Acclarix LX8 Diagnostic Ultrasound System
Device Facts
| Record ID | K162055 |
|---|---|
| Device Name | Acclarix LX8 Diagnostic Ultrasound System |
| Applicant | Edan Instruments, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 31, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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, and Neonatal (including abdominal and cephalic).
Device Story
The Acclarix LX8 is a trolley-based diagnostic ultrasound system. It uses piezoelectric transducer arrays to convert electronic voltage pulses into ultrasonic pressure waves, which are transmitted into the body. Reflected echoes are detected by the transducer and converted back into electrical signals for processing. The system analyzes these signals to generate diagnostic images or perform Doppler-based fluid flow analysis. It features a 21.5-inch display, touch screen, and physical controls. Operators (physicians or sonographers) use the system to measure anatomical structures and perform clinical analyses to support diagnosis. It supports various imaging modes including B-mode, M-mode, Color, PDI/DPDI, PW, CW, and 3D/4D. The device is used in clinical settings for a wide range of applications including abdominal, cardiac, and obstetric exams. It provides quantitative analysis packages for measurements like distance, volume, velocity, and heart rate.
Clinical Evidence
No clinical data was required or presented. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output measurements (NEMA UD 2, UD 3), and biocompatibility (ISO 10993).
Technological Characteristics
Trolley-based ultrasound system; piezoelectric transducer arrays; 21.5-inch display; multi-transducer ports. Operates in B, M, PW, CW, Color, PDI/DPDI, and 3D/4D modes. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993. Features include multi-beam forming, speckle resistance imaging (eSRI), and auto-IMT.
Indications for Use
Indicated for ultrasound evaluations in abdominal, gynecological (including endovaginal), obstetric, cardiac, small parts (breast, testes, thyroid), urological, musculoskeletal, peripheral vascular, intra-operative, pediatric, and neonatal (abdominal and cephalic) applications. Intended for use by qualified physicians or allied health professionals.
Regulatory Classification
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.
Predicate Devices
- Acclarix LX8 Diagnostic Ultrasound System (K160790)
- DC-8 Diagnostic Ultrasound System (K150080)
- Acclarix AX8 Diagnostic Ultrasound System (K161300)
Related Devices
- K180862 — Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System · Edan Instruments, Inc. · May 24, 2018
- K171824 — Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System · Edan Instruments, Inc. · Jul 18, 2017
- K160277 — LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 25, 2016
- K160790 — Acclarix LX8 Diagnostic Ultrasound System · Edan Instruments, Inc. · Apr 4, 2016
- K093714 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Dec 10, 2009
Submission Summary (Full Text)
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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 (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
{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<br>(Specify) [1] | Other<br>(Specify)[2][3][4] |
| | | | | | | | | |
| 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<br>Imaging<br>& 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<br>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.
[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) 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<br>(Specify) [1] | Other<br>(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<br>Imaging<br>& 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<br>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<br>(Specify) [1] | Other<br>(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<br>Imaging<br>& 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<br>Imaging<br>& 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<br>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<br>Imaging<br>& 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<br>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<br>(Specify) [1] | Other<br>(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<br>Imaging<br>& 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<br>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<br>(Specify) [1] | Other<br>(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<br>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<br>(Specify) [1] | Other<br>(Specify)<br>[2][3][4] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& 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<br>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<br>(Specify) [1] | Other<br>(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<br>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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{12}------------------------------------------------
#### Acclarix LX8 with L12-5D Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|--------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(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<br>& 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{13}------------------------------------------------
### Acclarix LX8 with MC8-4D Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(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<br>Imaging<br>& 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<br>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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{14}------------------------------------------------
### 510(k) Summary
### Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.<br>3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#,<br>Shekou, Nanshan Shenzhen, 518067 P.R. China<br>Tel.: (0755) 26858736<br>Fax: +1 (408) 418-4059 |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alice Yang |
| Date prepared: | July 21 2016 |
| 2. Device name<br>and classification: | Device Name: Acclarix LX8 Diagnostic Ultrasound System<br>Model: Acclarix LX8 Diagnostic Ultrasound System<br>Classification Name:<br>892.1550 System, Imaging, Pulsed Doppler, Ultrasonic<br>Product code: IYN<br>892.1560 Ultrasonic, Pulsed echo, Imaging Product code: IYO<br>892.1570 Transducer, Ultrasonic, Diagnostic Product code: ITX<br>Regulatory Class: Class II |
| 3.Premarket<br>Notification Class<br>III Certification<br>and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate<br>Device(s): | 1. Acclarix LX8 Diagnostic Ultrasound System/ K160790/<br>Edan Instruments, Inc.<br>2. DC-8 Diagnostic Ultrasound System/ K150080/ Shenzhen<br>Mindray Bio-Medical Electronics Co., Ltd.<br>3. Acclarix AX8 Diagnostic Ultrasound System/ K161300/<br>Edan Instruments, Inc., |
| 5. Reason for<br>Submission | Modification for previous cleared product Diagnostic<br>Ultrasound system, model Acclarix LX8. |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. |
| 7. Device<br>Description: | The Edan Acclarix LX8 Diagnostic Ultrasound system<br>consists of a main system along with associated transducers. |
| | The system circuitry generates an electronic voltage pulse,<br>which is transmitted to the transducer. In the transducer, a piezo<br>electric array converts the electronic pulse into an ultrasonic<br>pressure wave. When coupled to the body, the pressure wave<br>transmits through body tissues. The waves are then reflected<br>within the body and detected by the transducer, which then<br>converts back to an electrical signal. The Acclarix LX8<br>Diagnostic Ultrasound system then analyzes the returned signal<br>to generate an image or conduct Doppler processing. |
| | The Acclarix LX8 Diagnostic Ultrasoundsystem gives the<br>operator the ability to measure anatomical structures, and<br>offers analysis packages that provide information used by<br>competent health care professionals to make a diagnosis. |
| | The system provides both touch screen and hard buttons for the<br>User Interface. |
| 8. Intended Use: | The Acclarix LX8 Diagnostic Ultrasound System is intended<br>for use by a qualified physician or sonographer for ultrasound<br>evaluation. Clinical applications include: Abdominal,<br>Gynecology (including endovaginal), Obstetric, Cardiac, Small<br>parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal,<br>Peripheral vascular, Intra-operative, Pediatric and Neonatal<br>(including abdominal and cephalic). |
{15}------------------------------------------------
### 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<br>Ultrasound System<br>(Edan Instruments) | Acclarix LX8 r1.1 Diagnostic<br>Ultrasound System<br>(Edan Instruments) | Comparison<br>Result |
|------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K160790 | - |
| Intended Use | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | Same |
| Indications for<br>Use | The Acclarix LX8 Diagnostic<br>Ultrasound System is intended for<br>use by a qualified physician or | The Acclarix LX8 Diagnostic<br>Ultrasound System is intended for<br>use by a qualified physician or | Difference |
Table 9-1: Comparison between the subject Acclarix LX8 and the previous cleared Acclarix LX8
{16}------------------------------------------------
| | 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<br>Use | Trolley Mobile Equipment | Trolley Mobile Equipment | | | | |
| | Safety<br>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…
