V5MS TRANSDUCER

{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) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Signature of Officer Division Sign-Off Office of In Vitro Diagnostic Devices 510(k) Kla1807 Page 4 of {10}------------------------------------------------ #### 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>Abdominal | | | | | | | | | | | | Intraoperative<br>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<br>Conventional | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA K063138, E = added under Appendix E Additional Comments: Note 4 Tissue Equalization Technology (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off - Office of In Vitro Diagnostic Devices Page 5 of _ 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>Abdominal | | | | | | | | | | | | Intraoperative<br>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<br>Conventional | | | | | | | | | | | | Musculo-skeletal<br>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 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Conference of CDRH, Office of Division Sign-Off - Office of In Vitro Diagnostic Devices 10/18/07 Page 6 of 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(Note 1) | | P | P | P | P | P | P | | | Note 3 | | Intraoperative<br>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<br>Conventional | | | | | | | | | | | | Musculo-skeletal<br>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 # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) C División Sign-Off - Office of In Vitro Diagnostic Devices 510(k) \$121807 Page 7 of {13}------------------------------------------------ #### 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(Note 6) | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(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<br>Conventional | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by K063803, K072786, K081148, K082142, K093812, K111674, K112596 Additional Comments: Tissue Equalization Technology Note 4 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k) K121807 Page 8 of {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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>3D | |--------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative<br>Abdominal | | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | | Pediatric | | P | P | P | P | P | | | P* | | P | | Small Organ<br>(specify) | | | | | | | | | | | | | Neonatal<br>Cephalic | | | | | | | | | | | | | Adult<br>Cephalic | | | P | | | | | | | | | | Cardiac | | P | P | P | P | P | | | P* | | P | | Trans-<br>esophageal | | P | P | P | P | P | | | P* | | P | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | | Peripheral<br>Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-<br>skeletal<br>Conventional | | | | | | | | | | | | | Musculo-<br>skeletal<br>Superficial | | | | | | | | | | | | | Other<br>(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 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k) K121807 Page 9 of {15}------------------------------------------------ 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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | |------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | P | P | P | P | P | P | | P* | P | | Intraoperative<br>Abdominal | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | Pediatric | | P | P | P | P | P | P | | P* | P | | Small Organ<br>(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<br>(Conventional) | | | | | | | | | | | | Musculo-skeletal<br>(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 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k) K/2/807 Page 10 of {16}------------------------------------------------ 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<br>(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k) K121807 Page 11 of ___________________________________________________________________________________________________________________________________________________________________