MODEL EC9-4 TRANSDUCER

K060879 · Siemens Medical Solutions USA, Inc. · ITX · Apr 19, 2006 · Radiology

Device Facts

• Record ID: K060879
• Device Name: MODEL EC9-4 TRANSDUCER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: ITX · Radiology
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

EC9-4 is a convex array ultrasound transducer designed for use with the ACUSON Antares ultrasound system. It captures acoustic signals from internal anatomical structures during transrectal, transvaginal, fetal, neonatal, and small parts examinations. The transducer converts these signals into electrical data processed by the Antares system to generate real-time diagnostic images. Operated by clinicians in clinical settings, the device facilitates anatomical measurements and clinical diagnosis. The system adheres to ALARA principles for acoustic output. The output is displayed on the system monitor, allowing healthcare providers to visualize internal structures, assess pathology, and guide clinical decision-making. The device benefits patients by providing non-invasive, real-time diagnostic imaging for various clinical applications.

Clinical Evidence

No clinical data. Bench testing only, including compliance with safety and EMC standards (EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-2-37) and biological evaluation (ISO 10993-1).

Technological Characteristics

Convex array ultrasound transducer. Materials comply with ISO 10993-1. Operates with ACUSON Antares system. Adheres to AIUM/NEMA UD-2 and UD-3 standards for acoustic output. Safety compliance: UL 60601-1, CSA C22.2 No. 601-1, EN 60601-1 series.

Indications for Use

Indicated for transrectal, transvaginal, fetal, neonatal, and small parts imaging applications in patients requiring diagnostic ultrasound evaluation.

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

• EC9-4 Ultrasound Transducer (K050034)

Submission Summary (Full Text)

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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.,<br>Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 | APR 19 2006 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Patrick Lynch<br>Sr. Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] | |
| 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:

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.

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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 [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 rcgarding the content of this letter, please contact Andrew Kang. M.D. at [phone].

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:

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.

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
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reproductive, Abdominal