TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM

K140524 · Teratech Corp. · IYN · Mar 21, 2014 · Radiology

Device Facts

• Record ID: K140524
• Device Name: TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
• Applicant: Teratech Corp.
• Product Code: IYN · Radiology
• Decision Date: Mar 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) 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, Abdominal, Intra-Operative (abdominal, organs and vascular), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

Device Story

Portable tablet-based ultrasound system (uSmart3200T/BenQ UP200) for real-time diagnostic imaging and fluid flow analysis. System comprises a tablet computer and a proprietary ultrasound engine (housed in a base compartment) that controls transducer acoustic output and processes return echoes. Data transfers via FireWire (IEEE 1394) to the tablet for image generation and display. Operated by physicians in clinical settings. Features include B-mode, M-mode, Color/Power Doppler, and spectral Doppler. Enhanced Needle Visualization (ENV) available on 15L4 transducer. System supports various transducers for diverse clinical exams. Output displayed on 11.5" touch screen; aids clinicians in diagnostic evaluation and needle/catheter guidance. Benefits include portability and high-resolution imaging for point-of-care or clinical use.

Clinical Evidence

Bench testing only. Performance evaluated via acoustic tank testing for new transducers (15L4, 16HL7, 8EC4A) per IEC 60601-2-37. Biocompatibility testing performed per ISO 10993-5 and -10. Electrical safety and EMC compliance verified per IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-6.

Technological Characteristics

Portable tablet (4.9 lbs) with 11.5" touch screen and integrated Li-Polymer battery. Uses custom ultrasound engine for 128-channel transmit/receive. Connectivity via FireWire. Transducers use piezoelectric elements. Patient contact materials include ABS, Silicone, and PEI. Software runs on Windows. Sterilization/reprocessing per AAMI TIR No. 12.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, and peripheral vascular applications. Used by qualified physicians.

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

• Terason uSmart3200T Ultrasound System (K131209)
• Terason™ t3000 Ultrasound System (K112953)
• Terason™ T3200 Ultrasound System (K110020)

Submission Summary (Full Text)

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K140524
Page 1 of 15

### 510(k) Summary or Statement

### Teratech Corporation

### Terason uSmart3200T and BenQ UP200 Ultrasound System

### 1. Sponsor:

Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803

Contact Person: Ben Chiampa Director of Quality Assurance Telephone: [phone]

Date Prepared: February 18, 2014

### 2. Device Name

Terason uSmart3200 and BenQ UP200 Ultrasound System Proprietary Name: Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer

Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550, 90-IYN) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)

### 3. Predicate Device

Terason uSmart3200T Ultrasound System (K131209) Terason™ t3000 Ultrasound System (K112953) Terason™ T3200 Ultrasound System (K110020)

#### 4. Intended Use

The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) 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, Abdominal, Intra-Operative (abdominal, organs and vascular), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

### 5. Device Description

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The Terason uSmart3200T ultrasound system is a portable tablet style full feature, general purpose, and diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The Terason uSmart3200T Ultrasound System is equivalent to the previously cleared version of the uSmart3200T Ultrasound Systems. The modification includes the addition of 3 transducers (15L4, 16HL7, and 8EC4A) with the no change to tablet style computer form factor.

The Terason™ uSmart3200T ultrasound system was the previously cleared on the date of May 28, 2013 as described in the 510(k) submission (K131209). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. This data are then transferred to the tablet computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.

The Terason™ uSmart3200T ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11.5" backlit touch screen. The tablet dimensions (8.82"(H) x 12.64"(W) x 1.25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medicalgrade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the uSmart3200T. Optional accessories include a cart and printer.

### 6. Technology Characteristics

The design and construction of the Terason uSmart3200T is same to the Terason uSmart3200T Ultrasound system which was cleared in May 2013. These systems utilize a portable computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the tablet computer.

The uSmart3200T system contains the same ultrasound engine as the predicate device Terason T3200 ultrasound system for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet computer over a FireWire connection for further processing and generation and display of the ultrasound image

The differences between the Terason uSmart3200T and the previous Terason uSmart3200T Ultrasound System (the predicate device) include the following:

- Three transducers have been added to the system. The software has been modified to . control these transducers and ensure compliance to the standards controlling acoustic and thermal power.
- . Added support for 15L4, 16HL7 and 8EC4A transducers
- Confirmed transducer id numbers and names O
- Confirmed transducer geometries and characteristic parameters o
- o Confirmed 15L4 and 16HL7 acoustic tables and added 8EC4A acoustic tables
- Added 15L4, 16HL7 and 8EC4A to the table of allowed transducers o
- Added imaging presets for 15L4, 16HL7 and 8EC4A with o
- Musculoskeletal selections same as offered on Terason t3200 B
- . 8EC4A gynecological and prostate exams
- l 15L4 same exam and preset selections as 12L5A
- l Vascular exams and presets for 15L4 and 16HL7

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- Added the Vascular Application series with new exam license files .
- Added exam license files for gynecological and prostate exam types .
- . Added the Enhanced Needle Visualization (ENV) feature as a licensed option, available only on the 15L4 transducer
- . Added UI feature to optionally swap position of the Control Panel Area and the Thumbnail Area on the screen, left vs. right
- Removed TGC Display from the General tab of Setup .
- Added System Backup and Restore, initiated from the General tab of Setup ●
- Added Gesture options to the General tab of Setup .
- o Disable All Gestures
- Enable Double Tap Gesture o
- ECG options disable on General Tab of Setup .
- Added measurement configurations for Spectral Doppler and M-mode. .
- Added vessel name to the measurement configuration .
- . Added feature to modify user annotations
- In the Store/Acquire tab of Setup, added feature to enable retrospective acquisition of the . live image stream
- . Disabled selection of ECG related features on the Store/Acquire tab of Setup
- . Added DICOM communication option and features, Storage and Modality Worklist
- . Changed designation of Clinician to Operator on the Patient screen
- Added selection checkboxes to multiple selection list controls .
- . Added touch gestures for multiple selection in list controls
- Added touch gestures for freeze, play/pause, zoom and pan, depth, steering, split-� screen, spectral Doppler scale and baseline, color Doppler scale, review navigation, full screen, text and body markers
- . Added variable sector size and position for the 4V2A transducer
- Minor updates to soft key menus .
- Modified 12L5A Musculoskeletal presets to be the same selections as offered on the . Terason t3200
- . Added Musculoskeletal, Breast, Thyroid and Vascular Access exam measurements and annotations, same as offered on Terason t3200.
- 7. Table of Similarities and Differences Compared to the Predicate Devices

Terason uSmart3200T System and Transducers Comparison and Discussion (Transducers 8EC4A, 16HL7, and 15L4) and previously cleared 510(k) K131209 transducers (12L5A, 5C2A, and 4V2A)

### Terason uSmart3200T Tablet Computer

| Subject Device Model | Comparable Predicate<br>Device | Comparable Predicate<br>Devices |
|----------------------|---------------------------------|---------------------------------|
| Terason uSmart3200T | Terason uSmart3200T<br>K1301209 | Terason t3000<br>K112953 |
| (This Submission) | | |

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| Intended Use | Diagnostic Ultrasound | Diagnostic Ultrasound | Diagnostic Ultrasound |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | imaging or fluid flow | imaging or fluid flow | imaging or fluid flow |
| | analysis of the human | analysis of the human | analysis of the human |
| | body | body | body |
| Indication for Use | Fetal, Abdominal, Intra-<br>operative (Spec.),<br>Pediatric, Small Organ<br>(Thyroid, Breast, Testes,<br>etc.), Neonatal Cephalic,<br>Adult Cephalic, Trans-<br>rectal, Trans-vaginal,<br>Musculo-skel.<br>(Convent.), Musculo-<br>skel. (Superfic), Cardiac<br>Adult, Cardiac Pediatric,<br>Peripheral vessel | Fetal, Abdominal,<br>Pediatric, Small Organ<br>(Thyroid, Breast, Testes,<br>etc.), Neonatal Cephalic,<br>Adult Cephalic, Musculo-<br>skel. (Convent.),<br>Musculo-skel. (Superfic),<br>Cardiac Adult, Cardiac<br>Pediatric, Peripheral<br>vessel | Fetal, Abdominal, Intra-<br>operative (Spec.), Intra-<br>operative (Neuro),<br>Laparoscopic, Pediatric,<br>Small Organ (Thyroid,<br>Breast, Testes, etc.),<br>Neonatal Cephalic,<br>Adult Cephalic, Trans-<br>rectal, Trans-vaginal,<br>Musculo-skel.<br>(Convent.), Musculo-<br>skel. (Superficial),<br>Cardiac Adult, Cardiac<br>Pediatric, Peripheral<br>vessel |
| Transducer Types | Linear Array<br>Curved Array<br>Phased Array<br>Endocavity - curved<br>array<br>Hockey Stick - Linear | Linear Array<br>Curved Array<br>Phased Array<br>Endocavity - curved<br>array | Linear Array<br>Curved Array<br>Phased Array<br>Endocavity - curved<br>array<br>Hockey Stick - Linear<br>Bi-plane -Linear/curved |
| Acoustic Output and | Display Features for | Display Features for | Display Features for |
| FDA Limits | High Outputs | High Outputs | High Outputs |
| Global Maximum<br>Outputs/Worst Case<br>Setting | ISPTA3: 652.9 mW/cm²<br>(4V2A)<br>TI Type: TIC (15L4)<br>TI Value: 5.8 (15L4)<br>MI: 1.78 (8EC4A)<br>IPA3@MI Max: 1029<br>W/cm² (15L4) | ISPTA.3: 652.9 mW/cm²<br>(4V2A)<br>TI Type: TIB (4V2A)<br>TI Value: 5.6 (4V2A)<br>MI: 1.74 (4V2A)<br>IPA3@MI Max: 350.3<br>W/cm² (4V2A) | ISPTA.3: 678.1 mW/cm²<br>(12HL7)<br>TI Type: TIB (4V2A)<br>TI Value: 5.6 (4V2A)<br>MI: 1.5 (4V2A)<br>IPA3@MI Max: 227.3<br>W/cm² (4V2A) |
| Modes of Operation | B-Mode Grayscale | B-Mode Grayscale | B-Mode Grayscale |
| | Imaging | Imaging | Imaging |
| | Tissue Harmonic | Tissue Harmonic | Tissue Harmonic |
| | Imaging | Imaging | Imaging |
| | M-Mode (motion) | M-Mode (motion) | M-Mode (motion) |
| | Anatomical M-Mode | Anatomical M-Mode | Anatomical M-Mode |
| | Color M-Mode | Color M-Mode | Color M-Mode |
| | Color Power Doppler | Color Power Doppler | Color Power Doppler |
| | Velocity Color Doppler | Velocity Color Doppler | Velocity Color Doppler |
| | Duplex/Triplex - Doppler | Duplex/Triplex - Doppler | Duplex/Triplex - |
| | imaging | imaging | Doppler imaging |
| | Pulsed Wave (PW) | Pulsed Wave (PW) | Pulsed Wave (PW) |
| | Doppler | Doppler | Doppler |
| | TeraVision II | TeraVision II | TeraVision I |

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| | Postprocessing | Postprocessing | Postprocessing |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PW Doppler | Available for all<br>transducers<br>Triplex Mode<br>B-Mode and PW<br>Doppler<br>High PRF | Available for all<br>transducers<br>Triplex Mode<br>B-Mode and PW<br>Doppler<br>High PRF | Available for all<br>transducers<br>Triplex Mode<br>B-Mode and PW<br>Doppler<br>High PRF |
| Transducer Frequency | 2.0 - 15.0 MHz | 2.0 - 15.0 MHz | 2.0 - 10.0 MHz |
| #Transmit Channels | 128 Channels | 128 Channels | 128 Channels |
| # Receive Channels | 128 Channels | 128 Channels | 128 Channels |
| Acoustic Output<br>Measurement Standard | NEMA UD 2-2004<br>NEMA UD 3-2004 | NEMA UD 2-2004<br>NEMA UD 3-2004 | NEMA UD 2-2004<br>NEMA UD 3-2004 |
| DICOM | DICOM 3.0 Structured<br>Reporting, Worklist -<br>Image Viewer | DICOM 3.0 Structured<br>Reporting, Worklist -<br>Image Viewer | DICOM 3.0 Worklist -<br>Image Viewer |
| Product Safety<br>Certification | IEC60601-1<br>IEC60601-1-2<br>IEC60601-1-6<br>IEC60601-2-37 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-1-6<br>IEC60601-2-37 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-1-4<br>IEC60601-2-37 |
| EMC | IEC60601-1-2<br>CISPR11 Class B | IEC60601-1-2<br>CISPR11 Class B | IEC60601-1-2<br>CISPR11 Class B |
| System<br>Characteristics | uSmart3200T:<br>tablet computer<br>weighs 4.9 lbs (2.21 Kg)<br>11.5" backlit touch<br>screen.<br>Tablet dimensions<br>(8.82"(H) x 12.64"(W) x<br>1.25"(D)).<br>A Lithium-Polymer<br>battery (integrated into<br>the tablet) provides 2<br>hours of continuous<br>ultrasound scanning<br>Docking station (for<br>charging) that uses a<br>medical-grade power<br>supply<br>Data transferred to the<br>tablet computer over a<br>FireWire (aka IEEE<br>1394) | uSmart3200T:<br>tablet computer<br>weighs 4.9 lbs (2.21 Kg)<br>11.5" backlit touch<br>screen.<br>Tablet dimensions<br>(8.82"(H) x 12.64"(W) x<br>1.25"(D)).<br>A Lithium-Polymer<br>battery (integrated into<br>the tablet) provides 2<br>hours of continuous<br>ultrasound scanning<br>Docking station (for<br>charging) that uses a<br>medical-grade power<br>supply<br>Data transferred to the<br>tablet computer over a<br>FireWire (aka IEEE<br>1394) | Terason T3000:<br>Laptop Computer<br>weighs: 8.0 pounds (3.6<br>kg), LED backlit display<br>and keyboard, Laptop<br>dimensions (H): 2.5",<br>(W): 13.8", (D): 11.0"<br>A Lithium-Polymer<br>battery, (integrated into<br>the Laptop) provides 2<br>hours of continuous<br>ultrasound scanning.<br>Uses a medical-grade<br>power supply<br>Data transferred to the<br>laptop computer over a<br>FireWire (aka IEEE<br>1394) |

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There are no hardware design changes to the system (ultrasound engine and tablet computer). The hardware design released at the time original submission (K131209) already had all the necessary functions and features to support the changes in software and the additional 3 transducers. The hardware revisions of the ultrasound engine and tablet computer remain unchanged.

## 8EC4A Transducer

| Key Features | Subject Device Model<br>Terason 8EC4A<br>Transducer | Comparable<br>Predicate Device<br>Terason 8EC4A<br>Transducer | Same or Different |
|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K112953 | n/a |
| Indications for Use | The transducer is<br>intended to be used<br>with a conventional<br>ultrasound system<br>(Terason uSmart3200T)<br>to image trans-rectal<br>and trans-vaginal. | The transducer is<br>intended to be used<br>with a conventional<br>ultrasound system<br>(Terason t3000) to<br>image trans-rectal and<br>trans-vaginal. | Same. The proposed<br>transducer and the<br>predicate transducer<br>have the identical claim<br>of imaging similar<br>regions in the human<br>body. |
| Acoustic Array<br>Technology: | Piezoelectric elements | Piezoelectric elements | Same.<br>Effectiveness: Both<br>arrays allow focused<br> |
| Acoustic Array Style: | Endocavity Curved<br>Array | Endocavity Curved<br>Array | transmission and<br>reception of ultrasound<br>energy to enhance<br>image quality within the<br>region of interest. |
| Acoustic Array<br>Characteristics:<br>Element count...<br>Center frequency...<br>Element size (pitch x<br>elevation)...<br>Elevation focus... | 128<br>6.5<br>0.205mm X 5.0mm<br>30mm | 128<br>6.5<br>0.205mm X 5.0mm<br>30mm | Same: element count.<br>Acoustic characteristics<br>have met safety<br>guidelines of IEC60601-<br>2-37. Safety and<br>effectiveness<br>unchanged from<br>predicate. |
| Acoustic Array | The transducer imaging<br>performance has been<br>evaluated in an acoustic<br>tank. | The transducer<br>performance has been<br>evaluated in the<br>previous 510(k) filing<br>(K112953). | Same; The 8EC4A uses<br>a same acoustic array<br>as the predicate device<br>and therefore has same<br>acoustic characteristics.<br>To ensure proper safety<br>guidelines are met,<br>acoustic testing was<br>performed per the<br>IEC60601-2-37 |

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| Patient Contact<br>Material | ABS Silicone 747 | ABS Silicone 747 | Same |
|-----------------------------|------------------|------------------|------|
| | | | |

## Discussion:

The 8EC4A uses a same acoustic array as the predicate device and therefore has same acoustic characteristics. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard.

The 8EC4A consists of same patient contact material as the predicate device. To ensure proper safety guidelines are met, biocompatibility tests were run on the patient contact materials

### Transducer 16HL7

| Key Features | Subject Device Model<br>Terason 16HL7<br>Transducer | Comparable Predicate<br>Device<br>Terason 16HL7<br>Transducer | Same or Different |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K110020 | n/a |
| Indications for Use | The transducer is<br>intended to be used with<br>a conventional<br>ultrasound system<br>(Terason uSmart3200T)<br>to image intra-operative,<br>small parts, muskulo-<br>skel and peripheral<br>vascular regions. | The transducer is<br>intended to be used<br>with a conventional<br>ultrasound system<br>(Terason t3200) to<br>image intra-operative,<br>small parts, muskulo-<br>skel and peripheral<br>vascular regions. | Same. The proposed<br>transducer and the<br>predicate transducer<br>have the identical<br>claim of imaging<br>similar regions in the<br>human body. |
| Acoustic Array<br>Technology | Piezoelectric elements | Piezoelectric elements | Same |
| Transducer Style | Hockey-Stick Linear<br>Array | Hockey-Stick Linear<br>Array | Same. |
| Acoustic Array<br>Characteristics:<br>Element count...<br>Center frequency...<br>Element size (pitch x<br>elevation)...<br>Elevation focus... | 128<br>9.2 MHz<br>0.2mm X 3.5mm<br>12mm | 128<br>9.2 MHz<br>0.2mm X 3.5mm<br>12mm | Same. |
| Acoustic Output and<br>Device Settings | The transducer imaging<br>performance has been<br>evaluated in an acoustic<br>tank. | The transducer<br>performance has been<br>evaluated in the<br>previous 510(k) filing<br>(K110020) | Same. |

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| Patient Contact<br>Material | Silicone PEI | Silicone PEI | Same. |
|-----------------------------|--------------|--------------|-------|

### Discussion:

There are no differences between this device and the predicate device used in this comparison. The transducer has been added to the uSmart3200T Ultrasound system.

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 16HL7 transducer is substantially equivalent to the Terason 16HL7 transducer (K110020) with respect to safety and effectiveness.

### 15L4 Transducer

| Key Features | Subject Device Model<br>Terason 15L4<br>Transducer | Comparable<br>Predicate Device<br>Terason 15L4<br>Transducer | Same or Different |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K140524 | K110020 | n/a |
| Classification | ITX | ITX | Same |
| Indications for Use | The transducer is<br>intended to be used<br>with a conventional<br>ultrasound system<br>(Terason<br>uSmart3200T) to image<br>abdomen, small parts,<br>musculo-skel and<br>peripheral vascular<br>regions. | The transducer is<br>intended to be used<br>with a conventional<br>ultrasound system<br>(Terason T3200) to<br>image abdomen, small<br>parts, musculo-skel<br>and peripheral<br>vascular regions. | Same: The proposed<br>transducer and the<br>predicate transducer<br>have the identical claim<br>of imaging similar<br>regions in the human<br>body. |
| Acoustic Array<br>Technology: | Piezoelectric elements | Piezoelectric elements | Same: Safety<br>requirements of<br>IEC60601 are equally<br>met.<br>Effectiveness: Both<br>arrays allow focused<br>transmission and<br>reception of ultrasound<br>energy to enhance<br>image quality within the<br>region of interest. |
| Acoustic Array Style: | Linear Array | Linear Array | |

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| Acoustic Array<br>Characteristics:<br>Element count...<br>Center frequency...<br>Element size (pitch x<br>elevation)...<br>Elevation focus... | 128 elements<br>7.5 MHz<br>0.3mm X 4.0mm<br>20mm | 128 elements<br>7.5 MHz<br>0.3mm X 4.0mm<br>20mm | Same: element count.<br>Acoustic characteristics<br>have met safety<br>guidelines of IEC60601-<br>2-37. |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acoustic Output and<br>Device Settings | The transducer imaging<br>performance has been<br>evaluated in an<br>acoustic tank. | The transducer<br>performance has been<br>evaluated in the<br>previous 510(k) filing<br>(K110020). | Same; acoustic output<br>safety guidelines. Safety<br>is not compromised.<br>Effectiveness equal. |
| Patient Contact Material | The transducer uses<br>Silicone SIM R1001 as<br>a contact material. | The transducer uses<br>Silicone SIM R1001 as<br>a contact material. | Same. The 15L4<br>transducer consists of<br>same patient contact<br>materials as the<br>predicate device. The<br>safety of each device<br>with respect to<br>biocompatibility is<br>equivalent. |

### Discussion:

The 15L4 uses a same acoustic array than the predicate device and therefore has same acoustic characteristics. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard.

The 15L4 transducer consists of same patient contact materials as the predicate device.

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 15L4 transducer is substantially equivalent to the Terason 15L4 transducer (K110020) with respect to safety and effectiveness.

### Transducers previously cleared in submission K131209

### 12L5A Transducer

| Key Features | Subject Device Model | Comparable Predicate<br>Device | Same or Different |
|--------------|----------------------|--------------------------------|-------------------|
| | Terason 12L5A | Terason 12L5A | |

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| | Transducer | Transducer | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification | ITX | ITX | Same |
| 510(k) Number | KXXXXXX | K131209 | n/a |
| Indications for<br>Use | The transducer is intended<br>to be used with a<br>conventional ultrasound<br>system (Terason<br>uSmart3200T) to image<br>Fetal, Abdominal,<br>Pediatric, Small Organ,<br>Cephalic, Musculo-skel,<br>Cardiac and Peripheral<br>vessel. | The transducer is intended<br>to be used with a<br>conventional ultrasound<br>system (Terason<br>uSmart3200T) to image<br>Fetal, Abdominal,<br>Pediatric, Small Organ,<br>Cephalic, Musculo-skel,<br>Cardiac, and Peripheral<br>vessel. | Same. The proposed<br>transducer and the<br>predicate transducer have<br>the identical claim of<br>imaging similar regions in<br>the human body. |
| Acoustic Array<br>Technology: | Piezoelectric elements | Piezoelectric elements | Same. |
| Acoustic Array<br>Style: | Linear Array | Linear Array | Regarding Safety: Both<br>arrays allow focused<br>transmission and<br>reception of ultrasound<br>energy to enhance image<br>quality within the region of<br>interest. |
| Acoustic Array<br>Characteristics: | | | Same in elevation<br>Safety and effectiveness<br>unchanged from predicate |
| Element count... | 128 | 128 | |
| Center<br>frequency... | 7.5 | 7.5 | |
| Element size<br>(pitch x<br>elevation)... | 0.3mm X 4.0mm | 0.3mm X 4.0mm | |
| Elevation<br>focus... | 19mm | 19mm | |
| Acoustic Array | The transducer imaging<br>performance has been<br>evaluated in an acoustic<br>tank. | The transducer<br>performance has been<br>evaluated in the previous<br>510(k) filing (K131209). | Same. As the predicate<br>device and therefore has<br>same acoustic<br>characteristics. To ensure<br>proper safety guidelines<br>are met, acoustic testing |
| | | | was performed per the<br>IEC60601-2-37 standard. |
| Patient Contact<br>Material | Silicone ABS | Silicone ABS | Same. The 12L5A<br>transducer consists of<br>same patient contact<br>materials as the predicate<br>device. |

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

## 5C2A Transducers

| Key Features | Subject Device Model | Comparable<br>Predicate Device | Same or Different |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same…