(14 days)
The ClearVue850 Diagnostic Ultrasound system is a general purpose, portable, cart based ultrasound system, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG's, Ultrasound Lab physicians, and nurse practitioners, etc.,
The System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Tissue Harmonics, iSCAN, X-Res, Angio, 3D (freehand), 4D and SonoCT, Combined modes includes FloVue, Elastography (strain).
The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA 's Diagnostic Ultrasound Indications for Use Form section 1.3 which includes Fetal / OB, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Other: GYN, Other: Urology, Cardiac Pediatric, Transesophageal (Cardiac), Other (Fetal Echo), Peripheral vessel and Cerebral Vascular.
The ClearVue850 Diagnostic 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 ClearVue 850 System is substantially equivalent to the currently marketed and predicate ClearVue350/550 system(K120321) in terms of design and fundamental scientific technology. The ClearVue850 Model is provided with additional transducers D2CWC and L12-5 and software features and additional modes. The software feathres of the ClearVue 850 System include -Live Panoramic Imaging, FloVue, Strain Elastography Imaging, Curved ROI Tool, QLAB plug-ins IMT and GI3DQ, Stress Echo protocol.
The ClearVue 850 System supports CW Doppler transducer with external CW adapter module which gets attached to the SAM transducer connector, an Up/down mechanism for control panel. The system is designed to be highly reliable and easily serviceable.
This document is a 510(k) premarket notification for the Philips ClearVue 850 Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared devices.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a pass/fail manner. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly demonstrated by stating that the ClearVue 850 shares the same fundamental scientific technology, has similar intended uses and technological characteristics, and has undergone non-clinical testing for compliance with relevant safety and EMC standards.
The closest to "acceptance criteria" are the Indications for Use outlined in the tables (pages 4-11), which detail the clinical applications and modes of operation for the system and its various transducers. The device "meets" these by being listed for these applications. The "reported device performance" is a general statement of equivalency rather than specific metrics.
Table of Acceptance Criteria and Reported Device Performance:
Since explicit quantitative acceptance criteria are not presented, this table lists the stated "Indications for Use" as the de facto "acceptance criteria" that the device is intended to meet, and the "Reported Device Performance" as the claim of substantial equivalence for these indications.
| Acceptance Criteria (Indications for Use) | Reported Device Performance (Claim of Substantial Equivalence) |
|---|---|
| Diagnostic ultrasound imaging and fluid flow analysis for: Fetal / OB, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Other: GYN, Other: Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Other (Fetal Echo), Peripheral vessel and Cerebral Vascular. The document also lists specific applications for each transducer, some of which are 'new indications' (N) and some 'previously cleared' (P). | The ClearVue 850 System is substantially equivalent to the currently marketed and predicate ClearVue350/550 system (K120321) in terms of design and fundamental scientific technology. The ClearVue 850 is demonstrated to meet these indications for use through substantial equivalence to predicate devices (K120321, K132304, K141261). The document repeatedly states that the device introduces "no new indications for use, features, or technologies as compared to the currently marketed and predicate devices (EPIQ/ClearVue) that require clinical testing." Specific additions/equivalences mentioned: - L12-5 and D2CWC transducers: Added with equivalent additional indication for use to K132304.- FloVue: New indication, substantially equivalent to the coded pulse mode of GE K141261 (both help in simultaneous imaging of tissue and blood flow).- Elastography: Already cleared with EPIQ K132304.- Other software features: Live Panoramic Imaging, Strain Elastography Imaging, Curved ROI Tool, QLAB plug-ins IMT and GI3DQ, Stress Echo protocol, CW Doppler transducer with external CW adapter module. |
| Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards (Non-clinical performance data). | Non-clinical tests were performed to demonstrate compliance with these standards. |
Study Information:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states: "Summary of Clinical Tests: The ClearVue850 System introduces no new indications for use, features, or technologies as compared to the currently marketed and predicate devices (EPIQ/ClearVue) that require clinical testing." This indicates that no new primary clinical testing (test set) was performed specifically for this 510(k) submission. The substantial equivalence relies on the performance of the predicate devices. Therefore, there is no information about a test set sample size or its provenance in this document. -
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):
As no new clinical testing was performed for this submission, this information is not provided. The ground truth for the predicate devices' clearances would have involved relevant medical experts, but details are not in this document. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new clinical test set was used for this submission. -
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 MRMC study was performed or is mentioned. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool in the sense of providing automated interpretations to readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a diagnostic ultrasound system, which inherently involves a human operator and interpreter. It is not an algorithm that provides standalone diagnostic outputs without human interaction. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the purposes of this 510(k) submission, the "ground truth" relies on the established safety and effectiveness of the predicate devices. The document implies that the clinical safety and effectiveness of ultrasound systems with these characteristics are "well accepted." For the predicate devices, their ground truth would likely have been established through a combination of expert clinical interpretation, correlation with other imaging modalities, and potentially pathology or surgical outcomes, depending on the specific application. However, these details are not provided for the ClearVue 850 in this submission. -
The sample size for the training set:
Not applicable. This document describes a traditional 510(k) for an ultrasound system, not an AI/Machine Learning device that requires a distinct "training set" in the computational sense. The "training" for the device's development would be through extensive engineering, design, and internal validation processes based on established ultrasound principles and medical knowledge. -
How the ground truth for the training set was established:
Not applicable for the same reasons as above.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2015
Philips Healthcare % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K153480
Trade/Device Name: ClearVue 850 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 30, 2015 Received: December 2, 2015
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.
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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,
Robert Oaks
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)
Device Name ClearVue 850 Diagnostic Ultrasound System
Indications for Use (Describe)
The ClearVue850 Diagnostic Ultrasound system is a general purpose, portable, cart based ultrasound system, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG's, Ultrasound Lab physicians, and nurse practitioners, etc.,
The System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Tissue Harmonics, iSCAN, X-Res, Angio, 3D (freehand), 4D and SonoCT, Combined modes includes FloVue, Elastography (strain).
The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA 's Diagnostic Ultrasound Indications for Use Form section 1.3 which includes Fetal / OB, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Other: GYN, Other: Urology, Cardiac Pediatric, Transesophageal (Cardiac), Other (Fetal Echo), Peripheral vessel and Cerebral Vascular.
| 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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FORM FDA 3881 (8/14)
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No:
System: ClearVue 850 Diagnostic Ultrasound System
| 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 / OB | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6,7,8,9,10,11 | |
| Abdominal | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7, 8,9,10,11 | |
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7, 8,9,10,11 | |
| Small Organ (breast,thyroid, testicle) | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7,8,9,10,11,13,16 | |
| Neonatal Cephalic | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7, 8,9,10,11 | |
| Adult Cephalic | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7, 8,9,10,11 | |
| Trans-rectal | N | N | N | N | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | ||
| Trans-vaginal | N | N | N | N | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel.(Conventional) | N | N | N | N | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11,16 | ||
| Musculo-skel. (Superficial) | N | N | N | N | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11,16 | ||
| Intra-luminal | ||||||||
| Other: GYN | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7, 8,9,10,11 | |
| Other: Urology | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7, 8,9,10,11 | |
| Cardiac | Cardiac Adult | N | N | N | N | N | Note: 1,2,3,4 | Note: 8,9,11,12 |
| Cardiac Pediatric | N | N | N | N | N | Note: 1,2,3,4 | Note: 8,9,11,12 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6,8,9,11,12 | |
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note:1,2,3,4,15 | Note: 5,6,7,8,9,10,11,14,16 |
| Cerebral Vascular | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6,8,9,10,11,12 |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
N= new indication; P= previously cleared by FDA Additional Comments:
*Color Doppler includes Color Amplitude Doppler Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; Note 9: Harmonic Imaging B+M Note 2: Combined modes include: B+M+Color Note 10: 3D/4D Imaging Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 11: XRES Note 4: Combined modes include: B+CWD; B+Color+CWD; Note 12: TDI B+Amplitude+CWD Note 5: SonoCT Note 13: Elastography Note 6: Imaging for guidance of biopsy Note 14: FloVue Note15: Combined modes include: Note 7: Panoramic Imaging B+FloVue+PWD Note 8: Color Power Angio (CPA) Note 16: AutoSCAN
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No: System: ClearVue 850 Diagnostic 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 / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11 | |||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11 | |||
| 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: GYN | P | P | P | P | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | |||
| Other: Urology | P | P | P | P | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | |||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | |||
| PeripheralVessel | Peripheral Vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | ||
| Cerebral Vascular |
Additional Comments:
| *Color Doppler includes Color Amplitude Doppler | |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 9: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 10: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 12: TDI |
| Note 5: SonoCT | Note 13: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 14: FloVue |
| Note 7: Panoramic Imaging | Note 15: Combined modes include: B+FloVue+PWD |
| Note 8: Color Power Angio (CPA) | Note 16: AutoSCAN |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No: System: ClearVue 850 Diagnostic Ultrasound System
Transducer: V6-2
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 | Specific | B | M | PW D | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| (Track I only) | (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6, 8,9,10,11 | |||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6, 8,9,10,11 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| 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: GYN | P | P | P | P | Note: 1,2,3 | Note: 5,6, 8,9,10,11 | |||
| Other: Urology | P | P | P | P | Note: 1,2,3 | Note: 5,6, 8,9,10,11 | |||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8, 9,10,11 | |||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6,8, 9,10,11 | ||
| Cerebral Vascular | |||||||||
| N= new indication: P= previously cleared by FDA K120321 |
Additional Comments:
Additional Comments:
*Color Doppler includes Color Amplitude Doppler.
| *Color Doppler includes Color Amplitude Doppler | |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;B+M | Note 9: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 10: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD | Note 12: TDI |
| Note 5: SonoCT | Note 13: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 14: FloVue |
| Note 7: Panoramic Imaging | Note 15: Combined modes include: |
| Note 8: Color Power Angio (CPA) | Note 16: AutoSCAN |
| B+FloVue+PWD |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No: System: ClearVue850 Diagnostic Ultrasound System Transducer: C9-4v
Intended Use:
Clinical Application Mode of Operation (includes simultaneous B-mode) General Specific PW Color Combined Other B M CWD (Track I only) (Tracks I & III) D Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal / OB P P P P Note: 1,2,3 Note: 5,6, 8,10,11 Abdominal Intra-operative (Cardiac) Intra-operative (Vascular) Fetal Imaging Laparoscopic & Other Pediatric Small Organ (breast, thyroid, testicle) Neonatal Cephalic Adult Cephalic Trans-rectal P P P Note: 1,2,3 Note: 5,6, 8,10,11 P Trans-vaginal P P P P Note: 1,2,3 Note: 5,6, 8,10,11 Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Conventional) Musculo-skel. (Superficial) Intra-luminal P Other: GYN P P P Note: 1,2,3 Note: 5,6, 8,10,11 Other: Urology P P P P Note: 1,2,3 Note: 5,6, 8,10,11 Cardiac Adult Cardiac Pediatric Cardiac Trans-esophageal (Cardiac) Other (Fetal Echo) Peripheral Peripheral vessel Vessel Cerebral Vascular
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA K120321
Additional Comments:
| *Color Doppler includes Color Amplitude Doppler | |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;B+M | Note 9: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 10: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD | Note 12: TDI |
| Note 5: SonoCT | Note 13: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 14: FloVue |
| Note 7: Panoramic Imaging | Note15: Combined modes include:B+FloVue+PWD |
| Note 8: Color Power Angio (CPA) | Note 16: AutoSCAN |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No: System: ClearVue850 Diagnostic Ultrasound System Transducer: 3D9-3v 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 Specific PW Color Combined Other B M CWD (Track I only) (Tracks I & III) D Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal / OB P P P P Note: 1,2,3 Note: 5,6, 8,10,11 Abdominal Intra-operative (Cardiac) Intra-operative (Vascular) Fetal Imaging Laparoscopic & Other Pediatric Small Organ (breast, thyroid, testicle) Neonatal Cephalic Adult Cephalic Trans-rectal P P P Note: 1,2,3 Note: 5,6, 8,10,11 P Trans-vaginal P P P P Note: 1,2,3 Note: 5,6, 8,10,11 Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Conventional) Musculo-skel. (Superficial) Intra-luminal P Note: 1,2,3 Other: GYN P P P Note: 5,6, 8,10,11 Other: Urology P P P P Note: 1,2,3 Note: 5,6, 8,10,11 Cardiac Adult Cardiac Pediatric Cardiac Trans-esophageal (Cardiac) Other (Fetal Echo) Peripheral Peripheral vessel Vessel Cerebral Vascular N= new indication; P= previously cleared by FDA K120321
N= new indication; P= previously cleared by FDA K120321
Additional Comments:
| *Color Doppler includes Color Amplitude Doppler | |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;B+M | Note 9: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 10: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD | Note 12: TDI |
| Note 5: SonoCT | Note 13: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 14: FloVue |
| Note 7: Panoramic Imaging | Note15: Combined modes include:B+FloVue+PWD |
| Note 8: Color Power Angio (CPA) | Note 16: AutoSCAN |
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No: System: ClearVue850 Diagnostic Ultrasound System
Transducer: 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 / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | ||
| Small Organ (breast,thyroid, testicle) | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel.(Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 | |
| Cerebral Vascular |
Additional Comments:
| *Color Doppler includes Color Amplitude Doppler | |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;B+M | Note 9: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 10: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD | Note 12: TDI |
| Note 5: SonoCT | Note 13: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 14: FloVue |
| Note 7: Panoramic Imaging | Note 15: Combined modes include:B+FloVue+PWD |
| Note 8: Color Power Angio (CPA) | Note 16: AutoSCAN |
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No: System: ClearVue850 Diagnostic Ultrasound System Transducer: L12-5
Clinical Application Mode of Operation (includes simultaneous B-mode) General Specific PW Color Combined Other B M CWD (Track I only) (Tracks I & III) D Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal / OB Abdominal Intra-operative (Cardiac) Intra-operative (Vascular) Fetal Imaging Laparoscopic & Other Pediatric P P P P Note: 1,2,3 Note: 5,7,8,9,10,11,16 Small Organ (breast, N N N N Note: 1,2,3 Note: 5,7,8,9,10,11,13,16 thyroid, testicle) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. P P P P Note: 1,2,3 Note: 5,7,8,9,10,11,16 (Conventional) Musculo-skel. (Superficial) P P P P Note: 1,2,3 Note: 5,7,8,9,10,11,16 Intra-luminal Other: GYN Other: Urology Cardiac Adult Cardiac Pediatric Cardiac Trans-esophageal (Cardiac) Other (Fetal Echo) Peripheral Peripheral vessel Note: N N N N Note: 5,7,8,9,10,11,,14,16 1,2,3,15 Vessel Cerebral Vascular
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA K132304
Additional Comments:
| *Color Doppler includes Color Amplitude Doppler | |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;B+M | Note 9: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 10: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD | Note 12: TDI |
| Note 5: SonoCT | Note 13: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 14: FloVue |
| Note 7: Panoramic Imaging | Note15: Combined modes include: |
| B+FloVue+PWD | |
| Note 8: Color Power Angio (CPA) | Note 16: AutoSCAN |
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No: System: ClearVue 850 Diagnostic Ultrasound System
Transducer: S4-1
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 / OB | P | P | P | P | P | Note: 1,2,3,4 | Note:, 6, 8,9,10,11 | |
| Abdominal | P | P | P | P | P | Note: 1,2,3,4 | Note: 6, 8,9,10,11 | |
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 6, 8,9,10,11 | |
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | Note: 1,2,3,4 | Note: 6, 8,9,10,11 | |
| Adult Cephalic | P | P | P | P | P | Note: 1,2,3,4 | Note: 6, 8,9,10,11 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | P | Note: 1,2,3,4 | Note: 6, 8,9,10,11 | |
| Other: Urology | ||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 8,9,10,11,12 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 8,9,10,11,12 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note: 1,2,3,4 | Note: 6, 8,9,10,11 |
| Vessel | Cerebral Vascular | P | P | P | P | P | Note: 1,2,3,4 | Note: 6, 8,9,10,11 |
N= new indication; P= previously cleared by FDA K120321
| Additional Comments: | |
|---|---|
| *Color Doppler includes Color Amplitude Doppler | |
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 9: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 10: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD | Note 12: TDI |
| Note 5: SonoCT | Note 13: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 14: FloVue |
| Note 7: Panoramic Imaging | Note15: Combined modes include: B+FloVue+PWD |
| Note 8: Color Power Angio (CPA) | Note 16: AutoSCAN |
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No: System: ClearVue850 Diagnostic Ultrasound System Transducer: D2cwc 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 / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| 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: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular | ||||||||
| N= new indication; P= previously cleared by FDA- K132304*Color Doppler includes Color Amplitude DopplerNote 1: Combined modes include: B+PWD; B+Color; B+Amplitude; |
| *Color Doppler includes Color Amplitude Doppler | |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;B+M | Note 9: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 10: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD | Note 12: TDI |
| Note 5: SonoCT | Note 13: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 14: FloVue |
| Note 7: Panoramic Imaging | Note15: Combined modes include:B+FloVue+PWD |
| Note 8: Color Power Angio (CPA) | Note 16: AutoSCAN |
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| Philips Ultrasound, Inc. | Quality, Regulatory and SustainabilityClearVue850 Traditional 510(k) | Doc. ID:Revision:Doc. date:Page | 238512A2015 Sep 3016 of 96 |
|---|---|---|---|
| -------------------------- | -------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------- |
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: September 30, 2015
- 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: ClearVue850
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 ClearVue Diagnostic Ultrasound System | K120321 | 02/17/2012 |
| Reference Device | ||
| Philips EPIQ Diagnostic Ultrasound System | K132304 | 08/21/2013 |
| GE LOGIQ S7 Expert and LOGIQ S7 Pro | K141261 | 06/05/2014 |
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| Philips Ultrasound, Inc. | Quality, Regulatory and SustainabilityClearVue850 Traditional 510(k) | Doc. ID:Revision:Doc. date:Page | 238512A2015 Sep 3017 of 96 |
|---|---|---|---|
| -------------------------- | -------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------- |
4) Device Description
The ClearVue850 Diagnostic 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 ClearVue 850 System is substantially equivalent to the currently marketed and predicate ClearVue350/550 system(K120321) in terms of design and fundamental scientific technology. The ClearVue850 Model is provided with additional transducers D2CWC and L12-5 and software features and additional modes. The software feathres of the ClearVue 850 System include -Live Panoramic Imaging, FloVue, Strain Elastography Imaging, Curved ROI Tool, QLAB plug-ins IMT and GI3DQ, Stress Echo protocol.
The ClearVue 850 System supports CW Doppler transducer with external CW adapter module which gets attached to the SAM transducer connector, an Up/down mechanism for control panel. The system is designed to be highly reliable and easily serviceable.
5) Intended Use
The ClearVue850 system is a general purpose, portable, cart based ultrasound system, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG's, Ultrasound Lab physicians, and nurse practitioners, etc.,
The ClearVue850 System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), Mmode (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).
The ClearVue850 system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA's Diagnostic Ultrasound Indications for Use Form section 1.3 which includes Fetal / OB. Abdominal.Pediatric.Small Organ (breast, thyroid, testicle),Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal,Musculo-skel. (Conventional), Musculo-skel. (Superficial),Other: GYN,Other: Urology,Cardiac Adult,Cardiac Pediatric,Trans-esophageal (Cardiac),Other (Fetal Echo),Peripheral vessel and Cerebral Vascular
6) Comparison of the Design and Technological characteristics
A comparison of the design and technological characteristics of the ClearVue 850 System to the currently marketed and predicate CllearVue 350/550 is provided in Table 1 below:
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| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 238512 |
|---|---|---|---|
| ClearVue850 Traditional 510(k) | Revision:Doc. date:Page | A2015 Sep 3018 of 96 |
Technological Characteristics
| Feature | ProposedClearVue850 System | PredicateClearVue350/550(K120321) |
|---|---|---|
| IntendedUse | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows | Diagnosticultrasoundimaging or fluidflow analysis ofthe human bodyas follows |
| Indicationfor Use | ||
| Fetal/Obstetric | Fetal/Obstetric | |
| Abdominal | Abdominal | |
| Pediatric | Pediatric | |
| Small Organ (breast,thyroid, testicle) | Small Organ(prostate) | |
| Neonatal Cephalic | Neonatal Cephalic | |
| 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 | |
| Cardiac Pediatric | Cardiac Pediatric |
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| Philips Ultrasound, Inc. | Quality, Regulatory and SustainabilityClearVue850 Traditional 510(k) | Doc. ID:Revision:Doc. date:Page | 238512A2015 Sep 3019 of 96 |
|---|---|---|---|
| -------------------------- | -------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------- |
| Other (Fetal Echo) | Other (Fetal) | |
|---|---|---|
| Peripheral vessel | Peripheral vessel | |
| Cerebral Vascular | - | |
| Other: Urology | - | |
| Other (Carotid) | Other (Carotid) | |
| - | - | |
| - | - | |
| - | - | |
| - | - | |
| - | - | |
| - | - | |
| TransducerTypes | S4-1 Sector ArrayC5-2 Curved ArrayC9-4v Curved ArrayL12-4 BroadbandSector Linear Array3D9-3VV6-2L12-5D2CWc | S4-1 Sector ArrayC5-2 Curved ArrayC9-4v CurvedArrayL12-4 BroadbandSector LinearArray3D9-3VV6-2 |
| TransducerFrequency | 1-12Mhz | 1-12Mhz |
| Modes ofOperation | B (or 2-D), M-mode(including AnatomicalM-mode), Pulse WaveDoppler, ContinuousWave Doppler, ColorDoppler, TissueHarmonics, iSCAN, X-Res, Angio, 3D(freehand), 4D and | B (or 2-D), M-mode (includingAnatomical M-mode), PulseWave Doppler,Continuous WaveDoppler, ColorDoppler, TissueHarmonics, iSCAN,X-Res, angio, 3D |
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| Philips Ultrasound, Inc. | Quality, Regulatory and SustainabilityClearVue850 Traditional 510(k) | Doc. ID:Revision:Doc. date:Page | 238512A2015 Sep 3020 of 96 |
|---|---|---|---|
| -------------------------- | -------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------- |
| modes includesFloVue, Elastography(strain). | (freehand), andSonoCT. | |
|---|---|---|
| PWDoppler | Available | Available |
| CWDoppler | Available | Available |
| Patientcontactmaterials | Acrylonitrilebutadiene styreneSilicone RubberPVC - Flexible | Acrylonitrilebutadiene styreneSilicone RubberPVC - Flexible |
| 510(k)Track | Track 3 | Track 3 |
| RegulatoryClass | Class II | Class II |
Clear Vue850 System is a Track 3 system that employs the same fundamental scientific technology as that cleared with currently marketed and predicate ClearVue 350/550 (K120321) System and EPIQ K132304 System. The primary difference between ClearVue 350/550/650 (K120321) and ClearVue850 System submitted with this 510(k) is the addition of the L12-5 (K132304) and D2CWC (K132304) with an equivalent additional indication for use.
Elastography Indication for use is already cleared with EPIQ K132304. Flo Vue is a new indication for use in the proposed ClearVue850 System. FloVue from Philips is substantially equivalent to the coded pulse mode of currently marketed and reference GE K141261.Both FloVue and coded pulse helps in simultaneous imaging of tissue and blood flow.
6) Determination of Substantial Equivalence
Non-clinical performance data
Non-clinical tests performed on in this premarket notification submission for a determination of substantial equivalencedemonstrates compliance with the following standards:
- o IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
- 0 IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety -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 ●
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| Philips Ultrasound, Inc. | Quality, Regulatory and SustainabilityClearVue850 Traditional 510(k) | Doc. ID:Revision:Doc. date:Page | 238512A2015 Sep 3021 of 96 |
|---|---|---|---|
| -------------------------- | -------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------- |
- Design Reviews ●
- Verification and Validation ●
Summary of Clinical Tests
The ClearVue850 System introduces no new indications for use, features, or technologies as compared to the currently marketed and predicate devices (EPIQ/ClearVue) 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
ClearVue850 is substantially equivalent to the currently marketed and predicates in terms of indications for use, design, indications for use and technological characteristics.
ClearVue 850 is same as ClearVue (K120321) and EPIQ (K130304) transducers L12-5 and D2CWC and additional indications.
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.
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.