Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound image processing and does not mention any AI or ML capabilities.

Therapeutic

No
The device is described as an Ultrasound System for evaluation by imaging or fluid flow analysis, indicating a diagnostic rather than therapeutic purpose.

Diagnostic

Yes

The device is an ultrasound system intended for "evaluation by ultrasound imaging or fluid flow analysis of the human body" for various clinical applications, which directly aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a proprietary ultrasound engine, singleboard computer, transducers, battery, and power supply. It is a physical ultrasound system, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Teratech Corporation Terason™ uSmart3400 is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states it's for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This involves imaging the internal structures of the body directly, not analyzing samples taken from the body (like blood, urine, or tissue).
Device Description: The description details how the system acquires and processes ultrasound data from within the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.

IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health. This ultrasound system operates by sending and receiving sound waves to create images of internal anatomy, which is a form of in vivo (within the living body) diagnostic imaging.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

IYN, IYO, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular.

Indicated Patient Age Range

Fetal, Pediatric, Neonatal, Adult

Intended User / Care Setting

qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests:
The Terason™ uSmart3400 system has been tested for compliance to the following standards:

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety.
IEC 62366, Medical Devices: Application of usability engineering to medical devices.
IEC60601-1-6, Medical Electrical Equipment Part 1-6: General requirements for safety- Collateral standard: Usability
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
IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
NEMA UD 3 Acoustic Output Display
Biocompatibility Tests, ISO 10993 Part 5 and Part 10

Acoustic testing was performed per the IEC60601-2-37 standard for transducers 15L4, 5C2A, and 4V2A.
The transducer imaging performance for 5C2A and 4V2A has been evaluated in an acoustic tank.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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

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 t

1

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

5. 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.

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 Ultrasound
imaging or fluid flow analysis
of the human body	Diagnostic Ultrasound
imaging or fluid flow analysis
of the human body	Diagnostic Ultrasound
imaging or fluid flow analysis
of the human body
Indication for Use	Fetal, Abdominal, Pediatric,
Small Organ (Thyroid, Breast,
Testes), Neonatal Cephalic,
Adult Cephalic, Musculo-
skeleltal (Convent.), Musculo-
skeletal (Superfic.), Cardiac
Adult, Cardiac Pediatric,
Peripheral vessel	Fetal, Abdominal, Intra-
operative (abdominal,
thoracic and PV),
Laparoscopic, Pediatric, Small
Organ (Thyroid, Breast,
Testes), Neonatal and Adult
Cephalic, Trans-rectal and
Trans-vaginal, Musculo-skel.
(Convent.), Musculo-skel.
(Superfic), Cardiac Adult,
Cardiac Pediatric, Peripheral
vessel	Fetal, Abdominal, Intra-
operative (Spec.), Intra-
operative (Neuro),
Laparoscopic, Pediatric,
Small Organ (Thyroid, Breast,
Testes, etc.), Neonatal
Cephalic, Adult Cephalic,
Trans-rectal, Trans-vaginal,
Musculo-skel. (Convent.),
Musculo-skel. (Superficial),
Cardiac Adult, Cardiac
Pediatric, Peripheral vessel
Transducer Types	Linear Array
Curved Array
Phased Array	Linear Array
Curved Array	Linear Array
Curved Array
Phased Array
Endocavity - curved array
Hockey Stick - Linear
Bi-plane -Linear/curved
Acoustic Output and FDA
Limits	Display Features for High
Outputs	Display Features for High
Outputs	Display Features for High
Outputs
Global Maximum
Outputs/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 Imaging
Tissue Harmonic Imaging	B-Mode Grayscale Imaging
Tissue Harmonic Imaging	B-Mode Grayscale Imaging
Tissue Harmonic Imaging
M.Mode (motion)
	Anatomical M-Mode
Color M-Mode
Color Power Doppler
Velocity Color Doppler
Duplex/Triplex - Doppler
imaging
Pulsed Wave (PW) Doppler
TeraVision II Postprocessing	Anatomical M-Mode
Color M-Mode
Color Power Doppler
Velocity Color Doppler
Duplex/Triplex - Doppler
imaging
Pulsed Wave (PW) Doppler
TeraVision II Postprocessing	Anatomical M-Mode
Color M-Mode
Color Power Doppler
Velocity Color Doppler
Duplex/Triplex - Doppler
imaging
Pulsed Wave (PW) Doppler
TeraVision Postprocessing
PW Doppler	Available for all transducers
Triplex Mode
B-Mode and PW Doppler
High PRF	Available for all transducers
Triplex Mode
B-Mode and PW Doppler
High PRF	Available for all transducers
Triplex Mode
B-Mode and PW Doppler
High 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 Output
Measurement Standard	NEMA UD 2-2004
NEMA UD 3-2004	NEMA UD 2-2004
NEMA UD 3-2004	NEMA UD 2-2004
NEMA UD 3-2004
DICOM	DICOM 3.0 Structured
Reporting, Worklist - Image
Viewer	DICOM 3.0 Structured
Reporting, Worklist - Image
Viewer	DICOM 3.0 Worklist - Image
Viewer
Product Safety Certification	IEC60601-1
IEC60601-1-2
IEC60601-1-6
IEC60601-2-37
IEC60601-1-2	IEC60601-1
IEC60601-1-2
IEC60601-1-6
IEC60601-2-37
IEC60601-1-2	IEC60601-1
IEC60601-1-2
IEC60601-1-4
IEC60601-2-37
IEC60601-1-2
EMC	CISPR11 Class B	CISPR11 Class B	CISPR11 Class B
System
Characteristics	uSmart3400:
With integrated single-board
computer weighs 14.6 pounds
(6.62 Kg) 15.3" backlit screen.
System dimensions (3.5"(H) x
15.29"(W) x 15.58"(D)).
A Lithium-Polymer battery
(integrated into the tablet)
provides 2 hours of
continuous ultrasound
scanning. Uses a medical-
grade power supply
Data transferred to the tablet
computer over a FireWire
(aka IEEE 1394)	T3200:
Laptop Computer and console
weighs 10.5 pounds (4.8 Kg)
11.5" LED backlit display and
keyboard. System dimensions
(2.25"(H) x 14.35"(W) x
9.82"(D)).
A Lithium-Polymer battery
(integrated into the Laptop)
provides 2 hours of
continuous ultrasound
scanning. Uses a medical-
grade power supply
Data transferred to the tablet
computer over a FireWire
(aka IEEE 1394)	Terason T3000:
Laptop Computer
weighs: 8.0 pounds (3.6 kg),
LED backlit display and
keyboard. Laptop
dimensions (H): 2.5", (W):
13.8", (D): 11.0"
A Lithium-Polymer battery,
(integrated into the Laptop)
provides 2 hours of
continuous ultrasound
scanning. Uses a medical-
grade power supply
Data transferred to the
laptop computer over a
FireWire (aka IEEE 1394)

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5

15L4 Transducer

15L4 Transducer
Key Features	Subject Device Model
Terason 15L4
Transducer	Comparable Predicate
Device
Terason 15L4
Transducer	Same or Different
510(k) Number	K1XXXXXX	K110020	n/a
Classification	ITX	ITX	Same
Indications for Use	The transducer is
intended to be used
with a conventional
ultrasound system
(Terason uSmart3400)
to image abdomen,
small parts, musculo-
skel and peripheral
vascular regions.	The transducer is
intended to be used
with a conventional
ultrasound system
(Terason t3200) to
image abdomen, small
parts, musculo-skel
and peripheral
vascular regions.	Same: The proposed
transducer and the
predicate transducer
have the identical claim
of imaging similar
regions in the human
body.
Acoustic Array
Technology:	Piezoelectric elements	Piezoelectric elements	Same: Safety
requirements of
IEC60601 are equally
met.
Effectiveness: Both
arrays allow focused
transmission and
reception of ultrasound
energy to enhance
image quality within the
region of interest.
Acoustic Array Style:	Linear Array	Linear Array	Same: element count.
Acoustic characteristics
have met safety
guidelines of IEC60601-
2-37.
Acoustic Array
Characteristics:
Element count...
Center frequency...
Element size (pitch x
elevation)...
Elevation focus...	128 elements
7.5 MHz
0.3mm X 4.0mm
20mm	128 elements
7.5 MHz
0.3mm X 4.0mm
20mm
Acoustic Output and
Device Settings	Per acoustic output
testing.	The transducer
performance has been
evaluated in the
previous 510(k) filing	Same; acoustic output
safety guidelines. Safety
is not compromised.
Effectiveness equal.
		(K110020).
Patient Contact Material	The transducer uses
Silicone SIM R1001 as a
contact material.	The transducer uses
Silicone SIM R1001 as a
contact material.	Same. The 15L4
transducer consists of
same patient contact
materials as the
predicate device. The
safety of each device
with respect to
biocompatibility is
equivalent.

:

. .

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 Predicate
Device | Same or Different |
|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Terason 5C2A
Transducer | Terason 5C2A
Transducer | |
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXXX | K112953 | n/a |
| Indications for Use | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason uSmart3400)
to image Fetal, | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason t3000) to
image Fetal, | Same. The proposed
transducer and the
predicate transducer
have the identical claim
of imaging similar
regions in the human |
| | Abdominal, Pediatric
and Peripheral vessel. | Abdominal, Pediatric
and Peripheral vessel. | body. |
| Acoustic Array
Technology: | Piezoelectric elements | Piezoelectric elements | Same. |
| Acoustic Array Style: | Curved Array | Curved Array | Regarding Safety: Both
arrays allow focused
transmission and
reception of ultrasound
energy to enhance image
quality within the region
of interest. |
| Acoustic Array
Characteristics:
Element count...
Center frequency...
Element size (pitch x elevation)...
Elevation focus... | 128
3.5
0.5mm X 13.0mm
80mm | 128
3.5
0.5mm X 13.0mm
80mm | Same in elevation
Safety and effectiveness
unchanged from
predicate |
| Acoustic Array | The transducer
imaging performance
has been evaluated in
an acoustic tank. | The transducer
performance has been
evaluated in the
previous 510(k) filing
(K112953). | Same. As the predicate
device and therefore has
different acoustic
characteristics. To
ensure proper safety
guidelines are met,
acoustic testing was
performed per the
IEC60601-2-37 standard. |
| Patient Contact Material | Silicone ABS | Silicone ABS | Same. The 5C2A
transducer consists of
same patient contact
materials as the
predicate device. |
| Key Features | Subject Device Model | Comparable Predicate
Device | Same or Different |
| | Terason 4V2A
Transducer | Terason 4V2A
Transducer | |
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K112953 | n/a |
| Indications for Use | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason uSmart3400)
to image Fetal,
Abdominal, Pediatric,
Cephalic and Cardiac. | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason t3000) to
image Fetal,
Abdominal, Pediatric,
Cephalic and Cardiac. | Same. The proposed
transducer and the
predicate transducer
have the identical claim
of imaging similar
regions in the human
body. |
| Acoustic Array
Technology: | Piezoelectric elements | Piezoelectric elements | Same.
Regarding Safety: Both |
| Acoustic Array Style: | Phased Array | Phased Array | arrays allow focused
transmission and
reception of ultrasound
energy to enhance
image quality within the
region of interest. |
| Acoustic Array
Characteristics: | | | Same in elevation
Safety and effectiveness
unchanged from
predicate |
| Element count... | 64 | 64 | |
| Center frequency... | 2.8 | 2.8 | |
| Element size (pitch x
elevation)... | 256 microns X 12mm | 256 microns X 12mm | |
| Elevation focus... | 16.3mm | 16.3mm | |
| Acoustic Array | The transducer imaging
performance has been
evaluated in an
acoustic tank. | The transducer
performance has been
evaluated in the
previous 510(k) filing
(K112953). | Same. As the predicate
device and therefore has
different acoustic
characteristics. To
ensure proper safety
guidelines are met,
acoustic testing was
performed per the
IEC60601-2-37 standard. |
| Patient Contact
Material | Silicone Valox | Silicone Valox | Same. The 4V2A
transducer consists of
same patient contact
materials as the
predicate 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 Model
uSmart3400 | Comparable Predicate
Device
t3000
(K112953) | Same or Different |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| System
Characteristics | uSmart3400:
With integrated single
board computer
weighs 14.6 lbs (6.62
Kg)
15.6" backlit wide
screen.
Dimensions (3.5"(H) x
15.29"(W) x 15.58"(D)). | t3000:
With laptop computer
weighs 8.0 lbs (3.6 Kg)
11.5" LED backlit wide
screen.
Dimensions (2.5"(H) x
13.8"(W) x 11.0"(D)). | Different. Dimensions,
weight and display. |
| | A Lithium-Polymer
battery provides 1.5
hours of continuous
ultrasound scanning.
Data are transferred to
the host computer over
a FireWire (aka IEEE
1394). | A Lithium-Polymer
battery provides 1.5
hours of continuous
ultrasound scanning.
Data are transferred to
the host computer over
a FireWire (aka IEEE
1394). | Same. Ultrasound
engine, communication
protocol and hours of
continuous 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

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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

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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

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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)

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.

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	Color
Doppa	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
Fetal
Imaging
& 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)
Peripheral
Vessel	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

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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	Color
Doppa	Comb.
Modesb
	Ophthalmic
	Fetalh
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& 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)
Peripheral
Vessel	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

.

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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	Color
Doppa	Comb.
Modesb
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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)
Peripheral
Vessel	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

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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	Color
Doppa	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
Fetal
Imaging
& 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)
Peripheral
Vessel	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)

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