Xperius Ultrasound System

K182529 · Philips Ultrasound, Inc. · IYN · Oct 23, 2018 · Radiology

Device Facts

• Record ID: K182529
• Device Name: Xperius Ultrasound System
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Oct 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D), Color Doppler, M-Mode, and Color Power Angio (CPA) modes. It is indicated for diagnostic ultrasound imaging, and fluid flow analysis in the following applications: Abdominal Peripheral Vessel MSK Small Organ Pediatric

Device Story

Xperius Ultrasound System is a software-controlled diagnostic ultrasound device used in clinical settings (hospitals, clinics, surgery centers) by healthcare professionals. It acquires ultrasound data via transducers (C5-2, L12-4) and displays images in B-mode, Color Doppler, M-mode, and Color Power Angio (CPA). The system includes image optimization tools like SonoCT (compounding lines of sight) and XRES (adaptive image processing) to reduce artifacts and improve contrast. It supports clinical workflows including needle visualization, regional anesthesia, and vascular access. Output is displayed for clinician review to assist in diagnostic decision-making. The system integrates with DICOM networks for data management and reporting. It provides patient benefits through non-invasive diagnostic imaging and fluid flow analysis.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence was demonstrated through design features, indications for use, fundamental scientific technology, and non-clinical performance testing (bench testing).

Technological Characteristics

General-purpose ultrasound system; software-controlled. Transducers: C5-2 (curved array), L12-4 (linear array). Frequency: 1-6 MHz. Modes: B, M, Color Doppler, CPA. Features: SonoCT, XRES, iSCAN. Connectivity: DICOM. Power: Tablet-based with battery. Sterilization: Not applicable (external use). Software: Version 1.5.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in abdominal, peripheral vessel, musculoskeletal (conventional and superficial), small organ (breast, thyroid, testicle, prostate, scrotum), and pediatric applications. For use in hospitals, surgery centers, clinics, and physician offices.

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

• Philips Xperius Ultrasound System (K163020)

Reference Devices

• Philips ClearVue 850 Diagnostic Ultrasound System (K153480)
• Philips CX50 Diagnostic Ultrasound System (K162329)
• Philips Lumify Ultrasound System (K162549)

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: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.

October 23, 2018

Philips Ultrasound, Inc % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313

Re: K182529

Trade/Device Name: Xperius Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 15, 2018 Received: October 16, 2018

Dear Mark Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Image /page/1/Picture/5 description: The image shows the name "Michael D. O'hara -S" in large font. To the right of the name is a digital signature, which includes the name "Michael D. O'hara -S" again, as well as the date "2018.10.23 17:30:49-04'00'". The signature also includes information about the signer's identity, such as their country, organization, and organizational units.

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182529

Device Name Xperius Ultrasound System

### Indications for Use (Describe)

Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D), Color Doppler, M-Mode, and Color Power Angio (CPA) modes. It is indicated for diagnostic ultrasound imaging, and fluid flow analysis in the following applications: Abdominal Peripheral Vessel MSK Small Organ Pediatric

The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number: TBD Device name: Xperius Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---|---------|-----|-------------------|---------------------|----------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PW<br>D | CWD | Color<br>Doppler* | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal /Obstetric | | | | | | | |
| | Abdominal | P | N | | | P | | P(3,4,6,8,9)<br>N(5) |
| | Intra-operative (Vascular) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | N | | N(5) |
| | Small Organ (breast,<br>thyroid, testicle) | N | N | | | N | | N(5) |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | N | N | | | N | | N(5) |
| | Musculo-skel. (Superficial) | N | N | | | N | | N(5) |
| | Intra-luminal | | | | | | | |
| | Other (Urology) | | | | | | | |
| | Other (Gynecology) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | N | | | P | | P(3,4,6,8,9)<br>N(5) |
| | Cerebral Vascular | | | | | | | |
| N= new indication; P= previously cleared by FDA K163020; E= added under Appendix E | | | | | | | | |
| Other Modes<br>1. Harmonic (Tissue or Contrast)<br>2. Tissue Doppler Imaging<br>3. iScan<br>4. X-Res | 5. Angio Imaging (CPA)<br>6. SonoCT<br>7. Biopsy Guidance<br>8. Needle Visualization Regional anesthesia, Nerve<br>9., Vascular access | | | | | | | |
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|----------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------|---------|-----|-------------------|---------------------|----------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PW<br>D | CWD | Color<br>Doppler* | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal /Obstetric | | | | | | | |
| | Abdominal | P | N | | | P | | P(3,4,6,8,9)<br>N(5) |
| | Intra-operative (Vascular) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | N | | N(5) |
| | Small Organ (breast,<br>thyroid, testicle) | N | N | | | N | | N(5) |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | N | N | | | N | | N(5) |
| | Musculo-skel. (Superficial) | N | N | | | N | | N(5) |
| | Intra-luminal | | | | | | | |
| | Other (Urology) | | | | | | | |
| | Other (Gynecology) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | N | | | P | | P(3,6,4 8,9)<br>N(5) |
| | Cerebral Vascular | | | | | | | |
| | N= new indication; P= previously cleared by FDA K163020; E= added under Appendix E | | | | | | | |
| Other Modes | | | 5. Angio Imaging (CPA) | | | | | |
| 1. Harmonic (Tissue or Contrast) | | | 6. SonoCT | | | | | |
| 2. Tissue Doppler Imaging | | | 7. Biopsy Guidance | | | | | |
| 3. iScan | | | 8. Needle Visualization, Regional Anesthesia, Nerve | | | | | |
| 4. X-Res | | 9. Vascular Access | | | | | | |

510(k) Number: TBD

System: Xperius Ultrasound system

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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| 510(k) No: | TBD | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|---|---------|-----|-------------------|---------------------|---------------------|
| | System: Xperius Ultrasound System | | | | | | | |
| Transducer: | C5-2 | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PW<br>D | CWD | Color<br>Doppler* | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal /Obstetric | | | | | | | |
| | Abdominal | P | N | | | P | | P (3,4,6,8)<br>N(5) |
| | Intra-operative (Vascular) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | N | | N(5) |
| | Small Organ (breast,<br>thyroid, testicle) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | N | N | | | N | | N(5) |
| | Musculo-skel. (Superficial) | N | N | | | N | | N(5) |
| | Intra-luminal | | | | | | | |
| | Other (Urology) | | | | | | | |
| | Other (Gynecology) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | | | | P | | P (3,4,6,8)<br>N(5) |
| | Cerebral Vascular | | | | | | | |

N= new indication; P= previously cleared by FDA 163020; E=added under Appendix E

| Other Modes | 5. Angio Imaging (CPA) |
|----------------------------------|-------------------------------|
| 1. Harmonic (Tissue or Contrast) | 6. SonoCT |
| 2. Tissue Doppler Imaging | 7. Biopsy Guidance |
| 3. iScan | 8. Regional Anesthesia, Nerve |
| 4. X-Res | 9. Vascular Access |

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability<br>Xperius Traditional 510(k) | Doc. ID:<br>Revision:<br>Doc. date:<br>Page 1 of 95 | 254784<br>C<br>Oct 19, 2018 |
|--------------------------|----------------------------------------------------------------------|-----------------------------------------------------|-----------------------------|
|--------------------------|----------------------------------------------------------------------|-----------------------------------------------------|-----------------------------|

### 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92

- 1) Submitter's name, address, telephone number, contact person
Saraswathi Deora Program Manager- Q&R-Regulatory Affairs [e-mail]

On Behalf Of: Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431

Date Prepared: October 19, 2018

- Name of the device, including the trade or proprietary name if applicable, the common or usual 2) name, and the classification name, if known:

| Common/Usual Name: | Diagnostic Ultrasound system and transducers | | |
|---------------------------------------------------|----------------------------------------------|--------------|------------|
| Proprietary Name: | Xperius Ultrasound System | | |
| Classification: | Class II | | |
| 21 CFR Section | Classification Name | Product Code | |
| 892.1550 | System, Imaging, Pulsed Doppler, Ultrasonic | 90 IYN | |
| 892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | 90 IYO | |
| 892.1570 | Transducer, Ultrasonic, diagnostic | 90 ITX | |
| Substantially Equivalent Devices | | | |
| Primary Predicate Device | | | |
| Philips Xperius Ultrasound System | | K163020 | 11/16/2016 |
| Reference Devices | | | |
| Philips ClearVue 850 Diagnostic Ultrasound System | | K153480 | 12/16/2015 |

Philips CX50 and Sparq Diagnostic Ultrasound Systems K162329 09/14/2016 Philips Lumify Ultrasound System K162549 10/05/2016

#### Device Description 4)

3)

The modified/proposed Xperius Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.

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| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability<br>Xperius Traditional 510(k) | Doc. ID:<br>Revision:<br>Doc. date:<br>Page 2 of 95 | 254784<br>C<br>Oct 19, 2018 |
|--------------------------|----------------------------------------------------------------------|-----------------------------------------------------|-----------------------------|
|--------------------------|----------------------------------------------------------------------|-----------------------------------------------------|-----------------------------|

The modified Xperius Ultrasound System is substantially equivalent to the currently marketed and predicate Philips Xperius Ultrasound System (K163020), Philips ClearVue 850 Diagnostic Ultrasound System (K153480) in terms of design and fundamental scientific technology. The modified Xperius Ultrasound System is provided with additional indications.

#### ર) Intended Use

Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D), Color Doppler, M- Mode, and Color Power Angio (CPA) modes. It is indicated for diagnostic ultrasound imaging, and fluid flow analysis in the following applications: Abdominal Peripheral Vessel MSK Small Organ Pediatric

The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices

#### Comparison of the Design and Technological characteristics ರ್(

A comparison of the design and technological characteristics of the proposed Xperius System to the currently marketed and predicate Xperius is provided in Table 1 below:

| Feature | Proposed Xperius System | Predicate Xperius System<br>(K163020) | Reference ClearVue850<br>(K153480) |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body as follows | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human body<br>as follows | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human body<br>as follows |
| | - | - | Fetal/Obstetric |
| | Abdominal | Abdominal | Abdominal |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | - | Small Organ (breast,<br>thyroid, testicle) |
| | - | - | Adult Cephalic |
| | - | - | Trans-rectal |
| | - | - | Trans-vaginal |
| Indication for Use | Musculo-skel<br>(conventional) | - | Musculo-skel<br>(conventional) |
| | Musculo-skel (superficial) | - | Musculo-skel (superficial) |
| | - | - | Other (Gynecological) |
| | - | - | Cardiac Adult |
| | - | - | Trans-esoph. (Cardiac) |
| | Peripheral vessel | Peripheral vessel | Peripheral vessel |
| | Pediatric | - | Pediatric Neonatal Cephalic<br>Cardiac Pediatric Other<br>(Fetal) Other (Carotid) |
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 254784 |
| | Xperius Traditional 510(k) | Revision:<br>Doc. date:<br>Page 3 of 95 | C<br>Oct 19, 2018 |
| Feature | Proposed Xperius System | Predicate Xperius System<br>(K163020) | Reference ClearVue850<br>(K153480) |
| | | | Cerebral Vascular |
| Transducer Types | C5-2 Curved Array<br>L12-4 Broadband Sector<br>Linear Array | C5-2 Curved Array<br>L12-4 Broadband Sector<br>Linear Array | S4-1 Sector Array<br>C5-2 Curved Array<br>C9-4v Curved Array<br>L12-4<br>Broadband Sector Linear<br>Array<br>3D9-3V<br>V6-2<br>L12-5<br>D2CWc |
| Transducer<br>Frequency | 1-6 Mhz | 1-6Mhz | 1-12Mhz |
| Modes of Operation | B (or 2-D) Color Doppler,<br>M-mode and Color Power<br>Angio (CPA) modes modes<br>include Regional<br>Anesthesia, Vascular<br>access, Needle<br>Visualization, X-Res,<br>SonoCT, iSCAN) | B (or 2-D) Color Doppler,<br>modes include Regional<br>Anesthesia, Vascular<br>access, Needle<br>Visualization, X-Res,<br>SonoCT, iSCAN) | B (or 2-D), M-<br>mode (including<br>Anatomical M- mode),<br>Pulse Wave Doppler,<br>Continuous Wave Doppler,<br>Color Doppler, Tissue<br>Harmonics, iSCAN, X-Res,<br>Color Power Angio, 3D<br>(freehand), 4D and SonoCT,<br>Combined modes includes<br>FloVue, Elastography<br>(strain). |
| PW<br>Doppler | - | Not Available | Available |
| CW<br>Doppler | - | Not Available | Available |
| Patient contact<br>materials | - | Acrylonitrile butadiene<br>styrene<br>Silicone Rubber<br>PVC - Flexible | Acrylonitrile butadiene<br>styrene Silicone Rubber<br>PVC - Flexible |
| 510(k)<br>Track | - | Track 3 | Track 3 |
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 254784 |
| | Xperius Traditional 510(k) | Revision:<br>Doc. date:<br>Page 4 of 95 | C<br>Oct 19, 2018 |
| Feature | Proposed Xperius System | Predicate Xperius System<br>(K163020) | Reference ClearVue850<br>(K153480) |
| Regulatory Class | - | Class II | Class II |

# Technological Characteristics

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| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 254784 |
|--------------------------|----------------------------------------|--------------|--------------|
| | Xperius Traditional 510(k) | Revision: | C |
| | | Doc. date: | Oct 19, 2018 |
| | | Page 5 of 95 | |

Modified and proposed Xperius System that employs the same fundamental scientific technology as that cleared with currently marketed and predicate Philips Xperius Ultrasound System (K163020). The primary difference with an add additional Modes of Operation.

| Features | Proposed Xperius<br>Ultrasound System | Predicate<br>Xperius Ultrasound System (K163020) | Reference<br>ClearVue 850<br>Ultrasound System<br>(K153480) | Reference<br>CX50 Ultrasound<br>System<br>(K162329) | Reference<br>Lumify Ultrasound<br>System<br>(K162549) |
|-------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------|
| Software Revision | 1.5 | 1 | N/A | N/A | N/A |
| Analysis | Same | Non-Qlab quantification is explored, basic<br>measurements,<br>calculations, their configuration and use. Depth<br>and distance measurement | Same | Same | Same |
| Annotation | Same | Users describe the imaging situation and<br>findings, both during the imaging session and in<br>review, by adding words, phrases and body<br>marker graphics to the images. | Same | Same | Same |
| Capture | Same | Single frame and multi frame images (loops) are<br>saved in a persistent manner for later review.<br>The workflow and techniques surrounding<br>prospective and retrospective capture of these<br>images is considered, along with the system<br>impact of offering different post- processing<br>capabilities on the saved data, as well as the<br>size and timing constraints of the platform. | Same | Same | Same |
| Cineloop | Same | Immediate review of a frozen imaging data set is<br>called Cineloop (also known as Quick Review).<br>The feature covers the behavior of all of the<br>imaging modalities. | Same | Same | Same |

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| | | Philips Ultrasound, Inc. | | Quality, Regulatory and Sustainability<br>Xperius Traditional 510(k) | Doc. ID:<br>Revision:<br>Doc. date:<br>Page 6 of 95 | 254784<br>C<br>Oct 19, 2018 | | |
|------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Features | | Proposed Xperius<br>Ultrasound System | | Predicate<br>Xperius Ultrasound System (K163020) | | Reference<br>ClearVue 850<br>Ultrasound System<br>(K153480) | Reference<br>CX50 Ultrasound<br>System<br>(K162329) | Reference<br>Lumify Ultrasound<br>System<br>(K162549) |
| Color | | In addition to Color<br>Flow , CPA was added<br>Color Power Angio<br>(CPA): Real time two-<br>dimensional imaging<br>composed of a gray<br>scale image with flow<br>amplitude displayed as<br>a color overlay. | | The feature covers Color Flow. | | The feature covers<br>Color Flow, CPA, TDI<br>(Tissue Doppler<br>Imaging) and BFlow. | 2D Color<br>Doppler<br>Imaging<br>Tissue<br>Doppler<br>Imaging and<br>Harmonics<br>(Tissue and<br>Contrast)<br>Combination modes | The feature covers<br>Color Flow |
| Connectivity | | Same | | DICOM protocol support for networks, printers,<br>servers, and removable media. | | Same | Same | Same |
| DNL | | Same | | The Digital Navigation Link (DNL) provides a<br>peer-topeer network connection to an external<br>interventional workstation transmitting 2D and<br>3D ultrasound image data in real-time.<br>Communication between the two systems is<br>handled over a DICOM-like communication<br>protocol. | | Same | Same | Same |
| Echo | | Same | | 2D black and white image generation, acquired<br>black and white Mmode data, and anatomical<br>Mmode are covered by this feature. | | Same | Same | Same |
| External AV<br>Support | | Same | | Ultrasound systems support connections to<br>external audio/visual devices, such as external<br>monitors (for operating room or additional<br>viewing during scans, and for trade-show<br>exhibits with large screen monitors), external | | Same | N/A | N/A |

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| Features | Proposed Xperius<br>Ultrasound System | Predicate<br>Xperius Ultrasound System (K163020) | Reference<br>ClearVue 850<br>Ultrasound System<br>(K153480) | Reference<br>CX50 Ultrasound<br>System<br>(K162329) | Reference<br>Lumify Ultrasound<br>System<br>(K162549) |
|--------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------|
| | | real-time capture devices (e.g. VCR and DVR),<br>and external single frame capture devices (e.g.<br>printers). We may also have support of an<br>integrated (i.e. controlled by the system) VCR or<br>DVR with the system – both the recording of<br>voice and video onto the device and replay of<br>the device back into the system. | | | |
| Help | Same | The display of helpful information to the user<br>during the use of the ultrasound system. | Same | Same | Same |
| iSPI | Same | The intelligent Service Platform Interface that<br>provides common service features across Philips<br>products. | Same | N/A | N/A |
| Install and<br>Upgrades | Same | Installation of software and hardware<br>capabilities by all affected users of the system:<br>field service, manufacturing, engineers, and end<br>users (for upgrades and patches). | Same | Same | Same |
| Localization | No new languages.<br>Additional user<br>manuals: Czech, Slovak<br>and Korea | Provides the user with the ability to use the<br>system with their localization settings. This<br>includes the user interface language, the<br>keyboard language, and the locale for numeric,<br>and time display settings.…