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.

AI/ML Overview

The information provided is for the Humanscan M5S-D Transducer for use with the GE Vivid E9 Ultrasound System. This submission is a 510(k) premarket notification, which largely relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive de novo clinical studies with acceptance criteria and performance metrics typically seen for novel devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or reported device performance metrics in the format of a table as typically seen for new diagnostic algorithms. Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device, the GE Vivid E9 M5S-D transducer.

The "acceptance criteria" in this context are primarily related to safety and functionality, ensuring the new device performs equivalently to the predicate. The reported "performance" is that it conforms to these safety and functional standards and is substantially equivalent.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Safety	Conformity with applicable medical device safety standards (acoustic output, disinfection effectiveness, biocompatibility, cleaning, electromagnetic compatibility, thermal, electrical, and mechanical safety). Limits are same as predicate.	"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."
Intended Use	The intended use and clinical applications should be consistent with the predicate device.	"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." This matches the predicate's indications.
Technical Equivalence	The device is "identical to the GE, Vivid E9, M5S-D transducer and is, in fact, manufactured for GE by Humanscan Company, Ltd."	The device is explicitly stated to be identical to the predicate.
Classification	Consistent with the predicate device (Class II, Product Code ITX).	"Regulation Number: 21 CFR 892.1570, Regulation Name: Diagnostic ultrasonic transducer, Regulatory Class: II, Product Code: ITX" - This matches the predicate's classification.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a test set with a specific sample size for evaluating performance metrics through a clinical study. The evaluation appears to be primarily technical and engineering-based, focusing on safety and equivalence to the predicate transducer. There is no mention of patient data, retrospective or prospective studies, or country of origin for a "test set."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided because the submission does not detail a study involving expert-established ground truth for a test set. The evaluation is focused on technical specifications and substantial equivalence, not on diagnostic accuracy requiring human expert adjudication.

4. Adjudication Method

No adjudication method is described as there is no mention of a test set requiring expert review or ground truth establishment in this type of 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned. This type of study typically assesses the impact of AI on human reader performance, which is not applicable to an ultrasound transducer as described here, especially in a 510(k) submission demonstrating substantial equivalence.

6. Standalone Performance Study

No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done or mentioned. The device is a transducer, which is a component of an ultrasound system and requires a human operator for its intended use.

7. Type of Ground Truth Used

No specific "ground truth" (e.g., pathology, outcomes data) as understood in the context of diagnostic accuracy studies is mentioned. The ground for acceptance is primarily the technical specifications and safety standards aligned with the predicate device, confirmed through non-clinical tests. The "ground truth" is that the device is manufactured to the same specifications and meets the same safety profiles as the predicate.

8. Sample Size for the Training Set

No training set is mentioned as this is an ultrasound transducer, not an AI algorithm requiring training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned.

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: (510) 388-5001 Fax: (510) 276-2648 regman10@comcast.net 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 (240) 276-3666.

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:

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	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	Harmonicimaging	CodedPlus	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-skeletalConventional
Musculo-skeletalSuperficial
Other [4]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means ofAccess
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative
IntraoperativeNeurological
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

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.