SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM

K092058 · Sonosite,Inc. · IYN · Oct 2, 2009 · Radiology

Device Facts

• Record ID: K092058
• Device Name: SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
• Applicant: Sonosite,Inc.
• Product Code: IYN · Radiology
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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); Peripheral Vessel; Intra-operative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.

Device Story

Hand-carried diagnostic ultrasound system (<6 lbs) with touch screen interface; acquires/displays real-time 2D, Doppler, and Color Power Doppler (CPD) ultrasound data. Piezoelectric transducers transmit sound waves into body; reflected signals processed into images/flow analysis. Includes intima-media thickness (IMT) measurement for cardiovascular risk assessment. Used in clinics/point-of-care by physicians for imaging guidance (drainage, vascular access, nerve blocks) and general diagnostic exams. Features HIPAA-compliant security, USB support for peripherals, and SiteLink for data export. Displays bioeffects indices (MI/TI) per AIUM/NEMA standards. Benefits include portable, high-resolution imaging for rapid clinical assessment and procedural guidance.

Clinical Evidence

Bench testing only. Device conforms to AAMI/ANSI/ISO 10993 (biocompatibility), IEC 60601-1 (safety), IEC 60601-2-37 (ultrasound safety), and NEMA UD 2/UD 3 (acoustic output). No clinical data required for substantial equivalence.

Technological Characteristics

Piezoelectric transducer array (linear, curved, phased); frequency range 1.0-13.0 MHz. Modes: 2D, Color Doppler, Color Power Doppler, Tissue Harmonic Imaging, SonoMB Compound Imaging, Tissue Doppler. Connectivity: USB, SiteLink. Biocompatible patient-contact materials. Standards: IEC 60601-1, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993. Software-controlled system.

Indications for Use

Indicated for use by qualified physicians for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal/OB, abdominal, pediatric, small organ (breast, thyroid, testicles, prostate), peripheral vessel, intra-operative (abdominal/vascular), musculoskeletal (conventional/superficial), and cardiac (adult/pediatric) applications.

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 (K071134 and K082098)
• Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224)

Submission Summary (Full Text)

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KOS205Y

## OCT - 2 2009

## 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.

#### Submitter's name, address, telephone number, contact person: 1)

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: | June 19, 2009 |

#### 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 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 |

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

SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx Series Ultrasound System (K071134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224).

#### 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

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ultrasound data in 2D, Doppler, 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 that 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.

The system includes security support to facilitate HIPAA compliance.

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 two USB host supports for peripherals such as input devices and storage devices. Input devices include wired and wireless devices such as keyboard, and mouse. Storage devices include devices such as memory sticks, hard drives, and CDs. The system also features SiteLink™ allowing an additional method for the export of patient data.

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 [MI]" and "Thermal Index [T]]") 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 | Phased array |
| | Curved array | |

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<br>and testing |
| 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) |

FDA Consensus Standards

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| 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 |

:

and the comments of the comments of the comments of

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#### 5) Intended Use:

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

| Peripheral vessel |
|----------------------------------------|
| Fetal - OB/GYN |
| Abdominal |
| Musculo-skel. (Conventional) |
| Musculo-skel. (Superficial) |
| Cardiac |
| Pediatric |
| Small Organ |
| (breast, thyroid, testicles, prostate) |

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 transmits ultrasound energy into the thorax of patients using 2D, to obtain ultrasound images. The heart, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heart size can be assessed for the presence of pathology.

#### Gynecology and Infertility Imaging Applications

This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, 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.

### Interventional Imaging Applications

You can use the system for ultrasound guidance in drainage procedures, vascular line placement, peripheral nerve blocks, spinal nerve blocks and taps, amniccentesis and other obstetrical procedures, and provide assistance during abdominal, breast, and neurological surgery.

#### Obstetrical Imaging Applications

This system transmits uftrasound energy into the pelvis of pregnant women using 2D, color Doppler and color power Doppler (CPD) to obtain ultrasound images. The fetal anatomy, viability, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally. CPD 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.

#### Pediatric and Neonatal Imaging Applications

This system transmits ultrasound energy into the pediatric patients using 2D, color Doppler and color power Doppler (CPD) to obtain ultrasound images. The pediatric abdominal, pelvic, and surrounding anatomical structures can be assessed for the presence or absence of pathology.

Superficial Imaging Applications

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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, iymph 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 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 Doppler (CPD) 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 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 mages. Dopler 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 (AIUMNEMA 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.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular fashion around the bird. The text is in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

## OCT = 2 2009

Re: K092058

Trade/Device Name: SonoSite NanoMaxx™ Series Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 7, 2009 Received: July 8, 2009

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 Elastography for SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System, as described in your premarket notification:

### Transducer Model Number

C11n/8-5 C60n/5-2 L25n/13-6

L38n/10-5 P21n/5-1 Phased Array

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.

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Page 2 - Mr. Mark Job

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

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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/MedicalDevicesforYou/Industry/default.htm.

If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at [phone].

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## Indications for Use

# 510(k) Number (if known): # # K 092058

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); Peripheral Vessel; Intra-operative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.

Prescription Use: X (Part 21 CFR 801 Subpart D)

510(k) Number

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CHRH, Office of Device Evaluation (ODE)

Concurrence of CHRP

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

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## Table 1.3-1 Diagnostic Ultrasound Indications for Use Form - SonoSite NanoMaxx™ Series Ultrasound System

| System:<br>Transducer:<br>Intended Use:<br>Clinical Application | | SonoSite NanoMaxx™ Series Ultrasound System<br>N/A<br>Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows<br>Mode of Operation | | | | | | | | | | | | | | | | |
|-----------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---|--|--|---|-------------|--------|--|--|-------------------------------------------------|--|---|--|--|---|-------------|--------|
| | | | | | | | | | | | Abdominal | | N | | | N | B+CD, B+CPD | Note 1 |
| | | | | | | | | | | | Intra-operative (Abdominal Organs,<br>Vascular) | | N | | | N | B+CD, B+CPD | Note 1 |
| | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | |
| | Pediatric | | N | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | | N | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | N | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | N | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | N | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Cardiac Pediatric | | N | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | N | | | N | 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 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 Harmanic Imaging, SonoHD Compound Inaging, Tissue Dopler inaging. Color Dopler includes Color Dopler can be contined with any imaging note. Melutes inaging assist in the spinal cord to grovide guidance for central nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off, Division of Reproductive, Radiological De 510(k) Number

PAGE 53 of 1310

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| System:<br>Transducer:<br>Intended Use:<br>Clinical Application | | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | |
|-----------------------------------------------------------------|-------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|-----------------------|
| | | | C11n/8-5 8.0-5.0 MHz Curved Array<br>Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | | | | | |
| | | | Mode of Operation | | | | | |
| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal | N | | | | N | B+CD, B+CPD | Note 1 |
| | Intra-operative (Abdominal Organs,<br>Vascular) | N | | | | N | B+CD, B+CPD | Note 1 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | | | | N | B+CD, B+CPD | Note 1 |
| | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | N | | | | N | | |
| | 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 | N | | | | N | B+CD, B+CPD | Note 1 |
| | Other (Specify) | | | | | | | |

### Table 1.3-2 Diagnostic Ultrasound Indications for Use Form - C11n/8-5 Transducer

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

* Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

#### Additional Comments:

Note 1: Other indudes Color Power Dopler, Sont Color Power SonolH Compund maging. Con Copper incluse
Color Velociy Dopler can be combined with any imaging mode. Includes i or other anatomical structures, and expanded intended use for peripheral nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

..

(Division S Division of eproductive, Abdomina Radiological Devices 510(k) Number

PAGE 54 of 1310

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| System: | | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | | |
|---------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------|-----|-----|------------------|-----------------------|------------------|--|--|--|
| Transducer: | | C60n/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 | | | | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | | | | N | B+CD, B+CPD | Note 1 | | | |
| | Abdominal | N | | | | N | B+CD, B+CPD | Note 1 | | | |
| | Intra-operative (Abdominal Organs,<br>Vascular) | N | | | | N | B+CD, B+CPD | Note 1 | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | | | | N | B+CD, B+CPD | Note 1 | | | |
| | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | N | | | | N | B+CD, B+CPD | Note 1 | | | |
| | 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 | N | | | | N | B+CD, B+CPD | Note 1 | | | |
| | Other (Specify) | | | | | | | | | | |

## Table 1.3-3 Diagnostic Ultrasound Indications for Use Form - C60n/5-2 Transducer

N = new indication: P = previously cleared by FDA: E = added under this appendix

* Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

#### Additional Comments:

Note 1: Ober hokudes Color Power Dopler, Tissue Hamonic maging, Sonel Direction, Sonolf Dinajng, Sonola Compund imaging, placement of needles and cather in vascular or other analomical structures. Includes imaging of spinal cord to central nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

(Division Sign Off)

(Divisio Division of Reproductive. Abdom Radiological Devices 510(k) Number

PAGE 55 of 1310

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| 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 | Fetal | | | | | | |
| | | Abdominal | N | | | N | B+CD, B+CPD | Note 1 |
| | | Intra-operative (Abdominal Organs,<br>Vascular) | N | | | N | B+CD, B+CPD | Note 1 |
| | | Intra-operative (Neuro) | | | | | | |
| | | Laparoscopic | | | | | | |
| | | Pediatric | N | | | N | B+CD, B+CPD | Note 1 |
| | | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | N | | | N | B+CD, B+CPD | Note 1 |
| | | Neonatal Cephalic | | | | | | |
| | | Adult Cephalic | | | | | | |
| | | Trans-rectal | | | | | | |
| | | Trans-vaginal | | | | | | |
| | | Trans-urethral | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | |
| | | Musculo-skeletal (Conventional) | N | | | N | B+CD, B+CPD | Note 1 |
| | | Musculo-skeletal (Superficial) | N | | | N | B+CD, B+CPD | Note 1 |
| | | Intravascular | | | | | | |
| | | Other (Specify) | | | | | | |
| | Cardiac | Cardiac Adult | N | | | N | B+CD, B+CPD | Note 1 |
| | | Cardiac Pediatric | | | | | | |
| | | Intravascular (Cardiac) | | | | | | |
| | | Trans-esoph. (Cardiac) | | | | | | |
| | | Intra-cardiac | | | | | | |
| | | Other (Specify) | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | | | N | B+CD, B+CPD | Note 1 | |
| | Other (Specify) | | | | | | | |

## Table 1.3-4 Diagnostic Ultrasound Indications for Use Form – L25n/13-6 Transducer

N = new indication; P = previously cleared by FOA; E = added under this appendix

* Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

## Additional Comments:

Note 1: Other includes Code Power Dopler, Sonol Coppler, Sonold Compund maging . Color Dopter includes Color
Velodiy Dopler . Cola Oopler can be combined with any imaging na structures and an expanded intended use for imaging guidance for peripheral nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

(Divis Division of 510(k) Number

PAGE 56 of 1310

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

| System:<br>Transducer:<br>Intended Use:<br>Clinical Application | | SonoSite NanoMaxx™ Series Ultrasound System<br>L38n/10-5 10.05.0 MHz Linear Array Transducer<br>Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows | | | | | | | | | | | | | | | | |
|-----------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|--|--|---|-------------|-------------|------|--|-------------------------------------------------|-------------------------|--|--|--|---|-------------|--------|
| | | | | | | | | | | | Abdominal | N | | | | N | B+CD, B+CPD | Note 1 |
| | | | | | | | | | | | Intra-operative (Abdominal Organs,<br>Vascular) | N | | | | N | B+CD, B+CPD | Note 1 |
| | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | |
| | Pediatric | N | | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | N | | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | N | | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | |
| | Cardiac | Cardiac Adult | N | | | | N | B+CD, B+CPD | Note | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | | | | N | B+CD, B+CPD | Note 1 | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | |

## Table 1.3-5 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 Dopler, 3-D Imaging, Harmoric Imaging, Tlssue Molon Doppler, and Color Velocity Imaging

## Additional Comments:

Note 1: Other includes Color Power Oopler, combined B and Color Power Dopler, SonoMB Compound Imaging. Coior Dopler includes Color Velocity Doppler. Color Dopler can be combined with any imaging to assist in the placement of needles and cathers in vascular of other anatomical stockues and imaging guidance for perioral neve block procedures. Includes imaging of spinal card to realiza neve block procedures.

Prescription Use (Per 21 CFR/801.109)

(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Device 510(k) Number

PAGE 57 of 1310

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

| System: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | |
|---------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------|---|--|--|---|-------------|--------|
| Transducer: | | P21n/5-1 5.0-1.0 MHz Phased Array Transducer | | | | | | |
| Intended Use:<br>Clinical Application | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | | | | | | |
| | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | N | | | N | B+CD, B+CPD | Note 1 |
| | Abdominal | | N | | | N | B+CD, B+CPD | Note 1 |
| | Intra-operative (Abdominal Organs,<br>Vascular) | | N | | | N | B+CD, B+CPD | Note 1 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | N | | | N | B+CD, B+CPD | Note 1 |
| | Small Organ (Breast, Thyroid, Testicles,<br>Prostate) | | N | | | N | B+CD, B+CPD | Note 1 |
| | 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 | | N | | | N | B+CD, B+CPD | Note 1 |
| | Cardiac Pediatric | | N | | | N | B+CD, B+CPD | Note 1 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardlac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other…