnositic Ultrasound System complies with: (1) IEC 60601-1:2005/A1:2012 Electrical Safety (2) IEC 60601-1-2 Edition 3:2007-03 Electromagnetic Compatibility (3) IEC 60601-2-37 Edition 2.0 2007-08 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

(4) NEMA UD 3, Edition 2004 Standard for real-time display of thermal and mechanical

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acoustic output Indies on diagnostic ultrasound equipment.

(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.

(6) NEMA, UD2, Edition 2004 for acoustic output measurement methodology.

The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010

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

11. Substantially Equivalent Determination

Verification and validation testing has been conducted on the Acclarix LX8 Diagnostic Ultrasound System. This premarket notification submission demonstrates that Acclarix LX8 Diagnostic Ultrasound System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.