Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related terms, and the described features are standard for diagnostic ultrasound systems.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound system" and is intended for "diagnostic ultrasound imaging and fluid flow analysis," indicating its primary purpose is diagnosis rather than therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is "intended for diagnostic ultrasound imaging" and "indicated for diagnostic ultrasound imaging and fluid flow analysis." The "Device Description" also refers to it as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device is described as a "general purpose, portable, cart based ultrasound system" and mentions hardware components like transducers and an external CW adapter module. While it is software-controlled and includes software features, it is fundamentally a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the ClearVue850 Diagnostic Ultrasound system is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens taken from the human body. The description of the ClearVue850 clearly states it is a diagnostic ultrasound system used for imaging and fluid flow analysis within the body. It acquires ultrasound data directly from the patient.
The intended use and applications listed are all related to in-vivo imaging. Applications like Fetal/OB, Abdominal, Cardiac, etc., involve scanning the patient's body directly.
There is no mention of analyzing biological samples. The device description focuses on acquiring and displaying ultrasound data.

Therefore, the ClearVue850 is a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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. Additionally, tables list "Adult Cephalic", "Cardiac Adult", and "Cerebral Vascular".

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.,

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests performed on in this premarket notification submission for a determination of substantial equivalence demonstrates compliance with the following standards:

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
Design Reviews
Verification and Validation

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K120321

Reference Device(s)

K132304, K141261

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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.

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,

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

2

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)

3

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	Color
Doppler*	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
Peripheral
Vessel	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

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4

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	PW
D	CWD	Color
Doppler*	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
Peripheral
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

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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
Doppler*	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
Peripheral
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:

*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

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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

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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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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
(Track I only)	Specific
(Tracks I & III)	B	M	PW
D	CWD	Color
Doppler*	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)
Peripheral
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

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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	PW
D	CWD	Color
Doppler*	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	PW
D	CWD	Color
Doppler*	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)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
N= new indication; P= previously cleared by FDA- K132304
*Color Doppler includes Color Amplitude Doppler
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;
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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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 CFR
Section | Classification Name | Product
Code |
|-------------------|------------------------------------------------|-----------------|
| 892.1550 | System, Imaging, Pulsed Doppler,
Ultrasonic | 90 IYN |
| 892.1560 | System, Imaging, Pulsed Echo,
Ultrasonic | 90 IYO |
| 892.1570 | Transducer, Ultrasonic, diagnostic | 90 ITX |

3) Substantially Equivalent Devices
Primary Predicate Device
Philips 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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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:
	ClearVue850 Traditional 510(k)	Revision:
Doc. date:
Page	A
2015 Sep 30
18 of 96

Technological Characteristics

| Feature | Proposed
ClearVue850 System | Predicate
ClearVue350/550
(K120321) |
|-----------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended
Use | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body as follows | Diagnostic
ultrasound
imaging or fluid
flow analysis of
the human body
as follows |
| Indication
for 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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	Other (Fetal Echo)	Other (Fetal)
	Peripheral vessel	Peripheral vessel
	Cerebral Vascular	-
	Other: Urology	-
	Other (Carotid)	Other (Carotid)
	-	-
	-	-
	-	-
	-	-
	-	-
	-	-
Transducer
Types	S4-1 Sector Array
C5-2 Curved Array
C9-4v Curved Array
L12-4 Broadband
Sector Linear Array
3D9-3V
V6-2
L12-5
D2CWc	S4-1 Sector Array
C5-2 Curved Array
C9-4v Curved
Array
L12-4 Broadband
Sector Linear
Array
3D9-3V
V6-2
Transducer
Frequency	1-12Mhz	1-12Mhz
Modes of
Operation	B (or 2-D), M-mode
(including Anatomical
M-mode), Pulse Wave
Doppler, Continuous
Wave Doppler, Color
Doppler, Tissue
Harmonics, iSCAN, X-
Res, Angio, 3D
(freehand), 4D and	B (or 2-D), M-
mode (including
Anatomical M-
mode), Pulse
Wave Doppler,
Continuous Wave
Doppler, Color
Doppler, Tissue
Harmonics, iSCAN,
X-Res, angio, 3D

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| | modes includes
FloVue, Elastography
(strain). | (freehand), and
SonoCT. |
|---------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| PW
Doppler | Available | Available |
| CW
Doppler | Available | Available |
| Patient
contact
materials | Acrylonitrile
butadiene styrene
Silicone Rubber
PVC - Flexible | Acrylonitrile
butadiene styrene
Silicone Rubber
PVC - Flexible |
| 510(k)
Track | Track 3 | Track 3 |
| Regulatory
Class | 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 ●

Copies are uncontrolled

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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