E-CUBE 15

K121888 · Alpinion Medical Systems Co., Ltd. · IYO · Jul 26, 2012 · Radiology

Device Facts

• Record ID: K121888
• Device Name: E-CUBE 15
• Applicant: Alpinion Medical Systems Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Small Organ (breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

Device Story

E-CUBE 15 is an ultrasound imaging system for medical diagnosis. It processes ultrasonic signals from transducers to produce B-mode, M-mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Flow, and Power Doppler images. It features an 18.5-inch flat panel display, ergonomic control panel, and integrated gel warmer. Used in clinical settings by physicians, the system aids in evaluating soft tissue and blood flow. It includes automated measurement tools like Auto IMT and Auto traces. The device supports 3D/4D volume rendering. Data is stored on an integrated 500GB HDD or external media. Output is viewed by the clinician on the integrated monitor to inform diagnostic decisions. Benefits include improved diagnostic workflow and image quality for various clinical applications.

Clinical Evidence

No clinical studies were required to support substantial equivalence. The device was evaluated through bench testing, including biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety testing, confirming compliance with NEMA UD2, UD3, AIUM, IEC60601-1, IEC60601-1-2, IEC60601-2-37, and ISO 10993-1 standards.

Technological Characteristics

Ultrasound imaging system; 18.5" wide LCD; 3-4 active probe ports; 500GB HDD; integrated DVD-R/W; 8 USB ports; integrated gel warmer. Operating modes: B, M, PW/CW Doppler, Color/Power Doppler, THI, 3D/4D. Connectivity: USB, DICOM-compatible. Power: 100-240V, 50/60Hz. Biocompatible patient-contact materials per ISO 10993-1. Safety standards: IEC60601-1, IEC60601-1-2, IEC60601-2-37.

Indications for Use

Indicated for qualified physicians to evaluate soft tissue and blood flow in fetal, abdominal (renal/GYN/pelvic), small organ (breast/testes/thyroid), trans-rectal, trans-vaginal, musculoskeletal (conventional/superficial), adult cardiac, peripheral vascular, and urological (including prostate) applications.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• E-CUBE 9 Diagnostic Ultrasound System (K120060)

Submission Summary (Full Text)

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JUL 26 2012

510(K) E-CUBE 15

## 510(k) Summary

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

Date June 26" 2012 Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848, Primary Contact Person Donghwan Kim QARA Manager Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848. Phone: [phone] Fax: [phone] Emall: [e-mail] Secondary Contact Yuchi Chu Person Address: Suite 229, 10604 NE 38th Place, Kirkland, WA 98033, United States Phone: [phone] Fax: [phone] Email: [e-mail] Device Trade Name: E-CUBE 15 Common/Usual Name: Ultrasonic Pulsed Doppler Imaging System Classification Names System, Imaging, Pulsed Doppler Ultrasonic Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-Product Code: IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO , I Y/V Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX Predicate Device(s) K120060 E-CUBE 9 Diagnostic Utrasound System

ALPINION MEDICAL SYSTEMS Co., Ltd.

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## 510(k) E-CUBE 15

| Device Description: E-CUBE 15 product is an ultrasound imaging system for medical<br>diagnosis. The system platform provides optimal patient diagnosis<br>workflow with the 18.5° wide flat panel display, ergonomic control<br>panel with easy user interface, optimal image quality. |
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| Indications For Use: The device is intended for use by a qualified physician for the<br>evaluation of soft tissue and blood flow in the clinical applications;<br>Fetal; Abdominal (renal & GYN/pelvic); Small Organ (breast, testes,<br>Trans-reclal(TR);<br>thyrold);<br>Musculo-<br>skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac<br>(adult); Peripheral Vascular (PV); and Urology (including prostate). |

| Technology: E-CUBE 15 employs the same fundamental scientific technology as |
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| its predicate device. |

| Feature | Proposed<br>E-CUBE 15<br>ALPINION MEDICAL SYSTEMS Co.,<br>Ltd. | Predicate<br>E-CUBE 9<br>ALPINION MEDICAL SYSTEMS Co.,<br>Ltd. | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k)<br>Number | | K120060 | |
| Indications for<br>use | The device is intended for use by a<br>qualified physician for the evaluation of<br>soft tissue and blood flow in the clinical<br>applications:<br>Fétal:<br>Abdominal (renal & GYN/pelvic);<br>Small Organ (breast, testes, thyroid):<br>Trans-rectal(TR);<br>Trans-vaginal(TV):<br>Musculo-skeletal(Conventional);<br>Musculo-skeletal Superficial);<br>Cardiac (adult):<br>Peripheral Vascular (PV):<br>Urology (including prostate). | The device is intended for use by a<br>qualified physician for the evaluation of<br>soft tissue and blood flow in the clinical<br>applications:<br>Fetal:<br>Abdominal (renal & GYN/pelvic);<br>Pediatric;<br>Small Organ (breast, testes, thyroid);<br>Trans-rectal(TR);<br>Trans-vaginal(TV);<br>Musculo-skeletal(Conventional):<br>Musculo-skeletal (Superficial);<br>Cardiac (adult & pediatric);<br>Perpheral Vascular (PV):<br>Urology (including prostate). | |
| | Discussion of differences<br>●<br>The individual functions of E-CUBE 15 has essential performance and safety<br>effectiveness same as E-CUBE 9, even though E-CUBE 15 as limited scope of<br>the indications comparing with the predicate.<br>Therefore, E-CUBE 15 substantially equivalent with predicate device. | | |
| Dimensions<br>and weight | Weight: approx. 105kg<br>Height: 1413/1848 mm<br>Width: 585mm<br>Depth: 670mm | Weight: approx. 89.5kg<br>Height: 1340/1600 mm<br>Width: 590mm<br>Depth: 850mm | |
| Monitor | 18.5" Wide LCD | 17" Wide LCD | |
| | 18.5" Wide LCD | 18.5" Wide LCD | |
| | Display size: 1366 X 768 | Display size: 1366 X 768 | |
| | Recording area: 880 X 660 | Recording area: 880 X 660 | |
| | | | |
| | Adjustable Tilt/Swivel, up/down, rotate | Adjustable Tilt/Swivel, up/down, rotate | |
| | Digital Brightness/Contrast Adjustment | Digital Brightness/Contrast Adjustment | |
| | | | |
| Electrical | Voltage: 100~120V, 200~240V | Voltage: 100~120V, 200~240V | |
| power | Frequency: 50/60Hz | Frequency: 50/60Hz | |
| | Power: Max. 900 VA with Built-in and | Power: Max. 600 VA with Built-in and | |
| | On-Board Peripherals | On-Board Peripherals | |
| | | | |
| Consol design | • 3 active Probe Ports | • 3 active Probe Ports | |
| | (4 Probe Ports Option) | | |
| | • Touch panel | | |
| | • Integrated HDD (Capacity: 500G) | • Integrated HDD (Capacity: 500G) | |
| | • Integrated DVD-R/W Drive | • Integrated DVD-R/W Drive | |
| | • On-board Storage for Peripherals | • On-board Storage for Peripherals | |
| | - B/W Printer | - B/W Printer | |
| | Color Printer, | Color Printer, | |
| | DVD recorder | DVD recorder | |
| | • Control panel lift mechanism | • Control panel lift mechanism | |
| | • 5 Transducer holders, detachable for | • 5 Transducer holders, detachable for | |
| | cleaning and washing | cleaning and washing | |
| | • Integrated Gel warmer | • Integrated Gel warmer | |
| | - 3 temperature levels | - 3 temperature levels | |
| | • Front Handle | • Front Handle | |
| | • Rear Handle | • Rear Handle | |
| | • Wheel-lock Mechanism | • Wheel-lock Mechanism | |
| | - Front & Back -Wheel: Total lock | - Front & Back -Wheel: Total lock | |
| | • 8 USB ports: Touch module side (2ea) | • 5 USB ports: Front Side (1ea) Back | |
| | Back side (6ea) | side (6ea) | |
| | • Thumbnail images on-screen | • Thumbnail images on-screen | |
| | • On-line Help key | • On-line Help key | |
| | • ECG Module | • ECG Module | |
| | • Patient ECG Lead Wires | • Patient ECG Lead Wires | |
| | Discussion of differences | | |
| | E-CUBE 15 has 3 or 4 (optional) probe ports, 8 USB ports: Touch module side | | |
| | (2ea) Back side (6ea) and Touch panel. But, E-CUBE 9 has 3 probe ports and 5 | | |
| | USB ports: Front Side (1ea) Back side (6ea). It is not related with the safety, | | |
| | effectiveness and essential performance. | | |
| | | | |
| Operating | • B-Mode | • B-Mode | |
| Mode | • M-Mode | • M-Mode | |
| | • Anatomical M-mode | • Anatomical M-mode | |
| | • Pulsed Wave (PW) Doppler with High | • Pulsed Wave (PW) Doppler with High | |
| | PRF | PRF | |
| | • Continuous Wave (CW) Doppler | • Continuous Wave (CW) Doppler | |
| | • Color Flow-Mode | • Color Flow-Mode | |
| | | | |
| | Power Doppler Mode THI (PI/FTHI) Tissue Doppler Imaging Beam Steering Panoramic B/CF Spatial compounding Frequency compounding Xpeed on 2D / CF/PW Auto IMT Auto traces PW Directional Power Doppler Mode SRI Full SRI ECG | Power Doppler Mode THI (PI/FTHI) Tissue Doppler Imaging Beam Steering Panoramic B/CF Spatial compounding Frequency compounding Xpeed on 2D / CF/PW Auto IMT Auto traces PW Directional Power Doppler Mode SRI Full SRI ECG 3D/4D Volume Mode | |
| | Discussion of difference<br>3D/4D is an image representation of a volume or 3D object, such as the heart<br>or fetus. Surface rendering can be used to visualize surfaces. Another image<br>presentation is volume rendering, in which surfaces can be semitransparent or<br>2D slice planes through the object. Alternatively, there is simultaneous viewing<br>of different 2D-slice planes (side by side). | | |
| | E-CUBE 15 includes essential operating mode for diagnosis and is<br>Substantially Equivalent. | | |
| Labeling<br>and/or<br>promotional<br>materials | Section 6B Catalog E-CUBE 15 | Section 3C Catalog E-CUBE9 | |
| Accessories or<br>kits | Color printer<br>B/W printer<br>DVR<br>DVD-RW<br>Footswitch<br>Probe Holder<br>Ultrasonic gel<br>Cidex OPA (disinfectant agents)<br>Cidex Plus (disinfectant agents)<br>SC1-6 Biopsy guide kit<br>L3-12 Biopsy guide kit<br>E3-10 Reusable Biopsy needle guide<br>E3-10 Disposable Biopsy needle guide<br>ECG Module<br>Patient ECG Lead Wires | Color printer<br>B/W printer<br>DVR<br>DVD-RW<br>Footswitch<br>Probe Holder<br>Ultrasonic gel<br>Cidex OPA (disinfectant agents)<br>Cidex Plus (disinfectant agents)<br>SC1-6 Biopsy guide kit<br>L3-12 Biopsy guide kit<br>E3-10 Reusable Biopsy needle guide<br>E3-10 Disposable Biopsy needle guide<br>ECG Module<br>Patient ECG Lead Wires | |
| | | | |
| Measurement<br>and<br>Calculation<br>functions | 1. General<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | 1. General<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | |
| | 2. Abdomen<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | 2. Abdomen<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode. | |
| | 3. Small Parts<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | 3. Small Parts<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | |
| | 4. Obstetrics<br>1) B-Mode<br>2) M-Mode:<br>3) Doppler Mode | 4. Obstetrics<br>1) B-Mode<br>2) M-Mode:<br>3) Doppler Mode | |
| | 5. Gynecology<br>1) B-Mode<br>2) M-Mode:<br>3) Doppler Mode | 5. Gynecology<br>1) B-Mode<br>2) M-Mode:<br>3) Doppler Mode | |
| | 6. Cardiology<br>1) B-Mode:<br>2) M-Mode<br>3) Doppler Mode | 6. Cardiology<br>1) B-Mode:<br>2) M-Mode<br>3) Doppler Mode | |
| | 7. Vascular<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | 7. Vascular<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | |
| | 8. Urology<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | 8. Urology<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | |
| | | 9. Pediatrics<br>1) B-Mode<br>2) M-Mode<br>3) Doppler Mode | |
| | Discussion of difference | | |
| | Measurement and Calculation functions of E-CUBE 15 are not include Pediatrics. | | |
| | It is not related with the safety, effectiveness and essential performance. | | |
| Acoustic<br>output<br><Conclusion> | Track 3 | Track 3 | |

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#### 510(k) E-CUBE 15 대

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510(k) E-CUBE 15

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510(k) E-CUBE 15

(pediatric). The primary difference is cosmetic structure and component used only. Therefore, we can claim the substantially equivalence of E-CUBE 15 to the predicate device.

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ALPINION MEDICAL SYSTEMS Co., Ltd.

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Determination of Substantial Equivalenço:

#### Summary of Non-Clinical Tests:

E-CUBE 15 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 15 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 15:

- NEMA UD2, UD3 .
- AIUM Medical Ultrasound Safety .
- IEC60601-1 .
- IEC60601-1-2
- IEC60601-2-37 (3rd Edition)
- ISO 10993-1

Transducer materials and other patient contact materials are biocompatible.

#### Summary of Clinical Tests:

The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.

Conclusion:

Alpinion Medical Systems Co., Ltd. considers E-CUBE 15 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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.

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#### Appendix B - Decision Summary for Web Posting

Decision Summary, K 1 21 889

This 510(k) was reviewed under OIVD's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination.

#### OIVD, 6/12/12, v1.2

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Donghwan Kim QARA Manager Alpinion Medical Systems Co., Ltd. 1. 6. and 7FL Verdi Tower 72. Digital-ro (St) 26-gil (Rd), Guro-gu SEOUL 152-848 REPUBLIC OF KOREA

SEP 2 5 2012

Re: K121888 Trade/Device Name: E-CUBE 15 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: June 26, 2012 Received: June 28, 2012

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of July 26, 2012.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

This determination of substantial equivalence applies to the following transducers intended for use with the E-CUBE 15, as described in your premarket notification:

| Transducer Model Number | |
|-------------------------|--------|
| SC1-6H | L8-17X |
| L3-12H | SC1-4H |
| SP1-5X | E3-10H |

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can

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be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific ad…