CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

K162329 · Philips Health Care · IYN · Sep 14, 2016 · Radiology

Device Facts

• Record ID: K162329
• Device Name: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
• Applicant: Philips Health Care
• Product Code: IYN · Radiology
• Decision Date: Sep 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid) Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel

Device Story

Diagnostic ultrasound systems (CX50, Sparq) for imaging and fluid flow analysis. CX50: portable, laptop-style, 128-channel system. Sparq: cart-based system with capacitive touch interface. Both systems transmit electronic voltage pulses to transducers; piezoelectric arrays convert pulses into ultrasonic pressure waves. Echoes from body tissues/moving targets (blood) processed to display B-mode, M-mode, Doppler (PW/CW/Color/Tissue), and Harmonics. Used in clinical settings by healthcare professionals for anatomical measurement and diagnosis. Data stored locally or via network in standard formats (DICOM, JPEG, AVI).

Clinical Evidence

No clinical data required. Substantial equivalence demonstrated via non-clinical performance testing, including system-level verification, risk control validation, and usability testing with representative users, alongside compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, and ISO 10993.

Technological Characteristics

Portable (CX50) or cart-based (Sparq) ultrasound systems. 128 transmit/256 receive channels. Supports phased, linear, curved linear array, TEE, and pencil transducers. Frequency range 1.0–18.0 MHz. Connectivity via network, DVD, USB. Software-controlled. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, and ISO 10993.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in ophthalmic, fetal, abdominal, pediatric, small organ, adult/neonatal cephalic, trans-vaginal, trans-rectal, musculo-skeletal, gynecological, cardiac (adult/pediatric/TEE/intracardiac), and peripheral vessel applications.

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

• CX50 Diagnostic Ultrasound System (K123754)

Reference Devices

• EPIQ 5 Diagnostic Ultrasound System (K160807)
• EPIQ 7 Diagnostic Ultrasound System (K160807)
• Affiniti 50 Diagnostic Ultrasound System (K160807)
• Affiniti 70 Diagnostic Ultrasound System (K160807)
• St. Jude Medical ViewFlex Xtra (K121381)
• ClearVue (K120321)

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

September 14, 2016

Philips Healthcare % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K162329

Trade/Device Name: CX50 Diagnostic Ultrasound System, Sparq 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: August 17, 2016 Received: August 19, 2016

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES

SERVICES

Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K162329 510(k) Number (if known)

Device Name

CX50 Diagnostic Ultrasound System

Indications for Use (Describe)

Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

Type of Use (Select one or both, as applicable)

- × Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
Over-The-Counter Use (21 CFR 801

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Page 1 of 1 EF

PSC

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Traditional 510(k)

CX50 and Sparq Diagnostic Ultrasound Systems

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

CX50 Diagnostic Ultrasound System Device name:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | | |
|------------------------------|---------------------------------------------------------------------------------|---|---|------------------|-----|------------------|---------------------------------------------------|---------------------|--|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | P | P | P | | P | P | P (1,4,6,7) | |
| | Fetal/Obstetric | P | P | P | P | P | P | P (1,3-8) | |
| | Abdominal | P | P | P | P | P | P | P (1,3-9) | |
| | Intraoperative<br>(vascular/epicardial) | P | P | P | | P | P | P (1,3,4,5,7) | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | P | P | P | | P | P | P (1,3,4,5,7) | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P (1,3-8) | |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | P | P | P | | P | P | P (1,3-8) | |
| | Neonatal Cephalic | P | P | P | P | P | P | P(1-8) | |
| | Adult Cephalic | P | P | P | P | P | P | P (1,3-7) | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P (1,3-8) | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Musculo-skel<br>(conventional) | P | P | P | | P | P | P (1,3-8) | |
| | Musculo-skel (superficial) | P | P | P | | P | P | P (1,3-8) | |
| | Other (Gynecological) | P | P | P | | P | P | P (1,3-9) | |
| | Cardiac Adult | P | P | P | P | P | P | P(1-4) | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P (1-7) | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P(1-4) | |
| | Other (Intracardiac) | P | P | P | P | P | P | P (1-7) | |
| | Other (Fetal) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P (1,3-8) | |
| | Other (Carotid) | P | P | P | | P | P | P (1,3-8) | |
| | N= new indication; P= previously cleared by FDA | | | | | | | | |
| *Other modes: | | | | 5. Angio Imaging | | | | | |
| | 1. Harmonics (Tissue or Contrast) | | | 6. 3D Imaging | | | | | |
| | 2. Tissue Doppler Imaging | | | 7. SonoCT | | | | | |
| | 3. iSCAN | | | | | | 8. Biopsy guidance | | |
| | 4. X-Res | | | | | | 9. Infertility monitoring of follicle development | | |
| | Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | | | | | | | | |
| | Previous submission: K123754 - CX50 | | | | | | | | |

(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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| | Philips Ultrasound, Inc | |
|--|-------------------------|--|
|--|-------------------------|--|

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

C5-1 transducer for use with CX50 Diagnostic Ultrasound System Device name:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | | Mode of Operation | | | | | | |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----|---------------------------------------------------|------------------------------------|---------------------|--|--|
| | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) | | |
| General<br>(Track I<br>Only) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal/Obstetric | P | P | P | | P | P | P (1,3-8) | | |
| | Abdominal | P | P | P | | P | P | P (1,3-9) | | |
| | Intraoperative<br>(vascular/epicardial) | | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P (1,3-9) | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | | | |
| | Musculo-skel (superficial) | P | P | P | | P | P | P (1,3-8) | | |
| | Other (Gynecological) | P | P | P | | P | P | P (1,3-9) | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Other (Intracardiac) | | | | | | | | | |
| | Other (Fetal) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P (1,3-8) | | |
| | Other (Carotid) | | | | | | | | | |
| | N= new indication; P= previously cleared by FDA | | | | | | | | | |
| *Other modes: | | | | | | 5. Angio Imaging | | | | |
| 1. Harmonics (Tissue & Contrast) | | | 6. 3D Imaging | | | | | | | |
| 2. Tissue Doppler Imaging | | | 7. SonoCT | | | | | | | |
| 3. iSCAN | | | 8. Biopsy guidance | | | | | | | |
| 4. X-Res | | | | | | 9. Infertility monitoring of follicle development | | | | |
| Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | | | | | | | | | | |
| | Previous submission: K123754 - CX50 | | | | | | | | | |
| | (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 | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | |
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal/Obstetric | P | P | P | | P | P | P (1,3-8) | | |
| | Abdominal | P | P | P | | P | P | P (1,3-9) | | |
| | Intraoperative<br>(vascular/epicardial) | | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P (1,3-8) | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | P | P | P | | P | P | P (1,3-8) | | |
| | Neonatal Cephalic | P | P | P | | P | P | P (1-8) | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Musculo-skel (conventional) | P | P | P | | P | P | P (1,3-8) | | |
| | Musculo-skel (superficial) | P | P | P | | P | P | P (1,3-8) | | |
| | Other (Gynecological) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Other (Intracardiac) | | | | | | | | | |
| | Other (Fetal) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P (1,3-8) | | |
| | Other (Carotid) | P | P | P | | P | P | P (1,3-8) | | |
| | N= new indication; P= previously cleared by FDA | | | | | | | | | |
| *Other modes: | | | | | | 5. Angio Imaging | | | | |
| | 1. Harmonics (Tissue & Contrast) | | | | | 6. 3D Imaging | | | | |
| | 2. Tissue Doppler Imaging | | | | | 7. SonoCT | | | | |
| | 3. iSCAN | | | | | 8. Biopsy guidance | | | | |
| 4. X-Res<br>9. Infertility monitoring of follicle development | | | | | | | | | | |
| | Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | | | | | | | | | |
| | Previous submission: K123754 - CX50 | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal/Obstetric | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P (1,3,4,5,7) | | |
| | Intraoperative<br>(vascular/epicardial) | P | P | P | | P | P | P (1,3,4,5,7) | | |
| | Intraoperative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | P | P | P | | P | P | P (1,3,4,5,7) | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | | |
| | Other (Gynecological) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Other (Intracardiac) | | | | | | | | | |
| | Other (Fetal) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Carotid) | | | | | | | | | |
| | N= new indication; P= previously cleared by FDA | | | | | | | | | |
| *Other modes: | 1. Harmonics (Tissue & Contrast) | | 5. Angio Imaging | | | | | | | |
| | 2. Tissue Doppler Imaging | | 6. 3D Imaging | | | | | | | |
| | 3. iSCAN | | 7. SonoCT | | | | | | | |
| 4. X-Res | | 8. Biopsy guidance | | | | | | | | |
| | | | 9. Infertility monitoring of follicle development | | | | | | | |
| | Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | | | | | | | | | |
| | Previous submission: K123754 - CX50 | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal/Obstetric | P | P | P | | P | P | P (1,3-8) | | |
| | Abdominal | P | P | P | | P | P | P (1,3-9) | | |
| | Intraoperative<br>(vascular/epicardial) | | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P (1,3-9) | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P (1,3-9) | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | |…