GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X

K032656 · Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · IYN · Oct 30, 2003 · Radiology

Device Facts

• Record ID: K032656
• Device Name: GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
• Applicant: Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
• Product Code: IYN · Radiology
• Decision Date: Oct 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Story

GE LOGIQ 9 is a mobile, general-purpose diagnostic ultrasound system; console-based with digital acquisition, processing, and display. Inputs include ultrasonic signals from various probes; system processes these via digital beamforming and image enhancement algorithms (including IQ filter/Speckle Reduction Imaging). Outputs are displayed on CRT/LCD monitors for physician interpretation. Used in clinical settings by physicians for diagnostic imaging; aids in clinical decision-making by providing real-time anatomical and physiological visualization. Benefits include improved image quality and diagnostic capability through enhanced user interface and processing features.

Clinical Evidence

No clinical data required. Substantial equivalence supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in accordance with applicable standards.

Technological Characteristics

Mobile console-based ultrasound system; digital acquisition and processing. Features IQ filter and Speckle Reduction Imaging. Connectivity via standard ultrasound interfaces. Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485. Safety verified per medical device standards for acoustic output, electrical, and mechanical safety.

Indications for Use

Indicated for ultrasound evaluation of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal, urological (prostate), transvaginal, and intraoperative applications by qualified physicians.

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 9 Diagnostic Ultrasound System (K011188/K030934)

Submission Summary (Full Text)

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K 032656

Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 9 Ultrasound BT03/IQ August 26, 2003

### OCT 3 0 2003

## Attachment B:

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

| | | | <i>GE Medical Systems</i> |
|--|--|-----------------------------------------------------------------------------|---------------------------|
| | | <i>General Electric Company</i><br><i>P.O. Box 414, Milwaukee, WI 53201</i> | |

**Section a):**

| 1. Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC<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: | August 26, 2003 |
| 2. Device Name: | GE LOGIQ 9 Diagnostic Ultrasound System with IQ Filter,<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN |
| 3. Marketed Device: | GE LOGIQ 9 Diagnostic Ultrasound System K011188/K030934 (90-IYO/IYN)<br>A device currently in commercial distribution. |

4. Device Description: The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide. 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and image enhancement.

5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

6. Comparison with Predicate Device: The GE LOGIQ 9 with the IQ filter is of a comparable type and substantially equivalent to the current GE LOGIQ 9. It has the same technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and 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 quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 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 Medical Systems that the GE LOGIQ 9 BT03 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 3 0 2003

Mr. Allen Schuh Manager, Safety & Regulatory Engineering GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue MILWAUKEE WI 53219

### Re: K032656

Trade/Device Name: GE LOGIQ 9 Diagnostic Ultrasound System (added: Speckle Reduction Imaging) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging syster Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN. IYO, and ITX Dated: October 1, 2003 Received: October 2, 2003

Dear Mr. Schuh:

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 adultcration.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.