ClearVue850 Diagnostic Ultrasound System
Device Facts
| Record ID | K153480 |
|---|---|
| Device Name | ClearVue850 Diagnostic Ultrasound System |
| Applicant | Philips Health Care |
| Product Code | IYN · Radiology |
| Decision Date | Dec 16, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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
Device Story
ClearVue 850 is a portable, cart-based diagnostic ultrasound system; acquires ultrasound data via various transducers; displays images in B, M, Pulse Wave/Continuous Wave Doppler, Color Doppler, 3D/4D, and specialized modes (FloVue, Elastography, SonoCT, X-Res). Operated by clinicians (GPs, specialists, nurse practitioners) in clinics/hospitals. System includes CW Doppler adapter, up/down control panel, and software features like Live Panoramic Imaging, QLAB plug-ins (IMT, GI3DQ), and Stress Echo. Output provides diagnostic visualization and fluid flow analysis to assist clinicians in patient assessment and diagnosis. Benefits include versatile diagnostic imaging across multiple clinical applications.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical performance testing, including compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards, alongside design verification and validation.
Technological Characteristics
Portable, cart-based ultrasound system. Transducers: S4-1, C5-2, C9-4v, L12-4, 3D9-3V, V6-2, L12-5, D2CWC. Materials: ABS, Silicone Rubber, PVC. Modes: B, M, PW/CW Doppler, Color Doppler, Tissue Harmonics, 3D/4D, SonoCT, X-Res, FloVue, Elastography. Connectivity: CW adapter module. Software-controlled. No sterile components.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in Fetal/OB, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (conventional/superficial), GYN, Urology, Cardiac (adult/pediatric), Transesophageal (cardiac), Fetal Echo, Peripheral vessel, and Cerebral Vascular applications. Prescription use only.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Philips ClearVue Diagnostic Ultrasound System (K120321)
Reference Devices
Related Devices
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- K132341 — DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 15, 2013
- K120801 — CHISON DIAGNOSTIC ULTRASOUND SYSTEM · Chison Medical Imaging Co., Ltd. · Jun 14, 2012
- K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 18, 2017
- K201130 — ACUSON Juniper Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · May 26, 2020
Submission Summary (Full Text)
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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)
K153480
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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined<br>(Spec.) | Other<br>(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<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7, 8,9,10,11 |
| | Small Organ (breast,<br>thyroid, testicle) | N | N | N | N | N | Note: 1,2,3,4 | Note: 5,6, 7,<br>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.<br>(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 |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note:<br>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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PW<br>D | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / 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<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11 | |
| | Small Organ (breast,<br>thyroid, testicle) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel.<br>(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 | |
| Peripheral<br>Vessel | 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 | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(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<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast,<br>thyroid, testicle) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel.<br>(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 | |
| Peripheral<br>Vessel | 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;<br>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;<br>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;<br>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;<br>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:<br>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;<br>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;<br>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:<br>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: 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PW<br>D | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6, 7, 8,9,10,11 |
| | Small Organ (breast,<br>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.<br>(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) | | | | | | | |
| Peripheral<br>Vessel | 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;<br>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;<br>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:<br>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
{9}------------------------------------------------
#### 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;<br>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;<br>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
{10}------------------------------------------------
### 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PW<br>D | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / 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<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 6, 8,9,10,11 |
| | Small Organ (breast, thyroid,<br>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;<br>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
{11}------------------------------------------------
#### 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PW<br>D | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast,<br>thyroid, testicle) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other: GYN | | | | | | | |
| | Other: Urology | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |
| N= new indication; P= previously cleared by FDA- K132304<br>*Color Doppler includes Color Amplitude Doppler<br>Note 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;<br>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;<br>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:<br>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
{12}------------------------------------------------
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability<br>ClearVue850 Traditional 510(k) | Doc. ID:<br>Revision:<br>Doc. date:<br>Page | 238512<br>A<br>2015 Sep 30<br>16 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
1) 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
2) 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 CFR<br>Section | Classification Name | Product<br>Code |
|-------------------|------------------------------------------------|-----------------|
| 892.1550 | System, Imaging, Pulsed Doppler,<br>Ultrasonic | 90 IYN |
| 892.1560 | System, Imaging, Pulsed Echo,<br>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 |
Copies are uncontrolled
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| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability<br>ClearVue850 Traditional 510(k) | Doc. ID:<br>Revision:<br>Doc. date:<br>Page | 238512<br>A<br>2015 Sep 30<br>17 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:
{14}------------------------------------------------
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability | Doc. ID: | 238512 |
|--------------------------|----------------------------------------|---------------------------------|------------------------------|
| | ClearVue850 Traditional 510(k) | Revision:<br>Doc. date:<br>Page | A<br>2015 Sep 30<br>18 of 96 |
## Technological Characteristics
| Feature | Proposed<br>ClearVue850 System | Predicate<br>ClearVue350/550<br>(K120321) |
|-----------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended<br>Use | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body as follows | Diagnostic<br>ultrasound<br>imaging or fluid<br>flow analysis of<br>the human body<br>as follows |
| Indication<br>for Use | | |
| | Fetal/Obstetric | Fetal/Obstetric |
| | Abdominal | Abdominal |
| | Pediatric | Pediatric |
| | Small Organ (breast,<br>thyroid, testicle) | Small Organ<br>(prostate) |
| | Neonatal Cephalic | Neonatal Cephalic |
| | Adult Cephalic | Adult Cephalic |
| | Trans-rectal | Trans-rectal |
| | Trans-vaginal | Trans-vaginal |
| | Musculo-skel.<br>(Conventional) | Musculo-skel<br>(conventional) |
| | Musculo-skel.<br>(Superficial) | Musculo-skel<br>(superficial) |
| | Other (Gynecological) | Other<br>(Gynecological) |
| | Cardiac Adult | Cardiac Adult |
| | Cardiac Pediatric | Cardiac Pediatric |
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| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability<br>ClearVue850 Traditional 510(k) | Doc. ID:<br>Revision:<br>Doc. date:<br>Page | <b>238512</b><br>A<br>2015 Sep 30<br>19 of 96 |
|--------------------------|--------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------|
|--------------------------|--------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------|
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | Other (Fetal Echo) | Other (Fetal) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Peripheral vessel | Peripheral vessel |
| | Cerebral Vascular | - |
| | Other: Urology | - |
| | Other (Carotid) | Other (Carotid) |
| | - | - |
| | - | -…
