SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM

K071134 · Sonosite,Inc. · IYO · May 8, 2007 · Radiology

Device Facts

• Record ID: K071134
• Device Name: SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Sonosite,Inc.
• Product Code: IYO · Radiology
• Decision Date: May 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.

Device Story

SonoSite Maxx Series is a software-controlled, general-purpose diagnostic ultrasound system. It acquires and displays real-time ultrasound data (2D, M-Mode, PW/CW Doppler, Color Power Doppler, Velocity Color Doppler) using various curved, linear, phased, and intracavitary transducers. System includes ECG display for timing measurements; measurement tools for anatomical structures and fetal biometry; and intima-media thickness (IMT) calculation for carotid artery assessment. Used in clinics and hospitals by clinicians for diagnostic imaging and interventional guidance (biopsy, drainage, nerve blocks). Data is processed for display, storage, and communication via DICOM. System supports peripherals (printers, VCRs, storage devices) and mobile docking. Output assists physicians in assessing cardiovascular health, fetal development, and pathology. Benefits include real-time visualization for diagnostic assessment and procedural guidance.

Clinical Evidence

Bench testing only. The device was evaluated for safety and effectiveness through compliance with recognized consensus standards, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and acoustic output measurement (NEMA UD 2-2004, NEMA UD 3-2004). No clinical data was required for this 510(k) clearance.

Technological Characteristics

Piezoelectric transducer technology; 2.0–13.0 MHz frequency range. Modes: 2D, M-Mode, PW/CW Doppler, Color Power Doppler, Velocity Color Doppler. Connectivity: DICOM, USB, 802.11 wireless. Biocompatible patient-contact materials. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3. Software-controlled system.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in adults, pediatric, and neonatal patients across various clinical applications including abdominal, cardiac, OB/GYN, vascular, musculoskeletal, and intraoperative procedures. Contraindicated for Percutaneous Umbilical Blood Sampling (PUBS) and in vitro Fertilization (IVF).

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• SonoSite MicroMaxx Series Ultrasound System (K043559 and K053069)
• Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for SonoSite. The logo consists of a stylized letter 'S' in black, placed above the word 'SonoSite' in a sans-serif font. A horizontal line extends from the right side of the word 'SonoSite'.

4-8-2007

Image /page/0/Picture/3 description: The image shows a sequence of numbers and letters, specifically 'K071134'. The characters are written in a bold, handwritten style, giving them a distinct and somewhat irregular appearance. The contrast between the dark characters and the light background makes them easily readable.

WA 98021-3904 W

Telephone:[phone] csimile:1.425.951.1201 ww.sonosite.com

## 510(K) Summary of Safety and Effectiveness

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:

SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904

| Corresponding Official: | Daina L. Graham |
|-------------------------|----------------------------------------------------------|
| | Vice President, Regulatory Affairs and Quality Assurance |
| E-mail: | [e-mail] |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date prepared: | March 21, 2007 |

#### 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

#### Proprietary 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 | 90-LLZ |

#### 3) Identification of the predicate or legally marketed device:

SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite MicroMaxx Series Ultrasound System (K043559 and K053069), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224).

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#### 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 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections.

The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, bionsy, measurements and calculations, image storage and review, printing, and recording capabilities.

The system includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.

The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.

The system includes a variety of accessories including a mobile docking system, external monitor, bar code reader, digital video disk recorder, printer, VCR, and biopsy/needle guide kits. The system includes USB host support for peripherals such as input devices and storage devices include wired and wired and wireless devices such as keyboard, mouse, remote. Storage devices include wired and wireless devices such as memory sticks, hard drives, CDs, 802.11 devices.

The SonoSite Maxx Series Ultrasound System is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.

| Frequency Range: | 2.0 – 13.0 MHz | |
|-------------------|------------------------------|------------------------------------------------------|
| Transducer Types: | Linear array<br>Curved array | Intracavitary array<br>Phased array<br>Static probes |

| FDA Recognized Consensus Standards | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Reference No. | Title |
| AAMI/ANSI/ISO 10993-<br>1 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997) |
| AIUM | AIUM Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (2002) |
| ANSI/AAMI EC53 | ECG Cables and Electrodes except for sections 4.4 and 4.5.9 (1995) |
| EN 980 A1 | Graphical symbols for use in the labeling of medical devices (2003) |
| IEC 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988 |
| IEC 60601-1/A1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A1:1991 |
| IEC 60601-1/A2 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A2:1995 +<br>corrigendum June 1995 |

The SonoSite Maxx Series Ultrasound System is designed to comply with the following standards.

510(K) Summary Of Safety And Effectiveness

Page 2 of 6

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| Reference No. | Title |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | requirements for medical electrical systems - IEC 60601-1-1:2000 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1: General requirements for safety; 2. collateral standard:<br>electromagnetic compatibility; requirements and tests - IEC 60601-1-2:2001 |
| IEC 60601-1-4 | Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard:<br>Programmable electrical medical systems - IEC 60601-1-4:1996 Amendment A1 |
| IEC 60601-2-25 | Medical Electrical Equipment-Part 2. Particular Requirements for Safety-Section 25. Specification for<br>Electrocardiographs. (1999 |
| IEC 60601-2-37 | Medical Electrical Equipment - Part 2-37; Particular requirements for the safety of ultrasonic medical<br>diagnostic and monitoring equipment (2001) |
| IEC 60601-2-37/A1 | Medical Electrical Equipment - Part 2-37; Particular requirements for the safety of ultrasonic medical<br>diagnostic and monitoring equipment (2001)A1: 2004 |
| 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<br>Ultrasound Equipment, American Institute of Ultrasound in Medicine |

### Miscellaneous Design Standards

| Reference No. | Title |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5276-98 | Standard Test Methods for Drop Test of Loaded Containers by Free Fall (1998) |
| ASTM D999-96 | Standard Methods for Vibration Testing of Shipping Containers (1996) |
| CISPR 11 | Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Electromagnetic Disturbance<br>Characteristics - Limits and Methods of Measurement (2003) |
| EN 60529 | Degrees of protection provided by enclosures (IP Code) (1991 |
| JIS T 0601-1 | Medical Electrical Equipment - Part 1: General Requirements for Safety (Japan) (1999) |
| JIS T 1507 | Electronic Linear Scanning Ultrasonic Diagnostic Equipment (Japan) (1989) |
| RTCA/DO160D | Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne<br>Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B (1997) |
| UL 60601-1 | Underwriters Laboratories, Medical Electrical Equipment-Part 1: General Requirements for Safety (2003) |
| UL 94 | Underwriters Laboratories, Inc., Tests for Flammability of Plastic Materials for Parts in Devices and<br>Appliances, 5th Edition |
| EN ISO 13485 | Medical devices - Quality management systems - Requirements for regulatory purposes (2003) |
| EN ISO 14971 | Medical devices - Application of risk management to medical devices (2000) (ISO 14971:2000) (Superseded<br>standard: EN 1441) |
| ACR-NEMA DICOM<br>version 3.0 - 2003 | Digital Imaging and Communications in Medicine |

.

: :

.

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#### Intended Use: ട്)

The intended uses of the SonoSite Maxx Series Ultrasound System as defined by FDA guidance documents, are:

| Ophthalmic | Adult Cephalic |
|----------------------------------------|------------------------------|
| Fetal - OB/GYN | Trans-rectal |
| Abdominal | Trans-vaginal |
| Intra-operative | |
| (Abdominal organs and vascular) | Musculo-skel. (Conventional) |
| Intra-operative (Neuro.) | Musculo-skel. (Superficial) |
| Laparoscopic | Cardiac Adult |
| Pediatric | Cardiac Pediatric |
| Small Organ | |
| (breast, thyroid, testicles, prostate) | Trans-esophageal (card.) |
| Neonatal Cephalic | Peripheral vessel |

Typical examinations performed using the SonoSite Maxx Series Ultrasound System are:

### Abdominal Imaging Applications

This system transmits ultrasound energy into the abdomen of patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler 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 pathology transabdominally.

### Cardiac Imaging Applications

This system transmits ultrasound energy into the thorax of patients using 2D, M Mode, color Doppler (Color), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler to obtain ultrasound images. The heart, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heatt size can be assessed for the presence or absence of pathology.

The patient's electrocardiogram (ECG) may be obtained and is used for timing of diastolic and systolic function.

- 产 The ECG is not used to diagrose cardiac arrhythmias and is not designed for long term cardiac rhythm monitoring.
### Gynecology and Infertility Imaging Applications

This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), and pulsed wave (PW) Doppler to obtain ultrasound images. The uterus, ovaries, adnexa, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally.

#### Interventional and Intraoperative Imaging Applications

This system transmits ultrasound energy into the various parts of the body using 2D, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images that provide guidance during interventional and intraoperative procedures. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, spinal nerve blocks and taps, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance during abdominal, breast, neurological surgery, and vascular intraoperative procedures.

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### Obstetrical Imaging Applications

This system transmits ultrasound energy into the pelvis of pregnant women using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler 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 fransabdominally 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,

- 公 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

This system transmits ultrasound energy into the pediatric patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), pulsed wave (PW) Doppler, pulsed wave tissue Doppler (TDI PW), and continuous wave (CW) Doppler to obtain ultrasound images. The pediatric abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal head, and surrounding anatomical structures can be assessed for the presence or absence of pathology.

#### Prostate Imaging Applications

This system transmits ultrasound energy into the prostate of an adult male using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), and pulsed wave (PW) Doppler to obtain ultrasound images. The prostate gland can be assessed for the presence or absence of pathology.

#### Superficial Imaging Applications

This system transmits ultrasound energy into various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler 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 of pathology. This system can be used to provide ultrasound quidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps.

#### Transcranial Imaging Applications

This system transmits ultrasound energy into the cranium using 2D, color Doppier (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The anatomical structures and vascular anatomy of the brain can be assessed for presence of pathology. Two exam types support transcranial imaging: TCD and Orb. Imaging can be used temporally, trans-occipitally, or transorbitally.

- A To avoid injury to the patient, use only an orbital exam type (Orb) when performing imaging through the eye. The FDA has established lower acoustic energy limits for opthalmic use. The system will not exceed these limits only if the Orb exam type is selected.
#### Vascular Imaging Applications

This system transmits ultrasound energy into the various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The carotid arteries, deep veins, and arteries in the arms and legs, superficial veins in the arms and legs, great vessels in the abdomen, and various small vessels feeding organs can be assessed for the presence of pathology.

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#### 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 or M-mode images. Dopler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (M-Mode, 2D, PW Doppler, CW Doppler, velocity color Doppler, and Color Power Doppler) 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.

The device's acoustic output limits are:

| 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 for when used for ophthalmic applications are:

| ISPTA (d) | 50 mW/cm² | Maximum |
|-----------------------|-----------|---------|
| Tls/Tlb/Tlc | 0.0 - 1.0 | Range |
| Mechanical Index (MI) | 0.23 | Maximum |

The limits are the same as predicate Track 3 devices.

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Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2007

SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K071134

Trade Name: SonoSite MaxxTM Series Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO, IYN, ITX and LLZ Dated: April 20, 2007 Received: April 23, 2007

Dear Mr. Job:

This letter corrects our substantially equivalent letter of May 8, 2007.

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 Maxx™ Series Ultrasound System, as described in your premarket notification:

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### Transducer Model Number

| BPTRTx/8-5 | HFL50x/13-5 | P10x/8-4 |
|-------------|--------------|-----------|
| C8x/8-5 | ICTx/8-5 | P17x/5-1 |
| C11x/8-5 | L25x/13-6 | P21x/5-1 |
| D2x/2 | L38x/10-5 | SLAx/13-6 |
| D5x/5 | L52/x10-5 | SLTx/10-5 |
| C60x/5-2 | LAPx/12-5 | TCDx/2 |
| HFL38x/13-6 | MiniTEEx/7-3 | TEEx/8-3 |

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Ewa Czerska at [phone].

Sincerely yours,

Herbert Lemus

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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K071134

### Table 4.3- 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<br>follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | N | N | N | | N | B+M; B+PWD;<br>B+CD | |
| Fetal | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Abdominal | N | N | N | N | N | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Intra-operative (Abdominal<br>organs and vascular) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Neuro.) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Laparoscopic | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Pediatric | N | N | N | N | N | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Small Organ (breast, thyroid,<br>testicles, prostate) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Neonatal Cephalic | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Adult Cephalic | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-rectal | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-vaginal<br>Trans-urethral | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Musculo-skel. (Superfic.) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-luminal<br>Other (spec.) | | | | | | | |
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Cardiac Pediatric | N | N | N | N | N | B+M+ B+PWD;<br>B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.)<br>Other (spec.) | N | N | N | N | N | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Peripheral vessel<br>Other (spec.) | N | N | N | | N | B+M+ B+PWD;<br>B+CD | Note 1 |
| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
| Transducer: | BPTRTx/8-5 MHz 8.0-5.0 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | Other<br>(Spec.) |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | |
| Ophthalmic | | | | | | | |
| Fetal | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note<br>1 |
| Abdominal<br>Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>testicles. prostate) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note<br>1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note<br>1 |
| Trans-vaginal | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note<br>1 |
| 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 | | | | | | | |
| Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

### Additional Comments:

Note 1: Other includes Color Power Dopler, 3-D Imaging, Tissue Hamonis Imaging, Tissue Hamonis Imaging, SonoMB സ്ഥലം സംസ് അവാർ സംസ്ഥം (color contriel in opider) - Color Paring (nastir - Insult - Integrity (naging - Color Dopler - Color Dopler - Color Dopler - Color Dopler - Color Do with any imaging mode. Includes inaging to assist in the dises in teders on vasular o other andomical structures and maging gulatan or peripheral neve block procedures. Includes picture and storage functionality. Includes imaging of spinal cord to provide guitance for central nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

Nancy Broodon
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices

Indications for Use

Radiological Devices
510(k) Number K071134
27 of 1092 pages

Section 4.3

{10}------------------------------------------------

# Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form – BPTRTx/8-5 Transducer

N= new indication; P= previously cleared by FDA; E= added under Appendix E

### Additional Comments:

Not 1: Other insucles Color Power Dopler, 3-2 Inaging Tissue Hamnir, inging, Sonolles Inaging, Sonolle
Compund Imaging, Tisue Dopler Imaging fo guitane of viops; Color Dople

Prescription Use (Per 21 CFR 801.109)

Nancy C. Burgdon

ductive. Abd 510(k)

{11}------------------------------------------------

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------|
| Transducer: | C8x/8-5 8.0-5.0 MHz Curved Array 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 | P | P | P | CWD | P | B+M; B+PWD; B+CD | Note 1 |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid, testicles. prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Trans-vaginal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| 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 | | | | | | | |
| Other (spec.) | | | | | | | |

### Table 4.3- 3 Diagnostic Ultrasound Indications for Use Form - C8x/8-5 Transducer

N= new indication; P= previously cleared by FDA; E= added under Appendix E

### Additional Comments:

Note 1: Other includes Color Power Dopler, 3-0 Inaging, Tissue Hamonic maging, Sondres Imaging, Sonolles Inaging, Sonolla
Color Dopler Imaging and imaging for guidanes of bi with any imaging mode. Imaging to assist in the placed or other anatomical studium swas cleared in K0304G. All tiens marked "P" were previously cleared in 510(k) K043559.

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

oductive. Abdominal, Divis Rac 510(k

{12}------------------------------------------------

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|---------------|-------------------------|---------------|--|
| Transducer: | C11x/8-5 8.0-5.0 MHz Curved Array | | | | | | | |
| 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 | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Intra-operative (Neuro.) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Laparoscopic | | | | | | | | |
| 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 | 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 | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | |
| Musculo-skel. (Convent.) | | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | | |
| Intra-luminal | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Trans-esophageal (card.) | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) | | | | | | | | |

## Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form - C11x/8-5 Transducer

new indication; P= previously cleared by FDA; E= added under Appendix E

#### Additional Comments:

Note 1: Other includes Color Power Dopler 3-3 linaging, Tissue Harmon in the include in the inn , Sonoles integing, Sonoller . Color Dopler . Olor Dopler : with any imaging mode. Imaging to assist in the placers in vascular or other anatomical structures was previously cleared in 510(), K030849. An expanded intention guidance for peripheral neve block procedures was previously deared in K03367. All items marked "P" were previously cleared in 510(k) K043559.

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign-Off) 0
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071134

{13}------------------------------------------------

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer: | D2x/2 2.0 MHz Dual Element Circular Array | | | | | | |
| 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<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| 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 | | | | P | | | |
| Cardiac Pediatric | | | | P | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |

# Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form - D2x/2 Transducer

by FDA; E= added under Appendix E

### Additional Comments:

All items marked "P" were previously cleared in 510(k) K053069.

Prescription Use (Per 21 CFR 801.109)

Nancy Broadon

uctive, Abdominal, and

{14}------------------------------------------------

| System: | SonoSite Maxx ^TM Series Ultrasound System |
|---------------|------------------------------------------------------------------------------------|
| Transducer: | D5x/5 5.0 MHz Dual Element Circular Array |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
|----------------------------------------------------|---|---|-----|-----|---------------|------------------|---------------|
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| 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 | | | | N | | | |
| Cardiac Pediatric | | | | N | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |

# Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form – D5xJ5 Transducer

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{15}------------------------------------------------

| System: | SonoSite Maxx ™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|---------------|---------------------|---------------|
| Transducer: | C60x/5-2 5.0-2.0 MHz Curved Array | | | | | | |
| 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 | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Abdominal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Neuro.)<br>Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD;<br>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.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.)<br>Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Other (spec.) | | | | | | | |

# Table 4.3- 7 Diagnostic Ultrasound Indications for Use Form - C60x/5-2 Transducer

N= new indication; P= previously cleared by FDA; E= added under Appendix E

#### Additional Comments:

Note 1: Other includes Color Power Doppler, contined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, SonoRes Imaging, SonoMB Compound Imaging, Tissue Dopler Imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler can be combined with any imaging mode. Includes imaging to assist in the placement of necessar or other anatomical stuctures. Includes inaging of spinal cord to provide guidance for central neve block procedures. All items marked "P" were previously cleared in 510(k) K053069.

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hodson

ctive, Abdominal, and 510

{16}------------------------------------------------

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|--------|
| Transducer: | HFL38x/13-6 13.0-6.0 MHz Linear Array Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | Other<br>(Spec.) | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Other (spec.) |…