X-CUBE 50, X-CUBE 60 by Alpinion Medical Systems Co., Ltd.

The X-CUBE 50, X-CUBE 60 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; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate).

And, in the imaging modes of 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 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.

Device Description

The X-CUBE 50 and X-CUBE 60 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 50 and X-CUBE 60 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.

AI/ML Overview

This document is a 510(k) premarket notification for general purpose ultrasonic imaging systems (X-CUBE 50 and X-CUBE 60). It does not involve an AI-powered device, but rather a traditional medical imaging device. Therefore, the information requested regarding acceptance criteria and study for AI performance is not applicable.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices by comparing their intended use, imaging modes, physical specifications, and compliance with various safety and performance standards. It explicitly states: "The subject of this premarket submission, X-CUBE 50 and X-CUBE 60, did not require clinical studies to support substantial equivalence." This indicates that no new clinical performance data (which would include data for AI performance if it were an AI device) was generated or submitted for this clearance.

Therefore, I cannot provide the requested information as it pertains to a study proving an AI device meets acceptance criteria.

Summary

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October 13, 2022

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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: K220857

Trade/Device Name: X-cube 50, X-cube 60 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

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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

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Indications for Use

510(k) Number (if known) K220857

Device Name X-CUBE 50, X-CUBE 60

Indications for Use (Describe)

The X-CUBE 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv K220857

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

Mar 25th, 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 50, X-CUBE 60

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 K211300 X-CUBE 90 Ultrasonic Pulsed Doppler Imaging System K211299 X-CUBE 70 Ultrasonic Pulsed Doppler Imaging System
- Reference K213523 X-CUBE i9 Ultrasonic Pulsed Doppler Imaging System Devices K181277 E-CUBE 12 Ultrasonic Pulsed Doppler Imaging System K181617 E-CUBE 8 Ultrasonic Pulsed Doppler Imaging System

Device The X-CUBE 50 and X-CUBE 60 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 50 and X-CUBE 60 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices.

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

Patient population Adult and Pediatric
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
Acoustic output track: Track 3

Indications The X-CUBE 50, X-CUBE 60 diagnostic ultrasound systems are intended for For Use: 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); Peripheral Vessel(PV); and Urology(including prostate).

And, in the imaging modes of 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 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.

Differences The difference between the X-CUBE 50 and X-CUBE 60 is the number of between Tx/Rx channels. X-CUBE 50 operates with 64 channels, but X-CUBE 60 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.

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Determination of Substantial Equivalence: Comparison table with Predicate devices:

Model	ProposedX-CUBE 50,X-CUBE 60ALPINION MedicalSystems Co., Ltd.	PrimaryPredicateX-CUBE 90ALPINION MedicalSystems Co., Ltd.	SecondaryPredicateX-CUBE 70ALPINION MedicalSystems Co., Ltd.	ReferenceX-CUBE i9ALPINION MedicalSystems Co., Ltd.	ReferenceE-CUBE 12ALPINION MedicalSystems Co., Ltd.	ReferenceE-CUBE 8ALPINION MedicalSystems Co., Ltd.
Feature	K220857	K211300	K211299	K213523	K181277	K181617
	Indications for Use
- Fetal	√	√	√	√	√	√
- Abdominal(Renal&GYN/Pelvic)	√	√	√	√	√	√
- Intra-operative(Specify, Neuro)
- 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)	√	√	√	√	√	√
	Dimensions and Weight
Weight(Excluding options)	70kg	85kg	90kg	6kg	94 kg	55 kg
Height	1310/1670mm	1325/1560 mm	1325/1560 mm	62.5/352 mm	1,420/1,520 mm	830~1,430 mm
Width	560mm	554 mm	554 mm	385 mm	590 mm	532 mm
Depth	780mm	815 mm	815 mm	370 mm	895 mm	787 mm
Electrical Power
Voltage	100-120V~,200-240V~	100-120V~,200-240V~	100-120V~,200-240V~	20V---, 11A	100-120V~,200-240V~	100-120V~,200-240V~
Frequency	50-60 Hz	50-60 Hz	50-60 Hz	50-60 Hz	50/60 Hz	50-60 Hz
Power	Max. 600VA	Max. 700VA	Max. 700VA	Max. 220W	Max. 600VA	Max. 450VA
Imaging Modes
- 2D(B) mode	√	√	√	√	√	√
- Harmonic mode	√	√	√	√	√	√
- M mode	√	√	√	√	√	√
- Color M mode	√	√	√	√	√	√
- Anatomical M mode	√	√	√	√	√	√
- Color Flow Doppler(CF) mode	√	√	√	√	√	√
- Power Doppler (PD)mode	√	√	√	√	√	√
- Microvascular Imaging(MVI)	√	√	√	√	√	√
- Directional PD mode	√	√	√	√	√	√
- Pulsed wave Doppler(PWD) mode	√	√	√	√	√	√
- Continuous waveDoppler (CWD) mode	√	√	√	√	√	√
- High PRF Dopplermode	√	√	√	√	√	√
- Tissue Dopplerimaging (TDI) mode	√	√	√	√	√	√
- 3D/4D mode	√	√	√	√	√	√
Imaging Features
- Xpeed™	√	√	√	√	√	√
- Full SRI™	√	√	√	√	√	√
-Spatial CompoundingImage (SCI)	√	√	√	√	√	√
- Panoramic	√	√	√	√	√	√
- Stress Echo	√	√	√	√	√	√
- Cube Strain™	√	√	√	√	√	√
- Live HQ™	√	√	√	√	√	√
- Needle Vision™/Needle Vision™ Plus	√	√	√	√	√	√
- Elastography	√	√	√	√	√	√
- Cube view™	√	√	√	√	√	√
- Contrast EnhancedUltrasound (CEUS)	√	√	√	√	√	√
- Cube Note	√	√	√	√	√
- B-STIC	√	√	√		√
- Auto EF	√	√	√	√
- AnySlice™	√	√	√		√	√
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 ReusableBiopsy needle guide	√	√	√
EN3-10 ReusableBiopsy needle guide	√			√	√	√
VE3-10H ReusableBiopsy needle guide	√	√	√		√
VE3-10H DisposableBiopsy 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)	√	√	√	√	√	√
Cetylcide-G(Disinfectant agaents)	√	√	√	√	√	√
Sporicidin(Disinfectant agaents)	√	√	√	√	√	√
Thermal, mechanical and electrical safety
- NEMA UD2, UD3	√	√	√	√	√	√
- AIUM MedicalUltrasound Safety	√	√	√	√	√	√
- IEC 60601-1	√	√	√	√	√	√
- IEC 60601-1-2	√	√	√	√	√	√
- IEC 60601-2-37	√	√	√	√	√	√

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Summary of Non-Clinical Tests:

X-CUBE 50 and X-CUBE 60 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 50, X-CUBE 60 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 50 and X-CUBE 60:

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 50 and X-CUBE 60, did not require clinical studies to support substantial equivalence.

Discussion:

X-CUBE 50 and X-CUBE 60 were compared with the predicate device. The subject devices are in conformance with applicable safety standards.

Therefore, the differences between X-CUBE 50 and X-CUBE 60, and the predicate device would not affect the safety, effectivenes and essential performance.

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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 50 and X-CUBE 60 to be as safe, and effective as the predicate device.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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