SONOSITE EDGE ULTRASOUND SYSTEM

K113156 · Sonosite,Inc. · IYO · Nov 15, 2011 · Radiology

Device Facts

• Record ID: K113156
• Device Name: SONOSITE EDGE ULTRASOUND SYSTEM
• Applicant: Sonosite,Inc.
• Product Code: IYO · Radiology
• Decision Date: Nov 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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

Device Story

Portable, laptop-style diagnostic ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Operates on battery or AC power. Used by physicians in clinical settings for imaging/fluid flow analysis. Transforms acoustic signals into visual outputs via multiple imaging modes (B, M, PWD, CWD, Color Doppler, combined modes). Supports various transducers for specific anatomical applications. Output viewed by clinicians to guide diagnostic decisions, biopsies, and needle/catheter placement. Benefits include portable, high-resolution imaging for diverse clinical environments.

Clinical Evidence

No clinical data; bench testing only. Evaluated for electrical, thermal, mechanical, and EMC safety; cleaning/disinfection; biocompatibility; and acoustic output. Conforms to applicable medical device safety standards.

Technological Characteristics

Portable laptop-style digital electronic design. Supports multiple transducers (C8x, C11x, D2x, C60x, HFL38x, HFL50x, ICTx, L25x, L38xi, L38x, P10x, P21x, SLAx, TEEx). Imaging modes: B, M, PWD, CWD, Color Doppler, Tissue Doppler, Tissue Harmonic, SonoHD, SonoMB compound imaging. Biocompatible patient contact materials. Battery or AC powered.

Indications for Use

Indicated for ultrasound imaging or fluid flow analysis of the human body in patients requiring diagnostic evaluation across ophthalmic, fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, trans-rectal/vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Contraindications not specified.

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 Maxx Series Ultrasound System (K071134)
• SonoSite Maxx Series Ultrasound System (K082098)

Submission Summary (Full Text)

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# 510(K) Summary

# NOV 1 5 2011

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: | Scott E. Paulson<br>Sr. Regulatory Affairs Specialist |
|-------------------------|-------------------------------------------------------|
| E-mail: | [e-mail] |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date prepared: | October 4, 2011 |

#### 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 Edge™ Ultrasound System (subject to change)

#### Classification Names

| Name | FR Number | Product Code |
|---------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Picture Archiving and Communications System | 892.2050 | LLZ |

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

SonoSite Maxx Series Ultrasound System K071134 / K082098

#### 4) Device Description:

The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.

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## 5) Intended Use:

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

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

### 6) Technological Characteristics:

SonoSite Edge and Maxx Series Ultrasound Systems are both Track 3 devices that employ the same fundamental scientific technology.

### 7) Determination of Substantial Equivalence:

#### Summary of Non-Clinical Tests:

The SonoSite Edge Ultrasound System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to all applicable mandatory medical device safety standards. The Edge system also complies with voluntary standards which are detailed in Table 1.1-1 and 1.1-2 of this premarket submission. Assurance of quality was established by employing the following elements of product development: System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. All patient contact materials are biocompatible. Reports for these product development elements are referenced in Attachment 6.

#### Summary of Clinical Tests:

The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence.

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

| Reference No. | Title |
|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI/ISO 10993-1 | ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and<br>testing |
| AAMI/ANSI/ISO 10993-5 | ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In<br>Vitro cytotoxicity |
| AAMI/ANSI/ISO 10993-12 | ISO 10993-12:2007, Biological evaluation of medical devices -- Part 12: Sample<br>preparation and reference materials |

## FDA Consensus Standards

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human figures, one behind the other. The figures are connected by a flowing line that represents the interconnectedness of health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

NOV 1 5 2011

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

Re: K113156

Trade/Device Name: SonoSite Edge TM Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LLZ Dated: October 25, 2011 Received: October 26, 2011

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the SonoSite Edge ™ Ultrasound System, as described in your premarket notification:

## Transducer Model Number

C8x/8-5 MHz C11x/8-5 MHz D2x/2 MHz Dual Element Circular Array C60x/5-2 MHz

HFL38x/13-6 MHz HFL50x/15-6 MHz ICTx/8-5 MHz L25x/13-6 MHz L38xi/10-5 MHz

L38x/10-5 MHz P10x/8-4 MHz P21x/5-1 MHz SLAx/13-6 MHz TEEx/8-3 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 Lauren Hefner at [phone].

Sincerely vours.

Markut O'Keeffe fon

Mary S. Pastel, Sc.D. 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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## Indications for Use Form

KII 3156

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

Device Name: SonoSite Edge™ Ultrasound System

Indications for Use:

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

Division Chief Officer

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

510(k) K113156

Page 1 of 1

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Table 1.3-1 Diagnostic Ultrasound Indications for Use Form – SonoSite Edge™ Ultrasound System

| System: | SonoSite Edge™ Ultrasound System | | | | | | | |
|-------------------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------------|------------------|--|
| Transducer: | N/A | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 | |
| 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.)<br>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<br>Trans-esoph. (non-Card.) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 | |
| Musculo-skel. (Convent.) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 | |
| Musculo-skel. (Superfic.)<br>Intra-luminal<br>Other (spec.) | N | N | N | | N | B+M; B+PWD;<br>B+CD | Note 1 | |
| 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 Edge™ Ultrasound System | | | | | | | |
| Transducer: | C8x/8-5 MHz Transducer | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | | | | | | | |
| | body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| | Color<br>Combined | | | | | Other | | |
| | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) | |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | 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.) | | | | | | | | |

#### Additional Comments:

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(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K113156

{6}------------------------------------------------

## Table 1.3-2 Diagnostic Ultrasound Indications for Use Form – C8x/8-5 Transducer

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

## Additional Comments:

Not in Chier includes color pover Dopler Dopler liste hamonic maging, SonHD Imaging, SondHD inaging, SonolBonning ing maninia,
Close Dopler imaging (TD), inaging to guise Color Doppler includes velocity color Dopler can be combined with any imaging mode. M-Mode includes color M-Mode,

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

Prescription Use (Per 21 CFR 801.109)

Michael D'Okon

Division S Division of Radielegical De Office of In Vitro Diagnostie Device Evaluation and Safety

510K K113156

Page 61 of 3239

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Table 1.3-3 Diagnostic Ultrasound Indications for Use Form – C11x/8-5 Transducer

| System: | SonoSite Edge™ Ultrasound System | | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------------|------------------|--|
| Transducer: | C11x/8-5 MHz Transducer | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the<br>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 | P | P | P | P | P | B+M; B+PWD; B+CWD;<br>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 | B+M; B+PWD; B+CD | Note 1 | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD;<br>B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | | | | | | | | |
| 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;<br>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.) | | | | | | | | |

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

## Additional Comments:

Not 1: Other induces color pover Doper, contine (sea harmoin maging, SondHD imaging, SondHolle conponintaging,
issue bearinging guidance for perineral erre bicc proctures, in Mode includes color M-Mode.

All items marked *P" were previously cleared in 510(k) K071134.

Prescription Use (Per 21 CFR 801.109)

hll D Dth

(Uivision Sign on of Radiological Devices Office of I ice Evaluation and Safety

510K K113156

Page 62 of 3239

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Table 1.3-4 Diagnostic Ultrasound Indications for Use Form – D2x/2 Transducer

| System: | SonoSite Edge™ Ultrasound System |
|---------------|------------------------------------------------------------------------------------|
| Transducer: | D2x/2 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 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 | | | | P | | | |
| Cardiac Pediatric | | | | P | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |

## Additional Comments:

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

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K113156

{9}------------------------------------------------

| Table 1.3-5 Diagnostic Ultrasound Indications for Use Form - C60x/5-2 Transducer | | | | | |
|----------------------------------------------------------------------------------|--|--|--|--|--|
|----------------------------------------------------------------------------------|--|--|--|--|--|

| System: | SonoSite Edge™ Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer: | C60x/5-2 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Fetal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Small Organ (breast, thyroid, testicles, prostate) | | | | | | | |
| 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; B+CD | Note 1 |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Other (spec.) | | | | | | | |

## Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue hamonic imaging, SonoMBMBe compound maging, tissue Dopler imaging (TDI), imaging guidance for procedures, inaging of spinal cord to provide guidance for central neve block procedures, imaging for guidance of biopsy and imaging to assist in he des and catheres in vascular or ther anatonical structures. Color Dopler includes velocity color Doppler. Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.

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

Prescription Use (Per 21 CFR 801.109)

---

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K113/5C.

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

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

# Table 1.3-6 Diagnostic Ultrasound Indications for Use Form – HFL38x/13-6 Transducer

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

#### Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Dopler, tissue hamonic imaging, SonoMBMBe compound imaging, r on one mana o one popily concerner in and brown in and province maging somble content magnic
itsue operimania (TD), maging necessary (negera naging is spiral conter contact velocity color Doppler, Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.

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

Prescription Use (Per 21 CFR 801.109)

---

(Division Sign-Off)

Division of Radiological Devices Office of in Vitro Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety

510K K113/56

Page 65 of 3239

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

| System: | SonoSite Edge™ Ultrasound System | | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|--|
| Transducer: | HFL50x/15-6 MHz Transducer | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | |
| Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | |
| Intra-operative (Neuro.) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | |
| Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD; 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; B+CD | Note 1 | |
| Other (spec.) | | | | | | | | |

Table 1.3-7 Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 Transducer

## Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Dopler, tissue hamonic imaging, SonoHD2 imaging, SonoMBMBe compound imaging, tissue Dopler inaging (TD), imaging guidance for peripheral neve block procedures, imaging of spiral nerve block procedures, imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures. Color Doppler includes velocity color Doppler. Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.

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

Muchel DDK

(Division Sign-O Division of Radiological Devices Office of In Vitro Diagnostic Dev ice Evaluation and Safety

510K K113/56

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

| System: | SonoSite Edge™ Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|---------------|---------------------|------------------|
| Transducer: | ICTx/8-5 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | Combined<br>(Spec.) | Other<br>(Spec.) |
| | B | M | PWD | CWD | Color Doppler | | |
| Ophthalmic | | | | | | | |
| Fetal | P | P | P | | 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 1.3- 8 Diagnostic Ultrasound Indications for Use Form - ICTx/8-5 Transducer

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

## Additional Comments:

Note 1: Other includes color power Doper Doper, itsue hamnir imaging, SonoHD inaging, SonoHD inaging in analminal stuches: Color Doppler includes velocity color Doppler can be combined with any imaging mode. M-Mode indudes color M-Mode.

All items marked "P" were previously cleared in 510{k} K071134.

.(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K113156

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

| System: | SonoSite Edge™ Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer:. | L25x/13-6 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | P | P | | | P | B+M; B+CD | Note 1 |
| Fetal | | | | | | | |
| Abdominal | P | P | | | P | B+M; B+CD | Note 1 |
| Intra-operative (Abdominal organs and<br>vascular) | P | P | | | P | B+M; B+CD | Note 1 |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | | | P | B+M; B+CWD; B+CD | Note 1 |
| Small Organ (breast, thyroid, 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-skel. (Convent.) | P | P | | | P | B+M; B+CD | Note 1 |
| Musculo-skel. (Superfic.) | P | P | | | P | B+M; B+CD | Note 1 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | | | P | B+M; B+CD | Note 1 |
| Other (spec.) | | | | | | | |

Table 1.3- 9 Diagnostic Ultrasound Indications for Use Form – L25x/13-6 Transducer

## Additional Comments:

Note 1: Other induces color power Doppler, combined B and color power Doppler, tissue hamonic imaging, SonoHD2 imaging, SonoMBMBe compound imaging, tissue Doppler imaging (TD), imaging guidanal neve block procedures, imaging for maging to assist it the placent in needes and catheres in vascular or other anatomical structures. Cator Dopler. Color Dopler. Color Dopler can be combined with any inaging mode. M-Mode includes color M-Mode.

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

*(Division Sign Off)*

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K113156

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

| System: | SonoSite Edge™ Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer: | L38xi/10-5 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | N | N | N | | N | B+M; B+PWD; B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | N | N | N | | N | B+M; B+PWD; B+CD | Note 1 |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | N | B+M; B+PWD; B+CD | Note 1 |
| Small Organ (breast, thyroid, testicles. prostate) | N | N | N | | N | B+M; B+PWD; B+CD | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | N | N | N | | N | B+M; B+PWD; B+CD | Note 1 |
| Musculo-skel. (Superfic.) | N | N | N | | N | B+M; B+PWD; B+CD | Note 1 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | |…