Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound image processing and does not mention AI, ML, or related technologies.

Therapeutic

No

The device is described as a "general-purpose diagnostic ultrasound system" and its intended use is for "evaluation by ultrasound imaging or fluid flow analysis," which indicates diagnostic rather than therapeutic purposes.

Diagnostic

Yes

The "Device Description" section states that the Terason uSmart3200T Plus ultrasound system is a "full-feature, general purpose diagnostic ultrasound system".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable tablet-style, fullfeature, general purpose diagnostic ultrasound system" and includes details about hardware components like transducers, a tablet computer, a battery, and a docking station. It also mentions testing related to hardware standards (e.g., electrical safety, biocompatibility, acoustic output).

IVD (In Vitro Diagnostic)

Based on the provided information, the Teratech Corporation Terason™ uSmart3200T Plus is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states the device is for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This involves directly imaging the internal structures and processes of a living patient.
Device Description: The description details a system that acquires and displays "real-time ultrasound data" from the human body.
Input Imaging Modality: The input is explicitly stated as "Ultrasound," which is a non-invasive imaging technique applied to the patient.
Anatomical Site: The listed anatomical sites are all locations within the human body.
Intended User / Care Setting: The users are qualified medical professionals performing procedures on patients in a clinical setting.

In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. The Terason™ uSmart3200T Plus does not perform analysis on such specimens; it directly interacts with and images the living patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Teratech Corporation Terason uSmart3200T Plus is a prescription-only, general-purpose Ultrasound System intended for use by a qualified physician or accredited sonographer for evaluation by ultrasound imaging of the human body. The device is intended for use in a clinic, hospital or medical-emergency setting. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-Operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-vaginal, Trans-esophageal (noncardiac), Musculo-skeletal (Conventional); Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.

Product codes

IYN, IYO, ITX

Device Description

The Terason uSmart3200T Plus ultrasound system is a portable tablet-style, fullfeature, general purpose diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The Terason uSmart3200T Plus Ultrasound System is equivalent to the previously cleared versions of the uSmart3200T Ultrasound Systems. The modification includes the addition of 3 transducers: 14L3, 10BP4 and 15XL4.

The Terason™ uSmart3200T ultrasound system was the previously cleared on the date January 29, 2020 as described in the 510(k) submission (K193510). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet computer over a Universal Serial Bus (USB3) connection for further processing and generation/display of the ultrasound image.

The Terason™ uSmart3200T Plus ultrasound tablet weighs 9.8 pounds (4.2 Kq) and has an 15.6" backlit touch screen. The tablet dimensions (10.6"(H) x 15.6"(W) x 1.7"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medical-grade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the uSmart3200T Plus. Optional accessories include a cart and printer.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Intra-Operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-vaginal, Trans-esophageal (noncardiac), Musculo-skeletal (Conventional); Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), Peripheral Vascular; Trans-rectal.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Qualified physician or accredited sonographer for use in a clinic, hospital or medical-emergency setting.

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

The performance data used to validate the Terason uSmart3200T Plus and new transducers includes the following:

Acoustic output testing
B-Mode accuracy, and Doppler accuracy and sensitivity
General requirements for safety testing
Electromagnetic compatibility testing
Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment testing
Biocompatibility testing of patient contact materials
Burn-in testing
Software performance and regression testing.

The Terason uSmart3200T Plus system has been tested for compliance to the following standards:

AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment – Part 1: General requirements for safety and essential performance
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
EMC Test Report for the Terason uSmart3200T Plus
IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
Biocompatibility Tests, ISO 10993 Part 5, Part 10 and Part 12
Biocompatibility reports for the new transducers
AAMI TIR No. 12:210. Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.

The ultrasound system acoustic output was tested in accordance with the following:

IEC 61157. Ed. 2 2007-2008. Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3
NEMA UD 3, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2.

The ultrasound system B-Mode Accuracy, Doppler Accuracy and Doppler Sensitivity for each Terason transducer have been evaluated according to the following:

American Institute of Ultrasound in Medicine (AIUM) Quality Assurance Manual for Gray-Scale Ultrasound Scanners
AIUM Methods for Measuring Performance of Pulse-Echo Ultrasound Imaging Equipment, Part II: Digital Methods
AIUM Performance Criteria and Measurements for Doppler Ultrasound Devices.

The Terason uSmart3200T Plus Software has undergone Quality Assurance testing consistent with IEC 62304, Software Life Cycle Process, and IEC 62366, Application for Usability.

Key Metrics

Not Found

Predicate Device(s)

K193510

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

July 2, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Teratech Corporation % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K201633

Trade/Device Name: Terason™ uSmart 3200T Plus Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 12, 2020 Received: June 16, 2020

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K201633

Device Name

Terason uSmart3200T Plus Ultrasound System

Indications for Use (Describe)

The Teratech Corporation Terason uSmart32007 Plus is a prescription-only, general-purpose Ultrasound System intended for use by a qualified physician or accredited sonographer for evaluation by ultrasound imaging of the human body. The device is intended for use in a clinic, hospital or medical-emergency setting. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-Operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-vaginal, Trans-esophageal (noncardiac), Musculo-skeletal (Conventional); Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

K201633

Teratech Corporation

Terason uSmart3200T Plus Ultrasound System

1. Sponsor:

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

Contact Person: Ben Chiampa Director of Quality Assurance Telephone: 781-270-4143

Date Prepared: May 20, 2020

2. Device Name

Proprietary Name: Terason uSmart3200T Plus Ultrasound System Common / Usual Name: Diaqnostic Ultrasound System Classification Name: Class II

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

3. Predicate Device

Terason™ uSmart3200T Ultrasound System (K193510)

4. Intended Use

The Teratech Corporation Terason™ uSmart3200T Plus is a prescription-only, general-purpose Ultrasound System intended for use by a qualified physician or accredited sonographer for evaluation by ultrasound imaging or fluid flow

4

analysis of the human body. The device is intended for use in a clinic, hospital or medical-emergency setting. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.

5. Clinical Testing

Teratech Corporation certifies that the requirements of 42 U.S.C. 282(i), Section 402(i) of the Public Health Service Act, including 42 CFR part 11, do not apply because the application/submission which this 510(k) filing accompanies does not reference any clinical trial.

6. Device Description

The Terason uSmart3200T Plus ultrasound system is a portable tablet-style, fullfeature, general purpose diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The Terason uSmart3200T Plus Ultrasound System is equivalent to the previously cleared versions of the uSmart3200T Ultrasound Systems. The modification includes the addition of 3 transducers: 14L3, 10BP4 and 15XL4.

The Terason™ uSmart3200T ultrasound system was the previously cleared on the date January 29, 2020 as described in the 510(k) submission (K193510). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet computer over a Universal Serial Bus (USB3) connection for further processing and generation/display of the ultrasound image.

The Terason™ uSmart3200T Plus ultrasound tablet weighs 9.8 pounds (4.2 Kq) and has an 15.6" backlit touch screen. The tablet dimensions (10.6"(H) x 15.6"(W) x 1.7"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medical-grade power supply. The ultrasound transducer connector is identical to that used in the

5

Terason™ predicate device, the uSmart3200T Plus. Optional accessories include a cart and printer.

7. Technology Characteristics

The design and construction of the Terason uSmart3200T Plus is the same as the Terason uSmart3200T Plus Ultrasound system which was cleared in May 2015. This system utilizes a portable computer running Windows 10 to run the ultrasound application and a custom hardware designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is inside the tablet.

The uSmart3200T Plus system contains the same ultrasound engine as the predicate device Terason uSmart3200T Plus ultrasound system for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet computer over a USB3 connection for further processing, and generation and display of the ultrasound image

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

. Three transducers have been added to the system: 14L3, 10BP4, and 15XL4. The software has been modified to control these transducers and ensure compliance to the standards controlling acoustic and thermal power.
Added support for the 14L3, 10BP4, and 15XL4 transducers .
- o Confirmed transducer id numbers and names
- o Confirmed transducer geometries and characteristic parameters
- o Confirmed 14L3, 10BP4, and 15XL4 acoustic tables
- o Added 14L3, 10BP4, and 15XL4 to the table of allowed transducers
- o Added imaging presets for 14L3, 10BP4, and 15XL4 transducers.

6

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

Terason uSmart3200T Plus System and Transducers Comparison and Discussion New Transducers: 14L3, 10BP4, 15XL4 Previously cleared transducers (5V1A, 12L5A, 5C2A, 8EC4A, 16HL7, 15L4, 8L2, 8V3A, 9MC3, 8TE3, PDOF, 15L4A, 16L5, 15WL4, XY-Biplane, 10EC4) (K193510)

	Subject Device Model	Comparable Predicate Device	Same or Different
	Terason uSmart3200T Plus
(This Submission)	Terason uSmart3200T
K193510
Intended Use	Diagnostic Ultrasound imaging or fluid flow analysis of the human body	Diagnostic Ultrasound imaging or fluid flow analysis of the human body	Same.
Indication for Use	Ophthalmic, Fetal,
Abdominal, Intra-operative
(Spec.), Pediatric, Small Organ
(Thyroid, Breast, Testes, etc.),
Neonatal Cephalic, Adult
Cephalic, Trans-rectal, Trans-
vaginal, Trans-esophageal
(non-Cardiac), Musculo-skel.
(Convent.), Musculo-skel.
(Superfic), Cardiac Adult,
Cardiac Pediatric, Trans-
esophageal (Cardiac),
Peripheral vessel	Ophthalmic, Fetal,
Abdominal, Intra-operative
(Spec.), Pediatric, Small Organ
(Thyroid, Breast, Testes, etc.),
Neonatal Cephalic, Adult
Cephalic, Trans-rectal, Trans-
vaginal, Trans-esophageal
(non-Cardiac), Musculo-skel.
(Convent.), Musculo-skel.
(Superfic), Cardiac Adult,
Cardiac Pediatric, Trans-
esophageal (Cardiac),
Peripheral vessel	Same.
Transducer Types	Linear Array
Curved Array
Phased Array
Endocavity - curved array
Hockey Stick - Linear
Trans-esophageal
PDOF
192-Element
384-element
XY-Biplane
Endocavity-Biplane	Linear Array
Curved Array
Phased Array
Endocavity - curved array
Hockey Stick - Linear
Trans-esophageal
PDOF
192-Element
XY-Biplane	Different: Support for 384-
elements and biplane
transducers.
Acoustic Output and FDA
Limits	Display Features for High
Outputs	Display Features for High
Outputs	Same.
Global Maximum
Outputs/Worst Case Setting	ISPTA.3: 619 mW/cm² (10BP4C)
TI Type: TIC (14L3)
TI Value: 4.2 (14L3)
MI: 1.76 (15XL4)
IPA.3@MI Max: 776 W/cm²
(14L3)	ISPTA.3: 652.9 mW/cm² (4V2A)
TI Type: TIC (15L4)
TI Value: 5.8 (15L4)
MI: 1.78 (8EC4A)
IPA.3@MI Max: 827 W/cm²
(1514)	Different. Within Guideline
limits.
Modes of Operation	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	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	Same.
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	Same.
Transducer Frequency	2.0 – 15.0 MHz	2.0 – 15.0 MHz	Same.
#Transmit Channels	384 Channels	128 Channels	Different. Supports 384
elements.
# Receive Channels	384 Channels	128 Channels	Different. Supports 384
elements.
Acoustic Output
Measurement Standard	IEC 60601-2-37	NEMA UD 2-2004
NEMA UD 3-2004	Same.
DICOM	DICOM 3.0 Structured
Reporting, Worklist - Image
Viewer	DICOM 3.0 Structured
Reporting, Worklist - Image
Viewer	Same.
Product Safety Certification	AAMI/ANSI ES 60601-
1:2005/(R)2012 and A1:2012
Medical electrical equipment
– Part 1: General
requirements for safety and
essential performance
IEC60601-1
IEC60601-1-2
IEC60601-1-6
IEC60601-2-37	AAMI/ANSI ES 60601-
1:2005/(R)2012 and A1:2012
Medical electrical equipment
– Part 1: General
requirements for safety and
essential performance
IEC60601-1
IEC60601-1-2
IEC60601-1-6
IEC60601-2-37	Same.
EMC	IEC60601-1-2
CISPR11 Class B	IEC60601-1-2
CISPR11 Class B	Same.
System
Characteristics	uSmart3200T Plus:
tablet computer
weighs 9.8 lbs (4.2 Kg)
18" backlit touch screen.
Tablet dimensions (10.6"(H) x
15.6"(W) x 1.7"(D)).
A Lithium-Polymer battery
(integrated into the tablet)	uSmart3200T:
tablet computer
weighs 4.9 lbs (2.21 Kg)
11.5" backlit touch screen.
Tablet dimensions (8.82"(H) x
12.64"(W) x 1.25"(D)).
A Lithium-Polymer battery
(integrated into the tablet)	Different.
Larger screen
continuous ultrasound
scanning
Docking station (for charging)
that uses a medical-grade
power supply
Data transferred to the tablet
computer over a USB3
connection	continuous ultrasound
scanning
Docking station (for charging)
that uses a medical-grade
power supply
Data transferred to the tablet
computer over a USB3
connection

Terason uSmart3200T Plus Tablet Computer

7

8

Three transducers have been added to the Terason uSmart3200T Plus in this submission: 14L3, 10BP4, and 15XL4.

9

SUMMARY OF NEW AND ASSOCIATED PREDICATE TRANSDUCERS

New Subject Transducer	Comparable Predicate Transducer	Predicate Approvals and Systems
Terason 14L3	Terason 15L4	K193510 (Terason uSmart3200T)
Terason 10BP4	Terason 10EC4	K193510 (Terason uSmart3200T)
Terason 15XL4	Terason 15WL4	K193510 (Terason uSmart3200T)

TRANSDUCER PERFORMANCE SUMMARY

| Transducer | Indications | Mode | Global maximum output | 510(K)
control number |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------|--------------------------|
| 12L5A | Ophthalmic, Abdominal, Pediatric,
Small Organ (breast, testes, thyroid),
Neonatal and Adult Cephalic,
Musculo-sketetal (Conventional and
Superficial), and Peripheral Vascular | B, M,
PWD,
Color Doppler,
Combined | ISTPA.3 = 597(mW/cm²)
TI = 3.3
MI = 1.8 | K193510 |
| 5V1A | Fetal, Abdominal, Pediatric, Neonatal
and Adult Cephalic, Cardiac (adult
and pediatric) | B, M,
PWD,
Color Doppler,
CWD,
Combined | ISTPA.3 = 603 (mW/cm²)
TI = 5.6
MI = 1.5 | K193510 |
| 5C2A | Fetal, Abdominal, Pediatric, Small
Organ (Thyroid, Breast, Testes, etc.);
Musculo-sketetal (Conventional and
Superficial), Cardiac (adult and
pediatric) and Peripheral Vascular | B, M,
PWD,
Color Doppler,
Combined | ISTPA.3 = 660 (mW/cm²)
TI = 4.7
MI = 0.7 | K193510 |
| 8EC4A | Fetal, Trans-rectal, Trans-vaginal | B, M,
PWD,
Color Doppler,
Combined | ISTPA.3 = 633(mW/cm²)
TI = 2.29
MI = 1.8 | K193510 |
| 16HL7 | Intra-Operative (abdominal, organs
and vascular), Small Organ (Thyroid,
Breast, Testes); Musculo-skeletal
(Conventional and Superficial);
Peripheral Vascular. | B, M,
PWD,
Color Doppler,
Combined | ISTPA.3 = 554(mW/cm²)
TI = 1.22
MI = 1.6 | K193510 |
| 15L4 | Ophthalmic, Abdominal, Pediatric,
Small Organ (Thyroid, Breast,
Testes); Musculo-skeletal
(Conventional and Superficial);
Peripheral Vascular. | B, M,
PWD,
Color Doppler,
Combined | ISTPA.3 = 563(mW/cm²)
TI = 5.8
MI = 1.7 | K193510 |
| 8L2 | Abdominal, Pediatric, Musculo-
skeletal, Peripheral Vascular | B, M,
PWD,
Color Doppler,
Combined | ISTPA.3 = 598(mW/cm²)
TI = 2.8
MI = 1.7 | K193510 |
| 8V3A | Fetal, Abdominal, Pediatric, Cephalic,
and Cardiac | B, M,
PWD,
Color Doppler,
CWD,
Combined | ISTPA.3 = 560(mW/cm²)
TI = 4.7
MI = 1.7 | K193510 |
| 9MC3 | fetal, pediatric, small organs, cephalic
(neonatal and adult), cardiac and
peripheral vessels | B, M,
PWD,
Color Doppler,
CWD,
Combined | ISTPA.3 = 577(mW/cm²)
TI = 2.8
MI = 1.3 | K193510 |
| | | Combined | | |
| 8TE3 | Trans-esophageal (non-cardiac and
cardiac) | B, M,
PWD,
Color Doppler,
CWD,
Combined | $ISTPA.3 = 245(mW/cm2)$
$TI = 1.0$
$MI = 1.3$ | K193510 |
| PDOF | Cardiac | CWD | $ISTPA.3 = 506(mW/cm2)$
$TI = 4.2$
$MI = 0.1$ | K193510 |
| 15L4A | Ophthalmic, Abdominal, Pediatric,
Small Organ (Thyroid, Breast,
Testes); Musculo-skeletal
(Conventional and Superficial);
Peripheral Vascular | B, M,
PWD,
Color Doppler,
Combined | $ISTPA.3 = 620 (mW/cm2)$
$TI = 1.8$
$MI = 1.7$ | K193510 |
| 16L5 | Ophthalmic, Abdominal, Pediatric,
Small Organ (Thyroid, Breast,
Testes); Musculo-skeletal
(Conventional and Superficial);
Peripheral Vascular | B, M,
PWD,
Color Doppler,
Combined | $ISTPA.3 = 635 (mW/cm2)$
$TI = 1.6$
$MI = 1.7$ | K193510 |
| 15WL4 | Ophthalmic, Abdominal, Pediatric,
Small Organ (Thyroid, Breast,
Testes); Musculo-skeletal
(Conventional and Superficial);
Peripheral Vascular | B, M,
PWD,
Color Doppler,
Combined | $ISTPA.3 = 624 (mW/cm2)$
$TI = 3.3$
$MI = 1.8$ | K193510 |
| XY-Biplane | Fetal, Abdominal, Pediatric, Neonatal
and Adult Cephalic, Cardiac (adult
and pediatric) | B, M,
PWD,
Color Doppler,
CWD,
Combined | $ISTPA.3 = 650 (mW/cm2)$
$TI = 5.7$
$MI = 1.7$ | K193510 |
| 10EC4 | Fetal, Trans-rectal, Trans-vaginal | B, M,
PWD,
Color Doppler,
Combined | $ISTPA.3 = 616 (mW/cm2)$
$TI = 2.56$
$MI = 1.56$ | K193510 |
| 14L3 | Ophthalmic, Abdominal, Pediatric,
Small Organ (Thyroid, Breast,
Testes); Musculo-skeletal
(Conventional and Superficial);
Peripheral Vascular. | B, M,
PWD,
Color Doppler,
Combined | $ISTPA.3 = 618 (mW/cm2)$
$TI = 4.2$
$MI = 1.75$ | New |
| 10BP4 | Fetal, Trans-rectal, Trans-vaginal | B, M,
PWD,
Color Doppler,
Combined | $ISTPA.3 = 606 (mW/cm2)$
$TI = 0.99$
$MI = 1.75$ | New |
| 15XL4 | Abdominal, Pediatric, Small Organ
(Thyroid, Breast, Testes); Musculo-
skeletal (Conventional and
Superficial); Peripheral Vascular | B, M,
PWD,
Color Doppler,
Combined | $ISTPA.3 = 620 (mW/cm2)$
$TI = 3.3$
$MI = 1.8$ | New |

10

11

14L3 Transducer

Key Features	Subject Device Model	Comparable Predicate Device	Same or Different
	Terason uSmart3200T Plus 14L3
Transducer	Terason 15L4 Transducer
Device
Classification	Class II	Class II	Same
510(k) Number	KXXXXX	K193510	n/a
Indications for
Use	The transducer is intended to be
used with a conventional
ultrasound system (Terason
uSmart3200T Plus) to image
ophthalmic, abdomen, small
parts, musculo-skel, peripheral
vascular regions.	The transducer is intended to be
used with a conventional
ultrasound system (Terason
uSmart3200T) to image
ophthalmic, abdomen, small
parts, musculo-skel, 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.
Regarding Safety: Both arrays
allow focused transmission and
reception of ultrasound energy to
enhance image quality within the
region of interest.
Acoustic Array
Style:	Linear Transducer	Linear Transducer
Acoustic Array
Characteristics:
Element count...
Center
frequency
Element size
(diameter)...	128
5 MHz
0.3mm X 4.5mm	128
7.5 MHz
0.3mm X 4mm	Different.
The new transducer has the same
number of elements operating a
lower frequency for deeper
imaging.
Elevation focus...	20mm	16mm
Acoustic Array	The transducer performance has
been evaluated in an acoustic
tank.	The transducer performance has
been evaluated in the previous
510(k) filings (K193510).	Same. As the predicate device and
therefore has same acoustic
characteristics. To ensure proper
safety guidelines are met, acoustic
testing was performed per the
IEC60601-2-37 standard.
Patient Contact
Material	Silicone (proprietary)	Silicone R1001	Different.
The 14L3 has passed cytotoxicity,
sensitization, and irritation
biocompatibility tests.

Discussion:

There 14L3 has the same number of elements operating at a lower frequency than the predicate device used in this comparison. The transducer has been added to the uSmart3200T Plus Ultrasound system.

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 14L3 transducer is substantially equivalent to the predicate 15L4 transducer with respect to safety and effectiveness.

12

15XL4 Transducer

| Key Features | Subject Device Model
Terason 15XL4 Transducer | Comparable Predicate
Device
Terason 15WL4 Transducer | Same or Different |
|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | Class II | Class II | Same |
| 510(k) Number | K1XXXXX | K193510 | n/a |
| Indications for Use | The transducer is intended
to be used with a
conventional ultrasound
system (Terason
uSmart3200T Plus) to image
Abdominal, Pediatric,
Musculo-skeletal, Peripheral
Vascular. | The transducer is intended to
be used with a conventional
ultrasound system (Terason
uSmart3200T) to image
Abdominal, Pediatric,
Musculo-skeletal, Peripheral
Vascular. | Same. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Same. |
| Acoustic Array Style: | Linear Array | Linear Array | Same. Regarding Safety: This
array allows focused
transmission and reception of
ultrasound energy to enhance
image quality within the
region of interest. |
| Acoustic Array
Characteristics:
Element count... | 384 | 192 | Different.
Additional 192 elements
operating at the same
frequency. |
| Center frequency... | 6.3 MHz | 6.3 MHz | |
| Element size (pitch x
elevation)... | 0.286mm X 4mm | 0.286mm X 4mm | |
| Elevation focus... | 20mm | 16mm | |
| 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
(K193510). | Same. As the predicate
device and therefore has the
same acoustic characteristics.
To ensure proper safety
guidelines are met, acoustic
testing was performed per
the IEC60601-2-37 standard. |
| Patient Contact Material | SIM R1001 | SIM R1001 | Same. |
| Key Features | Subject Device Model | Comparable Predicate Devices | Same or Different |
| | Terason 10BP4 Transducer | Terason 10EC4 Transducer
Terason 15L4 Transducer | |
| Device Classification | Class II | Class II | Same |
| 510(k) Number | K1XXXXX | K193510 | n/a |
| Indications for Use | The transducer is intended
to be used with a
conventional ultrasound
system (Terason
uSmart3200T Plus) to image
Fetal, Trans-rectal, Trans-
vaginal. | The 10EC4 transducer is
intended to be used with a
conventional ultrasound
system (Terason
uSmart3200T) to image
Fetal, Trans-rectal, Trans-
vaginal. | Same.
Indications for Use. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Same.
Elements and shape are the
same. |
| Acoustic Array Style: | Linear and Micro-convex | Micro-convex (10EC4)
Linear (15L4) | |
| Manufacturer: | Vermon | Vermon | Same:
Same manufacturer. |
| Acoustic Array
Characteristics:
Element count...
Center frequency...
Element size (pitch x
elevation)...
ROC
Elevation focus... | 192 Curved and Linear
7.0 MHz
0.18mm X 4.2mm Curved
0.37mm X 5mm Linear
10 mm
20mm | 192 (10EC4) and 128 (15L4)
7.2 MHz (10EC4) 7.5 MHz
(15L4)
0.205mm X 5mm (10EC4)
0.3mm X 4mm (15L4),
8.8 mm (10EC4)
35 mm (10EC4), 16mm
(15L4) | Different.
The new 10BP4 provides a
slightly lower frequency
response. The 192 elements
have similar pitch and
elevation apertures compared
to the predicates. |
| 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
(K193510). | Same.
To ensure proper safety
guidelines are met, acoustic
testing was performed per
the IEC60601-2-37 standard. |
| Patient Contact Material | SIM R1002 (Silicone) | 15L4 transducer
SIM R1002 | Same.
The Silicone lens is identical
to the previously cleared
(K193510) 15L4 transducer
lens material |

The 15XL4 has an additional 192 elements that operate at the same frequency as the predicate device. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard. The 15XL4 transducer used with the uSmart3200T Plus consists of the same patient contact materials as the predicate device.

Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 15XL4 transducer meets safety and effectiveness guidelines.

13

10BP4 Transducer

14

The 10BP4 transducer is manufactured by Vermon that also makes other Terason transducers. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard. The 10BP4 transducer used with the uSmart3200T Plus consists of different contact materials when compared with the predicate device.

Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 10BP4 transducer meets safety and effectiveness guidelines.

Previously filed transducers:

The following transducers are identical to those previously cleared under FDA 510(k) K193510, May 9, 2015 for the Terason uSmart3200T:

. 4V2
. 5C2A
8EC4A ●
. 12L5A
15L4
. 16HL7
8L2
. 8TE3
8V3A
9MC3
PDOF
. 15L4A
રાજાર
. 15WL4
XY-Biplane
. 10EC4.

Conclusion:

The intended uses and features are consistent with the traditional clinical practices and FDA guidance of Diagnostic ultrasound systems and transducers. The uSmart3200T Plus and predicate device both conform to applicable electric safety medical device standards with compliance verified through independent evaluation. The uSmart3200T Plus and predicate device 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 uSmart3200T Plus ultrasound system is substantially equivalent with regards to safety and effectiveness to the predicate device.

15

9. Summary of Bench Tests and Non-Clinical Tests

The Terason uSmart3200T Plus system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).

AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 Medical electrical . equipment – Part 1: General requirements for safety and essential performance
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
EMC Test Report for the Terason uSmart3200T Plus .
. IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
Biocompatibility Tests, ISO 10993 Part 5, Part 10 and Part 12 ● ം Biocompatibility reports for the new transducers
AAMI TIR No. 12:210. Designing, Testing and Labeling Reusable . Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.

The ultrasound system acoustic output was tested in accordance with the following:

IEC 61157. Ed. 2 2007-2008. Standard Means for the Reporting of the . Acoustic Output of Medical Diagnostic Ultrasonic Equipment
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment, Revision 3
NEMA UD 3, Standard for Real-Time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2.

The ultrasound system B-Mode Accuracy, Doppler Accuracy and Doppler Sensitivity for each Terason transducer have been evaluated according to the following:

16

American Institute of Ultrasound in Medicine (AIUM) Quality Assurance . Manual for Gray-Scale Ultrasound Scanners
AIUM Methods for Measuring Performance of Pulse-Echo Ultrasound . Imaging Equipment, Part II: Digital Methods
AIUM Performance Criteria and Measurements for Doppler Ultrasound . Devices.

The Terason uSmart3200T Plus Software has undergone Quality Assurance testing consistent with IEC 62304, Software Life Cycle Process, and IEC 62366, Application for Usability.

The performance data used to validate the Terason uSmart3200T Plus and new transducers includes the following:

Acoustic output testing .
B-Mode accuracy, and Doppler accuracy and sensitivity .
General requirements for safety testing ●
Electromagnetic compatibility testing .
. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment testing
Biocompatibility testing of patient contact materials .
Burn-in testing ●
Software performance and regression testing. ●

10. Summary of Conclusions

The predicate system (uSmart3200T, K193510) and associated predicate transducers are legally marketed. The new system and associated transducers have the same intended use as the predicate system and devices. The Terason uSmart3200T Plus and associated transducers represent an improved implementation of familiar technology and therefore possess new technological characteristics that are validated in this filing.