E-CUBE 12

K181277 · Alpinion Medical Systems Co., Ltd. · IYN · Sep 28, 2018 · Radiology

Device Facts

• Record ID: K181277
• Device Name: E-CUBE 12
• Applicant: Alpinion Medical Systems Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Sep 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended 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).

Device Story

E-CUBE 12 is an ultrasound imaging system for medical diagnosis; provides soft tissue and blood flow visualization. System inputs include ultrasonic signals processed via various modes: 2D(B), Harmonic, M-mode, Color Flow, Power Doppler, Pulsed/Continuous Wave Doppler, and 3D/4D. Operates in clinical settings; used by physicians for diagnostic imaging. Features include Xpeed, Full SRI, spatial/frequency compounding, and specialized tools like Cube Strain, Live HQ, and Needle Vision. Output displayed on wide flat panel; assists clinicians in diagnostic decision-making. System platform emphasizes ergonomic interface and image quality. No clinical studies required for equivalence; safety established via bench testing and adherence to electrical/acoustic standards.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility, acoustic output measurement, and thermal, electrical, electromagnetic, and mechanical safety testing per IEC and NEMA standards.

Technological Characteristics

Ultrasound imaging system; 2D, M-mode, Doppler (Color, Power, PWD, CWD, TDI), and 3D/4D modes. Materials: Biocompatible patient-contact materials. Connectivity: Standard ultrasound interface. Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Acoustic output: NEMA UD 2, NEMA UD 3. Features: Xpeed, Full SRI, Spatial/Frequency Compounding, Cube Strain, Live HQ, Needle Vision.

Indications for Use

Indicated for use by qualified physicians for soft tissue and blood flow evaluation in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal/vaginal, musculoskeletal, cardiac, peripheral vascular, and urological clinical applications.

Regulatory Classification

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.

Predicate Devices

• E-CUBE 8 (K172732)
• E-CUBE 11 (K161439)
• E-CUBE 15 (K150773)
• HS70A (K173713)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Fax: [phone] Email: qa [e-mail]
- Secondary JULIAN LEE Contact Person Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States Phone: [phone] Fax: [phone] Email: [e-mail]
- 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
- Primary K172732 E-CUBE 8 Diagnostic Ultrasound System Predicate Device
- Predicate K161439 E-CUBE 11 Diagnostic Ultrasound System Devices K150773 E-CUBE 15 Diagnostic Ultrasound System K173713 HS70A Diagnostic Ultrasound System

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<br>E-CUBE 12<br>ALPINION Medical<br>Systems Co., Ltd. | Predicate<br>E-CUBE 8<br>ALPINION Medical<br>Systems Co., Ltd. | Predicate<br>E-CUBE 11<br>ALPINION Medical<br>Systems Co., Ltd. | Predicate<br>E-CUBE 15<br>ALPINION Medical<br>Systems Co., Ltd. | Predicate<br>HS70A<br>Samsung<br>Medison co., ltd |
|--------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------|
| Feature | - | K172732 | K161439 | K150773 | K173713 |
| Indications for Use | | | | | |
| - Fetal | √ | √ | √ | √ | √ |
| - Abdominal<br>(Renal&GYN/Pelvic) | √ | √ | √ | √ | √ |
| - Intra-operative<br>(Specify, Neuro) | | | | | √ |
| - Pediatric | √ | √ | √ | √ | √ |
| - Small Organ<br>(breast, testes, thyroid) | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ |
| - Musculo-skeletal<br>(Conventional) | √ | √ | √ | √ | √ |
| - Musculto skeletal<br>(Superficial) | √ | √ | √ | √ | √ |
| - Cardiac (Adult) | √ | √ | √ | √ | √ |
| - Cardiac (Pediatric) | √ | √ | √ | √ | √ |
| - Peripheral Vessel | √ | √ | √ | √ | √ |
| - Urology<br>(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™/<br>Needle Vision™ Plus | √ | √ | √ | √ | √ |
| - Elastography | √ | √ | √ | √ | √ |
| - Cube view™ | √ | √ | √ | | |
| - Volume Advance™ | | | | | |
| • Free Angle MSV | √ | √ | | | √ |
| • AnySlice™ | √ | √ | | | √ |
| • Volume Analysis | √ | √ | | | √ |
| Thermal, mechanical and electrical safety | | | | | |
| - NEMA UD2, UD3 | √ | √ | √ | √ | √ |
| - AIUM Medical<br>Ultrasound Safety | √ | √ | √ | √ | √ |
| - IEC 60601-1 | √ | √ | √ | √ | √ |
| - IEC 60601-1-2 | √ | √ | √ | √ | √ |
| - IEC 60601-2-37 | √ | √ | √ | √ | √ |

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# 510(k) E-CUBE 12

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## 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.

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- 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.