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(Pulse Repetition Frequency) 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

The provided document is a 510(k) Summary for the X-CUBE 50 and X-CUBE 60 diagnostic ultrasound systems. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for device performance. Instead, it states that the devices have been evaluated for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The performance is implicitly assessed against these standards and against the characteristics of the predicate devices.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Conforms to AAMI/ANSI/ISO10993-1:2009(R)2013
Acoustic Output	Conforms to NEMA UD 2-2004(R2009) and AIUM MUS, Third edition
Thermal Safety	Conforms to IEC 60601-1:2005+A1:2012 and IEC 60601-2-37:2007/AMD1:2015, NEMA UD 3-2004(R2009)
Electrical Safety	Conforms to IEC 60601-1:2005+A1:2012 and IEC 60601-2-37:2007/AMD1:2015
Electromag. Safety	Conforms to IEC60601-1-2:2014
Mechanical Safety	Conforms to IEC 60601-1:2005+A1:2012 and IEC 60601-2-37:2007/AMD1:2015
Quality Management System	Conforms to 21 CFR 820 and ISO 13485
Essential Performance	As safe and effective as the predicate device

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: “The subject of this premarket submission, X-CUBE 50 and X-CUBE 60, did not require clinical studies to support substantial equivalence.” Therefore, there is no specific test set or data provenance related to a clinical study. The evaluation appears to be based on adherence to standards and comparison of technical specifications with predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical studies with a specific test set requiring expert-established ground truth were performed.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies with a test set requiring adjudication were performed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The X-CUBE 50 and X-CUBE 60 are diagnostic ultrasound systems, not AI-powered interpretation software meant to assist human readers. The document does not describe any AI component or human reader effectiveness studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable, as the device is a diagnostic ultrasound system and not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies with a specific test set were performed to assess diagnostic accuracy against a ground truth.

8. The Sample Size for the Training Set

Not applicable, as the device is a diagnostic ultrasound system and not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as the device is a diagnostic ultrasound system and not an AI algorithm requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is not a traditional clinical trial or performance study against specific diagnostic metrics. Instead, it is an engineering and regulatory compliance assessment designed to demonstrate "substantial equivalence" to legally marketed predicate devices.

The proof that the device meets its implicit acceptance criteria (that it is as safe and effective as the predicate) is based on:

Non-Clinical Tests: Evaluation for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, confirming adherence to various international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AAMI/ANSI/ISO 10993-1, AAMI/ANSI/ISO 14971, AIUM MUS, NEMA UD 2, NEMA UD 3).
Quality Management System Measures: Adherence to 21 CFR 820 and ISO 13485, including medical device risk management, requirements reviews, design reviews, component verification, integration review, performance testing, safety testing, and design validation.
Comparison to Predicate Devices: A detailed comparison (table provided in the 510(k) summary) of the proposed devices (X-CUBE 50, X-CUBE 60) with predicate devices (K220857 X-CUBE 50, X-CUBE 60, and K221093 X-CUBE 70, X-CUBE 90). This comparison covers indications for use, physical dimensions, electrical power, imaging modes, imaging features, accessories, and compliance to safety standards. The document highlights that the new devices have minor changes (e.g., model name changes, addition of some transducers) and maintain the same operating principles, intended use, risk grade, and design/manufacturing characteristics as the predicate devices.
Conclusion of Substantial Equivalence: The manufacturer concluded that the differences between the proposed and predicate devices would not affect safety, effectiveness, and essential performance, thus arguing for substantial equivalence.

In essence, the proof relies on a comprehensive engineering and regulatory checklist showing that the new devices meet established safety standards and are technically similar to previously cleared devices for their intended use. No new clinical performance data was deemed necessary by the FDA for this 510(k) clearance process.

Summary

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April 17, 2023

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Alpinion Medical Systems Co., Ltd. % Boyeon CHO Quality Management Representative 4F, 15, Magokjungang 14-ro, Gangseo-gu Seoul. Seoul 07789 KOREA

Re: K223564

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: March 24, 2023 Received: March 27, 2023

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 S. Kang -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223564

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)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K223564

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

Mar 24th, 2023 Date
Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 4F, 15, Magokjungang 14-ro, Gangseo-gu, Seoul, 07789, Republic of Korea
Primary Boyeon CHO Contact Person Quality Management Representative(QMR) Address: 4F, 15, Magokjungang 14-ro, Gangseo-qu, Seoul, 07789, Republic of Korea Phone: +82.2.3777.8600 Fax: +82.2.3777.8691 Email: ga 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
Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX

Predicate Device K220857 X-CUBE 50, X-CUBE 60 Ultrasonic Pulsed Doppler Imaging System

Reference K221093 X-CUBE 70, X-CUBE 90 Ultrasonic Pulsed Doppler Imaging System Devices
Proposed New The new device are as follows compared to the cleared Predicate devices. Device - X-CUBE 50 Change model name: C1-7GT → C1-6C, Add model: C1-6CT - X-CUBE 60 Add models: L10-25H. SL3-19X. C1-6CT. C1-6C - Add accessories: EC2-11H/EV2-11H Disposable Biopsy needle guide

The X-CUBE 50 and X-CUBE 60 products are general purpose ultrasound Device imaging system for medical diagnosis assistance. Description: These products are used as an aid tool to diagnosis, such as a commonly used

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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.

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(Pulse Repetition Frequency) 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(Pulse Repetition Frequency) 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.

The difference between the X-CUBE 50 and X-CUBE 60 is the number of Differences Tx/Rx channels. X-CUBE 50 operates with 64 channels, but X-CUBE 60 between Proposed operates with 128 channels. The component constituting the Tx/Rx channel is Devices. the FE(Front End) board. Both devices are in the same except for the FE(Front End) board.

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Model	ProposedX-CUBE 50,X-CUBE 60ALPINION MedicalSystems Co., Ltd.	PredicateX-CUBE 50,X-CUBE 60ALPINION MedicalSystems Co., Ltd.	ReferenceX-CUBE 70,X-CUBE 90ALPINION MedicalSystems Co., Ltd.
Feature	K223564	K220857	K221093
	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	70kg	85kg
Height	1310/1670mm	1310/1670mm	1,440/1,605 mm
Width	560mm	560mm	580 mm
Depth	780mm	780mm	835 mm
	Electrical Power
Voltage	100-120V~,200-240V~	100-120V~,200-240V~	100-120V~,200-240V~
Frequency	50-60 Hz	50-60 Hz	50-60 Hz
Power	Max. 600VA	Max. 600VA	Max. 700VA
	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(PulseRepetition Frequency)Doppler mode	√	√	√
- 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(STIC)	√	√	√
- Auto EF	√	√	√
- AnySlice™	√	√	√
- X + Compare	√	√	√
- X + Assistant	√	√	√
- Time Intensity Curve(TIC) Analysis	√	√	√
- Auto NTMeasurements	√	√	√
- X + Auto Biometry	√	√	√
- Auto IMTMeasurements	√	√	√
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	√	√	√
EC2-11H/EV2-11HDisposable Biopsyneedle guide	√
EN3-10 ReusableBiopsy needle guide	√	√
EN3-10 DisposableBiopsy 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	√	√	√
Transducer Comparison (related to K223564)
C1-6C	√	√	√
C1-6CT	√
L10-25H	√		√
SL3-19X	√		√
- For C1-6C, only the model name has been changed from C1-7GT(K220857).- C1-6CT is the new model. However, except for the slight difference inApplicable frequency, C1-6CT and C1-6C are the same Convex typeprobe and provide the same applicable mode, indications for use, elementsize, element spacing.- L10-25H and SL3-19X are the same transducers as the predicatedevice(K221093).

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510(k) X-CUBE 50 & 60

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510(k) X-CUBE 50 & 60

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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: Electromaqnetic 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

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� 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, 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, effectiveness and essential performance.

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.