(39 days)
No
The document mentions "Adaptive image processing" and "millions of calculations" but does not explicitly state the use of AI, ML, or related terms like deep learning or neural networks. The description of image processing techniques like XRES and SonoCT are standard ultrasound image enhancement methods, not necessarily indicative of AI/ML.
No.
The device is clearly stated as intended for "diagnostic Ultrasound imaging" and its function is to "acquire ultrasound data and to display the data in various modes of operation," which indicates a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic Ultrasound imaging" and "is indicated for diagnostic ultrasound imaging". The "Device Description" also refers to it as a "general purpose, software controlled, diagnostic ultrasound system."
No
The device description explicitly states it is a "software controlled, diagnostic ultrasound system," implying the presence of hardware components (the ultrasound system itself) that the software controls. The performance studies also mention compliance with standards related to electrical safety and medical electrical equipment (IEC 60601 series), which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "diagnostic Ultrasound imaging" and "fluid flow analysis." These are imaging modalities used to visualize structures and processes within the body, not to perform tests on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces that it's a "diagnostic ultrasound system" that "acquire[s] ultrasound data and to display the data." This aligns with in-vivo imaging, not in-vitro testing.
- Lack of mention of sample analysis: There is no mention of the device being used to analyze biological samples or reagents, which is a core characteristic of IVD devices.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a physiological state, disease, or condition. This ultrasound system operates by sending and receiving sound waves into the body to create images.
N/A
Intended Use / Indications for Use
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)
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
General (Track I only) Specific (Tracks I & III)
Ophthalmic Ophthalmic
Fetal /Obstetric
Abdominal
Intra-operative (Vascular)
Intra-operative (Neuro)
Fetal Imaging & Other Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicle)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Urology)
Other (Gynecology)
Cardiac Cardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (Fetal Echo)
Peripheral Vessel Peripheral vessel
Cerebral Vascular
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Peripheral Vessel, MSK (Musculoskeletal), Small Organ (breast, thyroid, testicle), Pediatric. Specific applications listed are: Fetal /Obstetric, Intra-operative (Vascular and Neuro), Laparoscopic, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Cardiac), Intra-luminal, Urology, Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Fetal Echo, Cerebral Vascular.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, surgery centers, clinics, and physician offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests performed on in this premarket notification submission for a determination of substantial equivalence demonstrates compliance with the following standards
- AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance). IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
- . AAMI/ANSI/IEC 60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests and IEC 60601-1-2:2014: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- ISO 10993: Biological evaluation of medical devices ●
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety of ultrasonic ● medical diagnostic and monitoring equipment
Quality assurance measures applied to the system design and development include, but were not limited to the following: - Risk Analysis
- Product Specifications
- Design Reviews ●
- Verification and Validation
The proposed Xperius Ultrasound System did not require clinical studies since substantial equivalence to the currently marketed predicate devices, Philips Xperius Ultrasound System was demonstrated with the following attributes:
- Design features; ●
- Indication for use;
- Fundamental scientific technology; ●
- Non-clinical performance testing; and
- . Safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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 | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PW | |||||
| D | CWD | Color | ||||||
| Doppler* | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal /Obstetric | ||||||||
| Abdominal | P | N | P | P(3,4,6,8,9) | ||||
| N(5) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N(5) | ||||
| Small Organ (breast, | ||||||||
| thyroid, testicle) | N | N | N | N(5) | ||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. | ||||||||
| (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 | ||||||||
| Vessel | Peripheral vessel | P | N | P | P(3,4,6,8,9) | |||
| N(5) | ||||||||
| Cerebral Vascular | ||||||||
| N= new indication; P= previously cleared by FDA K163020; E= added under Appendix E | ||||||||
| Other Modes |
- Harmonic (Tissue or Contrast)
- Tissue Doppler Imaging
- iScan
- X-Res | 5. Angio Imaging (CPA)
- SonoCT
- Biopsy Guidance
- Needle Visualization Regional anesthesia, Nerve
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)
4
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PW | |||||
| D | CWD | Color | ||||||
| Doppler* | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal /Obstetric | ||||||||
| Abdominal | P | N | P | P(3,4,6,8,9) | ||||
| N(5) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N(5) | ||||
| Small Organ (breast, | ||||||||
| thyroid, testicle) | N | N | N | N(5) | ||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. | ||||||||
| (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 | ||||||||
| Vessel | Peripheral vessel | P | N | P | P(3,6,4 8,9) | |||
| 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)
5
| 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 | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PW | |||||
| D | CWD | Color | ||||||
| Doppler* | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal /Obstetric | ||||||||
| Abdominal | P | N | P | P (3,4,6,8) | ||||
| N(5) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N(5) | ||||
| Small Organ (breast, | ||||||||
| thyroid, testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. | ||||||||
| (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 | ||||||||
| Vessel | Peripheral vessel | P | P | P (3,4,6,8) | ||||
| 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)
6
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability
Xperius Traditional 510(k) | Doc. ID:
Revision:
Doc. date:
Page 1 of 95 | 254784
C
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
-
- Submitter's name, address, telephone number, contact person
Saraswathi Deora Program Manager- Q&R-Regulatory Affairs Saraswathi.Deora@philips.com
- Submitter's name, address, telephone number, contact person
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)
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
Xperius Traditional 510(k) | Doc. ID:
Revision:
Doc. date:
Page 2 of 95 | 254784
C
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
(K163020) | Reference ClearVue850
(K153480) |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body as follows | Diagnostic ultrasound
imaging or fluid flow
analysis of the human body
as follows | Diagnostic ultrasound
imaging or fluid flow
analysis of the human body
as follows |
| | - | - | Fetal/Obstetric |
| | Abdominal | Abdominal | Abdominal |
| | Small Organ (thyroid,
scrotum, prostate, breast) | - | Small Organ (breast,
thyroid, testicle) |
| | - | - | Adult Cephalic |
| | - | - | Trans-rectal |
| | - | - | Trans-vaginal |
| Indication for Use | Musculo-skel
(conventional) | - | Musculo-skel
(conventional) |
| | Musculo-skel (superficial) | - | Musculo-skel (superficial) |
| | - | - | Other (Gynecological) |
| | - | - | Cardiac Adult |
| | - | - | Trans-esoph. (Cardiac) |
| | Peripheral vessel | Peripheral vessel | Peripheral vessel |
| | Pediatric | - | Pediatric Neonatal Cephalic
Cardiac Pediatric Other
(Fetal) Other (Carotid) |
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 254784 |
| | Xperius Traditional 510(k) | Revision:
Doc. date:
Page 3 of 95 | C
Oct 19, 2018 |
| Feature | Proposed Xperius System | Predicate Xperius System
(K163020) | Reference ClearVue850
(K153480) |
| | | | Cerebral Vascular |
| Transducer Types | C5-2 Curved Array
L12-4 Broadband Sector
Linear Array | C5-2 Curved Array
L12-4 Broadband Sector
Linear Array | S4-1 Sector Array
C5-2 Curved Array
C9-4v Curved Array
L12-4
Broadband Sector Linear
Array
3D9-3V
V6-2
L12-5
D2CWc |
| Transducer
Frequency | 1-6 Mhz | 1-6Mhz | 1-12Mhz |
| Modes of Operation | B (or 2-D) Color Doppler,
M-mode and Color Power
Angio (CPA) modes modes
include Regional
Anesthesia, Vascular
access, Needle
Visualization, X-Res,
SonoCT, iSCAN) | B (or 2-D) Color Doppler,
modes include Regional
Anesthesia, Vascular
access, Needle
Visualization, X-Res,
SonoCT, iSCAN) | B (or 2-D), M-
mode (including
Anatomical M- mode),
Pulse Wave Doppler,
Continuous Wave Doppler,
Color Doppler, Tissue
Harmonics, iSCAN, X-Res,
Color Power Angio, 3D
(freehand), 4D and SonoCT,
Combined modes includes
FloVue, Elastography
(strain). |
| PW
Doppler | - | Not Available | Available |
| CW
Doppler | - | Not Available | Available |
| Patient contact
materials | - | Acrylonitrile butadiene
styrene
Silicone Rubber
PVC - Flexible | Acrylonitrile butadiene
styrene Silicone Rubber
PVC - Flexible |
| 510(k)
Track | - | Track 3 | Track 3 |
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 254784 |
| | Xperius Traditional 510(k) | Revision:
Doc. date:
Page 4 of 95 | C
Oct 19, 2018 |
| Feature | Proposed Xperius System | Predicate Xperius System
(K163020) | Reference ClearVue850
(K153480) |
| Regulatory Class | - | Class II | Class II |
Technological Characteristics
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9
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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
Ultrasound System | Predicate
Xperius Ultrasound System (K163020) | Reference
ClearVue 850
Ultrasound System
(K153480) | Reference
CX50 Ultrasound
System
(K162329) | Reference
Lumify Ultrasound
System
(K162549) |
|-------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------|
| Software Revision | 1.5 | 1 | N/A | N/A | N/A |
| Analysis | Same | Non-Qlab quantification is explored, basic
measurements,
calculations, their configuration and use. Depth
and distance measurement | Same | Same | Same |
| Annotation | Same | Users describe the imaging situation and
findings, both during the imaging session and in
review, by adding words, phrases and body
marker graphics to the images. | Same | Same | Same |
| Capture | Same | Single frame and multi frame images (loops) are
saved in a persistent manner for later review.
The workflow and techniques surrounding
prospective and retrospective capture of these
images is considered, along with the system
impact of offering different post- processing
capabilities on the saved data, as well as the
size and timing constraints of the platform. | Same | Same | Same |
| Cineloop | Same | Immediate review of a frozen imaging data set is
called Cineloop (also known as Quick Review).
The feature covers the behavior of all of the
imaging modalities. | Same | Same | Same |
11
| | | Philips Ultrasound, Inc. | | Quality, Regulatory and Sustainability
Xperius Traditional 510(k) | Doc. ID:
Revision:
Doc. date:
Page 6 of 95 | 254784
C
Oct 19, 2018 | | |
|------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Features | | Proposed Xperius
Ultrasound System | | Predicate
Xperius Ultrasound System (K163020) | | Reference
ClearVue 850
Ultrasound System
(K153480) | Reference
CX50 Ultrasound
System
(K162329) | Reference
Lumify Ultrasound
System
(K162549) |
| Color | | In addition to Color
Flow , CPA was added
Color Power Angio
(CPA): Real time two-
dimensional imaging
composed of a gray
scale image with flow
amplitude displayed as
a color overlay. | | The feature covers Color Flow. | | The feature covers
Color Flow, CPA, TDI
(Tissue Doppler
Imaging) and BFlow. | 2D Color
Doppler
Imaging
Tissue
Doppler
Imaging and
Harmonics
(Tissue and
Contrast)
Combination modes | The feature covers
Color Flow |
| Connectivity | | Same | | DICOM protocol support for networks, printers,
servers, and removable media. | | Same | Same | Same |
| DNL | | Same | | The Digital Navigation Link (DNL) provides a
peer-topeer network connection to an external
interventional workstation transmitting 2D and
3D ultrasound image data in real-time.
Communication between the two systems is
handled over a DICOM-like communication
protocol. | | Same | Same | Same |
| Echo | | Same | | 2D black and white image generation, acquired
black and white Mmode data, and anatomical
Mmode are covered by this feature. | | Same | Same | Same |
| External AV
Support | | Same | | Ultrasound systems support connections to
external audio/visual devices, such as external
monitors (for operating room or additional
viewing during scans, and for trade-show
exhibits with large screen monitors), external | | Same | N/A | N/A |
12
| Features | Proposed Xperius
Ultrasound System | Predicate
Xperius Ultrasound System (K163020) | Reference
ClearVue 850
Ultrasound System
(K153480) | Reference
CX50 Ultrasound
System
(K162329) | Reference
Lumify Ultrasound
System
(K162549) |
|--------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------|
| | | real-time capture devices (e.g. VCR and DVR),
and external single frame capture devices (e.g.
printers). We may also have support of an
integrated (i.e. controlled by the system) VCR or
DVR with the system – both the recording of
voice and video onto the device and replay of
the device back into the system. | | | |
| Help | Same | The display of helpful information to the user
during the use of the ultrasound system. | Same | Same | Same |
| iSPI | Same | The intelligent Service Platform Interface that
provides common service features across Philips
products. | Same | N/A | N/A |
| Install and
Upgrades | Same | Installation of software and hardware
capabilities by all affected users of the system:
field service, manufacturing, engineers, and end
users (for upgrades and patches). | Same | Same | Same |
| Localization | No new languages.
Additional user
manuals: Czech, Slovak
and Korea | Provides the user with the ability to use the
system with their localization settings. This
includes the user interface language, the
keyboard language, and the locale for numeric,
and time display settings. | Same | Same | Same |
| Output Control
System | Same | The Output Control System (OCS) monitors and
controls acoustic and thermal output emitted
from the system through
the transducer. Its design must meet system
requirements imposed by regulating industries.
OCS exposes the Auto-Test Interface (ATI) used
by the | Same | Same | Same |
13
| Philips Ultrasound, Inc. | | | Quality, Regulatory and Sustainability
Xperius Traditional 510(k) | | | Doc. ID:
Revision:
Doc. date:
Page 8 of 95 | 254784
C
Oct 19, 2018 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-----------------------------|
| Features | Proposed Xperius
Ultrasound System | Predicate
Xperius Ultrasound System (K163020) | Reference
ClearVue 850
Ultrasound System
(K153480) | Reference
CX50 Ultrasound
System
(K162329) | Reference
Lumify Ultrasound
System
(K162549) | | |
| Peripherals | Same | Acoustic Measurement Department (AMD) to
collect system data and verify OCS operation.
Peripherals assigns external devices, such as
printers and VCRs, to system hard keys and foot
switches, and manages tertiary devices such as
ambient light sensor and barcode scanner. | Same | Same | Same | | |
| Power
Management | Touch power switch at
the front of the tablet,
Lock button for locking
the screen, Increased
battery run time, User
replaceable battery | Peripheral : Printer
System startup and shutdown is more complex
with the portable nature of the system. Treating
power management as a feature allows us to
look at all the user interactions surrounding
turning on and off the system with and without
wall power (battery operations), portable mode,
low and | Same | Same | Same | | |
| Presets | New: FAST and Lung
presets and M-Mode
and CPA Mode added
in Xperius 1.5 Color
Power Angio (CPA):
Real time two-
dimensional imaging
composed of a gray
scale image with flow
amplitude displayed as
a color overlay.
M-Mode (MM): Gray
scale time motion
display having a | Presets manages persistent collections of
system settings. Preset collections are stored,
loaded, activated, backed-up, exported, and
imported. Activation of a preset collection
enhances clinical workflow by configuring the
system for a specific use. Factory presets can
be fine- tuned by the user's creating a custom
preset. The menu that offers presets for
activation can also be tailored by the user.
Tissue specific Presets" Nerve 0-4. Nerve 4-6
and vascular access | Same ClearVue 850
supports Modes of
Operation: B (or 2-D),
M-mode (including
Anatomical M- mode),
Pulse Wave Doppler,
Continuous Wave
Doppler, Color
Doppler, Tissue
Harmonics, iSCAN, X-
Res, Color Power
Angio, 3D (freehand),
4D and SonoCT,
Combined modes | CX50 Supports FAST
and Lung Presets | Lumify Supports FAST
and Lung Presets | | |
| | | Philips Ultrasound, Inc. Quality, Regulatory and Sustainability
Xperius Traditional 510(k) | | | Doc. ID:
Revision:
Doc. date:
Page 9 of 95 | 254784
C
Oct 19, 2018 | |
| | Features | Proposed Xperius
Ultrasound System | Predicate
Xperius Ultrasound System (K163020) | Reference
ClearVue 850
Ultrasound System
(K153480) | Reference
CX50 Ultrasound
System
(K162329) | Reference
Lumify Ultrasound
System
(K162549) | |
| | | selectable scroll rate.
In some screen formats
includes a 2D mode
image.
IQ (Image Quality)
Optimization of the
previously cleared
presets - Nerve 0-4 ,
Nerve 4-6 and Vascular
Access to enhance
nerve and vessel
visualization | | includes FloVue,
Elastography (strain). | | | |
| | Reporting | Same | Creation of a patient report from the data
entered into and acquired with the ultrasound
system. | Same | Same | Same | |
| | Review | Same | Review of stored images, measurements and
patient information has unique workflow.
Display and replay of the images, along with
post-processing capabilities is explored for the
platform. Includes ability to de-identify image
and exam information on both the display and
in exported images. | Same | Same | Same | |
| | Security | Same | A collection of system capabilities that allow
the ultrasound device to integrate with
customer sites protecting the device and
customer infrastructure from malware and | Same | Same | Same | |
| Philips Ultrasound, Inc. | | | Quality, Regulatory and Sustainability | | | Doc. ID: 254784 | |
| Xperius Traditional 510(k) | | | Revision: | C | | | |
| | | | Doc. date: | Oct 19, 2018 | | | |
| | | | Page 10 of 95 | | | | |
| Features | Proposed Xperius
Ultrasound System | Predicate
Xperius Ultrasound System (K163020) | Reference
ClearVue 850
Ultrasound System
(K153480) | Reference
CX50 Ultrasound
System
(K162329) | Reference
Lumify Ultrasound
System
(K162549) | | |
| | | protecting patient data from unauthorized
access.
Features include: Auditing, Encryption,
Whitelisting, and network time service. | | | | | |
| Service | Same | System capabilities for the user of field service
personnel to install, diagnose and repair an
ultrasound system. Special workflow is
considered as well as special tools or software
not used by the end clinical user. Local and
Remote service workflows and tools are
discussed
Remote Self Test is also included in this feature
as a special topic. | Same | Same | Same | | |
| Study
Management | Same | Overall creation, addition to and deletion of
a patient's information, images,
quantification findings and reports. | Same | Same | Same | | |
| Transducers | Same
C5-2 and L12-4No
new or additional
transducers are
added to Xperius
Ultrasound System
1.5 revision | Transducers detects the presence of a
transducer in a connector, recognizesthe
transducer model, manages the system files
and stored parameters associated with the
transducer, and selects the active transducer
among those connected.
Transducers implements the special
functions for TEE, bi-plane, matrix, and
mechanical 3D transducers.
C5-2 , L12-4 | ClearVue850 supports
S4-1 C5-2 , C9-4v
,L12-4
,3D9-3V,V6-2,
L12-5 D2CWc | CX50
Supports C5-1 C8-
5
C9-3io C9-3v
C10-3v
D2cwc D5cwc
L10-4 lap L12-3
L12-5 50 L15-7io
S5-1 S8-3 S12-4
S7-3t | Lumify supports
C5-2, L12-4, | | |
| | | Philips Ultrasound, Inc.
Quality, Regulatory and Sustainability
Xperius Traditional 510(k) | | Doc. ID: 254784
Revision: C
Doc. date: Oct 19, 2018
Page 11 of 95 | | | |
| Features | | Proposed Xperius
Ultrasound System | Predicate
Xperius Ultrasound System (K163020) | Reference
ClearVue 850
Ultrasound System
(K153480) | Reference
CX50 Ultrasound
System
(K162329) | Reference
Lumify Ultrasound
System
(K162549) | |
| User
Management | | Same | User Management authenticates, identifies,
and grants rights and privileges to users. It
supports identifying, auditing, and tracking
system usage and customization and
configuration of the system. The presence or
absence of an authenticated user also | Same | Same | Same | |
| SonoCT | | Same | Acquires multiple lines of sight and compounds
them in real time. The images have fewer
artifacts, improved contrast resolution and
better defined tissue margins. | Same | Same | N/A | |
| XRes | | Same | Adaptive image processing enhances image
quality through millions of calculations. XRES
works in tandem with SonoCT to further
reduce artifacts, and improve contrast
resolution and border definition | Same | Same | N/A | |
14
15
16
17
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 254784 |
|---|---|---|---|
| Revision: | C | ||
| Xperius Traditional 510(k) | Doc. date: | Oct 19, 2018 | |
| Page 12 of 95 |
Determination of Substantial Equivalence ର୍ଚ୍ଚ
Non-clinical performance data
Non-clinical tests performed on in this premarket notification submission for a determination of substantial equivalence demonstrates compliance with the following standards
- AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance). IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
- . AAMI/ANSI/IEC 60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests and IEC 60601-1-2:2014: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- ISO 10993: Biological evaluation of medical devices ●
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety of ultrasonic ● medical diagnostic and monitoring equipment
Quality assurance measures applied to the system design and development include, but were not limited to the following:
- Risk Analysis
- Product Specifications
- Design Reviews ●
- Verification and Validation
Summary of Clinical Tests
The proposed Xperius Ultrasound System did not require clinical studies since substantial equivalence to the currently marketed predicate devices, Philips Xperius Ultrasound System was demonstrated with the following attributes:
- Design features; ●
- Indication for use;
- Fundamental scientific technology; ●
- Non-clinical performance testing; and
- . Safety and effectiveness.
7) Conclusions
Proposed Xperius system is substantially equivalent to the currently marketed and predicates in terms of indications for use, design, indications for use and technological characteristics.
Xperius Ultrasound system is same as Philips Xperius Ultrasound System (K163020) with additional indications and modes of operation.
514 Performance Standards
There are no Sec. 514 performance standards for this device.
Prescription Status
This is a prescription device. The prescription device statement appears in the labeling.