(35 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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 5 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Modes of operation:
- Signal Mode:
B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI) - Combination Mode:
B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
Acoustic output track: Track 3
The provided text describes the acceptance criteria and the study conducted for the ALPINION MEDICAL SYSTEMS Co., Ltd.'s E-CUBE 5 Diagnostic Ultrasound System.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative way. Instead, it states that the E-CUBE 5's safety, effectiveness, and essential performance are considered substantially equivalent to the predicate device (E-CUBE 7) based on non-clinical testing and conformance to applicable medical device safety standards.
Acceptance Criteria (Implied from the document):
- Conformance to applicable medical device safety standards (e.g., NEMA UD2, UD3, AIUM Medical Ultrasound Safety, IEC60601-1, IEC60601-1-2, IEC60601-2-37).
- Biocompatibility of transducer materials and other patient contact materials.
- Evaluation of acoustic output.
- Evaluation of thermal, electrical, electromagnetic, and mechanical safety.
- Performance, technology, and software are substantially equivalent to the predicate device (E-CUBE 7).
Reported Device Performance (Implied from the document):
- The E-CUBE 5 was found to conform to the listed applicable medical device safety standards.
- Transducer materials and patient contact materials are biocompatible.
- Non-clinical testing verified design changes compared to the predicate device.
- The differences between E-CUBE 5 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 5.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "The subject of this premarket submission. E-CUBE 5, did not require clinical studies to support substantial equivalence." This means no clinical test set was used to evaluate the device's performance in humans. The evaluation was based on non-clinical tests. Therefore, there is no information on sample size or data provenance for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since no clinical studies were performed, there are no experts or ground truth established from human data as part of a clinical test set. The validation was based on non-clinical engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/CAD device. The submission does not mention any MRMC study or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a diagnostic ultrasound system, not an algorithm being evaluated in isolation. The evaluation was for the entire system and its transducers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be established by reference to engineering specifications, national and international safety standards, and established metrics for acoustic output and electrical safety. For example, for biocompatibility, the ground truth would be established by laboratory tests conforming to ISO standards for material compatibility.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The evaluation is for a diagnostic ultrasound system based on its hardware and software design, and adherence to safety and performance standards.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim OARA Manager 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu Seoul 152-848 REPUBLIC OF KOREA
Re: K142733
Trade/Device Name: E-CUBE 5 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 26, 2014 Received: September 29, 2014
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the E-CUBE 5 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C1-6T | L3-12T |
|---|---|
| EV3-10T | EC3-10T |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
{1}------------------------------------------------
Page 2-Mr. Kim
found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K142733
Device Name
E-CUBE 5 Diagnostic Ultrasound System
Indications for Use (Describe)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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{3}------------------------------------------------
E-CUBE 5 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | N | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | N | |
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | N | |
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | N | |
| Urology (including prostate) | N | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA ; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
{4}------------------------------------------------
E-CUBE 5 with C1-6T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
{5}------------------------------------------------
E-CUBE 5 with L3-12T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
{6}------------------------------------------------
E-CUBE 5 with EV3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 | N | N | N | N | N | N | N | ||
| Trans-vaginal | N | N | N | N | N | N | N | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | ||
| N = new indication; P = previously cleared by FDA; E = added under appendix |
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
{7}------------------------------------------------
E-CUBE 5 with EC3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 | N | N | N | N | N | N | N | ||
| Trans-vaginal | N | N | N | N | N | N | N | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
{8}------------------------------------------------
Section F 510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
| Date | Sep 5th 2014 |
|---|---|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd.Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,Seoul, Republic of Korea 152-848 |
| Primary ContactPerson | Donghwan KimQARA ManagerAddress: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,Seoul, Republic of Korea 152-848Phone: +82 70 7465 2068Fax: +82 2 851 5594Email: donghwan.kim@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 5 |
| 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 |
| Predicate Device(s) | K132687 E-CUBE 7 Diagnostic Ultrasound System |
| Device Description: | E-CUBE 5 product is an ultrasound imaging system for medicaldiagnosis. The system platform provides optimal patient diagnosisworkflow with the 15.6" wide flat panel display, ergonomic control panelwith easy user interface, optimal image quality. |
| Modes of operation:1. Signal Mode:B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode,Pulsed WaveDoppler(PWD) mode, Tissue Harmonic Imaging(THI)2. Combination Mode:B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/MAcoustic output track:Track 3 |
{9}------------------------------------------------
| C1-6T | L3-12T | EV3-10T | EC3-10T | |
|---|---|---|---|---|
| Applicablefrequency | 1~6MHz | 3~12MHz | 3~10MHz | 3~10 MHz |
| IntendedUsage | Fetal, AbdominalPediatric,Urology | Pediatric, SmallOrgan, Musculo-skeletal(Conventional),Musculo-skeletal(Superficial),Peripheralvessel | Trans-rectal,Trans-vaginal,Urology | Trans-rectal,Trans-vaginal,Urology |
| Foot printsize(mm) | 71.6 x 16.8 | 44.8 x 7.8 | 21.5 x 18.6 | 21.5 x 18.6 |
| Applicablemode | B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging | B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging | B/M/PWD/Color Doppler/Power DopplerImaging | B/M/PWD/Color Doppler/Power DopplerImaging |
| Scanningdepth(mm) | 300 | 100 | 100 | 100 |
| FOV | 60(°) | 142(°) | 142(°) | 142(°) |
| Steer Angle | N/A | Max 9(°) | N/A | N/A |
| Totalnumber ofelement | 128 | 128 | 128 | 128 |
| Elementspacing | 0.484mm | 0.3mm | 0.195mm | 0.195mm |
| elevatinglength | 13.5mm | 4.5mm | 6.0mm | 6.0mm |
Types of transducers compatible with the device:
Indications For Use: The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
Determination of Substantial Comparison with Predicate device:
Equivalence:
| Feature | ProposedE-CUBE 5 | PredicateE-CUBE 7(K132687) |
|---|---|---|
| Indicationsfor use | The device is intended for use by aqualified physician fortheevaluation of soft tissue and bloodflow in the clinical applications;Fetal;Abdominal (renal & GYN/pelvic);Pediatric;OrganSmall(breast.testes.thyroid);Trans-rectal(TR);Trans-vaginal(TV);Musculo-skeletal(Conventional);Musculo-skeletal Superficial);Peripheral Vascular (PV);Urology (including prostate). | The device is intended for use by aqualified physician fortheevaluation of soft tissue and bloodflow in the clinical applications;Fetal:Abdominal (renal & GYN/pelvic);Pediatric;Small Organ(breast,testes.thyroid);Trans-rectal(TR);Trans-vaginal(TV);Musculo-skeletal(Conventional);Musculo-skeletal Superficial);Cardiac (adult & pediatric);Peripheral Vascular (PV);Urology (including prostate). |
{10}------------------------------------------------
| Transducer | C1-6T | C1-6 |
|---|---|---|
| C5-8 | ||
| L3-12T | L3-12 | |
| L3-12H | ||
| L3-12HWD | ||
| L3-8L8-17 | ||
| EV3-10T | EV3-10 | |
| EC3-10T | EC3-10 | |
| E3-10EN3-10 | ||
| SP1-5 | ||
| SP3-8 | ||
| SC1-6 | ||
| VC1-6 | ||
| CW2.0 | ||
| CW5.0 | ||
| IO3-12 | ||
| Electricalpower | Voltage: 100 | Voltage: 100 |
| OperatingMode | B ModeM ModeColor Flow ModePower Doppler ModePulsed Wave Doppler ModeTissue Harmonic Imaging Mode | B ModeM ModeColor Flow ModePW Doppler ModePower Doppler ModeContinuous wave Doppler modeTissue Harmonic Imaging Mode3D/4D Mode |
| Xpeed™ | Xpeed™ | |
| Full SRI™ | Full SRI™ | |
| Spatial compounding | Spatial compounding | |
| Frequency Compounding | Frequency Compounding | |
| Panoramic | Panoramic | |
| Auto IMT Measurement | Auto IMT Measurement | |
| Thermal,mechanicalandelectricalsafety | The E-CUBE 5 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 7 has been designedto conform to the followingstandards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37 |
Summary of Non-Clinical Tests:
E-CUBE 5 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 5 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 5:
{11}------------------------------------------------
- Medical Device Risk Management �
- ◆ Requirements Reviews
- � Design Reviews
- � Component Verification
- � Integration Review (System Verification)
- � Performance Testing (System Verification)
- � Safety Testing (Compliance Test)
- � Design Validation
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission. E-CUBE 5, did not require clinical studies to support substantial equivalence.
Discussion:
E-CUBE 5 and the predicate device have differences in clinical applications and operating modes. Several transducers are changed for these purposes. These design changes have been verified via nonclinical testing. The subject device is in conformance with applicable safety standards. Therefore, the differences between E-CUBE 5 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 5.
- ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 5 to be as Conclusion: safe, as effective. Performance, technology and software are substantially equivalent to the predicate device.
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.
§ 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.