SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM

K101757 · Sonosite,Inc. · ITX · Aug 12, 2010 · Radiology

Device Facts

• Record ID: K101757
• Device Name: SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM
• Applicant: Sonosite,Inc.
• Product Code: ITX · Radiology
• Decision Date: Aug 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The intended uses of the SonoSite Series Ultrasound Systems remain the same as the information supplied in the predicate 510(k)'s K071134, K082098 and K092058, except for the following addition. Cardiac Imaging Applications This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap, DCPD, M-mode (where available), Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structure. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to access the presence and extent of some injuries and diseases. The ECG (where available) is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac rhythms and is not designed for long term cardiac rhythm monitoring.

Device Story

SonoSite Series Ultrasound Systems are portable, software-controlled diagnostic ultrasound systems; acquire and display high-resolution, real-time ultrasound data. Inputs: ultrasound signals via transducers (linear/phased array). Processing: system transforms signals into 2D, M-mode, Doppler (PW/CW), and Color Power Doppler images. Used in clinical settings by physicians for anatomical visualization, fluid flow analysis, and procedural guidance (e.g., pericardialcentesis, pleuralcentesis, nerve blocks). Output: visual display of cardiac, vascular, and organ structures. Clinicians use output to assess cardiac performance, identify fluid presence, and guide needle/catheter placement. Benefits: non-invasive diagnostic imaging and procedural guidance.

Clinical Evidence

Bench testing only. No new clinical data provided. Safety and effectiveness established via compliance with recognized standards (AAMI/ANSI/ISO 10993, IEC 60601-1, NEMA UD 2/3) and previous 510(k) clearances.

Technological Characteristics

Portable ultrasound system; linear and phased array transducers (1.0-13.0 MHz). Modes: B-mode, M-mode, PW/CW Doppler, Color Doppler, Power Doppler, Tissue Harmonic Imaging. Connectivity: standard ultrasound interfaces. Software-controlled. Compliance: IEC 60601-1, IEC 60601-2-37, NEMA UD 2/3, ISO 10993, ISO 9001, ISO 13485.

Indications for Use

Indicated for adult and pediatric patients for ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal/OB, abdominal, intra-operative, laparoscopic, pediatric, small organ, neonatal/adult cephalic, trans-rectal/vaginal/urethral/esophageal, musculoskeletal, and cardiac applications.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• SonoSite 180 Hand Carried Ultrasound System (K014116)
• NanoMaxx Series Ultrasound System (K092058)
• Maxx Series Ultrasound System (K071134)
• Maxx Series Ultrasound System (K082098)

Submission Summary (Full Text)

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## 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)

#### Manufacturer's Name & Address:

K10175'7

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

AUG 1 2 2010

Corresponding Official:

Mary K. Moore Vice President of Regulatory Affairs 21919 3010 Drive SE Bothell, WA 98021-3904

E-mail: mary [e-mail] Telephone: [phone] Facsimile: [phone]

Initial Distributor (if manufacturer is overseas):

Not Applicable

- Name of the device, including the trade or proprietary name if applicable, the 2) common or usual name, and the classification name, if known:
#### Device Names:

NanoMaxx™ Series Ultrasound System (subject to change) Maxx Series Ultrasound System (M Turbo , S Series™) (subject to change)

SonoSite® Ultrasound System (subject to change)

Common Name:

Diagnostic ultrasound system with accessories

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It

... ...

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# Classification:

| Regulatory Class: | II |
|-----------------------|-----------|
| Review Category: | Tier 2 |
| Classification Panel: | Radiology |

| 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 |

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

SonoSite, Inc., believes that the SonoSite Ultrasound Systems described in this Submission, and previously cleared on 510(k)'s K071134, K082098 and K092058 are substantially equivalent to the SonoSite 180 Hand Carried Ultrasound System (K014116).

#### 4) Device Description:

SonoSite ultrasound systems are highly portable, software-controlled ultrasound systems used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. The SonoSite 180™ Hand Carried Ultrasound System (K014116) provided clearance for a fully described cardiac indication including the imaging of surrounding structures, notably the Lung. The NanoMaxx Series Ultrasound System (K092058), and the Maxx Series (M turbo, S Series) Ultrasound System (K071134, K082098), which are collectively referred to as the SonoSite Ultrasound System, have all been previously cleared and are currently in interstate commerce.

This 510(k) premarket notification includes no changes, including no new system functions or technology changes, to the ultrasound systems, transducers, or accessories that were the subjects of the above-referenced submissions. This 510(k) premarket notification only extends the previously cleared indications to specifically identify the "Presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis and visualize bloodflow through cardiac valves". Additionally, the indications for use under K014116 specifically included the cardiac intended use; "The system can be used to assess the presence and extent of some injuries and diseases".

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This clinical application and intended use is consistent with current clinical practice and FDA guidelines. Ultrasound is commonly used to visualize existing landmarks in the anatomy, and the use of diagnostic ultrasound for the evaluation of fluid flow in the cardiac system, including lung is well established. Specific clinical application to the discrimination of Lung anatomy, including other types of anatomical detail, adds no significant risk to the general indication for use.

By this Submission, then, the clinical application of imaging guidance for the presence or absence of pathology of the cardiac system including the lung is being added in order to support marketing claims only. This update required no new technology, no new software, and no new instructions for use.

Previously cleared indications for use for each of the referenced SonoSite Ultrasound Systems and to the following transducers:

| System | Transducer | Transducer<br>Type | Frequency<br>Range |
|-----------------------------------------------|------------|--------------------|--------------------|
| NanoMaxx High-Resolution Ultrasound<br>System | P21n | Linear Array | 5.0 - 1.0 MHz |
| | L25n | Linear Array | 13.0 - 6.0 MHz |
| Maxx Series Ultrasound System | P21x | Linear Array | 5.0 - 1.0 MHz |
| | L25x | Linear Array | 13.0 - 6.0 MHz |

Each of the SonoSite Series Ultrasound Systems were designed, developed and tested per the applicable standards detailed below. Safety and effectiveness are established by developing product per industry recognized standards. SonoSite development records demonstrate compliance and are maintained in the Device History Record, in compliance with 21 CFR 820.

SonoSite performs testing in order to verify compliance with the standards. Testing reports have been provided in previous submissions per guidance. As this submission is in support of expanding marketing claims only, there have been no changes to technology, software or hardware. As such no additional testing was performed in support of this submission.

| 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 |

#### Applicable Standards

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| | systemic toxicity. |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-<br>1:1988 |
| IEC 60601-2-37 | Medical Electrical Equipment - Part 2-37; Particular requirements for the safety of<br>ultrasonic medical diagnostic and monitoring equipment (2001) |
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
| NEMA UD 3-2004 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices<br>on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine |

#### Miscellaneous Standards

| Reference No. | Title |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 9001:2008 | Quality management systems - Requirements International Organization for<br>Standardization (2008) |
| Title 21 CFR Part 820 | Quality System Regulation - Medical Devices: Current Good Manufacturing Practice<br>(CGMP); Final Rule |
| EN ISO 13485:2003 | Medical devices - Quality management systems - Requirements for regulatory<br>purposes (2003) |
| EN ISO 14971:2000 | Medical devices - Application of risk management to medical devices (2000)<br>(ISO 14971:2000) |
| RTCA D160E | Radio Technical Commission for Aeronautics: Environmental Conditions and Test<br>Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy |

#### 5) Intended Use:

The intended uses of the SonoSite Series Ultrasound Systems remain the same as the information supplied in the predicate 510(k)'s K071134, K082098 and K092058, except for the following addition.

#### Cardiac Imaging Applications

This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap, DCPD, M-mode (where available), Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structure. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to access the presence and extent of some injuries and diseases. The ECG (where available) is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac rhythms and is not designed for long term cardiac rhythm monitoring.

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### 6) Technological Characteristics:

The Technological Characteristics of the SonoSite Series Ultrasound Systems remain the same as those supplied and cleared in the predicate 510(k)'s K071134, K082098 and K092058.

#### 7) Conclusion

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The product development process conforms with 21 CFR 820, and ISO 13485:2003 quality systems. The device conforms to applicable electromedical 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 SonoSite, Inc. that the SonoSite Series Ultrasound System is substantially equivalent with regard to safety and effectiveness to other devices already cleared for marketing.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

#### Public Health Service

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

## AUG 1 2 2010

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

Re: K101757

Trade/Device Name: NonoMaxx: SonoSite NanoMaxx Series Ultrasound System, M Turbo: SonoSite Maxx Series Ultrasound System, S Series: SonoSite Maxx

Series Ultrasound System

Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX, and IYN Dated: July 28, 2010

Dear Ms. Stenberg:

Received: July 29, 2010

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 NonoMaxx: SonoSite NanoMaxx Series Ultrasound System, M Turbo: SonoSite Maxx Series Ultrasound System, S Series: SonoSite Maxx Series Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

L25n/13-6 P21n/5-1 Phased Array P21x/5-1 MHz L25x/13-6 MHz

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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 Paul Hardy at [phone].

Sincerely vours.

Marked D. O'Keeffe

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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510(k) Submission for SonoSite Ultrasound Systems

May 20, 2010

## Indications for Use

#### 510(k) Number (if known): TBD

AUG122200

Device Names:

- NanoMaxx: SonoSite NanoMaxx Series Ultrasound System .
- M Turbo: SonoSite Maxx Series Ultrasound System .
- . S Series: SonoSite Maxx Series Ultrasound System

#### Indications for Use:

The SonoSite Series Ultrasound Systems are 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: Ophthalmic, Fetal/OB; Abdominal; Intra-operative (abdominal organs and vascular); Laparoscopic; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Neonatal Cephalic; Adult Cephalic; Trans-recta;, Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; 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)

Mull O'Keeffe

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) . .

Page 1 of 1

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510(k) Submission for SonoSite Ultrasound Systems

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

| System: | SonoSite NanoMaxx™ 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 | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | | | | P | B+CD, B+CPD | Note 1 |
| | Abdominal | P | | | | P | B+CD, B+CPD | Note 1 |
| | Intra-operative (Abdominal Organs,<br>Vascular) | P | | | | P | B+CD, B+CPD | Note 1 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | P | B+CD, B+CPD | Note 1 |
| | Small Organ (Breast, Thyroid,<br>Testicles, Prostate) | P | | | | P | B+CD, B+CPD | Note 1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | | | | P | B+CD, B+CPD | Note 1 |
| | Musculo-skeletal (Superficial) | P | | | | P | B+CD, B+CPD | Note 1 |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult. | P | | | | P | B+CD, B+CPD | Note 1 |
| | Cardiac Pediatric | P | | | | P | B+CD, B+CPD | Note 1 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | | | | P | B+CD, B+CPD | Note 1 |
| | Other (Specify) | | | | | | | |

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

N = new indeston; P = previously classed by FDA; E = atded unter this appendic
° Examples of operation may indude; A-mode, Anplitude Dopler, 3-D Inaging, Harmonic Imaging, Ti

#### Additional Comments:

Note 1: Other Includes Color Power Doppler, combined B and Color Power Doppler, Tissue Harmonic Imaging, SonoHD, SonoMB Compound Imaging, Tissue Dopler Imaging. Color Dopler Includes Color Velocity Doppler can be combined with any imaging mode. Includes Imaging to assist in the placement of needles and cathers in vascular or other anatomical structures and imaging guidance for perioheral nerve block procedures. Indudes imaging of spinal cord to provide guidance for central nerve block procedures.

All Items marked "P" were previously cleared in 510{k) K092058

Prescription Use (Per 21 CFR 801.109)

Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety

**510(k) Number**

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## Table 1.3-2 Diagnostic Ultrasound Indications for Use Form – L25n/13-6 Transducer

| System:<br>Transducer:<br>Intended Use: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | | | | | | | |
|-----------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------|---|-----|-----|-------------------|--------------------|--------------------|--|--|--|--|--|--|
| | | L25n/13-6 13.0-6.0 MHz Linear Array | | | | | | | | | | | | |
| | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows | | | | | | | | | | | | |
| Clinical Application | | | | | | Mode of Operation | | | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other<br>(Specify) | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | |
| Fetal Imaging & | Fetal | | | | | | | | | | | | | |
| Other | Abdominal | P | P | | | P | B+CD, B+CPD | Note 1 | | | | | | |
| | Intra-operative (Abdominal<br>Organs, Vascular) | P | P | | | P | B+CD, B+CPD | Note 1 | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | |
| | Pediatric | P | P | | | P | B+CD, B+CPD | Note 1 | | | | | | |
| | Small Organ (Breast, Thyroid,<br>Testicles, Prostate) | P | P | | | P | B+CD, B+CPD | Note 1 | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | | | P | B+CD, B+CPD | Note 1 | | | | | | |
| | Musculo-skeletal (Superficial) | P | P | | | P | B+CD, B+CPD | Note 1 | | | | | | |
| | Intravascular | | | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | | | P | B+CD, B+CPD | Note 1 | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | |
| | Other | | | | | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | | | P | B+CD, B+CPD | Note 1 | | | | | | |
| Vessel | Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this spendic
* Examples of ober modes of operation nay include : A-mode, Anplibale Dopler, 3-D Inaging, Ham

#### Additional Comments:

Note 1: Other Includes Color Power Dopler, combined B and Color Power Dopler, SonoMB Compound Imaging, Color Dopler includes Color Velocity Doppler. Color Dopplar can be combined with any imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and an expanded intended use for peripheral neve block procedures. All items marked "P" were previously cleared in 510(k) K092058

Prescription Use (Per 21 CFR 801.109),

Prescription 003 (Ref.21 CFR 1306).

MLD/OK
Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number

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510(k) Submission for SonoSite Ultrasound Systems

### Table 1.3-3 Diagnostic Ultrasound Indications for Use Form – P21n/5-1 Phased Array Transducer

| System: | | SonoSite NanoMaxx™ Series Ultrasound System | | | | | | |
|------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------|---|-----|-----|-------------------|--------------------|---------------------|
| Transducer:<br>Intended Use: | | P21n/5-1 5.0-1.0 MHz Phased Array Transducer | | | | | | |
| | | 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 Doppler | Combined (Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & | Fetal | P | | | | P | B+CD, B+CPD | Note 1 |
| Other | Abdominal | P | | | | P | B+CD, B+CPD | Note 1 |
| | Intra-operative (Abdominal<br>Organs, Vascular) | P | | | | P | B+CD, B+CPD | Note 1 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | P | B+CD, B+CPD | Note 1 |
| | Small Organ (Breast, Thyroid,<br>Testicles, Prostate) | P | | | | P | B+CD, B+CPD | Note 1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | | | | P | B+CD, B+CPD | Note 1 |
| | Cardiac Pediatric | P | | | | P | B+CD, B+CPD | Note 1 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other | | | | | | | |
| Peripheral | Peripheral vessel | P | | | | P | B+CD, B+CPD | Note 1 |
| Vessel | Other (Specify) | | | | | | | |

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

N = new indicalion; P = periously class = p = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

#### Additional Comments:

Note 1: Other Includes Color Power Doppler, combined B and Color Power Dopler, Tissue Harmonic Inaging, SonoHD, SonoMB Compound Imaging, Tissue Dopler Imaging. Color Doppler Includes Color Velocity Doppler can be combined with any imaging mode. Includes Imaging to assist in the placement of needles and cathers in vascular or other analomical structures and imaging guidance for perioneral nerve block procedures. Includes imaging of spinal cord to provide guidance for central nerve block procedures.

All items marked "P" were previously cleared in 510(k) K071134 and K082098

Prescription Use (Per 21 CFR 801.109)

Mishael D. Hohn

Division Sign-Off Office of In Vitro Diagnostic Device Omeo of in vide Blaghosa
Evaluation and Safety () {
510(k) Number ರ್ಗ 510(k) Number

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## Table 1,3-4 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 | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | P | P | P | | P | B+M; B+PWD; B+CD | |
| Fetal Imaging &<br>Other | 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<br>Organs, Vascular) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| | Intra-operative (Neuro) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| | 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,<br>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 | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| | Musculo-skeletal (Superficial) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | 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 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| | Intra-cardiac | | | | | | B+M; B+PWD; B+CD | |
| | Other | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| | Other (Specify) | | | | | | | |

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

N = new lndication: P = previously class = ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

#### Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, SonoHD trraging, SonoMB Compound Imaging, Color Doppler indudes Color Velodiy Doppier . Odor Dopier can be combined with any imaging to assist in the placement of needles and cabester in vascular or other analomical structures and an expanded intended use for imaging guidance for peripheral nerve block procodures.

All items marked "P" were previously cleared in 510(k) K071134 and K082098

Prescription Use (Per 21 CFR 801.109)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number

Page 58 of 1041

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### Table 1.3-5 Diagnostic Ultrasound Indications for Use Form – P21x/5-1MHz Transducer

| System: | | SonoSite Maxx™ Series Ultrasound System | | | | | | | | | |
|---------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------|---|-----|-----|------------------|-------------------------|---------------------|--|--|--|
| Transducer: | | P21x/ 5.0 - 1.0 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 | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | | | |
| Fetal Imaging & | Fetal | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | | | |
| Other | Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | | | |
| | Intra-operative (Abdominal<br>Organs, 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 | Note 1 | | | |
| | Small Organ (Breast, Thyroid,<br>Testicles, Prostate) | P | P | P | | P | B+M; B+PWD<br>B+CD | Note 1 | | | |
| | Neonatal Cephalic | P | P | P | | P | B+M; B+PWD<br>B+CD | Note 1 | | | |
| | Adult Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | B+CD, B+CPD | Note 1 | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Cardiac | 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 | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other | | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | B+CD, B+CPD | Note 1 | | | |
| Vessel | Other (Specify) | | | | | | | | | | |

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

N = new indicalion; P = previously classed by FDA; E = added under bis appendix
* Examples of other notes of opention may include Dopler, 3-D Inaging, Harmonic imaging, Tis

#### Additional Comments:

Not 1: Other includes Color Power Dopler, Smolf Imaging, SonolfB imaging, SonalB Compund maging, Color Dopper
includes Color Velociy Dopler can be cambinel with any imaging g

All Items marked "P" were previously cleared in 510(k) K071134 and K082098

Prescription Use (Per 21 CFR 801.109)

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number

Page 59 of 1041

- Division Sign-Off
。

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## Table 1.3-6 Diagnostic Ultrasound Indications for Use Form – L25x/13-6 MHz Transducer

| System: | | SonoSite Maxx TM Series Ultrasound System | | | | | | |
|---------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------|---|---------|------------------|--------------------|---------------------|--|
| Transducer: | | L25x/ 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 | P | P | | P | B+M; B+CD | Note 1 | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal | P | P | | P | B+M; B+CD | Note 1 | |
| | Intra-operative (Abdominal<br>Organs, Vascular) | P | P | | P | B+M; B+CD | Note 1 | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | | P | B+M; B+CD | Note 1 | |
| | Small Organ (Breast, Thyroid,<br>Testicles, Prostate) | P | P | | P | B+M; B+CD | Note 1 | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | | P | B+M; B+CD | Note 1 | |
| | Musculo-skeletal (Superficial) | P | P | | P | B+M; B+CD | Note 1 | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | | P | B+M, B+CD, B+CPD | Note 1 | |
| | Other (Specify) | | | | | | | |

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

N = now locklass). P = previously cleaned by FDA; E = actor under this appends
^ Examples of other modes of operation may industr. Ample; Ample; 3-D Inaging, Hamonic braging,

#### Additional Comments:

Note 1: Other Includes Color Power Dopler, contined B and Color Power Doppler, Tissue Harmonic Imaging, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD Tissue Doplar Imaging. Color Doppler interests of the Populer, itsee Names , San II, San Millian, San Millian Singlian including model, Including mode, Includes includes inc assist in the placement of needles in vascular or other and micel structures and insigning guidance for priseiners newell material procedures. Includes imaging of spinal cord to provide guidance for central nerve block procedures.

All Items marked "P" were previously cleared in 510(k) K043559 and K053069

Prescription Use (Per 21 CFR 801.109)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safe 510(k) Number -_

Page 60 of 1041