(120 days)
Not Found
No
The document does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development.
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," which points to a diagnostic, rather than therapeutic, purpose.
Yes
The device description explicitly states, "E-CUBE 11 product is an ultrasound imaging system for medical diagnosis." The intended use also outlines its role in evaluating soft tissue and blood flow across various clinical applications, which are diagnostic in nature.
No
The device description explicitly states "E-CUBE 11 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." This describes a hardware system, not a software-only device.
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 being used by a qualified physician for the evaluation of soft tissue and blood flow in various anatomical sites. This is a description of a diagnostic imaging procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is described as an "ultrasound imaging system for medical diagnosis." Ultrasound is a non-invasive imaging modality used to visualize internal structures of the body.
- Input Imaging Modality: The input modality is Ultrasound, which is an in-vivo imaging technique.
- Anatomical Site: The listed anatomical sites are all locations within the human body where ultrasound imaging is performed.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates by sending and receiving sound waves to create images of internal structures directly within the patient.
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); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).
Product codes
IYN, IYO, ITX
Device Description
E-CUBE 11 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
Ultrasonic pulsed doppler imaging system
Anatomical Site
Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).
Indicated Patient Age Range
Adult, Pediatric, Fetal, Neonatal
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
E-CUBE 11 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 11 and its application comply with voluntary standards as detailed in this premarket submission. The subject of this premarket submission, E-CUBE 11, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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
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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim Quality Management Representative (QMR) 1FL and 6FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu Seoul 08393 REPUBLIC OF KOREA
September 22, 2016
Re: K161439 Trade/Device Name: E-CUBE 11 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 19, 2016 Received: August 22, 2016
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of September 21, 2016.
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
1
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
Jeff Bollyer
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: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name E-CUBE 11
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); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac 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
"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 11 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 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | N | ||
| 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 | ||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| 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 | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | 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, Office of In-Vitro Diagnostic Devices (OIVD)
4
E-CUBE 11 with SC1-4HS 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 | P | P | P | P | P | P | P | P | |||
| 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 | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Other (Specify) | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Other (Specify) | |||||||||||
| Peripheral vessel | |||||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K150773; 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 11 with SC1-6H 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 | P | P | P | P | P | P | P | |||
| 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 | ||||||||||
| 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 | ||||||||||
| Other (Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral vessel | ||||||||||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K150773; 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)
6
E-CUBE 11 with SC1-4H 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 | P | P | P | P | P | P | P | |||
| 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 | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral vessel | ||||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K150773; 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 11 L3-12H™ 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 | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | N | P | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | P | N | P | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | N | P | ||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) |
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)
8
E-CUBE 11 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 | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| 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 | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K150773; 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 11 with SP1-5 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 | 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 | |||||||||
| 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 | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
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)
10
E-CUBE 11 with MP3-8 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) | |||||||||
| 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 | |||||||||
| Other (Specify) | |||||||||
| 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 | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | P | P |
| Abdominal | P | P | P | P | P | P | P | P | P |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P | P |
| 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 | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P | 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)
11
E-CUBE 11 with SVC1-6H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA K150773; 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 11 with EV3-10H 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 | (Specify) | (Specify) | ||||||||
| Imaging | ||||||||||||
| 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 | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K150773; 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 11 with EC3-10H 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 | |||||||||
| 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 | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K150773; 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)
14
E-CUBE 11 with VE3-10H 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 | P |
| Trans-vaginal | P | P | P | P | P | P | P | P | P |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| ( Conventional ) | |||||||||
| Musculo-skeletal | |||||||||
| ( Superficial ) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K150773; 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 11 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 | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K150773; 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 11 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 | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K150773; 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;
May 17th, 2016 Date
- ALPINION MEDICAL SYSTEMS Co., Ltd. Submitter: Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, 08393, Republic of Korea
- Primary Contact Donghwan Kim Person Quality Management Representative(QMR) Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, 08393, Republic of Korea Phone: +82 70 7465 2068 Fax: +82 2 6220 2162 Email: qa ra@alpinion.com
Secondary JULIAN LEE Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States Contact Person Phone: 425 949 1059 Fax: 425 949 4910 Email: julian.lee@alpinionusa.com
Device Trade E-CUBE 11 Name:
Common/ Ultrasonic Pulsed Doppler Imaging System Usual Name:
- Classification System, Imaging, Pulsed Doppler Ultrasonic Names
- 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
K150773 E-CUBE 15 Diagnostic Ultrasound System Primary Predicate Device
- K153424 E-CUBE i7 Diagnostic Ultrasound System Predicate K132687 E-CUBE 7 Diagnostic Ultrasound System Device
E-CUBE 11 product is an ultrasound imaging system for medical diagnosis. Device This innovative system platform provides optimal patient diagnosis workflow Description: with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
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
| SC1-4HS | SC1-4H | SC1-6H | L3-12H | SVC1-6H | |
|---|---|---|---|---|---|
| Transducer | |||||
| type | Convex | Convex | Convex | Linear | Volume |
| Convex | |||||
| Applicable | |||||
| frequency | 1~4MHz | 1~4MHz | 1~6MHz | 3~12MHz | 1~6MHz |
| Intended | |||||
| usage | Fetal, | ||||
| Abdominal, | |||||
| Pediatric, | |||||
| Urology | |||||
| (including | |||||
| prostate) | Fetal, | ||||
| Abdominal, | |||||
| Pediatric, | |||||
| Urology | |||||
| (including | |||||
| prostate) | Fetal, | ||||
| Abdominal, | |||||
| Pediatric, | |||||
| Musculo- | |||||
| skeletal | |||||
| (Conventional) | |||||
| Musculo- | |||||
| skeletal | |||||
| (Superficial), | |||||
| Urology | |||||
| (including | |||||
| prostate) | Small Organ | ||||
| (breast, | |||||
| testes, thyroid), | |||||
| Musculo- | |||||
| skeletal | |||||
| (Conventional) | |||||
| Musculo- | |||||
| skeletal | |||||
| (Superficial), | |||||
| Peripheral | |||||
| vessel | Fetal, | ||||
| Abdominal, | |||||
| Pediatric, | |||||
| Urology | |||||
| (including | |||||
| prostate) | |||||
| 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/ | |||||
| Other | |||||
| Scanning | |||||
| Depth (mm) | 300 | 300 | 300 | 100 | 300 |
| Total number | |||||
| of element | 166 | 192 | 192 | 192 | 192 |
| Predicate | Previously | ||||
| cleared | |||||
| (K150773) | Previously | ||||
| cleared | |||||
| (K150773) | Previously | ||||
| cleared | |||||
| (K150773) | Previously | ||||
| cleared | |||||
| (K150773) | Previously | ||||
| cleared | |||||
| (K150773) |
Types of transducers compatible with the device :
19
| EV3-10H | VE3-10H | EC3-10H | CW2.0 | CW5.0 | |
|---|---|---|---|---|---|
| Transducer | |||||
| type | Endocavity | Volume | |||
| Endocavity | Endocavity | Pencil | |||
| Doppler | Pencil | ||||
| Doppler | |||||
| Applicable | |||||
| frequency | 3~10MHz | 3~10MHz | 3~10MHz | 2.0MHz | 5.0MHz |
| Intended | |||||
| usage | Fetal, | ||||
| Trans-rectal, | |||||
| Trans-vaginal, | |||||
| Urology | |||||
| (including | |||||
| prostate) | Fetal, | ||||
| Trans-rectal, | |||||
| Trans-vaginal, | |||||
| Urology | |||||
| (including | |||||
| prostate) | Fetal, | ||||
| Trans-rectal, | |||||
| Trans-vaginal, | |||||
| Urology | |||||
| (including | |||||
| prostate) | Cardiac Adult, | ||||
| Cardiac | |||||
| Pediatric | Cardiac Adult, | ||||
| Cardiac | |||||
| Pediatric | |||||
| Applicable | |||||
| mode | B/M/PWD/ | ||||
| Color | |||||
| Doppler/ | |||||
| Power | |||||
| Doppler/ | |||||
| Tissue | |||||
| Harmonic | |||||
| Imaging/ | |||||
| Combined | B/M/PWD/ | ||||
| Color | |||||
| Doppler/ | |||||
| Power | |||||
| Doppler/ | |||||
| Tissue | |||||
| Harmonic | |||||
| Imaging/ | |||||
| Combined/ | |||||
| Other | B/M/PWD/ | ||||
| Color | |||||
| Doppler/ | |||||
| Power | |||||
| Doppler/ | |||||
| Tissue | |||||
| Harmonic | |||||
| Imaging/ | |||||
| Combined | CWD | CWD | |||
| Scanning | |||||
| Depth (mm) | 140 | 140 | 140 | N/A | N/A |
| Total number | |||||
| of element | 192 | 192 | 192 | 2 | |
| (TX1, RX1) | 2 | ||||
| (TX1, RX1) | |||||
| Predicate | Previously | ||||
| cleared | |||||
| (K150773) | Previously | ||||
| cleared | |||||
| (K150773) | Previously | ||||
| cleared | |||||
| (K150773) | Previously | ||||
| cleared | |||||
| (K150773) | Previously | ||||
| cleared | |||||
| (K150773) |
| L3-12HWD | SP1-5 | MP3-8 | |
|---|---|---|---|
| Transducer | |||
| type | Linear | Sector | |
| Phased | Sector Phased | ||
| Applicable | |||
| frequency | 3~12MHz | 1~5MHz | 3~8MHz |
| Intended | |||
| usage | Small Organ | ||
| (breast, | |||
| testes, thyroid), | |||
| Musculo- | |||
| skeletal | |||
| (Conventional) | |||
| Musculo- | |||
| skeletal | |||
| (Superficial), | |||
| Peripheral | |||
| vessel | Abdominal, | ||
| Pediatric, | |||
| Adult Cephalic, | |||
| Cardiac Adult, | |||
| Cardiac | |||
| Pediatric | Abdominal, | ||
| Pediatric, | |||
| Adult Cephalic, | |||
| Cardiac Adult, | |||
| Cardiac Pediatric | |||
| Applicable | |||
| mode | 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 | |||
| Scanning | |||
| Depth (mm) | 100 | 300 | 300 |
| Total number | |||
| of element | 192 | 64 | 64 |
| Predicate | Previously | ||
| cleared | |||
| (K132687) | Previously | ||
| cleared | |||
| (K132687) | SP3-8/SP3-8T | ||
| (K132687/K153424) |
20
Substantial Equivalence:
- The device is intended for use by a qualified physician for the evaluation of Indications soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & For Use: GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vessel (PV); and Urology (including prostate).
| Determination | Comparison table with Predicate devices: |
|---|---|
| of |
| Feature | Proposed
E-CUBE 11 | Predicate
E-CUBE 15
K150773 | Predicate
E-CUBE i7
K153424 | Predicate
E-CUBE 7
K132687 |
|------------------------------------------------|-----------------------|-----------------------------------|-----------------------------------|----------------------------------|
| Indications for Use | | | | |
| - Fetal | √ | √ | √ | √ |
| - Abdominal
(renal&GYN/pelvic) | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ |
| - Small Organ
(breast, testes, thyroid) | √ | √ | √ | √ |
| - 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
(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 | √ | √ | | √ |
| Imaging Functions | | | | |
| - Xpeed™ | √ | √ | √ | √ |
| - Full SRI™ | √ | √ | √ | √ |
| -Spatial Compounding
Image (SCI) | √ | √ | √ | √ |
| - Frequency | √ | √ | | √ |
| Compounding image
(FCI) | | | | |
| - Panoramic | √ | √ | √ | √ |
| - Stress Echo | √ | √ | | |
| - Cube StrainTM | √ | √ | | |
| - Live HQTM | √ | √ | | |
| - Needle VisionTM
/ Needle VisionTM
Plus | | √ | √ | |
| - Elastography | √ | √ | | |
| - Cube viewTM | √ | | √ | |
| 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
Summary of Non-Clinical Tests:
E-CUBE 11 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 11 and its application comply with voluntary standards as detailed in this premarket submission.
- � IEC60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety
- � IEC60601-1-2, Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- � IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- � ISO10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- � ISO14971, Application of risk management to medical devices
- � AIUM Medical Ultrasound Safety
- � NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- � NEMA UD 3, 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 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.
22
Summary of Clinical Tests:
The subject of this premarket submission, E-CUBE 11, did not require clinical studies to support substantial equivalence.
Discussion:
E-CUBE 11 was compared with the predicate devices. The subject device is in conformance with applicable safety standards.
Therefore, the differences between E-CUBE 11 and the predicate devices would not affect the safety, effectiveness and essential performance.
- Conclusion: ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 11 to be as safe, 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.