(94 days)
None
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not mention any AI/ML-specific features or performance metrics.
No
The device is described as an "ultrasound imaging system for medical diagnosis" and is intended for "evaluation of soft tissue and blood flow." Its purpose is diagnostic, not therapeutic.
Yes
The device explicitly states in the 'Device Description' that it is an "ultrasound imaging system for medical diagnosis," and its 'Intended Use' describes evaluation of various soft tissues and blood flow, all indicative of diagnostic purposes.
No
The device description explicitly states it is an "ultrasound imaging system" and mentions hardware components like a "wide flat panel display" and "ergonomic control panel," indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an ultrasound imaging system for evaluating soft tissue and blood flow in various anatomical sites. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, or tissue samples) in vitro.
- Device Description: The description reinforces that it's an ultrasound imaging system for medical diagnosis.
- Input Imaging Modality: It uses ultrasonic pulsed doppler imaging, which is an in vivo imaging technique, not an in vitro diagnostic method.
- Anatomical Site: The device is used to image various parts of the human body directly.
- No mention of analyzing biological specimens: There is no indication that this device is used to analyze samples taken from a patient outside of the body.
IVD devices are specifically designed to perform tests on biological specimens to provide information for diagnosis, monitoring, or screening. This ultrasound system operates by sending sound waves into the body and interpreting the reflected echoes to create images, which is a fundamentally different process from in vitro diagnostics.
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); Neonatal Cephalic, Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
Product codes
IYN, IYO, ITX
Device Description
E-CUBE 8 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging or fluid flow analysis
Anatomical Site
Not Found
Indicated Patient Age Range
Fetal, Pediatric, Neonatal, Adult
Intended User / Care Setting
qualified physician
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)
The subject of this premarket submission, E-CUBE 8, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K161439 E-CUBE 11 Diagnostic Ultrasound System, K153424 E-CUBE i7 Diagnostic Ultrasound System, K132687 E-CUBE 7 Diagnostic Ultrasound System, K163691 HS70A Diagnostic Ultrasound System, K163120 EPIQ 5 / EPIQ 7 Diagnostic Ultrasound System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 14, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ALPINION MEDICAL SYSTEMS Co., Ltd. % Boyeon CHO Quality Management Representative (QMR) 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu Seoul. 08393 REPULIC OF KOREA
Re: K172732
Trade/Device Name: E-CUBE 8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 27, 2017 Received: November 29, 2017
Dear Boyeon CHO:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K172732
Device Name E-CUBE 8
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); Neonatal Cephalic, Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
E-CUBE 8 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 | N |
| Abdominal | N | N | N | N | N | N | N | N | N |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | N |
| Small Organ | |||||||||
| (breast, testes, thyroid) | N | N | N | N | N | N | N | N | N |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N |
| Adult Cephalic | N | N | N | N | N | N | N | N | N |
| Trans-rectal | N | N | N | N | N | N | N | N | N |
| Trans-vaginal | N | 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 | N |
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | N | N | N |
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | N | N | N |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | N |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | N | N |
| Urology (including prostate) | N | 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, Office of In-Vitro Diagnostic Devices (OIVD)
4
E-CUBE 8 with C1-6CT 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) | 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 | N | N | N | N | N | N |
N = new indication; P = previously cleared; 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, Office of In-Vitro Diagnostic Devices (OIVD)
5
E-CUBE 8 with C5-8NT Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | Other**
(Specify) |
|------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|--|----------------------|
| | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Tissue
Harmonic
Imaging | Combined*
(Specify) | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | P | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | |
| Small Organ
(breast, testes, thyroid) | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | | N | N | N | N | | |
| Adult Cephalic | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Cardiac Adult | P | P | P | | P | P | P | P | | |
| Cardiac Pediatric | N | N | N | | N | N | N | N | | |
| 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 K153424; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
6
E-CUBE 8 L3-12T with 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 | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | P | P | P | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | P | P | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K153424; 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, Office of In-Vitro Diagnostic Devices (OIVD)
7
E-CUBE 8 with L3-12H 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 | 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) | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | N | N | N | N | N | N | N | |||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | P | P | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | P | P | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | |||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K161439; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD) Prescription User (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
8
E-CUBE 8 L3-12H™P with 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) | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | P | P | P | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | P | P | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K161439; 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, Office of In-Vitro Diagnostic Devices (OIVD)
9
E-CUBE 8 with SP3-8T 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 | N | |
| Abdominal | P | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P | |
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | |
| Adult Cephalic | P | P | P | P | P | P | P | P | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K153424; 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, Office of In-Vitro Diagnostic Devices (OIVD)
10
E-CUBE 8 with P1-5CT 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 | N | N | N | N | N | N | N | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | |
| 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
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
11
E-CUBE 8 with VC1-6T 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 | 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) | |||||||||
| 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 |
N = new indication; P = previously cleared; 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, Office of In-Vitro Diagnostic Devices (OIVD)
12
E-CUBE 8 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 | Power | Tissue | Combined* | Other** | |
| Doppler | Doppler | Harmonic | |||||||
| Imaging | (Specify) | (Specify) | |||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | P | ||
| 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 | N | N | N | N | N | N | N | ||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K153424; 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, Office of In-Vitro Diagnostic Devices (OIVD)
13
E-CUBE 8 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 | N | N | N | N | N | N | N | N | |
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | P | |
| Trans-vaginal | P | P | P | P | P | P | P | P | |
| 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 | N | N | N | N | N | N | N | N | |
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K153424; 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)
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14
E-CUBE 8 with E3-10 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 | |||||||||
| r | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | P | ||
| 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 | N | N | N | N | N | N | N | N | |
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K132687; 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, Office of In-Vitro Diagnostic Devices (OIVD)
15
E-CUBE 8 with CW2.0 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 | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K161439; 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, Office of In-Vitro Diagnostic Devices (OIVD)
16
E-CUBE 8 with CW5.0 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 | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | ||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K161439; 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, Office of In-Vitro Diagnostic Devices (OIVD)
17
510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
| Date | September 8th, 2017 | C1-6CT | C5-8NT | P1-5CT | SP3-8T | VC1-6T | |
|---|---|---|---|---|---|---|---|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd. | ||||||
| Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu, | |||||||
| Seoul, Republic of Korea | Transducer | ||||||
| type | Convex | Convex | Sector | ||||
| Phased | Sector | ||||||
| Phased | Volume | ||||||
| Convex | |||||||
| Primary Contact | |||||||
| Person | Boyeon CHO | ||||||
| Quality Management Representative(QMR) | |||||||
| Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu, | |||||||
| Seoul, Republic of Korea | |||||||
| Phone: +82 70 7465 2104 | |||||||
| Fax: +82 2 851 5595 | |||||||
| Email: qa_ra@alpinion.com | Applicable | ||||||
| frequency | 1~6MHz | 5~8MHz | 1~5MHz | 3~8MHz | 1~6MHz | ||
| 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 | Intended | ||||||
| usage | Fetal, | ||||||
| Abdominal, | |||||||
| Pediatric, | |||||||
| Musculo- | |||||||
| skeletal, | |||||||
| Urology | Fetal, | ||||||
| Pediatric, | |||||||
| Cardiac Adult, | |||||||
| Cardiac | |||||||
| Pediatric | Abdominal, | ||||||
| Pediatric, | |||||||
| Adult | |||||||
| Cephalic, | |||||||
| Cardiac Adult, | |||||||
| Cardiac | |||||||
| Pediatric | Abdominal, | ||||||
| Pediatric, | |||||||
| Adult | |||||||
| Cephalic, | |||||||
| Cardiac Adult, | |||||||
| Cardiac | |||||||
| Pediatric | Fetal, | ||||||
| Abdominal, | |||||||
| Pediatric, | |||||||
| Urology | |||||||
| Device Trade | |||||||
| Name: | E-CUBE 8 | Applicable | |||||
| mode | B/M/PWD/ | ||||||
| Color | |||||||
| Doppler/ | |||||||
| Power | |||||||
| Doppler/ | |||||||
| Tissue | |||||||
| Harmonic | |||||||
| Imaging/ | |||||||
| Combined | B/M/PWD/ | ||||||
| Color | |||||||
| Doppler/ | |||||||
| Power | |||||||
| Doppler/ | |||||||
| Tissue | |||||||
| Harmonic | |||||||
| Imaging/ | |||||||
| Combined | B/M/PWD/ | ||||||
| CWD | |||||||
| Color | |||||||
| Doppler/ | |||||||
| Power | |||||||
| Doppler/ | |||||||
| Tissue | |||||||
| Harmonic | |||||||
| Imaging/ | |||||||
| Combined | B/M/PWD/ | ||||||
| CWD | |||||||
| Color | |||||||
| Doppler/ | |||||||
| Power | |||||||
| Doppler/ | |||||||
| Tissue | |||||||
| Harmonic | |||||||
| Imaging/ | |||||||
| Combined | B/M/PWD/ | ||||||
| Color | |||||||
| Doppler/ | |||||||
| Power | |||||||
| Doppler/ | |||||||
| Tissue | |||||||
| Harmonic | |||||||
| Imaging/ | |||||||
| Combined/ | |||||||
| Others | |||||||
| Common/ | |||||||
| Usual Name: | Ultrasonic Pulsed Doppler Imaging System | Scanning | |||||
| Depth (mm) | 300 | 140 | 300 | 300 | 300 | ||
| Classification | |||||||
| Names | System, Imaging, Pulsed Doppler Ultrasonic | Total number | |||||
| of element | 128 | 128 | 64 | 64 | 128 | ||
| 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 | New | |||||
| (SC1-6H:K161439, | |||||||
| C5-1:K163120) | Previously | ||||||
| cleared | |||||||
| (K153424) | New | ||||||
| (SP1-5T:K153424, | |||||||
| S5-1:K163120) | Previously | ||||||
| cleared | |||||||
| (K153424) | New | ||||||
| (VC1-6:K132687) | |||||||
| Primary | |||||||
| Predicate | |||||||
| Device | K161439 E-CUBE 11 Diagnostic Ultrasound System | ||||||
| Predicate | |||||||
| Devices | K153424 E-CUBE i7 Diagnostic Ultrasound System | ||||||
| K132687 E-CUBE 7 Diagnostic Ultrasound System | |||||||
| K163691 HS70A Diagnostic Ultrasound System | |||||||
| K163120 EPIQ 5 / EPIQ 7 Diagnostic Ultrasound System | |||||||
| Device | |||||||
| Description: | E-CUBE 8 product is an ultrasound imaging system for medical diagnosis. | ||||||
| This innovative system platform provides optimal patient diagnosis workflow | |||||||
| with the wide flat panel display, ergonomic control panel with easy user | |||||||
| interface, optimal image quality. |
ALPINION MEDICAL SYSTEMS Co., Ltd.
18
1. Signal Mode:
2D(B) mode, Harmonic mode (HAR), M mode, Color M mode, Anatomical M mode, Color Flow Doppler(CF) Mode, Power Doppler(PD) Mode, Directional
PD mode, Pulsed Wave Doppler(PWD) Mode, Continuous Wave Doppler(CWD) Mode, High PRF Doppler mode, Tissue Doppler Imaging(TDI) Mode, 3D/4D mode
2. Combination Mode:
B/Color Doppler, B/PWD, B/Color Doppler/PWD
Acoustic output track: _
Track 3
Types of transducers compatible with the device :
19
510(k) E-CUBE 8
| L3-12T | L3-12H | L3-12HWD | EC3-10T | EV3-10T | |
|---|---|---|---|---|---|
| Transducer | |||||
| type | Linear | Linear | Linear | Endocavity | Endocavity |
| Applicable | |||||
| frequency | 3~12MHz | 3~12MHz | 3~12MHz | 3~10MHz | 3~10MHz |
| Intended | |||||
| usage | Pediatric, | ||||
| Small Organ, | |||||
| Musculo- | |||||
| skeletal, | |||||
| Peripheral | |||||
| vessel | Pediatric, | ||||
| Small Organ, | |||||
| Musculo- | |||||
| skeletal, | |||||
| Peripheral | |||||
| vessel | Pediatric, | ||||
| Small Organ, | |||||
| Musculo- | |||||
| skeletal, | |||||
| Peripheral | |||||
| vessel | Fetal. | ||||
| Trans-rectal, | |||||
| Trans- | |||||
| vaginal, | |||||
| Urology | Fetal, | ||||
| Trans-rectal, | |||||
| Trans- | |||||
| vaginal, | |||||
| Urology | |||||
| Applicable | |||||
| mode | B/M/PWD/ | ||||
| Color | |||||
| Doppler/ | |||||
| Power | |||||
| Doppler/ | |||||
| Tissue | |||||
| Harmonic | |||||
| Imaging/ | |||||
| Combined | B/M/PWD/ | ||||
| Color | |||||
| Doppler/ | |||||
| Power | |||||
| Doppler/ | |||||
| Tissue | |||||
| Harmonic | |||||
| Imaging/ | |||||
| Combined | B/M/PWD/ | ||||
| Color | |||||
| Doppler/ | |||||
| Power | |||||
| Doppler/ | |||||
| Tissue | |||||
| Harmonic | |||||
| Imaging/ | |||||
| Combined | B/M/PWD/ | ||||
| Color | |||||
| Doppler/ | |||||
| Power | |||||
| Doppler/ | |||||
| Tissue | |||||
| Harmonic | |||||
| Imaging/ | |||||
| Combined | B/M/PWD/ | ||||
| Color | |||||
| Doppler/ | |||||
| Power | |||||
| Doppler/ | |||||
| Tissue | |||||
| Harmonic | |||||
| Imaging/ | |||||
| Combined | |||||
| Scanning | |||||
| Depth (mm) | 100 | 100 | 100 | 100 | 100 |
| Total number | |||||
| of element | 128 | 192 | 192 | 128 | 128 |
| Predicate | Previously | ||||
| cleared | |||||
| (K153424) | Previously | ||||
| cleared | |||||
| (K161439) | Previously | ||||
| cleared | |||||
| (K161439) | Previously | ||||
| cleared | |||||
| (K153424) | Previously | ||||
| cleared | |||||
| (K153424) |
| E3-10 | CW2.0 | CW5.0 | |
|---|---|---|---|
| Transducer | |||
| type | Endocavity | Pencil | |
| Doppler | Pencil | ||
| Doppler | |||
| Applicable | |||
| frequency | 3~10MHz | 2.0MHz | 5.0MHz |
| Intended | |||
| usage | Fetal, | ||
| Trans-rectal, | |||
| Trans- | |||
| vaginal, | |||
| Urology | Cardiac Adult, | ||
| Cardiac | |||
| Pediatric | Cardiac Adult, | ||
| Cardiac | |||
| Pediatric | |||
| Applicable | |||
| mode | B/M/PWD/ | ||
| Color | |||
| Doppler/ | |||
| Power | |||
| Doppler/ | |||
| Tissue | |||
| Harmonic | |||
| Imaging/ | |||
| Combined | CWD | CWD | |
| Scanning | |||
| Depth (mm) | 140 | N/A | N/A |
| Total number | |||
| of element | 128 | 2 | |
| (TX1, RX1) | 2 | ||
| (TX1, RX1) | |||
| Predicate | Previously | ||
| cleared | |||
| (K132687) | Previously | ||
| cleared | |||
| (K161439) | Previously | ||
| cleared | |||
| (K161439) |
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, Neonatal Cephalic, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
20
Determination of
Substantial Equivalence: Comparison table with Predicate devices:
| Model | Proposed
E-CUBE 8
ALPINION Medical
Systems Co., Ltd. | Predicate
E-CUBE 11
ALPINION Medical
Systems Co., Ltd.
K161439 | Predicate
E-CUBE i7
ALPINION Medical
Systems Co., Ltd.
K153424 | Predicate
E-CUBE 7
ALPINION Medical
Systems Co., Ltd.
K132687 | Predicate
HS70A
Samsung
Medison co., ltd
K163691 | Predicate
EPIQ 5 and EPIQ 7
Philips Ultrasound,
Inc.
K163120 |
|--------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------|
| Feature | | | | | | |
| Indications for Use | | | | | | |
| - Fetal | √ | √ | √ | √ | √ | √ |
| - Abdominal
(Renal&GYN/Pelvic) | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ |
| - Small Organ
(breast, testes, thyroid) | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | | √ | | √ | √ |
| - Adult Cephalic | √ | √ | √ | | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ | √ |
| - Musculto skeletal
(Superficial) | √ | √ | √ | √ | √ | √ |
| - Cardiac (Adult) | √ | √ | √ | √ | √ | √ |
| - Cardiac (Pediatric) | √ | √ | √ | √ | √ | √ |
| - Peripheral Vessel | √ | √ | √ | √ | √ | √ |
| - Urology
(including prostate) | √ | √ | √ | √ | √ | √ |
| Imaging modes | | | | | | |
| - 2D(B) mode | √ | √ | √ | √ | √ | √ |
| - Harmonic mode | √ | √ | √ | √ | √ | √ |
| - M mode | √ | √ | √ | √ | √ | √ |
| - Color M mode | √ | √ | √ | | √ | √ |
| - Anatomical M mode | √ | √ | √ | | √ | √ |
| - Color Flow Doppler (CF)
mode | √ | √ | √ | √ | √ | √ |
| - Power Doppler (PD)
mode | √ | √ | √ | √ | √ | √ |
| - Directional PD mode | √ | √ | √ | | √ | √ |
| | | | | | | |
| - Pulsed wave Doppler
(PWD) mode | √ | √ | √ | √ | √ | √ |
| - Continuous wave
Doppler (CWD) mode | √ | √ | √ | √ | √ | |
| - High PRF Doppler mode | √ | √ | √ | √ | √ | |
| - Tissue Doppler
imaging (TDI) mode | √ | √ | √ | √ | √ | |
| - 3D/4D mode | √ | √ | √ | √ | √ | |
| Imaging modes | | | | | | |
| - 2D(B) mode | √ | √ | √ | √ | √ | √ |
| - Harmonic mode | √ | √ | √ | √ | √ | √ |
| - M mode | √ | √ | √ | √ | √ | √ |
| - Color M mode | √ | √ | √ | √ | √ | |
| - Anatomical M mode | √ | √ | √ | √ | √ | |
| - Color Flow Doppler (CF) mode | √ | √ | √ | √ | √ | √ |
| - Power Doppler (PD) mode | √ | √ | √ | √ | √ | √ |
| - Directional PD mode | √ | √ | √ | √ | √ | |
| - Pulsed wave Doppler
(PWD) mode | √ | √ | √ | √ | √ | √ |
| - Continuous wave
Doppler (CWD) mode | √ | √ | √ | √ | √ | |
| - High PRF Doppler mode | √ | √ | √ | √ | √ | √ |
| - Tissue Doppler
imaging (TDI) mode | √ | √ | √ | √ | √ | √ |
| - 3D/4D mode | √ | √ | √ | √ | √ | √ |
| Imaging Functions | | | | | | |
| - Xpeed™ | √ | √ | √ | √ | √ | √ |
| - Full SRI™ | √ | √ | √ | √ | √ | √ |
| -Spatial Compounding
Image (SCI) | √ | √ | √ | √ | √ | √ |
| - Frequency Compounding
image(FCI) | √ | √ | √ | √ | √ | √ |
| - Panoramic | √ | √ | √ | √ | √ | √ |
| - Stress Echo | √ | √ | √ | √ | √ | |
| - Cube Strain™ | √ | √ | √ | √ | √ | √ |
| - Live HQ ™ | √ | √ | √ | √ | √ | √ |
| - Needle Vision™ /
Needle Vision™ Plus | √ | √ | √ | √ | √ | √ |
| - Elastography | √ | | | | √ | |
| | | | | | | |
| - Cube view™ | √ | √ | √ | √ | | |
| - Volume Advance™ | | | | | | |
| • Free Angle MSV | √ | | | | √ | |
| • AnySlice™ | √ | | | | √ | |
| • Volume Analysis | √ | | | | √ | |
| Thermal, Mechanical and Electrical safety | | | | | | |
| NEMA UD2, UD3 | √ | √ | √ | √ | √ | √ |
| AIUM Medical Ultrasound Safety | √ | √ | √ | √ | √ | √ |
| IEC 60601-1 | √ | √ | √ | √ | √ | √ |
| IEC 60601-1-2 | √ | √ | √ | √ | √ | √ |
| IEC 60601-2-37 | √ | √ | √ | √ | √ | √ |
ALPINION MEDICAL SYSTEMS Co., Ltd.
21
510(k) E-CUBE 8
22
510(k) E-CUBE 8
23
Summary of Non-Clinical Tests:
E-CUBE 8 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 8 and its application comply with voluntary standards as detailed in this premarket submission.
- � IEC60601-1:2005(Third Edition)+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety
- � IEC60601-1-2 Edition 3:2007-03, Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- � IEC60601-2-37 Edition 2.0:2007, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- ◆ AAMI/ANSI/ISO10993-1:2009(R)2013, Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing
- � AAMI/ANSI/ISO14971:2007/(R)2010, Medical devices-Application of risk management to medical devices
- � AIUM MUS, Third edition, Medical Ultrasound Safety
- � NEMA UD 2-2004(R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- � NEMA UD 3-2004(R2009), Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic ultrasound Equipment
The following quality management system measures were applied to the development of E-CUBE 8:
- 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 8, did not require clinical studies to support substantial equivalence.
Discussion:
E-CUBE 8 was compared with the predicate devices. The subject device is in conformance with applicable safety standards.
Therefore, the differences between E-CUBE 8 and the predicate devices would not affect the safety, effectiveness and essential performance.
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ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 8 to be as safe, Conclusion: as effective. Performance, technology and software are substantially equivalent to the predicate devices.
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.