The Teratech Corporation Terason™ uSmart3400 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, Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular.

Device Description

The Terason™ uSmart3400 ultrasound system is a portable, full-featured ultrasound system used to acquire and display high-resolution, real-time ultrasound data using multiple image modes. This system contains a proprietary ultrasound engine (identical to 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 host singleboard computer (previously laptop computer) over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image. Three transducers (15L4, 5C2A, 4V2A) connect to the system using the identical connector to the predicate device, Terason t3200.

The Terason™ uSmart3400 ultrasound EBook weighs 14.6 pounds and has a 15.3" backlit screen. The system dimensions (3.5"(H) x 15.3"(W) x 15.6"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the EBook) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for charging). The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the t3200. Optional accessories include a cart and printer.

AI/ML Overview

The provided information describes a 510(k) summary for the Terason™ uSmart3400 Ultrasound System, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing the new device to existing cleared devices rather than providing detailed clinical study results with specific performance metrics against defined acceptance criteria in the manner one might find for a novel AI-powered diagnostic device.

Therefore, the following information is extracted and presented based on the context of this 510(k) summary. Acceptance criteria and performance are primarily discussed in terms of substantial equivalence to predicate devices through technical comparisons and compliance with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are compliance with established medical device standards and demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness. The "reported device performance" is essentially the comparison of the uSmart3400 and its transducers against the predicate devices across various technical and functional aspects.

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance / Comparison to Predicate	Result
Intended Use	Identical or equivalent intended use.	System: "general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body." - Matches predicate device's general intended use, though specific applications list varies slightly between predicates (K110020, K112953).Transducers (15L4, 5C2A, 4V2A): "identical claims of imaging similar regions in the human body" compared to their previously cleared versions.	Met
Indications for Use	Substantially equivalent clinical applications.	System: Fetal, Abdominal, Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular. This list is a subset of a predicate (K110020) and overlaps significantly with another (K112953).Transducers: Each transducer (15L4, 5C2A, 4V2A) maintains the identical indications for use as its previously cleared version.	Met
Technology Characteristics	Equivalent core technology, or changes do not raise new safety/effectiveness concerns.	Engine: Identical proprietary ultrasound engine to predicate Terason t3200, including beamformer chip. Connectors are identical.Software: Modified for improved user workflow and ease of use, considered "commensurate with a diagnostic medical ultrasound application."Main Chassis: Replaces laptop computer in predicates, housing engine. Different form factor, weight, and display size but ultrasound engine, communication protocol, and hours of continuous operation are same.Transducers: 15L4, 5C2A, 4V2A are stated to use the "same acoustic array" and "same patient contact materials" as their predicate versions.	Met
Acoustic Output	Compliance with acoustic output standards (NEMA UD 2 & 3, IEC 60601-2-37). Safety limits are not exceeded or are equivalent.	Global Maximum Outputs for the 15L4 transducer are given and compared to predicate 15L4. Values are similar (e.g., ISPTA.3: 618.4 mW/cm² vs 562.1 mW/cm²; MI: 1.75 vs 1.70). Acoustic output testing per IEC60601-2-37 was performed for all transducers.	Met
Modes of Operation	Equivalent imaging modes.	Terason uSmart3400 supports B-Mode, Tissue Harmonic, Anatomical M-Mode, Color M-Mode, Color Power Doppler, Velocity Color Doppler, Duplex/Triplex - Doppler imaging, Pulsed Wave (PW) Doppler, and TeraVision II Postprocessing. This set of modes is either identical or a subset of the predicate devices.	Met
Product Safety	Compliance with relevant electrical and medical device safety standards.	Compliance achieved for: IEC60601-1, IEC60601-1-2, IEC60601-1-6, IEC60601-2-37.	Met
Electromagnetic Compatibility (EMC)	Compliance with EMC standards.	CISPR11 Class B. Tested per IEC60601-1-2.	Met
Biocompatibility	Patient contact materials are biocompatible and equivalent.	All transducers use same patient contact materials as their predicate versions (e.g., Silicone SIM R1001 for 15L4, Silicone ABS for 5C2A, Silicone Valox for 4V2A). Biocompatibility tests (ISO 10993 Part 5 and Part 10) were performed.	Met
Quality Systems	Manufactured under Good Manufacturing Practices (GMPs) and ISO-13485 quality systems.	Stated compliance with FDA GMPs and ISO-13485.	Met

Study Details:

Detailed analysis of "studies" within the context of this 510(k) summary:

It's crucial to understand that a 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, rather than conducting new, large-scale clinical trials that would define novel acceptance criteria and extensive performance metrics. The "studies" referenced are conformity assessments against recognized standards and technical comparisons.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of clinical performance evaluation studies for this 510(k). The "testing" involves technical compliance to standards and comparison of specifications.
Data Provenance: The data primarily comes from bench testing, engineering analysis, and comparisons to specifications of previously cleared devices.
- Acoustic output testing was performed per IEC60601-2-37.
- Biocompatibility testing per ISO 10993 Parts 5 and 10.
- Electrical and EMC testing per IEC 60601 series and CISPR11.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The ground truth here is the adherence to recognized medical device standards and the established safety and performance characteristics of the predicate devices. Experts involved would be engineers, regulatory specialists, and standard body members who define these compliance requirements, not clinical experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable. There is no clinical test set requiring adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is typically conducted for AI-powered diagnostic devices to assess the comparative performance of human readers with and without AI assistance. This 510(k) is for a conventional ultrasound system and does not involve AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This is not an AI algorithm.

7. Type of Ground Truth Used:

Engineering and Regulatory Standards (e.g., IEC 60601 series, NEMA UD series, ISO 10993, CISPR11): These standards define the "ground truth" for safety, electrical performance, acoustic output, and biocompatibility.
Predicate Device Specifications and Performance: The performance and safety of the previously cleared predicate devices serve as the benchmark for "ground truth" for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This is not an AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

{0}------------------------------------------------

510(k) Summary

APR 2 5 2014

4140834

Teratech Corporation

Terason™ uSmart3400 Ultrasound System

1. Sponsor:

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

Contact Person: Ben Chiampa, Quality Assurance and Regulatory Affairs Telephone: 781-270-4143

March 21, 2014 Date Prepared:

2. Device Name

Terason™ uSmart3400 Ultrasound System Proprietary Name: Common / Usual Name: Diagnostic Ultrasound System Diagnostic Ultrasound Transducer Classification Name:

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 Devices

Terason™ t3200 Ultrasound System (K110020) Terason T3000 Ultrasound System with Needle Guidance (K112953).

4. Intended Use

{1}------------------------------------------------

(thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular.

5. Device Description

6. Technology Characteristics

The design and construction of the Terason™ uSmart3400 is similar to the Terason™ t3200 and Terason™ t3000 systems. These systems utilize a laptop computer running Windows 7 to execute the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. For the uSmart3400, the engine is housed in a compartment that is attached to the base of the single-board computer.

The similarity and difference between the Terason™ uSmart3400 and the Terason t3200 Ultrasound System (the predicate device) include the following:

The engines are the identical with no modification in the custom . beamformer chip that provides for improved filtering of the return signal for wider bandwidth and better resolution across the entire image field. The engine connector to the transducers is identical to predicate device t3200.

{2}------------------------------------------------

The ultrasound application software has been modified to improve the . user workflow and ease of use commensurate with a diagnostic medical ultrasound application.
The main chassis, containing the single-board computer, replaces the . laptop computer in the predicate t3200 and t3000 devices.

Transducers: The Terason uSmart3400 will support 3 transducers. These transducers have been previously cleared.

15L4: Cleared in 510k submission K110020 (January 20, 2011) .
5C2A: Cleared in 510k submission K112953 (February 3, 2012) .
4V2A: Cleared in 510k submission K112953 (February 3, 2012). .

The following provides additional details of the three transducers, presented in this submission, that were previously cleared.

15L4: equivalent indications for use, frequency settings, shape of transducer . head and needle guide/software brackets. Same manufacturer, same acoustic array and patient contact materials.
5C2A: equivalent indications for use, frequency settings, and needle guide . bracket / software. Same manufacturer, same shape, same acoustic array and patient contact materials.
4V2A: equivalent indications for use, frequency settings, and needle guide . bracket / software. Same manufacturer, same shape, same acoustic array and patient contact materials.

{3}------------------------------------------------

7. Table of Similarities and Differences Compared to the Predicate Devices

Terason uSmart3400 System and Transducers Comparison and Discussion Previously cleared 510(k) transducers 15L4 (K110020) and 5C2A, 4V2A (K112953)

Terason uSmart3400

	Subject Device Model	Comparable Predicate Device	Comparable Predicate Devices
	Terason uSmart3400	Terason t3200	Terason t3000
	(This Submission)	(K110020)	(K112953)
Intended Use	Diagnostic Ultrasoundimaging or fluid flow analysisof the human body	Diagnostic Ultrasoundimaging or fluid flow analysisof the human body	Diagnostic Ultrasoundimaging or fluid flow analysisof the human body
Indication for Use	Fetal, Abdominal, Pediatric,Small Organ (Thyroid, Breast,Testes), Neonatal Cephalic,Adult Cephalic, Musculo-skeleltal (Convent.), Musculo-skeletal (Superfic.), CardiacAdult, Cardiac Pediatric,Peripheral vessel	Fetal, Abdominal, Intra-operative (abdominal,thoracic and PV),Laparoscopic, Pediatric, SmallOrgan (Thyroid, Breast,Testes), Neonatal and AdultCephalic, Trans-rectal andTrans-vaginal, Musculo-skel.(Convent.), Musculo-skel.(Superfic), Cardiac Adult,Cardiac Pediatric, Peripheralvessel	Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro),Laparoscopic, Pediatric,Small Organ (Thyroid, Breast,Testes, etc.), NeonatalCephalic, Adult Cephalic,Trans-rectal, Trans-vaginal,Musculo-skel. (Convent.),Musculo-skel. (Superficial),Cardiac Adult, CardiacPediatric, Peripheral vessel
Transducer Types	Linear ArrayCurved ArrayPhased Array	Linear ArrayCurved Array	Linear ArrayCurved ArrayPhased ArrayEndocavity - curved arrayHockey Stick - LinearBi-plane -Linear/curved
Acoustic Output and FDALimits	Display Features for HighOutputs	Display Features for HighOutputs	Display Features for HighOutputs
Global MaximumOutputs/Worst Case Setting	ISPTA.3: 618.4 mW/cm² (15L4)TI Type: TIC (15L4)TI Value: 5.29 (15L4)MI: 1.75 (15L4)IPA.3@MI Max: 970.6 W/cm²(15L4)	ISPTA.3: 562.1 mW/cm² (15L4)TI Type: TIC (15L4)TI Value: 5.80 (15L4)MI: 1.70 (15L4)IPA.3@MI Max: 1029 W/cm²(15L4)	ISPTA.3: 678.1 mW/cm²(12HL7)TI Type: TIB (4V2A)TI Value: 5.6 (4V2A)MI: 1.5 (4V2A)IPA.3@Mi Max: 227.3 W/cm²(4V2A)
Modes of Operation	B-Mode Grayscale ImagingTissue Harmonic Imaging	B-Mode Grayscale ImagingTissue Harmonic Imaging	B-Mode Grayscale ImagingTissue Harmonic ImagingM.Mode (motion)
	Anatomical M-ModeColor M-ModeColor Power DopplerVelocity Color DopplerDuplex/Triplex - DopplerimagingPulsed Wave (PW) DopplerTeraVision II Postprocessing	Anatomical M-ModeColor M-ModeColor Power DopplerVelocity Color DopplerDuplex/Triplex - DopplerimagingPulsed Wave (PW) DopplerTeraVision II Postprocessing	Anatomical M-ModeColor M-ModeColor Power DopplerVelocity Color DopplerDuplex/Triplex - DopplerimagingPulsed Wave (PW) DopplerTeraVision Postprocessing
PW Doppler	Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF	Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF	Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF
Transducer Frequency	2.0 - 15.0 MHz	2.0 - 11.0 MHz	2.0 - 10.0 MHz
#Transmit Channels	128 Channels	128 Channels	128 Channels
# Receive Channels	128 Channels	128 Channels	128 Channels
Acoustic OutputMeasurement Standard	NEMA UD 2-2004NEMA UD 3-2004	NEMA UD 2-2004NEMA UD 3-2004	NEMA UD 2-2004NEMA UD 3-2004
DICOM	DICOM 3.0 StructuredReporting, Worklist - ImageViewer	DICOM 3.0 StructuredReporting, Worklist - ImageViewer	DICOM 3.0 Worklist - ImageViewer
Product Safety Certification	IEC60601-1IEC60601-1-2IEC60601-1-6IEC60601-2-37IEC60601-1-2	IEC60601-1IEC60601-1-2IEC60601-1-6IEC60601-2-37IEC60601-1-2	IEC60601-1IEC60601-1-2IEC60601-1-4IEC60601-2-37IEC60601-1-2
EMC	CISPR11 Class B	CISPR11 Class B	CISPR11 Class B
SystemCharacteristics	uSmart3400:With integrated single-boardcomputer weighs 14.6 pounds(6.62 Kg) 15.3" backlit screen.System dimensions (3.5"(H) x15.29"(W) x 15.58"(D)).A Lithium-Polymer battery(integrated into the tablet)provides 2 hours ofcontinuous ultrasoundscanning. Uses a medical-grade power supplyData transferred to the tabletcomputer over a FireWire(aka IEEE 1394)	T3200:Laptop Computer and consoleweighs 10.5 pounds (4.8 Kg)11.5" LED backlit display andkeyboard. System dimensions(2.25"(H) x 14.35"(W) x9.82"(D)).A Lithium-Polymer battery(integrated into the Laptop)provides 2 hours ofcontinuous ultrasoundscanning. Uses a medical-grade power supplyData transferred to the tabletcomputer over a FireWire(aka IEEE 1394)	Terason T3000:Laptop Computerweighs: 8.0 pounds (3.6 kg),LED backlit display andkeyboard. Laptopdimensions (H): 2.5", (W):13.8", (D): 11.0"A Lithium-Polymer battery,(integrated into the Laptop)provides 2 hours ofcontinuous ultrasoundscanning. Uses a medical-grade power supplyData transferred to thelaptop computer over aFireWire (aka IEEE 1394)

{4}------------------------------------------------

{5}------------------------------------------------

15L4 Transducer

15L4 Transducer
Key Features	Subject Device ModelTerason 15L4Transducer	Comparable PredicateDeviceTerason 15L4Transducer	Same or Different
510(k) Number	K1XXXXXX	K110020	n/a
Classification	ITX	ITX	Same
Indications for Use	The transducer isintended to be usedwith a conventionalultrasound system(Terason uSmart3400)to image abdomen,small parts, musculo-skel and peripheralvascular regions.	The transducer isintended to be usedwith a conventionalultrasound system(Terason t3200) toimage abdomen, smallparts, musculo-skeland peripheralvascular regions.	Same: The proposedtransducer and thepredicate transducerhave the identical claimof imaging similarregions in the humanbody.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same: Safetyrequirements ofIEC60601 are equallymet.Effectiveness: Botharrays allow focusedtransmission andreception of ultrasoundenergy to enhanceimage quality within theregion of interest.
Acoustic Array Style:	Linear Array	Linear Array	Same: element count.Acoustic characteristicshave met safetyguidelines of IEC60601-2-37.
Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...Elevation focus...	128 elements7.5 MHz0.3mm X 4.0mm20mm	128 elements7.5 MHz0.3mm X 4.0mm20mm
Acoustic Output andDevice Settings	Per acoustic outputtesting.	The transducerperformance has beenevaluated in theprevious 510(k) filing	Same; acoustic outputsafety guidelines. Safetyis not compromised.Effectiveness equal.
		(K110020).
Patient Contact Material	The transducer usesSilicone SIM R1001 as acontact material.	The transducer usesSilicone SIM R1001 as acontact material.	Same. The 15L4transducer consists ofsame patient contactmaterials as thepredicate device. Thesafety of each devicewith respect tobiocompatibility isequivalent.

. .

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

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.

5C2A Transducers

Key Features	Subject Device Model	Comparable PredicateDevice	Same or Different
	Terason 5C2ATransducer	Terason 5C2ATransducer
Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXXX	K112953	n/a
Indications for Use	The transducer isintended to be usedwith a conventionalultrasound system(Terason uSmart3400)to image Fetal,	The transducer isintended to be usedwith a conventionalultrasound system(Terason t3000) toimage Fetal,	Same. The proposedtransducer and thepredicate transducerhave the identical claimof imaging similarregions in the human
	Abdominal, Pediatricand Peripheral vessel.	Abdominal, Pediatricand Peripheral vessel.	body.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same.
Acoustic Array Style:	Curved Array	Curved Array	Regarding Safety: Botharrays allow focusedtransmission andreception of ultrasoundenergy to enhance imagequality within the regionof interest.
Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch x elevation)...Elevation focus...	1283.50.5mm X 13.0mm80mm	1283.50.5mm X 13.0mm80mm	Same in elevationSafety and effectivenessunchanged frompredicate
Acoustic Array	The transducerimaging performancehas been evaluated inan acoustic tank.	The transducerperformance has beenevaluated in theprevious 510(k) filing(K112953).	Same. As the predicatedevice and therefore hasdifferent acousticcharacteristics. Toensure proper safetyguidelines are met,acoustic testing wasperformed per theIEC60601-2-37 standard.
Patient Contact Material	Silicone ABS	Silicone ABS	Same. The 5C2Atransducer consists ofsame patient contactmaterials as thepredicate device.
Key Features	Subject Device Model	Comparable PredicateDevice	Same or Different
	Terason 4V2ATransducer	Terason 4V2ATransducer
Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXX	K112953	n/a
Indications for Use	The transducer isintended to be usedwith a conventionalultrasound system(Terason uSmart3400)to image Fetal,Abdominal, Pediatric,Cephalic and Cardiac.	The transducer isintended to be usedwith a conventionalultrasound system(Terason t3000) toimage Fetal,Abdominal, Pediatric,Cephalic and Cardiac.	Same. The proposedtransducer and thepredicate transducerhave the identical claimof imaging similarregions in the humanbody.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same.Regarding Safety: Both
Acoustic Array Style:	Phased Array	Phased Array	arrays allow focusedtransmission andreception of ultrasoundenergy to enhanceimage quality within theregion of interest.
Acoustic ArrayCharacteristics:			Same in elevationSafety and effectivenessunchanged frompredicate
Element count...	64	64
Center frequency...	2.8	2.8
Element size (pitch xelevation)...	256 microns X 12mm	256 microns X 12mm
Elevation focus...	16.3mm	16.3mm
Acoustic Array	The transducer imagingperformance has beenevaluated in anacoustic tank.	The transducerperformance has beenevaluated in theprevious 510(k) filing(K112953).	Same. As the predicatedevice and therefore hasdifferent acousticcharacteristics. Toensure proper safetyguidelines are met,acoustic testing wasperformed per theIEC60601-2-37 standard.
Patient ContactMaterial	Silicone Valox	Silicone Valox	Same. The 4V2Atransducer consists ofsame patient contactmaterials as thepredicate device.

{7}------------------------------------------------

・

{8}------------------------------------------------

Discussion:

The 5C2A 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 5C2A 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 5C2A transducer is substantially equivalent to the Terason 5C2A transducer (K112953) with respect to safety and effectiveness.

4V2A Transducer

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

Discussion:

The 4V2A 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 4V2A transducer consists of same patient contact materials as the predicate device.

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

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 4V2A transducer is substantially equivalent to the Terason 4V2A transducer (K112953) with respect to safety and effectiveness.

	Subject Device ModeluSmart3400	Comparable PredicateDevicet3000(K112953)	Same or Different
SystemCharacteristics	uSmart3400:With integrated singleboard computerweighs 14.6 lbs (6.62Kg)15.6" backlit widescreen.Dimensions (3.5"(H) x15.29"(W) x 15.58"(D)).	t3000:With laptop computerweighs 8.0 lbs (3.6 Kg)11.5" LED backlit widescreen.Dimensions (2.5"(H) x13.8"(W) x 11.0"(D)).	Different. Dimensions,weight and display.
	A Lithium-Polymerbattery provides 1.5hours of continuousultrasound scanning.Data are transferred tothe host computer overa FireWire (aka IEEE1394).	A Lithium-Polymerbattery provides 1.5hours of continuousultrasound scanning.Data are transferred tothe host computer overa FireWire (aka IEEE1394).	Same. Ultrasoundengine, communicationprotocol and hours ofcontinuous operation.

Terason uSmart3400 Computer

The computer has a different form factor, weight and display size. The hardware ultrasound engine already had all the necessary functions and features to support the 3 transducers. The hardware revisions of the ultrasound engine remain unchanged.

Accessories / Kits:

uSmart3400 Transducer	Accessory Description	Manufacturer / Part #	FDA 510k Clearance #
15L4	Biopsy Kit	Civco #612-085	K882383/A
15L4	Sterile Sheath	Civco #610-002	K970513

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

Conclusion:

The intended uses and features are consistent with the traditional clinical practices and FDA guidance for clearance of Diagnostic ultrasound systems and transducers. The uSmart3400 and predict devices both conform to applicable electric safety medical device standards with compliance verified through independent evaluation. The uSmart3400 and predicate devices both meet FDA requirements for track 3 devices, indications for use, biocompatibility similarities, and are manufactured using FDA GMPs and ISO-13485 quality systems. Teratech Corporation believes that the uSmart3400 ultrasound system is substantially equivalent with regards to safety and effectiveness to the predicate devices as noted above.

B1. Non Clinical Tests

The Terason™ uSmart3400 system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).

IEC 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Basic Safety.
- Intertek Test Record Number 100825086BOX-002. o
IEC 62366, Medical Devices: Application of usability engineering to . medical devices.
- Intertek Project: 100825086BOX-005. o
IEC60601-1-6, Medical Electrical Equipment Part 1-6: General . requirements for safety- Collateral standard: Usability
- Intertek Project: 100825086BOX-007. o
IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2; General . requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests
- IEC60601-1-2 IEI Integration Corp. Test Report Number, o CE130709D16.

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

IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- o Transducer Model 5C2A: Intertek Report Number IEC60601-2-37 uSmart3400 5C2A: 100825086BOX-004
- o Transducer Model 15L4: Intertek Report Number IEC60601-2-37 uSmart3400 15L4: 100825086BOX-006
- o Transducer Model 4V2A: Intertek Report Number IEC60601-2-37 uSmart3400 4V2A: 100825086BOX-003.
NEMA UD 3 Acoustic Output Display . Terason uSmart3400 Ultrasound System User Guide, Volumes 1 and 2 (16-3401 and 16-3402).
Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
- Biocompatibility reports for all transducers o

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

Image /page/13/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is composed of three stylized, curved shapes that resemble a person embracing another person.

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

April 25, 2014

Teratech Corp. % Mark Job Responsible Third Party Official 1394 25" STREET NW BUFFALO MN 55313

Re: K140834

Trade/Device Name: Terason uSmart3400 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 01. 2014 Received: April 2, 2014

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for I mis determination of bassumar of Ultrasound System, as described in your premarket notification:

Transducer Model Number

4V2A 5C2A 15L4

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA). IT your device is classified (see above) ins existing major regulations affecting your device can be It may be subject to additions, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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

Page 2-Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htmi.

Sincerely yours.

Smh

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See P R A Statement on last page.

510(k) Number (if known) K140834

Device Name

Terason uSmart3400 Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

Over The Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Page 1 of 5

Concurrence of Center for Devices and Radiological Health (C D R H) (Signature)

Image /page/15/Picture/13 description: The image contains a signature or some type of handwritten text. The text appears to be stylized and difficult to read. It is written in black ink on a white background.

FORM FDA 3881 (1/14)

P S C Publishing Services (301) 443-6740 EF

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

510(k) Number (if known):

Device Name: Terason uSmart3400 Ultrasound System

Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation						Otherc
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb
Ophthalmic	Ophthalmic
	Fetalh	N	N	N		N	N	N
	Abdominald:	N	N	N		N	N	N
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatricc:	N	N	N		N	N	N
	Small Organ (Thyroid, Breast,Testes, etc.)d:	N	N	N		N	N	N
	Neonatal Cephalicc:	N	N	N		N	N	N
	Adult Cephalicd:	N	N	N		N	N	N
	Trans-rectali:
	Trans-vaginali:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:	N	N	N		N	N	N
	Musculo-skel. (Superfic)d:	N	N	N		N	N	N
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	N	N	N		N	N	N
	Cardiac Pediatric	N	N	N		N	N	N
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesseld:	N	N	N		N	N	N
	Other (Specify)

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

14 Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

8 +M: B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

9 Includes ultrasound guidance for placement of needles, catheters.

· Abdominal, thoracic and peripheral vessel.

Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

Includes ultrasound guidance of transvaginal biosy, infertility monitoring of follicle development.

Includes aniasound generalism in the mility monitoring of follicle development.

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

Concurrence of Center for Devices and Radiological Health

Prescription Use (Per 21CFR 801.109)

Page 2 of 5

{17}------------------------------------------------

510(k) Number (if known): ___

Device Name:	Terason uSmart3400 – 15L4 Transducer
Indications For Use:	Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation						Otherc
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb
	Ophthalmic
	Fetalh
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,Testes, etc.)d:	P1	P1	P1		P1	P1	P1
	Neonatal Cephalicd:
	Adult Cephalicd:
	Trans-rectalf:
	Trans-vaginald:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)g:	P1	P1	P1		P1	P1	P1
	Musculo-skel. (Superfic)g:	P1	P1	P1		P1	P1	P1
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesseld:	P1	P1	P1		P1	P1	P1
	Other (Specify)

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

Not now maloution, T = provised) electional Power Doppler (DPD), and (non-directional) Power Doppler.

0 B+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

9 Includes ultrasound guidance for placement of needles, catheters.

® Abdominal, thoracic and peripheral vessel.

I Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

Includes guidance of amniocentesis, intertility monitoring of follicle development.

Additional Comments: P': uses previously cleared under K110020

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

Concurrence of Center for Devices and Radiological Health

Prescription Use (Per 21CFR 801.109)

Page 3 of 5

{18}------------------------------------------------

510(k) Number (if known): __

Device Name:	Terason uSmart3400 – 5C2A Transducer
Indications For Use:	Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation						Otherc
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetalh	P1	P1	P1		P1	P1	P1
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,Testes, etc.)f:
	Neonatal Cephalicd:
	Adult Cephalicg:
	Trans-rectali:
	Trans-vaginali:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)g:
	Musculo-skel. (Superfic)g:
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesseld:	P1	P1	P1		P1	P1	P1
	Other (Specify)

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

1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

b B+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

1 Includes ultrasound guidance for placement of needles, catheters.

· Abdominal, thoracic and peripheral vessel.

Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherspy

Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

Includes guidance of amniocentesis, intertility monitoring of follicle development.

Additional Comments: P1: uses previously cleared under K112953

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

Concurrence of Center for Devices and Radiological Health

Prescription Use (Per 21CFR 801.109)

Page 4 of 5

{19}------------------------------------------------

510(k) Number (if known): _

Device Name:	Terason uSmart3400 - 4V2A Transducer
Indications For Use:	Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows.

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalh	P1	P1	P1		P1	P1	P1
	Abdominalo:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatrico:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,Testes, etc.)k:
	Neonatal Cephalico:	P1	P1	P1		P1	P1	P1
	Adult Cephalico:	P1	P1	P1		P1	P1	P1
	Trans-rectali:
	Trans-vaginalo:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)o:
	Musculo-skel. (Superfic)o:
	Intra-luminal
	Other (Specify)
	Cardiac Adult	P1	P1	P1		P1	P1	P1
Cardiac	Cardiac Pediatric	P1	P1	P1		P1	P1	P1
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesselo:
	Other (Specify)

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

Ne new moleation, 1 = provides), alouicul by Por (DPD), and (non-directional) Power Doppler.

8+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

· Abdominal, thoracic and peripheral vessel.

Ancludes uitrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

Additional Comments: P : uses previously cleared under K112953

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

Concurrence of Center for Devices and Radiological Health

Prescription Use (Per 21CFR 801.109)

Page 5 of 5

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.