K Number
K221093
Device Name
X-CUBE 70, X-CUBE 90
Date Cleared
2022-10-14

(184 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The X-CUBE 70 and X-CUBE 90 diagnostic ultrasound systems are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic: Adult Cephalic: Trans-raginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph(Cardiac), Peripheral Vessel(PV); and Urology(including prostate). And, the imaging modes are 2D(B) mode; Harmonic mode(HAR); 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. The X-CUBE 70 and X-CUBE 90 are intended to be used in a hospital or medical clinic.
Device Description
The X-CUBE 70 and X-CUBE 90 products are general purpose ultrasound imaging system for medical diagnosis assistance. These products are used as an aid tool to diagnosis, such as a commonly used ultrasound diagnostic device. Also X-CUBE 70 and X-CUBE 90 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices. This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.
More Information

No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.

No.
The device is clearly stated to be for "diagnostic ultrasound systems" and is used as an "aid tool to diagnosis," not for treatment.

Yes
The "Intended Use / Indications for Use" section explicitly states that the X-CUBE 70 and X-CUBE 90 are "diagnostic ultrasound systems." The "Device Description" also refers to them as "general purpose ultrasound imaging system for medical diagnosis assistance" and an "aid tool to diagnosis, such as a commonly used ultrasound diagnostic device."

No

The device description explicitly states "general purpose ultrasound imaging system" and mentions "systems platform" with a "wide flat panel display" and "ergonomic control panel," indicating it includes hardware components beyond just software.

Based on the provided information, the X-CUBE 70 and X-CUBE 90 diagnostic ultrasound systems are not In Vitro Diagnostic (IVD) devices.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
  • Device Function: The X-CUBE 70 and X-CUBE 90 are described as "general purpose ultrasound imaging system for medical diagnosis assistance." They use ultrasonic waves to create images of internal body structures and blood flow within the body.
  • Intended Use: The intended use clearly states evaluation of soft tissue and blood flow in various anatomical sites on or within the patient.

Therefore, since these systems operate by imaging structures inside the body using ultrasound and do not involve testing specimens taken from the body, they do not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The X-CUBE 70 and X-CUBE 90 diagnostic ultrasound systems are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph(Cardiac), Peripheral Vessel(PV); and Urology(including prostate).

And, the imaging modes are 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.

The X-CUBE 70 and X-CUBE 90 are intended to be used in a hospital or medical clinic.

Product codes

IYN, IYO, ITX

Device Description

The X-CUBE 70 and X-CUBE 90 products are general purpose ultrasound imaging system for medical diagnosis assistance.

These products are used as an aid tool to diagnosis, such as a commonly used ultrasound diagnostic device.

Also X-CUBE 70 and X-CUBE 90 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices.

This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Doppler Imaging System

Anatomical Site

Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Trans-esoph (Cardiac); Peripheral Vessel (PV); Urology (including prostate).

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

licensed physician who is qualified for the evaluation of soft tissue and blood flow / hospital or medical clinic

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

The subject of this premarket submission, X-CUBE 70 and X-CUBE 90, did not require clinical studies to support substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K211299, K211300

Reference Device(s)

K181277, K181617, K161439

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

October 14, 2022

Image /page/0/Picture/1 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alpinion Medical Systems Co., Ltd. % Boyeon Cho Quality Management Representative 5FL. I dong, 77, heungan-daero 81beon-gil dongan-gu Anvang-si. Gyeonggi-do 14117 KOREA

Re: K221093

Trade/Device Name: X-cube 70, X-cube 90 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 13, 2022 Received: September 13, 2022

Dear Boyeon Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality 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: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K221093

Device Name X-CUBE 70, X-CUBE 90

Indications for Use (Describe)

The X-CUBE 70 and X-CUBE 90 diagnostic ultrasound systems are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic: Adult Cephalic: Trans-raginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph(Cardiac), Peripheral Vessel(PV); and Urology(including prostate).

And, the imaging modes are 2D(B) mode; Harmonic mode(HAR); 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.

The X-CUBE 70 and X-CUBE 90 are intended to be used in a hospital or medical clinic.

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 instructions, search existing data 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."

3

510(k) Summary

K221093

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

April 6th, 2022 Date

  • ALPINION MEDICAL SYSTEMS Co., Ltd. Submitter: Address: 5FL, I dong, 77, heungan-daero 81 beon-gil dongan-gu Anyang-si, Gyeonggi-do, 14117, REPUBLIC OF KOREA
  • Primary Boyeon CHO Contact Person Quality Management Representative(QMR) Address: 5FL, I dong, 77, heungan-daero 81 beon-gil dongan-qu Anyang-si, Gyeonggi-do, 14117, REPUBLIC OF KOREA Phone: +82 70 7465 2104 Fax: +82 2 851 5595 Email: qa ra@alpinion.com

Secondary Kevin CHUN Contact Person Address: 21222 30th Dr SE Ste C-122, Bothell, WA 98021, United States Phone: 425 949 1059 Fax: 425 949 4910 Email: kevin.chun@alpinionusa.com

Device X-CUBE 70, X-CUBE 90

Trade 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
  • Predicate Device K211299 X-CUBE 70 Diagnostic Ultrasound System K211300 X-CUBE 90 Diagnostic Ultrasound System
    • Reference K181277 E-CUBE 12 Diagnostic Ultrasound System Devices K181617 E-CUBE 8 Diagnostic Ultrasound System K161439 E-CUBE 11 Diagnostic Ultrasound System
  • Proposed Device The new technology of the subject device is as follows compared to the cleared New Technology Predicate and Reference devices.
  1. Diagnostic Feature Attenuation Imaging (ATI) 2D Shear Wave Elastography (2D SWE) Radiant View (Brilliant flow) Color STIC

4

3D color

  • Please refer to page F-8 for Technological Characteristics of The new diagnostic features.

Device The X-CUBE 70 and X-CUBE 90 products are general purpose ultrasound Description: imaging system for medical diagnosis assistance.

These products are used as an aid tool to diagnosis, such as a commonly used ultrasound diagnostic device.

Also X-CUBE 70 and X-CUBE 90 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices.

This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.

  1. Patient population Adult and Pediatric.

  2. 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

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

  2. Acoustic output track: Track 3

Indications The X-CUBE 70 and X-CUBE 90 diagnostic ultrasound systems are intended For Use: for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph(Cardiac), Peripheral Vessel(PV); and Urology(including prostate).

And, the imaging modes are 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.

The X-CUBE 70 and X-CUBE 90 are intended to be used in a hospital or medical clinic.

The difference between the X-CUBE 90 and X-CUBE 70 is the number of Differences between Tx/Rx channels. X-CUBE 90 operates with 192 channels, but X-CUBE 70 Proposed operates with 128 channels. The component constituting the Tx/Rx channel is Devices. the FE board. Both devices are in the same except for the FE board.

5

Determination of Substantial Equivalence: Comparison table with Predicate devices:

| Model | Proposed
X-CUBE 70,
X-CUBE 90
ALPINION Medical
Systems Co., Ltd.
K221093 | Primary
Predicate
X-CUBE 70
ALPINION Medical
Systems Co., Ltd.
K211299 | Secondary
Predicate
X-CUBE 90
ALPINION Medical
Systems Co., Ltd.
K211300 | Reference
E-CUBE 12
ALPINION Medical
Systems Co., Ltd.
K181277 | Reference
E-CUBE 8
ALPINION Medical
Systems Co., Ltd.
K181617 | Reference
E-CUBE 11
ALPINION Medical
Systems Co., Ltd.
K161439 | Height | 1,440/1,605 mm | 1,325/1,560 mm | 1,325/1,560 mm | 1,420/1,520 mm | 8301,430 mm | 1,455/1,695 mm |
|--------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|
| Feature | Indications for Use | | | | | | Width | 580 mm | 554 mm | 554 mm | 590 mm | 532 mm | 590 mm |
| - Fetal | √ | √ | √ | √ | √ | √ | Depth | 835 mm | 815 mm | 815 mm | 895 mm | 787 mm | 895 mm |
| - Abdominal
(Renal&GYN/Pelvic) | √ | √ | √ | √ | √ | √ | | Electrical Power | | | | | |
| - Intra-operative
(Specify, Neuro) | | | | | | | Voltage | 100-120V
,
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ |
| - Pediatric | √ | √ | √ | √ | √ | √ | Frequency | 50-60 Hz | 50-60 Hz | 50-60 Hz | 50/60 Hz | 50-60 Hz | 50/60 Hz |
| - Small Organ
(breast, testes, thyroid) | √ | √ | √ | √ | √ | √ | Power | Max. 700VA | Max. 700VA | Max. 700VA | Max. 600VA | Max. 450VA | Max. 600VA |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ | | Imaging modes | | | | | |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ | - 2D(B) mode | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ | - Harmonic mode | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ | - M mode | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ | √ | - Color M mode | √ | √ | √ | √ | √ | √ |
| - Musculto skeletal
(Superficial) | √ | √ | √ | √ | √ | √ | - Anatomical M mode | √ | √ | √ | √ | √ | √ |
| - Cardiac (Adult) | √ | √ | √ | √ | √ | √ | - Color Flow Doppler
(CF) mode | √ | √ | √ | √ | √ | √ |
| - Cardiac (Pediatric) | √ | √ | √ | √ | √ | √ | - Power Doppler (PD) mode | √ | √ | √ | √ | √ | √ |
| - Trans-esoph (Cardiac) | √ | | | | | | - Directional PD mode | √ | √ | √ | √ | √ | √ |
| - Peripheral Vessel | √ | √ | √ | √ | √ | √ | - Microvascular Imaging
(MVI) | √ | √ | √ | | | |
| - Urology
(including prostate) | √ | √ | √ | √ | √ | √ | - Pulsed wave Doppler
(PWD) mode | √ | √ | √ | √ | √ | √ |
| | Dimensions and weight | | | | | | - Continuous wave
Doppler (CWD) mode | √ | √ | √ | √ | √ | √ |
| Weight
(Excluding options) | 85kg | 90kg | 85kg | 94 kg | 55 kg | 94 kg | - High PRF Doppler
mode | √ | √ | √ | √ | √ | √ |
| - Tissue Doppler
imaging (TDI) mode | √ | √ | √ | √ | √ | √ | | | | | | | |
| - 3D/4D mode | √ | √ | √ | √ | √ | √ | | | | | | | |
| | Imaging Functions | | | | | | | | | | | | |
| - Xpeed™ | √ | √ | √ | √ | √ | √ | | | | | | | |

6

7

- Full SRI™
-Spatial Compounding
Image (SCI)
- Frequency
Compounding
image(FCI)
- Panoramic
- Stress Echo
- Cube Strain™
- Live HQ ™
- Needle Vision™/
Needle Vision™ Plus
- Elastography
- Cube view™
- Contrast Enhanced
Ultrasound (CEUS)
- Cube Note
- B-STIC
- Auto EF
- Point Shear Wave
Elastography (PSWE)
- Attenuation Imaging
(ATI)
- 2D Shear Wave
Elastography (2D SWE)
- Radiant View
(Brilliant flow)
- Color STIC
- 3D color
Volume Advance™
• Free Angle MSV
• AnySlice™
• Volume Analysis

ALPINION MEDICAL SYSTEMS Co., Ltd.

8

Accessories or kits
Color printer
B/W printer
DVD-RW
Foot switch
Wireless LAN
SC1-6 Biopsy guide kit
L3-12 Biopsy guide kit
L3-12X Biopsy guide kit
EV2-11H Reusable
Biopsy needle guide
VE3-10H Reusable
Biopsy needle guide
VE3-10H Disposable
Biopsy needle guide
ECG module / cable
Disinfectant & Ultrasound Gel
Ultrasonic gel
Cidex OPA
(Disinfectant agaents)
Cidex Plus
(Disinfectant agaents)
Gigasept FF
(Disinfectant agaents)
Virkon
(Disinfectant agaents)
Wavicide-01
(Disinfectant agaents)
AIDAL PLUS
(Disinfectant agaents)
Sporicidin
(Disinfectant agaents)
Thermal, mechanical and electrical safety
- NEMA UD2, UD3
- AIUM Medical
Ultrasound Safety
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-2-37

9

10

Technological Characteristics of New Diagnostic Feature

  • ◆ Attenuation Imaging (ATI)
    Attenuation imaging is a feature that provides attenuation imaging may be used as an aid in diagnoss and monitoring patients using the attenuation coefficient of ultrasound propagation

  • ♦ 2D Shear Wave Elastography (2D SWE)
    2D Shear Wave Elastography (2D SWE) is a feature that provides elasticity information of human tissue. 2D SWE may be used as and monitoring patients using the shear wave propagation

  • ♦ Radiant View (Brilliant Flow)
    Radiant View (Brilliant Flow) is the feature that spearance in Color images. This feature makes it easy to understand the structure of blood flow and blood vessels.

  • � 3D color
    3D Color imaging modes are useful for imaging structures that cannot be obtained in 2D color mode structures.

  • ◆ Color STIC
    Color STIC (Spatial Temporal Image Correlation) can visualize the heart and vasularity of a fetus in 3D B+CF mode. This acquisition method is designed for beating (fetal heart) as well as blood perfused organs.

11

Summary of Non-Clinical Tests:

X-CUBE 70 and X-CUBE 90 have 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. X-CUBE 70, X-CUBE 90 and its application comply with voluntary standards as detailed in this premarket submission.

  • � IEC60601-1:2005(Third Edition)+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety
  • � IEC60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
  • � IEC60601-2-37:2007/AMD1:2015, Medical Electrical Equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • � AAMI/ANSI/ISO10993-1:2009(R)2013, Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing within a risk management process
  • � AAMI/ANSI/ISO14971:2007/(R)2010, Medical devices-Application of risk management to medical devices
  • ◆ AIUM MUS, Third edition, Medical Ultrasound Safety
  • � NEMA UD 2-2004(R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
  • ◆ NEMA UD 3-2004(R2009), Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic ultrasound Equipment

The following quality management system measures were applied to the development of X-CUBE 70 and X-CUBE 90:

  • Medical Device Risk Management �
  • � Requirements Reviews
  • � Desian 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, X-CUBE 70 and X-CUBE 90, did not require clinical studies to support substantial equivalence.

Discussion:

X-CUBE 70 and X-CUBE 90 were compared with the predicate device. The subject device is in conformance with applicable safety standards.

Therefore, the differences between X-CUBE 70 and X-CUBE 90 and the predicate device would not affect the safety, effectiveness and essential performance.

12

  • Conclusion: The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The devices are designed to conform to applicable medical device safety standards and compliance. Therefore, ALPINION MEDICAL SYSTEMS Co., Ltd. considers X-CUBE 70 and X-CUBE 90 to be as safe, and effective as the predicate device.