CX50 DIAGNOSTIC ULTRASOUND SYSTEM

K081802 · Philips Ultrasound, Inc. · ITX · Jul 11, 2008 · Radiology

Device Facts

• Record ID: K081802
• Device Name: CX50 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Philips Ultrasound, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jul 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: [Clinical Application Table entries for Cardiac Adult, Cardiac Pediatric, and Trans-esoph. (Cardiac) using B, M, PWD, CWD, Color Doppler, Combined, and Other modes (Harmonics, Tissue Doppler Imaging)].

Device Story

Compact diagnostic ultrasound system; consists of console, display, and transducers (S5-1, X7-2t, D2CWC). System generates electronic voltage pulses sent to transducer; piezo-electric array converts pulses to ultrasonic pressure waves. Waves transmit through body tissues; reflected energy converted back to electrical signals. System performs signal processing to generate images; Doppler functions process shift frequencies from moving targets (blood) to display flow. Used in clinical settings by trained professionals. Output viewed on display screen to assist in diagnostic decision-making regarding cardiac structure and function. Benefits include non-invasive visualization and hemodynamic analysis.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence based on technological characteristics, acoustic output measurements, and compliance with electrical/physical safety standards.

Technological Characteristics

Compact ultrasound console with piezo-electric transducer arrays. Supports B-mode, M-mode, PWD, CWD, Color Doppler, Tissue Doppler, and Harmonics. Acoustic output complies with Track 3 FDA limits. Designed to electrical/physical safety standards. Connectivity via transducer ports.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, specifically targeting cardiac applications (adult, pediatric, trans-esophageal) in patients requiring cardiovascular assessment. Prescription use only.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Philips HD11 ultrasound system (K043535)
• General Electric Vivid-i ultrasound system (K061525)

Reference Devices

• Philips iU22 Ultrasound System (K042540)

Submission Summary (Full Text)

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LORIS02
CX50 Diagnostic Ultrasound System

#### 3.2 Summary of Safety and Effectiveness

JUL 11 2008

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 C.F.R. 8807.92.

The submitter of this premarket notification is:

Rob Butler Manager, Regulatory Affairs Philips Ultrasound, Inc. 3000 Minuteman Road Andover, MA 01810-6302 Tel: [phone] Fax: [phone]

This summary was prepared on May 8, 2008.

The proprietary name of the device is the CX50 Diagnostic Ultrasound System. In combination with transducers - S5-1, X7-2t, D2CWC -- the system is commonly known as a diagnostic ultrasound system and transducers.

These devices are classified as follows:

| 90IYN | | Ultrasonic Pulsed Doppler Imaging System |
|-------|--|------------------------------------------|
|-------|--|------------------------------------------|

- 901YO Ultrasonic Pulsed Echo Imaging System
- 90ITX Diagnostic Ultrasound Transducer

As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.

The CX50 is a compact diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. It is substantially equivalent to the currently marketed Philips HD11 ultrasound system and transducers cleared in K043535 and the General Electric Vivid-i ultrasound system and transducers cleared in K061525.

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The CX50 system and transducers function in a manner identical to currently marketed Philips ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The CX50 is intended for diagnostic ultrasound imaging and fluid flow analysis.

The CX50 is substantially equivalent in safety and effectiveness to the predicates identified above:

- . Both the predicate devices and the CX50 are indicated for the diagnostic ultrasonic imaging and fluid flow analysis.
- Both the predicate devices and the CX50 have the same gray-scale and Doppler . capabilities.
- Both the predicate devices and the CX50 use essentially the same technologies for . imaging, Doppler functions and signal processing.
- . Both the predicate devices and the CX50 have acoustic output levels below the Track 3 FDA limits.
- Both the predicate devices and the CX50 are manufactured under equivalent quality . systems.
- . Both the predicate devices and the CX50 are manufactured of materials with equivalent biosafety. The materials have been evaluated and found to be safe for this application.
- . Both the predicate devices and CX50 are designed and manufactured to the same electrical and physical safety standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 11 2008

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

Re: K081802

Trade/Device Name: CX50 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: ITX, IYN, and IYO Dated: June 25, 2008 Received: June 26, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the CX50 Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

#### SS-I X7-2t D2cwc

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS)

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Page 2 - Mr. Job

regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Paul Hardy at [phone].

Sincerely yours,

Joye M. King

fr

C. Brogdon Director. Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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#### 4.3.2 Indications for Use Tables

#### 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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal/Obstetric | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph. (non-Card.)<br>Intra-luminal<br>Musculo-skel<br>(conventional)<br>Musculo-skel (superficial)<br>Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac)<br>Other (Fetal) | N | N | N | N | N | N | N |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

new indication; P= previously cleared by FDA; E= added under Appendix E

* Other modes: Harmonics (Tissue & Contrast), Tissue Doppler Imaging

Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission: No previous 510(k)s are associated with this product

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Aran Khan

Prescription Use (Per 21 CFR 801.109) - .

(Division Sign-Off)
• Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081802

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### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

Device name: S5-1 transducer for use with CX50 Diagnostic Ultrasound System 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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal/Obstetric | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

new indication; P= previously cleared by FDA; E= added under Appendix E

* Other modes: Harmonics (Tissue & Contrast), Tissue Doppler Imaging Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission: K042540 - use of S5-1 transducer with Philips iU22 Ultrasound System

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Aoputho Why

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 08 18.02 510(k) Number _

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#### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

T

510(k) Number:

X7-2t 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 | | | | | | |
|------------------------------|-----------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| 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 | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E * Other modes: Harmonics (Tissue & Contrast), Tissue Doppler Imaging

Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission: K043535 - use of X7-2t transducer with Philips HD11 Ultrasound System (transducer referred to as "T6H" in that submission)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

toni M Whay

(Division Sign-Off) V-7
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number /C081802

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## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

Device name: D2cwc transducer for use with CX50 Diagnostic Ultrasound System 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) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal/Obstetric | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | |
| | Other (Gynecological) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Fetal) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| * Other modes: | | | | | | | | | |
| Combined modes: | | | | | | | | | |

Previous submission: K043535 - use of D2cwc transducer with Philips HD11 Ultrasound System

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

logut In Whay

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices KO81802 510(k) Number _