Sonosite PX Ultrasound System
Device Facts
| Record ID | K200964 |
|---|---|
| Device Name | Sonosite PX Ultrasound System |
| Applicant | FUJIFILM Sonosite, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | May 8, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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.
Device Story
Sonosite PX is a general-purpose, software-controlled diagnostic ultrasound system. It acquires and displays real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Tissue Harmonic Imaging. The system supports needle guidance via fixed-angle in-plane or transverse-angle out-of-plane brackets. Used in hospitals, clinics, and point-of-care settings by physicians and healthcare professionals. The system features a 12.1-inch capacitive touch screen and 15.6-inch LED LCD monitor. It provides measurement and calculation packages for obstetrical, cardiac, and vascular applications. Output is displayed for clinician review to assist in diagnosis and needle/catheter placement. The device benefits patients by providing high-resolution imaging for clinical evaluation and procedural guidance.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical, thermal, mechanical, and EMC safety, biocompatibility, and acoustic output evaluation.
Technological Characteristics
Materials: Silicone rubber, polysulfone, PVC, silicone RTV adhesive. Sensing: Ultrasonic pulsed Doppler/echo imaging. Energy: Battery or AC power (100-240 VAC). Form factor: Stand-mounted with 12.1" touch interface and 15.6" LED LCD. Connectivity: Wireless 802.11 (a/b/g/n), USB 3.0/2.0. Software: Rule-based/algorithmic processing for imaging modes and measurements. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1, NEMA UD 2-2004.
Indications for Use
Indicated for prescription use by qualified physicians/healthcare professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. Applications include abdominal, adult/pediatric cardiac, fetal OB/GYN, musculoskeletal (conventional/superficial), ophthalmic, pediatric, peripheral vessel, small organ (breast, thyroid, testicles, prostate), transvaginal, and needle guidance.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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
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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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) | |
|-------------------------------------------------------------------------------------------------------|--|
| <div> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |
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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 human<br>body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | c, e, f | | |
| Fetal – OB/GYN | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | c, e, f, h | | |
| Abdominal | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD; | c, e, f | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | | |
| Intra-operative (Neuro.)<br>Laparoscopic | | | | | | | | | |
| Pediatric | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD; | b, c, e, f, h | | |
| Small Organ (breast, thyroid,<br>testicles, prostate) | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | b, c, e, f, h | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | f | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | N | N | N | N | N | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | b, c, e, f, h | | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | b, c, e, f, h | | |
| Intra-luminal | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; B+CWD;<br>B+C; (B+C)+PWD;<br>(B+C)+CWD | c, d, g, f | | |
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+CWD;<br>B+C; (B+C)+PWD;<br>(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;<br>(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<br>body as follows: | | | | | | | |
| | Clinical Application | Mode of Operation | | | | | | | |
| | | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) | |
| | Ophthalmic | N | N | N | | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | e, f | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | B+M; B+PWD; B+C;<br>(B+C)+PWD; | b, c, e, f, h | |
| | Small Organ (breast, thyroid,<br>testicles. prostate) | N | N | N | | N | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | b, c, e, f, h | |
| | Musculo-skel. (Superfic.) | N | N | N | | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | b, c, e, f, h | |
| | Intra-luminal | | | | | | | | |
| | Cardiac Adult | N | N | N | | N | B+M;B+PWD;B+C;(B+C)+<br>PWD | f | |
| | Cardiac Pediatric | N | N | N | | N | B+M;B+PWD;B+C;(B+C)+<br>PWD | f | |
| | Trans-esophageal (card.) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Peripheral vessel | N | N | N | | N | B+M; B+PWD; B+C;<br>(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 human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | N | B+M; B+PWD; B+C;<br>(B+C)+PWD; | b, c, e, f |
| Small Organ (breast, thyroid,<br>testicles, prostate) | N | N | N | | N | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | b, c, e, f |
| Musculo-skel. (Superfic.) | N | N | N | | N | B+M; B+PWD; B+C;<br>(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;<br>(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 | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | N | N | N | | N | B+M; B+PWD, B+C;<br>(B+C)+PWD | e, f | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | B+M; B+PWD; B+C;<br>(B+C)+PWD; | b, c, e, f | |
| Small Organ (breast, thyroid,<br>testicles, prostate) | N | N | N | | N | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | b, c, e, f | |
| Musculo-skel. (Superfic.) | N | N | N | | N | B+M; B+PWD; B+C;<br>(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;<br>(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 human<br>body as follows: | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | c, e, f |
| Fetal - OB/GYN | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | c, e, f |
| Abdominal | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | c, e, f |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | b, c, e, f |
| Small Organ (breast, thyroid,<br>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;<br>(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;<br>(B+C)+PWD | f |
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | f |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | N | N | N | N | N | B+M; B+PWD; B+C;<br>(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<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal - OB/GYN | N | N | N | | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | c, g |
| Abdominal | N | N | N | | N | B+M; B+PWD; B+C;<br>(B+C)+PWD; | c, e, f |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>testicles. prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | N | N | N | | N | B+M; B+PWD; B+C;<br>(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;<br>B+C; (B+C)+PWD;<br>(B+C)+CWD | c, d, g, f |
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+CWD;<br>B+C; (B+C)+PWD;<br>(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 human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | N | N | N | | N | B+M; B+PWD; B+C;<br>(B+C)+PWD | c, e, f, h |
| Fetal - OB/GYN<br>Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>testicles. prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | N | N | N | | N | B+M; B+PWD; B+C;<br>(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.
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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.
- 2. 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 |
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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.
{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<br>System<br>(This submission) | SonoSite Edge II<br>Ultrasound System<br>(K162045) | SonoSite X-Porte<br>Ultrasound System<br>(K171437) |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging<br>or fluid flow analysis of the<br>human body | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the<br>human body |…
