Who is the manufacturer of SONOSITE MAXX SERIES ULTRASOUND SYSTEM?

FUJIFILM Sonosite, Inc. filed the 510(k) submission for SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K130173).

What is the FDA product code for SONOSITE MAXX SERIES ULTRASOUND SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SONOSITE MAXX SERIES ULTRASOUND SYSTEM?

510(k) clearance (submission type: Traditional).

Does SONOSITE MAXX SERIES ULTRASOUND SYSTEM use AI or machine learning?

Yes. SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K130173) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for SONOSITE MAXX SERIES ULTRASOUND SYSTEM?

SonoSite Maxx™ Series Ultrasound System (K082098, K101757); SonoSite Edge Ultrasound System (K113156); Terason t3000 Ultrasound System (K112953).

Who can help prepare an FDA 510(k) submission like SONOSITE MAXX SERIES ULTRASOUND SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like SONOSITE MAXX SERIES ULTRASOUND SYSTEM get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

SONOSITE MAXX SERIES ULTRASOUND SYSTEM

K130173 · FUJIFILM Sonosite, Inc. · IYN · Mar 25, 2013 · Radiology

Device Facts

Record ID	K130173
Device Name	SONOSITE MAXX SERIES ULTRASOUND SYSTEM
Applicant	FUJIFILM Sonosite, Inc.
Product Code	IYN · Radiology
Decision Date	Mar 25, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric, 3rd-Party Reviewed

Intended Use

The SonoSite Maxx 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 include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skel. (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel

Device Story

General purpose, software-controlled diagnostic ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Inputs: ultrasound signals from various transducers (linear, curved, intracavitary, phased array, static, TEE). Processing: beamforming (128/128 digital channels), noise reduction (SonoRes/SonoHD), image compounding (SonoMB), and Doppler analysis. Outputs: B-mode, M-mode, 3D/4D, color/power/spectral Doppler, and tissue harmonic imaging displayed on integrated 10.4" LCD. Used in clinical settings by physicians for diagnostic imaging, biopsy/needle guidance, and fluid flow analysis. Features ECG acquisition, DICOM 3.0 connectivity, and wireless/Bluetooth for image transfer/remote control. Benefits: provides real-time anatomical/hemodynamic information to aid clinical decision-making and procedural guidance.

Clinical Evidence

Bench testing only. Evaluated for electrical, thermal, mechanical, and EMC safety; cleaning/disinfection; biocompatibility; and acoustic output. Conforms to IEC 60601-1, IEC 60601-1-2, ISO 10993, and NEMA UD 2/3 standards. No clinical data presented.

Technological Characteristics

128/128 digital channel beamformer; 1.0-15.0 MHz transducer frequency range. Materials: ABS, Cycoloy, Polysulfone, Polyurethane, PVC, Silicone Rubber. Connectivity: DICOM 3.0, 802.11 wireless, Bluetooth 2.0. Power: Battery or AC. Software-controlled; includes automated IMT measurement (SonoCalc). Sterilization: Compatible with standard cleaning/disinfection protocols.

Indications for Use

Indicated for qualified physicians to perform ultrasound imaging or fluid flow analysis. Clinical applications: Ophthalmic, Fetal, OB/GYN, Abdominal, Intraoperative (abdominal/vascular/neuro), Pediatric, Small Organ (breast/thyroid/testicle/prostate), Neonatal/Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal, Cardiac (Adult/Pediatric), Trans-esophageal, and Peripheral Vessel.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

SonoSite Maxx™ Series Ultrasound System (K082098, K101757)
SonoSite Edge Ultrasound System (K113156)
Terason t3000 Ultrasound System (K112953)

Related Devices

K002185 — SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM · Medison America, Inc. · Aug 1, 2000
K152763 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 21, 2015
K093462 — SONIX ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Nov 20, 2009
K042326 — ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Sep 16, 2004
K132768 — S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM · Sonoscape Company Limited · Oct 4, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ K!30173 Page 1 of 9 #### 510(K) Summary MAR 2 5 2013 This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807,92. #### 1) Submitter's name, address, telephone number, contact person: FUJIFILM SonoSite, Inc. 21919 30" Drive SE Bothell, WA 98021-3904 | Corresponding Official: | Scott Paulson | |-------------------------|-----------------------------| | | Manager, Regulatory Affairs | | E-mail: | Scott.Paulson@sonosite.com | | Telephone: | (425) 951-6926 | | Facsimile: | (425) 491-8356 | | Date prepared: | December 21, 2012 | ### 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known: Common/ Usual Name Diagnostic Ultrasound System with Accessories Proprietarv Name SonoSite Maxx™ 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 | | Picture Archiving and Communications System | 892.2050 | LLZ | ### 3} Identification of the predicate or legally marketed device: FUJIFILM SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx™ Series Ultrasound System (K082098, K101757), the SonoSite Edge Ultrasound System (K113156), the Terason t3000 Ultrasound System (K112953). {1}------------------------------------------------ #### 4) Device Description: The SonoSite Maxx 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 a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power. #### 5) Intended Use: The SonoSite Maxx 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 include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel {2}------------------------------------------------ Technological Characteri (9 Sonolite Max Seies Vitrasund System is Track Indamental scientife tembley a Max seritif technoleg a Max serit and Edge Utrasound System is Trace Utrasond System is ubstantily OMA Access Systems LL | Feature | SonoSite Maxx Series Ultrasound System (This Submission) | SonoSite Maxx Series Ultrasound System (K082098, K101757) | SonoSite Edge™ Ultrasound System (K113156) | Terason T3000 Ultrasound System (K112953) | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | | | | | Indications for Use | Opthalmic Fetal - OB/GYN Abdominal Intraoperative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) | Opthalmic Fetal - OB/GYN Abdominal Intraoperative (abdominal organs and vascular) Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (breast, thyroid, testicle, prostate) | Opthalmic Fetal - OB/GYN Abdominal Intraoperative (abdominal organs and vascular) Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (breast, thyroid, testicle, prostate) | Fetal - OB/GYN Abdominal Intraoperative (abdominal organs and vascular) Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (breast, thyroid, testicle, prostate) | | | Neonatal Cephalic Adult Cephalic Trans-Rectal Trans-Vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) | Neonatal Cephalic Adult Cephalic Trans-Rectal Trans-Vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) | Neonatal Cephalic Adult Cephalic Trans-Rectal Trans-Vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) | Neonatal Cephalic Adult Cephalic Trans-Rectal Trans-Vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric | | | Peripheral Vessel Biopsy guidance Needle guidance | Peripheral Vessel Biopsy guidance Needle guidance | Peripheral Vessel Biopsy guidance Needle guidance | Peripheral Vessel Biopsy guidance Needle guidance | | Transducer Types | Linear Array Curved Linear Array Intracavitary | Linear Array Curved Linear Array Intracavitary | Linear Array Curved Linear Array Intracavitary | Linear Array Curved Linear Array | {3}------------------------------------------------ | Feature | SonoSite Maxx Series Ultrasound System (This Submission) | SonoSite Maxx Series Ultrasound System (K082098, K101757) | SonoSite Edge™ Ultrasound System (K113156) | Terason T3000 Ultrasound System (K112953) | |---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Transducer Frequency | 1.0-15.0 MHz | 1.0-15.0 MHz | 1.0-15.0 MHz | Unknown | | | Phased Array Static Probes Trans-esophageal | Phased Array Static Probes Trans-esophageal Wobbler Probes | Phased Array Static Probes Trans-esophageal | Phased Array Endocavitary Microconvex | | Modes of Operation | B-mode Grayscale Imaging 3D/4D Grayscale Imaging Tissue Harmonic Imaging M-mode Anatomical M-Mode Color M-Mode Color Power Doppler Zoom Combination Modes | B-mode Grayscale Imaging 3D/4D Grayscale Imaging Tissue Harmonic Imaging M-mode Anatomical M-Mode Color M-Mode Color Power Doppler Zoom Combination Modes | B-mode Grayscale Imaging Tissue Harmonic Imaging M-mode Color M-Mode Color Power Doppler Zoom Combination Modes | 2D/B-Mode M-Mode Power Doppler Directional Power Doppler Color Doppler Pulsed Wave Spectral Doppler Continuous Wave Spectral Doppler Duplex Doppler (Simultaneous, Real-Time 2-D and Spectral Doppler Display) Triplex Display (Simultaneous, Real-Time 2-D, Color Doppler and Spectral Doppler Display) ECG trace | | PW Doppler | Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler | Available | | CW Doppler | Continuous Wave (CW) Doppler | Continuous Wave (CW) Doppler | Continuous Wave (CW) Doppler | Available | | | SonoRes/SonoHD Noise Reduction SonoMB Image Compounding Steered CW Doppler Velocity Color Doppler Color TDI | SonoRes/SonoHD Noise Reduction SonoMB Image Compounding Steered CW Doppler Velocity Color Doppler Color TDI | SonoHD2 Noise Reduction SonoMB/MBe Image Compounding Steered CW Doppler Velocity Color Doppler Color TOI | | | Velocity Color Doppler | Available | Available | Available | Unknown | | Elastography (Strain), and Strain Rate Imaging | Available | Available | Available | Unknown | | ECG Feature | Available | Available | Available | Available | | DICOM | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 | | Feature | SonoSite Maxx Series Ultrasound System (This Submission) | SonoSite Maxx Series Ultrasound System (K082098, K101757) | SonoSite Edge™ Ultrasound System (K113156) | Terason T3000 Ultrasound System (K112953) | | IMT Measurement | SonoCalc IMT provides the capability for automated measurement of intima- media thickness (IMT) of the carotid artery. | SonoCalc IMT provides the capability for automated measurement of intima- media thickness (IMT) of the carotid artery. | SonoCalc IMT provides the capability for automated measurement of intima- media thickness (IMT) of the carotid artery. | Unknown | | #Transmit Channels | 128 digital channels | 128 digital channels | 128 digital channels | Unknown | | #Receive Channels | 128 digital channels (using SA) | 128 digital channels (using SA) | 128 digital channels (using SA) | Unknown | | Patient Contact Materials | Transducers: Acrylonitrile-butadien-styrene (ABS) Cycoloy Dow Medical Adhesive, Type A Epoxy paste adhesive, Polysulfone Polyurethane Poly-Vinyl-Chloride (PVC) Silicone Rubber Urethane Needle Guides: Acetal copolymer Acrylonitrile-butadien-styrene (ABS) | Transducers: Acrylonitrile-butadien-styrene (ABS) Cycoloy Dow Medical Adhesive, Type A Epoxy paste adhesive, Polysulfone Polyurethane Poly-Vinyl-Chloride (PVC) Silicone Rubber Urethane Needle Guides: Acetal copolymer Acrylonitrile-butadien-styrene (ABS) | Transducers: Acrylonitrile-butadien-styrene (ABS) Cycoloy Dow Medical Adhesive, Type A Epoxy paste adhesive, Polysulfone Polyurethane Poly-Vinyl-Chloride (PVC) Silicone Rubber Urethane Needle Guides: Acetal copolymer Acrylonitrile-butadien-styrene (ABS) | Transducers (10VSS only): Polycarbonate Silicon Rubber Poly-Vinyl-Chloride (PVC) | | System Characteristics | M Series: Beamformer 128/128 using SA (configurable) Hand held display and control Single 10.4" Liquid Crystal Display (LCD) 256 gray shades on LCD Dimensions: 10.9"(W) x 11.8 (L) x 3.0"(H) | M Series: Beamformer 128/128 using SA (configurable) Hand held display and control Single 10.4" Liquid Crystal Display (LCD) 256 gray shades on LCD Dimensions: 10.9"(W) x 11.8 (L) x 3.0"(H) | Edge: Beamformer 128/128 using SA (configurable) Hand held display and control Single 12.1" Liquid Crystal Display (LCD) 256 gray shades on LCD Dimensions: 12.9"(W) x 12.4 (L) x 2.5" (H) | T3000 15.4" (diagonal) TFTLED backlit hi-res widescreen display Anti-glare screen Adjustable brightness Dimensions:14.35 x 9.82 x 2.25" | | | Weight: 8.3 lbs Battery operated (1.5 - 4 hour operation per charge) 100 - 240V options, 50/60 Hz | Weight: 8.3 lbs Battery operated (1.5 - 4 hour operation per charge) 100 - 240V options, 50/60 Hz | Weight: 8.5 lbs Battery operated (1.5 - 4 hour operation per charge) 100 - 240V options, 50/60 Hz, 15VDC output | Weight:10.5lbs/4.8kg RechargeableLithium-lonbatteryor ACpower | | | Various obstetrical, cardiac, volume, M- | Various obstetrical, cardiac, volume, M- | | Universal medical-gradepower supply Inputvoltage: 100to240 V AC | | Feature | SonoSite Maxx Series Ultrasound System (This Submission) | SonoSite Maxx Series Ultrasound System (K082098, K101757) | SonoSite Edge™ Ultrasound System (K113156) | Terason T3000 Ultrasound System (K112953) | | | mode, PW and CW Doppler measurement and calculation packages ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media Measurement on Recalled Images. Wireless 802.11 (a\b\g) support for image transfer and Bluetooth® 2.0. for voice activated remote control. | mode, PW and CW Doppler measurement and calculation packages ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media Measurement on Recalled Images. Wireless 802.11 (a\b\g) support for image transfer and Bluetooth® 2.0. for voice activated remote control. | Various obstetrical, cardiac, volume, M- mode, PW and CW Doppler measurement and calculation packages ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media Wireless 802.11 (a\b\g) support for image transfer | Frequency:50to60 Hz Preset-specific caliper measurements and annotations User-configurable measurements and annotations Electronicbeam steering OmniBeam™ TeraVision™ II Split-screendualdisplay Simultaneous2D/Color Trapezoidal imaging | | | S Series: Beamformer 128/128 using SA (configurable) Hand held display and control Single 10.4" Liquid Crystal Display (LCD) 256 gray shades on LCD Dimensions: 11.5"(W) x 14.8 (L) x 2.8"(H) Weight: 8.5 lbs Battery operated (1.5 - 4 hour operation per charge) | S Series: Beamformer 128/128 using SA (configurable) Hand held display and control Single 10.4" Liquid Crystal Display (LCD) 256 gray shades on LCD Dimensions: 11.5"(W) x 14.8 (L) x 2.8"(H) Weight: 8.5 lbs Battery operated (1.5 - 4 hour operation per charge) | Various obstetrical, cardiac, volume, and M-mode measurement and calculation packages ECG acquisition and display capabilities Image storage on removable media Measurement on recalled images Wireless 802.11 (a\b\g) support for image transfer and Bluetooth® 2.0 for voice activated remote control | | | 510(k) Track | Track 3 | Track 3 | Track 3 | Track 3 | . Page 18 of 723 {4}------------------------------------------------ . . {5}------------------------------------------------ Page 20 of 723 . . : {6}------------------------------------------------ ### 7) Determination of Substantial Equivalence: ### Summary of Non-Clinical Tests: The SonoSite Maxx Series Ultrasound System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to all applicable mandatory medical device safety standards. The Maxx Series system also complies with voluntary standards which are detailed in Table 1.1-2 of this premarket submission. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. All patient contact materials are biocompatible. Reports for these elements of product development are referenced in Attachment 6. ### Summary of Clinical Tests: The SonoSite Maxx Series Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence. The SonoSite Maxx Series Ultrasound System is designed to comply with the following' standards. | Reference No. | Title | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AAMI/ANSI/ISO 10993-1 | ISO 10993-1:2003(E), Biological evaluation of medical devices - Part 1: Evaluation and testing | | AAMI/ANSI/ISO 10993-5 | ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity | | AAMI/ANSI/ISO 10993-12 | ISO 10993-12:2007, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | | AAMI/ANSI/ISO 10993-10 | ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | | AAMI/ANSI/ISO 10993-11 | ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity. | | IEC 60601-1 | IEC 60601-1:1988, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 | | IEC 60601-1-1 | IEC 60601-1-1:2000, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems | | IEC 60601-1-2 | IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3) | | IEC 60601-1-4 | IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1 | #### FDA Consensus Standards {7}------------------------------------------------ | IEC 60601-2-37 | IEC 60601-2-37:2001, Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine | | AAMI/ANSI EC53 | AAMI / ANSI EC53:1995/(R) 2008, ECG cables and leadwires | | AIUM MUS | AIUM MUS, Medical Ultrasound Safety | | ISO /FDIS 15223-1 | Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements | . ## Miscellaneous Standards 通 | Reference No. | Title | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Title 21 CFR Part 820 | Quality System Regulation - Medical Devices: Current Good Manufacturing Practice (CGMP); Final Rule | | ISO 9001 | ISO 9001:2008, Quality management systems -- Requirements International Organization for Standardization | | ISO 13485 | ISO 13485:2003, Medical devices - Quality management systems - Requirements for regulatory purposes | | ISO 14971 | ISO 14971:2007, Medical devices - Application of risk management to medical devices | | RTCA D160E | Radio Technical Commission for Aeronautics: Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy | | CAN/CSA C22.2 | CAN/CSA C22.2, No. 60601-1, Canadian Standards Association, Medical Electrical Equipment-Part 1. General Requirements for Safety | | EN 60529 | Degrees of protection provided by enclosures (IP Code) (1992) | | UL 94 | Underwriters Laboratories, Inc., Tests for Flammability of Plastic Materials for Parts in Devices and Appliances, 5th Edition | | CISPR 11 | International Electrotechnical Commission, International Special Committee on Radio Interference. Industrial, Scientific, and Medical (ISM) Equipment - Radio-Frequency Disturbance Characteristics-Limits and Methods of Measurement. Classification for the ultrasound system, docking system, accessories, and peripherals when configured together: Group 1, Class A. | | NEMA PS 3.15 | Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. 118 | | HIPAA | The Health Insurance and Portability and Accountability Act, Pub.L. No. 104-191 | | HIPAA | 45 CFR 160, General Administrative Requirements | | HIPAA | 45 CFR 164, Security and Privacy | {8}------------------------------------------------ K130173 Page 9 of 9 #### 8) Conclusion: Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The product development process conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable electro medical device safety standards with compliance verified through independent evaluation and ongoing factory audits. Medical diagnostic ultrasound has an established history of safety and effectiveness. It is the opinion of FUJIFILM SonoSite, Inc. that the SonoSite Maxx™ Series Ultrasound System is substantially equivalent with regard to safety and effectiveness to other devices already cleared for market. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 25, 2013 FujiFilm SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 24th Street NW BUFFALO MN 55313 Re: K130173 Trade/Device Name: SonoSite Maxx™ Series Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, LLZ Dated: March 12, 2013 Received: March 13, 2013 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 SonoSite Maxx166 Series Ultrasound System as described in your premarket notification: #### Transducer Model Number P11x/10-5 HFL38x/13-6 P10x/8-4 L38xi/10-5 HFL50x/15-6 P21x/5-1 C8x/8-5 ICTx/8-5 SLAx/13-6 C11x/8-5 L25x/13-6 TEEx/8-3 D2x/2 L38x/10-5 L52x/10-5 C60x/5-2 {10}------------------------------------------------ Page 2 - Mr. Mark Job 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 Mr. Joshua Nipper at (301) 796-6524. Sincerely yours, for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosures {11}------------------------------------------------ #### Indications for Use Form #### 510(k) Number (if known): TBD Device Name: SonoSite Maxx™ Series Ultrasound System Indications for Use: The SonoSite Maxx™ 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 include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel. 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) ![](https://i.imgur.com/99999999999999999999999999999999.png) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) _ K130173 Page 1 of 1 {12}------------------------------------------------ Table 1.3- 1 Diagnostic Ultrasound Indications for Use Form – SonoSite Maxx™ Series Ultrasound System | System: | SonoSite Maxx™ Series Ultrasound System | | | | | | | |-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------------|------------------| | Transducer: | N/A | | | | | | | | Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | Clinical Application | Mode of Operation | | | | | | | | | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | | Ophthalmic | P | P | P | | P | B+M; B+PWD; B+CD | | | Fetal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | | Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Intra-operative (Neuro.) Laparoscopic | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | | Small Organ (breast, thyroid, testicles, prostate) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Neonatal Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Adult Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Trans-rectal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Trans-vaginal Trans-urethral | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Trans-esoph. (non-Card.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Musculo-skel. (Superfic.) Intra-luminal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Other (spec.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | | Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | | Trans-esophageal (card.) Other (spec.) | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | | Peripheral vessel Other (spec.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | System: | SonoSite Maxx™ Series Ultrasound System | | | | | | | | Transducer: | P11x/10-5 MHz Transducer | | | | | | | | Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | Clinical Application | Mode of Operation | | | | | | | | | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | | Ophthalmic | | | | | | | | | Fetal | | | | | | | | | Abdominal | | | | | | | | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | N | N | | | N | B+M; B+CD | Note 1 | | Small Organ (breast, thyroid, testicles. prostate) | | | | | | | | | Neonatal Cephalic | | | | | | | | | Adult Cephalic | | | | | | | | | Trans-rectal | | | | | | | | | Trans-vaginal | | | | | | | | | Trans-urethral | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | Intra-luminal | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac Pediatric | | | | | | | | | Trans-esophageal (card.) | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral vessel | N | N | | | N | B+M; B+CD | Note 1 | | Other (spec.) | | | | | | | | #### Additional Comments: Note 1: Other includes color power Doppler, combined B and color power Doppler, 3-D/4-D imaging, SoneRes/SonoHD imaging, SonoMBIMBe compund imaging (TD), color TDI, elastography imaging, strain rate inaging, and imaging for guidance of biopsy. Color Doppler includes velocity color Doppler can be combined with any imaging to assist in the placement of needles and catheters in vascular or other and imaging guidance for peripheral neve block procedures. Includes imaging of spinal cord to provide guidance for central new block procedure archiving, communications and storage inchinality. M-Modes antomical M-Mode, and All items marked "P" were previously cleared in 510(k) K082098. {13}------------------------------------------------ Table 1.3- 2 Diagnostic Ultrasound Indications for Use Form – P11x/10-5 Transducer #### Additional Comments: Note 1: Other includes color power Doppler, combined B and color power Dopler. M-Mode. SonoRes/SonoHD imaging for guidance of biopsy and imaging to assist in the placement of needler or other analomical structures. Color Doppler can be combined with any imaging mode, Can be used with disposable kit cleared with K113680. {14}------------------------------------------------ Table 1.3-3 Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 Transducer | System: | | SonoSite Maxx™ Series Ultrasound System | | | | | | | |----------------------------------------------------|--|------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------| | Transducer: | | L38xi/10-5 MHz Transducer | | | | | | | | Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | | | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Intra-operative (Abdominal organs and vascular) | | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Small Organ (breast, thyroid, testicles. prostate) | | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | |…