(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and features.
No
The device is described as a "diagnostic ultrasound system" intended for "diagnosis of patients" and for "evaluation by ultrasound imaging," not for treating conditions.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The Sonosite PX Ultrasound System is intended to be used...for diagnosis of patients." Additionally, the 'Device Description' refers to it as a "diagnostic ultrasound system."
No
The device description explicitly states it is a "full featured, general purpose, software controlled, diagnostic ultrasound system" and mentions working with "two different types of needle guide brackets" and "Each Sonosite PX transducer". This indicates the device includes significant hardware components (ultrasound system, transducers, needle guide brackets) in addition to software.
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 derived from the human body (like blood, urine, tissue) outside of the body. They are used to provide information about a physiological state, health, or disease.
- The Sonosite PX Ultrasound System is a diagnostic imaging system that uses ultrasound waves to visualize structures within the human body. It directly images internal anatomy in real-time.
The intended use and device description clearly state that the system is used for "evaluation by ultrasound imaging of the human body" and to "acquire and display high-resolution, real-time ultrasound data" of internal structures. This is the core function of an in-vivo 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 Needle Guidance
This device is indicated for Prescription Use Only.
The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthicare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
Product codes
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), 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. The Sonosite PX Ultrasound System also includes needle guidance capability. The system is capable of working with two different types of needle guide brackets available, including 1) Fixed-angle, in-plane brackets where a pair of guidelines are generated that represent the path of the needle and 2) Transverse-angle, out-of-plane brackets (adjustable depths) where the quidelines appear down the center of the imaqe. Each Sonosite PX transducer has an appropriate needle quide bracket kit to support needle quidance with the system.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physicians and healthcare professionals. Medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care.
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 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, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation. All patient contact materials are biocompatible.
The Sonosite PX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a stylized human figure on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a larger, bolder font than the rest of the text.
FUJIFILM SonoSite, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
May 8, 2020
Re: K200964
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: April 9, 2020 Received: April 10, 2020
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR
1
- 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 (QS) 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
Thalia T. Mills, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K200964
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 Needle Guidance
This device is indicated for Prescription Use Only.
The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthicare 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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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
1.3 INDICATIONS FOR USE
The indications for use are listed in the FDA defined tables on the following pages.
4
| System: | Sonosite PX 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 | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | c, e, f | ||||||||
| Fetal – OB/GYN | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | c, e, f, h | ||||||||
| Abdominal | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD; | c, e, f | ||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD; | b, c, e, f, h | ||||||||
| Small Organ (breast, thyroid, | |||||||||
| testicles, prostate) | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | b, c, e, f, h | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | f | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | c, e, f, h | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | b, c, e, f, h | ||||||||
| Musculo-skel. (Superfic.) | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | b, c, e, f, h | ||||||||
| Intra-luminal | |||||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; B+CWD; | |||
| B+C; (B+C)+PWD; | |||||||||
| (B+C)+CWD | c, d, g, f | ||||||||
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+CWD; | |||
| B+C; (B+C)+PWD; | |||||||||
| (B+C)+CWD | c, d, g, f | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral vessel | N | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | b, c, e, f, h | ||||||||
| Other (spec.) | |||||||||
| System: | Sonosite PX Ultrasound System | ||||||||
| Transducer: | L19-5 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 | N | N | N | N | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | e, f | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD; | b, c, e, f, h | ||||||||
| Small Organ (breast, thyroid, | |||||||||
| testicles. prostate) | N | N | N | N | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | b, c, e, f, h | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | b, c, e, f, h | ||||||||
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | b, c, e, f, h | ||||||||
| Intra-luminal | |||||||||
| Cardiac Adult | N | N | N | N | B+M;B+PWD;B+C;(B+C)+ | ||||
| PWD | f | ||||||||
| Cardiac Pediatric | N | N | N | N | B+M;B+PWD;B+C;(B+C)+ | ||||
| PWD | f | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; B+C; | ||||
| (B+C)+PWD | b, c, e, f, h | ||||||||
| Other (spec.) |
Table 1.3-1: Diagnostic Ultrasound Indications for Use Form – Sonosite PX Ultrasound System
Additional Comments:
a. B = B Mode; M= M Mode including simultaneous; PWD = Pulse Wave Dopler; CWD= Continuous Wave Doppler; C = Color Doppler; C = Color Doppler; C = Color Doppler (Velocity Color Doppler or CVD, Color Power Doppler or CPD, Variance or Var)
b. Steep Needle Profiling (SNP) = Needle enhancement in B mode
c. Tissue Harmonic Imaging (THI)
d. Tissue Doppler Imaging (TDI)
e. Multi-beam Imaging (SonoMB) in B-Mode
f. Color Doppler includes Power/Velocity
g. Color Doppler includes Velocity/Variance
h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
5
Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – L19-5 MHz Transducer
Additional Comments:
a. 2D = B Mode; M= M Mode including simultaneous; PWD = Pulse Wave Dopler; CWD= Continuous Wave Doppler; C = Color Doppler (Velocity Color Doppler or CVD, Color Power Doppler or CPD, Variance or Var)
b. Steep Needle Profiling (SNP) = Needle enhancement in B mode
c. Tissue Harmonic Imaging (THI)
d. Tissue Doppler Imaging (TDI)
e. Multi-beam Imaging (SonoMB) in B-Mode
f. Color Doppler includes Power/Velocity
g. Color Doppler includes Velocity/Variance
h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
6
| System: | Sonosite PX Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | L15-4 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 | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD; | b, c, e, f | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | b, c, e, f | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | b, c, e, f | ||||||
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | b, c, e, f | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | b, c, e, f | ||||||
| Other (spec.) |
Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – L15-4 MHz Transducer
Additional Comments:
a. 2D = B Mode; M= M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD= Continuous Wave Doppler; C = Color Doppler (Velocity Color Doppler or CVD, Color Power Doppler or CPD, Variance or Var)
b. Steep Needle Profiling (SNP) = Needle enhancement in B mode
c. Tissue Harmonic Imaging (THI)
d. Tissue Doppler Imaging (TDI)
e. Multi-beam Imaging (SonoMB) in B-Mode
f. Color Doppler includes Power/Velocity
g. Color Doppler includes Velocity/Variance
h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
7
| System: | Sonosite PX Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L12-3 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 | N | N | N | N | B+M; B+PWD, B+C; | |||
| (B+C)+PWD | e, f | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD; | b, c, e, f | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicles, prostate) | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | b, c, e, f | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | b, c, e, f | |||||||
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | b, c, e, f | |||||||
| Intra-luminal | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; B+C; | |||
| (B+C)+PWD | b, c, e, f | |||||||
| Other (spec.) |
Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – L12-3 MHz Transducer
Additional Comments:
a. 2D = B Mode; M= M Mode including simultaneous; PWD = Pulse Wave Dopler; CWD= Continuous Wave Doppler; C = Color Doppler (Velocity Color Doppler or CVD, Color Power Doppler or CPD, Variance or Var)
b. Steep Needle Profiling (SNP) = Needle enhancement in B mode
c. Tissue Harmonic Imaging (THI)
d. Tissue Doppler Imaging (TDI)
e. Multi-beam Imaging (SonoMB) in B-Mode
f. Color Doppler includes Power/Velocity
g. Color Doppler includes Velocity/Variance
h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
8
| System: | Sonosite PX Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C5-1 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 | N | N | N | N | N | B+M; B+PWD; B+C; | |
| (B+C)+PWD | c, e, f | ||||||
| Fetal - OB/GYN | N | N | N | N | N | B+M; B+PWD; B+C; | |
| (B+C)+PWD | c, e, f | ||||||
| Abdominal | N | N | N | N | N | B+M; B+PWD; B+C; | |
| (B+C)+PWD | c, e, f | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | B+M; B+PWD; B+C; | |
| (B+C)+PWD | b, c, e, f | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | B+M; B+PWD; B+C; | |
| (B+C)+PWD | b, c, e, f | ||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; B+C; | |
| (B+C)+PWD | f | ||||||
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+C; | |
| (B+C)+PWD | f | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | N | N | N | N | N | B+M; B+PWD; B+C; | |
| (B+C)+PWD | b, c, e, f | ||||||
| Other (spec.) |
Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – C5-1 MHz Transducer
Additional Comments:
a. 2D = B Mode; M= M Mode including simultaneous; PWD = Pulse Wave Dopler; CWD= Continuous Wave Doppler; C = Color Doppler
(Velocity Color Doppler or CVD, Color Power Doppler or CPD, Variance or Var)
b. Steep Needle Profiling (SNP) = Needle enhancement in B mode
c. Tissue Harmonic Imaging (THI)
d. Tissue Doppler Imaging (TDI)
e. Multi-beam Imaging (SonoMB) in B-Mode
f. Color Doppler includes Power/Velocity
g. Color Doppler includes Velocity/Variance
h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
9
| Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – P5-1 MHz Transducer | |||||||
|---|---|---|---|---|---|---|---|
| System: | Sonosite PX Ultrasound System | ||||||
| Transducer: | P5-1 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 | |||||||
| Fetal - OB/GYN | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | c, g | ||||||
| Abdominal | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD; | c, e, f | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, | |||||||
| testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | f | ||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; B+CWD; | |
| B+C; (B+C)+PWD; | |||||||
| (B+C)+CWD | c, d, g, f | ||||||
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+CWD; | |
| B+C; (B+C)+PWD; | |||||||
| (B+C)+CWD | c, d, g, f | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 1 3-6: Diagnostic | Illtrasound Indications for Use Form P5-1 MHz Transducer
Additional Comments:
a. 2D = B Mode; M= M Mode including simultaneous; PWD = Pulse Wave Dopler; CWD= Continuous Wave Doppler; C = Color Doppler (Velocity Color Doppler or CVD, Color Power Doppler or CPD, Variance or Var)
- b. Steep Needle Profiling (SNP) = Needle enhancement in B mode
c. Tissue Harmonic Imaging (THI)
d. Tissue Doppler Imaging (TDI)
e. Multi-beam Imaging (SonoMB) in B-Mode
f. Color Doppler includes Power/Velocity
g. Color Doppler includes Velocity/Variance
h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
10
Table 1.3-7: Diagnostic Ultrasound Indications for Use Form - IC10-3 MHz Transducer
| System: | Sonosite PX Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | IC10-3 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 | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | c, e, f, h | ||||||
| Fetal - OB/GYN | |||||||
| 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 | N | N | N | N | B+M; B+PWD; B+C; | ||
| (B+C)+PWD | c, e, f, h | ||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Additional Comments:
a. 2D = B Mode; M= M Mode including simultaneous; PWD = Pulse Wave Dopler; CWD= Continuous Wave Doppler; C = Color Doppler
(Velocity Color Doppler or CVD, Color Power Doppler or CPD, Variance or Var)
b. Steep Needle Profiling (SNP) = Needle enhancement in B mode
b. Steep Needle Profiling (SNP) = Needle enhancement in B mode
c. Tissue Harmonic Imaging (THI)
d. Tissue Doppler Imaging (TDI)
e. Multi-beam Imaging (SonoMB) in B-Mode
f. Color Doppler includes Power/Velocity
g. Color Doppler includes Velocity/Variance
h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
11
ATTACHMENT 1 – Summary of Safety and Effectiveness
Summary of Safety and Effectiveness
In accordance with the requirements addressed by the Safe Medical Devices Act of 1990 and FDA's Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, this Attachment provides the "510(k) Summary" of safety and effectiveness information to support the determination of substantial equivalence to currentlymarketed predicate devices.
A "Certification" is also included herein.
12
510(k) Summary/Statement Certification
- Re: 510(k) Premarket Notification Sonosite PX Ultrasound System
CHECK ONLY ONE:
- X_ 1. 510(k) Summary. Attached is a summary of safety and effectiveness information upon which an equivalence determination could be based.
-
- 510(k) Statement I certify that, in my capacity as
of (company),
I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
Sudiptā Chakrabortī
02/18/2020
Date
Sudipta Chakrabarti Sr. Regulatory Affairs Specialist FUJIFILM SonoSite, Inc.
13
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: | Sudipta Chakrabarti |
|---|---|
| Sr. Regulatory Affairs Specialist | |
| E-mail: | sudipta.chakrabarti@fujifilm.com |
| Telephone: | (425) 951-1371 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | August 30, 2019 |
| Alternate Contact: | Anoush Frankian |
| Sr. Manager, Regulatory Affairs | |
| E-mail: | anoush.frankian@fujifilm.com |
| Telephone: | (425) 951-6824 |
| Facsimile: | (425) 951-1201 |
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 PX Ultrasound System
Classification Names
| Name | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | OIJ |
14
3) Identification of the predicate or legally marketed device:
Primary Predicate: SonoSite Edge II Ultrasound System (K162045)
Secondary Predicate: SonoSite X-Porte Ultrasound System (K171437)
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), 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. The Sonosite PX Ultrasound System also includes needle guidance capability. The system is capable of working with two different types of needle guide brackets available, including 1) Fixed-angle, in-plane brackets where a pair of guidelines are generated that represent the path of the needle and 2) Transverse-angle, out-of-plane brackets (adjustable depths) where the quidelines appear down the center of the imaqe. Each Sonosite PX transducer has an appropriate needle quide bracket kit to support needle quidance with the system.
15
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 Needle Guidance
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.
16
6) Technological Characteristics:
Sonosite PX, Edge II, and X-Porte Ultrasound Systems are Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.
| Feature | Sonosite PX Ultrasound
System
(This submission) | SonoSite Edge II
Ultrasound System
(K162045) | SonoSite X-Porte
Ultrasound System
(K171437) |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging
or fluid flow analysis of the
human body | Diagnostic ultrasound
imaging or fluid flow
analysis of the
human body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body |
| Indications for
Use | 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
Needle Guidance | Abdominal
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Fetal - OB/GYN
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Ophthalmic
Pediatric
Small Organ (breast,
thyroid, testicles,
prostate)
Trans-vaginal
Peripheral vessel
Neonatal Cephalic
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
testicles, prostate)
Trans-vaginal
Peripheral vessel
Neonatal Cephalic
Trans-esophageal
(cardiac)
Needle Guidance |
| Transducer
Types | Linear Array
Curved Array
Phased Array
Intracavitary | Linear Array
Curved Linear Array
Phased Array
Intracavitary
Trans-esophageal | Linear Array
Curved Linear Array
Phased Array
Intracavitary
Static Probes
Trans-esophageal |
| Transducer
Frequency | 1.0-19.0 MHz | 1.0 – 15.0 MHz | 1.0 – 15.0 MHz |
| Global
Maximum
Outputs/Worst
Case Setting | $I_{spta.3}$ : 607 mW/cm^2 (L12-3)
TI Type: TIB (P5-1)
TI Value: 4.87 (P5-1)
MI: 1.72 (L12-3)
$I_{pa.3}$ @MI Max: 793 mW/cm^2
(L15-4) | $I_{spta.3}$ : 598.9 (HFL50x)
TI Type: TIB (rP19x)
TI Value: 4.98
(rP19x)
MI: 1.7 (rP19x) | $I_{spta.3}$ : 629.3 (P21xp)
TI Type: TIB (P21xp)
TI Value: 4.0 (P21xp)
MI: 1.7 (P21xp)
$I_{pa.3}$ @MI Max: 678 (L38xp) |
| Feature | Sonosite PX Ultrasound System
(This submission) | SonoSite Edge II Ultrasound System
(K162045) | SonoSite X-Porte Ultrasound System
(K171437) |
| | | Ipa.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 |
| Modes of Operation | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode | 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
Speckle reduction algorithm
SonoMB/MBe Image | Color M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction | Simultaneous M-Mode
Color Power Doppler
Zoom
Combination Modes
Simultaneous PW Imaging
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction |
| | Compounding
CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) | SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) | SonoMB/MBe Image
Compounding
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 Procedure Step (PPS), Storage Commitment |
| #Transmit Channels | 128 digital channels | 128 digital channels | 128 digital channels |
| #Receive Channels | 128 digital channels | 64 digital channels | 64 digital channels
(128 digital channels using
Synthetic Aperture) |
| Feature | Sonosite PX Ultrasound
System
(This submission) | SonoSite Edge II
Ultrasound System
(K162045) | SonoSite X-Porte
Ultrasound System
(K171437) |
| | | (128 digital channels
using Synthetic
Aperture) | |
| Patient Contact
Materials | Silicone Rubber
Polysulfone
PolyVinylChloride (PVC)
Silicone RTV Adhesive
Silicone | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Cycoloy
Epoxy paste
adhesive
Polyethylene (PE)
Ionomer
Polyetheretherketone
(PEEK)
Polycarbonate
Polysulfone
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) Ionomer
Polyetheretherketone
(PEEK)
Polysulfone
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-
styrene (ABS) |
| Product Safety
Certification | AAMI/ANSI ES60601-1:2005
(R2012)
IEC 60601-2-
37:2007+AMD1:2015
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
NEMA UD 2-2004 (R2009)
IEC 62359:2010+AMD1:2017 | 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 | 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 |
| Feature | Sonosite PX Ultrasound
System
(This submission) | SonoSite Edge II
Ultrasound System
(K162045) | SonoSite X-Porte
Ultrasound System
(K171437) |
| 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 | AAMI / ANSI / IEC
60601-1-
2:2007(R)2012 CISPR
11, Group 1,
Class A | IEC 60601-1-2:2007
CISPR 11
IEC 61000-4 pt 2-5 |
| DICOM
Airborne
Equipment
Standards | DICOM PS3.15 2019
Not applied | NEMA PS3.15 2003
RTCA/DO160
(section 21) | NEMA PS3.15 2003
RTCA/DO160D (section
21) |
| System
Characteristics | Sonosite PX: | Edge II: | X-Porte (stand
configuration): |
| | Beamformer 128/128 using
SA (configurable)
12.1" Capacitive touch
screen interface
15.6" 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
LCD | Beamformer 128/128
using SA (configurable)
12.1" Capacitive touch
screen interface
19" LED LCD HD monitor
256 gray shades on LED
LCD |
| | 2 USB 3.0
4 USB 2.0 | 2 USB ports | 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) | Dimensions: 12.8"(W) x
12.1" (L) x 2.5"(H) | 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) | Weight: 9.0 lbs | Weight: 149.35 lbs (fully
configured w/ 3
transducers |
| | System operates via battery or AC power
Battery life: 1 hour imaging -
10 days idle
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
Output 2: 100-240VAC, 50-60 Hz
(AC Printer)
Various obstetrical, cardiac,
volume, M-mode, PW and
CW Doppler measurement
and calculation packages
Wireless 802.11 (a/b/g/n)
support for image transfer
Additional system features:
Assisted Cardiac Output
(ACO) – Available on
Sonosite PX system | System operates via
battery or AC power
Battery life: 1.5 - 4
hour operation per
Charge
100 – 240V options,
50/60 Hz, 15VDC
Output
Various obstetrical,
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
Wireless 802.11(b/g/n)
support for image transfer
Additional system
features:
Assisted Cardiac Output (ACO) –
Available on Edge II system | System operates via
battery or AC power
Battery life: 1 hour
operational - 3 days idle
Input: 100 – 240 VAC,
50/60 Hz
Output 1: 24VDC output, 275
W max
Output 2: 100-240VAC,
50-60 Hz (AC Printer, DC
Printer)
Various obstetrical,
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.
Wireless 802.11 (a/b/g/n)
support for image transfer
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.
Weight: 32.80 lbs (w/ 1
transducer)
AC power only.
100 – 240V options, 50/60
Hz |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
17
18
19
20
A1 510(k) Summary
21
7) Determination of Substantial Equivalence:
Summary of Technological Comparison to Predicate Devices:
Sonosite PX Ultrasound System is enhanced implementation of previous FDA Cleared predicate devices Sonosite Edge II Ultrasound System (K162045) and Sonosite X-Porte Ultrasound System (K171437). 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 Sonosite Edge II Ultrasound System (K162045) and Sonosite X-Porte Ultrasound System (K171437). The Sonosite PX Ultrasound device and predicates share indications for use, share modes of operation and have biosafety equivalence. The primary differences are a new form factor to the control panel, which now includes both touch and tactile control panel. Display size on the Sonosite PX is slightly different than those on the predicate devices, but performance evaluation has deemed the screen size not to impact intended use and image quality of the system. Additionally, the Sonosite PX Ultrasound System has a higher transducer frequency range compared to the predicate devices. Where differences are noted with respect to transducer frequency, between the range for the subject device and the predicates, testing to applicable performance standards demonstrates that it does not introduce any new safety or effectiveness concerns. The Sonosite PX Ultrasound system remains substantially unchanged from the predicate with respect to its intended use and performance claims.
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 mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation. All patient contact materials are biocompatible.
22
The Sonosite PX Ultrasound System is designed to comply with the following FDA recognized standards.
| Reference No. | Recognition
No. | Title |
|----------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 | 2-220 | AAMI ANSI ISO 10993-1:2009/(R) 2013, 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 |
| 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 |
| NEMA UD 2-2004 | 12-105 | NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment Revision 3 |
Summary of Clinical Tests:
The Sonosite PX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
Conclusion
Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The Sonosite PX Ultrasound device and predicates conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The Sonosite PX Ultrasound 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, 21CFR820 quality system. FUJIFILM SonoSite, Inc. believes that the Sonosite PX Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices.