(94 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); Neonatal Cephalic, Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 8 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Here's an analysis of the acceptance criteria and study information for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 8 ultrasound system, based on the provided text:
Important Note: The provided document is a 510(k) Premarket Notification from the FDA for a medical ultrasound system. It primarily focuses on demonstrating "substantial equivalence" to existing predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study in the way an AI/ML device might. Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with ground truth, and training set details) are not applicable or not provided in this type of regulatory document for a general ultrasound system. The "studies" mentioned are largely non-clinical engineering and safety compliance tests.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the E-CUBE 8 are primarily related to its equivalency with predicate devices regarding Indications for Use, Imaging Modes, Imaging Functions, and adherence to established safety and performance standards. The reported device performance is that it meets these criteria by incorporating similar or improved features and by complying with relevant medical device standards.
| Acceptance Criteria Category | Specific Criterion (Example for one transducer/mode) | Reported Device Performance (E-CUBE 8) |
|---|---|---|
| Indications for Use | Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional & Superficial), Cardiac (adult & pediatric), Peripheral Vessel, Urology (including prostate) (Across various transducers) | The device supports all listed clinical applications as "new indication" (N) or "previously cleared" (P) for each transducer (e.g., Fetal, Abdominal, Pediatric, Musculo-skeletal, Urology for C1-6CT) The entire system comprehensively covers all indications through the combination of its various transducers. |
| Imaging Modes | B mode, M mode, PWD, CWD, Color Doppler, Power Doppler, Tissue Harmonic Imaging, Combined, 3D/4D (across various transducers) | All listed imaging modes are supported by the E-CUBE 8 system and its compatible transducers. (e.g., C1-6CT supports B/M/PWD/Color Doppler/Power Doppler/Tissue Harmonic Imaging/Combined). |
| Imaging Functions | Xpeed™, Full SRI™, Spatial Compounding Image (SCI), Frequency Compounding Image (FCI), Panoramic, Stress Echo, Cube Strain™, Live HQ ™, Needle Vision™ / Needle Vision™ Plus, Elastography, Cube view™, Free Angle MSV, AnySlice™, Volume Analysis | All listed imaging functions are supported, matching or exceeding features found in predicate devices. For instance, Xpeed™, Full SRI™, SCI, FCI, Panoramic, Stress Echo, Cube Strain™, Live HQ™, Needle Vision™/Needle Vision™ Plus, Cube view™, Free Angle MSV, AnySlice™, Volume Analysis are all supported. Elastography is also included. |
| Safety and Performance Standards | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AAMI/ANSI/ISO10993-1, AAMI/ANSI/ISO14971, AIUM Medical Ultrasound Safety, NEMA UD2, NEMA UD3 | E-CUBE 8 was found to conform to all applicable medical device safety, electromagnetic compatibility, acoustic output, and biological evaluation standards. |
Study Information
-
Sample size used for the test set and the data provenance:
- N/A. The document does not describe a "test set" in the context of a dataset used for performance evaluation (e.g., for an AI/ML algorithm). The "testing" involved non-clinical validation against engineering specifications and industry standards.
- Data Provenance: Not applicable in the context of device performance testing. The provenance of regulatory compliance data is the manufacturing and testing environment of ALPINION Medical Systems Co., Ltd., based in the Republic of Korea.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information is not relevant or provided for a general ultrasound system's 510(k) submission. "Ground truth" in this context would primarily relate to the accuracy of physical measurements and image quality, which are assessed through engineering tests rather than expert interpretation of a diagnostic dataset.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No adjudication method for a test set is mentioned, as there isn't a diagnostic performance study described that would require it.
-
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:
- No. An MRMC comparative effectiveness study was not performed or referenced. This document is for a traditional ultrasound imaging system, not an AI-assisted diagnostic device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a diagnostic ultrasound system intended for use by a qualified physician. Its performance is inherent to the imaging capabilities and is not evaluated as a standalone algorithm without human intervention.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this type of submission, "ground truth" refers to the established engineering specifications, physical laws, and recognized standards against which the device's technical performance (e.g., acoustic output, image resolution, measurement accuracy) is validated. It does not involve medical ground truth from patient data like pathology or outcomes.
-
The sample size for the training set:
- N/A. This device does not use a "training set" in the context of machine learning. Its functionality is based on established ultrasound physics and engineering design.
-
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this device.
{0}------------------------------------------------
December 14, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ALPINION MEDICAL SYSTEMS Co., Ltd. % Boyeon CHO Quality Management Representative (QMR) 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu Seoul. 08393 REPULIC OF KOREA
Re: K172732
Trade/Device Name: E-CUBE 8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 27, 2017 Received: November 29, 2017
Dear Boyeon CHO:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K172732
Device Name E-CUBE 8
Indications for Use (Describe)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Neonatal Cephalic, Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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{3}------------------------------------------------
E-CUBE 8 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | N | N |
| Abdominal | N | N | N | N | N | N | N | N | N |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | N |
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | N | N |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N |
| Adult Cephalic | N | N | N | N | N | N | N | N | N |
| Trans-rectal | N | N | N | N | N | N | N | N | N |
| Trans-vaginal | N | N | N | N | N | N | N | N | N |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | N | N |
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | N | N |
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | N | N | N |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | N |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | N | N |
| Urology (including prostate) | N | N | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA ; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{4}------------------------------------------------
E-CUBE 8 with C1-6CT Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{5}------------------------------------------------
E-CUBE 8 with C5-8NT Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other**(Specify) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | |||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | |||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ(breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | |||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |||
| Cardiac Pediatric | N | N | N | N | N | N | N | |||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | N | N | N | N | N | N | N | |||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K153424; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{6}------------------------------------------------
E-CUBE 8 L3-12T with Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 | P | P | P | P | P | P | P | ||
| Small Organ(breast, testes, thyroid) | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | P | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K153424; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{7}------------------------------------------------
E-CUBE 8 with L3-12H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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) | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | N | N | N | N | N | N | N | |||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | P | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | |||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K161439; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD) Prescription User (Per 21 CFR 801.109)
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{8}------------------------------------------------
E-CUBE 8 L3-12H™P with Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | P | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K161439; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{9}------------------------------------------------
E-CUBE 8 with SP3-8T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | N | |
| Abdominal | P | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P | |
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | |
| Adult Cephalic | P | P | P | P | P | P | P | P | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K153424; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{10}------------------------------------------------
E-CUBE 8 with P1-5CT Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | N | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
E-CUBE 8 with VC1-6T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | N |
N = new indication; P = previously cleared; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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E-CUBE 8 with EV3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | Power | Tissue | Combined* | Other** | |
| Doppler | Doppler | HarmonicImaging | (Specify) | (Specify) | |||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | P | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K153424; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{13}------------------------------------------------
E-CUBE 8 with EC3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | N | |
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | P | |
| Trans-vaginal | P | P | P | P | P | P | P | P | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | N | |
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K153424; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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{14}------------------------------------------------
E-CUBE 8 with E3-10 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDopplerr | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | P | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | N | |
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K132687; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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{15}------------------------------------------------
E-CUBE 8 with CW2.0 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K161439; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{16}------------------------------------------------
E-CUBE 8 with CW5.0 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | ||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K161439; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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{17}------------------------------------------------
510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
| Date | September 8th, 2017 | C1-6CT | C5-8NT | P1-5CT | SP3-8T | VC1-6T | |
|---|---|---|---|---|---|---|---|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd.Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu,Seoul, Republic of Korea | Transducertype | Convex | Convex | SectorPhased | SectorPhased | VolumeConvex |
| Primary ContactPerson | Boyeon CHOQuality Management Representative(QMR)Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu,Seoul, Republic of KoreaPhone: +82 70 7465 2104Fax: +82 2 851 5595Email: qa_ra@alpinion.com | Applicablefrequency | 1~6MHz | 5~8MHz | 1~5MHz | 3~8MHz | 1~6MHz |
| SecondaryContact Person | JULIAN LEEAddress: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United StatesPhone: 425 949 1059Fax: 425 949 4910Email: julian.lee@alpinionusa.com | Intendedusage | Fetal,Abdominal,Pediatric,Musculo-skeletal,Urology | Fetal,Pediatric,Cardiac Adult,CardiacPediatric | Abdominal,Pediatric,AdultCephalic,Cardiac Adult,CardiacPediatric | Abdominal,Pediatric,AdultCephalic,Cardiac Adult,CardiacPediatric | Fetal,Abdominal,Pediatric,Urology |
| Device TradeName: | E-CUBE 8 | Applicablemode | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | B/M/PWD/CWDColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | B/M/PWD/CWDColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined/Others |
| Common/Usual Name: | Ultrasonic Pulsed Doppler Imaging System | ScanningDepth (mm) | 300 | 140 | 300 | 300 | 300 |
| ClassificationNames | System, Imaging, Pulsed Doppler Ultrasonic | Total numberof element | 128 | 128 | 64 | 64 | 128 |
| 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 | New(SC1-6H:K161439,C5-1:K163120) | Previouslycleared(K153424) | New(SP1-5T:K153424,S5-1:K163120) | Previouslycleared(K153424) | New(VC1-6:K132687) |
| PrimaryPredicateDevice | K161439 E-CUBE 11 Diagnostic Ultrasound System | ||||||
| PredicateDevices | K153424 E-CUBE i7 Diagnostic Ultrasound SystemK132687 E-CUBE 7 Diagnostic Ultrasound SystemK163691 HS70A Diagnostic Ultrasound SystemK163120 EPIQ 5 / EPIQ 7 Diagnostic Ultrasound System | ||||||
| DeviceDescription: | E-CUBE 8 product is an ultrasound imaging system for medical diagnosis.This innovative system platform provides optimal patient diagnosis workflowwith the wide flat panel display, ergonomic control panel with easy userinterface, optimal image quality. |
ALPINION MEDICAL SYSTEMS Co., Ltd.
{18}------------------------------------------------
1. Signal Mode:
2D(B) mode, Harmonic mode (HAR), M mode, Color M mode, Anatomical M mode, Color Flow Doppler(CF) Mode, Power Doppler(PD) Mode, Directional
PD mode, Pulsed Wave Doppler(PWD) Mode, Continuous Wave Doppler(CWD) Mode, High PRF Doppler mode, Tissue Doppler Imaging(TDI) Mode, 3D/4D mode
2. Combination Mode:
B/Color Doppler, B/PWD, B/Color Doppler/PWD
Acoustic output track: _
Track 3
Types of transducers compatible with the device :
{19}------------------------------------------------
510(k) E-CUBE 8
| L3-12T | L3-12H | L3-12HWD | EC3-10T | EV3-10T | |
|---|---|---|---|---|---|
| Transducertype | Linear | Linear | Linear | Endocavity | Endocavity |
| Applicablefrequency | 3~12MHz | 3~12MHz | 3~12MHz | 3~10MHz | 3~10MHz |
| Intendedusage | Pediatric,Small Organ,Musculo-skeletal,Peripheralvessel | Pediatric,Small Organ,Musculo-skeletal,Peripheralvessel | Pediatric,Small Organ,Musculo-skeletal,Peripheralvessel | Fetal.Trans-rectal,Trans-vaginal,Urology | Fetal,Trans-rectal,Trans-vaginal,Urology |
| Applicablemode | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined |
| ScanningDepth (mm) | 100 | 100 | 100 | 100 | 100 |
| Total numberof element | 128 | 192 | 192 | 128 | 128 |
| Predicate | Previouslycleared(K153424) | Previouslycleared(K161439) | Previouslycleared(K161439) | Previouslycleared(K153424) | Previouslycleared(K153424) |
| E3-10 | CW2.0 | CW5.0 | |
|---|---|---|---|
| Transducertype | Endocavity | PencilDoppler | PencilDoppler |
| Applicablefrequency | 3~10MHz | 2.0MHz | 5.0MHz |
| Intendedusage | Fetal,Trans-rectal,Trans-vaginal,Urology | Cardiac Adult,CardiacPediatric | Cardiac Adult,CardiacPediatric |
| Applicablemode | B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined | CWD | CWD |
| ScanningDepth (mm) | 140 | N/A | N/A |
| Total numberof element | 128 | 2(TX1, RX1) | 2(TX1, RX1) |
| Predicate | Previouslycleared(K132687) | Previouslycleared(K161439) | Previouslycleared(K161439) |
Indications For Use:
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Neonatal Cephalic, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
{20}------------------------------------------------
Determination of
Substantial Equivalence: Comparison table with Predicate devices:
| Model | ProposedE-CUBE 8ALPINION MedicalSystems Co., Ltd. | PredicateE-CUBE 11ALPINION MedicalSystems Co., Ltd.K161439 | PredicateE-CUBE i7ALPINION MedicalSystems Co., Ltd.K153424 | PredicateE-CUBE 7ALPINION MedicalSystems Co., Ltd.K132687 | PredicateHS70ASamsungMedison co., ltdK163691 | PredicateEPIQ 5 and EPIQ 7Philips Ultrasound,Inc.K163120 |
|---|---|---|---|---|---|---|
| Feature | ||||||
| Indications for Use | ||||||
| - Fetal | √ | √ | √ | √ | √ | √ |
| - Abdominal(Renal&GYN/Pelvic) | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ |
| - Small Organ(breast, testes, thyroid) | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | ||
| - Adult Cephalic | √ | √ | √ | √ | √ | |
| - Trans-rectal | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal(Conventional) | √ | √ | √ | √ | √ | √ |
| - Musculto skeletal(Superficial) | √ | √ | √ | √ | √ | √ |
| - Cardiac (Adult) | √ | √ | √ | √ | √ | √ |
| - Cardiac (Pediatric) | √ | √ | √ | √ | √ | √ |
| - Peripheral Vessel | √ | √ | √ | √ | √ | √ |
| - Urology(including prostate) | √ | √ | √ | √ | √ | √ |
| Imaging modes | ||||||
| - 2D(B) mode | √ | √ | √ | √ | √ | √ |
| - Harmonic mode | √ | √ | √ | √ | √ | √ |
| - M mode | √ | √ | √ | √ | √ | √ |
| - Color M mode | √ | √ | √ | √ | √ | |
| - Anatomical M mode | √ | √ | √ | √ | √ | |
| - Color Flow Doppler (CF)mode | √ | √ | √ | √ | √ | √ |
| - Power Doppler (PD)mode | √ | √ | √ | √ | √ | √ |
| - Directional PD mode | √ | √ | √ | √ | √ | |
| - Pulsed wave Doppler(PWD) mode | √ | √ | √ | √ | √ | √ |
| - Continuous waveDoppler (CWD) mode | √ | √ | √ | √ | √ | |
| - High PRF Doppler mode | √ | √ | √ | √ | √ | |
| - Tissue Dopplerimaging (TDI) mode | √ | √ | √ | √ | √ | |
| - 3D/4D mode | √ | √ | √ | √ | √ | |
| Imaging modes | ||||||
| - 2D(B) mode | √ | √ | √ | √ | √ | √ |
| - Harmonic mode | √ | √ | √ | √ | √ | √ |
| - M mode | √ | √ | √ | √ | √ | √ |
| - Color M mode | √ | √ | √ | √ | √ | |
| - Anatomical M mode | √ | √ | √ | √ | √ | |
| - Color Flow Doppler (CF) mode | √ | √ | √ | √ | √ | √ |
| - Power Doppler (PD) mode | √ | √ | √ | √ | √ | √ |
| - Directional PD mode | √ | √ | √ | √ | √ | |
| - Pulsed wave Doppler(PWD) mode | √ | √ | √ | √ | √ | √ |
| - Continuous waveDoppler (CWD) mode | √ | √ | √ | √ | √ | |
| - High PRF Doppler mode | √ | √ | √ | √ | √ | √ |
| - Tissue Dopplerimaging (TDI) mode | √ | √ | √ | √ | √ | √ |
| - 3D/4D mode | √ | √ | √ | √ | √ | √ |
| Imaging Functions | ||||||
| - Xpeed™ | √ | √ | √ | √ | √ | √ |
| - Full SRI™ | √ | √ | √ | √ | √ | √ |
| -Spatial CompoundingImage (SCI) | √ | √ | √ | √ | √ | √ |
| - Frequency Compoundingimage(FCI) | √ | √ | √ | √ | √ | √ |
| - Panoramic | √ | √ | √ | √ | √ | √ |
| - Stress Echo | √ | √ | √ | √ | √ | |
| - Cube Strain™ | √ | √ | √ | √ | √ | √ |
| - Live HQ ™ | √ | √ | √ | √ | √ | √ |
| - Needle Vision™ /Needle Vision™ Plus | √ | √ | √ | √ | √ | √ |
| - Elastography | √ | √ | ||||
| - Cube view™ | √ | √ | √ | √ | ||
| - Volume Advance™ | ||||||
| • Free Angle MSV | √ | √ | ||||
| • AnySlice™ | √ | √ | ||||
| • Volume Analysis | √ | √ | ||||
| Thermal, Mechanical and Electrical safety | ||||||
| NEMA UD2, UD3 | √ | √ | √ | √ | √ | √ |
| AIUM Medical Ultrasound Safety | √ | √ | √ | √ | √ | √ |
| IEC 60601-1 | √ | √ | √ | √ | √ | √ |
| IEC 60601-1-2 | √ | √ | √ | √ | √ | √ |
| IEC 60601-2-37 | √ | √ | √ | √ | √ | √ |
ALPINION MEDICAL SYSTEMS Co., Ltd.
{21}------------------------------------------------
510(k) E-CUBE 8
{22}------------------------------------------------
510(k) E-CUBE 8
{23}------------------------------------------------
Summary of Non-Clinical Tests:
E-CUBE 8 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 8 and its application comply with voluntary standards as detailed in this premarket submission.
- � IEC60601-1:2005(Third Edition)+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety
- � IEC60601-1-2 Edition 3:2007-03, Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- � IEC60601-2-37 Edition 2.0:2007, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- ◆ AAMI/ANSI/ISO10993-1:2009(R)2013, Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing
- � AAMI/ANSI/ISO14971:2007/(R)2010, Medical devices-Application of risk management to medical devices
- � AIUM MUS, Third edition, Medical Ultrasound Safety
- � NEMA UD 2-2004(R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- � NEMA UD 3-2004(R2009), Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic ultrasound Equipment
The following quality management system measures were applied to the development of E-CUBE 8:
- Medical Device Risk Management �
- � Requirements Reviews
- � Design Reviews
- � Component Verification
- Integration Review (System Verification) �
- Performance Testing (System Verification) �
- Safety Testing (Compliance Test) �
- Design Validation �
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, E-CUBE 8, did not require clinical studies to support substantial equivalence.
Discussion:
E-CUBE 8 was compared with the predicate devices. The subject device is in conformance with applicable safety standards.
Therefore, the differences between E-CUBE 8 and the predicate devices would not affect the safety, effectiveness and essential performance.
{24}------------------------------------------------
ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 8 to be as safe, Conclusion: as effective. Performance, technology and software are substantially equivalent to the predicate devices.
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.
§ 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.