SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM

{0}------------------------------------------------ # 510(K) Summary of Safety and Effectiveness ... NOV 1 9 2010 This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, and Section 807.92. . ### 1. Submitter's name, address, telephone number, contact person: SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904 Corresponding Official: Jessica R. Stenberg Sr. Regulatory Affairs Specialist Jessica. Stenberg@sonosite.com E-mail: Telephone: (425) 951-1432 (425) 951-1201 Facsimile: Date prepared: July 30, 2010 - Name of the device, including the trade or proprietary name if applicable, the common or 2. usual name, and the classification name, if known: #### Common/ Usual Name Diagnostic Ultrasound System with Accessories Proprietary Name SonoSite® NanoMaxx™ Series Ultrasound System (subject to change) Classification Names | Name | FR Number | Product Code | |------------------------------------------|-----------|--------------| | Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | | Medical image communications device | 892.2020 | LMD | 3. Identification of the predicate or legally marketed device: SonoSite, Inc. believes that the system described in this substantially equivalent to the SonoSite NanoMaxx Series Ultrasound System (K092058) and the Maxx Series Ultrasound System (K071134 and K082098). #### 4. Device Description: The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, M-Mode, Color Power Doppler or in a combination of these modes. The hand-carried system weighs less than 6 pounds and has a touch screen interface with minimal controls to facilitate disinfection and cleaning. The system provides measurement capabilities for anatomical structures and fetal biometry ປັກຄູ້ 143 of 2166 {1}------------------------------------------------ K102390 P. 2 of 5 provide information used for clinical diagnostic purposes. The system also includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images, which is used in conjunction with traditional risk assessment models to assess individual cardiovascular disease risk. NOV 1 9 2010 The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities, including wireless networking, to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images. Security support is also provided to facilitate HIPAA compliance. The system supports the eFilm Lite™ application, which allows studies stored on a memory device in DICOMDIR format to be viewed. This viewing software can be launched on a PC when the license option is enabled. The system includes a variety of accessories including a stand, dock featuring a video in/out port, a printer port, printer, VESA mounting arm and needle guide kits. The system includes three USB host supports for peripherals and an Ethernet port for data transfer of patient data. The system also features SiteLink™ allowing an additional method for the export of patient data. Storage devices include memory sticks. The V-Universal™ stand provides a mobile work platform for the NanoMaxx, as well as a storage area for transducers and other supplies. It also provides connections for system accessories and peripherals. The PowerPark docking stand consists of two components, the dock (plugs into a power outlet and sits on the floor) and the stand module (attaches to underside of stand). An AC adapter on the stand module allows for manual connection to AC power. The PowerPack battery uses lithium-ion technology and mounts on the V Universal™ stand. LED lights on the PowerPack indicate the amount of available battery power, as well as charge status. SonoSite Workflow Solutions (SWS) is a software program for organizing exams from the NanoMaxx. SWS operates on a host server and users require a login to access the program. Patient exam information can be transferred from the ultrasound to SWS by exporting data from the ultrasound to a USB storage device, then importing it from the USB storage device. The use of a USB keyboard, barcode reader and medical grade printer is supported by the system, which allows manual entry of patient demographics, scanning entry of patient demographics and the capability to print images and/or reports. The system/transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The system monitor displays the current output level in terms of the bioeffects indices ("Mechanical Index [M]" and "Thermal Index [TI]") in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. | Frequency Range: | 1.0 — 13.0 MHz | | |-------------------|------------------------------|--------------| | Transducer Types: | Linear array<br>Curved array | Phased array | The SonoSite Maxx Series Ultrasound System is designed to comply with the following standards. Page 144 of 2166 {2}------------------------------------------------ K102390 2. 3 de ਹੈ 1 9 2010 ### FDA Consensus Standards : | Reference No. | Title | NOV | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | AAMI/ANSI/ISO 10993-1 | ISO 10993-1:2003(E),, Biological evaluation of medical devices -- Part 1: Evaluation<br>and testing | | | AAMI/ANSI/ISO 10993-5 | ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity | | | AAMI/ANSI/ISO 10993-12 | ISO 10993-12:2007, Biological evaluation of medical devices -- Part 12: Sample<br>preparation and reference materials | | | AAMI/ANSI/ISO 10993-10 | ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for<br>irritation and delayed-type hypersensitivity | | | AAMI/ANSI/ISO 10993-11 | ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11: Tests for<br>systemic toxicity. | | | IEC 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-<br>1:1988 | | | IEC 60601-2-37 | Medical Electrical Equipment - Part 2-37; Particular requirements for the safety of<br>ultrasonic medical diagnostic and monitoring equipment (2001) | | | NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | | | NEMA UD 3-2004 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices<br>on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine | | ### Miscellaneous Standards | Reference No. | Title · | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 9001:2008 | Quality management systems -- Requirements International Organization for<br>Standardization (2008) | | Title 21 CFR Part 820 | Quality System Regulation - Medical Devices: Current Good Manufacturing Practice<br>(CGMP); Final Rule | | EN ISO 13485:2003 | Medical devices - Quality management systems - Requirements for regulatory<br>purposes (2003) | | EN ISO 14971:2000 | Medical devices - Application of risk management to medical devices (2000)<br>(ISO 14971:2000) | | RTCA D160E | Radio Technical Commission for Aeronautics: Environmental Conditions and Test<br>Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy | {3}------------------------------------------------ #### Intended Use: 5. The intended uses of the SonoSite NanoMaxx Series Ultrasound System as defined by FDA guidance documents are: | Peripheral vessel | |-------------------------------------------------------| | Fetal - OB/GYN | | Abdominal | | Musculo-skel. (Conventional) | | Musculo-skel. (Superficial) | | Cardiac | | Pediatric | | Small Organ<br>(breast, thyroid, testicles, prostate) | | Trans-rectal | | Trans-vaginal | NOV 1 9 2010 Typical examinations performed using the SonoSite NanoMaxx Series Ultrasound System are: #### Abdominal Imaging Applications This system transmits ultrasound energy into the abdomen of patients using 2D, color Doppler (Color), color power Doppler (CPD) to obtain ultrasound images. The liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally. #### Cardiac Imaging Applications This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap DCPD, M-mode, Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structures. This system can be used to assess overall cardiac performance and size. determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to assess the presence and extent of some injuries and diseases. #### Gynecology and Infertility Imaging Applications This system transmits ultrasound energy in the pelvis and lower abdomen using 20, color Doppler, and color power Doppler (CPD) to obtain ultrasound images. The uterus, adnexa, and surrounding anatomical structures can be assessed for the presence of pathology transabdominally. #### Obstetrical Imaging Applications This system transmits ultrasound energy into the pelvis of pregnant women using 2D, M Mode, color Doppler (Color) and color power (CPD) to obtain ultrasound images. The fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally. CPD and color Doppler (Color) imaging is intended for high-risk pregnant women. High-risk pregnancy indications include, but are not limited to, multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus. - A To prevent injury or misdiagnosis do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been validated to be proven effective for these two uses. CPD, or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation (IUGR). #### Pediatric and Neonatal Imaging Applications Page 146 of 2166 {4}------------------------------------------------ This system transmits ultrasound energy into the pediatic patients using 2D, color Doppler, and color power Doppler (CPD) to obtain ultrasound images. The pediatic abdominal, pelvic, and surrounding anatomical structures can be assessed for the presence or absence of pathology. NOV 1 9 2010 #### Superficial Imaging Applications This system transmits ultrasound energy into various parts of the body using 2D, color Doppler and color power Doppler (CPD) to obtain ultrasound images. The breast, thyroid, testicle, lymph nodes, hernias; musculoskeletal structures, soft tissue structures, and surrounding anatomical structures can be assessed for the presence or absence of pathology. This system can be used to provide ultrasound guidance for drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps. #### Vascular Imaging Applications This system transmits ultrasound energy into the various parts of the body using 2D, color Doppler and color power Doppier (CPD) to obtain ultrasound images. The carotid arteries, deep veins, and arteries in the arms and legs, superficial veins and legs, great vessels in the abdomen, and various small vessels feeding organs can be assessed for the presence or absence of pathology. #### 6. Technological Characteristics: This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, velocity color) are the same as a combination of the predicate devices identified in item 3. Transducer patient contact materials are biocompatible. This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUMINEMA UD 3-2004) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle. | ISPTA (d) | 720 mW/cm² | Maximum | |-----------------------|---------------|---------| | Tis/Tlb/Tlc | 0.0 - 4.0 | Range | | Mechanical Index (MI) | 1.9 | Maximum | | ISPPA (d) | 0 - 700 W/cm² | Range | The device's acoustic output limits are: The limits are the same as predicate Track 3 devices, K102390 2,5 of 5 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 NOV 1 9 2010 Re: K102390 Trade/Device Name: SonoSite NanoMaxx™ Series Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LMD Dated: November 1, 2010 Received: November 2, 2010 Dear Me. 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 SonoSite NanoMaxx™ Series Ultrasound System, as described in your premarket notification: ### Transducer Model Number | C11/n8-5 | |-----------| | C60n/5-2 | | ICTn/8-5 | | L25n/13-6 | | L38n/10-5 | {6}------------------------------------------------ ### L52n/10-5 P21n/5-1Phased Arrav 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 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. go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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 Brendan O'Leary at (301) 796-6898. Sincerely yours. Signature David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure(s) {7}------------------------------------------------ K102390 1 of 9 ### Indications for Use Form ### NOV 1 > 2010 ### 510(k) Number (if known): TBD K102390 Device Name: NanoMaxx: SonoSite NanoMaxx™ Series Ultrasound System #### Indications for Use: The SonoSite NanoMaxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Trans-rectal; Trans-vaginal Peripheral Vessel; Intraoperative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric. 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 OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 102390 {8}------------------------------------------------ NOV 1 9 2010 | System: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | | | |---------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------|---|---------|------------------|--------------------|---------------------|--|--|--| | Transducer: | | N/A | | | | | | | | | | Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows | | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | | | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD CWD | Color<br>Doppler | Combined (Specify) | Other*<br>(Specify) | | | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal Imaging &<br>Other | Fetal | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Abdominal | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Intra-operative (Abdominal Organs,<br>Vascular) | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | N | N | | N | B+M, B+CD, B+CPD | Note 1 | | | | | | Trans-vaginal | N | N | | N | B+M, B+CD, B+CPD | Note 1 | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | Musculo-skeletal (Conventional) | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Musculo-skeletal (Superficial) | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Intravascular | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Cardiac | Cardiac Adult | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Cardiac Pediatric | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | N | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Other (Specify) | | | | | | | | | | # Table 1.3-1 Diagnostic Ultrasound Indications for Use Form – SonoSite NanoMaxx™ Series Ultrasound System N = new Indication; P = previously cleared by FDA; E = added under this appendix " Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Dopler, and Color Velocity Imaging ### Additional Comments: Note 1: Other includes Color Power Dopler, combined B and Color Power Dopler, Tissue Hamonic Imaging, SonoHD, SonoHD, SonoMB Compound Imaging, Tissue Dopter maging. Color Dopler includes Color Dopler can be combined with any institutions in any institle (113). placement of neaders in results of other and institution will many hilaging guident in peripher increasing to the may of the may on spinal cord to provide guidance for central nerve block procedures. All items marked "P" were previously cleared in 510(k) K092058 Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number {9}------------------------------------------------ NOV 1 9 2010 | System:<br>Transducer:<br>Intended Use:<br>Clinical Application | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | |-----------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------|---|-----|-----|------------------|--------------------|---------------------| | | | C11n/8-5 8.0-5.0 MHz Curved Array | | | | | | | | | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | | | | | | | | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging &<br>Other | Fetal | | | | | | | | | | Abdominal | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Intra-operative (Abdominal Organs,<br>Vascular) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | P | N | | | P | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Other (Specify) | | | | | | | | ### Table 1.3-2 Diagnostic Ultrasound Indications for Use Form - C11n/8-5 Transduction N = new indication; P = previously cleared by FDA; E = added under this appendix ി and Color Velocity Imaging # Additional Comments: Note 1: Other Includes Color Power Dopler, combined B and Color Power Dopier, Sonol# Compund maging, Color Doppler includes receive in anales outh enter opper, control maging mode controller contronment maging. Ont Dople includes Color Velocity Dopler can e combred with any inaging tricher in re All items marked "P" were previously cleared in 510(k) K092058 Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number {10}------------------------------------------------ | System: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | | | | |------------------------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------|--|--|---|------------------|--------|--|--|--| | Transducer:<br>Intended Use:<br>Clinical Application | | C60n/5-2 5.0-2.0 MHz Curved Array<br>Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows | | | | | | | | | | | | | | | | | | | | | | | | | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal Imaging &<br>Other | Fetal | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Abdominal | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Intra-operative (Abdominal Organs,<br>Vascular) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Pediatric | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | Musculo-skeletai (Conventional) | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | Peripheral | Peripheral vessel | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | Wessel | Other (Specify) | | | | | | | | | | | ### Table 1.3-3 Diagnostic Ultrasound Indications for Use Form - C60n/5-2 Transducer NOV 1 > 2010 N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may indude: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging ### Additional Comments: Note 1: Other includes Color Power Dopler, combined B and Color Power Dopter, Tissue Harmonic Imaging, SonoHD Imaging, SonoHD Imaging, Tissue Doppler Inaging. Color Dopper includes Color Doppler an be contined with any imaging, Golivia maging model. Includes inaging model hollows inaging bassist in the placement of needles and cather in vascular or other and on on spinal cord to provide guldare for central new block . procedures. All items marked "P" were previously cleared In 510(k) K092058 Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Office of In Vitro Diagnostic Device Onloo of in Vido Blagnost Evaluation and Safety JA 1102 રવાળ 510(k) Number {11}------------------------------------------------ NOV 1 9 2010 K102390 PS of 9 ### Table 1.3-4 Diagnostic Ultrasound Indications for Use Form - ICTn/8-5 Transduc | System: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | | | | |---------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------|---|---------|--|------------------|--------------------|---------------------|--|--|--| | Transducer: | | ICTn/8-5MHz Curved Array | | | | | | | | | | | Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows | | | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | | | | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD CWD | | Color<br>Doppler | Combined (Specify) | Other*<br>(Specify) | | | | | Ophthalmic | Ophthalmic | | | | | | | | | | | | Fetal Imaging & | Fetal | N | N | | | N | B+M, B+CD, B+CPD | Note 1 | | | | | Other | Abdominal | | | | | | | | | | | | | Intra-operative (Abdominal Organs,<br>Vascular) | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Trans-rectal | N | N | | | N | B+M, B+CD, B+CPD | Note 1 | | | | | | Trans-vaginal | N | N | | | N | B+M, B+CD, B+CPD | Note 1 | | | | | | Trans-urethral | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | | | | Vessel | Other (Specify) | | | | | | | | | | | N = new Indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may indude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppier, and Color Velocity Imaging ### Additional Comments: Note 1: Other Includes Color Power Doppler, combined B and Color Power Doppler, SonoMB Compound Imaging, Color Dopler includes Color Velocity Doppler. Color Dopler can be combined with any imaging to assist in the placement of needles and catheles in vascular or other anatomical structures, and expanded intended use for imaging guidance for peripheral nerve block procedures. Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number {12}------------------------------------------------ K102390 B li of g NOV 1 y 2010 # Table 1.3-5 Diagnostic Ultrasound Indications for Use Form -- L25n/13-6 Transducer | System: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | |---------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------|---|-----|-----|------------------|--------------------|--------------------| | Transducer: | | L25n/13-6 13.0-6.0 MHz Linear Array | | | | | | | | Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging &<br>Other | Fetal | | | | | | | | | | Abdominal | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Intra-operative (Abdominal Organs,<br>Vascular) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Small Organ (Breast, Thyroid,<br>Testicles, Prostate) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Musculo-skeletal (Superficial) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | Other (Specify) | | | | | | | | N = new Indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include Oppoller, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging #### Additional Comments: Note 1: Other hictides Color Power Dopler, Online Power Dopler, SonoHD Imaging, SonoMB Compund ingging. Color Doppler Includes Color Velocity Dopler Color Dopler can be cont induss Dolly Valory Doppic. Ook Dopper and an any maging mode. Innging guidance for periodentility for periodent of the consent of the consent of All items marked "P" were previously cleared in 510(k) K092058 Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number {13}------------------------------------------------ K102390 P. 7 of 9 NOV 1 9 2010 | System: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | | | |---------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------|---|-----|-----|------------------|--------------------|---------------------|--|--| | Transducer: | | L38n/10-5 10.05.0 MHz Linear Array Transducer | | | | | | | | | | Intended Use:<br>Clinical Application | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows | | | | | | | | | | | | Mode of Operation | | | | | | | | | | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other*<br>(Specify) | | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal Imaging &<br>Other | Fetal | | | | | | | | | | | | Abdominal | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | Intra-operative (Abdominal Organs,<br>Vascular) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Pediatric | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | Small Organ (Breast, Thyroid,<br>Testicles, Prostate) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | Musculo-skeletal (Conventional) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | Musculo-skeletal (Superficial) | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | Intravascular | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Cardiac | Cardiac Adult | P | N | | | P | B+M, B+CD, B+CPD | Note | | | | | Cardiac Pediatric | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | N | | | P | B+M, B+CD, B+CPD | Note 1 | | | | | Other (Specify) | | | | | | | | | | ### Table 1.3-6 Diagnostic Ultrasound Indications for Use Form - L38n/10-5 Transducer N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may Include: A-mode, Amplitude Dopplier, 3-D Imaging, Tissue Motion Doppier, and Color Velocity Imaging #### Additional Comments: Note 1: Other includes Color Power Dopler, combined B and Color Power Dopler, SonoHD Imaging, SonoMB Compound Imaging. Color Doppler includes Color Velocity Dopler can be combined with any Imaging mode. Includes imaging to assist In the placement of needles and cathelers in vascular or other anatomical studing guidance for peripheal news block procedures. Includes includes includes in All items marked "P" were proviously cleared in 510(k) K092058 Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) (Division Sign-Off) Office of In Vitro Diagnostic Device Evaluation and Safety 4102390 {14}------------------------------------------------ K102390 P. 8 of 9 NOV 1 9 2010 #### 510(k) Number _ | System: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | | | | |------------------------------------------------------|-------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------|--|------------------|--------------------|---------------------|--|--|--| | Transducer:<br>Intended Use:<br>Clinical Application | | | L52n 10-5 MHz Linear Array<br>Diagnostic ultrasound imaging or fluid flow analysis of animal bodies as<br>follows<br>Mode of Operation | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | General<br>(Track 1 Only)…