HUMANSCAN M5S-D ULTRASOUND TRANSDUCER

K083824 · Humanscan Company, Ltd. · ITX · Feb 10, 2009 · Radiology

Device Facts

• Record ID: K083824
• Device Name: HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
• Applicant: Humanscan Company, Ltd.
• Product Code: ITX · Radiology
• Decision Date: Feb 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

When used with the GE Vivid E9 Ultrasound System, the Humanscan M5S-D is a phased array ultrasound transducer and is indicated primarily for ultrasonic evaluation of cardiology conditions and also for evaluation of fetal/obstetrics, abdominal, pediatric, adult cephalic and urology/prostate use.

Device Story

Humanscan M5S-D is a matrix array ultrasound probe with 192 elements; designed for use with GE Vivid E9 ultrasound system. Device functions as phased array transducer; captures ultrasonic signals for diagnostic imaging and fluid flow analysis. Operated by clinicians in clinical settings. Output displayed on GE Vivid E9 system monitor; assists physicians in evaluating cardiac, fetal, abdominal, pediatric, cephalic, and urological conditions. Benefits include non-invasive diagnostic visualization of internal structures and blood flow.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, disinfection effectiveness, biocompatibility, cleaning, electromagnetic compatibility, and thermal/electrical/mechanical safety. Conforms to applicable medical device safety standards.

Technological Characteristics

Matrix array ultrasound probe; 192 elements; phased array technology. Designed for integration with GE Vivid E9 system. Evaluated for biocompatibility, acoustic output, and electrical/mechanical safety per medical device standards.

Indications for Use

Indicated for ultrasonic evaluation of cardiology (adult/pediatric), fetal/obstetrics, abdominal, pediatric, adult cephalic, and urology/prostate conditions. Prescription use only.

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 E9, M5S-D transducer

Submission Summary (Full Text)

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Humanscan M5S-D Transd

FEB 10 2009

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

- 1. Submitter's name, address, telephone number, contact person: Company Information:
Humanscan Company Ltd. 302 Sinha APT, Factory Sinha Estate #672 Sunggok-dong, Kyunggi-do, Korea 5Ra 301 Contact: Sung Min Rhim, President & CEO

### Submitter:

Gary J. Allsebrook, Consultant Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116 Telephone: [phone] Fax: [phone] [e-mail] Email Prepared February 9, 2009

- · 2. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

Humanscan M5S-D Transducer

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Vivid E9 Ultrasound System

| Classification Names: | CFR Number | Product Code |
|----------------------------------|------------|--------------|
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

- ldentification of the predicate or legally marketed device: 3. The device is identical to the GE, Vivid E9, M5S-D transducer and is, in fact, manufactured for GE by Humanscan Company, Ltd.
#### Device Description: 4,

The Cardiac Ultrasound Transducer (M5S-D) is a matrix array probe with 192 elements for GE's ultrasound diagnostic system, Vivid E 9.

#### 5. Intended Use(s):

When used with the GE Vivid E9 Ultrasound System, the Humanscan M5S-D is a phased array ultrasound transducer and is indicated primarily for ultrasonic evaluation of cardiology conditions and also for evaluation of fetal/obstetrics, abdominal, pediatric, adult cephalic and urology/prostate use.

#### 6. Non-clinical tests:

The Humanscan M5S-D was evaluated, by GE, for acoustic output, disinfection effectiveness, biocompatibility, cleaning a and electromagnetic compatibility, as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

The limits are the same as the predicate Track 3 devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HUMANSCAN Company Ltd. % Mr. Gary Allsebrook Consultant Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 93478-1116

FEB 1 0 2009

Re: K083824

Trade/Device Name: Humanscan M5S-D Ultrasound Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: December 18, 2008 Received: December 24, 2008

Dear Mr. Allsebrook:

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 ffor 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 Humanscan M5S-D Ultrasound Transducer, as described in your premarket notification:

Transducer Model Number

#### M5S-D

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. Allsebrook

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 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 vours.

Heidi Lemun
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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# Indications for Use

510(k) Number (if known): K083824

Device Name: Humanscan M5S-D Ultrasound Transducer

Indications For Use:

The Humanscan M5S-D is phased array ultrasound transducer, for the GE Vivid E9 Ultrasound System, and indicated primarily for ultrasonic evaluation of cardiology conditions. It is also indicated for evaluation of fetal/obstetrics, abdominal, pediatric, adult cephalic, and urology/prostate use.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Reimer

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 08 3 510(k) Number

Page 1 of

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## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM Humanscan M5S-D Transducer for use with GE Vivid E9 Ultrasound System

### 510(k) No.: 083824

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

| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | | | |
|----------------------------------|---------------------------------------------------|---|-----|-----|------------------|--------------------|------------------|--------------------|---------------------|---------------|------------------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>imaging | Coded<br>Plus | Other<br>(Spec.) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other [4] | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of<br>Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K08921; E= added under Appendix E

Note 2: Small Organ includes breast, testes and thyroid

Note 3: Cardiac is Adult and Pediatric

Note 4: Other Use includes Urology/Prostate

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Heiles Power

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

510(k) Number K08382