minisono

K182845 · Alpinion Medical Systems Co., Ltd. · IYN · Dec 27, 2018 · Radiology

Device Facts

• Record ID: K182845
• Device Name: minisono
• Applicant: Alpinion Medical Systems Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).

Device Story

The minisono is a portable diagnostic ultrasound imaging system consisting of a transducer and a USB cable, designed to interface with a tablet PC (Microsoft Surface Pro). It captures ultrasound signals to produce B-mode, M-mode, Pulsed Wave Doppler (PWD), Color Doppler, Power Doppler, and Tissue Harmonic Imaging outputs. Operated by qualified physicians in clinical settings, the device provides real-time imaging for soft tissue and blood flow evaluation. The system utilizes image processing technologies (Xpeed, SRI, Spatial Compounding) to enhance image quality. The output is displayed on the tablet screen, allowing clinicians to perform diagnostic assessments, which aids in clinical decision-making and patient management. The device is intended for use in various clinical applications including fetal, abdominal, pediatric, small organ, musculoskeletal, peripheral vascular, and urological exams.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety testing, and compliance with NEMA UD2/UD3 and IEC standards.

Technological Characteristics

Portable ultrasound system; USB-connected transducer; tablet-based (Microsoft Surface Pro). Imaging modes: B, M, PWD, Color/Power Doppler, Tissue Harmonic Imaging. Transducers: C1-6 (1-6 MHz) and L3-12 (3-12 MHz). Image processing: Xpeed, SRI, Spatial Compounding. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993, AIUM/NEMA UD 2.

Indications for Use

Indicated for qualified physicians to evaluate soft tissue and blood flow in fetal, abdominal, pediatric, small organ (breast, testes, thyroid), musculoskeletal (conventional/superficial), peripheral vascular, and urological (including prostate) clinical applications.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• E-CUBE i7 Diagnostic Ultrasound System (K153424)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are displayed side-by-side.

Alpinion Medical Systems Co., Ltd. Boyeon CHO QARA Manager 5fl, i dong, 77, heungan-daero 81 beon-gil dongan-gu Anyang-si, Gyeonggi-do, 14117 REPUBLIC OF KOREA

Re: K182845

Trade/Device Name: minisono Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 30, 2018 Received: December 3, 2018

Dear Boyeon CHO:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare 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.

December 27, 2018

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael D.'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{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)

#### K182845

Device Name minisono

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; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); 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 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}------------------------------------------------

## Diagnostic Ultrasound Indications for Use

## minisono Ultrasound Imaging System: minisono C1-6

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

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

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

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

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

Concurrence of CDRH

Prescription User (Per 21 CFR 801.109)

{4}------------------------------------------------

## Diagnostic Ultrasound Indications for Use

## minisono Ultrasound Imaging System: minisono L3-12

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

| Clinical Application | Mode of Operation | | | | | | | | |
|------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------|
| | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | N | |
| Small Organ | N | N | N | | N | N | N | N | |
| (breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| 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 | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | N | N | N | | N | N | N | N | |
| 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

Prescription User (Per 21 CFR 801.109)

{5}------------------------------------------------

# 510(k) Summary

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

| Date | Oct. 5th, 2018 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd.<br>Address: 5fl, i dong ,77, heungan-daero 81beon-gil, dongan-gu, anyang-<br>si, gyeonggi-do , REPUBLIC OF KOREA, 14117 |
| Primary Contact<br>Person | Boyeon CHO<br>Quality Management Representative(QMR)<br>Address: 5fl, i dong ,77, heungan-daero 81beon-gil, dongan-gu, anyang-<br>si, gyeonggi-do , REPUBLIC OF KOREA, 14117<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Person | Kevin Chun<br>Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Trade Name: | minisono |
| Common/Usual<br>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<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX |
| Primary Predicate<br>Device | K153424 E-CUBE i7 Diagnostic Ultrasound System |
| Device Description: | minisono product is an ultrasound imaging system for medical diagnosis.<br>This device is available for portable and tablet PC (Microsoft corp.,<br>Surface pro). Also, this innovative system platform provides optimal<br>patient diagnosis workflow with the tablet PC, optimal image quality. |
| | 1. Signal Mode:<br>B(2D) mode, M mode, Pulsed Wave Doppler(PWD) mode, Color Doppler,<br>Power Doppler, Tissue Harmonic Imaging |
| | 2. Combination Mode:<br>B/Color Doppler, B/PWD, B/Color Doppler/PWD |

Acoustic output track: Track 3

{6}------------------------------------------------

| | minisono C1-6 | minisono L3-12 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Applicable<br>frequency | 1~6MHz | 3~12MHz |
| Intended Usage | Fetal,<br>Abdominal,<br>Pediatric,<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Peripheral vessel<br>Urology (including<br>prostate) | Abdominal<br>Pediatric<br>Small Organ<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Peripheral vessel |
| Applicable<br>mode | B mode,<br>M mode,<br>PWD mode,<br>Color Doppler<br>Power Doppler<br>Tissue Harmonic Imaging<br>Combined | B mode,<br>M mode,<br>PWD mode,<br>Color Doppler<br>Power Doppler<br>Tissue Harmonic Imaging<br>Combined |
| Scanning<br>depth(mm) | 300 | 100 |
| FOV | 60(°) | N/A |
| Steer Angle | N/A | Max 9(°) |
| Total number of<br>element | 128 | 128 |

Types of transducers compatible with the device:

Indications For Use:

The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).

#### Determination of Comparison with Predicate devices: Substantial : minisono and E-CUBE i7

## Equivalence:

| Feature | Proposed<br>minisono | Predicate<br>E-CUBE i7<br>(K153424) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | The device is intended for use<br>by a qualified physician for the<br>evaluation of soft tissue and<br>blood flow in the clinical<br>applications; | The device is intended for use<br>by a qualified physician for the<br>evaluation of soft tissue and<br>blood flow in the clinical<br>applications; |
| | Fetal;<br>Abdominal;<br>Pediatric;<br>Small Organ (breast, testes,<br>thyroid); | Fetal;<br>Abdominal;<br>Pediatric;<br>Small Organ (breast, testes,<br>thyroid);<br>Adult Cephalic;<br>Trans-rectal(TR);<br>Trans-vaginal(TV); |
| | Musculo-<br>skeletal(Conventional);<br>Musculo-skeletal (Superficial); | Musculo-<br>skeletal(Conventional);<br>Musculo-skeletal (Superficial);<br>Cardiac (Adult); |

{7}------------------------------------------------

| | Peripheral Vessel (PV);<br>Urology (including prostate). | Cardiac (Pediatric);<br>Peripheral Vessel (PV);<br>Urology (including prostate). |
|---------------------|----------------------------------------------------------|----------------------------------------------------------------------------------|
| | | |
| Electrical<br>power | Voltage: 5Vdc, == 1A | Voltage: 19V, == 10.53A<br>Frequency: 50/60Hz<br>Power: 200W Max |
| Imaging | 2D (B) mode | 2D (B) mode |
| modes | M mode | M mode |
| | | Anatomical M |
| | Color Flow Doppler (CF) mode | Color Flow Doppler (CF) mode |
| | Power Doppler (PD) mode | Power Doppler (PD) mode |
| | Pulsed wave Doppler (PWD) | Directional PD<br>Pulsed wave Doppler (PWD) |
| | mode | mode |
| | | Continuous wave Doppler |
| | | (CWD) mode |
| | Tissue Harmonic Imaging | Tissue Harmonic Imaging |
| | mode | mode |
| Image | Xpeed™ | Xpeed™ |
| processing | SRI™ | Full SRI™ |
| technology | Spatial<br>Compounding<br>Image | Spatial Compounding<br>Image |
| | (SCI) | (SCI) |
| Software | | Panoramic |
| feature | | Needle Vision™ |
| | Needle Vision™ Plus | /Needle Vision™ Plus |
| | | Cube View™ |
| Thermal, | The minisono has been | The E-CUBE i7 has been |
| mechanical<br>and | designed to conform to the<br>following standards: | designed to conform to the<br>following standards: |
| electrical | - NEMA UD2, UD3 | - NEMA UD2, UD3 |
| safety | - AIUM Medical Ultrasound | - AIUM Medical Ultrasound |
| | Safety | Safety |
| | - IEC60601-1 | - IEC60601-1 |
| | - IEC60601-1-2 | - IEC60601-1-2 |
| | - IEC60601-2-37 | - IEC60601-2-37 |

Summary of Non-Clinical Tests:

minisono 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. minisono and its application comply with voluntary standards as detailed in this premarket submission.

- IEC 60601-1:2005+AMD1:2012 (3.1ed, 2012-08-20 published), + Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2:2014 (4.0ed, 2014-02-25 published), Medical � Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- � IEC 60601-1-6:2010+AMD1:2013(3.0ed, 2013-10-28), Medical

{8}------------------------------------------------

electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability

- � IEC60601-2-37:2007(2.0ed. 2007-08-09 published). Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- ISO10993-1:2009(5.0ed, � 2018-08 published), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- � ાડળ 10993-5:2009(3.0ed, 2009-06 published), Biological evaluation of medical devices -- Part 5: Tests for in vitro cvtotoxicity
- � 10993-10:2010(3.0ed, 2010-08 published), ISO Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- � ISO14971:2007(2.0ed, 2007-03 published), Application of risk management to medical devices
- AIUM/NEMA UD 2:2004 (R2009) Rev.3, 2009-08-21 published, � 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 minisono:

- � 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, minisono, did not require clinical studies to support substantial equivalence.

## Discussion:

minisono is a new device and simple diagnostic device. minisono (minisono C1-6 & minisono L3-12) are composed system and USB cable. Software is installed to the tablet PC (Microsoft corp., Surface pro). minisono's functions of imaging/software are same as predicate E-CUBE i7 functions.

Also, the subject device is in conformance with applicable safety standards.

Therefore, the differences between minisono and the predicate devices would not affect the safety, effectiveness and essential performance.

- Conclusion: ALPINION MEDICAL SYSTEMS Co., Ltd. considers minisono to be as safe, as effective. Performance, technology and software are substantially equivalent to the predicate devices.

{9}------------------------------------------------

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.