(35 days)
Not Found
No
The document describes a standard ultrasound imaging system with various operational modes. There is no mention of AI, ML, deep learning, or any related terms in the provided text. The description focuses on the hardware, display, user interface, and traditional ultrasound imaging modes.
No.
The device is described as an "ultrasound imaging system for medical diagnosis," and its intended use is for "evaluation of soft tissue and blood flow." Imaging and evaluation are diagnostic purposes, not therapeutic.
Yes
Explanation: The "Device Description" section states that the "E-CUBE 5 product is an ultrasound imaging system for medical diagnosis." The "Intended Use / Indications for Use" further specifies its use for "evaluation of soft tissue and blood flow."
No
The device description explicitly states it is an "ultrasound imaging system" and mentions hardware components like a "15.6" wide flat panel display" and "ergonomic control panel," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The purpose is to provide information for diagnosis, monitoring, or screening.
- This device is an ultrasound imaging system. It uses ultrasonic waves to create images of internal body structures in vivo (inside the body).
- The intended use and device description clearly state its purpose is for imaging soft tissue and blood flow in various anatomical sites. This is a diagnostic imaging modality, not an in vitro diagnostic test.
Therefore, the E-CUBE 5 Diagnostic Ultrasound System falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
E-CUBE 5 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Modes of operation:
- Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI)
- Combination Mode: B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
Acoustic output track: Track 3
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Soft tissue, Fetal, Abdominal (renal & GYN/pelvic), Pediatric, Small Organ (breast, testes, thyroid), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Peripheral Vascular, Urology (including prostate)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician / Not Found
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)
E-CUBE 5 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 5 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 5:
- Medical Device Risk Management
- Requirements Reviews
- Design Reviews
- Component Verification
- Integration Review (System Verification)
- Performance Testing (System Verification)
- Safety Testing (Compliance Test)
- Design Validation
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.
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim OARA Manager 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu Seoul 152-848 REPUBLIC OF KOREA
Re: K142733
Trade/Device Name: E-CUBE 5 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 26, 2014 Received: September 29, 2014
Dear Mr. Kim:
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.
This determination of substantial equivalence applies to the following transducers intended for use with the E-CUBE 5 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C1-6T | L3-12T |
|---|---|
| EV3-10T | EC3-10T |
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
1
Page 2-Mr. Kim
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.
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,
Smh
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142733
Device Name
E-CUBE 5 Diagnostic Ultrasound System
Indications for Use (Describe)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
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
E-CUBE 5 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ | |||||||||
| (breast, testes, thyroid) | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | N | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | N | N | |
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | N | N | |
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | N | |
| Urology (including prostate) | N | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA ; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
4
E-CUBE 5 with C1-6T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
5
E-CUBE 5 with L3-12T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | N | N | N | N | N | N | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
6
E-CUBE 5 with EV3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | N | ||
| Trans-vaginal | N | N | N | N | N | N | N | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | ||
| N = new indication; P = previously cleared by FDA; E = added under appendix |
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
7
E-CUBE 5 with EC3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | N | ||
| Trans-vaginal | N | N | N | N | N | N | N | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
8
Section F 510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
| Date | Sep 5th 2014 |
|---|---|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd. |
| Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, | |
| Seoul, Republic of Korea 152-848 | |
| Primary Contact | |
| Person | Donghwan Kim |
| QARA Manager | |
| Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, | |
| Seoul, Republic of Korea 152-848 | |
| Phone: +82 70 7465 2068 | |
| Fax: +82 2 851 5594 | |
| Email: donghwan.kim@alpinion.com | |
| Secondary Contact | |
| Person | JULIAN LEE |
| Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States | |
| Phone: 425 949 1059 | |
| Fax: 425 949 4910 | |
| Email: julian.lee@alpinionusa.com | |
| Device Trade Name: | E-CUBE 5 |
| Common/Usual | |
| Name: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Names | System, Imaging, Pulsed Doppler Ultrasonic |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO | |
| Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX | |
| Predicate Device(s) | K132687 E-CUBE 7 Diagnostic Ultrasound System |
| Device Description: | E-CUBE 5 product is an ultrasound imaging system for medical |
| diagnosis. The system platform provides optimal patient diagnosis | |
| workflow with the 15.6" wide flat panel display, ergonomic control panel | |
| with easy user interface, optimal image quality. | |
| Modes of operation: |
- Signal Mode:
B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode,
Pulsed Wave
Doppler(PWD) mode, Tissue Harmonic Imaging(THI) - Combination Mode:
B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
Acoustic output track:
Track 3 |
9
| C1-6T | L3-12T | EV3-10T | EC3-10T | |
|---|---|---|---|---|
| Applicable | ||||
| frequency | 1~6MHz | 3~12MHz | 3~10MHz | 3~10 MHz |
| Intended | ||||
| Usage | Fetal, Abdominal | |||
| Pediatric, | ||||
| Urology | Pediatric, Small | |||
| Organ, Musculo- | ||||
| skeletal | ||||
| (Conventional), | ||||
| Musculo-skeletal | ||||
| (Superficial), | ||||
| Peripheral | ||||
| vessel | Trans-rectal, | |||
| Trans-vaginal, | ||||
| Urology | Trans-rectal, | |||
| Trans-vaginal, | ||||
| Urology | ||||
| Foot print | ||||
| size | ||||
| (mm) | 71.6 x 16.8 | 44.8 x 7.8 | 21.5 x 18.6 | 21.5 x 18.6 |
| Applicable | ||||
| mode | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler | ||||
| Imaging | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler | ||||
| Imaging | ||||
| Scanning | ||||
| depth(mm) | 300 | 100 | 100 | 100 |
| FOV | 60(°) | 142(°) | 142(°) | 142(°) |
| Steer Angle | N/A | Max 9(°) | N/A | N/A |
| Total | ||||
| number of | ||||
| element | 128 | 128 | 128 | 128 |
| Element | ||||
| spacing | 0.484mm | 0.3mm | 0.195mm | 0.195mm |
| elevating | ||||
| length | 13.5mm | 4.5mm | 6.0mm | 6.0mm |
Types of transducers compatible with the device:
Indications For Use: The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
Determination of Substantial Comparison with Predicate device:
Equivalence:
| Feature | Proposed
E-CUBE 5 | Predicate
E-CUBE 7
(K132687) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The device is intended for use by a
qualified physician for
the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal;
Abdominal (renal & GYN/pelvic);
Pediatric;
Organ
Small
(breast.
testes.
thyroid);
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal Superficial);
Peripheral Vascular (PV);
Urology (including prostate). | The device is intended for use by a
qualified physician for
the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal:
Abdominal (renal & GYN/pelvic);
Pediatric;
Small Organ
(breast,
testes.
thyroid);
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal Superficial);
Cardiac (adult & pediatric);
Peripheral Vascular (PV);
Urology (including prostate). |
10
| Transducer | C1-6T | C1-6 |
|---|---|---|
| C5-8 | ||
| L3-12T | L3-12 | |
| L3-12H | ||
| L3-12HWD | ||
| L3-8 | ||
| L8-17 | ||
| EV3-10T | EV3-10 | |
| EC3-10T | EC3-10 | |
| E3-10 | ||
| EN3-10 | ||
| SP1-5 | ||
| SP3-8 | ||
| SC1-6 | ||
| VC1-6 | ||
| CW2.0 | ||
| CW5.0 | ||
| IO3-12 | ||
| Electrical | ||
| power | Voltage: 100 | |
| Frequency: 50/60Hz | ||
| Power: Max. 450 VA with Built-in | ||
| and On-Board Peripherals | Voltage: 100 | |
| Frequency: 50/60Hz | ||
| Power: Max. 600 VA with Built-in | ||
| and On-Board Peripherals | ||
| Operating | ||
| Mode | B Mode | |
| M Mode | ||
| Color Flow Mode | ||
| Power Doppler Mode | ||
| Pulsed Wave Doppler Mode | ||
| Tissue Harmonic Imaging Mode | B Mode | |
| M Mode | ||
| Color Flow Mode | ||
| PW Doppler Mode | ||
| Power Doppler Mode | ||
| Continuous wave Doppler mode | ||
| Tissue Harmonic Imaging Mode | ||
| 3D/4D Mode | ||
| Xpeed™ | Xpeed™ | |
| Full SRI™ | Full SRI™ | |
| Spatial compounding | Spatial compounding | |
| Frequency Compounding | Frequency Compounding | |
| Panoramic | Panoramic | |
| Auto IMT Measurement | Auto IMT Measurement | |
| Thermal, | ||
| mechanical | ||
| and | ||
| electrical | ||
| safety | The E-CUBE 5 has been designed | |
| to conform to the following | ||
| standards: |
- NEMA UD2, UD3
- AIUM Medical Ultrasound Safety
- IEC60601-1
- IEC60601-1-2
- IEC60601-2-37 | The E-CUBE 7 has been designed
to conform to the following
standards: - NEMA UD2, UD3
- AIUM Medical Ultrasound Safety
- IEC60601-1
- IEC60601-1-2
- IEC60601-2-37 |
Summary of Non-Clinical Tests:
E-CUBE 5 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 5 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 5:
11
- Medical Device Risk Management �
- ◆ Requirements Reviews
- � Design Reviews
- � Component Verification
- � Integration Review (System Verification)
- � Performance Testing (System Verification)
- � Safety Testing (Compliance Test)
- � Design Validation
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission. E-CUBE 5, did not require clinical studies to support substantial equivalence.
Discussion:
E-CUBE 5 and the predicate device have differences in clinical applications and operating modes. Several transducers are changed for these purposes. These design changes have been verified via nonclinical testing. The subject device is in conformance with applicable safety standards. Therefore, the differences between E-CUBE 5 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 5.
- ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 5 to be as Conclusion: safe, as effective. Performance, technology and software are substantially equivalent to the predicate device.
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.