(93 days)
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).
E-CUBE i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable(only body) and mobile(with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
- Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode
- Combination Mode: B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE i7 ultrasonic pulsed doppler imaging system (K153424):
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel device's primary clinical efficacy study. Therefore, the "acceptance criteria" discussed here are primarily related to safety, performance, and equivalence to existing devices, not necessarily a clinical effectiveness threshold. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted to confirm compliance with recognized medical device standards and comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are predominantly compliance with recognized standards and equivalence in features and performance to predicate devices. The "reported device performance" is demonstrated by affirming compliance and similarity.
| Acceptance Criteria Category | Specific Criteria / Performance Target | Reported Device Performance (E-CUBE i7) |
|---|---|---|
| Indications for Use | Must be substantially equivalent or expanded upon predicate devices. | Expanded indications compared to K121937 (E-CUBE inno) by adding "Adult Cephalic", "Trans-rectal", "Trans-vaginal", "Cardiac Pediatric". Substantially equivalent to K150773 (E-CUBE 15) and K151663 (RS80A) for all broad categories. |
| Safety Standards Compliance | Conformity to specific medical device safety standards. | Conforms to NEMA UD2, UD3; AIUM Medical Ultrasound Safety; IEC60601-1; IEC60601-1-2; IEC60601-2-37; ISO10993-1; ISO14971. |
| Biocompatibility | Patient contact materials must be biocompatible. | Transducer materials and other patient contact materials are biocompatible. |
| Acoustic Output | Must meet specified limits for medical ultrasound equipment. | Evaluated for acoustic output (Track 3). |
| Electrical Safety | Must conform to relevant electrical safety standards. | Conforms to IEC60601-1 and IEC60601-1-2. |
| Electromagnetic Compatibility (EMC) | Must conform to relevant EMC standards. | Conforms to IEC60601-1-2. |
| Mechanical Safety | Must conform to relevant mechanical safety standards. | Evaluated for mechanical safety. |
| Imaging Modes | Must include equivalent or enhanced imaging capabilities compared to predicate. | Includes 2D (B), M, Anatomical M, Color Flow (CF), Power Doppler (PD), Directional PD, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Tissue Doppler Imaging (TDI). Adds Anatomical M, Directional PD, TDI (compared to K121937). |
| Image Processing Technology | Must include equivalent or enhanced image processing compared to predicate. | Includes Xpeed™, Full SRI™, Spatial Compounding Image (SCI). Adds Spatial Compounding Image (SCI) compared to K121937. Adds High PRF Doppler compared to K150773. |
| Software Features | Must include equivalent or enhanced software features compared to predicate. | Includes Panoramic, Needle Vision™/Needle Vision™ Plus, Cube View™. Adds Panoramic, Needle Vision™/Needle Vision™ Plus, Cube View™ compared to K121937. |
| Transducer Compatibility | Must be compatible with transducers with similar performance characteristics and clinical applications as predicate devices. | Demonstrates compatibility with 9 transducers (C1-6T, L3-12T, EC3-10T, EV3-10T, I08-17T, SP1-5T, SP3-8T, C5-8NT) and lists their intended usage and operating modes, showing equivalence or expansion to predicate transducers. |
| Quality Management System | Evidence of robust development process. | Applied quality management measures including Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), Design Validation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document explicitly states: "The subject of this premarket submission, E-CUBE i7, did not require clinical studies to support substantial equivalence." This means there was no clinical test set of patients or images used for efficacy comparison. The "test set" for this submission primarily consisted of the device itself and its components tested against engineering and safety standards.
- Data Provenance: Not applicable for a clinical test set in this context. The data provenance would be internal engineering tests and design documentation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as there was no clinical study involving human reads or a ground truth established by experts for a test set. This submission is based on engineering verification and validation (V&V) against technical standards and comparison to predicate devices, which involves engineers, quality assurance personnel, and regulatory specialists.
4. Adjudication Method for the Test Set
- Not applicable as there was no clinical test set requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No MRMC study was done. This device is an ultrasonic imaging system, not an AI-assisted diagnostic tool. Its substantial equivalence is based on its core imaging capabilities and safety, not on improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No standalone algorithm performance study was done. The E-CUBE i7 is a diagnostic ultrasound system intended to be operated by a qualified physician, not an autonomous algorithmic device.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the adherence to established international and national medical device standards (e.g., IEC, NEMA, AIUM, ISO) for safety and performance, and the documented specifications and performance of legally marketed predicate devices. This is established through engineering testing and documented comparisons, rather than clinical outcomes, pathology, or expert consensus on patient data.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a hardware and software system, not a machine learning model that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There was no training set for a machine learning model.
{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, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim OARA Manager 1FL and 6FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd) Guro-gu, Seoul 08393 REPUBLIC OF KOREA
Re: K153424 Trade/Device Name: E-CUBE i7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 29, 2016 Received: February 1, 2016
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153424
Device Name E-CUBE i7
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) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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{3}------------------------------------------------
E-CUBE i7 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 | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | 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 | N | N | N | N | N | N | N | ||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | N | N | |
| Trans-rectal | N | N | N | N | N | N | N | ||
| Trans-vaginal | N | N | N | N | N | N | N | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | ||
| (Conventional) | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | ||
| (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 | 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
{4}------------------------------------------------
E-CUBE i7 with C1-6T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | 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 | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K 142733; 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
{5}------------------------------------------------
E-CUBE i7 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 | ColorDoppler | PowerDoppler | TissueHarmonicImaging | 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 | 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 | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K 142733; 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
{6}------------------------------------------------
E-CUBE i7 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 | ColorDoppler | PowerDoppler | TissueHarmonicImaging | 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 | 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 | ||||||||||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K 142733; 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
{7}------------------------------------------------
E-CUBE i7 with L3-12T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ | P | P | P | P | P | P | P | ||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | P | P | P | P | P | P | P | ||
| (Conventional) | |||||||||
| Musculo-skeletal | P | P | P | P | P | P | P | ||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | ||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K 142733; 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
{8}------------------------------------------------
E-CUBE i7 with C5-8NT 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 | ColorDoppler | PowerDoppler | TissueHarmonicImaging | 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 | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | N | N | N | N | N | N | N | |||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
{9}------------------------------------------------
E-CUBE i7 with IO8-17T 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 | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
{10}------------------------------------------------
E-CUBE i7 with SP1-5T 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 | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| 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 | N | 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 | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
{11}------------------------------------------------
E-CUBE i7 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 | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| 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 | N | 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 | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
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510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
| Date | November 23rd 2015 |
|---|---|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd.Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,Seoul, 08393, Republic of Korea |
| Primary ContactPerson | Donghwan KimQuality Management Representative(QMR)Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,Seoul, 08393, Republic of KoreaPhone: +82 70 7465 2068Fax: +82 2 6220 2162Email: qa_ra@alpinion.com |
| Secondary ContactPerson | JULIAN LEEAddress: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United StatesPhone: 425 949 1059Fax: 425 949 4910Email: julian.lee@alpinionusa.com |
| Device Trade Name: | E-CUBE i7 |
| Common/UsualName: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Names | System, Imaging, Pulsed Doppler Ultrasonic |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX |
| Primary PredicateDevice | K121937 E-CUBE inno Diagnostic Ultrasound System |
| Predicate Device(s) | K150773 E-CUBE 15 Diagnostic Ultrasound SystemK151663 RS80A Diagnostic Ultrasound SystemK142733 E-CUBE 5 Diagnostic Ultrasound System |
| Device Description: | E-CUBE i7 product is an ultrasound imaging system for medicaldiagnosis. This device is available for portable(only body) and mobile(withsystem cart). Also, this innovative system platform provides optimalpatient diagnosis workflow with the 15.6" wide flat panel display,ergonomic control panel with easy user interface, optimal image quality. |
| 1. Signal Mode:B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode,Pulsed Wave Doppler(PWD) mode, Continuous wave Doppler (CWD)mode, Tissue Doppler Imaging(TDI) mode2. Combination Mode:B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M |
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Acoustic output track:
Track 3
Types of transducers compatible with the device:
| C1-6T | L3-12T | EC3-10T | EV3-10T | I08-17T | SP1-5T | SP3-8T | C5-8NT | ||
|---|---|---|---|---|---|---|---|---|---|
| Applicablefrequency | 1~6MHz | 3~12MHz | 3~10MHz | 3~10MHz | Applicablefrequency | 8~17MHz | 1~5MHz | 3~8MHz | 5~8MHz |
| IntendedUsage | Fetal,Abdominal,Pediatric,Urology | Pediatric,Small Organ,Musculoskeletal(Conventional),Musculo-skeletal(Superficial),Peripheralvessel | Trans-rectal,Trans-vaginal,Urology | Trans-rectal,Trans-vaginal,Urology | IntendedUsage | Small Organ,Musculo-skeletal(Conventional),Musculo-skeletal(Superficial) | Abdominal,Pediatric,Adult Cephalic,Cardiac Adult | Abdominal,Pediatric,Adult CephalicCardiac Adult,Cardiac Pediatric | Abdominal,Pediatric,Cardiac Pediatric |
| Applicablemode | B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined | B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined | B/M/PWD/Color Doppler/Power Doppler/Combined | B/M/PWD/Color Doppler/Power Doppler/Combined | Applicablemode | B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined | B/M/PWD/CWDColor Doppler/Power Doppler/Tissue HarmonicImaging/Combined | B/M/PWD/CWDColor Doppler/Power Doppler/Tissue HarmonicImaging/Combined | B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined |
| Scanningdepth(mm) | 300 | 100 | 100 | 100 | Scanningdepth(mm) | 300 | 300 | 300 | 140 |
| FOV | 60(°) | N/A | 142(°) | 142(°) | FOV | N/A | 90(°) | 90(°) | 93.6(°) |
| Steer Angle | N/A | Max 9(°) | N/A | N/A | Steer Angle | 15(°) | 45(°) | 45(°) | N/A |
| Totalnumber ofelement | 128 | 128 | 128 | 128 | Totalnumber ofelement | 128 | 64 | 64 | 128 |
| Predicate | Previouslycleared(K142733) | Previouslycleared(K142733) | Previouslycleared(K142733) | Previouslycleared(K142733) | Predicate | I08-17(K150772) | SP1-5i/SP1-5X(K121937/K150773) | SP3-8/SP1-5X(K150773/K150773) | C5-8N(K150772) |
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).
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Determination of
Substantial Equivalence: Comparison with Predicate devices:
- E-CUBE i7 and E-CUBE inno (Primary Predicate Device)
| Feature | ProposedE-CUBE i7 | PredicateE-CUBE inno(K121937) |
|---|---|---|
| Indicationsfor use | The device is intended for use by aqualified physician for theevaluation of soft tissue and bloodflow 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 Vessel (PV);Urology (including prostate). | The device is intended for use by aqualified physician for theevaluation of soft tissue and bloodflow in the clinical applications;Fetal;Abdominal (renal & GYN/pelvic);Pediatric;Small Organ (breast, testes,thyroid);Musculo-skeletal (Conventional);Musculo-skeletal (Superficial);Cardiac (Adult);Peripheral Vascular (PV);Urology (including prostate). |
| Electricalpower | Voltage: 19V, ---10.53AFrequency: 50/60HzPower: 200W Max | Voltage:24V---, 6.5AFrequency: 50/60HzPower: 120 VA MAX withPeripherals |
| Imagingmodes | 2D (B) modeM modeAnatomical MColor Flow Doppler (CF) modePower Doppler (PD) modeDirectional PDPulsed wave Doppler (PWD) modeContinuous wave Doppler (CWD)modeTissue Doppler imaging (TDI)mode | 2D (B) modeM modeColor Flow (CF) modePower Doppler (PD) modePulsed wave Doppler (PWD) modeContinuous wave Doppler (CWD)mode |
| Imageprocessingtechnology | Xpeed™Full SRI™Spatial Compounding Image (SCI) | Xpeed™SRI |
| Softwarefeature | PanoramicNeedle Vision™/Needle Vision™ PlusCube View™ | |
| Thermal,mechanicalandelectricalsafety | The E-CUBE i7 has been designedto conform to the followingstandards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37 | The E-CUBE inno has beendesigned to conform to thefollowing standards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37 |
| 2) E-CUBE i7 and E-CUBE 15 | ||
| Feature | ProposedE-CUBE i7 | PredicateE-CUBE 15(K150773) |
| Indicationsfor use | The device is intended for use by aqualified physician for theevaluation of soft tissue and bloodflow 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 Vessel (PV);Urology (including prostate). | The device is intended for use by aqualified physician for theevaluation of soft tissue and bloodflow 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);Urology (including prostate). |
| Electricalpower | Voltage: 19V, ===10.53AFrequency: 50/60HzPower: 200W Max | Voltage: 100 |
| Imagingmodes | 2D (B) ModeM ModeAnatomical MM color ModeColor Flow Doppler (CF) ModePower Doppler (PD) ModeDirectional PDPulsed wave Doppler (PWD) ModeContinuous wave Doppler (CWD)ModeTissue Doppler imaging (TDI)Mode | 2D(B) ModeM ModeColor Flow Doppler (CF) ModePower Doppler (PD) ModePulsed wave Doppler (PWD) ModeContinuous wave Doppler (CWD)ModeTissue Doppler imaging (TDI)ModeElastography3D/4D Mode |
| Imageprocessingtechnology | Xpeed™Full SRITMSpatial Compounding Image (SCI)High PRF Doppler | Xpeed™FullSRITMSpatial Compounding Image (SCI)Frequency Compounding Image(FCI) |
| Softwarefeature | Panoramic | PanoramicStress EchoCube Strain™Live HQ™ |
| Needle Vision™/Needle Vision™PlusCube View™ | Needle Vision™/Needle Vision™Plus | |
| Thermal,mechanicalandelectricalsafety | The E-CUBE i7 has been designedto conform to the followingstandards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37 | The E-CUBE 15 has beendesigned to conform to thefollowing standards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37 |
| Feature | ProposedE-CUBE i7 | PredicateRS80A(K151663) |
| Imagingmodes | 2D (B) ModeM ModeAnatomical MM color ModeColor Flow Doppler (CF) ModePower Doppler (PD) ModeDirectional PDPulsed wave Doppler (PWD) ModeContinuous wave Doppler (CWD) ModeTissue Doppler imaging (TDI) Mode | 2D-ModeM-ModeAnatomical ModeColor M-ModeColor DopplerPower Doppler (PD)S-FlowPulsed Wave (PW) SpectralDopplerContinuous Wave (CW) DopplerTissue Doppler Imaging (TDI)Tissue Doppler Wave (TDW)ElastoScan Mode3D imaging Mode4D imaging Mode |
| Imageprocessingtechnology | XpeedTMFull SRITMSpatial Compounding Image (SCI) | Q scanClearvisionMultiVision |
| Softwarefeature | High PRF DopplerPanoramicNeedle VisionTM/Needle VisionTM PlusCube ViewTM | HPRFPanoramicStressEchoStrain+Needle Mate |
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2) E-CUBE i7 and E-CUBE 15
{16}------------------------------------------------
3) E-CUBE i7 and RS80A
4) E-CUBE i7 and E-CUBE 5/E-CUBE 15/E-CUBE inno
| Transducertype | ProposedE-CUBE i7 | PredicateE-CUBE 5(K142733) | PredicateE-CUBE 15(K150773) | PredicateE-CUBE inno(K121937) |
|---|---|---|---|---|
| Convex | C1-6TC5-8NT | C1-6T | C5-8N | |
| Linear | L3-12TIO8-17T | L3-12T | IO8-17 | |
| Endocavity | EC3-10TEV3-10T | EC3-10TEV3-10T | ||
| Sector phased | SP1-5TSP3-8T | SP1-5X | SP1-5i |
{17}------------------------------------------------
Summary of Non-Clinical Tests:
E-CUBE i7 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 i7 and its application comply with voluntary standards as detailed in this premarket submission.
- � 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
The following quality management system measures were applied to the development of E-CUBE i7:
- 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 i7, did not require clinical studies to support substantial equivalence.
Discussion: E-CUBE i7 was compared with the predicate devices (K121937, K150773, K151663, and K142733) The subject device is in conformance with applicable safety standards.
Therefore, the differences between E-CUBE i7 and the predicate devices would not affect the safety, effectiveness and essential performance.
- ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE i7 to be as Conclusion: 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 quidance documents.
§ 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.