SONOSITE EDGE ULTRASOUND SYSTEM

K133454 · FUJIFILM Sonosite, Inc. · IYN · Dec 16, 2013 · Radiology

Device Facts

• Record ID: K133454
• Device Name: SONOSITE EDGE ULTRASOUND SYSTEM
• Applicant: FUJIFILM Sonosite, Inc.
• Product Code: IYN · Radiology
• Decision Date: Dec 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

Device Story

Portable, laptop-style diagnostic ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Operates on battery or AC power. Used by physicians in clinical settings for imaging/fluid flow analysis. Inputs: ultrasound signals from various transducers (linear, curved, phased, intracavitary). Processing: digital electronic design; supports multiple imaging modes (B-mode, M-mode, Doppler, etc.); includes SonoHD2 noise reduction and SonoMB/MBe image compounding. Outputs: real-time images on 12.1" LCD; DICOM-compatible image storage. Clinical decision-making: assists in diagnosis, needle guidance, and catheter placement. Benefits: portable, high-resolution diagnostic imaging.

Clinical Evidence

Bench testing only. No clinical studies required. Evidence includes design phase reviews, risk assessment, system/software verification, hardware verification, safety compliance (electrical, thermal, mechanical, EMC), biocompatibility, and human factors validation. Conforms to NEMA UD 2 and UD 3 standards.

Technological Characteristics

Portable laptop form factor (12.9"x12.4"x2.5"); 128 transmit/receive channels; 12.1" LCD. Materials: ABS, Cycoloy, Dow Medical Adhesive, Epoxy, Polysulfone UDEL P1700, Polyurethane, PVC, Silicone Rubber, Urethane. Transducers: 1.0-15.0 MHz. Connectivity: DICOM 3.0, Wireless 802.11 a/b/g. Software: SonoCalc IMT for automated intima-media thickness measurement.

Indications for Use

Indicated for qualified physicians to perform diagnostic ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal, OB/GYN, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel 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

• SonoSite Edge Ultrasound System (K113156)
• SonoSite Maxx Series Ultrasound System (K130173)

Reference Devices

• K071134
• K082098
• K113680

Submission Summary (Full Text)

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K133454
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# 510(K) Summary

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

### 1) Submitter's name, address, telephone number, contact person:

FUJIFILM SonoSite, Inc. 21919 30" Drive SE Bothell, WA 98021-3904

Corresponding Official:

E-mail: Telephone: . Facsimile: Date prepared: Patricia Liau Regulatory Affairs Specialist [e-mail] [phone] [phone] October 17, 2013

### 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

### Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

SonoSite Edge® Ultrasound System (subject to change)

### Classification Names

| Name | FR Number | Product Code |
|---------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Picture Archiving and Communications System | 892.2050 | LLZ |

### 3) Identification of the predicate or legally marketed device:

| SonoSite Edge Ultrasound System | K113156 |
|----------------------------------------|---------|
| SonoSite Maxx Series Ultrasound System | K130173 |

### 4) Device Description:

The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.

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### 5) Intended Use:

The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

- Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
### 6) Technological Characteristics:

SonoSite Edge and Maxx Series Ultrasound Systems are both Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

| Feature | SonoSite Edge<br>Ultrasound System<br>(This Submission) | SonoSite Edge<br>Ultrasound System<br>(K113156) | SonoSite M-Turbo (Maxx Series) Ultrasound<br>System<br>(K130173) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body |
| Indications for<br>Use | Opthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Intra-operative (abdominal organs<br>and vascular)<br>Intra-operative (Neuro.)<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle. prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-Rectal<br>Trans-Vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal (cardiac)<br>Peripheral Vessel<br>Needle guidance | Opthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Intra-operative (abdominal organs<br>and vascular)<br>Intra-operative (Neuro.)<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-Rectal<br>Trans-Vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal (cardiac)<br>Peripheral Vessel<br>Needle guidance | Opthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Intra-operative (abdominal organs<br>and vascular)<br>Intra-operative (Neuro.)<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-Rectal<br>Trans-Vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal (cardiac)<br>Peripheral Vessel<br>Needle guidance |
| Transducer<br>Types | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array |
| Feature | SonoSite Edge<br>Ultrasound System<br>(This Submission) | SonoSite Edge<br>Ultrasound System<br>(K113156) | SonoSite M-Turbo (Maxx<br>Series) Ultrasound<br>System<br>(K130173) |
| | Static Probes | Static Probes | Static Probes |
| | Trans-esophageal | Trans-esophageal | Trans-esophageal |
| Transducer<br>Frequency | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Global | <i>I</i> spta 3: .709 (TEEX) | <i>I</i> spta 3: .709 (TEEX) | <i>I</i> spta 3: .709 (TEEx) |
| Maximum | TI Type: TIB(P21x)<br>TI Value: 3.7 (P21x) | TI Type: TIB(P21x)<br>TI Value: 3.7 (P21x) | TI Type: TIB(P21x)<br>TI Value: 3.9 (P21x) |
| Outputs/Worst | MI: 1.5 (P21x & L38xi) | MI: 1.5 (P21x & L38xi) | MI: 1.51 (P21x) |
| Case Setting | <i>I</i> pa 3@MI Max: 776 (L38xi) | <i>I</i> pa 3@MI Max: 776 (L38xi) | <i>I</i> pa 3@MI Max: 439.9 (L38x) |
| Acoustic | Display Feature for Higher | Display Feature for Higher | Display Feature for Higher |
| Output Display | Outputs<br>MI Output Display | Outputs<br>MI Output Display | Outputs<br>MI Output Display |
| & FDA Limits | TI Output Display | TI Output Display | TI Output Display |
| Modes of | B-mode Grayscale Imaging | B-mode Grayscale Imaging | B-mode Grayscale Imaging |
| Operation | | | 3D/4D Grayscale Imaging |
| | Tissue Harmonic Imaging | Tissue Harmonic Imaging | Tissue Harmonic Imaging |
| | M-mode | M-mode | M-mode<br>Anatomical M-Mode |
| | Color M-Mode | Color M-Mode | Color M-Mode |
| | Color Power Doppler | Color Power Doppler | Color Power Doppler |
| | Zoom | Zoom | Zoom |
| | Combination Modes | Combination Modes | Combination Modes |
| | Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler |
| | Continuous Wave (CW) Doppler<br>SonoHD2 Noise Reduction | Continuous Wave (CW) Doppler<br>SonoHD2 Noise Reduction | Continuous Wave (CW) Doppler<br>SonoRes/SonoHD Noise |
| | SonoMB/MBe Image | SonoMB/MBe Image | Reduction |
| | Compounding | Compounding | SonoMB Image Compounding |
| | Steered CW Doppler | Steered CW Doppler | Steered CW Doppler |
| | Velocity Color Doppler | Velocity Color Doppler | Velocity Color Doppler |
| | Color TDI | Color TDI | Color TDI |
| PW Doppler | Available on all imaging<br>transducers except D2x/2 MHz. | Available on all imaging<br>transducers except D2x/2 MHz. | Available on all imaging<br>transducers except D2x/2 MHz |
| | Adjustable sample volume size:<br>1.0 - 25 mm | Adjustable sample volume size:<br>1.0 – 25 mm | Adjustable sample volume size:<br>1.0 - 25 mm |
| | Simultaneous or duplex mode of<br>operation | Simultaneous or duplex mode of<br>operation | Simultaneous or duplex mode of<br>operation |
| | Simultaneous B-mode and PW<br>Doppler | Simultaneous B-mode and PW<br>Doppler | Simultaneous B-mode and PW<br>Doppler |
| | High PRF capability | High PRF capability | High PRF capability |
| CW Doppler | Available on C11x, D2x/2, P10x,<br>P21x, TEEx | Available on C11x, D2x/2, P10x,<br>P21x, TEEx | Available on C11x, D2x/2, P10x,<br>P17x, P21x, TEEx |
| | Simultaneous or duplex mode of<br>operation | Simultaneous or duplex mode of<br>operation | Simultaneous or duplex mode of<br>operation |
| | Simultaneous B-mode and CW<br>Doppler | Simultaneous B-mode and CW<br>Doppler | Simultaneous B-mode and CW<br>Doppler |
| Velocity Color | Available on all transducers<br>except D2x/2 | Available on all transducers<br>except D2x/2 | Available on all transducers<br>except D2x/2 |
| Doppler | | | |
| Elastography<br>(Strain), and | Available on all transducers<br>except D2x/2 | Available on all transducers<br>except D2x/2 | Available on all transducers<br>except D2x/2 |
| Strain Rate | | | |
| Imaging | | | |
| ECG Feature | One 3-lead ECG input, or<br>One external ECG input, or | One 3-lead ECG input, or<br>One external ECG input, or | One 3-lead ECG input, or<br>One external ECG input, or |
| | One other physio input | One other physio input | One other physio input |
| DICOM | DICOM 3.0 CStore, Print, and<br>Modality Worklist service class | DICOM 3.0 CStore, Print, and<br>Modality Worklist service class | DICOM 3.0 CStore, Print, and<br>Modality Worklist service class |
| | user features | user features. | user features. |

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| Feature | SonoSite Edge<br>Ultrasound System<br>(This Submission) | SonoSite Edge<br>Ultrasound System<br>(K113156) | SonoSite M-Turbo (Maxx<br>Series) Ultrasound<br>System<br>(K130173) | | | |
|-----------------------|---------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------|-----------------------|-----------------------|-----------------------|
| IMT | SonoCalc IMT provides the | SonoCalc IMT provides the | SonoCalc IMT provides the | | | |
| | capability for automated | capability for automated | capability for automated | | | |
| Measurement | measurement of intima-media | measurement of intima-media | measurement of intima-media | | | |
| | thickness (IMT) of the carotid | thickness (IMT) of the carotid | thickness (IMT) of the carotid | | | |
| | artery. IMT functionality is | artery. IMT functionality is | artery. IMT functionality is | | | |
| | available both on the ultrasound | available both on the ultrasound | available both on the ultrasound | | | |
| | system and in a stand alone | system and in a stand alone | system and in a stand alone | | | |
| | software program that runs on a | software program that runs on a | software program that runs on a | | | |
| | personal computer. | personal computer. | personal computer. | | | |
| | 128 digital channels | 128 digital channels | 128 digital channels | | | |
| #Transmit<br>Channels | | | | | | |
| #Receive | 128 digital channels (using SA) | 128 digital channels (using SA) | 128 digital channels (using SA) | | | |
| Channels | | | | | | |
| Patient | Transducers: | Transducers: | Transducers: | | | |
| Contact | Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene | | | |
| Materials | (ABS) | (ABS) | (ABS) | | | |
| | Cycoloy | Cycoloy | Cycoloy | | | |
| | Dow Medical Adhesive, Type A | Dow Medical Adhesive, Type A | Dow Medical Adhesive, Type A | | | |
| | Epoxy paste adhesive, | Epoxy paste adhesive. | Epoxy paste adhesive. | | | |
| | Polysulfone UDEL P1700 | Polysulfone UDEL P1700 | Polysulfone UDEL P1700 | | | |
| | Polyurethane | Polyurethane | Polyurethane | | | |
| | Poly-Vinyl-Chloride (PVC) | Poly-Vinyl-Chloride (PVC) | Poly-Vinyl-Chloride (PVC) | | | |
| | Silicone Rubber | Silicone Rubber | Silicone Rubber | | | |
| | Urethane | Urethane | Urethane | | | |
| | | | | | | |
| | Needle Guides: | Needle Guides: | Needle Guides: | | | |
| | Acetal copolymer | Acetal copolymer | Acetal copolymer | | | |
| | Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene | | | |
| | (ABS) | (ABS) | (ABS) | | | |
| | CAN/CSA C22.2 No. 601.1 | CAN/CSA C22.2 No. 601.1 | CAN/CSA C22.2 No. 601.1 | | | |
| Product Safety | EN 60601-1 | EN 60601-1 | EN 60601-1 | | | |
| Certification | EN 60601-1-1 | EN 60601-1-1 | EN 60601-1-1 | | | |
| | UL 60601-1 | UL 60601-1 | UL 60601-1 | | | |
| | JIS T 0601-1, JIS T 1507 | JIS T 0601-1, JIS T 1507 | JIS T 0601-1, JIS T 1507 | | | |
| | CEI/IEC 61157 | CEI/IEC 61157 | CEI/IEC 61157 | | | |
| | ANSI/AAMI EC53 | ANSI/AAMI EC53 | ANSI/AAMI EC53 | | | |
| EMC | EN 60601-1-2:2007 | EN 60601-1-2:2007 | EN 60601-1-2:2007 | | | |
| Compliance | CISPR 11 | CISPR 11 | CISPR 11 | | | |
| | IEC 61000-4 pt 2-5 | IEC 61000-4 pt 2-5 | IEC 61000-4 pt 2-5 | | | |
| | | |…