(20 days)
No
The document describes a transducer and ultrasound systems with standard measurement and analysis packages, but there is no mention of AI or ML capabilities. The performance studies section explicitly states "no change to software or hardware," further indicating the absence of new, potentially AI/ML-driven features.
No.
The Intended Use / Indications for Use clearly state that the system provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes, indicating a diagnostic rather than therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the various ACUSON ultrasound systems, which the V5Ms transducer is intended to be used with, provide "information that is used for clinical diagnosis purposes."
No
The device description clearly details a physical ultrasound transducer with mechanical components (gastroscope control housing, flexible guide tube, acoustic array, motor, control wires, knobs). This is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
- Device Function: The V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer and the associated ultrasound systems are used to image anatomical structures within the body using ultrasound technology. This is an in vivo process (within a living organism), not an in vitro process (outside the body, typically in a lab).
- Intended Use: The intended uses listed for the transducer and the systems are all related to imaging and measurement of internal structures for clinical diagnosis purposes. This is consistent with the function of an ultrasound system, not an IVD.
- Lack of Specimen Examination: There is no mention of examining blood, tissue, or other specimens derived from the human body.
Therefore, the V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer and the associated ultrasound systems are medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications.
ACUSON Antares Ultrasound System
The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.
ACUSON CV70 Cardiovascular System
The CV70 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Gephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.
ACUSON Cypress Ultrasound System
The Cypress platform is intended for use in the following applications: General Imaging and Cardiology for Fetal. Abdominal. Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intraluminal and Intra-cardiac applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
ACUSON S1000/S2000 Ultrasound System
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal. Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal(conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging."
ACUSON SC2000 Ultrasound System
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.
ACUSON Sequoia Ultrasound System
The Siemens ACUSON Sequoia ultrasound imaging system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
ACUSON X300 Ultrasound System
The Siemens ACUSON X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides measurement of anatomical structures and analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients reqarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The V5Ms Transesophageal Transducer consists of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be articulated in both the anterior/posterior and left/right directions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Transesophageal, Abdominal, Small Parts, Transcranial, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, Peripheral Vascular, Fetal, Intraoperative, Intracardiac, Intraluminal, Small Organs (breast, testes, thyroid, penis), Transrectal, Transvaginal, Gastrointestinal, Urology.
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
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)
Performance data is not required for this modification as there is no change to software or hardware. Nonclinical tests contained in this submission include biocompatibility testing per ISO10993-1 (cytotoxicity, sensitization, irritation).
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.
K063803, K052331, K112596, K113179, K063085, K063803, K063138, K032111, K050240, K072786, K081148, K082142, K093812, K111674, K072365, K102017, K052410, K051139, K041319, K032114, K022567, K002807, K973767, K090276, K093531
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
V5Ms Transesophageal Transduce Special 510(k) Submission
JUL 1 0 2012
Siemens Medical Solutions USA, Inc. Ultrasound Division
SECTION 11 510(k) Summary
11.1. Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division 685 Ease Middlefield Road Mountain View, California 94043
- 11.2. Contact Person: Shelly Pearce Regulatory Affairs Specialist Title: Telephone: (650) 694 5988 (650) 694 5580 Fax:
11.3. Submission Date: May 7, 2012
11.4. Device Name: V5Ms Transesophageal Transducer (K052021)
used for
ACUSON Antares Diagnostic Ultrasound System (K063803), ACUSON Cypress Diagnostic Ultrasound System (K052331), ACUSON S1000/S2000 Diagnostic Ultrasound System (K112596), ACUSON SC2000 Diagnostic Ultrasound System (K113179), ACUSON Sequoia Diagnostic Ultrasound System (K063085), ACUSON X300 Diagnostic Ultrasound System (K063803)
11.5. Common Name: Diagnostic Ultrasound Transducer
11.6. Classification:
Regulatory Class: Review Category: Tier II Classification Panel: Radiology
Diagnostic Ultrasound Transducer
FR Number Product Code 892.1570 90-ITX
A. Legally Marketed Predicate Devices
The Siemens V5Ms Transesophageal Transducer is Phased Array Transducers for Transesophageal Echocardiolgraphy, and is substantially equivalent to our current product, the Siemens V5Ms Transesophageal Transducer(K052021) for ACUSON Antares Diagnostic Ultrasound System (K063803), ACUSON Cypress Diagnostic Ultrasound System (K052331), ACUSON S1000/S2000 Diagnostic Ultrasound System (K112596), ACUSON SC2000 Diagnostic Ultrasound System (K113179), ACUSON Sequoia Diagnostic Ultrasound System (K063085), and ACUSON X300 Diagnostic Ultrasound System (K063803)
B. Device Description:
The V5Ms Transesophageal Transducer consists of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be
1
articulated in both the anterior/posterior and left/right directions.
C. Intended Use
V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications.
ACUSON Antares Ultrasound System a.
The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal. Great Vessel, 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.
ACUSON CV70 Cardiovascular System b.
The CV70 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Gephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.
ACUSON Cypress Ultrasound System C.
The Cypress platform is intended for use in the following applications:
General Imaging and Cardiology for Fetal. Abdominal. Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intraluminal and Intra-cardiac applications, and intended uses as defined in the FDA quidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes
d. ACUSON S1000/S2000 Ultrasound System
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal. Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal(conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the
2
American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging."
ACUSON SC2000 Ultrasound System e.
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD); and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures.
Transcranial Imaging Applications
3
The system transmits ultrasound enerqy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
f. ACUSON Sequoia Ultrasound System
The Siemens ACUSON Sequoia ultrasound imaging system is intended for the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
ACUSON X300 Ultrasound System g.
The Siemens ACUSON X300 ultrasound imaging system is intended for the following applications:
General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides measurement of anatomical structures and analysis packages that provide information that is used for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients reqarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
D. Substantial Equivalence
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
E. Performance Data
Performance data is not required for this modification as there is no change to software or hardware.
F. A brief discussion of nonclinical tests submitted, referenced, or relied on in
the 510(k) for a determination of substantial equivalence.
The product modification is for patient contact materials only. There have been no changes to software or hardware. Nonclinical tests contained in this submission include biocompatibility testing per ISO10993-1 (cytotoxicity, sensitization, irritation).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with outstretched arms, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K121807
Trade/Device Name: V5Ms Transesophageal Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: June 19, 2012 Received: June 20, 2012
Dear Mr. Job:
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, 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 V5Ms Transesophageal Transducer, as described in your premarket notification:
Transducer Model Number
V5Ms Transesophageal Transducer
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 895. In addition, FDA may
JUL 1 0 2012
5
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.
Sincerely Yours.
Michael D. O'Higgins
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known): kl Z-1 8 07
Device Name: V5Ms Transesophageal Transducer
Indications For Use:
V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications.
Acuson Antares Ultrasound System
The Acuson Antares ultrasound imaging system is intended for the following applications:
Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.
ACUSON CV70 Cardiovascular System
The CV70 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac. Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Gephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.
ACUSON Cypress Ultrasound System
The Cypress platform is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal. Peripheral Vessel, Intra-luminal and Intra-cardiac applications, and intended uses as defined in the FDA guidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes
ACUSON S1000/S2000 Ultrasound System
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
7
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal(conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging."
Acuson SC2000 Ultrasound System
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to
8
acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
ACUSON Sequoia Ultrasound System
The Siemens ACUSON Sequoia ultrasound imaging system is intended for the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA quidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
ACUSON X300 Ultrasound System
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts. Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial,
9
OB/GYN, 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 Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Kla1807
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510 (k) Number (if known):
Device Name: Intended Use: V5Ms Multiplane TEE Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | P | P | P | P | P | P | BMDC | Note 4 | ||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K063138, E = added under Appendix E
Additional Comments:
Note 4 Tissue Equalization Technology
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510(k
, . . .
11
510 (k) Number (if known):
Device Name:
V5Ms Phased Sector Array TEE Transducer for use with;
Intended Use:
ACUSON CV70 Cardiovascular System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | P | P | P | P | P | P | BMDC | Note 2,3 | ||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K032111, K050240; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
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510(K
12
510 (k) Number (if known):
Device Name:
V5Ms Phased Sector Array TEE Transducer for use with:
Intended Use:
ACUSON Cypress ultrasound system Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Note 1) | P | P | P | P | P | P | Note 3 | |||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | Note 3,4 | |||
| Transesophageal | P | P | P | P | P | P | Note 3,4 | |||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K052331; E = added under Appendix E ;
Additional Comments:
-
Note 1 For example: cardiac
Note 3 Harmonic imaging -
Note 4 Contrast agent imaging
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510(k) $121807
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510(k) Number (if known):
Device Name:
V5Ms Multiplane TEE Transducer for user with ACUSON S1000/S2000 Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | P | P | P | P | P | P | BMDC | Note 4 | |
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K063803, K072786, K081148, K082142, K093812, K111674, K112596
Additional Comments:
Tissue Equalization Technology Note 4
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14
510(k) Number (if known):
Device Name:
V5M TEE for use with ACUSON SC2000
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D |
|--------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | P* | | P |
| Small Organ
(specify) | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult
Cephalic | | | P | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | P* | | P |
| Trans-
esophageal | | P | P | P | P | P | | | P* | | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral
Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-
skeletal
Conventional | | | | | | | | | | | |
| Musculo-
skeletal
Superficial | | | | | | | | | | | |
| Other
(specify) | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179
Additional Comments:
*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color. Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power, Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
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Siemens Medical Solutions USA, Inc. Ultrasound Division
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
V5M TEE for use with ACUSON Sequoia Diagnostic Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K063085, #K052410, #K051139, #K041319, #K032114, #K022567, #K002807, and #K973767.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
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510(k) K/2/807
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510(k) Number (if known):
Device Name:
Intended Use:
V5Ms TEE Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation Color Combine Other Specific Color Amplitude Other ( Track1 B M PWD CWD A Velocity ಧ (Tracks11& 3) Doppler Doppler (Specify) (Specify) Only) Imaging Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Note Cardiac Adult P P P P P P BMDC 2,3,7,8,9,11 Cardiac Note Cardiac P P P P P P BMDC Pediatric 2,3,7,8,9,11 Intra-vascular (Cardiac) Trans-Note P P P P P P BMDC esophageal 2,3,7,8,9,11 (Cardiac) Intra-cardiac · Other (Specify) Peripheral Peripheral vessel Other Vessel (Specify)
N = new indication; P = previously cleared by K090276, and K093531
| Note 1 | For example: breast, testes, thyroid, penis, prostate, etc. | Note 2 | Ensemble tissue harmonic imaging |
|---|---|---|---|
| Note 3 | 3D imaging | Note 4 | B&W SieScape panoramic imaging |
| Note 5 | Power SieScape panoramic imaging | Note 6 | For example: abdominal, vascular |
| Note 7 | Contrast agent imaging | Note 8 | SieClear multi-view spatial compounding |
| Note 9 | Tissue Equalization Technology | Note 10 | Intracardiac imaging |
| Note 11 | Dynamic TCE | ||
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