GE LOGIQ P6

K073297 · General Electric Co. · IYN · Dec 18, 2007 · Radiology

Device Facts

• Record ID: K073297
• Device Name: GE LOGIQ P6
• Applicant: General Electric Co.
• Product Code: IYN · Radiology
• Decision Date: Dec 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic; Fetal / Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Other (Urology/Prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); Intraoperative (abdominal, thoracic, vascular); Intraoperative Neurological.

Device Story

Mobile diagnostic ultrasound system; provides digital acquisition, processing, and display of ultrasound images/blood flow data. User interface includes keyboard, specialized controls, and color LCD display. Operated by qualified physicians in clinical settings. Transforms acoustic signals into visual outputs for evaluation of soft tissue and blood flow. Modification integrates features from existing GE systems to improve imaging capability and acoustic control. Output assists clinicians in diagnostic decision-making across various anatomical regions. Benefits include non-invasive visualization of internal structures and hemodynamics.

Clinical Evidence

No clinical data required. Bench testing performed to evaluate acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Device conforms to applicable medical device safety standards.

Technological Characteristics

Mobile console (49cm x 64cm x 135-141cm); digital acquisition/processing/display; color video LCD; computer keyboard; specialized controls. Supports B, M, PW/CW/Color/Power Doppler, Color M, Harmonic Imaging, Coded Pulse, and 4D/Realtime 3D modes. Conforms to 21 CFR 820, ISO 9001, and ISO 13485 quality systems.

Indications for Use

Indicated for qualified physician use for evaluation of soft tissue and blood flow in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transesophageal, transrectal, transvaginal, and intraoperative clinical 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

• GE LOGIQ P5 Diagnostic Ultrasound System (K060993)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification GE Healthcare - LOGIQ P6 Ultrasound System November 21, 2007

# Attachment B:

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

DEC 1 8 2007

GE Healthcare

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Section a):

| 1. | Submitter: | GE Healthcare<br>PO Box 414<br>Milwaukee, WI 53201 |
|----|------------------|---------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Allen Schuh,<br>Manager, Safety and Regulatory Engineering<br>Telephone: [phone]; Fax: [phone] |
| | Date Prepared: | November 21, 2007 |
| 2. | Device Name: | GE LOGIQ P6 Diagnostic Ultrasound System<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN |
| 3. | Marketed Device: | GE LOGIQ P5 Diagnostic Ultrasound System, K060993 currently in commercial |

distribution.

4. Device Description: The GE LOGIQ P6 is full-featured, general-purpose diagnostic ultrasound system consisting of a mobile console approximately 49 cm wide, 64 cm deep and 135-141 cm high that provide digital acquisition, processing and display capability. The user interface includes a computer keyboard. specialized controls and color video LCD display. The modification combines features of the unmodified system with additional features from other systems currently marketed by GE Healthcare to provide users with improved imaging capability and acoustic control.

5. Indications for Use: The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial: Urology (including prostate): Transesophageal (TE): Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neurological).

6. Comparison with Predicate Device: The LOGIQ P6 is of comparable type and substantially equivalent to the current GE LOGIQ P5. They have the same technological characteristics, are comparable in key safety and effectiveness features, utilize similar design, construction, and materials. The LOGIQ P6 has the same intended uses and basic operating modes as the predicate device.

#### Section b):

1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable 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 to 21 CFR 820, ISO 9001 and 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ P6 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the eagle.

DEC 1 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226

Re: K073297

Trade/Device Name: GE LOGIQ P6 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: November 21, 2007 Received: November 23, 2007

Dear Mr. Schuh:

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 LOGIQ P6 Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

#### 4DE7C

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

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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 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 Lauren Hefner at [phone].

Sincerely yours,

Herbert Lewin
for Nancy C. Brogdon

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

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Special 510(k) Premarket Notification GE Healthcare - LOGIQ P6 Ultrasound System November 21, 2007

Diagnostic Ultrasound Indications for Use Form

## GE LOGIQ P6 Ultrasound System

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 | Other** |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | P |
| 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 | P |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | N | P |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | N | P |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | P |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | P |
| 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 | P |
| Transrectal | P | P | P | P | P | P | P | P | P | N | P |
| Transvaginal | P | P | P | P | P | P | P | P | P | N | P |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | P | P | P | P | P | P | P | P | P | P | P |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P | P |
| 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, and 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.

[**] Other mode is 4D / Realtime 3D

(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 Reproductive, Abdomin Radiological Device 510(k) Number

Prescription User (Per 21 CFR 801.109)

E-2

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#### Special 510(k) Premarket Notification GE Healthcare - LOGIQ P6 Ultrasound System November 21, 2007

Diagnostic Ultrasound Indications for Use Form

### GE LOGIQ P6 with 4DE7C 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 | Other<br>** |
| 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 | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | N | N | N | N | N | N | N | N | N | N | N |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | N | N | N | N | N | N | N | N | N | N | N |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | N |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

Notes: [1] Abdominal includes GYN;

[4] Other use includes Urology;

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

[**] Other mode is 4D / Realtime 3D

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

ulum

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

Prescription User (Per 21 CFR 801.109)

E-20