(26 days)
No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that would typically indicate the use of AI/ML. The description focuses on standard ultrasound imaging modes and features.
No
The device is described as a "diagnostic ultrasound system" and its intended use is for "evaluation by ultrasound imaging... for diagnosis of patients". It consistently refers to diagnostic applications rather than therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients." Additionally, the "Device Description" calls it a "diagnostic ultrasound system."
No
The device description explicitly states it is a "full featured, general purpose, software controlled, diagnostic ultrasound system" and mentions hardware components like transducers, accessories including needle guide starter kits, and an ECG-specific port. This indicates it is a hardware system controlled by software, not a software-only device.
Based on the provided information, the Sonosite PX Ultrasound System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis. The Sonosite PX Ultrasound System is used for imaging the human body directly using ultrasound waves.
- The intended use and device description clearly state that it is a general purpose ultrasound system for imaging the human body. It describes various clinical applications and exam types that involve scanning different parts of the body.
- There is no mention of analyzing biological specimens or performing tests on samples taken from the patient.
Therefore, the Sonosite PX Ultrasound System is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Fetal - OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Organ (breast, thyroid, testicles, prostate), Transvaginal, Transesophageal (cardiac), Transrectal, Needle Guidance. Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD. This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, OIJ
Device Description
The Sonosite PX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode (including Simultaneous M-Mode and anatomical M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. including Triplex imaging. The system includes a variety of accessories including optional needle guide starter kits. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Fetal - OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Organ (breast, thyroid, testicles, prostate), Transvaginal, Transesophageal (cardiac), Transrectal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physicians and healthcare professionals in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
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 PX 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.
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
December 27, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FUJIFILM Sonosite, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114
Re: K213763
Trade/Device Name: Sonosite PX Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OIJ Dated: November 30, 2021 Received: December 1, 2021
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213763
Device Name Sonosite PX Ultrasound System
Indications for Use (Describe)
The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include:
| Abdominal |
|---|
| Adult cephalic |
| Cardiac Adult |
| Cardiac Pediatric |
| Fetal - OB/GYN |
| Musculo-skeletal (Conventional) |
| Musculo-skeletal (Superficial) |
| Ophthalmic |
| Pediatric |
| Peripheral Vessel |
| Small Organ (breast, thyroid, testicles, prostate) |
| Transvaginal |
| Transesophageal (cardiac) |
| Transrectal |
| Needle Guidance |
Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler
Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD
This device is indicated for Prescription Use Only.
The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
| 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
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:
| Manufacturer Name:
Address: | FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021-3904 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Anoush Frankian |
| | Sr. Manager, Regulatory Affairs |
| E-mail: | anoush.frankian@fujifilm.com |
| Telephone: | (425) 951-6824 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | October 18, 2021 |
| Regulatory Lead &
Alternate Contact: | Medha Sateesh Bharadwaj |
| E-mail: | medha.bharadwaj@fujifilm.com |
| Telephone: | (631) 532-7229 |
| Facsimile: | (425) 951-1201 |
| 2) Device | |
| Trade Name: | Sonosite PX Ultrasound System |
| Common Name: | Diagnostic Ultrasound System and Transducers with
Accessories |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging System
Ultrasonic Pulsed Echo Imaging System
Diagnostic Ultrasound Transducer |
| Regulation Number: | 21 CFR 892.1550
21 CFR 892.1560
21 CFR 892.1570 |
| Primary Product Code: | IYN |
| Secondary Product Codes: | IYO
ITX
OIJ |
| Device Class: | Class II |
| Classification Panel: | Radiology |
4
3) Predicate Device:
Primary Predicate: Sonosite PX Ultrasound System (K200964)
Reference Device: SonoSite Edge II Ultrasound System (K162045)
4) Device Description:
The Sonosite PX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode (including Simultaneous M-Mode and anatomical M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. including Triplex imaging.
The system includes a variety of accessories including optional needle guide starter kits. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
5) Intended Use/Indications for Use:
The Sonosite PX 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:
Abdominal Adult Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Transesophageal (cardiac) Transrectal Needle Guidance
5
Modes of operation include: B Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (CWD), Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD
This device is indicated for Prescription Use Only.
The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
6
6) Technological Characteristics:
The Sonosite PX Ultrasound System, subject device of this submission, is equivalent to the previously cleared Sonosite PX (K20096) and Edge II (K162045) Ultrasound Systems in terms of both the intended use and technological characteristics. The Sonosite PX (subject device) uses the same fundamental scientific technology as the predicate device.
| Feature | Sonosite PX Ultrasound
System | Sonosite PX Ultrasound
System | SonoSite Edge II Ultrasound
System | Evaluation of
Differences |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (This submission) | (K200964) | (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 | The intended use of
the Sonosite PX is
identical to the
predicate and
reference devices. |
| Indications for
Use | Abdominal
Adult Cephalic
Cardiac Adult
Cardiac
Pediatric
Fetal - OB/GYN
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Ophthalmic
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Transvaginal
Peripheral Vessel
Trans-Rectal
Trans-esophageal (cardiac)
Needle guidance | Abdominal
Adult Cephalic
Cardiac Adult
Cardiac
Pediatric
Fetal - OB/GYN
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Ophthalmic
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Peripheral Vessel
Transvaginal
Needle guidance | Abdominal
Adult
Cephalic
Cardiac Adult
Cardiac Pediatric
Fetal - OB/GYN
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Ophthalmic
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Transvaginal
Peripheral Vessel
Needle guidance
Neonatal
Cephalic
Trans-Rectal
Trans-esophageal (cardiac)
Needle guidance | The Indications for
Use are a subset of
Sonosite PX
Ultrasound system
(primary predicate-
K200964) and
Sonosite Edge II
Ultrasound system
(reference device-
K162045). |
| Transducer
Types | Linear Array
Curved Linear
Array Phased Array
Intracavitary
Trans-esophageal | Linear Array
Curved Linear
Array Phased Array
Intracavitary | Linear Array
Curved Linear Array
Phased Array
Intracavitary
Trans-esophageal | Transducer types for
Sonosite PX are all a
subset of Sonosite
PX Ultrasound
system (primary
predicate) and
Sonosite Edge II
Ultrasound system
(reference
device). |
| Transducer
Frequency | 1.0-19.0 MHz | 1.0-19.0 MHz | 1.0 - 15.0 MHz | The frequency range
for Sonosite PX is
unchanged and the
same as the primary
predicate Sonosite PX
(K200964) |
| Global | Ispta.3: 607 mW/cm^2 | Ispta.3: 607 mW/cm^2 | Ispta.3: 598.9 | Acoustic output is |
| Maximum
Outputs/Worst
Case Setting | (L12-3)
TI Type: TIB (P5-1)
TI Value: 4.87 (P5-1)
MI: 1.72 (L12-3)
Ipa.3@MI Max: 793
mW/cm^2 (L15-4) | (L12-3)
TI Type: TIB (P5-1)
TI Value: 4.87 (P5-
- MI: 1.72 (L12-3)
Ipa.3@MI Max: 793 mW/cm^2
(L15-4) | (HFL50x)
TI Type: TIB
(rP19x)
TI Value: 4.98
(rP19x) MI: 1.7
(rP19x)
Ipa.3@MI Max: 776 (L38xi) | less than FDA
established limits. |
| 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 | MI & TI are always
displayed and a power
management system
ensures that they
never exceed the
derated FDA limits. |
| Modes of
Operation | | | | |
| | B-mode Grayscale
Imaging | B-mode Grayscale Imaging | B-mode Grayscale Imaging | Modes of operation
are a subset of
Sonosite PX
Ultrasound system
(primary predicate)
and Sonosite Edge II
Ultrasound system
(reference device).
The AMM imaging
frame and transmit
sequence is identical
to regular
simultaneous 2D/M-
mode as seen on
predicate device
Sonosite PX
(K200964). The only
difference is the AMM
line is extracted from
the 2D image data
based on the AMM
line position the user
specified and the
display in the sweep
field of view. |
| | Tissue Harmonic Imaging | Tissue Harmonic Imaging | Tissue Harmonic Imaging | |
| | M-mode
Simultaneous M- Mode
AMM | M-mode
Simultaneous M- Mode | M-mode Color M-Mode | |
| | Color Power Doppler
Zoom | Color Power Doppler Zoom | Color Power Doppler Zoom | |
| | Combination Modes
Pulsed Wave (PW)
Doppler | Combination Modes Pulsed
Wave (PW) Doppler | Combination Modes
Pulsed Wave (PW) Doppler | |
| | Continuous Wave (CW)
Doppler | Continuous Wave (CW)
Doppler | Continuous Wave (CW)
Doppler | |
| | Speckle reduction algorithm
(formerly branded as
SonoHD2 Noise Reduction) | Speckle reduction algorithm
(formerly branded as
SonoHD2 Noise Reduction) | SonoHD2 Noise Reduction | |
| | SonoMB/MBe Image
Compounding | SonoMB/MBe Image
Compounding | SonoMB/MBe Image
Compounding | |
| | CW Doppler
Velocity Color Doppler Tissue
Doppler Imaging (TDI) | CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging
(TDI) | Steered CW Doppler Velocity
Color Doppler
Tissue Doppler Imaging (TDI) | |
| DICOM | DICOM 3.0
Store and Offline Media | DICOM 3.0 Store, Print,
Modality Worklist, Perform
Procedure Step(PPS),
Storage Commitment | DICOM 3.0 Store, Print,
Modality Worklist, Perform
ProcedureStep (PPS),
Storage Commitment | Includes a subset
of thisinformation |
| #Transmit
Channels | 128 digital channels | 128 digital channels | 128 digital channels | - |
| #Receive
Channels | 128 digital channels | 64 digital channels
(128 digital channels
usingSynthetic
Aperture) | 64 digital channels
(128 digital channels using
Synthetic Aperture) | - |
| Patient
Contact
Materials | Transducers:
Silicone Rubber
Polysulfone
Poly Vinyl Chloride
(PVC)
Silicone RTV Adhesive
Silicone
Polymethyl-pentene Epoxy
Paste Adhesive
Polyurethane
FKM rubber
Thermoplastic
polyurethane
Needle Guides: Acetal
copolymer Acrylonitrile-
butadien-
styrene (ABS) | Transducers:
Silicone
Rubber
Polysulfon
e UDEL
P1700
Poly Vinyl Chloride
(PVC)Silicone RTV
Adhesive Silicone
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) | Transducers:
Acrylonitrile-butadien- styrene
(ABS) Cycoloy Epoxy paste
adhesive Polyethylene (PE)
lonomer Polyetheretherketone
(PEEK)Polycarbonate
Polysulfone
UDEL
Polyurethane
Poly Vinyl Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber Urethane
Needle Guides:
Acetal copolymer Acrylonitrile-
butadien-styrene
(ABS) | All patient contact
materials have been
testedto ISO 10993-1.
Materials used in
SonositePX have
undergone identical
biocompatibility and
cleaning/disinfection
testing to the
predicate devices.
Bio-compatibility
summary test results
are provided in
D00414, Bio-
compatibility Test
Report, included in
Attachment 6 ofthis
submission. |
| Product
Safety
Certification | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-
37:2007+AMD 1:2015
CAN/CSA-C22.2 No.
60601-1:14 JSA JIS T
0601-1:2017,
JSA JIS T 0601-2-37 IEC
61157:2007+AMD1:2013 | AAMI/ANSI ES60601-1:2005
(R2012
IEC 60601-2-
37:2007+AMD 1:2015
CAN/CSA-C22.2 No. 60601-1:14
JSAJIS T 0601-1:2017,
JSA JIS T 0601-2-37
IEC 61157:2007+AMD1:2013 | 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 | |
| | IEC 62359:2010+AMD1:2017 | NEMA UD 2-2004 (R2009)
IEC 62359:2010+AMD1:2017 | | |
| EMC
Compliance | IEC 60601-1-2:2014
CISPR 11:2015+AMD1:2016
+AMD2:2019 IEC
61000-4-2.
IEC 61000-4-3
IEC 61000-4-4.
IEC 61000-4-5
IEC 61000-4-6.
IEC 61000-4-8
IEC 61000-4-11 | IEC 60601-1-2:2014
CISPR 11:2015+AMD1:2016
+AMD2
IEC 61000-4-2.
IEC 61000-4-3
IEC 61000-4-4.
IEC 61000-4-5
IEC 61000-4-6.
IEC 61000-4-8
IEC 61000-4-11 | AAMI / ANSI / IEC 60601-1-
2:2007(R)2012 CISPR 11,
Group 1,
Class A | |
| DICOM | DICOM PS3.15 2011 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | |
| Airborne
Equipment
Standards | none applied | none applied | RTCA/DO160 (section 21) | Airborne
equipment
standards have
not been applied
to the Sonosite
PXultrasound
system and
labeling will not claim
to this. |
| System | Sonosite PX: | Sonosite PX: | Edge II: | Sonosite PX 2.0 |
| Characteristics | Beamformer 128/128 using
SA (configurable)
12.1" Capacitive touch
screen interface
19" LED LCD HD monitor
256 gray shades on LED LCD | Beamformer 128/128 using
SA (configurable)
12.1" Capacitive touch
screen interface
19" LED LCD HD monitor
256 gray shades on LED LCD | Beamformer 128/128
using SA (configurable)
Hand held display and control
Single 12.1" Liquid Crystal
Display (LCD)
256 gray shades on LCD2 | includes a non-
diagnostic ECG
module.Like
reference device
Edge II ultrasound
system (K162045),
this module
provides ECG
tracing of the |
| | 2 USB 3.0
4 USB 2.0 | 2 USB 3.0
4 USB 2.0 | USB ports | cardiac signal
synchronized with
the ultrasound |
| | Stand Base Dimensions:
26.4" L x 21.2" W
Stand Height (max): 64"
(monitor up)
Stand Height (min): 42.2"
(monitor down)
Weight: 149.35 lbs (fully
configured w/ 3 transducers
and stand base
Weight: 32.80 lbs
(w/ 1 transducer) | Stand Base Dimensions:
26.4" L x 21.2" W
Stand Height (max): 64"
(monitor up)
Stand Height (min): 42.2"
(monitor down)
Weight: 149.35 lbs (fully
configured w/ 3 transducers
and stand base
Weight: 32.80 lbs (w/1
transducer) | Dimensions: 12.8"(W) x
12.1" (L) x 2.5"(H)
Weight: 9.0 lbs | image. |
| | 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 imaging
- 10 days idle | Battery life: 1 hour imaging -
10 days idle | Battery life: 1.5 - 4 hour
operation per charge | |
| | Input: 100 - 240 VAC, 50/60
Hz
Output 1: 26.7VDC output,
220 W max
System on stand: | Input: 100 - 240 VAC, 50/60
Hz
Output 1: 26.7VDC output, 220
W max
System on stand: | 100 - 240V options, 50/60Hz,
15VDC output | |
| | Input: 100 - 240 VAC, 50/60
Hz
Output 1: 26.7VDC output,
220 W max
Output 2: 100-240VAC, 50-60
Hz
(AC Printer) | Input: 100 - 240 VAC, 50/60
Hz
Output 1: 26.7VDC output, 220
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 | |
| | Non-diagnostic ECG tracing | | Non-diagnostic ECG tracing,
CW/PW Doppler Audio Spectral
Doppler Audio
and image storage on
removable media | |
| | Wireless 802.11 (a/b/g/n) | Wireless 802.11
(a/b/g/n) support for
image transfer | Wireless 802.11 (b/g/n) support
for image transfer | |
| | Additional system features:
Assisted CardiacOutput (ACO) -
Available on Sonosite PX
system | Additional system features:
Assisted Cardiac Output (ACO) - Available on
Sonosite PX system | Additional system features:
Assisted Cardiac Output (ACO) –
Available on Edge II system | |
| 510(k) Track | Track 3 | Track 3 | Track 3 | |
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7) Determination of Substantial Equivalence:
Summary of Technological Comparison to Predicate Devices:
The Sonosite PX Ultrasound System, subject device of this submission, is enhanced implementation of previous FDA Cleared predicate devices Sonosite PX (K200964) and Sonosite Edge II Ultrasound System (K162045). The technological characteristics and physical design are unchanged from the primary predicate Sonosite PX (K200964) and reference device Edge II (K162045) ultrasound systems. The primary function of Sonosite PX Ultrasound System and the predicate devices is diagnostic ultrasound imaging or fluid flow analysis of the human body. The Sonosite PX Ultrasound System employs the same fundamental scientific characteristics as the currently marketed predicate devices. The Sonosite PX Ultrasound device and predicates share indications for use, share modes of operation and have biosafety equivalence.
The following lists an overview of differences between the proposed subject device (Sonosite PX Ultrasound System) and its predicates.
- Addition of T8-3 transducer, which is substantially equivalent to the TEExi transducer . previously cleared on Edge II (K153626).
- Addition of C10-3 transducer, which is substantially equivalent to the C5-1 and C35x . transducers previously cleared on Sonosite PX (K200964) and Edge II (K162045) respectively.
- . Addition of two new clinical indications: trans-esophaqeal and trans-rectal, which are the same indications cleared on Edge II (K162045).
- Addition of non-diagnostic ECG module which provides ECG tracing of the cardiac signal synchronized with the ultrasound image, similar to the module cleared on Edge II (K162045).
- Addition of compatible OEM Needle Guide for use with C10-3 transducer. The needle ● guidance has been cleared (K093713).
- Addition of PIV exam type (preset) to work with L12-3 transducer. The PIV exam type ● (preset) is already available on predicated device Sonosite PX (K200964) transducer L19-5.
- Addition of Anatomical M-Mode available on P5-1 and T8-3 probes in cardiac exams. ● Anatomical M-Mode (AMM) is a display option in simultaneous 2D-Mode, which is available in Sonosite PX (K200964). The AMM uses 2D data instead of M-mode data.
- . Addition of Cleaning Mode for device, which locks the user interface touch screen so that user can wipe the screen without accidentally touching or moving controls.
- Addition of carotid exam and measurements. The carotid exam type and measurements have the same imaging optimization as the arterial exam type on predicate Sonosite PX (K200964). The carotid exam type provides carotid blood flow calculations using either the right or left side. This is similar to what is seen in arterial exam for the reference device (K162045). However the subject device provides the user with the ability to evaluate fluid responsiveness for calculating stenosis in the carotid specifically.
- Addition of Qview. The Qview feature provides a communication pathway with QPathE. To ● access the reporting capability of QPathE, the user can access the product through the Sonosite PX system by opening the Qview feature. Both Qview and QPathE are products of Telexy Healthcare.
- . Addition of Customized Exam Setting. This allows for the customer to use the exams
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provided to them on the Sonosite PX and customize the settings to have their most preferred or used exams placed in an order based on the use of the system and exam presets. This does not change the function of the device or exam types. Rather allows for preferences for exams to be customized through this settings tool.
The transducer types for the subject device are all a subset of the primary predicate (Sonosite PX -K200964) and reference device (Sonosite Edge II - K162045). The transducer frequency range is unchanged and the same as the primary predicate Sonosite PX (K200964). The transducers have been tested to performance standards and the acoustic output is less than FDA established limits. Similar to the predicates, MI and TI values are always displayed and a power management system ensures that they never exceed the derated FDA limits.
The changes implemented on the Sonosite PX leverage existing technological characteristics and features available on both the primary predicate (K200964) and reference device (K162045). The submission device is substantially equivalent to the predicates with respect to the intended use and technological characteristics.
Summary of Non-Clinical Tests:
The Sonosite PX 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 medical device safety standards. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation. All patient contact materials are biocompatible.
The Sonosite PX Ultrasound System is designed to comply with the following FDA recognized standards.
| Reference No. | Recognition
No. | Title |
|---------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 | 2-258 | ISO 10993-1:2018, Biological evaluation of medical
devices -- Part 1: Evaluation and testing within a risk
management process |
| IEC 60601-1 | 19-4 | 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 | 19-8 | ANSI AAMI IEC 60601-1-2:2014
Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential performance
-- Collateral Standard: Electromagnetic disturbances --
Requirements and tests |
| IEC 60601-1-6 | 5-89 | IEC 60601-1-6 Edition 3.1 2013-10
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance
- Collateral standard: Usability |
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| IEC 60601-2-37 | 12-293 | IEC 60601-2-37 Edition 2.1 2015
Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment |
|----------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304 | 13-79 | ANSI AAMI IEC 62304:2006/A1:2016
Medical device software - Software life cycle processes
[Including Amendment 1 (2016) |
| ISO 14971 | 5-40 | ANSI AAMI ISO 14971:2007/(R) 2010 - Medical devices
- Application of risk management to medical devices |
| IEC 62359 | 12-316 | IEC 62359:2010+AMD1:2017
Ultrasonics - Field characterization - Test methods for
the determination of thermal and mechanical indices
related to medical diagnostic ultrasonic fields. |
Summary of Clinical Tests:
The Sonosite PX Ultrasound System and transducers, subject of this submission, did not reguire clinical studies to support the determination of substantial equivalence.
Conclusion
The Sonosite PX Ultrasound System meets FDA requirements for Track 3 devices, shares indications for use with the primary predicate and reference device. With successful verification and validation testing and conformance to applicable electromedical device safety standards as well as compliance verified through independent evaluation as part of the nonclinical testing summarized above, FUJIFILM Sonosite considers the proposed Sonosite PX Ultrasound System to be as safe, as effective and performance that is substantially equivalent to the primary predicate.