(19 days)
Not Found
No
The 510(k) summary describes an ultrasound transducer and its intended use, with no mention of AI, ML, or advanced image processing features that would typically indicate the presence of such technology.
No
The device is an ultrasound transducer used for imaging and diagnostic purposes, not for treating conditions.
Yes
The device is an ultrasound transducer used for imaging, which is a diagnostic procedure. The "Intended Use / Indications for Use" section explicitly states its applications for transrectal, transvaginal, fetal, neonatal, and small parts on an ultrasound imaging platform, all of which are diagnostic uses.
No
The device description explicitly states it is an "endocavity curved array ultrasound transducer," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that the EC9-4 is an ultrasound transducer. Ultrasound transducers are used to generate and receive sound waves to create images of internal body structures. This is an in vivo (within the living body) imaging technique, not an in vitro test on a sample.
- Intended Use: The intended use describes imaging applications (transrectal, transvaginal, fetal, neonatal, small parts) on an ultrasound platform. This aligns with in vivo imaging, not in vitro testing.
Therefore, the EC9-4 endocavity curved array ultrasound transducer is an imaging device, not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
90-ITX, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
transrectal, transvaginal, fetal, neonatal, small parts, abdominal, intraoperative, pediatric, transcranial, OB/GYN, cardiac, transesophageal, pelvic, urology, vascular, musculoskeletal, superficial musculoskeletal, peripheral vascular, cephalic
Indicated Patient Age Range
neonatal, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 | APR 19 2006 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Patrick Lynch
Sr. Regulatory Affairs Specialist
Telephone: (425) 557-1825
Fax: (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:
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.
1
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.
-
- 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.
- ACUSON Antares™ ultrasound system is intended for use in the following 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),
2
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
3
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
4
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
Sign Off)
reproductive, Abdominal