FUJIFILM SonoSite X-Porte Ultrasound System

• K Number: K152209
• Device Name: FUJIFILM SonoSite X-Porte Ultrasound System
• Manufacturer: FUJIFILM SONOSITE,INC.
• Date Cleared: 2015-08-19 ( 12 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals 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) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel

Device Description

The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purpostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.

Predicate Devices

K142017, K133454

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and features.

Therapeutic

No
This device is an ultrasound system intended for diagnostic imaging and fluid flow analysis, not for therapeutic intervention.

Diagnostic

Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is "intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body." Evaluation is a form of diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "custom fabricated digital electronic design" and a "full featured, general purpostic ultrasound system" that includes hardware components like a stand, battery, and the ability to connect transducers. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states that the system is for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This involves imaging the internal structures and functions of a living person.
• Device Description: The description details a system that acquires and displays real-time ultrasound data from within the body.
• Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The X-Porte does not perform this function.

The X-Porte is a medical imaging device used for diagnostic purposes in vivo (within the living body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals 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) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purpostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Abdominal organs and vascular (intra-operative), Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, 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 physicians and healthcare professionals

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 X-Porte Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142017, K133454

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

August 19, 2015

Fujifilm Sonosite, Inc. % Mark Job Responsible Third Party Official 1394 25th Street, NW BUFFALO MN 55313

Re: K152209

Trade/Device Name: FUJIFILM Sonosite X-porte Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 21, 2015 Received: August 7, 2015

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara For

Robert Ochs Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) TBD

Device Name

FUJIFILM SonoSite X-Porte Ultrasound System

Indications for Use (Describe)

The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals 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) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) 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)

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Table 1.3-1: Diagnostic Ultrasound Indications for Use Form – FUJIFILM SonoSite X-Porte Ultrasound System

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	N/A
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+CD	1-5
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Abdominal	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	1-5
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1-5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CWD; B+CD	1-5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	P		P	B+M; B+PWD; B+CD	1-5
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Trans-rectal
Trans-vaginal	P	P	P		P	B+M; B+PWD; B+CD	1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1-5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	1-5
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	1-5
Trans-esophageal (card.)	N	N	N	N	N	B+M; B+PWD;
B+CWD; B+CD	1,3,5
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1-5
Other (spec.)

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

• 2: Tissue Harmonic Imaging (THI)
• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)
• 5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017 and K133134.

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System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	C11xp/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+CD	1,5
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,5
Small Organ (breast, thyroid,
testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,5
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1,5
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	B+M; B+PWD; B+CD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,5
Other (spec.)

Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – C11xp/8-5 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

2: Tissue Harmonic Imaging (THI)

• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017.

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System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	C35xp/8-3 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical Application	Mode of Operation							Other
(Spec.)
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
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	1,2,4,5
Musculo-skel. (Superfic.)
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	1,2,4,5
Other (spec.)

Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – C35xp/8-3 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

2: Tissue Harmonic Imaging (THI)

• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017.

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System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	C60xp/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	P	P	P		P	B+M; B+PWD; B+CD	1,2,5
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
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	1,2,4,5
Musculo-skel. (Superfic.)
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	1,2,4,5
Other (spec.)

Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C60xp/5-2 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

• 2: Tissue Harmonic Imaging (THI)
• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)
• 5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K133134.

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Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – HFL38xp/13-6 Transducer

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	HFL38xp/13-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
	body as follows:
Clinical Application	Mode of Operation
		Color
Combined
Other
	B	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
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	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	E	E	E		E	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	E	E	E		E	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017.

Prescription Use (Per 21 CFR 801.109)

Page 6 of 14

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Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – HFL50xp/15-6 Transducer

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	HFL50xp/15-6 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	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
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	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
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	1,4,5
Other (spec.)

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K133134.

Prescription Use (Per 21 CFR 801.109)

Page 7 of 14

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Table 1.3-7: Diagnostic Ultrasound Indications for Use Form – HSL25xp/13-6 Transducer

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	HSL25xp/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		P	B+M; B+PWD; B+CD	1,4,5
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
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	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017.

Prescription Use (Per 21 CFR 801.109)

Page 8 of 14

10

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	ICTxp/9-5 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	P	P	P		P	B+M; B+PWD; B+CD	1,5
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	P	P	P		P	B+M; B+PWD; B+CD	1,5
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 – ICTxp/9-5Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

• 2: Tissue Harmonic Imaging (THI)
• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)
• 5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K133134.

Prescription Use (Per 21 CFR 801.109)

Page 9 of 14

11

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	L25xp/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		P	B+M; B+PWD; B+CD	1,4,5
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
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	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

Table 1.3-9: Diagnostic Ultrasound Indications for Use Form – L25xp/13-6 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

• 2: Tissue Harmonic Imaging (THI)
• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)
• 5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017 and K133134.

Prescription Use (Per 21 CFR 801.109)

Page 10 of 14

12

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	L38xp/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	1,4,5
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
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	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

Table 1.3-10: Diagnostic Ultrasound Indications for Use Form – L38xp/10-5 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

2: Tissue Harmonic Imaging (THI)

• 3: Tissue Doppler Imaging (TDI)
  4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017 and K133134.

Prescription Use (Per 21 CFR 801.109)

Page 11 of 14

13

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	P10xp/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	1,5
Abdominal	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1,5
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,5
Small Organ (breast, thyroid,
testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,5
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1,5
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	1,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1,3,5
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1,3,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,5
Other (spec.)

Table 1.3-11: Diagnostic Ultrasound Indications for Use Form – P10xp/8-4 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

2: Tissue Harmonic Imaging (THI)

• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)
• 5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017.

14

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	P21xp/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
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Abdominal	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1-3,5
Intra-operative (Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD	1-3,5
Small Organ (breast, thyroid,	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
testicles, prostate)
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1-3,5
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1-3,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Other (spec.)

Table 1.3-12: Diagnostic Ultrasound Indications for Use Form – P21xp/5-1 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

• 2: Tissue Harmonic Imaging (THI)
• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)
• 5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K142017 and K133134.

15

System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	TEExp/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.)	N	N	N	N	N	B+M; B+PWD; B+CWD; B+CD	1,3,5
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-13: Diagnostic Ultrasound Indications for Use Form – TEExp/8-3 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous M-Mode.

• 2: Tissue Harmonic Imaging (THI)
• 3: Tissue Doppler Imaging (TDI)
• 4: Steep Needle Profiling (Sono MBe)
• 5: Multi-beam Imaging (SonoMB) in B-Mode

Prescription Use (Per 21 CFR 801.109)

Page 14 of 14

16

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 30th Drive SE Bothell, WA 98021-3904

Corresponding Official:	Patricia Liau
	Supervisor, Regulatory Affairs
E-mail:	[e-mail]
Telephone:	[phone]
Facsimile:	[phone]
Date prepared:	July 20, 2015

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 X-Porte™ 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

3) Identification of the predicate or leqally marketed device:

SonoSite X-Porte Ultrasound System K142017 SonoSite Edge Ultrasound System K133454

4) Device Description:

The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purpostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.

17

5) Intended Use:

The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals 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) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel

6) Technological Characteristics:

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

| Feature | SonoSite X-Porte
Ultrasound System
(This submission) | SonoSite X-Porte
Ultrasound System
(K142017) | SonoSite Edge
Ultrasound System
(K133454) |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Intraoperative (abdominal organs
and vascular)
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel
Needle guidance | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs
and vascular)
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel
Needle guidance | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (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
Static Probes
Trans-esophageal |
| Transducer | Trans-esophageal
1.0 - 15.0 MHz | 1.0 — 15.0 MHz | 1.0 — 15.0 MHz |
| Feature | SonoSite X-Porte
Ultrasound System
(This submission) | SonoSite X-Porte
Ultrasound System
(K142017) | SonoSite Edge
Ultrasound System
(K133454) |
| Frequency
Acoustic
Output Display
& FDA Limits | ISTPA.3 ≤ 720 (mW/cm²)
TI ≤ 4.0
MI ≤1.9
Display Feature for Higher
Outputs
MI Output Display
TI Output Display | ISTPA.3 ≤ 720 (mW/cm²)
TI ≤ 4.0
MI ≤1.9
Display Feature for Higher
Outputs
MI Output Display
TI Output Display | ISTPA.3 ≤ 720 (mW/cm²)
TI ≤ 4.0
MI ≤1.9
Display Feature for Higher
Outputs
MI Output Display
TI Output Display |
| Modes of
Operation | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Simultaneous M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Simultaneous M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) |
| PW Doppler | Available | Available | Available |
| CW Doppler | Available | Available | Available |
| Velocity Color
Doppler | Available | Available | Available |
| Elastography
(Strain), and
Strain Rate
Imaging | Not available | Not available | Available |
| ECG Feature | 3-lead ECG input | 3-lead ECG input | 3-lead ECG input |
| DICOM | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| IMT
Measurement | Not available | Not available | Available |
| #Transmit
Channels | 128 digital channels | 128 digital channels | 128 digital channels |
| #Receive
Channels | 64 digital channels
(128 digital channels using
Synthetic Aperture) | 64 digital channels
(128 digital channels using
Synthetic Aperture) | 64 digital channels
(128 digital channels using
Synthetic Aperture) |
| Patient
Contact
Materials | Transducers:
Acrylonitrile-butadien-styrene
(ABS)
Cycoloy
Dow Medical Adhesive, Type A
Epoxy paste adhesive
Polyethylene (PE) Ionomer
Polyetheretherketone (PEEK)
Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) | Transducers:
Acrylonitrile-butadien-styrene
(ABS)
Cycoloy
Dow Medical Adhesive, Type A
Epoxy paste adhesive
Polyethylene (PE) Ionomer
Polyetheretherketone (PEEK)
Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) | Transducers:
Acrylonitrile-butadien-styrene
(ABS)
Cycoloy
Dow Medical Adhesive, Type A
Epoxy paste adhesive
Polyethylene (PE) Ionomer
Polyetheretherketone (PEEK)
Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) |
| System | X-Porte (stand configuration):
Beamformer 128/128 using SA | X-Porte (stand configuration):
Beamformer 128/128 using SA | Edge:
Beamformer 128/128 using SA |
| Feature | SonoSite X-Porte
Ultrasound System
(This submission) | SonoSite X-Porte
Ultrasound System
(K142017) | SonoSite Edge
Ultrasound System |
| | | | (K133454) |
| Characteristics | (configurable)
12.1" Capacitive touch screen
interface
19" LED LCD HD monitor
256 gray shades on LED LCD | (configurable)
12.1" Capacitive touch screen
interface
19" LED LCD HD monitor
256 gray shades on LED LCD | (configurable)
Hand held display and control
Single 12.1" Liquid Crystal Display
(LCD)
256 gray shades on LCD |
| | 6 USB 2.0 ports | 6 USB 2.0 ports | 2 USB ports |
| | Stand Base Dimensions: 26.4" L x
21.2" W
Stand Height (max): 64" (monitor
up)
Stand Height (min): 42.2" (monitor
down) | Stand Base Dimensions: 26.4" L x
21.2" W
Stand Height (max): 64" (monitor
up)
Stand Height (min): 42.2" (monitor
down) | Dimensions: 12.9"(W) x 12.4 (L) x
2.5"(H) |
| | Weight: 149.35 lbs (fully
configured w/ 3 transducers | Weight: 149.35 lbs (fully
configured w/ 3 transducers | Weight: 8.5 lbs
Battery operated (1.5 - 4 hour
operation per charge) |
| | System operates via battery or AC
power | System operates via battery or AC
power | System operates via battery or AC
power |
| | Battery life: 1 hour operational - 3
days idle | Battery life: 1 hour operational - 3
days idle | 100 - 240V options, 50/60 Hz,
15VDC output |
| | Input: 100 – 240 VAC, 50/60 Hz
Output 1: 24VDC output, 275 W
max
Output 2: 100-240VAC, 50-60 Hz
(AC Printer) | Input: 100 – 240 VAC, 50/60 Hz
Output 1: 24VDC output, 275 W
max
Output 2: 100-240VAC, 50-60 Hz
(AC Printer) | Various obstetrical, cardiac,
volume, M-mode, PW and CW
Doppler measurement and
calculation packages |
| | Various obstetrical, cardiac,
volume, M-mode, PW and CW
Doppler measurement and
calculation packages | Various obstetrical, cardiac,
volume, M-mode, PW and CW
Doppler measurement and
calculation packages | ECG acquisition and display
capabilities
CW/PW Doppler Audio |
| | ECG acquisition and display
capabilities
CW/PW Doppler Audio | ECG acquisition and display
capabilities
CW/PW Doppler Audio | Spectral Doppler Audio and image
storage on removable media |
| | Spectral Doppler Audio and image
storage on removable media
Measurement on Recalled
Images. | Spectral Doppler Audio and image
storage on removable media
Measurement on Recalled
Images. | Wireless 802.11 (a/b/g) support for
image transfer |
| | Wireless 802.11 (a/b/g/n) support
for image transfer | Wireless 802.11 (a/b/g/n) support
for image transfer | |
| | X-Porte (desktop configuration): | X-Porte (desktop configuration): | |
| | Same software
features/capabilities as the stand
configuration. Does not have the
stand, touch panel interface, DVR,
and mobile power unit. | Same software
features/capabilities as the stand
configuration. Does not have the
stand, touch panel interface, DVR,
and mobile power unit. | |
| | Weight: 32.80 lbs (w/ 1
transducer) | Weight: 32.80 lbs (w/ 1
transducer) | |
| 510(k) Track | AC power only.
100 - 240V options, 50/60 Hz
Track 3 | AC power only.
100 - 240V options, 50/60 Hz
Track 3 | Track 3 |
| | | | |

18

19

20

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The X-Porte 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 applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirement, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical 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/(R)2013, 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	AAMI / ANSI / IEC 60601-1-2:2007(R)2012, 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
IEC 62359	IEC 62359:2010, Ultrasonics - Field Characterization - Test Methods For The
Determination Of Thermal And Mechanical Indices Related To Medical Diagnostic
Ultrasonic Fields [Including: Technical Corrigendum 1 (2011)] (Edition 2)
ISO 14971	ISO 14971: 2007, Medical devices - Application of risk management to medical
devices
NEMA UD 2-2004	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
NEMA PS 3.15	NEMA Ps 3.15:2011, Digital Imaging and Communications in Medicine (DICOM),
Part 15: Security and System Management Profiles

The X-Porte Ultrasound System is designed to comply with the following voluntary standards.

Summary of Clinical Tests:

The SonoSite X-Porte Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

8) Conclusion:

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The X-Porte device and predicates conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The X-Porte device and predicates 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 X-Porte Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices.