(28 days)
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.
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.
The provided text is a 510(k) Pre-Market Notification for the FUJIFILM SonoSite PX Ultrasound System. It focuses on demonstrating substantial equivalence to existing predicate devices (SonoSite Edge II Ultrasound System and SonoSite X-Porte Ultrasound System) rather than presenting a study to prove acceptance criteria for a new AI/algorithm-based diagnostic device.
Therefore, many of the requested details about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, and comparative effectiveness studies are not applicable as they are specific to studies evaluating the performance of diagnostic algorithms.
However, I can extract and summarize the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, AUC) for an AI or algorithmic function. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards.
The "reported device performance" in this context refers to the device's ability to perform various ultrasound imaging modes across different clinical applications, which is considered equivalent to the predicate devices.
| Feature / Criterion | Sonosite PX Ultrasound System (This submission) | Predicate Devices (SonoSite Edge II & X-Porte) |
|---|---|---|
| Intended Use | 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 (Clinical Applications) | 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. | Similar clinical applications (Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Fetal - OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Small Organ, Trans-vaginal, Peripheral vessel, Neonatal Cephalic, Trans-Rectal (Edge II), Trans-esophageal (Cardiac) (Edge II & X-Porte), Needle Guidance). Some minor differences exist (e.g., PX has "Adult Cephalic" but not "Neonatal Cephalic" explicitly listed in its primary indication table, though it is general purpose). |
| Modes of Operation | B-mode Grayscale Imaging, Tissue Harmonic Imaging, M-mode, Simultaneous M-Mode, Color Power Doppler, Zoom, Combination Modes, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Speckle reduction algorithm, SonoMB/MBe Image Compounding, CW Doppler, Velocity Color Doppler, Tissue Doppler Imaging (TDI). | Similar modes, including B-mode, M-mode, PW Doppler, CW Doppler, Color Power Doppler, Tissue Harmonic Imaging, SonoHD2 Noise Reduction (instead of speckle reduction algorithm, though similar function), SonoMB/MBe Image Compounding, Velocity Color Doppler, Tissue Doppler Imaging (TDI). |
| Transducer Frequency Range | 1.0-19.0 MHz | 1.0-15.0 MHz |
| Acoustic Output (Worst Case) | I_spta.3: 607 mW/cm^2 (L12-3); 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) [Edge II], 629.3 (P21xp) [X-Porte]; TI Value: 4.98 (rP19x) [Edge II], 4.0 (P21xp) [X-Porte]; MI: 1.7 (rP19x) [Edge II], 1.7 (P21xp) [X-Porte]; I_pa.3 @MI Max: 776 (L38xi) [Edge II], 678 (L38xp) [X-Porte]. |
| Product Safety Certification | Complies with AAMI/ANSI ES60601-1, IEC 60601-2-37, CAN/CSA-C22.2 No. 60601-1, JSA JIS T 0601-1, IEC 61157, NEMA UD 2-2004, IEC 62359. | Complies with similar and relevant versions of safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, NEMA UD2-2004, IEC 62359). |
| EMC Compliance | Complies with IEC 60601-1-2:2014, CISPR 11:2015+AMD1:2016+AMD2:2019, IEC 61000-4 series. | Complies with AAMI / ANSI / IEC 60601-1-2:2007 (R)2012 CISPR 11, IEC 61000-4 pt 2-5 (X-Porte). |
| Number of Transmit/Receive Channels | 128 digital channels (Transmit), 128 digital channels (Receive) | 128 digital channels (Transmit) [Edge II & X-Porte]; 64 digital channels (Receive) [Edge II & X-Porte], with X-Porte also noting "128 digital channels using Synthetic Aperture". |
| Biocompatibility | All patient contact materials are biocompatible (Silicone Rubber, Polysulfone, PolyVinylChloride (PVC), Silicone RTV Adhesive, Silicone). | Patient contact materials listed for transducers and needle guides, similar materials used (e.g., ABS, Polysulfone, Polyurethane, Silicone Rubber, PVC). |
2. Sample size used for the test set and data provenance:
- Not Applicable. The document explicitly states: "The Sonosite PX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." Non-clinical tests were conducted for safety and technological characteristics, not for clinical performance evaluation comparable to an AI algorithm's test set.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not Applicable. No clinical test set requiring expert ground truth was conducted for this submission. The device is a general-purpose ultrasound system, and its functionality relies on the interpretation of images by qualified healthcare professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring adjudication was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- Not Applicable. This is a submission for a general-purpose ultrasound imaging system, not an AI-assisted diagnostic algorithm. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is an imaging system, not a standalone algorithm. Its intended use is for qualified physicians and healthcare professionals to perform evaluations using the ultrasound images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As no clinical studies were performed to establish performance metrics for a diagnostic algorithm, no specific ground truth type was established for that purpose. The "ground truth" for demonstrating substantial equivalence was conformity to recognized safety standards and verification of technological functionality against predicate devices.
8. The sample size for the training set:
- Not Applicable. This device is an ultrasound system. While it includes "software controlled" elements and features like "Speckle reduction algorithm" and "SonoMB/MBe Image Compounding," these are traditional image processing techniques inherent to ultrasound technology, not machine learning algorithms that would require a distinct "training set" in the modern AI sense.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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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
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- 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
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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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1.3 INDICATIONS FOR USE
The indications for use are listed in the FDA defined tables on the following pages.
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| System: | Sonosite PX Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | N/A | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler(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 (Abdominalorgans 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 humanbody as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler(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 (Abdominalorgans 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
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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
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| System: | Sonosite PX Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | L15-4 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler(C) | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominalorgans 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
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| 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 | ColorDoppler(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 (Abdominalorgans 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
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| System: | Sonosite PX Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C5-1 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler(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 (Abdominalorgans 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
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| 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 humanbody as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler(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 (Abdominalorgans 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
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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 humanbody as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler(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/GYNAbdominal | |||||||
| Intra-operative (Abdominalorgans 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
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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.
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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.
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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 |
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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.
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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.
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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 UltrasoundSystem(This submission) | SonoSite Edge IIUltrasound System(K162045) | SonoSite X-PorteUltrasound System(K171437) |
|---|---|---|---|
| Intended Use | Diagnostic ultrasound imagingor fluid flow analysis of thehuman body | Diagnostic ultrasoundimaging or fluid flowanalysis of thehuman body | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody |
| Indications forUse | AbdominalAdult CephalicCardiac AdultCardiac PediatricFetal - OB/GYNMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)OphthalmicPediatricPeripheral vesselSmall Organ (breast, thyroid,testicles, prostate)TransvaginalNeedle Guidance | AbdominalAdult CephalicCardiac AdultCardiac PediatricFetal - OB/GYNMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)OphthalmicPediatricSmall Organ (breast,thyroid, testicles,prostate)Trans-vaginalPeripheral vesselNeonatal CephalicTrans-RectalTrans-esophageal(cardiac)Needle Guidance | AbdominalAdult CephalicCardiac AdultCardiac PediatricFetal - OB/GYNMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)OphthalmicPediatricSmall Organ (breast, thyroidtesticles, prostate)Trans-vaginalPeripheral vesselNeonatal CephalicTrans-esophageal(cardiac)Needle Guidance |
| TransducerTypes | Linear ArrayCurved ArrayPhased ArrayIntracavitary | Linear ArrayCurved Linear ArrayPhased ArrayIntracavitaryTrans-esophageal | Linear ArrayCurved Linear ArrayPhased ArrayIntracavitaryStatic ProbesTrans-esophageal |
| TransducerFrequency | 1.0-19.0 MHz | 1.0 – 15.0 MHz | 1.0 – 15.0 MHz |
| GlobalMaximumOutputs/WorstCase 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 OutputsMI Output DisplayTI Output Display | Display Feature for Higher OutputsMI Output DisplayTI Output Display | Display Feature for Higher OutputsMI Output DisplayTI Output Display |
| Modes of Operation | B-mode Grayscale ImagingTissue Harmonic ImagingM-mode | B-mode Grayscale ImagingTissue Harmonic ImagingM-mode | B-mode Grayscale ImagingTissue Harmonic ImagingM-mode |
| Simultaneous M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSpeckle reduction algorithmSonoMB/MBe Image | Color M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise Reduction | Simultaneous M-ModeColor Power DopplerZoomCombination ModesSimultaneous PW ImagingPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise Reduction | |
| CompoundingCW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI) | SonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI) | SonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI) | |
| DICOM | DICOM 3.0Store 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 usingSynthetic Aperture) |
| Feature | Sonosite PX UltrasoundSystem(This submission) | SonoSite Edge IIUltrasound System(K162045) | SonoSite X-PorteUltrasound System(K171437) |
| (128 digital channelsusing SyntheticAperture) | |||
| Patient ContactMaterials | Silicone RubberPolysulfonePolyVinylChloride (PVC)Silicone RTV AdhesiveSilicone | Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyEpoxy pasteadhesivePolyethylene (PE)IonomerPolyetheretherketone(PEEK)PolycarbonatePolysulfonePolyurethanePoly-Vinyl-Chloride(PVC)Silicone RTVAdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS) | Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive,Type AEpoxy paste adhesiveEpoxy resinPolyetherimidePolyethylene (PE) IonomerPolyetheretherketone(PEEK)PolysulfonePolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS) |
| Product SafetyCertification | AAMI/ANSI ES60601-1:2005(R2012)IEC 60601-2-37:2007+AMD1:2015CAN/CSA-C22.2 No. 60601-1:14JSA JIS T 0601-1:2017, JSAJIS T 0601-2-37IEC 61157:2007+AMD1:2013NEMA UD 2-2004 (R2009)IEC 62359:2010+AMD1:2017 | AAMI/ANSIES60601-1:2005(R2012)IEC 60601-2-37:2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004IEC 62359:2010 | AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.601.1JIS T 0601-1, JIS T 1507CEI/IEC 61157ANSI/AAMI EC53NEMA UD2-2004IEC 62359:2010 |
| Feature | Sonosite PX UltrasoundSystem(This submission) | SonoSite Edge IIUltrasound System(K162045) | SonoSite X-PorteUltrasound System(K171437) |
| EMCCompliance | IEC 60601-1-2:2014CISPR 11:2015+AMD1:2016+AMD2:2019IEC 61000-4-2IEC 61000-4-3IEC 61000-4-4IEC 61000-4-5IEC 61000-4-6IEC 61000-4-8IEC 61000-4-11 | AAMI / ANSI / IEC60601-1-2:2007(R)2012 CISPR11, Group 1,Class A | IEC 60601-1-2:2007CISPR 11IEC 61000-4 pt 2-5 |
| DICOMAirborneEquipmentStandards | DICOM PS3.15 2019Not applied | NEMA PS3.15 2003RTCA/DO160(section 21) | NEMA PS3.15 2003RTCA/DO160D (section21) |
| SystemCharacteristics | Sonosite PX: | Edge II: | X-Porte (standconfiguration): |
| Beamformer 128/128 usingSA (configurable)12.1" Capacitive touchscreen interface15.6" LED LCD HD monitor256 gray shades on LED LCD | Beamformer 128/128using SA (configurable)Hand held displayand controlSingle 12.1" LiquidCrystal Display (LCD)256 gray shades onLCD | Beamformer 128/128using SA (configurable)12.1" Capacitive touchscreen interface19" LED LCD HD monitor256 gray shades on LEDLCD | |
| 2 USB 3.04 USB 2.0 | 2 USB ports | 6 USB 2.0 ports | |
| Stand Base Dimensions: 26.4"L x 21.2" WStand Height (max): 64"(monitor up)Stand Height (min): 42.2"(monitor down) | Dimensions: 12.8"(W) x12.1" (L) x 2.5"(H) | Stand Base Dimensions:26.4" L x 21.2" WStand Height (max): 64"(monitor up)Stand Height (min): 42.2"(monitor down) | |
| Weight: 149.35 lbs (fullyconfigured w/ 3 transducersand stand baseWeight: 32.80 lbs (w/1 transducer) | Weight: 9.0 lbs | Weight: 149.35 lbs (fullyconfigured w/ 3transducers | |
| System operates via battery or AC powerBattery life: 1 hour imaging -10 days idleInput: 100 – 240 VAC, 50/60 HzOutput 1: 26.7VDC output, 220 W maxSystem on stand:Input: 100 – 240 VAC, 50/60 HzOutput 1: 26.7VDC output, 220 W maxOutput 2: 100-240VAC, 50-60 Hz(AC Printer)Various obstetrical, cardiac,volume, M-mode, PW andCW Doppler measurementand calculation packagesWireless 802.11 (a/b/g/n)support for image transferAdditional system features:Assisted Cardiac Output(ACO) – Available onSonosite PX system | System operates viabattery or AC powerBattery life: 1.5 - 4hour operation perCharge100 – 240V options,50/60 Hz, 15VDCOutputVarious obstetrical,cardiac, volume, M- mode,PW and CW Dopplermeasurement andcalculation packagesECG acquisition anddisplay capabilitiesCW/PW Doppler AudioSpectral Doppler Audioand image storage onremovable mediaWireless 802.11(b/g/n)support for image transferAdditional systemfeatures:Assisted Cardiac Output (ACO) –Available on Edge II system | System operates viabattery or AC powerBattery life: 1 houroperational - 3 days idleInput: 100 – 240 VAC,50/60 HzOutput 1: 24VDC output, 275W maxOutput 2: 100-240VAC,50-60 Hz (AC Printer, DCPrinter)Various obstetrical,cardiac, volume, M-mode,PW and CW Dopplermeasurement andcalculation packagesECG acquisition anddisplay capabilities CW/PWDoppler Audio SpectralDoppler Audio and imagestorage on removablemedia Measurement onRecalled Images.Wireless 802.11 (a/b/g/n)support for image transferX-Porte (desktopconfiguration):Same softwarefeatures/capabilities as thestand configuration. Doesnot have the stand, touchpanel interface, DVR, andmobile power unit.Weight: 32.80 lbs (w/ 1transducer)AC power only.100 – 240V options, 50/60Hz | |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
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A1 510(k) Summary
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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.
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The Sonosite PX Ultrasound System is designed to comply with the following FDA recognized standards.
| Reference No. | RecognitionNo. | Title |
|---|---|---|
| ISO 10993-1 | 2-220 | AAMI ANSI ISO 10993-1:2009/(R) 2013, Biologicalevaluation of medical devices -- Part 1: Evaluation andtesting 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 (ConsolidatedText) Medical electrical equipment -- Part 1: Generalrequirements for basic safety and essential performance(IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 | 19-8 | ANSI AAMI IEC 60601-1-2:2014Medical electrical equipment -- Part 1-2: Generalrequirements 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 2013-10Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance- Collateral standard: Usability |
| IEC 60601-2-37 | 12-293 | IEC 60601-2-37 Edition 2.1 2015Medical electrical equipment - Part 2-37: Particularrequirements for the basic safety and essentialperformance of ultrasonic medical diagnostic andmonitoring equipment |
| IEC 62304 | 13-79 | ANSI AAMI IEC 62304:2006/A1:2016Medical 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 DiagnosticUltrasound 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.
§ 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.