Acclarix LX8 Diagnostic Ultrasound System

• K Number: K162055
• Device Name: Acclarix LX8 Diagnostic Ultrasound System
• Manufacturer: EDAN INSTRUMENTS INC
• Date Cleared: 2017-01-31 ( 190 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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.

Predicate Devices

K160790, K150080, K161300

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ultrasound technology and signal processing, with no mention of AI or ML capabilities. The performance studies section also does not describe any AI/ML specific validation.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound system" and its intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," suggesting it is used for diagnosis, not treatment.

Diagnostic

Yes
The "Intended Use" explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" section repeatedly refers to it as the "Acclarix LX8 Diagnostic Ultrasound system" and mentions that it "offers analysis packages that provide information used by competent health care professionals to make a diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "main system along with associated transducers" and describes the hardware components involved in generating and receiving ultrasonic waves.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
• Device Function: The description clearly states that the Edan Acclarix LX8 Ultrasound system uses ultrasonic waves transmitted into the body to create images and analyze fluid flow. This is an in vivo (within the body) diagnostic method.
• Intended Use: The intended use describes imaging and analysis of the human body directly, not testing of samples taken from the body.
• Device Description: The description focuses on the generation and detection of ultrasonic waves within the body.

Therefore, the Edan Acclarix LX8 Ultrasound system is a diagnostic imaging device that operates in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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)

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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 Ultrasoundsystem 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Adults, pregnant women, pediatric patients, and neonates.

Intended User / Care Setting

Qualified physician or sonographer. Not specified.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160790, K150080, K161300

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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.

1

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 [phone] or [phone] 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 [phone] or [phone] 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

2

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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3

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
Fetal
Imaging
& 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
Peripheral
vascular	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)

4

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
Fetal
Imaging
& 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
Peripheral
vascular	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)

5

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) *
Fetal
Imaging
& 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)

6

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
Fetal
Imaging
& 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
Peripheral
vascular	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+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)

7

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) *
Fetal
Imaging
& 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
Peripheral
vascular	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)

8

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) *
Fetal
Imaging
& 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
Peripheral
vascular	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)

9

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) *
Fetal
Imaging	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:

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)

10

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
Fetal
Imaging
& 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
Peripheral
vascular	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)

11

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) *
Fetal
Imaging	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.

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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) *
Fetal
Imaging
& 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
Peripheral
vascular	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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14

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. China
Tel.: [phone]
Fax: [phone] |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alice Yang |
| Date prepared: | July 21 2016 |
| 2. Device name
and classification: | Device Name: Acclarix LX8 Diagnostic Ultrasound System
Model: Acclarix LX8 Diagnostic Ultrasound System
Classification Name:
892.1550 System, Imaging, Pulsed Doppler, Ultrasonic
Product code: IYN
892.1560 Ultrasonic, Pulsed echo, Imaging Product code: IYO
892.1570 Transducer, Ultrasonic, Diagnostic Product code: ITX
Regulatory Class: Class II |
| 3.Premarket
Notification Class
III Certification
and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate
Device(s): | 1. Acclarix LX8 Diagnostic Ultrasound System/ K160790/
Edan Instruments, Inc.
2. DC-8 Diagnostic Ultrasound System/ K150080/ Shenzhen
Mindray Bio-Medical Electronics Co., Ltd.
3. Acclarix AX8 Diagnostic Ultrasound System/ K161300/
Edan Instruments, Inc., |
| 5. Reason for
Submission | Modification for previous cleared product Diagnostic
Ultrasound system, model Acclarix LX8. |
| 6. Pre-Submission,
IDE | Not applicable, there is no prior submission. |
| 7. 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 Ultrasoundsystem 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. |
| 8. Intended Use: | The Acclarix LX8 Diagnostic Ultrasound System is intended
for use by a qualified physician or 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). |

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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 Diagnostic
Ultrasound System
(Edan Instruments) | Acclarix LX8 r1.1 Diagnostic
Ultrasound System
(Edan Instruments) | Comparison
Result |
|------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K160790 | - |
| Intended Use | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Same |
| Indications for
Use | The Acclarix LX8 Diagnostic
Ultrasound System is intended for
use by a qualified physician or | The Acclarix LX8 Diagnostic
Ultrasound System is intended for
use 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 and
Use	Trolley Mobile Equipment	Trolley Mobile Equipment
	Safety
Standards	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 Contact
Materials	Complies with ISO 10993	Complies with ISO 10993
	Mode of
Operations
Measurements	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 and
Heart Rate	M-Mode: Distance, Time, Slope and
Heart 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 of
Operation	Applying high voltage burst to the
Piezoelectric material in the
transducer and detect reflected echo
to construct diagnostic image	Applying high voltage burst to the
Piezoelectric material in the
transducer and detect reflected echo
to construct diagnostic image	Same
Acoustic
Output	Track 3: MI, TIS, TIC, TIB(TI
Range 0-6.0)	Track 3: MI, TIS, TIC, TIB(TI
Range 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 190
W/cm² max	maximum or Derated ISPPA 190
W/cm² max
Transducer
Types	Convex Array	Convex Array	Difference
	Linear Array	Linear Array
	Endocavity-Micro Convex Array	Endocavity-Micro Convex Array
	Phased Array	Phased Array
	Micro Convex Array
Transducer
Frequency	1-17.0 MHz	1-17.0 MHz	Same
Primary
Display	Primary Screen: 21.5 inch
(1920 x 1080)	Primary Screen: 21.5 inch
(1920 x 1080)	Same
Transducer
Ports	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) | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Power
Requirements | 100-240V, 50/60Hz, 2.5A max | 100-240V, 50/60Hz, 2.5A max | Same |
| Features | 3D/4D, CW, HPRF, Dual screen
display, Panorama, Spatial
Compounding Imaging, Frequency
Compounding Imaging,
Multi-Beam-Forming, Speckle
Resistance Imaging(eSRI),
One-Key-Optimization, B-Steer,
Digital Zoom, Needle Visualization, Auto IMT | 3D/4D, CW, HPRF, Dual screen
display, Panorama, Spatial
Compounding Imaging, Frequency
Compounding Imaging,
Multi-Beam-Forming, Speckle
Resistance 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 Diagnostic
Ultrasound System
(Edan Instruments) | DC-8 Diagnostic Ultrasound System
(Shenzhen Mindray Bio-Medical
Electronics Co., Ltd.) | Comparison
Result |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K150080 | |
| Intended Use | Diagnostic ultrasound imaging or fluid
flow analysis of the human body | Diagnostic ultrasound imaging or fluid
flow analysis of the human body | Same |
| Indications for
Use | The Acclarix LX8 Diagnostic
Ultrasound System is intended for
use by a qualified physician or
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). | The DC-8 diagnostic ultrasound
system is applicable for adults,
pregnant women, pediatric patients
and neonates. It is intended for use in
fetal, abdominal, pediatric, small
organ (breast, thyroid, testes),
neonatal cephalic, adult cephalic,
trans-rectal, trans-vaginal,
musculo-skeletal (conventional,
superficial), cardiac adult, cardiac
pediatric, peripheral vessel, urology
and transesophageal (Cardiac) exams. | Difference |
| Transducer Type | Convex Array
Linear Array
Endocavity-Micro Convex Array
Phased Array
Micro-Convex Array | Convex Array
Linear Array
Endocavity-Micro Convex Array
Phased Array
Micro-Convex Array | Same |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10, -12
AIUM, NEMA UD 2, UD 3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
AIUM, NEMA UD 2, UD 3
ISO 10993-1, -5, -10, -12 | Same |
| 3D/4D feature | Static 3D
4D (Real-time 3D) | Static 3D
4D ( Real-time 3D ) | Same |
| Auto IMT | Automatic detection of IMT when ROI
is set
Support CCA, ICA, BIF
Support Far Intima and Near Intima | Automatic detection of IMT when ROI
is set
Support CCA, ICA, ECA, Bulb IMT
Support Near wall and far wall
detection | Difference |

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| Item | Acclarix LX8 r1.21 Diagnostic
Ultrasound System
(Edan Instruments) | Acclarix AX8 Diagnostic Ultrasound
System
(Edan Instruments) | Comparison
Result |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K161300 | - |
| Intended Use | Diagnostic ultrasound imaging or fluid
flow analysis of the human body | Diagnostic ultrasound imaging or fluid
flow analysis of the human body | Same |
| Indications for
Use | The Acclarix LX8 Diagnostic
Ultrasound System is intended for
use by a qualified physician or
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). | The Edan Acclarix AX8 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, and Intra-operative. | Difference |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10, -12
AIUM, NEMA UD 2, UD 3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10, -12
AIUM, NEMA UD 2, UD 3 | Same |
| Transducer
Needle Guide
adaptors | Mechanical Needle guide adaptors
which clip on transducer to provide a
fixed angle of insertion for needle. | Mechanical Needle guide adaptors
which clip on transducer to provide a
fixed 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

19

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.