(27 days)
Not Found
No
The document describes standard ultrasound imaging features and processing techniques (noise reduction, image compounding) but does not mention AI, ML, or related concepts.
No
The device is described as a "general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of blood flow analysis of the human body." It acquires and displays real-time ultrasound data, indicating its use for diagnostic imaging rather than therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of blood flow analysis of the human body." Evaluation and analysis of the human body using imaging are fundamental aspects of diagnostic procedures. The specific clinical applications listed further confirm its diagnostic purpose across various anatomical sites.
No
The device description explicitly states it is a "custom fabricated digital electronic design" and mentions hardware verification, indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "evaluation by ultrasound imaging of thid flow analysis of the human body." This involves imaging the internal structures and processes of the body directly, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on acquiring and displaying real-time ultrasound data, which is an imaging modality used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This ultrasound system operates by sending sound waves into the body and interpreting the reflected echoes to create images, which is a different principle entirely.
N/A
Intended Use / Indications for Use
The 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 of thid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal – OB/GYN Abdominal 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 readily 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal – OB/GYN, Abdominal, 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, vascular or other anatomical structures.
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 reguire 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.
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
§ 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2017
FUJIFILM SonoSite, Inc. % Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K171437
Trade/Device Name: 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: May 12, 2017 Received: May 16, 2017
Dear Mr. Mark 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
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171437
Device Name SonoSite X-Porte Ultrasound System
Indications for Use (Describe)
The 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 of thid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal – OB/GYN Abdominal 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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3
Table 1.3-1: Diagnostic Ultrasound Indications for Use Form – SonoSite X-Porte Ultrasound System
| System: | 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 | |||||||
| (C) | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1-5 | ||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,2,5 | ||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD; | |
| B+C; (B+C)+PWD; | |||||||
| (B+C)+CWD | 1,2,5 | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+CWD; | ||
| B+C; (B+C)+PWD; | |||||||
| (B+C)+CWD | 1-5 | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,5 | ||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,5 | ||||||
| Trans-rectal | |||||||
| Trans-vaginal | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,5 | ||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,2,4,5 | ||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; | |
| B+C; (B+C)+PWD; | |||||||
| (B+C)+CWD | 1-3 | ||||||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; | |
| B+C; (B+C)+PWD; | |||||||
| (B+C)+CWD | 1-3 | ||||||
| Trans-esophageal (card.) | P | P | P | P | P | B+M; B+PWD; B+CWD; | |
| B+C; (B+C)+PWD; | |||||||
| (B+C)+CWD | 1,3 | ||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+C; | ||
| B+C; (B+C)+PWD | 1,2,4-6 | ||||||
| Other (spec.) |
Additional Comments:
1: Includes imaging to assist in the placement of needles and cather 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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K152209, K142017, K133134. Prescription Use (Per 21 CFR 801.109)
4
| System: | 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 | |||||||||
| (C) | Combined | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | 1,5 | ||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | 1,5 | ||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | P | P | P | P | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | 1,5 | ||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid, | |||||||||
| testicles. prostate) | P | P | P | P | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | 1,5 | ||||||||
| 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 | P | P | P | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | 1,5 | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | 1,5 | ||||||||
| Other (spec.) |
Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – C11xp/8-5 MHz Transducer
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K142017.
5
| System: | 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 | B | M | PWD | CWD | Color | ||
| Doppler | |||||||
| (C) | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,2,5 | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 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+C; | ||
| (B+C)+PWD | 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+C; | ||
| (B+C)+PWD | 1,2,4,5 | ||||||
| Other (spec.) |
Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – C35xp/8-3 MHz Transducer
Additional Comments:
1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging quidance 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
- 6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K142017.
6
| System: | 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 | |||||||
| (C) | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | P | P | P | P | P | B+M; B+PWD; B+C; | |
| (B+C)+PWD | 1,2,5 | ||||||
| Fetal | P | P | P | P | P | B+M; B+PWD; B+C; | |
| (B+C)+PWD | 1,2,5 | ||||||
| Abdominal | |||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | P | P | P | P | P | B+M; B+PWD; B+C; | |
| (B+C)+PWD | 1,2,4,5 | ||||||
| Pediatric | |||||||
| 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 | P | B+M; B+PWD; B+C; | |
| (B+C)+PWD | 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 | P | B+M; B+PWD; B+C; | |
| (B+C)+PWD | 1,2,4,5 | ||||||
| Other (spec.) |
Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C60xp/5-2 MHz Transducer
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K133134.
7
| System: | SonoSite X-Porte Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | D2xp/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 | |||||||
| (C) | 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 | E | E | |||||
| Cardiac Pediatric | E | E | |||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – D2xp/2 MHz Transducer
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
- 6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "E" were released via Letter to File/Non-filing Justification documentation since K152209.
8
| System: | 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 | ||||||
| B | M | PWD | Color | ||||
| Doppler | |||||||
| (C) | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Abdominal | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles. prostate) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,5 | ||||||
| Cardiac Pediatric | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,5 | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+C; | ||
| B+PW; (B+C)+PWD | 1,4,5,6 | ||||||
| Other (spec.) |
Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – HFL38xp/13-6 MHz Transducer
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K152209 and K142017.
9
Table 1.3-7: Diaqnostic Ultrasound Indications for Use Form – HFL50xp/15-6 MHz Transducer
| System: | 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 | |||||||
| (C) | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Abdominal | |||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles. prostate) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | 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+C; | ||
| (B+C)+PWD | 1,4,5 | ||||||
| Other (spec.) |
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K133134.
10
| Table 1.3-8: Diagnostic Ultrasound Indications for Use Form - HSL25xp/13-6 MHz Transducer | |
|---|---|
| ------------------------------------------------------------------------------------------- | -- |
| System: | 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 | ||||||||
| (C) | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicles. prostate) | P | P | P | P | B+M; B+PWD; B+C | 1,4,5 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; B+C | 1,4,5 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Cardiac Pediatric | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5,6 | |||||||
| Other (spec.) |
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K142017.
11
| System: | 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 | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Doppler | ||||||||
| (C) | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 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 | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Trans-vaginal | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 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 1.3-9: Diagnostic Ultrasound Indications for Use Form – ICTxp/9-5 MHz Transducer
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K133134.
12
| System: | 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 | |||||||
| Color | ||||||||
| Doppler | Combined | Other | ||||||
| B | M | PWD | CWD | (C) | (Spec.) | (Spec.) | ||
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicles, prostate) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 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+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Cardiac Pediatric | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5,6 | |||||||
| Other (spec.) |
Table 1.3-10: Diagnostic Ultrasound Indications for Use Form - L25xp/13-6 MHz Transducer
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K142017 and K133134.
13
| Table 1.3-11: Diaqnostic Ultrasound Indications for Use Form – L38xp/10-5 MHz Transducer | |
|---|---|
| ------------------------------------------------------------------------------------------ | -- |
| System: | 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 | ||||||||
| (C) | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal | P | P | P | |||||
| Abdominal | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicles. prostate) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Cardiac Pediatric | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,5 | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1,4,5,6 | |||||||
| Other (spec.) |
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K142017 and K133134.
14
| Table 1.3-12: Diagnostic Ultrasound Indications for Use Form - P10xp/8-4 MHz Transducer | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ----------------------------------------------------------------------------------------- |
| System: | 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 | ||||||||
| (C) | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+CWD; | |||
| B+C; (B+C)+PWD | 1 | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD; B+CWD; | |||
| B+C; (B+C)+PWD | 1 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicles. prostate) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; | ||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1,3 | |||||||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; | ||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1,3 | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Peripheral vessel | ||||||||
| Other (spec.) | ||||||||
| System: | SonoSite X-Porte Ultrasound System | |||||||
| Transducer: | rP19xp/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 | ||||||||
| (C) | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | E | E | E | E | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-2 | |||||||
| Fetal | E | E | E | E | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Abdominal | E | E | E | E | B+M; B+PWD; B+CWD; | |||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1-2 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicles, prostate) | E | E | E | E | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Neonatal Cephalic | E | E | E | E | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Adult Cephalic | E | E | E | E | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | E | E | E | E | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-2 | |||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | E | E | E | E | E | B+M; B+PWD; B+CWD; | ||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1-3 | |||||||
| Cardiac Pediatric | E | E | E | E | E | B+M; B+PWD; B+CWD; | ||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1-3 | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | E | E | E | E | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-2 | |||||||
| Peripheral vessel | ||||||||
| Other (spec.) | ||||||||
| System: | 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 | ||||||||
| (C) | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1 | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD; B+CWD; | |||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1-3 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+C | 1-3 | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicles, prostate) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | P | P | P | P | P | B+M; B+PWD; B+CWD; | ||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1-3 | |||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; | ||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1-3 | |||||||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; | ||
| B+C; (B+C)+PWD; | ||||||||
| (B+C)+CWD | 1-3 | |||||||
| Trans-esophageal (card.) | (B+C)+CWD | |||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | 1-3 | |||||||
| Other (spec.) | ||||||||
| System: | 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 | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Doppler | ||||||||
| (C) | 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 | ||||||||
| P | P | P | P | P | B+M; B+PWD; B+CWD; | |||
| B+C; | 1,3 | |||||||
| Trans-esophageal (card.) | (B+C)+PWD; (B+C)+CWD | |||||||
| Other (spec.) | ||||||||
| Peripheral vessel | ||||||||
| Other (spec.) |
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
6: B+PWD and (B+C)+PWD includes Simultaneous PW
All items marked "P" were previously cleared in 510(k) K142017.
15
Table 1.3-13 – Diagnostic Ultrasound Indications for Use Form – rP19xp/5-1 MHz Transducer
Additional Comments:
1: Includes imaging to assist in the placement of needler 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
6: B+PWD and (B+C)+PWD includes Update and Simultaneous PW
All items marked "E" were released via Letter to File/Non-filing Justification documentation since K152209. Prescription Use (Per 21 CFR 801.109)
16
Table 1.3-14: Diagnostic Ultrasound Indications for Use Form – P21xp/5-1 MHz Transducer
Additional Comments:
1: Includes imaging to assist in the placement of needles and catheters in vascular or other 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
- 6: B+PWD and (B+C)+PWD includes Update and Simultaneous PW
All items marked "P" were previously cleared in 510(k) K142017 and K133134. Prescription Use (Per 21 CFR 801.109)
17
Table 1.3-15: Diagnostic Ultrasound Indications for Use Form – TEExp/8-3 MHz Transducer
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
6: B+PWD and (B+C)+PWD includes Update and Simultaneous PW
All items marked "P" were previously cleared in 510(k) K152209.
18
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: | Jordan Lydia Grimmer
Sr. Regulatory Affairs Specialist |
|-------------------------|-----------------------------------------------------------|
| E-mail: | jordan.grimmer@fujilfim.com |
| Telephone: | (425) 951-6984 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | April 19, 2017 |
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
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 legally marketed device:
| SonoSite X-Porte Ultrasound System | K152209 |
|---|---|
| SonoSite Edge Ultrasound System | K133454 |
| SonoSite Edge II Ultrasound System | K162045 |
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 readily 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.
19
5) Intended Use:
The 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 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, Edge, and Edge II 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
(K152209) | SonoSite Edge
Ultrasound System
(K133454) | SonoSite Edge II
Ultrasound System
(K162045) |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body |
| Indications for
Use | Ophthalmic
Fetal - OB/GYN
Abdominal | Ophthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal
organs and vascular) | Ophthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal
organs and vascular)
Intra-operative (Neuro.) | Ophthalmic
Fetal - OB/GYN
Abdominal |
| | Pediatric
Small Organ (breast,
thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic | Pediatric
Small Organ (breast,
thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic | Pediatric
Small Organ (breast,
thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Rectal | 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 | Trans-Vaginal
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal
(cardiac)
Peripheral Vessel | Trans-Vaginal
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal
(cardiac)
Peripheral Vessel | Trans-Vaginal
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal
(cardiac)
Peripheral Vessel |
| Feature | SonoSite X-Porte
Ultrasound System
(This submission) | SonoSite X-Porte
Ultrasound System
(K152209) | SonoSite Edge
Ultrasound System
(K133454) | SonoSite Edge II
Ultrasound System
(K162045) |
| | Needle
guidance | Needle
guidance | Needle
guidance | Needle
guidance |
| Transducer
Types | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Static Probes
Trans-esophageal | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Trans-esophageal | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Static Probes
Trans-esophageal | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Trans-esophageal |
| Transducer
Frequency | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Global
Maximum
Outputs/Worst
Case Setting | $I_{spta.3}$ : 629.3 (P21xp)
TI Type: TIB (P21xp)
TI Value: 4.0 (P21xp)
MI: 1.7 (P21xp)
$I_{pa.3}$ @MI Max: 678 (L38xp) | $I_{spta.3}$ : 629.3 (P21xp)
TI Type: TIB (P21xp)
TI Value: 4.0 (P21xp)
MI: 1.7 (P21xp)
$I_{pa.3}$ @MI Max: 678 (L38xp) | $I_{spta.3}$ : 709 (TEEx)
TI Type: TIB (P21x)
TI Value: 3.7 (P21x)
MI: 1.51 (P21x)
$I_{pa.3}$ @MI Max: 776 (L38xi) | $I_{spta.3}$ : 598.9 (HFL50x)
TI Type: TIB (rP19x)
TI Value: 4.98 (rP19x)
MI: 1.7 (rP19x)
$I_{pa.3}$ @MI Max: 776 (L38xi) |
| Acoustic
Output Display
& FDA Limits | Display Feature for Higher
Outputs
MI Output Display
TI Output Display | Display Feature for Higher
Outputs
MI Output Display
TI Output Display | Display Feature for Higher
Outputs
MI Output Display
TI Output Display | Display Feature for Higher
Outputs
MI Output Display
TI Output Display |
| Feature | SonoSite X-Porte
Ultrasound System
(This submission) | SonoSite X-Porte
Ultrasound System
(K152209) | SonoSite Edge
Ultrasound System
(K133454) | SonoSite Edge II
Ultrasound System
(K162045) |
| Modes of
Operation | B-mode Grayscale
Imaging
Tissue Harmonic Imaging
M-mode
Simultaneous M-Mode
Color Power Doppler
Zoom
Combination Modes
Simultaneous PW Imaging
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) | 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 on all imaging
transducers except D2xp.
Adjustable sample volume
size: 1.0 – 25 mm
Simultaneous or duplex
mode of operation
Simultaneous B-mode and
PW Doppler
High PRF capability | Available on all imaging
transducers.
Adjustable sample volume
size: 1.0 – 25 mm
Simultaneous or duplex
mode of operation
Simultaneous B-mode and
PW Doppler
High PRF capability | Available on all imaging
transducers except D2x/2
MHz.
Adjustable sample volume
size: 1.0 – 25 mm
Simultaneous or duplex
mode of operation
Simultaneous B-mode and
PW Doppler
High PRF capability | Available on all imaging
transducers except P11x.
Adjustable sample volume
size: 1.0 – 25 mm
Simultaneous or duplex
mode of operation
Simultaneous B-mode and
PW Doppler
High PRF capability |
| CW Doppler | Available on D2xp, P10xp,
rP19xp, P21xp, TEExp
Simultaneous or duplex
mode of operation
Simultaneous B-mode and
CW Doppler | Available on P10xp,
P21xp, TEExp
Simultaneous or duplex
mode of operation
Simultaneous B-mode and
CW Doppler | Available on C11x, D2x,
P10x, P21x, TEEx
Simultaneous or duplex
mode of operation
Simultaneous B-mode and
CW Doppler | Available on P10x, rP19x,
TEExi
Simultaneous or duplex
mode of operation
Simultaneous B-mode and
CW Doppler |
| Velocity Color
Doppler | Available on all
transducers except D2xp. | Available on all
transducers | Available on all
transducers except D2x | Available on all
transducers |
| Elastography
(Strain), and
Strain Rate
Imaging | Not available | Not available | Available on all
transducers except D2x | Not available |
| Feature | SonoSite X-Porte
Ultrasound System
(This submission) | SonoSite X-Porte
Ultrasound System
(K152209) | SonoSite Edge
Ultrasound System
(K133454) | SonoSite Edge II
Ultrasound System
(K162045) |
| ECG Feature | One 3-lead ECG input, or
One external ECG input,
or
ECG Slave Cable
One other physio input | One 3-lead ECG input, or
One external ECG input,
or
One other physio input | One 3-lead ECG input, or
One external ECG input,
or
One other physio input | 3-lead ECG input, or
ECG Slave Cable |
| DICOM | DICOM 3.0 Store, Print,
Modality Worklist, Perform
Procedure Step (PPS),
Storage Commitment | DICOM 3.0 Store, Print,
Modality Worklist, Perform
Procedure Step (PPS),
Storage Commitment | DICOM 3.0 Store, Print,
and Modality Worklist
service class user features | DICOM 3.0 Store, Print,
Modality Worklist, Perform
Procedure Step (PPS),
Storage Commitment |
| IMT
Measurement | Not available | Not available | SonoCalc IMT provides
the capability for
automated measurement
of intima-media thickness
(IMT) of the carotid artery.
IMT functionality is
available both on the
ultrasound system and in
a stand alone software
program that runs on a
personal computer. | Not available |
| #Transmit
Channels | 128 digital 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) | 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
Epoxy resin
Polyetherimide
Polyethylene (PE)
lonomer
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)
lonomer
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
Epoxy resin
Polyetherimide
Polyethylene (PE)
lonomer
Polyetheretherketone
(PEEK)
Polycarbonate
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
Epoxy paste adhesive
Polyethylene (PE)
lonomer
Polyetheretherketone
(РЕЕК)
Polycarbonate
Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-
styrene (ABS) |
| Feature | SonoSite X-Porte
Ultrasound System
(This submission) | SonoSite X-Porte
Ultrasound System
(K152209) | SonoSite Edge
Ultrasound System
(K133454) | SonoSite Edge II
Ultrasound System
(K162045) |
| Product Safety
Certification | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
601.1
JIS T 0601-1, JIS T 1507
CEI/IEC 61157
ANSI/AAMI EC53
NEMA UD2-2004
IEC 62359:2010 | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
601.1
JIS T 0601-1, JIS T 1507
CEI/IEC 61157
ANSI/AAMI EC53
NEMA UD2-2004
IEC 62359:2010 | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
601.1
JIS T 0601-1, JIS T 1507
CEI/IEC 61157
ANSI/AAMI EC53
NEMA UD2-2004
AIUM RTD2-2004 (NEMA
UD3-2004 (R2009)) | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
60601-1:08
NEMA UD2-2004
IEC 62359:2010 |
| EMC
Compliance | IEC 60601-1-2:2007
CISPR 11
IEC 61000-4 pt 2-5 | IEC 60601-1-2:2007
CISPR 11
IEC 61000-4 pt 2-5 | IEC 60601-1-2:2007
CISPR 11
IEC 61000-4 pt 2-5 | AAMI / ANSI / IEC 60601-
1-2:2007(R)2012
CISPR 11, Group 1, Class
A |
| DICOM | NEMA PS3.15 2003 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | NEMA PS3.15 2003 |
| Airborne
Equipment
Standards | RTCA/DO160D (section
21) | RTCA/DO160D (section
21) | RTCA/DO160D (section
21) | RTCA/DO160 (section 21) |
| System
Characteristics | X-Porte (stand
configuration):
Beamformer 128/128
using SA (configurable)
12.1" Capacitive touch
screen interface
19" LED LCD HD monitor
256 gray shades on LED
LCD | X-Porte (stand
configuration):
Beamformer 128/128
using SA (configurable)
12.1" Capacitive touch
screen interface
19" LED LCD HD monitor
256 gray shades on LED
LCD
6 USB 2.0 ports | Edge:
Beamformer 128/128
using SA (configurable)
Hand held display and
control
Single 12.1" Liquid Crystal
Display (LCD)
256 gray shades on LCD
2 USB ports | Edge II:
Beamformer 128/128
using SA (configurable)
Hand held display and
control
Single 12.1" Liquid Crystal
Display (LCD)
256 gray shades on LCD |
| | 6 USB 2.0 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) | 2 USB ports
Dimensions: 12.8"(W) x
12.1" (L) x 2.5"(H) |
| | Weight: 149.35 lbs (fully
configured w/ 3
transducers
System operates via
battery or AC power
Battery life: 1 hour
operational - 3 days idle | Weight: 149.35 lbs (fully
configured w/ 3
transducers
System operates via
battery or AC power
Battery life: 1 hour
operational - 3 days idle | Weight: 8.5 lbs
Battery operated (1.5 - 4
hour operation per charge)
System operates via
battery or AC power | Weight: 9.0 lbs
System operates via
battery or AC power
Battery life: 1.5 - 4 hour
operation per charge |
| | Input: 100 - 240 VAC,
50/60 Hz
Output 1: 24VDC output,
275 W max | Input: 100 – 240 VAC,
50/60 Hz
Output 1: 24VDC output,
275 W max
Output 2: 100-240VAC,
50-60 Hz (AC Printer) | 100 - 240V options, 50/60
Hz, 15VDC output | 100 - 240V options, 50/60
Hz, 15VDC output |
| Feature | SonoSite X-Porte
Ultrasound System
(This submission) | SonoSite X-Porte
Ultrasound System
(K152209) | SonoSite Edge
Ultrasound System
(K133454) | SonoSite Edge II
Ultrasound System
(K162045) |
| | Output 2: 100-240VAC, 50-60 Hz (AC Printer, DC Printer) | Various obstetrical, | Various obstetrical, | Various obstetrical, |
| | Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages | cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages | cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages | cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages |
| | ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media Measurement on Recalled Images. | ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media Measurement on Recalled Images. | ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media | ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media |
| | Wireless 802.11 (a/b/g/n) support for image transfer | Wireless 802.11 (a/b/g/n) support for image transfer | Wireless 802.11 (a/b/g) support for image transfer | Wireless 802.11 (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) | | |
| | AC power only.
100 - 240V options, 50/60 Hz | AC power only.
100 - 240V options, 50/60 Hz | | |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Track 3 |
20
21
22
23
24
25
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 reguire 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.