(16 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "general purpose, software controlled, diagnostic ultrasound system" that is "substantially equivalent" to predicate devices without mentioning new AI/ML features.
No
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic Ultrasound imaging." Diagnostic devices identify conditions, while therapeutic devices treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging..." and "It is indicated for diagnostic ultrasound imaging and fluid flow analysis..." The "Device Description" also refers to it as a "diagnostic ultrasound system".
No
The device is described as a "general purpose, software controlled, diagnostic ultrasound system" and mentions compliance with hardware safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37), indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Philips Xperius Ultrasound system is a diagnostic ultrasound system that uses sound waves to create images of internal body structures. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "diagnostic Ultrasound imaging" and "fluid flow analysis" within the body (Abdominal, Peripheral Vessel).
- Device Description: The description reinforces that it "acquire[s] ultrasound data and... display[s] the data in various modes of operation."
The information provided consistently describes a device that operates in vivo (within the living body) using ultrasound technology, not in vitro (in glass or outside the body) for analyzing specimens.
N/A
Intended Use / Indications for Use
Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D) and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal Peripheral Vessel
The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Peripheral Vessel
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:
- IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety o Collateral standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety of o 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 Xperius Ultrasound System introduces no new indications for use, features, or technologies as compared to the currently marketed and predicate devices Philips CX50 and Sparq Diagnostic Ultrasound System (K162329) and ClearVue850 (K153480) the reference systems K101757 that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both the currently marketed predicate and subject devices.
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
Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2016
Philips Healthcare % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K163020
Trade/Device Name: Xperius Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 28, 2016 Received: October 31, 2016
Dear Mr. 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 may, therefore, market the device, subject to the general controls provisions of the Act. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert 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)
K163020
Device Name Xperius Ultrasound System
Indications for Use (Describe)
Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D) and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal
Peripheral Vessel
The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices.
Type of Use (Select one or both, as applicable)
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 | N | N | N(3,4,6,8,9) | ||||||
| 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 Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | N | N | N(3,4,6,8,9) | |||||
| Cerebral Vascular | |||||||||
| N= new indication; P= previously cleared by FDA K; E= added under Appendix E | |||||||||
| Other Modes | 5. Angio Imaging | ||||||||
| 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 | ||||||||
| 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
510(k) Number: TBD System: Xperius Ultrasound system Device name: L12-4
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 Imaging | ||||||||
| & Other | Fetal /Obstetric | |||||||
| Abdominal | P | P | P(3,6) N( | |||||
| 4,8,9) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Intra-operative (Neuro) | ||||||||
| 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 | N | N | P(3,6) N(4, | ||||
| 8,9) | ||||||||
| Cerebral Vascular | ||||||||
| N= new indication; P= previously cleared by FDA K162329; E= added under Appendix E | ||||||||
| Other Modes | 5. Angio Imaging | |||||||
| 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 |
- X-Res 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)
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 Imaging | |||||||||
| & Other | Fetal /Obstetric | ||||||||
| Abdominal | P | P | P(3,4,6) N 8 | ||||||
| Intra-operative (Vascular) | |||||||||
| Intra-operative (Neuro) | |||||||||
| 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 | P | P | P(3,4,6) N 8 | |||||
| Cerebral Vascular | |||||||||
| N= new indication: P= previously cleared by FDA K153480 |
| Other Modes | 5. Angio Imaging |
|---|---|
| 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 | Doc. ID: | 243503 |
|---|---|---|---|
| Revision: | B | ||
| Doc. date: | 2016 Sep 27 | ||
| Xperius Traditional 510(k) | Page | 16 of 87 |
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 On Behalf of: Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431
Date prepared: Sep 27, 2016
- 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 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 |
3) Substantially Equivalent Devices
| Primary Predicate Device | ||
|---|---|---|
| Philips CX50 and Sparq Diagnostic Ultrasound System | K162329 | 09/14/2016 |
| Philips ClearVue 850 Diagnostic Ultrasound System | K153480 | 12/16/201 |
| Reference Device | ||
| SonoSite NanoMaxx Series Ultrasound System | K101757 | 08/12/2012 |
| eZono 3000 | K120234 | 04/19/2012 |
| Copies are uncontrolled |
7
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability
Xperius Traditional 510(k) | Doc. ID:
Revision:
Doc. date:
Page | 243503
B
2016 Sep 27
17 of 87 |
| -------------------------- | ---------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------- |
|---|
4) Device Description
The 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.
The Xperius Ultrasound System is substantially equivalent to the currently marketed and predicate Philips CX50 and Sparq Diagnostic Ultrasound System K162329 and ClearVue 850 K153480 in terms of design and fundamental scientific technology. The Xperius Ultrasound System is provided with additional indications.
5) Intended Use
Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D) and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal Peripheral Vessel
The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices.
6) Comparison of the Design and Technological characteristics
A comparison of the design and technological characteristics of the proposed Xperius System to the currently marketed and predicate Sparq and ClearVue850 is provided in Table 1 below:
Technological Characteristics
| Feature | Proposed Xperius
Ultrasound System | Predicate CX 50
Sparq System
(K162329) | Predicate
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 | |
8
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 243503 |
|---|---|---|---|
| Xperius Traditional 510(k) | Revision: | ||
| Doc. date: | B | ||
| 2016 Sep 27 | |||
| Page | 18 of 87 |
| Indication
| for Use | |||
|---|---|---|---|
| - | Ophthalmic | ||
| - | Fetal/Obstetric | Fetal/Obstetric | |
| Abdominal | Abdominal | Abdominal | |
| Intraoperative | |||
| (vascular/epicardi | |||
| al) | - | ||
| - | Small Organ | ||
| (thyroid, | |||
| scrotum, breast) | Small Organ | ||
| (breast, thyroid, | |||
| testicle) | |||
| - | Adult Cephalic | Adult Cephalic | |
| - | Trans-rectal | Trans-rectal | |
| - | Trans-vaginal | Trans-vaginal | |
| - | Musculo-skel | ||
| (conventional) | Musculo-skel | ||
| (conventional) | |||
| - | Musculo-skel | ||
| (superficial) | Musculo-skel | ||
| (superficial) | |||
| - | Other | ||
| (Gynecological) | Other | ||
| (Gynecological) | |||
| - | Cardiac Adult | Cardiac Adult | |
| - | Trans-esoph. | ||
| (Cardiac) | Trans-esoph. | ||
| (Cardiac) | |||
| Peripheral vessel | Peripheral vessel | Peripheral vessel | |
| - | Pediatric | ||
| Neonatal Cephalic | |||
| Cardiac Pediatric | |||
| Other (Fetal) | |||
| Other (Carotid) | |||
| Cerebral Vascular | |||
| Other: Urology |
9
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 243503 |
|---|---|---|---|
| Revision: | B | ||
| Xperius Traditional 510(k) | Doc. date: | 2016 Sep 27 | |
| Page | 19 of 87 |
| Transducer
Types | C5-2 Curved Array
L12-4 Broadband
Sector Linear Array | C5-1
L15-7io
X7-2t
C6-2
C9-4v
L12-4 | 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 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | S4-2 | |
| | | | |
| Transducer
Frequency | 1-6Mhz | 1-12Mhz | 1-12Mhz |
| Modes of
Operation | B (or 2-D) Color
Doppler,
modes includes
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
Doppler Imaging
and Harmonics
(Tissue and
Contrast) modes.
Needle
Visualization
iScan
4. X-Res, Sono CT | B (or 2-D), M-
mode (including
Anatomical M-
mode), Pulse
Wave Doppler,
Continuous Wave
Doppler, Color
Doppler, Tissue
Harmonics, ISCAN,
X-Res, Angio, 3D
(freehand), 4D
and SonoCT,
Combined modes
includes FloVue,
Elastography
(strain). |
| PW
Doppler | Not Available | Available | Available |
| CW
Doppler | Not Available | Available | Available |
| Patient
contact
materials | Acrylonitrile
butadiene styrene
Silicone Rubber
PVC - Flexible | Acrylonitrile
butadiene
styrene
Silicone Rubber
PVC - Flexible | Acrylonitrile
butadiene styrene
Silicone Rubber
PVC - Flexible |
| 510(k)
Track | Track 3 | Track 3 | Track 3 |
| Regulatory Class | Class II | Class II | Class II |
Xperius Ultrasound System is a Track 3 system that employs the same fundamental scientific technology as that cleared with currently marketed and predicate Philips CX50 and Sparq Diagnostic Ultrasound System (K162329) and ClearVue850 K153480. The primary difference with an additional indication for use.
10
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 243503 |
|---|---|---|---|
| Xperius Traditional 510(k) | Revision: | B | |
| Doc. date: | 2016 Sep 27 | ||
| Page | 20 of 87 |
Xperius Ultrasound System is designed to cater to the specific target market in Ultrasound Guided Regional Anesthesia and Vascular Access by leveraging the Philips Common platform architecture and design which is used for developing the predicate devices such as CX50. Sparq and ClearVue products.
6) Determination of Substantial Equivalence
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:
- o IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety o Collateral standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety of o 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 Xperius Ultrasound System introduces no new indications for use, features, or technologies as compared to the currently marketed and predicate devices Philips CX50 and Sparq Diagnostic Ultrasound System (K162329) and ClearVue850 (K153480) the reference systems K101757 that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both the currently marketed predicate and subject devices.
7) Conclusions
Proposed Xperius Ultrasound 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 CX50 and Sparq Diagnostic Ultrasound System (K162329) and ClearVue850 (K153480) transducers L12-4 and C5-2 and additional indications.
514 Performance Standards
There are no Sec. 514 performance standards for this device.
11
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 243503 |
|---|---|---|---|
| Revision: | B | ||
| Xperius Traditional 510(k) | Doc. date: | 2016 Sep 27 | |
| Page | 21 of 87 |
Prescription Status
This is a prescription device. The prescription device statement appears in the labeling.
Sterilization Site(s)
Not applicable. No components supplied sterile.
Track This is a Track 3 system