(137 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like deep neural networks (DNNs). The description focuses on standard ultrasound imaging system features and performance testing related to safety and standards compliance.
No
The device is described as an "ultrasound imaging system for medical diagnosis" and is intended for "evaluation of soft tissue and blood flow," indicating diagnostic rather than therapeutic use.
Yes
The "Device Description" explicitly states that the product is "an ultrasound imaging system for medical diagnosis." The "Intended Use" also describes its use for "evaluation of soft tissue and blood flow."
No
The device description explicitly states it is an "ultrasound imaging system" and mentions hardware components like a "wide flat panel display" and "ergonomic control panel," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "evaluation of soft tissue and blood flow" in various anatomical sites. This describes an imaging device used for direct patient examination, not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's an "ultrasound imaging system for medical diagnosis." Ultrasound is a non-invasive imaging modality.
- Input Imaging Modality: The input is "Ultrasonic," which is used for imaging the body directly.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device is an imaging system used to visualize structures within the body.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal, Abdominal (renal & GYN/pelvic), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac (adult& pediatric), Peripheral Vascular (PV), and Urology (including prostate).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
E-CUBE 12 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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).
Indicated Patient Age Range
Adult, Pediatric, Neonatal
Intended User / Care Setting
Qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, E-CUBE 12, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K172732, K161439, K150773, K173713
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
September 28, 2018
Alpinion Medical Systems Co., Ltd. Boyeon Cho Quality Management Representative 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu SEOUL, 0839 SOUTH KOREA
Re: K181277
Trade/Device Name: E-CUBE 12 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 23, 2018 Received: August 27, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (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 (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.
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 comprehensive regulatory information about medical devices and radiation-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 A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181277
Device Name E-CUBE 12
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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510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
- May 9th, 2018 Date
- Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu, Seoul, Republic of Korea
- Primary Contact Boyeon CHO Person Quality Management Representative(QMR) Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-qu, Seoul, Republic of Korea Phone: +82 70 7465 2104 Fax: +82 2 851 5595 Email: qa ra@alpinion.com
- Secondary JULIAN LEE Contact Person Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States Phone: 425 949 1059 Fax: 425 949 4910 Email: julian.lee@alpinionusa.com
- Device Trade E-CUBE 12 Name:
- Common/ Ultrasonic Pulsed Doppler Imaging System
Usual Name:
- Classification System, Imaging, Pulsed Doppler Ultrasonic Names
- Product Code: Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
E-CUBE 12 product is an ultrasound imaging system for medical diagnosis. Device Description: 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.
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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
Indications The device is intended for use by a qualified physician for the evaluation of For Use: 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; Cardiac Pediatric; Peripheral Vessel; and Urology (including prostate).
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Determination of Substantial Equivalence: Comparison table with Predicate devices:
| Model | Proposed
E-CUBE 12
ALPINION Medical
Systems Co., Ltd. | Predicate
E-CUBE 8
ALPINION Medical
Systems Co., Ltd. | Predicate
E-CUBE 11
ALPINION Medical
Systems Co., Ltd. | Predicate
E-CUBE 15
ALPINION Medical
Systems Co., Ltd. | Predicate
HS70A
Samsung
Medison co., ltd |
|--------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------|
| Feature | - | K172732 | K161439 | K150773 | K173713 |
| Indications for Use | | | | | |
| - Fetal | √ | √ | √ | √ | √ |
| - Abdominal
(Renal&GYN/Pelvic) | √ | √ | √ | √ | √ |
| - Intra-operative
(Specify, Neuro) | | | | | √ |
| - Pediatric | √ | √ | √ | √ | √ |
| - Small Organ
(breast, testes, thyroid) | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ |
| - Musculto skeletal
(Superficial) | √ | √ | √ | √ | √ |
| - Cardiac (Adult) | √ | √ | √ | √ | √ |
| - Cardiac (Pediatric) | √ | √ | √ | √ | √ |
| - Peripheral Vessel | √ | √ | √ | √ | √ |
| - Urology
(including prostate) | √ | √ | √ | √ | √ |
| Imaging modes | | | | | |
| - 2D(B) mode | √ | √ | √ | √ | √ |
| - Harmonic mode | √ | √ | √ | √ | √ |
| - M mode | √ | √ | √ | √ | √ |
| - Color M mode | √ | √ | √ | √ | √ |
| - Anatomical M mode | √ | √ | √ | √ | √ |
| - Color Flow Doppler (CF) mode | √ | √ | √ | √ | √ |
| - Power Doppler (PD) mode | √ | √ | √ | √ | √ |
| - Directional PD mode | √ | √ | √ | √ | √ |
| - Pulsed wave Doppler (PWD) mode | √ | √ | √ | √ | √ |
| - Continuous wave Doppler (CWD) mode | √ | √ | √ | √ | √ |
| - High PRF Doppler mode | √ | √ | √ | √ | √ |
| - Tissue Doppler imaging (TDI) mode | √ | √ | √ | √ | √ |
| - 3D/4D mode | √ | √ | √ | √ | √ |
| Imaging Functions | | | | | |
| - Xpeed™ | √ | √ | √ | √ | √ |
| - Full SRI™ | √ | √ | √ | √ | √ |
| -Spatial Compounding Image (SCI) | √ | √ | √ | √ | √ |
| - Frequency Compounding image(FCI) | √ | √ | √ | √ | √ |
| - Panoramic | √ | √ | √ | √ | √ |
| - Stress Echo | √ | √ | √ | √ | √ |
| - Cube Strain™ | √ | √ | √ | √ | √ |
| | | | | | |
| - Live HQ ™ | √ | √ | √ | √ | √ |
| - Needle Vision™/
Needle Vision™ Plus | √ | √ | √ | √ | √ |
| - Elastography | √ | √ | √ | √ | √ |
| - Cube view™ | √ | √ | √ | | |
| - Volume Advance™ | | | | | |
| • Free Angle MSV | √ | √ | | | √ |
| • AnySlice™ | √ | √ | | | √ |
| • Volume Analysis | √ | √ | | | √ |
| Thermal, mechanical and electrical safety | | | | | |
| - NEMA UD2, UD3 | √ | √ | √ | √ | √ |
| - AIUM Medical
Ultrasound Safety | √ | √ | √ | √ | √ |
| - IEC 60601-1 | √ | √ | √ | √ | √ |
| - IEC 60601-1-2 | √ | √ | √ | √ | √ |
| - IEC 60601-2-37 | √ | √ | √ | √ | √ |
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7
510(k) E-CUBE 12
8
Summary of Non-Clinical Tests:
E-CUBE 12 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 12 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 12:
- 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 12, did not require clinical studies to support substantial equivalence.
Discussion:
E-CUBE 12 was compared with the predicate devices. The subject device is in conformance with applicable safety standards.
Therefore, the differences between E-CUBE 12 and the predicate devices would not affect the safety, effectiveness and essential performance.
9
- ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 12 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.