GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM

K092756 · Ge Vingmed Ultrasound AS · ITX · Sep 28, 2009 · Radiology

Device Facts

• Record ID: K092756
• Device Name: GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Ge Vingmed Ultrasound AS
• Product Code: ITX · Radiology
• Decision Date: Sep 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

Diagnostic Ultrasound imaging, measurement and analysis of the human body in clinical applications of Fetal/OB; Abdominal; Pediatric; Urology; Cardiac (adult and pediatric), Peripheral Vessel and Thoracic/Pleural motion and fluid detection; Its compact size, high degree of portability and simplified user interface enable it for adjunctive use for patient examination in primary care and in special care areas.

Device Story

Compact, portable diagnostic ultrasound system; features integrated keyboard, fold-up LCD display, and fixed wired electronic-array transducer. Inputs: ultrasonic signals via transducer. Processing: digital acquisition and signal processing. Outputs: real-time ultrasound images on integrated display. Used in primary care and special care areas by clinicians for adjunctive patient examination. Enables rapid visualization, measurement, and analysis of human anatomy; supports clinical decision-making through immediate diagnostic imaging.

Clinical Evidence

No clinical data required. Substantial equivalence established via non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing.

Technological Characteristics

Compact portable ultrasound system; fixed wired electronic-array transducer (Model G3S). Modes: B-mode, Color Doppler, Combined (B/Color), Harmonic Imaging. Digital acquisition and processing. Conforms to 21 CFR 820, ISO 9001, ISO 13485. Safety verified via independent evaluation of acoustic, electrical, and mechanical parameters.

Indications for Use

Indicated for ultrasound imaging, measurement, and analysis of human body in Fetal/OB, Abdominal (including renal), Pediatric, Urology, Cardiac (adult/pediatric), Peripheral Vessel, and Thoracic/Pleural (fluid/motion detection) applications. For use by clinicians in primary care and special care areas.

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

• GE Vivid-e Ultrasound System (K072797)
• GE Venue 40 Ultrasound System (K091164)
• Acuson P10 Ultrasound System (K063761)

Submission Summary (Full Text)

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K092756

Traditional 510(k) Premarket Notification GE Vscan - Compact Diagnostic Ultrasound System July 14. 2009

# Attachment B

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

| SEP | 2 2009 |
|-----|--------|
|-----|--------|

| 1. Submitter: | GE Vingmed Ultrasound AS<br>Strandpromenaden 45<br>N-3183, Horten, Norway |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jan Tore Thollefsen,<br>Regulatory Affairs Leader<br>Telephone: [phone]; Fax: [phone] |
| Date Prepared: | July 13, 2009 |
| 2. Device Name: | GE Vscan Diagnostic Ultrasound System<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |
| | 200 |
| 3. Marketed Devices: | GE Vivid-e Ultrasound System, K072797 currently in commercial distribution.<br>GE Venue 40 Ultrasound System, K091164 currently in commercial distribution.<br>Acuson P10 Ultrasound System, K063761 currently in commercial distribution. |

Device Description: The GE Vscan is compact and portable diagnostic ultrasound system with ব integrated keyboard, fold-up LCD type display and fixed wired electronic-array transducer. It has an overall size approximately 73 mm wide, 135 mm deep and 28 mm high in transport configuration, and provides digital acquisition, processing and display capability. The user interface includes an intuitive layout of specialized controls and a color LCD display.

5. Indications for Use: The GE Vscan is indicated for ultrasound imaging, measurement and analysis of the human body in clinical applications of Fetal/OB; Abdominal; Pediatric; Urology; Cardiac (adult and pediatric), Peripheral Vessel and Thoracic/Pleural motion and fluid detection; Its compact size, high degree of portability and simplified user interface enable it for adjunctive use for patient examination in primary care and in special care areas.

6. Comparison with Predicate Device: The modified GE Vscan is of a comparable type and substantially equivalent to the currently marketed GE Vivid e, GE Venue 40 and Acuson P10. It is a compact and readily portable unit comparable in key safety and effectiveness features and with the same patient contact materials as currently marketed transducer. GE Vscan has the same intended uses as the predicate devices.

#### Section b):

Section a):

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 ISO13485 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 Vscan 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 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

## SEP 2 8 2009

GE Vingmed Ultrasound AS % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K092756

Trade/Device Name: GE Vscan-Compact Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: September 8, 2009 Received: September 9, 2009

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 GE Vscan-Compact Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

### G3S

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.

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Page 2 - Mr. Job

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 1000-1050.

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 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.

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

Sincerely vours.

. Herbert Lehman

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

Enclosure(s)

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## Diagnostic Ultrasound Indications for Use Form

### GE Vscan Ultrasound System

Intended Use: Diagnostic Ultrasound imaging, measurement and analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | | | | |
|---------------------------|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | 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 | Ophthalmic | | | | | | | | | | | |
| | Fetal | N | | | | N | | | N | N | | |
| | Abdominal[1] | N | | | | N | | | N | N | | |
| | Intra-operative (Specify) | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | N | | | | N | | | N | N | | |
| | Small Organ (specify) | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | |
| | Other (specify)[2] | N | | | | N | | | N | N | | |
| | Cardiac Adult | N | | | | N | | | N | N | | |
| Cardiac | Cardiac Pediatric | N | | | | N | | | N | N | | |
| | Intravascular (Cardiac) | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (specify) | | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | | | | | | | | N | | |
| | Other (specify) | | | | | | | | | | | |

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

Notes: [1] Abdominal includes Renal.

[2] Other use includes Urology and Thoracic/Pleural detection of fluid and pleural motion/sliding.

[*] Combined mode is B/Color.

[*] Coded Pulse is for digitally encoded harmonics.

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

Prescription User (Per 21 CFR 801.109) .

E-2

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev

510(k) Number

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## Diagnostic Ultrasound Indications for Use Form

## GE Vscan Ultrasound System with G3S transducer

Intended Use: Diagnostic Ultrasound imaging, measurement and analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | | | | |
|---------------------------|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | 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 | Ophthalmic | | | | | | | | | | | |
| | Fetal | N | | | | N | | | N | N | | |
| | Abdominal[1] | N | | | | N | | | N | N | | |
| | Intra-operative (Specify) | | | | | | | | | | | |
| | Intra-operative (Neuro) . | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | N | | | | N | | | N | N | | |
| | Small Organ (specify) | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | |
| | Other (specify)[2] | N | | | | N | | | N | N | | |
| | Cardiac Adult | N | | | | N | | | N | N | | |
| Cardiac | Cardiac Pediatric | N | | | | N | | | N | N | | |
| | Intravascular (Cardiac) | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (specify) | | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | | | | | | | | N | | |
| | Other (specify) | | | | | | | | | | | |

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

Notes: [1] Abdominal includes Renal.

[2] Other use includes Urology and Thoracic/Pleural detection of fluid and pleural motion/sliding.

[*] Combined mode is B/Color.

[*] Coded Pulse is for digitally encoded harmonics.

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

HER PAGE IF NEEDED)
uation (ODE)

Division Sign-Off

vision of Reproductive, Abdominal,

and Radiological De 510(k) Number

Prescription User (Per 21 CFR 801.109)

E-3