GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

K101149 · Ge Vingmed Ultrasound AS · IYO · Oct 13, 2010 · Radiology

Device Facts

• Record ID: K101149
• Device Name: GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
• Applicant: Ge Vingmed Ultrasound AS
• Product Code: IYO · Radiology
• Decision Date: Oct 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Device Story

GE Vivid E9 BT10 is a mobile diagnostic ultrasound console for echocardiography, vascular, and general imaging. System utilizes electronic array transducers to acquire, process, and display digital ultrasound data. Operated by physicians or under their direction in clinical settings. Provides B-mode, M-mode, PW/CW/Color/Power Doppler, and real-time 3D/4D volume imaging. Features include high-resolution LCD display and touch panel for user control. Software processes raw acoustic signals into visual images for clinical analysis. Output assists clinicians in diagnostic assessment of anatomy and blood flow, supporting clinical decision-making across various specialties. Benefits include improved performance and productivity for diagnostic examinations.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection validation, and electromagnetic compatibility testing, all conforming to harmonized medical device safety standards.

Technological Characteristics

Mobile console with electronic array transducers. Modalities: B, M, PW/CW/Color/Power Doppler, Color M, Harmonic, Coded Pulse, RT3D/4D. Connectivity: Digital acquisition/display. Software: Enhanced performance features. Sterilization: Compatible with standard cleaning/disinfection protocols. Conforms to 21 CFR 820, ISO 9001:2008, and ISO 13485:2003.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients of all ages (pediatric to adult) for cardiac, fetal, abdominal, small organ, neonatal/adult cephalic, peripheral vascular, musculoskeletal, urological, transesophageal, transvaginal, and intraoperative applications.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• GE Vivid E9 Ultrasound System (K081921)
• GE Logiq E9 Ultrasound System (K092271)

Reference Devices

• GE LOGIQ E9 BT08 (K073408)

Submission Summary (Full Text)

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K101149 pg //2

Special 510(k) Premarket Notification GE Vivid E9 BT10 Ultrasound System April 21, 2010

OCT 1 3 2010

# Attachment B

## Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c)

#### Section a):

1

| Submitter: | GE Healthcare<br>9900 W Innovation Dr., RP-2138<br>Wauwatosa, WI 53226<br>USA |
|-----------------|----------------------------------------------------------------------------------------|
| Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>Telephone: [phone]; Fax: [phone] |

Date Prepared:April 21, 2010

- 2. Device Name: GE Vivid E9 Diagnostic Ultrasound System Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX
- 3. Marketed Devices: GE Vivid E9 Ultrasound System, K081921, and GE Logig E9 Ultrasound System. K092271. currently in commercial distribution.
- 4. Device Description: The GE Vivid E9 Diagnostic Ultrasound is a full-featured echocardiography imaging and analysis system with additional capability in vascular and general ultrasound imaging. It consists of a mobile console with multiple electronic array transducers that provide digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high-resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users.
- ട്. Indications for Use: The GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
- Comparison with Predicate Device: The GE Vivid E9 BT10 is of a comparable type and 6. substantially equivalent to the current GE Vivid E9 with enhanced performance and added transducers; 4V-D, 12S-D, ML6-15-D and i13L, which are new to GE Vivid E9. It has the same overall characteristics, key safety and effectiveness features, physical design, general overall construction, materials, and has the same intended uses and operating modes as the predicate device. The additional software features are similar to other cleared GE Ultrasound systems like GE Logiq E9.

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#### Section b):

- 1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility as well as thermal, electrical and mechanical safety, and has been found to conform with applicable and harmonized medical device safety standards.
- 2. Clinical Tests: None required.
- 3. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2008 and ISO13485:2003 quality systems. The device conforms to applicable medical device safety standards. Compliance is verified through 30 party product certifications and regular production monitoring. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE Vivid E9 Diagnostic Ultrasound system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

GE Vingmed Ultrasound AS % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Dr., RP-2138 WAUWATOSA WI 53226

OCT 1 3 2010

Re: K101149

Trade/Device Name: GE Vivid E9 BT10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 27, 2010 Received: August 30, 2010

Dear Mr. Behn:

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 GE Vivid E9 BT10 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

ML6-15-D 12S-D 4V-D i13L

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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 895. 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) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1.000-1050.

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 and 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.

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

Sincerely yours,

Signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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#### Diagnostic Ultrasound Indications for Use Form

#### GE Vivid E9 BT10 Ultrasound System

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

| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | P. |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | P | P | P | P | P | P | P | P | | | |
| Transvaginal | P | P | P | P | P | P | P | P | | P | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | P | P | P | P | P | P | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid.

{3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

K10114

Prescription User (Per 21 CFR 801.109)510K

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### Diagnostic Ultrasound Indications for Use Form

## GE Vivid E9 BT10 with ML6-15-D Transducer

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

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|--------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric[2] | N | N | N | | N | N | N | N | N | N | |
| Small Organ [1][2] | N | N | N | | N | N | N | N | N | N | |
| Neonatal Cephalic | N | N | N | | N | N | N | N | N | N | N |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular[2] | N | N | N | | N | N | N | N | N | N | |
| Musculo-skeletal Conventional[2] | N | N | N | | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication, (Transducer previously cleared on GE LOGIQ E9 BT08 (K073408); P = previously cleared by FDA; E = added under Appendix E

Notes:

[1] Small organ includes breast, testes, thyroid.

[2] Needle guidance imaging

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[ + ] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription User (Per 21 CFR 801.109)

Division of Radiological Devices OMSION of RadioIQgical Device Evaluation and Safety

619K ICIO1149

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#### Diagnostic Ultrasound Indications for Use Form

### GE Vivid E9 BT10 with 12S-D Transducer

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

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|--------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | N |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [1] | N | N | N | N | N | N | N | N | N | N | N |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

Notes: [1] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

[+] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

દ્વાદા

Prescription User (Per 21 CFR 801.109)

{7}------------------------------------------------

#### Diagnostic Ultrasound Indications for Use Form

### GE Vivid E9 BT10 with 4V-D Transducer

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | N |
| Abdominal [1] | N | N | N | N | N | N | N | N | N | N | N |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | N |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | N | N |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [3] | N | N | N | N | N | N | N | N | N | N | N |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Cardiac is Adult and Pediatric.

[3] Other use includes Urology/Prostate

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
ical Devices

Civision of Radiological Devices Division of Radiological Device Evaluation and Safety

510K K101149

Prescription User (Per 21 CFR 801.109)

{8}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form GE Vivid E9 BT10 with i13L Transducer

Mode of Operation Clinical Application Power Combined Harmonic RT3D Color Color M Coded PW CW B M Doppler Doppler Doppler Modes lmaging Pulse Mode * Doppler Doppler Anatomy/ Region of Interest . . Ophthalmic Fetal / Obstetrics N N N N N N N N Abdominal(1) Pediatric Small Organ (specify) Neonatal Cephalic -Adult Cephalic N N N N N N N N Cardiac-21 Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify) Exam Type, Means of Access Transesophageal Transrectal ; Transvaginal Transuretheral N N N N N N Intraoperative(3) N N Intraoperative Neurological Intravascular Laparoscopic

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

Lopatooople ================================================================================================================================================================== E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Cardiac is Adult and Pediatric via Intraoperative;

[3] Intraoperative includes abdominal, thoracic, and vascular.

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF. NEEDERAT

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitre Diagnostic Device Evaluation and Safety

510K R.101149

Prescription User (Per 21 CFR 801.109)