The EC9-4 endocavity curved array ultrasound transducer is primarily indicated for transrectal and transvaginal, fetal and neonatal and small parts applications on the ACUSON Antares ultrasound imaging platform.

Device Description

Presently cleared EC9-4 endocavity curved array ultrasound transducer is primarily indicated for transrectal and transvaginal, fetal and neonatal and small parts applications on the ACUSON Antares ultrasound imaging platform.

AI/ML Overview

This 510(k) summary describes a device modification to an existing ultrasound transducer, the EC9-4. As such, it focuses on demonstrating substantial equivalence to the previously cleared device rather than presenting a de novo study with detailed acceptance criteria and performance data in the way a new device submission might. Therefore, many of the requested elements (e.g., acceptance criteria, test set details, expert ground truth, MRMC study, training set details) are not explicitly provided in the document for this specific modification.

Here's a breakdown of the available information and what can be inferred:

Acceptance Criteria and Device Performance

Since this is a modification to a previously cleared device (EC9-4 transducer cleared under K050034), the "acceptance criteria" are primarily implicit: demonstrating continued mechanical, electrical, and acoustical safety, and maintaining the same performance characteristics as the predicate device. The document states the modified device is "substantially equivalent in its technology and functionality to the EC9-4 transducer which is already cleared." There are no explicit quantitative acceptance criteria or reported performance metrics provided in this document.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Safety	Conforms to UL 60601-1, CSA C22.2 No. 601-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-2-37.
Electrical Safety	Conforms to UL 60601-1, CSA C22.2 No. 601-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-2-37.
Acoustic Output Safety	Conforms to AIUM/NEMA UD-2, 1998, AIUM/NEMA UD-3, 1998. Acoustic output in accordance with ALARA principle.
Biological Safety	Conforms to ISO 10993-1.
Functionality	Substantially equivalent to the previously cleared EC9-4 transducer (K050034). No specific performance metrics for image quality, resolution, etc., are provided as part of this modification summary.

Study Details

Given that this is a "Special 510(k): Device Modification" focused on substantial equivalence, the "study" conducted is likely a series of verification and validation tests to ensure the modified device still meets all relevant safety, performance, and regulatory standards, and remains functionally equivalent to its predicate. The document refers to conformance to various product safety standards.

Sample size used for the test set and the data provenance: Not explicitly stated. For a device modification of an ultrasound transducer, the "test set" would typically involve testing the physical device itself (electrical, mechanical, acoustic, biological safety testing), not a dataset of patient images.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. "Ground truth" in this context would relate to objective measurements of the transducer's physical and acoustic properties, or clinical performance if a clinical study were performed (which is not indicated in this summary for this modification).
Adjudication method: Not applicable or not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for an ultrasound transducer, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used: For safety and performance tests, the "ground truth" would be the established engineering and medical device standards (e.g., UL, CSA, AIUM/NEMA, ISO). For example, acoustic output measurements would be compared against the limits defined in AIUM/NEMA standards.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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EC9-4 ultrasound transducer Special 510 (k): Device Modification

SECTION 11

510(k) Summary of Safety and Effectiveness

Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393	APR 19 2006
Contact Person:	Patrick LynchSr. Regulatory Affairs SpecialistTelephone: (425) 557-1825Fax: (425) 391-9198
Submission Date:	March 22, 2006
Device Name:	EC9-4 Ultrasound Transducer
Common Name:	Diagnostic Ultrasound Transducer
Classification:
Regulatory Class:	II
Review Category:	Tier II
Classification Panel:	Radiology
21 CFR 892.1550

Diagnostic Ultrasound Transducer	FR #	Product Code
	892.1570	90-ITX

Predicate Devices:

The EC9-4 transducer has already been cleared on the following Siemens Medical Solutions' ultrasound platform:

· ACUSON Antares™ ultrasound platform (#K050034)

Device Description:

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Intended Use:

EC9-4 is a convex array ultrasound transducer intended for fetal, small organ, neonatal cephalic, transvaginal and transrectal applications on the ACUSON Antares™ ultrasound system.

1. ACUSON Antares™ ultrasound system is intended for use in the following applications:
  General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Antares ultrasound system has been designed to conform to the following product safety standards:

UL 60601-1, Safety Requirements for Medical Equipment .
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound
AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. 93/42/EEC Medical Device Directive
Safety and EMC Requirements for Medical Equipment .
. EN 60601-1
- . EN 60601-1-1
- . EN 60601-1-2
- . EN 60601-2-37
ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing

The systems' acoustic output is in accordance with ALARA principle (as low as reasonably achievable)

Technological Comparison to Predicate Devices:

EC9-4 ultrasound transducer is substantially equivalent in its technology and functionality to the EC9-4 transducer which is already cleared under the following 510(k) premarket notification number: K050034 (ACUSON Antares ultrasound system),

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 1 9 2006

Mr. Patrick Lynch Senior Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Ultrasound Division Headquarters 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393

Re: K060879

Trade Name: EC9-4 Ultrasound Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: March 30, 2006 Received: March 31, 2006

Dear Mr. Lynch:

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, thereforc, 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 ACUSON Antares™ Ultrasound System, as described in your premarket notification:

Transducer Model Number

1-09-4

ling Public . I

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Page 2 - Mr. Lynch

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.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions rcgarding the content of this letter, please contact Andrew Kang. M.D. at (301) 594-1212.

Sincerely yours,

1/ January 3, 1942

Nancy C. Brogdon Director. Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Siemens Medical Solutions USA, Inc. Ultrasound Division

EC9-4 ultrasound transduccr Special 510(k): Device Modification

510(k) Number (if known): K060879

Device Name: EC9-4 ultrasound transducer

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

S. C. Dunston
Sign Off)
reproductive, Abdominal

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.