E-CUBE 12

K142884 · Alpinion Medical Systems Co., Ltd. · IYN · Oct 28, 2014 · Radiology

Device Facts

• Record ID: K142884
• Device Name: E-CUBE 12
• Applicant: Alpinion Medical Systems Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Oct 28, 2014
• 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); Adult Cephalic; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).

Device Story

E-CUBE 12 is a diagnostic ultrasound imaging system; utilizes ultrasound transducers to capture acoustic signals from human tissue; processes signals to generate real-time images and blood flow data; supports B-mode, M-mode, Color Flow, Power Doppler, Pulsed Wave Doppler, and Tissue Harmonic Imaging; features 21.5-inch display and ergonomic control panel; operated by physicians in clinical settings; provides visual output for diagnostic assessment of soft tissue and hemodynamics; aids clinical decision-making by enabling non-invasive visualization of internal structures and vascular flow; benefits patients through diagnostic imaging without ionizing radiation.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence is based on non-clinical bench testing, including biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety testing, and adherence to recognized standards (NEMA UD2, UD3, IEC 60601 series).

Technological Characteristics

Ultrasound imaging system; supports B, M, PWD, Color/Power Doppler, and THI modes. Transducers include curved linear and linear arrays (1-12 MHz). Connectivity includes built-in and on-board peripherals. Safety standards: NEMA UD2, UD3, AIUM, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Biocompatible patient-contact materials.

Indications for Use

Indicated for qualified physicians to evaluate soft tissue and blood flow in fetal, abdominal, pediatric, small organ, adult cephalic, 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 15 Diagnostic Ultrasound System (K123610)

Submission Summary (Full Text)

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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, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or banner.

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: K142884

Trade/Device Name: E-CUBE 12 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 30, 2014 Received: October 2, 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 12 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

SC1-4H SC1-6 L3-12 L3-12H SP1-5

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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.f)

for

Janine M. Morris 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) K142884

Device Name

E-CUBE 12 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); Adult Cephalic; 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) | <div> <span style="font-size: 20px;">×</span> </div> |
|----------------------------------------------|------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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## E-CUBE 12 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 | Color<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(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<br>(breast, testes, thyroid) | N | N | N | | N | N | N | N | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | N | N | N | | N | N | N | N | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | N | | | |
| Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | N | | | |
| Intravascular | | | | | | | | | | | |
| Cardiac Adult | N | N | N | | N | N | N | N | | | |
| 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 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

Prescription User (Per 21 CFR 801.109)

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# E-CUBE 12 with SC1-4H Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | | | Mode of Operation | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---------|---------|----------|-----------|-----------|
| | в | M | PWD | CWD | Color | Power | Tissue | Combined* | Other** |
| | | | | | Doppler | Doppler | Harmonic | (Specify) | (Specify) |
| | | | | | | | lmaging | | |
| Ophthalmic | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | |
| Abdominal | P | P | P | | P | P | P | P | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | |
| Small Organ | | | | | | | | | |
| (breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Conventional) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate)<br>M = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = | P | P | P<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | P | P | P | P | |

N = new indication; P = previously cleared by FDA K 121888; 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)

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# E-CUBE 12 with SC1-6 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | |
| Abdominal | P | P | P | | P | P | P | P | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | |
| Small Organ<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | |

N = new indication; P = previously cleared by FDA K111864; 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)

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# E-CUBE 12 with L3-12 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | |
| Small Organ<br>(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<br>(Conventional) | P | P | P | | P | P | P | P | |
| Musculo-skeletal<br>(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 K111864; 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)

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# E-CUBE 12 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 | Color<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | |
| Small Organ<br>(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<br>(Conventional) | P | P | P | | P | P | P | P | |
| Musculo-skeletal<br>(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 K111864; E = added under appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH

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# E-CUBE 12 with SP1-5 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(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<br>(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<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | P | P | P | | P | P | P | P | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | | | | | | | | | |

N = new indication; P = previously cleared by FDA K111864; 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)

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# Section F 510(k) Summary

In accordance with 21CFR807.92, the following summary of information is provided:

Sep 19th 2014 Date 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 Contact Donghwan Kim Person QARA Manager Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848 Phone: [phone] Fax: [phone] Email: [e-mail] Secondary Contact JULIAN LEE Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States Person Phone: [phone] Fax: [phone] Email: [e-mail] E-CUBE 12 Device Trade Name: Common/Usual Ultrasonic Pulsed Doppler Imaging System 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 K123610 E-CUBE 15 Diagnostic Ultrasound System Predicate Device(s) Device Description: E-CUBE 12 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 21.5" wide flat panel display, ergonomic control panel with 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 Wave Doppler(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/M Acoustic output track: Track 3

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| | SC1-4H | SC1-6 | L3-12 | L3-12H | SP1-5 |
|------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Applicable<br>frequency | 1~4MHz | 1~6MHz | 3~12MHz | 3~12MHz | 1~5MHz |
| Intended<br>Usage | Fetal,<br>Abdominal,<br>Pediatric,<br>Urology | Fetal,<br>Abdominal,<br>Pediatric,<br>Urology | Pediatric.<br>Small Organ,<br>Musculoskele<br>tal<br>(conventional<br>& superficial),<br>Peripheral<br>vessel | Pediatric,<br>Small Organ,<br>Musculoskele<br>tal<br>(conventional<br>& superficial),<br>Peripheral<br>vessel | Abdominal,<br>Pediatric,<br>Cardiac Adult |
| Foot print<br>size (mm) | 72.4 x 16.8 | 72.4 x 16.8 | 44.8 x 7.8 | 44.8 x 7.8 | 24.8 x 17.6 |
| Applicable<br>mode | B/M/PWD/<br>Color<br>Doppler/<br>Power<br>Doppler/<br>Tissue<br>Harmonic<br>Imaging | B/M/PWD/<br>Color<br>Doppler/<br>Power<br>Doppler/<br>Tissue<br>Harmonic<br>Imaging | B/M/PWD/<br>Color<br>Doppler/<br>Power<br>Doppler | B/M/PWD/<br>Color<br>Doppler/<br>Power<br>Doppler | B/M/PWD/<br>CWD/<br>Color<br>Doppler/<br>Power<br>Doppler/<br>Tissue<br>Harmonic<br>Imaging |
| Scanning<br>depth(mm) | 300 | 300 | 100 | 100 | 300 |
| FOV | 60(°) | 60(°) | N/A | N/A | 90(°) |
| Steer Angle | N/A | N/A | Max 9(°) | 15(°) | 45(°) |
| Geometrical<br>configuration | Curved linear<br>array 60mm<br>Radius of<br>curvature | Curved linear<br>array 60mm<br>Radius of<br>curvature | Linear array<br>38.4mm<br>aperture | Linear array<br>38.4mm<br>aperture | Linear<br>phased array |
| Total number<br>of element | 192 | 128 | 128 | 192 | 64 |
| Element<br>spacing | 0.342mm | 0.484mm | 0.3mm | 0.2mm | 0.3mm |
| elevating<br>length | 13.5mm | 13.5mm | 4.5mm | 4.5mm | 13.5mm |

| | | | | 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); Adult Cephalic; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate). E-CUBE 12 employs the same fundamental scientific technology as its

### Technology:

Determination of Substantial Equivalence:

| Feature | Proposed<br>E-CUBE 12 | Predicate<br>E-CUBE 15<br>(K123610) |
|---------|-----------------------|-------------------------------------|
|---------|-----------------------|-------------------------------------|

predicate device.

Comparison with Predicate device:

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# 510(k) E-CUBE 12

| Indications<br>for use | The device is intended for use by a<br>qualified physician for the<br>evaluation of soft tissue and blood<br>flow in the clinical applications;<br>Fetal;<br>Abdominal (renal & GYN/pelvic);<br>Pediatric;<br>Small Organ (breast, testes,<br>thyroid);<br>Adult Cephalic;<br>Musculo-skeletal(Conventional);<br>Musculo-skeletal Superficial);<br>Cardiac (adult & pediatric);<br>Peripheral Vascular (PV);<br>Urology (including prostate). | The device is intended for use by a<br>qualified physician for the<br>evaluation of soft tissue and blood<br>flow in the clinical applications;<br>Fetal;<br>Abdominal (renal & GYN/pelvic);<br>Pediatric;<br>Small Organ (breast, testes,<br>thyroid);<br>Trans-rectal(TR);<br>Trans-vaginal(TV);<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac (adult & pediatric);<br>Peripheral Vascular (PV);<br>Urology (including prostate). |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Transducer | SC1-4H<br>SC1-6<br>L3-12<br>L3-12H | SC1-4H<br>SC1-6H<br>SVC1-6<br>L3-12H<br>L3-12X<br>L3-8<br>L8-17X |
| | SP1-5 | SP1-5X<br>SP3-8<br>E3-10H<br>CW2.0<br>CW5.0 |
| Electrical<br>power | Voltage: 100~120V, 200~240V<br>Frequency: 50/60Hz<br>Power: Max. 900 VA with Built-in<br>and On-Board Peripherals | Voltage: 100~120V, 200~240V<br>Frequency: 50/60Hz<br>Power: Max. 900 VA with Built-in<br>and On-Board Peripherals |
| Operating<br>Mode | B(2D) Mode<br>M Mode<br>Color Flow (CF) Mode<br>Power Doppler (PD) Mode<br>Pulsed Wave Doppler (PWD)<br>Mode<br>Tissue Harmonic Imaging (THI)<br>Mode<br>Beam Steering<br>Spatial Compounding<br>Frequency Compounding<br>Xpeed™<br>Auto traces PW<br>Directional Power Doppler Mode<br>SRI<br>Full SRI™ | B Mode<br>M Mode<br>Color Flow (CF) Mode<br>Power Doppler (PD) Mode<br>Pulsed Wave Doppler (PWD)<br>Mode<br>Continuous Wave (CW) Doppler<br>Mode<br>Tissue Harmonic Imaging (THI)<br>Mode<br>3D/4D Volume Mode<br>Beam Steering<br>Panoramic B/CF<br>Spatial Compounding<br>Frequency Compounding<br>Xpeed on 2D / CF/PW<br>Auto IMT<br>Auto traces PW<br>Directional Power Doppler Mode<br>SRI<br>Full SRI |

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| Thermal,<br>mechanical<br>and<br>electrical<br>safety | The E-CUBE 12 has been<br>designed to conform to the<br>following standards:<br>- NEMA UD2, UD3<br>- AIUM Medical Ultrasound Safety<br>- IEC60601-1<br>- IEC60601-1-2<br>- IEC60601-2-37 | The E-CUBE 15 has been<br>designed to conform to the<br>following standards:<br>- NEMA UD2, UD3<br>- AIUM Medical Ultrasound Safety<br>- IEC60601-1<br>- IEC60601-1-2<br>- IEC60601-2-37 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |

#### 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. 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 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 non-clinical testing. The subject device is in conformance with applicable safety standards. Therefore, the differences between E-CUBE 12 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 12.

- ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 12 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.