Terason uSmart3200T Ultrasound System
Device Facts
| Record ID | K193510 |
|---|---|
| Device Name | Terason uSmart3200T Ultrasound System |
| Applicant | Teratech Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Jan 28, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The Teratech Corporation Terason™ uSmart3200T 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 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.
Device Story
Portable tablet-style diagnostic ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Proprietary ultrasound engine controls acoustic output and processes return echoes; data transferred via USB3 to tablet for image generation/display. Used in clinics, hospitals, or emergency settings by physicians or sonographers. Includes 11.5" touchscreen, integrated Lithium-Polymer battery, and docking station. Supports multiple imaging modes (B-Mode, Tissue Harmonic, M-Mode, Color/Power/PW Doppler). Provides clinicians with real-time visualization for diagnostic evaluation of human body structures and fluid flow. Benefits include portability for point-of-care use and expanded clinical utility via new transducer support.
Clinical Evidence
Bench testing only. Performance validated via acoustic output testing (NEMA UD 2, NEMA UD 3), B-Mode/Doppler accuracy and sensitivity testing (AIUM standards), electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1), and biocompatibility (ISO 10993). Software validated per IEC 62304 and IEC 62366. No clinical data presented.
Technological Characteristics
Portable tablet (Windows 10) with internal ultrasound engine. Transducers: Piezoelectric arrays (linear, phased, micro-convex, biplane). Connectivity: USB3. Power: Lithium-Polymer battery, medical-grade power supply. Materials: Silicone, Valox, RTV 630, SI 67. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993. Software: Ultrasound application for acoustic control and image processing.
Indications for Use
Indicated for ultrasound imaging and fluid flow analysis in ophthalmic, fetal, abdominal, intra-operative, pediatric, small organ (thyroid, breast, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-esophageal (cardiac/non-cardiac), musculo-skeletal, cardiac, and peripheral vascular applications. For use by qualified physicians or sonographers in clinical, hospital, or emergency settings.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Terason uSmart3200T Ultrasound System (K150533)
- Terason 4V2A Transducer (K150533)
- Terason 12L5A Transducer (K150533)
- Terason 15L4 Transducer (K150533)
- Terason 8EC4A Transducer (K150533)
Related Devices
- K201633 — Terason uSmart 3200T Plus Ultrasound System · Teratech Corporation · Jul 2, 2020
- K150533 — Terason uSmart3200T Ultrasound System · Teratech Corp. · May 9, 2015
- K113156 — SONOSITE EDGE ULTRASOUND SYSTEM · Sonosite,Inc. · Nov 15, 2011
- K152983 — FUJIFILM SonoSite iViz Ultrasound System · FUJIFILM Sonosite, Inc. · Nov 12, 2015
- K113663 — SONIXTABLET ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Jan 25, 2012
Submission Summary (Full Text)
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January 28, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Teratech Corporation % Mr. Mark Job Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K193510
Trade/Device Name: Terason uSmart3200T 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: January 17, 2020 Received: January 21, 2020
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. 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
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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 (QS) 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 mediation-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
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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: 06/30/2020 See P R A Statement on last page.
510(k) Number: K193510
Device Name
Terason uSmart3200T Ultrasound System
Indications for Use (Describe)
The Teratech Corporation Terason™ uSmart3200T is a prescription-only, generalpurpose Ultrasound System intended for use by a qualified physician or accredited sonographer for evaluation by ultrasound imaging or fluid flow 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 (noncardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), 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)
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FORM FDA 3881 (7/17)
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## 510(k) Summary
# K193510
### Teratech Corporation
### Terason uSmart3200T 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: August 15, 2018 Revised: January 6, 2020
### 2. Device Name
Proprietary Name: Terason uSmart3200T Ultrasound System Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer
Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550, 90-IYN) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)
### 3. Predicate Device
Terason™ uSmart3200T Ultrasound System (K150533)
Supporting Predicate Devices: Terason™ 4V2A Transducer (K150533) Terason™ 12L5A Transducer (K150533) Terason™ 15L4 Transducer (K150533) Terason™ 8EC4A Transducer (K150533)
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### 4. Intended Use
The Teratech Corporation Terason™ uSmart3200T 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 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. Device Description
The Terason uSmart3200T 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 Ultrasound System is equivalent to the previously cleared versions of the uSmart3200T Ultrasound Systems. The modification includes the addition of 6 transducers (5V1A. 15L4A. 16L5, 15WL4. XY-Biplane, 10EC4), the Ophthalmic IFU associated with the 15L4A transducer with no change to the tablet-style computer form factor.
The Terason™ uSmart3200T ultrasound system was the previously cleared on the date May 9, 2015 as described in the 510(k) submission (K150533). 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 ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11.5" backlit touch screen. The tablet dimensions (8.82"(H) x 12.64"(W) x 1.25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medical-grade power supply. The ultrasound transducer connector is identical to that used in the Terason™
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predicate device, the uSmart3200T. Optional accessories include a cart and printer.
# 6. Technology Characteristics
The design and construction of the Terason uSmart3200T is the same as the Terason uSmart3200T 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 system contains the same ultrasound engine as the predicate device Terason uSmart3200T 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 and the previous Terason uSmart3200T Ultrasound System (the predicate device) include the following:
- . Six transducers have been added to the system. The new Ophthalmic Indication for Use is associated with the 15L4A transducer. The software has been modified to control these transducers and ensure compliance to the standards controlling acoustic and thermal power.
- Added support for the 5V1A, 15L4A, 16L5, 15WL4, XY-Biplane, 10EC4 . transducers
- Confirmed transducer id numbers and names
- o Confirmed transducer geometries and characteristic parameters
- o Confirmed 5V1A, 15L4A, 16L5, 15WL4, XY-Biplane, 10EC4 and ophthalmic-15L4A acoustic tables
- o Added 5V1A, 15L4A, 16L5, 15WL4, XY-Biplane, 10EC4 to the table of allowed transducers
- o Added imaging presets for 5V1A. 15L4A. 16L5, 15WL4A, XY-Biplane, 10EC4 transducers. Added presets for the new 15L4A ophthalmic mode.
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# 7. Table of Similarities and Differences Compared to the Predicate Devices
Terason uSmart3200T System and Transducers Comparison and Discussion New Transducers 5V1A, 15L4A, 16L5, 15WL4, XY-Biplane, 10EC4 and for Ophthalmic Indication for Use 15L4A Previously cleared transducers (12L5A, 5C2A, 4V2A, 8EC4A, 16HL7, 15L4, 8L2, 8TE3, 8V3A, 9MC3) (K150533)
| | Subject Device Model | Comparable Predicate Device | Same or Different |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | Terason uSmart3200T | Terason uSmart3200T | |
| | (This Submission) | K150533 | |
| Intended Use | Diagnostic Ultrasound<br>imaging or fluid flow analysis<br>of the human body | Diagnostic Ultrasound<br>imaging or fluid flow analysis<br>of the human body | Same. |
| Indication for Use | Ophthalmic, Fetal,<br>Abdominal, Intra-operative<br>(Spec.), Pediatric, Small Organ<br>(Thyroid, Breast, Testes, etc.),<br>Neonatal Cephalic, Adult<br>Cephalic, Trans-rectal, Trans-<br>vaginal, Trans-esophageal<br>(non-Cardiac), Musculo-skel.<br>(Convent.), Musculo-skel.<br>(Superfic), Cardiac Adult,<br>Cardiac Pediatric, Trans-<br>esophageal (Cardiac),<br>Peripheral vessel | Ophthalmic, Fetal,<br>Abdominal, Intra-operative<br>(Spec.), Pediatric, Small Organ<br>(Thyroid, Breast, Testes, etc.),<br>Neonatal Cephalic, Adult<br>Cephalic, Trans-rectal, Trans-<br>vaginal, Trans-esophageal<br>(non-Cardiac), Musculo-skel.<br>(Convent.), Musculo-skel.<br>(Superfic), Cardiac Adult,<br>Cardiac Pediatric, Trans-<br>esophageal (Cardiac),<br>Peripheral vessel | Same. |
| Transducer Types | Linear Array<br>Curved Array<br>Phased Array<br>Endocavity - curved array<br>Hockey Stick - Linear<br>Trans-esophageal<br>PDOF<br>192-Element<br>XY-Biplane | Linear Array<br>Curved Array<br>Phased Array<br>Endocavity - curved array<br>Hockey Stick - Linear<br>Trans-esophageal<br>PDOF | Different: Support for 192-<br>elements and biplane<br>transducers. |
| Acoustic Output and FDA<br>Limits | Display Features for High<br>Outputs | Display Features for High<br>Outputs | Same. |
| Global Maximum<br>Outputs/Worst Case Setting | ISPTA.3: 660 mW/cm² (5C2A)<br>TI Type: TIC (15L4)<br>TI Value: 5.8 (15L4)<br>MI: 1.8 (Various)<br>IPA.3@MI Max: 829 W/cm²<br>(15L4) | ISPTA.3: 652.9 mW/cm² (4V2A)<br>TI Type: TIC (15L4)<br>TI Value: 5.8 (15L4)<br>MI: 1.78 (8EC4A)<br>IPA.3@MI Max: 827 W/cm²<br>(15L4) | Different. Within Guideline<br>limits. |
| Modes of Operation | B-Mode Grayscale Imaging<br>Tissue Harmonic Imaging<br>M-Mode (motion)<br>Anatomical M-Mode | B-Mode Grayscale Imaging<br>Tissue Harmonic Imaging<br>M-Mode (motion)<br>Anatomical M-Mode | Same. |
| | Color Power Doppler<br>Velocity Color Doppler<br>Duplex/Triplex – Doppler<br>imaging<br>Pulsed Wave (PW) Doppler<br>TeraVision II Postprocessing | Color Power Doppler<br>Velocity Color Doppler<br>Duplex/Triplex – Doppler<br>imaging<br>Pulsed Wave (PW) Doppler<br>TeraVision II Postprocessing | |
| PW Doppler | Available for all transducers<br>Triplex Mode<br>B-Mode and PW Doppler<br>High PRF | Available for all transducers<br>Triplex Mode<br>B-Mode and PW Doppler<br>High PRF | Same. |
| Transducer Frequency | 2.0 - 15.0 MHz | 2.0 - 15.0 MHz | Same. |
| #Transmit Channels | 192 Channels | 128 Channels | Different. Supports 192<br>elements. |
| # Receive Channels | 192 Channels | 128 Channels | Different. Supports 192<br>elements. |
| Acoustic Output<br>Measurement Standard | NEMA UD 2-2004<br>NEMA UD 3-2004 | NEMA UD 2-2004<br>NEMA UD 3-2004 | Same. |
| DICOM | DICOM 3.0 Structured<br>Reporting, Worklist - Image<br>Viewer | DICOM 3.0 Structured<br>Reporting, Worklist - Image<br>Viewer | Same. |
| Product Safety Certification | AAMI/ANSI ES 60601-<br>1:2005/(R)2012 and A1:2012<br>Medical electrical equipment<br>– Part 1: General<br>requirements for safety and<br>essential performance<br>IEC60601-1<br>IEC60601-1-2<br>IEC60601-1-6<br>IEC60601-2-37 | AAMI/ANSI ES 60601-<br>1:2005/(R)2012 and A1:2012<br>Medical electrical equipment<br>– Part 1: General<br>requirements for safety and<br>essential performance<br>IEC60601-1<br>IEC60601-1-2<br>IEC60601-1-6<br>IEC60601-2-37 | Same. |
| EMC | IEC60601-1-2<br>CISPR11 Class B | IEC60601-1-2<br>CISPR11 Class B | Same. |
| System<br>Characteristics | uSmart3200T:<br>tablet computer<br>weighs 4.9 lbs (2.21 Kg)<br>11.5" backlit touch screen.<br>Tablet dimensions (8.82"(H) x<br>12.64"(W) x 1.25"(D)).<br>A Lithium-Polymer battery<br>(integrated into the tablet)<br>provides 2 hours of<br>continuous ultrasound<br>scanning<br>Docking station (for charging)<br>that uses a medical-grade<br>power supply | uSmart3200T:<br>tablet computer<br>weighs 4.9 lbs (2.21 Kg)<br>11.5" backlit touch screen.<br>Tablet dimensions (8.82"(H) x<br>12.64"(W) x 1.25"(D)).<br>A Lithium-Polymer battery<br>(integrated into the tablet)<br>provides 2 hours of<br>continuous ultrasound<br>scanning<br>Docking station (for charging)<br>that uses a medical-grade<br>power supply | Different.<br>USB3 instead of IEEE 1394 |
| Data transferred to the tablet computer over a USB3 connection | Data transferred to the tablet computer over a FireWire (aka IEEE 1394) | | |
#### Terason uSmart3200T Tablet Computer
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Six transducers have been added to the Terason uSmart3200T in this submission: 5V1A, 15L4A, 16L5, 15WL4, XY-Biplane, 10EC4. The new indications for use (IFU) that are included in this submission are for Ophthalmic use with the high-frequency transducers.
# SUMMARY OF NEW AND ASSOCIATED PREDICATE TRANSDUCERS
| New Subject Transducer | Comparable Predicate Transducer | Predicate Approvals and Systems |
|------------------------|---------------------------------|---------------------------------|
| Terason 5V1A | Terason 4V2A | K150533 (Terason uSmart3200T) |
| Terason 15L4A | Terason 12L5A | K150533 (Terason uSmart3200T) |
| Terason 16L5 | Terason 15L4 | K150533 (Terason uSmart3200T) |
| Terason 15WL4 | Terason 15L4 | K150533 (Terason uSmart3200T) |
| Terason XY-Biplane | Terason 15L4 | K150533 (Terason uSmart3200T) |
| Terason 10EC4 | Terason 8EC4A | K150533 (Terason uSmart3200T) |
### TRANSDUCER PERFORMANCE SUMMARY
| Transducer | Indications | Mode | Global maximum output | 510(K)<br>control number |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|--------------------------|
| 12L5A | Ophthalmic, Abdominal, Pediatric,<br>Small Organ (breast, testes, thyroid),<br>Neonatal and Adult Cephalic,<br>Musculo-sketetal (Conventional and<br>Superficial), and Peripheral Vascular | B, M,<br>PWD,<br>Color Doppler,<br>Combined | $I_{STPA.3}$ = 597 (mW/cm²)<br>TI = 3.3<br>MI = 1.8 | K150533 |
| 4V2A | Fetal, Abdominal, Pediatric, Neonatal<br>and Adult Cephalic, Cardiac (adult<br>and pediatric) | B, M,<br>PWD,<br>Color Doppler,<br>CWD,<br>Combined | $I_{STPA.3}$ = 603 (mW/cm²)<br>TI = 5.6<br>MI = 1.5 | K150533 |
| 5C2A | Fetal, Abdominal, Pediatric, Small<br>Organ (Thyroid, Breast, Testes, etc.);<br>Musculo-sketetal (Conventional and<br>Superficial), Cardiac (adult and<br>pediatric) and Peripheral Vascular | B, M,<br>PWD,<br>Color Doppler,<br>Combined | $I_{STPA.3}$ = 660 (mW/cm²)<br>TI = 4.7<br>MI = 0.7 | K150533 |
| 8EC4A | Fetal, Trans-rectal, Trans-vaginal | B, M,<br>PWD,<br>Color Doppler,<br>Combined | $I_{STPA.3}$ = 633(mW/cm²)<br>TI = 2.29<br>MI = 1.8 | K150533 |
| 16HL7 | Intra-Operative (abdominal, organs<br>and vascular), Small Organ (Thyroid,<br>Breast, Testes); Musculo-skeletal<br>(Conventional and Superficial);<br>Peripheral Vascular. | B, M,<br>PWD,<br>Color Doppler,<br>Combined | $I_{STPA.3}$ = 554(mW/cm²)<br>TI = 1.22<br>MI = 1.6 | K150533 |
| 15L4 | Ophthalmic, Abdominal, Pediatric,<br>Small Organ (Thyroid, Breast,<br>Testes); Musculo-skeletal<br>(Conventional and Superficial);<br>Peripheral Vascular. | B, M,<br>PWD,<br>Color Doppler,<br>Combined | $I_{STPA.3}$ = 563(mW/cm²)<br>TI = 5.8<br>MI = 1.7 | K150533 |
| 8L2 | Abdominal, Pediatric, Musculo- | B, M, | $I_{STPA.3}$ = 598(mW/cm²) | K150533 |
| | skeletal, Peripheral Vascular | PWD,<br>Color Doppler,<br>Combined | TI = 2.8<br>MI = 1.7 | |
| 8V3A | Fetal, Abdominal, Pediatric, Cephalic,<br>and Cardiac | B, M,<br>PWD,<br>Color Doppler,<br>CWD,<br>Combined | ISTPA.3 = 560(mW/cm²)<br>TI = 4.7<br>MI = 1.7 | K150533 |
| 9MC3 | fetal, pediatric, small organs, cephalic<br>(neonatal and adult), cardiac and<br>peripheral vessels | B, M,<br>PWD,<br>Color Doppler,<br>CWD,<br>Combined | ISTPA.3 = 577(mW/cm²)<br>TI = 2.8<br>MI = 1.3 | K150533 |
| 8TE3 | Trans-esophageal (non-cardiac and<br>cardiac) | B, M,<br>PWD,<br>Color Doppler,<br>CWD,<br>Combined | ISTPA.3 = 245(mW/cm²)<br>TI = 1.0<br>MI = 1.3 | K150533 |
| PDOF | Cardiac | CWD | ISTPA.3 = 506(mW/cm²)<br>TI = 4.2<br>MI = 0.1 | K150533 |
| 5V1A | Fetal, Abdominal, Pediatric, Neonatal<br>and Adult Cephalic, Cardiac (adult<br>and pediatric) | B, M,<br>PWD,<br>Color Doppler,<br>CWD,<br>Combined | ISTPA.3 = 653 (mW/cm²)<br>TI = 5.6<br>MI = 1.7 | New |
| 15L4A | Ophthalmic, Abdominal, Pediatric,<br>Small Organ (Thyroid, Breast,<br>Testes); Musculo-skeletal<br>(Conventional and Superficial);<br>Peripheral Vascular | B, M,<br>PWD,<br>Color Doppler,<br>Combined | ISTPA.3 = 620 (mW/cm²)<br>TI = 1.8<br>MI = 1.7 | New |
| 16L5 | Ophthalmic, Abdominal, Pediatric,<br>Small Organ (Thyroid, Breast,<br>Testes); Musculo-skeletal<br>(Conventional and Superficial);<br>Peripheral Vascular | B, M,<br>PWD,<br>Color Doppler,<br>Combined | ISTPA.3 = 635 (mW/cm²)<br>TI = 1.6<br>MI = 1.7 | New |
| 15WL4 | Ophthalmic, Abdominal, Pediatric,<br>Small Organ (Thyroid, Breast,<br>Testes); Musculo-skeletal<br>(Conventional and Superficial);<br>Peripheral Vascular | B, M,<br>PWD,<br>Color Doppler,<br>Combined | ISTPA.3 = 624 (mW/cm²)<br>TI = 3.3<br>MI = 1.8 | New |
| XY-Biplane | Fetal, Abdominal, Pediatric, Neonatal<br>and Adult Cephalic, Cardiac (adult<br>and pediatric) | B, M,<br>PWD,<br>Color Doppler,<br>CWD,<br>Combined | ISTPA.3 = 650 (mW/cm²)<br>TI = 5.7<br>MI = 1.7 | New |
| 10EC4 | Fetal, Trans-rectal, Trans-vaginal | B, M,<br>PWD,<br>Color Doppler,<br>Combined | ISTPA.3 = 616 (mW/cm²)<br>TI = 2.56<br>MI = 1.56 | New |
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#### 5V1A Transducer
| Key Features | Subject Device Model<br>Terason 5V1A Transducer | Comparable Predicate<br>Device<br>Terason 4V2A Transducer | Same or Different |
|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXXX | K150533 | n/a |
| Indications for Use | The transducer is intended to<br>be used with a conventional<br>ultrasound system (Terason<br>uSmart3200T) to image<br>Fetal, Abdominal, Pediatric,<br>Cephalic, and Cardiac | The transducer is intended to<br>be used with a conventional<br>ultrasound system (Terason<br>uSmart3200T) to image<br>Fetal, Abdominal, Pediatric,<br>Cephalic, and Cardiac | Same. The proposed<br>transducer and the predicate<br>transducer have the identical<br>claim of imaging similar<br>regions in the human body. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Same.<br>Regarding Safety: Same.<br>Effectiveness: Both arrays<br>allow focused transmission |
| | | | and reception of ultrasound<br>energy to enhance image<br>quality within the region of<br>interest. |
| Acoustic Array Style: | Phased Array | Phased Array | |
| Acoustic Array<br>Characteristics:<br>Element count... | 64 | 64 | Same.<br>Identical pitch and center<br>frequency. External<br>components are used in the<br>5V1A to tune the transducer<br>array. |
| Center frequency... | 2.8 | 2.8 | |
| Element size (pitch x<br>elevation)... | 256 microns X 12mm | 256 microns X 12mm | |
| Elevation focus... | 16.3mm | 16.3mm | |
| Acoustic Array | The transducer imaging<br>performance has been<br>evaluated in an acoustic<br>tank. | The transducer performance<br>has been evaluated in the<br>previous 510(k) filing<br>(K150533). | Same: The 5V1A uses the<br>same acoustic array materials<br>as the predicate device and<br>therefore has same acoustic<br>characteristics. To ensure<br>proper safety guidelines are<br>met, acoustic testing was<br>performed per the IEC60601-<br>2-37 standard. |
| Patient Contact Material | Silicone Valox | Silicone Valox | Same: Biocompatible. |
| Key Features | Subject Device Model<br>Terason 15L4A Transducer | Comparable Predicate<br>Device<br>Terason 12L5A | Same or Different |
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K150533 | n/a |
| Indications for Use | The transducer is intended to<br>be used with a conventional<br>ultrasound system (Terason<br>uSmart3200T) to image<br>ophthalmic, abdomen, small<br>parts, musculo-skel,<br>peripheral vascular regions.<br>Ophthalmic is the new IFU. | The transducer is intended to<br>be used with a conventional<br>ultrasound system (Terason<br>uSmart3200T) to image<br>ophthalmic, abdomen, small<br>parts, musculo-skel,<br>peripheral vascular regions.<br>Ophthalmic included. | Same. The proposed<br>transducer and the predicate<br>transducer have the identical<br>claim of imaging similar<br>regions in the human body. |
| Acoustic Array Technology | Piezoelectric elements | Piezoelectric elements | Same |
| Transducer Style | Linear | Linear | Same. |
| Acoustic Array<br>Characteristics:<br>Element count... | 128 | 128 | Different.<br>Different element size and<br>elevation focus. |
| Center frequency... | 7.5 MHz | 7.5 MHz | |
| Element size (pitch x<br>elevation)... | 0.3mm X 4.25mm | 0.3mm X 4mm | |
| Elevation focus... | 16mm | 13mm | |
| Acoustic Output and Device<br>Settings | The transducer performance<br>has been evaluated in an<br>acoustic tank. | The transducer performance<br>has been evaluated in the<br>previous 510(k) filings<br>(K150533). | Same. |
| Patient Contact Material | RTV 630 | Silicone | Different. The 15L4A and the<br>predicate 12L5A transducers<br>are both manufactured by<br>Apex and consist of<br>comparable patient contact<br>materials. |
| Key Features | Subject Device Model<br>Terason uSmart3200T 16L5<br>Transducer | Comparable Predicate Device<br>Terason 15L4 Transducer | Same or Different |
| Device<br>Classification | ITX | ITX | Same |
| 510(k) Number | KXXXXXX | K150533 | n/a |
| Indications for<br>Use | The transducer is intended to be<br>used with a conventional<br>ultrasound system (Terason<br>uSmart3200T) to image<br>ophthalmic, abdomen, small<br>parts, musculo-skel, peripheral<br>vascular regions. | The transducer is intended to be<br>used with a conventional<br>ultrasound system (Terason<br>uSmart3200T) to image<br>ophthalmic, abdomen, small<br>parts, musculo-skel, peripheral<br>vascular regions. | Same. The proposed transducer<br>and the predicate transducer<br>have the identical claim of<br>imaging similar regions in the<br>human body. |
| Acoustic Array<br>Technology: | Piezoelectric elements | Piezoelectric elements | Same.<br>Regarding Safety: Both arrays<br>allow focused transmission and<br>reception of ultrasound energy to<br>enhance image quality within the<br>region of interest. |
| Acoustic Array<br>Style: | Linear Transducer | Linear Transducer | Different.<br>The new transducer has 64 more<br>elements operating at a higher<br>nominal center frequency. |
| Acoustic Array<br>Characteristics:<br>Element count...<br>Center<br>frequency<br>Element size<br>(diameter)...<br>Elevation focus... | 192<br>10 MHz<br>0.2mm X 3.5mm<br>16mm | 128<br>7.5 MHz<br>0.3mm X 4mm<br>16mm | |
| Acoustic Array | The transducer performance has<br>been evaluated in an acoustic<br>tank. | The transducer performance has<br>been evaluated in the previous<br>510(k) filings (K150533). | Same. As the predicate device<br>and therefore has same acoustic<br>characteristics. To ensure proper<br>safety guidelines are met,<br>acoustic testing was performed |
#### Discussion:
The 5V1A uses the same acoustic array materials as the predicate (4V2A) 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 transducer has been added to the uSmart3200T Ultrasound system.
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The 5V1A consists of same patient contact material as the predicate device. To ensure proper safety guidelines are met, biocompatibility tests were run on the patient contact materials.
______________________________________________________________________________________________________________________________________________________________________________
#### Transducer 15L4A
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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#### Discussion:
The 15L4A transducer exhibits a wider frequency range than the predicate device used in this comparison. The transducer has been added to the uSmart3200T Ultrasound system.
Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 15L4A transducer is substantially equivalent to the predicate 12L5A transducer with respect to safety and effectiveness.
#### 16L5 Transducer
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| Patient Contact Material | Silicone | Silicone R1001 | Same. The 16L5 transducer consists of a comparable patient contact material as the predicate device. |
|--------------------------|----------|----------------|------------------------------------------------------------------------------------------------------|
|--------------------------|----------|----------------|------------------------------------------------------------------------------------------------------|
#### Discussion:
There 16L5 has more elements operating at a higher frequency than the predicate device used in this comparison. The transducer has been added to the uSmart3200T Ultrasound system.
Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 16L5 transducer is substantially equivalent to the predicate 15L4 transducer with respect to safety and effectiveness.
#### 15WL4 Transducer
| Key Features | Subject Device Model | Comparable Predicate<br>Device | Same or Different |
|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| | Terason 15WL4 Transducer | Terason 15L4 Transducer | |
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K150533 | n/a |
| Indications for Use | The transducer is intended<br>to be used with a<br>conventional ultrasound<br>system (Terason<br>uSmart3200T) to image<br>Abdominal, Pediatric,<br>Musculo-skeletal, Peripheral<br>Vascular. | The transducer is intended to<br>be used with a conventional<br>ultrasound system (Terason<br>uSmart3200T) to image<br>Abdominal, Pediatric,<br>Musculo-skeletal, Peripheral<br>Vascular. | Same. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Same.<br>Same. Regarding Safety: This<br>array allows focused |
| Acoustic Array Style: | Linear Array | Linear Array | transmission and reception of<br>ultrasound energy to enhance<br>image quality within the<br>region of interest. |
| Acoustic Array<br>Characteristics:<br>Element count...<br>Center frequency...<br>Element size (pitch x<br>elevation)... | 192<br>9.0 MHz<br>0.3mm X 4mm | 128<br>7.5 MHz<br>0.3mm X 4mm | Different.<br>Additional 64 elements<br>operating at a higher<br>frequency. |
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| Elevation focus... | 16mm | 16mm | |
|--------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acoustic Array | The transducer imaging<br>performance has been<br>evaluated in an acoustic<br>tank. | The transducer performance<br>has been evaluated in the<br>previous 510(k) filing<br>(K150533). | Same. As the predicate<br>device and therefore has the<br>same acoustic characteristics.<br>To ensure proper safety<br>guidelines are met, acoustic<br>testing was performed per<br>the IEC60601-2-37 standard. |
| Patient Contact Material | SIM R1001 | SIM R1001 | Same. |
The 15WL4 has an additional 64 elements that operate at a higher frequency than the predicate device. To ensure proper safety guid…
