Who is the manufacturer of TERASON USMART3400 ULTRASOUND SYSTEM?

Teratech Corp. filed the 510(k) submission for TERASON USMART3400 ULTRASOUND SYSTEM (K140834).

What is the FDA product code for TERASON USMART3400 ULTRASOUND SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for TERASON USMART3400 ULTRASOUND SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TERASON USMART3400 ULTRASOUND SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TERASON USMART3400 ULTRASOUND SYSTEM

Q: What are the predicate devices for TERASON USMART3400 ULTRASOUND SYSTEM?

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

K140834 · Teratech Corp. · IYN · Apr 25, 2014 · Radiology

Device Facts

Record ID	K140834
Device Name	TERASON USMART3400 ULTRASOUND SYSTEM
Applicant	Teratech Corp.
Product Code	IYN · Radiology
Decision Date	Apr 25, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

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.

Device Story

Portable ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Proprietary ultrasound engine controls acoustic output/processes return echoes; data transferred via FireWire (IEEE 1394) to host single-board computer for image generation/display. Used in clinical settings by physicians; provides diagnostic imaging/fluid flow analysis to aid clinical decision-making. Benefits include portability (14.6 lbs) and battery-powered operation (2 hours). System includes 15.3" backlit screen; supports three previously cleared transducers (15L4, 5C2A, 4V2A).

Clinical Evidence

Bench testing only. Compliance verified via IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6/62366 (usability), and IEC 60601-2-37 (ultrasonic safety). Acoustic output measured per NEMA UD 2-2004 and UD 3-2004. Biocompatibility confirmed per ISO 10993 parts 5 and 10.

Technological Characteristics

Portable ultrasound system; single-board computer; Windows 7 OS. Custom beamformer chip; 128 transmit/receive channels. Transducers: 15L4 (linear), 5C2A (curved), 4V2A (phased). Patient contact materials: Silicone SIM R1001, Silicone ABS, Silicone Valox. Connectivity: FireWire (IEEE 1394). Power: Lithium-Polymer battery, medical-grade power supply. Safety: IEC 60601-1, IEC 60601-2-37.

Indications for Use

Indicated for qualified physicians to perform ultrasound imaging or fluid flow analysis of the human body. Clinical applications: Fetal, Abdominal, Pediatric, Small Organ (thyroid, breast, testes), Neonatal/Adult Cephalic, Musculoskeletal (conventional/superficial), Cardiac (adult/pediatric), and Peripheral Vascular.

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

Submission Summary (Full Text)

{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) | {4}------------------------------------------------ . . , . . . {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 | {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) 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 {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 | 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: | | | | |…

TERASON USMART3400 ULTRASOUND SYSTEM

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TERASON USMART3400 ULTRASOUND SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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