VUE 100 ULTRASOUND IMAGING SYSTEM

K040652 · Mobilsonic, Inc. · IYO · May 17, 2004 · Radiology

Device Facts

• Record ID: K040652
• Device Name: VUE 100 ULTRASOUND IMAGING SYSTEM
• Applicant: Mobilsonic, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The VUE 100 ultrasound system is used by or under the direction of a certified physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, and small organ applications.

Device Story

VUE 100 is a portable ultrasound imaging system; acquires and displays real-time 2D ultrasound images. System utilizes mechanical sector probes (4S2 3MHz and 6S4 5MHz). Operated by or under direction of certified physician in clinical settings. Device transforms ultrasonic pulsed echo signals into visual output on 5.6-inch LCD monitor. Supports digital archival and VCR recording. Provides fetal and abdominal measurement and analysis (M&A) capabilities. Healthcare providers use visual output for diagnostic assessment of abdominal, peripheral vascular, fetal, and small organ structures. Benefits include non-invasive diagnostic imaging.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable ultrasound system; mechanical sector probes (3MHz and 5MHz); 5.6-inch LCD display; 2D imaging mode; digital archival; UL 2601 electrical safety; Track 1 ultrasound safety.

Indications for Use

Indicated for diagnostic ultrasound imaging of the human body, specifically abdominal, peripheral vascular, fetal, and small organ (thyroid, breast, testicles) applications. For use by or under the direction of a certified physician.

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

• Pie Medical 50S Tringa (K020112)

Submission Summary (Full Text)

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K040652

MAY 1 7 2004

510(K) Summary VUE 100 Mobilsonic, Inc.

### Section 3: 510(k) Summary

This summary of safety and effectiveness has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR807.92(a).

#### Submitter Information

Mobilsonic Inc. 560 Parrott Street San Jose, CA 95112 [phone] Phone: [phone] Fax: Bao Le Contact Person: February 18, 2004 Date:

#### Device Information

VUE 100 Ultrasound Imaging System Trade Name: Ultrasound Imaging System Common Name: Classification Name: Ultrasonic Pulsed Echo Imaging System (FR# 892.1560) Classification Number: 90-IYO

#### Predicate Device

| Company | Device Name | 510(k) Number |
|-------------|-------------|---------------|
| Pie Medical | 50S Tringa | K020112 |

Additional substantial equivalence information is provided in the following Comparison Chart for Substantial Equivalence.

#### Device Description

The VUE 100 is a portable ultrasound system. It is used to acquire and display real time 2D ultrasound images. Currently the system supports two mechanical sector probes, 4S2 (3MHz) and 6S4 (5MHz).

#### Intended Use(s)

The VUE 100 ultrasound system is used by or under the direction of a certified physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, and small organ applications.

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510(k) Summary VUE 100 Mobilsonic Inc.

| General Characteristics | Mobilsonic<br>VUE 100<br>(This Submission) | Pie Medical<br>50S Tringa<br>(K020112) |
|-------------------------------|--------------------------------------------|----------------------------------------|
| Intended use | | |
| Fetal | Yes | Yes |
| Abdominal | Yes | Yes |
| Pediatric | Yes | Yes |
| Small Organ | Yes | Yes |
| Peripheral Vascular | Yes | Yes |
| Cardiac | No | Yes |
| Neonatal Cephalic | No | No |
| Adult Cephalic | No | No |
| Transesophageal | No | No |
| Transrectal | No | No |
| Transvaginal | No | No |
| Transurethral | No | No |
| Intravascular | No | No |
| Musculoskeletal | No | No |
| Transducer type | | |
| Mechanical Sector | Yes | Yes |
| Linear | No | No |
| Convex | No | No |
| 2D Freq MHZ | 3.0/5.0 | 3.5/5.0/7.5 |
| CFM/Doppler Freq MHZ | N/A | N/A |
| Biopsy Guidance | No | No |
| Display type | LCD | LCD |
| Imaging modes | 2D | 2D/M-Mode |
| Monitor size (inches) | 5.6 | 5.4 |
| Digital archival capabilities | Yes | Yes |
| VCR | Yes | Yes |
| M&A capabilities | Fetal & Abdominal | Cardiac, Fetal &<br>Abdominal |
| Safety | | |
| Electrical safety | UL 2601 | EN60601-1 |
| Ultrasound safety | Track 1 | Track 1 |

## Comparison Chart for Substantial Equivalence

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2004

Mr. Bao Le Regulatory Engineer Mobilsonic, Inc. 560 Parrott Street SAN JOSE CA 95112

Re: K040652

Trade Name: VUF 100 Ultrasound Imaging System 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 1YO and ITX Dated: April 22, 2004 Received: April 26, 2004

Dear Mr. Le:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have levewed your Society of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regarly the enactment date of the Medical Device Amendments, or to commerce pror to may 20, 1775, an accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general bonanifacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial cquivalence applies to the following transducers intended for use with the VUE 100 Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

4S2 Mechanical Sector Probe (3MHz) 6S4 Mechanical Sector Probe (5MHz)

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to can adam Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I reast of devilsed that i be rise complies with other requirements of the Act or any For than antines 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); line Act 3 requirements, merading, but notacturing practice requirements as set forth in the quality labeling (21 CFR Part 801); good manalactaning product 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 I mis device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Information, including deousing September 30, 1997 "Information for Manufacturers Seeking Appendix O, (cherosco) of the Ocher 5 Sopted Systems and Transducers." If the special report is Marketing Citatine of Diagnoste Offices (e.g., acoustic output greater than approved levels), then moonly contains anaceopacity 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 rno special roported "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 rcsults 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 IT you desire specific ad riot for your 2017 594-4591. Additionally, for questions on the promotion contact the Office of your device, please contact the Office of Compliance at [phone]. Also, and acreentialing or your are and the by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely vours,

David Ingram

fp

Nancy 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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# Diagnostic Ultrasound Indications for Use Form

Device Name: VUE 100 Ultrasound Imaging System

Device Name: VOE 100 oultrasound imaging of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|-------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | | | | | | | | |
| Abdominal | | N | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | N | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA Additional Comments: Small organs include Thyroid, Breast, and Testicles.

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

Prescription Use (Per 21 CFR 801.109)

Daniel A. Byron

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devic 510(k) Number

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### Diagnostic Ultrasound Indications for Use Form

Device Name: 4S2 Mechanical Sector Probe (3MHz)

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

| Clinical Application | A | B | M | PWD CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|-------------------------------|---|---|---|---------|---------------|-------------------|------------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | N | | | | | | | |
| Abdominal | | N | | | | | | | |
| Intraoperative | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ | | N | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | |
| Other (specify) | | | | | | | | | |

N = new indication; P = previously cleared by FDA Additional Comments: Small organs include Thyroid, Breast, and Testicles.

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

Prescription Use (Per 21 CFR 801.109)

David G. Lynn

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

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# Diagnostic Ultrasound Indications for Use Form

Device Name: 6S4 Mechanical Sector Probe (5MHz)

Device Name: Dognostic ultrasound imaging of the human body as follows:

| Clinical Application | A | B | M | PWD/CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|-------------------------------|---|---|---|---------|---------------|-------------------|------------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | N | | | | | | | |
| Abdominal | | N | | | | | | | |
| Intraoperative | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ | | N | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | |
| Other (specify) | | | | | | | | | |

N = new indication; P = previously cleared by FDA N = new indioution,

> (Please do not WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David br hoppn
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 5 1 0(k) Number