SONOSITE EDGE ULTRASOUND SYSTEM

• K Number: K133454
• Device Name: SONOSITE EDGE ULTRASOUND SYSTEM
• Manufacturer: FUJIFILM SONOSITE,INC.
• Date Cleared: 2013-12-16 ( 34 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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 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.

Predicate Devices

K113156, K130173

Reference Devices

K071134, K082098, K113680

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound image processing techniques and automated measurement features, but does not mention AI, ML, or related concepts.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" intended for "evaluation by ultrasound imaging or fluid flow analysis," indicating it is used for diagnosis rather than treatment.

Diagnostic

Yes
The Device Description explicitly states: "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."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable laptop style, full featured, general purpose, diagnostic ultrasound system" and a "custom fabricated digital electronic design," indicating it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the SonoSite Edge Ultrasound System is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use clearly states it's for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This involves imaging the internal structures of the body, which is the domain of diagnostic imaging devices, not IVDs.
• Device Description: The description focuses on acquiring and displaying real-time ultrasound data, a characteristic of imaging systems.
• Anatomical Sites: The listed anatomical sites are all internal or external parts of the human body that are imaged directly.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining features of IVD devices.

In summary, the SonoSite Edge Ultrasound System is a diagnostic imaging device that uses ultrasound technology to visualize the human body. It does not perform in vitro tests on biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes

90-IYN, 90-IYO, 90-ITX, LLZ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, 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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K113156, K130173

Reference Device(s)

K071134, K082098, K113680

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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K133454
Page 1 of 6

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
Ultrasound System
(This Submission) | SonoSite Edge
Ultrasound System
(K113156) | SonoSite M-Turbo (Maxx Series) Ultrasound
System
(K130173) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body |
| Indications for
Use | Opthalmic
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
Needle guidance | Opthalmic
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
Needle guidance | Opthalmic
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
Needle guidance |
| Transducer
Types | Linear Array
Curved Linear Array
Intracavitary
Phased Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array |
| Feature | SonoSite Edge
Ultrasound System
(This Submission) | SonoSite Edge
Ultrasound System
(K113156) | SonoSite M-Turbo (Maxx
Series) Ultrasound
System
(K130173) |
| | Static Probes | Static Probes | Static Probes |
| | Trans-esophageal | Trans-esophageal | Trans-esophageal |
| Transducer
Frequency | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Global | I spta 3: .709 (TEEX) | I spta 3: .709 (TEEX) | I spta 3: .709 (TEEx) |
| Maximum | TI Type: TIB(P21x)
TI Value: 3.7 (P21x) | TI Type: TIB(P21x)
TI Value: 3.7 (P21x) | TI Type: TIB(P21x)
TI Value: 3.9 (P21x) |
| Outputs/Worst | MI: 1.5 (P21x & L38xi) | MI: 1.5 (P21x & L38xi) | MI: 1.51 (P21x) |
| Case Setting | I pa 3@MI Max: 776 (L38xi) | I pa 3@MI Max: 776 (L38xi) | I pa 3@MI Max: 439.9 (L38x) |
| Acoustic | Display Feature for Higher | Display Feature for Higher | Display Feature for Higher |
| Output Display | Outputs
MI Output Display | Outputs
MI Output Display | Outputs
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
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
SonoHD2 Noise Reduction | Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction | Continuous Wave (CW) Doppler
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
transducers except D2x/2 MHz. | Available on all imaging
transducers except D2x/2 MHz. | Available on all imaging
transducers except D2x/2 MHz |
| | Adjustable sample volume size:
1.0 - 25 mm | Adjustable sample volume size:
1.0 – 25 mm | Adjustable sample volume size:
1.0 - 25 mm |
| | Simultaneous or duplex mode of
operation | Simultaneous or duplex mode of
operation | Simultaneous or duplex mode of
operation |
| | Simultaneous B-mode and PW
Doppler | Simultaneous B-mode and PW
Doppler | Simultaneous B-mode and PW
Doppler |
| | High PRF capability | High PRF capability | High PRF capability |
| CW Doppler | Available on C11x, D2x/2, P10x,
P21x, TEEx | Available on C11x, D2x/2, P10x,
P21x, TEEx | Available on C11x, D2x/2, P10x,
P17x, P21x, TEEx |
| | Simultaneous or duplex mode of
operation | Simultaneous or duplex mode of
operation | Simultaneous or duplex mode of
operation |
| | Simultaneous B-mode and CW
Doppler | Simultaneous B-mode and CW
Doppler | Simultaneous B-mode and CW
Doppler |
| Velocity Color | Available on all transducers
except D2x/2 | Available on all transducers
except D2x/2 | Available on all transducers
except D2x/2 |
| Doppler | | | |
| Elastography
(Strain), and | Available on all transducers
except D2x/2 | Available on all transducers
except D2x/2 | Available on all transducers
except D2x/2 |
| Strain Rate | | | |
| Imaging | | | |
| ECG Feature | One 3-lead ECG input, or
One external ECG input, or | One 3-lead ECG input, or
One external ECG input, or | One 3-lead ECG input, or
One external ECG input, or |
| | One other physio input | One other physio input | One other physio input |
| DICOM | DICOM 3.0 CStore, Print, and
Modality Worklist service class | DICOM 3.0 CStore, Print, and
Modality Worklist service class | DICOM 3.0 CStore, Print, and
Modality Worklist service class |
| | user features | user features. | user features. |

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3

| Feature | SonoSite Edge
Ultrasound System
(This Submission) | SonoSite Edge
Ultrasound System
(K113156) | SonoSite M-Turbo (Maxx
Series) Ultrasound
System
(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
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 | | | |
| | | | | | | |
| DICOM | NEMA PS3.15 2003 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | | | |
| | | | | | | |
| Airborne | RTCA/DO160D (section 21) | RTCA/DO160D (section 21) | RTCA/DO160D (section 21) | | | |
| Equipment | | | | | | |
| Standards | | | | | | |
| | | | | | | |
| System | Edge: | Edge: | M Series: | | | |
| Characteristics | Beamformer 128/128 using SA | Beamformer 128/128 using SA | Beamformer 128/128 using SA | | | |
| | (configurable) | (configurable) | (configurable) | | | |
| | Hand held display and control | Hand held display and control | Hand held display and control | | | |
| | Single 12.1" Liquid Crystal Display | Single 12.1" Liquid Crystal Display | Single 10.4" Liquid Crystal Display | | | |
| | (LCD)
256 gray shades on LCD | (LCD)
256 gray shades on LCD | (LCD)
256 gray shades on LCD | | | |
| | | | | | | |
| | Dimensions: 12.9"(W) x 12.4 (L) x | Dimensions: 12.9"(W) x 12.4 (L) x | Dimensions: 10.9"(W) x 11.8 (L) x | | | |
| | 2.5"(H) | 2.5"(H) | 3.0"(H) | | | |
| | | | | | | |
| | Weight: 8.5 lbs | Weight: 8.5 lbs | Weight: 8.3 lbs | | | |
| | Battery operated (1.5 - 4 hour | Battery operated (1.5 - 4 hour | Battery operated (1.5 - 4 hour | | | |
| | operation per charge) | operation per charge) | operation per charge) | operation per charge) | operation per charge) | operation per charge) |

4

	SonoSite Edge	SonoSite Edge	SonoSite M-Turbo (Maxx
	Ultrasound System	Ultrasound System	Series) Ultrasound
Feature	(This Submission)	(K113156)	System
			(K130173)
	100 - 240V options, 50/60 Hz,
15VDC output	100 - 240V options, 50/60 Hz,
15VDC output	100 - 240V options, 50/60 Hz
			Various obstetrical, cardiac,
	Various obstetrical, cardiac.
volume, M-mode, PW and CW	Various obstetrical, cardiac,
volume, M-mode, PW and CW	volume, M-mode, PW and CW
Doppier measurement and
	Doppler measurement and
calculation packages	Doppler measurement and
calculation packages	calculation packages
			ECG acquisition and display
	ECG acquisition and display
capabilities	ECG acquisition and display
capabilities	capabilities
CW/PW Doppler Audio
	CW/PW Doppler Audio	CWIPW Doppler Audio	Spectral Doppler Audio and image
	Spectral Doppler Audio and image	Spectral Doppler Audio and image	storage on removable media
	storage on removable media	storage on removable media	Measurement on Recalled
lmages.
	Wireless 802 11 (a\b\g) support for
image transfer	Wireless 802.11 (a\b\g) support for
image transfer	Wireless 802.11 {a\b\q} support for
image transfer and Bluetooth® 20.
for voice activated remote control.
			S Series:
			Beamformer 128/128 using SA
			(configurable)
Hand held display and control
			Single 10.4" Liquid Crystal Display
			(LCD)
256 gray shades on LCD
			Dimensions: 11.5"(W) x 14.8 (L) x
2.8"(H)
			Weight: 8.5 Ibs
			Battery operated (1.5 - 4 hour
operation per charge)
			100 - 240V options, 50/60 Hz
			Various obstetrical, cardiac.
			volume, and M-mode
measurement and calculation
			packages
			ECG acquisition and display
			capabilities
Image storage on removable
			media
			Measurement on recalled images
			Wireless 802.11 {a\b\g} support for
			image transfer and Bluetooth® 2.0
for voice activated remote control
510(k) Track	Track 3	Track 3	Track 3

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7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The SonoSite Edge Ultrasound System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to all applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. All patient contact materials are biocompatible. Reports for these elements of product development are referenced in Attachment 6.

Reference No.	Title
AAMI/ANSI/ISO 10993-1	ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and
testing within a risk management process
IEC 60601-1	AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37	IEC 60601-2-37:2007, Particular Requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment
ISO 14971	ISO 14971: 2007, Medical devices - Application of risk management to medical

The Edge Ultrasound System is designed to comply with the following voluntary standards.

NEMA UD 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD 3-2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine NEMA PS 3.15 NEMA Ps 3.15.2011, Digital Imaging and Communications in Medicine (DICOM), Part 15: Security and System Management Profiles

Summary of Clinical Tests:

devices

The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence.

Conclusion: 8)

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The Edge and predicate device both conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The Edge and predicate device both meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and are manufactured using the same ISO 13485 quality system. FUJIFILM SonoSite, Inc. believes that the Edge Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate device.

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is oriented to follow the curve of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 16, 2013

FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K133454

Trade/Device Name: Sonosite Edge® Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 11, 2013 Received: November 12, 2013

Dear Mr. Job:

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. 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Edge® Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C8x/8-5 MHz	C11x/8-5 MHz	D2x/2 MHz
C60x/5-2 MHz	HFL38x/13-6 MHz	HFL50x/15-6 MHz
ICTx/8-5 MHz	L25x/13-6 MHz	L38xi/10-5 MHz
L38x/10-5 MHz	P10x/8-4 MHz	P11x/10-5 MHz
P21x/5-1 MHz	SLAx/13-6 MHz	TEEX/8-3 MHz

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

7

Page 2-Mr. Job

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 (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address a

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You mav obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

8

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) TBD K133454

Device Name

SonoSite Edge Ultrasound System

Indications for Use (Describe)

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

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)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY *

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Page 8 of 30

9

Table 1.3-1 Diagnostic Ultrasound Indications for Use Form – FUJIFILM SonoSite Edge Ultrasound System

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical Application	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Fetal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Abdominal	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Pediatric
Small Organ (breast, thyroid,
testicles, prostate)	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Neonatal Cephalic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Adult Cephalic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Trans-rectal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Trans-vaginal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Trans-esophageal (card.)
Other (spec.)	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Peripheral vessel	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
System:		FUJIFILM SonoSite Edge Ultrasound System
Transducer:		C8x/8-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Trans-vaginal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

Additional Comments :-

All items marked "P" were previously cleared in 510(k) K113156.

ﺍﻟﻤﻮﺍﺻﻞ ﺍﻟﻤﺮﺍﺣﻞ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﺴﻮﺍﺭﻱ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﻤﺘﻮﺳﻂ. ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟ

10

Table 1.3-2 Diagnostic Ultrasound Indications for Use Form - C8x/8-5 Transducer

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

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoMBIMBe compund imaging itsue Dopler imaging (TD), inacing to guidance of biopsy and in the placement of needes and cathers in
vascular or other anatomical structures Color Dopler Mode includes color M-Mode.

All items marked "P" were previously cleared in 510(k) K071134 and K082098.

Prescription Use (Per 21 CFR 801.109)

Page 3 of 17

Page 10 of 30

11

Table 1.3-3 Diagnostic Ultrasound Indications for Use Form - C11x/8-5 Transducer

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	C11x/8-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD:
B+CWD; B+CD	Note 1
Intra-operative (Abdominal organs and
vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Laparoscopic
Pediatric	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)						B+M; B+PWD:
B+CD	Note 1
Neonatal Cephalic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Other (spec.)

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

Additional Comments:

Note 1 · Other includes color power Doppier, combined B and color power Doppler, issue harmonic imaging, SonoMBIMBe compound imaging, issue Doppler imaging (TDI), imaging guidance for penpheral herve block procedures, imaging to assist in the placement of needles and cather andomical stuctures. Color Doppler includes velocity color Dopler. Color
Dopler can be combined with any imaging mode. M-Mo

All items marked "P" were previously cleared in 510(k) K071134.

Prescription Use (Per 21 CFR 801.109)

Page 4 of 17

12

System:		FUJIFILM SonoSite Edge Ultrasound System
Transducer:		D2x/2 MHz Dual Element Circular Array
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult				P
Cardiac Pediatric				P
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-4 Diagnostic Ultrasound Indications for Use Form – D2x/2 Transducer

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

Additional Comments:

All items marked "P" were previously cleared in 510(k) K071134.

Prescription Use (Per 21 CFR 801.109)

Page 5 of 17

the first and the comments of the comments of the comments of the comments of the comments of the comments of the section of the section of the section of the section of the

13

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	C60x/5-2 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Other (spec.)

Table 1.3-5 Diagnostic Ultrasound Indications for Use Form – C60x/5-2 Transducer

Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Doppler, iissue harmonic imaging, SonoHD2 imaging, SonoMBIMBe room in may also potor inaging to block on por por and include maging, sondro condegrine commender
compund imaging (TD), maging bidane in period neve block groenent of spins anatomical structures. Color Doppler includes velocity color Doppler can be combined with any imaging mode. M-Made includes color M-Mode.

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All items marked "P" were previously cleared in 510(k) K071134.

14

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	HFL38x/13-6 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles, prostate)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Other (spec.)

Table 1.3-6 Diagnostic Ultrasound Indications for Use Form -- HFL38x/13-6 Transducer

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoMBAMBe compund imaging tissue Dopler imaging (TD), imaging guideral nerve block procedures, imaging of spinal cord to povide guidence in vascular or the anatomical structures. Calor Doppler includes velocity color Doppier can be combined with any imaging mode. M-Mote includes cator M-Mode.

All items marked "P" were previously cleared in 510(k) K071134.

---

Prescription Use (Per 21 CFR 801.109)

ﻤﺴﻴﻨﻴﻨﻴﺔ

15

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	HFL50x/15-6 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD:
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD:
B+CD	Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
						B+M; B+PWD;
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Other (spec.)

Table 1.3-7 Diagnostic Ultrasound Indications for Use Form - HFL50x/15-6 Transducer

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

ﻠﻴﻨﺖ ﺍﻟﻤﺴﺎ

Additional Comments:

Note 1: Other includes color power Doppler, combined B and cotor power Doptler, tissue harmonic imaging, SonoHD2 imaging, SonoMBIMBe compound imaging, tissue Doppler imaging gurdance for perioheral neve block procedures, imaging of spinal cord to provide guidance for central nerve block procedures, imaging to guidance of biopsy and imaging to assist in the placement of needler or other anatomical structures. Color Doppler includes velocity color Doppler can be combined with any maging mode. M-Mode includes color M-Mode.

and a wall and the most of the resear

ﺘﻌﺪﺩ ﺍﻟﻤﻌﻠﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

All items marked "P" were previously cleared in 510(k) K071134.

Prescription Use (Per 21 CFR 801.109)

and the same of the same of the same of the states of the same of the same of the

16

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	ICTx/8-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD:
B+CD	Note 1
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles. prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	B+M; B+PWD:
B+CD	Note 1
Trans-vaginal	P	P	P		P	B+M; B+PWD:
B+CD	Note 1
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-8 Diagnostic Ultrasound Indications for Use Form -- ICTx/8-5 Transducer

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

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, lissue harmonic imaging, SonoMBMBe compound imaging (TD). imaging (TDI). imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in offically in and copper magnig roy, magnig of gudance of bippy and minghis in the concerner of recors and cambres model.
vasular or the analomical stuctures. Coor Dopler in

All items marked "P" were previously cleared in 510(k) K071134.

Prescription Use (Per 21 CFR 801.109)

Page 9 of 17

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Page 16 of 30

17

Table 1.3-9 Diagnostic Ultrasound Indications for Use Form - L25x/13-6 Transducer

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	L25x/13-6 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P			P	B+M; B+CD	Note 1
Fetal
Abdominal	P	P			P	B+M; B+CD	Note 1
Intra-operative (Abdominal organs and
vascular)	P	P			P	B+M; B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P			P	B+M; B+CD	Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	Note 1
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	Note 1
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	Note 1
Other (spec.)

Additional Comments:

Not 1: Ohe includes colo contined and color power Doper, issue harmoni, maging, Sondh24.
compund inaging tissue Dopler imaging golderes incontent inaging in guidance di cingi Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.

All items marked "P" were previously cleared in 510(k) K071134 and K082098.

Prescription Use (Per 21 CFR 801,109)

ﻀﻤﻨﺸ

Page 10 of 17

---

Page 17 of 30

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ﺘﺤﻘﻪ

==============================================================================================================================================================================

18

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	L38xi/10-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-luminal
Other (spec:)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Other (spec.)

Table 1.3-10 Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 Transducer

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, iissue harmonic imaging, SonoHB/MB compound inaging, tissue Doppler imaging (TDI), imaging guidance for periores imaging of spinal cord to provide guidance for central nerve block procedures, imaging to gird inaging to assist in the placement of needles and cathers in vascular or other anatomical structures. Color Doppler includes velocity color Dopler can be combined with any imaging mode. M-Mode includes color M-Mode.

---

---

and and the state of the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the state of the

All items marked "P" were previously cleared in 510(k) K113156.

19

Table 1.3-11 Diagnostic Ultrasound Indications for Use Form - L38x/10-5
Transducer

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	L38x/10-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Other (spec.)

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoHD2 imaging, SonoMBIMBe compound imaging, tissue Doppler imaging (TD)), imaging guidance for perinteral neve block procedures, imaging of spinal cord to provide guidance lor central neve block proceded to bopsy and integing to assis in the placement on needes and cathers in rascular or che M-Mode.

and and the same and think and the compress of the final comments and instruments of the while while would

---

All items marked "P" were previously cleared in 510(k) K071134.

all differentle to the block the election in the block and the block and and comments of the seat of the

20

Table 1.3-12 Diagnostic Ultrasound Indications for Use Form - P10x/8-4 Transducer

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	P10x/8-4 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Abdominal	P	P	P	P	P	B+M; B+PWD; B+CWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Intra-operative (Neuro.)	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Neonatal Cephalic	P	P	P		P	B+M; B+PWD ,
B+CD	Note 1
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD:
B+CD	Note 1
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD;
B+CD	Note 1
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Other (spec.)

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

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoMB/MBe compound imaging, tissue Doppler imaging (TDI, imaging guidance for perioheral nerve block procedures, imaging for guidance of biopsy and imaging to assist in the placement of needler or vascular or other anatomical structures. Color Doppler includes velocity color and maging to assist in the placement of neceise in vasular of the mindinical shortined shortheres. Ook Door and mich

All items marked "P" were previously cleared in 510(k) K071134.

Prescription Use (Per 21 CFR 801.109)

Page 13 of 17

21

Table 1.3-13 Diagnostic Ultrasound Indications for Use Form - P11x/10-5 Transducer

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	P11x/10-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal organs
and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	Note 1
Small Organ (breast, thyroid,
testicles. prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	Note 1
Other (spec.)

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

Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Dopler, M-Mode, SonoHD2 imaging, SonoMBMBe compound imaging, wou'r. Online middles color popler, comained in model popier and inaging to assist in the placement of needes and catheters in vascular or other anatomical structures. Color Dopler can be combined with any imaging mode. Can be used with disposable kit cleared with K113680.

All items marked "P" were previously cleared in 510(k) K130173.

22

Table 1.3-14 Diagnostic Ultrasound Indications for Use Form – P21x/5-1 Transducer

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	P21x/5-1 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Fetal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Abdominal	P	P	P	P	P	B+M; B+PWD; B+CWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Neonatal Cephalic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD;
B+CD	Note 1
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD;
B+CD	Note 1
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Other (spec.)

Additional Comments:

Note 1; Other includes color power Doppier, combined B and color power Doppler, tissue harmonic imaging, SonoMBIMBe compound imaging tissue Doppler imaging (TDI), color TDI, imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Color Dopter includes velocity color Doppler can be combined with any imaging mode M-Mode includes color M-Mode .___________________________________________________________________________________________________________________________________________ ﻟﺘﻘﺪﻳﻤﺔ ﺍﻟﻤﺴﺎ 174 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 ------------

All items marked "P" were previously cleared in 510(k) K071134.

23

Table 1.3-15 Diagnostic Ultrasound Indications for Use Form - SLAx/13-6 Transducer

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	SLAx/13-6 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD:
B+CD	Note 1
Intra-operative (Neuro.)	P	P	P		P	B+M; B+PWD:
B+CD	Note 1
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD:
B+CD	Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Other (spec.)

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoHD2 imaging, SonoMBMBe Noter in the minder collection on over por respect note hights in only of in an anyag condines
compuni maging listic magins con contribus no sections . incoln on guidance .

11 - 15 - 12 - 12 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -

All items marked "P" were previously cleared in 510(k) K071134 and K082098. 『

24

Table 1.3-16 Diagnostic Ultrasound Indications for Use Form – TEEx/8-3 Transducer

System:	FUJIFILM SonoSite Edge Ultrasound System
Transducer:	TEEx/8-3 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of
the human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles. prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)	P	P	P	P	P	B+M; B+PWD; B+CWD;
B+CD	Note 1
Other (spec.)
Peripheral vessel
Other (spec.)

to any the this with a string world resident in all street and state and

Additional Comments:

Note 1: Qther includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoMBIMBe compound imaging, tissue Doppler imaging (TDI, color TDI, imaging to guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other analorical structures. Color Doppler. Color Dopler. Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.

13 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -

---

All items marked "P" were previously cleared in 510(k) K071134.

Prescription Use (Per 21 CFR 801.109)

And The Bank States

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