HUMANSCAN M5S-D ULTRASOUND TRANSDUCER

• K Number: K083824
• Device Name: HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
• Manufacturer: HUMANSCAN COMPANY, LTD.
• Date Cleared: 2009-02-10 ( 50 days)
• Product Code: ITX
• Regulation Number: 892.1570

Intended 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.

Device Description

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

Predicate Devices

Vivid E9 Ultrasound System

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard ultrasound transducer and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.

Therapeutic

No
The device is described as an "ultrasound transducer" for a diagnostic ultrasound system, primarily used for "ultrasonic evaluation" of various conditions. Its intended use is for imaging and evaluation, not for treating or preventing disease.

Diagnostic

Yes
The 'Intended Use / Indications for Use' section states that the device is "indicated primarily for ultrasonic evaluation of cardiology conditions" and "also indicated for evaluation of fetal/obstetrics, abdominal, pediatric, adult cephalic, and urology/prostate use", which describes diagnostic purposes. Additionally, the 'Device Description' mentions it is for "GE's ultrasound diagnostic system".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "phased array ultrasound transducer" and a "matrix array probe," which are hardware components. The performance studies also focus on hardware-related aspects like acoustic output, disinfection, biocompatibility, and safety standards.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
• Device Function: The Humanscan M5S-D is an ultrasound transducer. It uses sound waves to create images of internal body structures. This is a form of in vivo (within the living body) diagnostic imaging.
• Intended Use: The intended use clearly states it's for "ultrasonic evaluation of cardiology conditions" and other anatomical sites. This involves imaging the body directly, not testing samples taken from the body.

Therefore, based on the provided information, the Humanscan M5S-D is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

90-ITX, ITX

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiology, fetal/obstetrics, abdominal, pediatric, adult cephalic, urology/prostate

Indicated Patient Age Range

pediatric, adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Vivid E9 Ultrasound System

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.

Summary

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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

1

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.

2

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.

3

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)

4

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
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
imaging	Coded
Plus	Other
(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
Conventional
Musculo-skeletal
Superficial
Other [4]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of
Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative
Intraoperative
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