K Number
K181617
Device Name
E-CUBE 8
Date Cleared
2018-10-11

(114 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardia (adult& pediatric), Peripheral Vascular (PV), and Urology (including prostate).
Device Description
E-CUBE 8 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
More Information

Not Found

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.

No
The device is an ultrasound imaging system intended for medical diagnosis and evaluation, not for treatment.

Yes
The "Device Description" explicitly states, "E-CUBE 8 product is an ultrasound imaging system for medical diagnosis." The "Intended Use / Indications for Use" section also describes its use for "evaluation of soft tissue and blood flow," which is a diagnostic purpose. Furthermore, the predicate devices are all named "Diagnostic Ultrasound System."

No

The device description explicitly states "E-CUBE 8 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality." This describes a hardware system, not software only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as an ultrasound imaging system for the evaluation of soft tissue and blood flow in various clinical applications. This involves imaging the body directly.
  • Device Description: The description confirms it's an ultrasound imaging system for medical diagnosis.
  • Input Imaging Modality: The input is Ultrasound, which is an in-vivo imaging technique.
  • Anatomical Site: The device is used to image various parts of the human body.

IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to obtain information about a person's health. This device operates by imaging the body inside 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, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardia (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 8 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

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

Combination Mode:
B/Color Doppler, B/PWD, B/Color Doppler/PWD

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

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), Cardiac (Pediatric), Peripheral Vessel, 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)

Summary of Non-Clinical Tests:
E-CUBE 8 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 8 and its application comply with voluntary standards as detailed in this premarket submission.

Summary of Clinical Tests:
The subject of this premarket submission, E-CUBE 8, 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, K153424, K132687, K163691, K163120

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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 11, 2018

Alpinion Medical Systems Co., Ltd. Boyeon CHO QARA Manager 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu SEOUL 08393 REPUBLIC OF KOREA

Re: K181617

Trade/Device Name: E-CUBE 8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 10, 2018 Received: July 12, 2018

Dear Boyeon CHO:

We have reviewed vour 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

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hsl 2. Nils

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

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181617

Device Name E-CUBE 8

Indications for Use (Describe)

The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal, Abdominal (renal & GYN/pelvic), Pediatric, Small Organ (breast, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardia (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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instruction of infinition for sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to;

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)


PSC Publishing Services (301) 443-6740 EF

3

E-CUBE 8 Ultrasound System

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP
Small Organ
(breast, testes, thyroid)PPPPPPP
Neonatal CephalicPPPPPPP
Adult CephalicPPPPPPP
Trans-rectalPPPPPPPN
Trans-vaginalPPPPPPPN
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPPP
Musculo-skeletal
(Superficial)PPPPPPP
Intravascular
Cardiac AdultPPPPPPPP
Cardiac PediatricPPPPPPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPPPN
Urology (including prostate)PPPPPPPP

N = new indication; P = previously cleared by FDA K172732 ; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

4

E-CUBE 8 with C1-6CT Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPPP
Musculo-skeletal
(Superficial)PPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

5

E-CUBE 8 with C5-8NT Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerPower DopplerTissue Harmonic ImagingCombined* (Specify)Other** (Specify)
Ophthalmic
Fetal
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)
Neonatal CephalicPPPPPPP
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac AdultPPPPPPP
Cardiac PediatricPPPPPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

6

E-CUBE 8 L3-12T with Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerPower DopplerTissue Harmonic ImagingCombined* (Specify)Other** (Specify)
Ophthalmic
Fetal
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)PPPPPPP
Neonatal CephalicPPPPPPP
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPPP
Musculo-skeletal
(Superficial)PPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

7

E-CUBE 8 with L3-12H Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
Fetal
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)PPPPPPP
Neonatal CephalicPPPPPPP
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPPP
Musculo-skeletal
(Superficial)PPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD) Prescription User (Per 21 CFR 801.109)

8

E-CUBE 8 L3-12H™ with Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerPower DopplerTissue Harmonic ImagingCombined* (Specify)Other** (Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)PPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPPPPP
Musculo-skeletal (Superficial)PPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

9

E-CUBE 8 with SP3-8T Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerPower DopplerTissue Harmonic ImagingCombined* (Specify)Other** (Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)
Neonatal CephalicPPPPPPP
Adult CephalicPPPPPPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac AdultPPPPPPP
Cardiac PediatricPPPPPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

10

E-CUBE 8 with P1-5CT Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerPower DopplerTissue Harmonic ImagingCombined* (Specify)Other** (Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult CephalicPPPPPPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac AdultPPPPPPP
Cardiac PediatricPPPPPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

11

E-CUBE 8 with VC1-6T Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP
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)PPPPPPPPP

N = new indication; P = previously cleared FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

12

E-CUBE 8 with EV3-10T Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPP
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPP
Trans-vaginalPPPPPPP
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 vesselPPPPPPP
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

13

E-CUBE 8 with EC3-10T Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerPower DopplerTissue Harmonic ImagingCombined* (Specify)Other** (Specify)
Ophthalmic
FetalPPPPPPP
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPP
Trans-vaginalPPPPPPP
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 vesselPPPPPPP
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

14

E-CUBE 8 with E3-10 Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
Doppler
rTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPP
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPP
Trans-vaginalPPPPPPP
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 vesselPPPPPPP
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

15

E-CUBE 8 with CW2.0 Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

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E-CUBE 8 with CW5.0 Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

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E-CUBE 8 with VE3-10H Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPPP
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPPP
Trans-vaginalPPPPPPPP
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 vesselNNNNNNNN
Urology (including prostate)PPPPPPPP

N = new indication; P = previously cleared by FDA K161439; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

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E-CUBE 8 with SC1-6H Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPPP
Musculo-skeletal
(Superficial)PPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNNN
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K161439; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

19

E-CUBE 8 with SC1-4H Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)NNNNNNN
Musculo-skeletal
(Superficial)NNNNNNN
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNNN
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K161439; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

20

E-CUBE 8 with SC1-4HS Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)NNNNNNN
Musculo-skeletal
(Superficial)NNNNNNN
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNNN
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K161439; E = added under appendix

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

21

E-CUBE 8 with L8-17H Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalNNNNNNN
AbdominalNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNNN
Small OrganNNNNNNN
(breast, testes, thyroid)
Neonatal CephalicNNNNNNN
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalNNNNNNN
(Conventional)
Musculo-skeletalNNNNNNN
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNNN
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, Office of In-Vitro Diagnostic Devices (OIVD)

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E-CUBE 8 with IO8-17T Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)PPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPPP
Musculo-skeletal
(Superficial)PPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K153424; E = added under appendix

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

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

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23

510(k) Summary

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

  • July 18th, 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 8 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 K153424 E-CUBE i7 Diagnostic Ultrasound System K132687 E-CUBE 7 Diagnostic Ultrasound System K163691 HS70A Diagnostic Ultrasound System K163120 EPIQ 5 / EPIQ 7 Diagnostic Ultrasound System
    • E-CUBE 8 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.

24

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

C1-6CTC5-8NTSC1-4HSC1-4HSSC1-6H
Transducer
typeConvexConvexConvexConvexConvex
Applicable
frequency1~6MHz5~8MHz1~4MHz1~4MHz1~6MHz
Intended
usageFetal,
Abdominal,
Pediatric,
Musculo-
skeletal,
Peripheral
vessel
UrologyAbdominal,
Pediatric,
Neonatal
Cephalic
Cardiac Adult,
Cardiac
Pediatric
Peripheral
vesselFetal,
Abdominal,
Pediatric,
Musculo-
skeletal,
Peripheral
vessel
UrologyFetal,
Abdominal,
Pediatric,
Musculo-
skeletal,
Peripheral
vessel
UrologyFetal,
Abdominal,
Pediatric,
Musculo-
skeletal,
Peripheral
vessel
Urology
Applicable
modeB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
Combined
Scanning
Depth (mm)300140300300300
Total number
of element128128192166192
PredicatePreviously
cleared
(K172732)Previously
cleared
(K153424)Previously
cleared
(K161439)Previously
cleared
(K161439)Previously
cleared
(K161439)

Types of transducers compatible with the device :

25

CW2.0CW5.0EV3-10TEC3-10TE3-10
Transducer
typePencil
DopplerPencil
DopplerEndocavityEndocavityEndocavity
Applicable
frequency2.0MHz5.0MHz3~10MHz3~10MHz3~10MHz
Intended
usageCardiac Adult,
Cardiac
PediatricCardiac Adult,
Cardiac
Pediatric
Peripheral
vesselFetal,
Trans-rectal,
Trans-
vaginal,
Peripheral
vessel
UrologyFetal,
Trans-rectal,
Trans-
vaginal,
Peripheral
vessel
UrologyFetal,
Trans-rectal,
Trans-
vaginal,
Peripheral
vessel
Urology
Applicable
modeCWDCWDB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
Combined
Scanning
Depth (mm)N/AN/A100100140
Total number
of element2
(TX1, RX1)2
(TX1, RX1)128128128
PredicatePreviously
cleared
(K161439)Previously
cleared
(K161439)Previously
cleared
(K153424)Previously
cleared
(K153424)Previously
cleared
(K132687)

26

L3-12HL3-12TL3-12HWDL8-17HIO8-17T
Transducer
typeLinearLinearLinearLinearLinear
Applicable
frequency3~12MHz3~12MHz3~12MHz8~17MHz8~17MHz
Intended
usageAbdominal
Pediatric,
Small Organ
(breast,
testes,
thyroid),
Neonatal
Cephalic
Musculo-
skeletal,
Peripheral
vesselAbdominal
Pediatric,
Small Organ
(breast,
testes,
thyroid),
Neonatal
Cephalic
Musculo-
skeletal,
Peripheral
vesselFetal
Abdominal
Pediatric,
Small Organ
(breast,
testes,
thyroid),
Neonatal
Musculo-
skeletal,
Peripheral
vesselFetal,
Abdominal,
Pediatric,
Small Organ
(breast,
testes,
thyroid),
Neonatal
Cephalic,
Musculo-
skeletal,
Peripheral
vesselSmall Organ
(breast,
testes,
thyroid),
Musculo-
Skeletal,
Peripheral
vessel
Applicable
modeB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
Combined
Scanning
Depth (mm)100100100100100
Total number
of element192128192192128
PredicatePreviously
cleared
(K161439)Previously
cleared
(K153424)Previously
cleared
(K161439)NEWPreviously
cleared
(K153424)

27

SP3-8TP1-5CTVE3-10HVC1-6T--
Transducer
typeSector
PhasedSector
PhasedVolume
EndocavityVolume
Convex
Applicable
frequency3~8MHz1~5MHz3~10MHz1~6MHz
Intended
usageFetal
Abdominal,
Pediatric,
Neonatal
Cephalic
Adult
Cephalic,
Cardiac Adult,
Cardiac
PediatricFetal
Abdominal,
Pediatric,
Adult
Cephalic,
Cardiac Adult,
Cardiac
Pediatric
Peripheral
vesselFetal,
Trans-rectal,
Trans-vaginal,
Peripheral
vessel,
UrologyFetal,
Abdominal,
Pediatric,
Urology
Applicable
modeB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
CombinedB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
Combined/
OthersB/M/PWD/
Color
Doppler/
Power
Doppler/
Tissue
Harmonic
Imaging/
Combined/
Others
Scanning
Depth (mm)300300140300--
Total number
of element6464192128--
PredicatePreviously
cleared
(K1534324)Previously
cleared
(K172732)Previously
cleared
(K161439)Previously
cleared
(K172732)--

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, Musculoskeletal (Conventional); Musculo-skeletal (Superficial), Cardiac (Adult& Pediatric), Peripheral Vascular(PV) and Urology (including prostate).

28

Determination of

Substantial Equivalence: Comparison table with Predicate devices:

| Model | Proposed
E-CUBE 8
ALPINION Medical
Systems Co., Ltd. | Predicate
E-CUBE 8
ALPINION Medical
Systems Co., Ltd.
K172732 | Predicate
E-CUBE 11
ALPINION Medical
Systems Co., Ltd.
K161439 | Predicate
E-CUBE i7
ALPINION Medical
Systems Co., Ltd.
K153424 | Predicate
E-CUBE 7
ALPINION Medical
Systems Co., Ltd.
K132687 | Predicate
HS70A
Samsung
Medison co., ltd
K163691 | Predicate
EPIQ 5 and EPIQ 7
Philips Ultrasound
Inc.
K163120 |
|--------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------|
| Feature | - | | | | | | |
| Indications for Use | | | | | | | |
| - Fetal | √ | √ | √ | √ | √ | √ | √ |
| - Abdominal
(Renal&GYN/Pelvic) | √ | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ | √ |
| - Small Organ
(breast, testes, thyroid) | √ | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ | √ | √ |
| - Musculto skeletal
(Superficial) | √ | √ | √ | √ | √ | √ | √ |
| - Cardiac (Adult) | √ | √ | √ | √ | √ | √ | √ |
| - Cardiac (Pediatric) | √ | √ | √ | √ | √ | √ | √ |
| - Peripheral Vessel | √ | √ | √ | √ | √ | √ | √ |
| - Urology
(including prostate) | √ | √ | √ | √ | √ | √ | √ |
| Imaging modes | | | | | | | |
| - 2D(B) mode | √ | √ | √ | √ | √ | √ | √ |
| - Harmonic mode | √ | √ | √ | √ | √ | √ | √ |
| - M mode | √ | √ | √ | √ | √ | √ | √ |
| - Color M mode | √ | √ | √ | √ | √ | √ | √ |
| - Anatomical M mode | √ | √ | √ | √ | √ | √ | √ |
| - Color Flow Doppler (CF) mode | √ | √ | √ | √ | √ | √ | √ |
| - Power Doppler (PD) mode | √ | √ | √ | √ | √ | √ | √ |
| - Directional PD mode | √ | √ | √ | √ | √ | √ | √ |
| - Pulsed wave Doppler
(PWD) mode | √ | √ | √ | √ | √ | √ | √ |
| - Continuous wave
Doppler (CWD) mode | √ | √ | √ | √ | √ | √ | √ |
| - High PRF Doppler mode | √ | √ | √ | √ | √ | √ | √ |
| - Tissue Doppler
imaging (TDI) mode | √ | √ | √ | √ | √ | √ | √ |
| - 3D/4D mode | √ | √ | √ | √ | √ | √ | √ |
| Imaging modes | | | | | | | |
| - 2D(B) mode | √ | √ | √ | √ | √ | √ | √ |
| - Harmonic mode | √ | √ | √ | √ | √ | √ | √ |
| - M mode | √ | √ | √ | √ | √ | √ | √ |
| - Color M mode | √ | √ | √ | √ | √ | √ | √ |
| - Anatomical M mode | √ | √ | √ | √ | √ | √ | √ |
| - Color Flow Doppler (CF)
mode | √ | √ | √ | √ | √ | √ | √ |
| - Power Doppler (PD)
mode | √ | √ | √ | √ | √ | √ | √ |
| - Directional PD mode | √ | √ | √ | √ | √ | √ | √ |
| - Pulsed wave Doppler
(PWD) mode | √ | √ | √ | √ | √ | √ | √ |
| - Continuous 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 viewTM | √ | √ | √ | √ | √ | √ | |
| - Volume AdvanceTM | | | | | | | |
| • Free Angle MSV | √ | | | | | √ | |
| • AnySliceTM | √ | √ | | | | √ | |
| • Volume Analysis | √ | √ | | | | √ | |
| Thermal, Mechanical and Electrical safety | | | | | | | |
| NEMA UD2, UD3 | √ | √ | √ | √ | √ | √ | √ |
| AIUM Medical Ultrasound Safety | √ | √ | √ | √ | √ | √ | √ |
| IEC 60601-1 | √ | √ | √ | √ | √ | √ | √ |
| IEC 60601-1-2 | √ | √ | √ | √ | √ | √ | √ |
| IEC 60601-2-37 | √ | √ | √ | √ | √ | √ | √ |

ALPINION MEDICAL SYSTEMS Co., Ltd.

29

30

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Summary of Non-Clinical Tests:

E-CUBE 8 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 8 and its application comply with voluntary standards as detailed in this premarket submission.

  • � IEC60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
  • � 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
  • � NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
  • � NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic ultrasound Equipment

The following quality management system measures were applied to the development of E-CUBE 8:

  • Medical Device Risk Management �
  • � Requirements Reviews
  • � Design Reviews
  • � Component Verification
  • � Integration Review (System Verification)
  • � Performance Testing (System Verification)
  • � Safety Testing (Compliance Test)
  • � Design Validation

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, E-CUBE 8, did not require clinical studies to support substantial equivalence.

Discussion:

E-CUBE 8 was compared with the predicate devices. The subject device is in conformance with applicable safety standards.

Additionally, the differences between E-CUBE 8 (Subjective) and E-CUBE 8 (Predicate) are monitor's option (with/without touchscreen) and applications of transducer.

Therefore, the differences between E-CUBE 8 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 8 to be as safe, Conclusion: as effective. Performance, technology and software are substantially equivalent to the predicate devices.

ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.