Acclarix LX8 Diagnostic Ultrasound System
Device Facts
| Record ID | K160790 |
|---|---|
| Device Name | Acclarix LX8 Diagnostic Ultrasound System |
| Applicant | Edan Instruments, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 4, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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, and Peripheral vascular, and Intra-operative.
Device Story
Diagnostic ultrasound system; utilizes piezoelectric transducer arrays to convert electronic voltage pulses into ultrasonic pressure waves; waves reflect off body tissues and are detected by transducer; system analyzes returned signals to generate images or perform Doppler processing; provides B-mode, M-mode, Color, PDI/DPDI, PW, CW, and 3D modes; operated by physicians or sonographers in clinical settings; features touch screen and hard button interface; enables anatomical measurements and analysis packages to support clinical diagnosis; trolley-mounted mobile equipment.
Clinical Evidence
No clinical data; bench testing only. Verification and validation testing demonstrated substantial equivalence to predicate device.
Technological Characteristics
Trolley-mounted ultrasound system; piezoelectric transducer arrays (convex, linear, endocavity-micro convex, phased); frequency range 2.5-15.0 MHz; 21.5-inch display; multi-transducer ports; electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; acoustic output per NEMA UD 2/UD 3; biocompatibility per ISO 10993.
Indications for Use
Indicated for ultrasound evaluation of abdominal, gynecological (including endovaginal), obstetric, cardiac, small parts (breast, testes, thyroid), urological, musculoskeletal, and peripheral vascular structures, and intra-operative procedures. For use by qualified physicians or sonographers.
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 AX8 Diagnostic Ultrasound System (K150999)
Reference Devices
- ZS3 Ultrasound System (K141641)
Related Devices
- K123185 — DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2, 2012
- K152396 — S12 Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Sep 3, 2015
- K981510 — SONOACE 6000/ ULTRAMARK 400 · Medison America, Inc. · May 8, 1998
- K962142 — SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · May 29, 1997
- K213642 — Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert · GE Healthcare · Jan 13, 2022
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2016
EDAN INSTRUMENTS, INC. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K160790
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: March 21, 2016 Received: March 22, 2016
Dear Mr. Job:
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 D.'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known)
# K160790
Device Name Acclarix LX8 Diagnostic Ultrasound System
#### Indications for Use (Describe)
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), Obstetic, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, and Peripheral vascular, and Intra-operative.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------|--------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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#### 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 | N | N | N | | N | N | N | |
| | Abdominal | N | N | N | N | N | N | N | |
| | Intra-operative (Specify) | N | N | N | | N | N | N | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | N | N | N | | N | N | N | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N | |
| | Trans-vaginal | N | N | N | | N | N | N | |
| | 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 | N | N | N | N | N | N | N | |
| | Pediatric Cardiac | N | N | N | N | N | N | N | |
| Cardiac | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral<br>vascular | 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+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW, B+CW, B+Color+CW, B+PDI/DPDI+CW,
Note * Small Organ includes Thyroid, Testes, Breast
| | | | | [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
(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
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) [2][3] |
| Ophthalmic | Ophthalmic | Ophthalmic | | | | | | | |
| | | Fetal / Obstetrics | | | | | | | |
| | | Abdominal | | | | | | | |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro logical) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | | Small Organ (Specify) * | N | N | N | N | N | N | N |
| | | Neonatal Cephalic | | | | | | | |
| | | 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) ** | | | | | | | |
| Cardiac | | Adult Cardiac | | | | | | | |
| | | Pediatric Cardiac | | | | | | | |
| | | Intravascular(Cardiac) | | | | | | | |
| | | Trans-esoph.(Cardiac) | | | | | | | |
| | | Intra- cardiac | | | | | | | |
| | | | | | | | | | |
| Peripheral<br>vascular | | Peripheral vascular | N | N | N | N | N | N | N |
| | | 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+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)
{5}------------------------------------------------
### ACCLARIX LX8 with E8-4D 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) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | N | N | N | | N | N | N |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N |
| | Trans-vaginal | N | N | N | | N | N | N |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| 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+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** 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
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) [2][3] | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / Obstetrics | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) * | N | N | N | | N | N | N | |
| | Neonatal Cephalic | | | | | | | | |
| | 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) ** | | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | | |
| | Pediatric Cardiac | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | N | N | N | | N | N | N | |
| | 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+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)
{7}------------------------------------------------
#### ACCLARIX LX8 with C5-2XD 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) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | N | N | N | | N | N | N |
| | Abdominal | N | N | N | | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | 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<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+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** 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
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 / Obstetrics | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | N | N | N | N | N | N | N |
| | Pediatric Cardiac | N | N | N | N | N | N | N |
| 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+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
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) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | N | N | N | | N | N | N |
| | 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) | N | N | N | | N | N | N |
| | Musculo-skeletal (Superficial) | N | N | N | | N | N | N |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| 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+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)
{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 | N | N | N | | N | N | N | |
| | 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+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.
[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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### 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#,<br>Shekou, Nanshan Shenzhen, 518067 P.R. China | | |
| | Tel.: (0755) 26858739 | | |
| | Fax: +1 (408) 418-4059 | | |
| Contact Person: | Queena Chen | | |
| Date prepared: | March 28, 2016 | | |
| 2. Device name<br>and classification: | Device Name: Diagnostic Ultrasound System<br>Model: Acclarix LX8 | | |
| | Classification Name: | | |
| | 892.1550 | System, Imaging, Pulsed Doppler, Ultrasonic<br>Product code: IYN | |
| | 892.1560 | Ultrasonic, Pulsed echo, Imaging<br>Product code: IYO | |
| | 892.1570 | Transducer, Ultrasonic, Diagnostic<br>Product code: ITX | |
| | 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): | Acclarix AX8 Diagnostic Ultrasound System/ K150999/<br>Shenzhen EDAN Instruments, Inc. | | |
| | ZS3 Ultrasound System / K141641 (Reference) / ZONARE<br>Medical Systems, Inc | | |
| 5. Reason for<br>Submission | Acclarix LX8 is a new device. | | |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. | | |
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| <b>7. Device</b><br><b>Description:</b> | The Edan Acclarix LX8 Ultrasound system consists of a main<br>system along with associated transducers. |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The system circuitry generates an electronic voltage pulse,<br>which is transmitted to the transducer. In the transducer, a<br>piezo electric array converts the electronic pulse into an<br>ultrasonic pressure wave. When coupled to the body, the<br>pressure wave transmits through body tissues. The waves are<br>then reflected within the body and detected by the transducer,<br>which then converts back to an electrical signal. The Acclarix<br>LX8 system then analyzes the returned signal to generate an<br>image or conduct Doppler processing. |
| | The Acclarix LX8 system gives the operator the ability to<br>measure anatomical structures, and offers analysis packages<br>that provide information used by competent health care<br>professionals to make a diagnosis. |
| | The system provides both touch screen and hard buttons for the<br>User Interface. |
| <b>8. Intended Use:</b> | The ACCLARIX LX8 Diagnostic Ultrasound System is<br>intended for use by a qualified physician or sonographer for<br>ultrasound evaluation. Clinical applications include:<br>Abdominal, Gynecology (including endovaginal), Obstetric,<br>Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology,<br>Musculoskeletal, and Peripheral vascular, and Intra-operative. |
### 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 Diagnostic<br>Ultrasound System<br>(Edan Instruments) | Acclarix AX8 Diagnostic<br>Ultrasound System (Edan<br>Instruments) | ZS3 Ultrasound Systems<br>(ZONARE Medical<br>Systems) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Current Submission | K150999 | K141641 |
| Intended Use | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human body | Same | Same |
| Indications for<br>Use | The Acclarix LX8<br>Diagnostic Ultrasound<br>System is intended for use<br>by a qualified physician or<br>sonographer for ultrasound<br>evaluation. Clinical<br>applications include: | Same | The ZS3 Ultrasound System<br>is intended for use by a<br>qualified physician for<br>ultrasound evaluation of<br>Ophthalmic; Fetal/obstetric,<br>gynecological; Abdominal<br>(renal, GYN/Pelvic); |
| | Abdominal, Gynecology<br>(including endovaginal),<br>Obstetric, Cardiac, Small<br>parts (Breast, Testes,<br>Thyroid, etc.), Urology,<br>Musculoskeletal, and<br>Peripheral vascular, and<br>Intra-operative. | | Intra-operative (abdominal,<br>thoracic, and vascular),<br>Intra-operative neurological;<br>Pediatric: small organ<br>(thyroid, breast, testes, etc.),<br>Adult & Neonatal Cephalic;<br>Trans-rectal, Trans-vaginal,<br>Trans-cranial,<br>Trans-esophageal<br>(non-cardiac and cardiac);<br>Musculoskeletal<br>(conventional &<br>superficial); 3D/4D; Cardiac<br>- Adult/ Pediatric/ Fetal;<br>Echo, Intra-Cardiac; Pelvic;<br>Peripheral vascular;<br>harmonic tissue and contrast<br>imaging and Tissue<br>elasticity. |
| Installation and<br>Use | Trolley Mobile Equipment | Portable (laptop) Mobile<br>Equipment | Same |
| Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-37<br>ISO 10993-1, -5, -10, -12<br>AIUM, NEMA UD 2, UD3 | Same | Same |
| Patient Contact<br>Materials | Complies with ISO 10993 | Same | Same |
| Mode of<br>Operations | B-Mode, M-Mode, Color,<br>PDI/DPDI, PW, CW, 3D<br>(Note 1) | Same except 3D | B-Mode, M-Mode, PWD<br>Mode, CWD, CD Mode,<br>Elastorgraphy, Contrast<br>Enhanced, 3D/4D, ECG(for<br>cardiac cycle referenced<br>timing only)<br>Combined Modes include<br>B+CD, B+PW, B+CD+PW,<br>B+M, M+CM,<br>B+CD+M+CM,<br>B+Elastorgraphy, B+CEUS,<br>and + ECG Trace |
| Measurements | B-Mode: Distance,<br>Circ/Area, Angle, Volume,<br>Stenosis ratio<br><br>M-Mode: Distance, Time,<br>Slope and Heart Rate | Same | B-mode (2D): Depth,<br>Distance, Cire/Area/Volume<br><br>M-Mode: Depth, Distance,<br>HR |
| | D-Mode: Velocity, RI,<br>Time, PI, Heart Rate, Auto<br>Trace, PG, S/D, ΔV,<br>Acceleration, PHT, VTI | | PWD(Manual): Velocity,<br>Velocity Pairs, RI, Accl,<br>S/D, A/B, PI, HR/<br>PWD(AutoTrace: RI, PI,<br>Accl, S/D, HR, AT, TAMX) |
| | | | and TAMN) |
| Principle of<br>Operation | Applying high voltage burst<br>to the Piezoelectric material<br>in the transducer and detect<br>reflected echo to construct<br>diagnostic image | Same | Same |
| Acoustic<br>Output | Track 3: MI, TIS, TIC,<br>TIB(TI Range 0-6.0)<br>Derated ISPTA: 720 W/cm²<br>maximum, Mechanic Index<br><1.9 maximum or Derated<br>ISPPA 190 W/cm² max | Same | Same |
| Transducer<br>Types | Convex Array<br>Linear Array<br>Endocavity-Micro Convex<br>Array<br>Phased Array | Same | Linear Array<br>Curved Linear Array<br>Phased Array<br>Trans-esophageal<br>Pencil Probe<br>Intracavitary |
| Transducer<br>Frequency | 2.5-15.0 MHz | Same | 1.0 - 20.0 MHz |
| Primary<br>Display | Primary Screen: 21.5 inch<br>(1920 x 1080)<br>(Note 2) | Primary Screen: 15 inch<br>(1920x1080) | Color 19" Liquid Crystal<br>Display (LCD) |
| Transducer<br>Ports | Multi-Transducer Port<br>(Four)<br>(Note 3) | One | Multi-Transducer Port<br>(Three) |
| Dimensions/<br>Weight | Height: 53 - 70 in<br>(1355-1780mm)<br>Width: 23 in (585mm)<br>Depth: 36.6 in (930mm)<br>Weight: 111 Kg(no<br>peripherals)<br>(Note 4) | Height: 3 in (77mm)<br>Width: 16 in (407mm)<br>Depth: 15.3 in (388mm)<br>Weight: 9.1Kg(with<br>rechargeable battery,<br>without power adaptor or<br>transducers.) | Height. max (in operational<br>use) 157.5cm (62in)<br>Height. min (in operational<br>use) 128cm (50.5in)<br>Height min (displayed lower<br>for transport) 104cm (41in)<br>Width: 51cm (21.1in)<br>Depth: 72cm(28.2)<br>Weight: 65.3kg (144lb) |
| Power<br>Requirements | 100-240V, 50/60Hz, 2.5A<br>max | Same | 100-240V options,<br>~50-60Hz, 6A max |
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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.
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### Non-clinical test:
The Acclarix LX8 Ultrasound Imaging System complies with:
(1) IEC 60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (5) NEMA UD 3 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.
(6) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12
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 Ultrasound Imaging System. This premarket notification submission demonstrates that Acclarix LX8 Ultrasound Imaging System is substantially equivalent to the predicate devices.
