(16 days)
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.
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.
The provided document is a 510(k) summary for the Philips Xperius Ultrasound System. It is a premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices, not a study that proves the device meets specific acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Philips CX50 and Sparq Diagnostic Ultrasound System K162329, and ClearVue 850 K153480) for its intended use, design, and technological characteristics. It does not contain information about specific acceptance criteria and a study proving the device meets those criteria in the way a clinical performance study would for a novel AI-powered diagnostic device.
Here's a breakdown of why the requested information cannot be fully provided from this document and what can be inferred:
The document explicitly states:
"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." (Page 20)
This statement indicates that a de novo clinical study with specific acceptance criteria and performance metrics for an AI algorithm was not performed, nor was it required for this 510(k) submission. The device is being cleared based on its similarity to existing, cleared ultrasound systems. Therefore, most of your requested points related to AI performance, ground truth, expert consensus, and multi-reader studies are not applicable to this 510(k) submission as presented.
However, I can extract information related to the device's indications for use and operational modes as they reflect the intended performance of the device, which is foundational to any future performance evaluation if it were a novel device requiring such studies.
Inferred Information from the 510(k) Submission:
Since this is a 510(k) for an ultrasound system, not explicitly an AI/ML device requesting de novo clearance with novel performance claims, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" are typically handled differently. The acceptance criteria essentially align with demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards for diagnostic ultrasound equipment.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a 510(k) submission when demonstrating substantial equivalence are typically:
- Intended Use Equivalence: The new device has the same intended use as the predicate device(s).
- Technological Characteristics Equivalence: The new device has the same technological characteristics as the predicate, or if there are differences, those differences do not raise different questions of safety and effectiveness.
- Performance Data: Non-clinical (and sometimes clinical) performance data demonstrate that the device performs as intended and is as safe and effective as the predicate.
For this specific submission, the reported "performance" is implicitly its ability to perform diagnostic ultrasound imaging in the specified modes and applications, which is assumed to be equivalent to the predicate devices.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance (as stated or implied in the 510(k) Summary) |
|---|---|
| 1. Indications for Use Equivalence | Substantially Equivalent to predicate devices (K162329, K153480). New indications are for specific modes/applications already present on predicate devices. |
| 2. Technological Characteristics Equivalence | Substantially Equivalent to predicate devices (K162329, K153480) in design and fundamental scientific technology. |
| 3. Safety & Performance Standards Compliance | In Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. |
| 4. Quality Assurance Measures Applied | Measures Applied: Risk Analysis, Product Specifications, Design Reviews, Verification and Validation. |
| 5. Clinical Test Requirement | Not Required for new indications for use, features, or technologies compared to predicates. Clinical safety and effectiveness are "well accepted." |
| Note: This table reflects the basis for clearance under 510(k), not specific quantitative performance metrics as would be seen for a de novo AI device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. The document explicitly states, "The Xperius Ultrasound System introduces no new indications for use, features, or technologies... that require clinical testing." Therefore, there was no independent test set or study data described in the traditional sense for assessing novel performance.
- The "test set" implicitly refers to the rigorous non-clinical testing against standards (IEC 60601 series) described in the "Non-clinical performance data" section, but no sample sizes or data provenance are relevant for these types of engineering and safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Since no clinical test set requiring ground truth establishment was performed, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC comparative effectiveness study was not performed. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool. The document states it is "a general purpose, software controlled, diagnostic ultrasound system."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. The device is a hardware and software integrated ultrasound imaging system intended for human-in-the-loop operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No clinical study requiring ground truth was performed.
8. The sample size for the training set
- Not Applicable / Not Provided. The document describes a general-purpose ultrasound system. It is not an AI/ML device in the context that would typically require a "training set" for a diagnostic algorithm with specific performance claims. While internal software development would involve testing, it's not described as an AI training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set ground truth description is relevant or provided for this type of 510(k) submission.
In summary: The provided document is a 510(k) premarket notification for a new ultrasound system, Xperius, demonstrating its substantial equivalence to previously cleared predicate devices. It explicitly states that no new clinical testing was required because the device does not introduce new indications, features, or technologies that raise new questions of safety or effectiveness. Therefore, the detailed information typically requested for evaluating a novel AI/ML device's performance against specific acceptance criteria in a clinical study is not present in this document. The "acceptance criteria" for this submission are met by demonstrating equivalence to predicates and compliance with standard electrical and medical device safety requirements.
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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
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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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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 | PWD | CWD | ColorDoppler* | 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) | |||||||||
| PeripheralVessel | 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)
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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 | PWD | CWD | ColorDoppler* | 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) | ||||||||
| PeripheralVessel | 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 | PWD | CWD | ColorDoppler* | 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) | |||||||||
| PeripheralVessel | 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 CFRSection | Classification Name | ProductCode |
|---|---|---|
| 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 |
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| Philips Ultrasound, Inc. | Quality, Regulatory and SustainabilityXperius Traditional 510(k) | Doc. ID:Revision:Doc. date:Page | 243503B2016 Sep 2717 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 XperiusUltrasound System | Predicate CX 50Sparq System(K162329) | PredicateClearVue850K153480 |
|---|---|---|---|
| IntendedUse | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows | Diagnosticultrasoundimaging or fluidflow analysis ofthe human bodyas follows |
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| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 243503 |
|---|---|---|---|
| Xperius Traditional 510(k) | Revision:Doc. date: | B2016 Sep 27 | |
| Page | 18 of 87 |
| Indicationfor Use | |||
|---|---|---|---|
| - | Ophthalmic | ||
| - | Fetal/Obstetric | Fetal/Obstetric | |
| Abdominal | Abdominal | Abdominal | |
| Intraoperative(vascular/epicardial) | - | ||
| - | 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 | |
| - | PediatricNeonatal CephalicCardiac PediatricOther (Fetal)Other (Carotid)Cerebral VascularOther: 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 |
| TransducerTypes | C5-2 Curved ArrayL12-4 BroadbandSector Linear Array | C5-1L15-7ioX7-2tC6-2C9-4vL12-4 | S4-1 Sector ArrayC5-2 Curved ArrayC9-4v CurvedArrayL12-4 BroadbandSector LinearArray3D9-3VV6-2L12-5D2CWc |
|---|---|---|---|
| S4-2 | |||
| TransducerFrequency | 1-6Mhz | 1-12Mhz | 1-12Mhz |
| Modes ofOperation | B (or 2-D) ColorDoppler,modes includesRegional Anesthesia,Vascular access,Needle VisualizationX-res, SonoCT, iSCAN | B (or 2-D), M-mode (includingAnatomical M-mode), PulseWave Doppler,Continuous WaveDoppler, ColorDoppler, TissueDoppler Imagingand Harmonics(Tissue andContrast) modes.NeedleVisualizationiScan4. X-Res, Sono CT | B (or 2-D), M-mode (includingAnatomical M-mode), PulseWave Doppler,Continuous WaveDoppler, ColorDoppler, TissueHarmonics, ISCAN,X-Res, Angio, 3D(freehand), 4Dand SonoCT,Combined modesincludes FloVue,Elastography(strain). |
| PWDoppler | Not Available | Available | Available |
| CWDoppler | Not Available | Available | Available |
| Patientcontactmaterials | Acrylonitrilebutadiene styreneSilicone RubberPVC - Flexible | AcrylonitrilebutadienestyreneSilicone RubberPVC - Flexible | Acrylonitrilebutadiene styreneSilicone RubberPVC - 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.
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| 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
§ 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.