E-CUBE i7

• K Number: K153424
• Device Name: E-CUBE i7
• Manufacturer: ALPINION MEDICAL SYSTEMS CO., LTD.
• Date Cleared: 2016-02-26 ( 93 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

Device Description

E-CUBE i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable(only body) and mobile(with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality. 1. Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode 2. Combination Mode: B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M

Predicate Devices

K121937, K150773, K151663, K142733

Reference Devices

K121937, K150773, K151663, K142733

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound imaging system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".

Therapeutic

No
The device is described as an "ultrasound imaging system for medical diagnosis" and its intended use is for "evaluation of soft tissue and blood flow," which points to diagnostic rather than therapeutic purposes.

Diagnostic

Yes

The device description explicitly states, "E-CUBE i7 product is an ultrasound imaging system for medical diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "ultrasound imaging system" and mentions hardware components like a "body," "system cart," "flat panel display," and "control panel," indicating it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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 the "evaluation of soft tissue and blood flow" in various anatomical sites. This describes an imaging system used for direct visualization and assessment of internal structures and physiological processes within the body.
• Device Description: The device is described as an "ultrasound imaging system for medical diagnosis." Ultrasound is a non-invasive imaging modality that uses sound waves to create images of internal body structures.
• Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform tests on samples; it generates images of the body itself.

The information provided consistently points to this being a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac 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 i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable (only body) and mobile (with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

1. Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode
2. Combination Mode: B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

Indicated Patient Age Range

Not Found

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 i7, did not require clinical studies to support substantial equivalence.

Summary of Non-Clinical Tests:
E-CUBE i7 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 i7 and its application comply with voluntary standards as detailed in this premarket submission.

• IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
• IEC60601-2-37. Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• ISO10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
• ISO14971, Application of risk management to medical devices
• AIUM Medical Ultrasound Safety

The following quality management system measures were applied to the development of E-CUBE i7:

• 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.

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.

K121937, K150773, K151663, K142733

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

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2016

ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim OARA Manager 1FL and 6FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd) Guro-gu, Seoul 08393 REPUBLIC OF KOREA

Re: K153424 Trade/Device Name: E-CUBE i7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 29, 2016 Received: February 1, 2016

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.

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 (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.

1

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.

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153424

Device Name E-CUBE i7

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; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac 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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E-CUBE i7 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
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	N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N	N	N
Small Organ	N	N	N		N	N	N	N
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N
Trans-rectal	N	N	N		N	N	N	N
Trans-vaginal	N	N	N		N	N	N	N
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal	N	N	N		N	N	N	N
(Conventional)
Musculo-skeletal	N	N	N		N	N	N	N
(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	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

4

E-CUBE i7 with C1-6T Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	Combined*
(Specify)	Other**
(Specify)
Ophthalmic
Fetal	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)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA K 142733; 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 i7 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	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	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	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
Urology (including prostate)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA K 142733; 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 i7 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
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	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	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
Urology (including prostate)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA K 142733; 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 i7 with L3-12T Transducer

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

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

N = new indication; P = previously cleared by FDA K 142733; 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 i7 with C5-8NT 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
Abdominal	N	N	N		N	N	N	N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	N
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric	N	N	N		N	N	N	N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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E-CUBE i7 with IO8-17T 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
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)	N	N	N		N	N	N	N
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)	N	N	N		N	N	N	N
Musculo-skeletal
(Superficial)	N	N	N		N	N	N	N
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA; E = added under appendix

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

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

Concurrence of CDRH

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E-CUBE i7 with SP1-5T 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
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	N	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
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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E-CUBE i7 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
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	N	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
Urology (including prostate)

N = new indication; P = previously cleared by FDA; E = added under appendix

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

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

Concurrence of CDRH

12

510(k) Summary

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

Date	November 23rd 2015
Submitter:	ALPINION MEDICAL SYSTEMS Co., Ltd.
Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,
Seoul, 08393, Republic of Korea
Primary Contact
Person	Donghwan Kim
Quality Management Representative(QMR)
Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,
Seoul, 08393, Republic of Korea
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Secondary Contact
Person	JULIAN LEE
Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Device Trade Name:	E-CUBE i7
Common/Usual
Name:	Ultrasonic Pulsed Doppler Imaging System
Classification Names	System, Imaging, Pulsed Doppler Ultrasonic
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 Predicate
Device	K121937 E-CUBE inno Diagnostic Ultrasound System
Predicate Device(s)	K150773 E-CUBE 15 Diagnostic Ultrasound System
K151663 RS80A Diagnostic Ultrasound System
K142733 E-CUBE 5 Diagnostic Ultrasound System
Device Description:	E-CUBE i7 product is an ultrasound imaging system for medical
diagnosis. This device is available for portable(only body) and mobile(with
system cart). Also, this innovative system platform provides optimal
patient diagnosis workflow with the 15.6" wide flat panel display,
ergonomic control panel with easy user interface, optimal image quality.
	1. Signal Mode:
B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode,
Pulsed Wave Doppler(PWD) mode, Continuous wave Doppler (CWD)
mode, Tissue Doppler Imaging(TDI) mode

2. Combination Mode:
   B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M |

13

Acoustic output track:

Track 3

Types of transducers compatible with the device:

	C1-6T	L3-12T	EC3-10T	EV3-10T		I08-17T	SP1-5T	SP3-8T	C5-8NT
Applicable
frequency	1~6MHz	3~12MHz	3~10MHz	3~10MHz	Applicable
frequency	8~17MHz	1~5MHz	3~8MHz	5~8MHz
Intended
Usage	Fetal,
Abdominal,
Pediatric,Urology	Pediatric,
Small Organ,
Musculoskeletal
(Conventional),
Musculo-skeletal
(Superficial),
Peripheral
vessel	Trans-rectal,
Trans-vaginal,
Urology	Trans-rectal,
Trans-vaginal,
Urology	Intended
Usage	Small Organ,
Musculo-skeletal
(Conventional),
Musculo-skeletal
(Superficial)	Abdominal,
Pediatric,
Adult Cephalic,
Cardiac Adult	Abdominal,
Pediatric,
Adult Cephalic
Cardiac Adult,
Cardiac Pediatric	Abdominal,
Pediatric,
Cardiac Pediatric
Applicable
mode	B/M/PWD/
Color Doppler/
Power Doppler/
Tissue Harmonic
Imaging/
Combined	B/M/PWD/
Color Doppler/
Power Doppler/
Tissue Harmonic
Imaging/
Combined	B/M/PWD/
Color Doppler/
Power Doppler/
Combined	B/M/PWD/
Color Doppler/
Power Doppler/
Combined	Applicable
mode	B/M/PWD/
Color Doppler/
Power Doppler/
Tissue Harmonic
Imaging/
Combined	B/M/PWD/CWD
Color Doppler/
Power Doppler/
Tissue Harmonic
Imaging/
Combined	B/M/PWD/CWD
Color Doppler/
Power Doppler/
Tissue Harmonic
Imaging/
Combined	B/M/PWD/
Color Doppler/
Power Doppler/
Tissue Harmonic
Imaging/
Combined
Scanning
depth(mm)	300	100	100	100	Scanning
depth(mm)	300	300	300	140
FOV	60(°)	N/A	142(°)	142(°)	FOV	N/A	90(°)	90(°)	93.6(°)
Steer Angle	N/A	Max 9(°)	N/A	N/A	Steer Angle	15(°)	45(°)	45(°)	N/A
Total
number of
element	128	128	128	128	Total
number of
element	128	64	64	128
Predicate	Previously
cleared
(K142733)	Previously
cleared
(K142733)	Previously
cleared
(K142733)	Previously
cleared
(K142733)	Predicate	I08-17
(K150772)	SP1-5i/SP1-5X
(K121937/K150773)	SP3-8/SP1-5X
(K150773/K150773)	C5-8N
(K150772)

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; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

14

Determination of

Substantial Equivalence: Comparison with Predicate devices:

1. E-CUBE i7 and E-CUBE inno (Primary Predicate Device)

| Feature | Proposed
E-CUBE i7 | Predicate
E-CUBE inno
(K121937) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal (Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vessel (PV);
Urology (including prostate). | 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);

Musculo-skeletal (Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);

Peripheral Vascular (PV);
Urology (including prostate). |
| Electrical
power | Voltage: 19V, ---10.53A
Frequency: 50/60Hz
Power: 200W Max | Voltage:24V---, 6.5A
Frequency: 50/60Hz
Power: 120 VA MAX with
Peripherals |
| Imaging
modes | 2D (B) mode
M mode
Anatomical M
Color Flow Doppler (CF) mode
Power Doppler (PD) mode
Directional PD
Pulsed wave Doppler (PWD) mode
Continuous wave Doppler (CWD)
mode
Tissue Doppler imaging (TDI)
mode | 2D (B) mode
M mode
Color Flow (CF) mode
Power Doppler (PD) mode
Pulsed wave Doppler (PWD) mode
Continuous wave Doppler (CWD)
mode |
| Image
processing
technology | Xpeed™
Full SRI™
Spatial Compounding Image (SCI) | Xpeed™
SRI |
| Software
feature | Panoramic
Needle Vision™
/Needle Vision™ Plus
Cube View™ | |
| Thermal,
mechanical
and
electrical
safety | The E-CUBE i7 has been designed
to conform to the following
standards:

• NEMA UD2, UD3
• AIUM Medical Ultrasound Safety
• IEC60601-1
• IEC60601-1-2
• IEC60601-2-37 | The E-CUBE inno has been
  designed to conform to the
  following standards:
• NEMA UD2, UD3
• AIUM Medical Ultrasound Safety
• IEC60601-1
• IEC60601-1-2
• IEC60601-2-37 |
  | 2) E-CUBE i7 and E-CUBE 15 | | |
  | Feature | Proposed
  E-CUBE i7 | Predicate
  E-CUBE 15
  (K150773) |
  | 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;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vessel (PV);
Urology (including prostate). | 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;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vascular (PV);
Urology (including prostate). |
| Electrical
power | Voltage: 19V, ===10.53A
Frequency: 50/60Hz
Power: 200W Max | Voltage: 100120V, 200240V
Frequency: 50/60Hz
Power: Max. 900 VA with Built-in
and On-Board Peripherals |
| Imaging
modes | 2D (B) Mode
M Mode
Anatomical M
M color Mode
Color Flow Doppler (CF) Mode
Power Doppler (PD) Mode
Directional PD
Pulsed wave Doppler (PWD) Mode
Continuous wave Doppler (CWD)
Mode
Tissue Doppler imaging (TDI)
Mode | 2D(B) Mode
M Mode
Color Flow Doppler (CF) Mode
Power Doppler (PD) Mode
Pulsed wave Doppler (PWD) Mode
Continuous wave Doppler (CWD)
Mode
Tissue Doppler imaging (TDI)
Mode
Elastography
3D/4D Mode |
| Image
processing
technology | Xpeed™
Full SRITM
Spatial Compounding Image (SCI)
High PRF Doppler | Xpeed™
FullSRITM
Spatial Compounding Image (SCI)
Frequency Compounding Image
(FCI) |
| Software
feature | Panoramic | Panoramic
Stress Echo
Cube Strain™
Live HQ™ |
| | Needle Vision™/Needle Vision™
Plus
Cube View™ | Needle Vision™/Needle Vision™
Plus |
| Thermal,
mechanical
and
electrical
safety | The E-CUBE i7 has been designed
to conform to the following
standards:

• NEMA UD2, UD3
• AIUM Medical Ultrasound Safety
• IEC60601-1
• IEC60601-1-2
• IEC60601-2-37 | The E-CUBE 15 has been
  designed to conform to the
  following standards:
• NEMA UD2, UD3
• AIUM Medical Ultrasound Safety
• IEC60601-1
• IEC60601-1-2
• IEC60601-2-37 |
  | Feature | Proposed
  E-CUBE i7 | Predicate
  RS80A
  (K151663) |
  | Imaging
  modes | 2D (B) Mode
  M Mode
  Anatomical M
  M color Mode
  Color Flow Doppler (CF) Mode
  Power Doppler (PD) Mode
  Directional PD
  Pulsed wave Doppler (PWD) Mode
  Continuous wave Doppler (CWD) Mode
  Tissue Doppler imaging (TDI) Mode | 2D-Mode
  M-Mode
  Anatomical Mode
  Color M-Mode
  Color Doppler
  Power Doppler (PD)
  S-Flow
  Pulsed Wave (PW) Spectral
  Doppler
  Continuous Wave (CW) Doppler
  Tissue Doppler Imaging (TDI)
  Tissue Doppler Wave (TDW)
  ElastoScan Mode
  3D imaging Mode
  4D imaging Mode |
  | Image
  processing
  technology | XpeedTM
  Full SRITM
  Spatial Compounding Image (SCI) | Q scan
  Clearvision
  MultiVision |
  | Software
  feature | High PRF Doppler
  Panoramic
  Needle VisionTM/Needle VisionTM Plus
  Cube ViewTM | HPRF
  Panoramic
  StressEcho
  Strain+
  Needle Mate |

15

2) E-CUBE i7 and E-CUBE 15

16

3) E-CUBE i7 and RS80A

4) E-CUBE i7 and E-CUBE 5/E-CUBE 15/E-CUBE inno

| Transducer
type | Proposed
E-CUBE i7 | Predicate
E-CUBE 5
(K142733) | Predicate
E-CUBE 15
(K150773) | Predicate
E-CUBE inno
(K121937) |
|--------------------|-----------------------|------------------------------------|-------------------------------------|---------------------------------------|
| Convex | C1-6T
C5-8NT | C1-6T | C5-8N | |
| Linear | L3-12T
IO8-17T | L3-12T | IO8-17 | |
| Endocavity | EC3-10T
EV3-10T | EC3-10T
EV3-10T | | |
| Sector phased | SP1-5T
SP3-8T | | SP1-5X | SP1-5i |

17

Summary of Non-Clinical Tests:

E-CUBE i7 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 i7 and its application comply with voluntary standards as detailed in this premarket submission.

• � IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
• � IEC60601-2-37. Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• � ISO10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
• ISO14971, Application of risk management to medical devices ◆
• � AIUM Medical Ultrasound Safety

The following quality management system measures were applied to the development of E-CUBE i7:

• 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 i7, did not require clinical studies to support substantial equivalence.

Discussion: E-CUBE i7 was compared with the predicate devices (K121937, K150773, K151663, and K142733) The subject device is in conformance with applicable safety standards.

Therefore, the differences between E-CUBE i7 and the predicate devices would not affect the safety, effectiveness and essential performance.

• ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE i7 to be as Conclusion: safe, 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 quidance documents.