(41 days)
Not Found
No
The document does not mention AI, ML, or any related technologies. The description focuses on standard ultrasound processing and hardware modifications.
No
Explanation: The device is described as a "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," and a "diagnostic ultrasound system." Its purpose is for imaging and analysis, not for treatment.
Yes
The "Device Description" explicitly states, "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."
No
The device description explicitly states it is a "portable tablet-style, fullfeature, general purpose diagnostic ultrasound system" and mentions hardware components like a "proprietary ultrasound engine," "tablet computer," "USB3 connection," "transducer connector," "Lithium-Polymer battery," and "docking station." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Teratech Corporation Terason™ uSmart3200T is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Intended Use: The intended use of the Terason™ uSmart3200T is for ultrasound imaging or fluid flow analysis of the human body. This involves using sound waves to create images of internal structures, which is an in vivo (within the living body) process, not an in vitro (in glass/outside the body) process.
- Device Description: The device description clearly states it's a "general purpose diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data". This aligns with in vivo imaging.
- Input Imaging Modality: The input modality is Ultrasound, which is an in vivo imaging technique.
The device is a diagnostic imaging system that operates by interacting directly with the patient's body, not by analyzing specimens taken from the body.
N/A
Intended Use / Indications for Use
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 (non-cardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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™ predicate device, the uSmart3200T. Optional accessories include a cart and printer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging
Anatomical Site
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-skel. (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.
Indicated Patient Age Range
Neonatal, Adult, Pediatric
Intended User / Care Setting
Qualified physician or accredited sonographer. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Terason uSmart3200T 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
- 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 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 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.
Key results: Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 15WL4 transducer meets safety and effectiveness guidelines. Teratech Corporation, Inc. believes the Terason Biplane transducer meets safety and effectiveness guidelines. Teratech Corporation, Inc. believes the Terason 10EC4 transducer meets safety and effectiveness guidelines. The intended uses and features are consistent with the traditional clinical practices and FDA guidance of Diagnostic ultrasound systems and transducers. The uSmart3200T and predicate device both conform to applicable electric safety medical device standards with compliance verified through independent evaluation. The uSmart3200T 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 ultrasound system is substantially equivalent with regards to safety and effectiveness to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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 (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
2
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)
3
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™
5
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.
6
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 | ||
| 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 | |||
| XY-Biplane | Linear Array | ||
| Curved Array | |||
| Phased Array | |||
| Endocavity - curved array | |||
| Hockey Stick - Linear | |||
| Trans-esophageal | |||
| PDOF | Different: Support for 192- | ||
| 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: 660 mW/cm² (5C2A) | ||
| TI Type: TIC (15L4) | |||
| TI Value: 5.8 (15L4) | |||
| MI: 1.8 (Various) | |||
| IPA.3@MI Max: 829 W/cm² | |||
| (15L4) | 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 | |||
| (15L4) | Different. Within Guideline | ||
| limits. | |||
| Modes of Operation | B-Mode Grayscale Imaging | ||
| Tissue Harmonic Imaging | |||
| M-Mode (motion) | |||
| Anatomical M-Mode | B-Mode Grayscale Imaging | ||
| Tissue Harmonic Imaging | |||
| M-Mode (motion) | |||
| Anatomical M-Mode | Same. | ||
| Color Power Doppler | |||
| Velocity Color Doppler | |||
| Duplex/Triplex – Doppler | |||
| imaging | |||
| Pulsed Wave (PW) Doppler | |||
| TeraVision II Postprocessing | Color Power Doppler | ||
| Velocity Color Doppler | |||
| Duplex/Triplex – Doppler | |||
| imaging | |||
| Pulsed Wave (PW) Doppler | |||
| TeraVision II 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 | Same. | ||
| Transducer Frequency | 2.0 - 15.0 MHz | 2.0 - 15.0 MHz | Same. |
| #Transmit Channels | 192 Channels | 128 Channels | Different. Supports 192 |
| elements. | |||
| # Receive Channels | 192 Channels | 128 Channels | Different. Supports 192 |
| elements. | |||
| Acoustic Output | |||
| Measurement Standard | NEMA UD 2-2004 | ||
| NEMA UD 3-2004 | 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: | ||
| 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) | |||
| provides 2 hours of | |||
| continuous ultrasound | |||
| scanning | |||
| Docking station (for charging) | |||
| that uses a medical-grade | |||
| power supply | 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) | |||
| provides 2 hours of | |||
| continuous ultrasound | |||
| scanning | |||
| Docking station (for charging) | |||
| that uses a medical-grade | |||
| power supply | Different. | ||
| 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
7
8
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)
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 | $I_{STPA.3}$ = 597 (mW/cm²)
TI = 3.3
MI = 1.8 | K150533 |
| 4V2A | Fetal, Abdominal, Pediatric, Neonatal
and Adult Cephalic, Cardiac (adult
and pediatric) | B, M,
PWD,
Color Doppler,
CWD,
Combined | $I_{STPA.3}$ = 603 (mW/cm²)
TI = 5.6
MI = 1.5 | K150533 |
| 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 | $I_{STPA.3}$ = 660 (mW/cm²)
TI = 4.7
MI = 0.7 | K150533 |
| 8EC4A | Fetal, Trans-rectal, Trans-vaginal | B, M,
PWD,
Color Doppler,
Combined | $I_{STPA.3}$ = 633(mW/cm²)
TI = 2.29
MI = 1.8 | K150533 |
| 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 | $I_{STPA.3}$ = 554(mW/cm²)
TI = 1.22
MI = 1.6 | K150533 |
| 15L4 | Ophthalmic, Abdominal, Pediatric,
Small Organ (Thyroid, Breast,
Testes); Musculo-skeletal
(Conventional and Superficial);
Peripheral Vascular. | B, M,
PWD,
Color Doppler,
Combined | $I_{STPA.3}$ = 563(mW/cm²)
TI = 5.8
MI = 1.7 | K150533 |
| 8L2 | Abdominal, Pediatric, Musculo- | B, M, | $I_{STPA.3}$ = 598(mW/cm²) | K150533 |
| | skeletal, Peripheral Vascular | PWD,
Color Doppler,
Combined | TI = 2.8
MI = 1.7 | |
| 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 | K150533 |
| 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 | K150533 |
| 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 | K150533 |
| PDOF | Cardiac | CWD | ISTPA.3 = 506(mW/cm²)
TI = 4.2
MI = 0.1 | K150533 |
| 5V1A | Fetal, Abdominal, Pediatric, Neonatal
and Adult Cephalic, Cardiac (adult
and pediatric) | B, M,
PWD,
Color Doppler,
CWD,
Combined | ISTPA.3 = 653 (mW/cm²)
TI = 5.6
MI = 1.7 | New |
| 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 | New |
| 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 | New |
| 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 | New |
| 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 | New |
| 10EC4 | Fetal, Trans-rectal, Trans-vaginal | B, M,
PWD,
Color Doppler,
Combined | ISTPA.3 = 616 (mW/cm²)
TI = 2.56
MI = 1.56 | New |
9
10
5V1A Transducer
| Key Features | Subject Device Model
Terason 5V1A Transducer | Comparable Predicate
Device
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
be used with a conventional
ultrasound system (Terason
uSmart3200T) to image
Fetal, Abdominal, Pediatric,
Cephalic, and Cardiac | The transducer is intended to
be used with a conventional
ultrasound system (Terason
uSmart3200T) 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: Same.
Effectiveness: Both arrays
allow focused transmission |
| | | | and reception of ultrasound
energy to enhance image
quality within the region of
interest. |
| Acoustic Array Style: | Phased Array | Phased Array | |
| Acoustic Array
Characteristics:
Element count... | 64 | 64 | Same.
Identical pitch and center
frequency. External
components are used in the
5V1A to tune the transducer
array. |
| 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
(K150533). | Same: The 5V1A uses the
same acoustic array materials
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 Valox | Silicone Valox | Same: Biocompatible. |
| Key Features | Subject Device Model
Terason 15L4A Transducer | Comparable Predicate
Device
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
be used with a conventional
ultrasound system (Terason
uSmart3200T) to image
ophthalmic, abdomen, small
parts, musculo-skel,
peripheral vascular regions.
Ophthalmic is the new IFU. | 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.
Ophthalmic included. | 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 |
| Transducer Style | Linear | Linear | Same. |
| Acoustic Array
Characteristics:
Element count... | 128 | 128 | Different.
Different element size and
elevation focus. |
| Center frequency... | 7.5 MHz | 7.5 MHz | |
| Element size (pitch x
elevation)... | 0.3mm X 4.25mm | 0.3mm X 4mm | |
| Elevation focus... | 16mm | 13mm | |
| Acoustic Output and Device
Settings | The transducer performance
has been evaluated in an
acoustic tank. | The transducer performance
has been evaluated in the
previous 510(k) filings
(K150533). | Same. |
| Patient Contact Material | RTV 630 | Silicone | Different. The 15L4A and the
predicate 12L5A transducers
are both manufactured by
Apex and consist of
comparable patient contact
materials. |
| Key Features | Subject Device Model
Terason uSmart3200T 16L5
Transducer | Comparable Predicate Device
Terason 15L4 Transducer | Same or Different |
| Device
Classification | ITX | ITX | Same |
| 510(k) Number | KXXXXXX | K150533 | n/a |
| Indications for
Use | 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. | 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 | Different.
The new transducer has 64 more
elements operating at a higher
nominal center frequency. |
| Acoustic Array
Characteristics:
Element count...
Center
frequency
Element size
(diameter)...
Elevation focus... | 192
10 MHz
0.2mm X 3.5mm
16mm | 128
7.5 MHz
0.3mm X 4mm
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 (K150533). | Same. As the predicate device
and therefore has same acoustic
characteristics. To ensure proper
safety guidelines are met,
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.
11
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
12
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
13
| 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
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
to be used with a
conventional ultrasound
system (Terason
uSmart3200T) 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.
Same. Regarding Safety: This
array allows focused |
| Acoustic Array Style: | Linear Array | Linear Array | 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)... | 192
9.0 MHz
0.3mm X 4mm | 128
7.5 MHz
0.3mm X 4mm | Different.
Additional 64 elements
operating at a higher
frequency. |
14
| Elevation focus... | 16mm | 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 | |||
| (K150533). | 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. |
The 15WL4 has an additional 64 elements that operate at a higher frequency than the predicate device. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard. The 15WL4 transducer used with the uSmart3200T 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 15WL4 transducer meets safety and effectiveness guidelines.
XY-Biplane Transducer
| Key Features | Subject Device Model | Comparable Predicate
Device | Same or Different |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | Terason Biplane Transducer | Terason 15L4 Transducer | |
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K150533 | n/a |
| Indications for Use | The transducer is intended
to be used with a
conventional ultrasound
system (Terason
uSmart3200T) to image
Fetal, Abdominal, Pediatric,
Cephalic, and Cardiac. | The transducer is intended
to be used with a
conventional ultrasound
system (Terason
uSmart3200T) to image
Abdominal, Pediatric,
Musculo-skeletal, Peripheral
Vascular. | Different.
Different indications for use. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Different. |
| Acoustic Array Style: | Biplane Phased Array | Linear Array | Different.
Different array types but
same manufacturer
(Vermon). |
| Acoustic Array
Characteristics: | | | Different. |
| Element count... | 128 (2 x 64 orthogonal) | 128 | Biplane operates at a lower |
| Center frequency... | 2.8 MHz | 7.5 MHz | frequency. Identical number |
| Element size (pitch x | 0.28mm X 18mm | 0.3mm X 4mm | of linear elements, however,
in a different configuration. |
15
| elevation)
Elevation focus | TBD | 16mm | Significantly taller elements
with comparable width. |
|-------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
(K150533). | Same. As the predicate
device and therefore has
identical 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. |
The XY-Biplane transducer is a dual phased array made by the same manufacturer as the 15L4 transducer (Vermon). To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard. The Biplane transducer used with the uSmart3200T 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 Biplane transducer meets safety and effectiveness guidelines.
10EC4 Transducer
| Key Features | Subject Device Model | Comparable Predicate
Device | Same or Different |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | Terason 10EC4 Transducer | Terason 8EC4A Transducer | |
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXXX | K150533 | n/a |
| Indications for Use | The transducer is intended
to be used with a
conventional ultrasound
system (Terason
uSmart3200T) to image
Fetal, Trans-rectal, Trans-
vaginal. | The 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: | Micro-convex | Micro-convex | Same. |
| Manufacturer: | Vermon | Apex | Different:
New manufacturer for EC
transducer. |
| Acoustic Array
Characteristics: | | | Different.
The new 10EC4 provides |
16
| Element count... | 192 | 128 | higher frequency response.
192 elements with finer pitch
and larger elevation
aperatures are used in the
new transducer. The
elevation focus is over 2:1. |
|----------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Center frequency... | 7.2 MHz | 6.5 MHz | |
| Element size (pitch x
elevation)... | 0.144mm X 6mm | 0.205mm X 5mm | |
| ROC | 8.8mm | 10mm | |
| Elevation focus... | 35mm | 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
(K150533). | Same.
To ensure proper safety
guidelines are met, acoustic
testing was performed per
the IEC60601-2-37 standard. |
| Patient Contact Material | SI 67 | RTV 664 | Different.
Different Silicone material.
The material has passed
biocompatibility tests. |
The 10EC4 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 10EC4 transducer used with the uSmart3200T 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 10EC4 transducer meets safety and effectiveness guidelines.
Previously filed transducers:
The following transducers are identical to those previously cleared under FDA 510(k) K150533, May 9, 2015 for the Terason uSmart3200T:
- 4V2
- 5C2A
- 8EC4A
- 12L5A ●
- 15L4
- 16HL7
- . 8L2
- 8TE3 ●
- . 8V3A
- 9MC3 ●
- PDOF. ●
Conclusion:
The intended uses and features are consistent with the traditional clinical practices and FDA guidance of Diagnostic ultrasound systems and transducers. The uSmart3200T and predicate device both conform to applicable electric safety medical device standards with compliance verified through independent evaluation. The uSmart3200T 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 ultrasound system is substantially equivalent with regards to safety and effectiveness to the predicate device.
17
8. Summary of Bench Tests and Non-Clinical Tests
The Terason uSmart3200T 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 .
- . 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:
18
- 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 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 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. ●
9. Summary of Conclusions
The predicate system (uSmart3200T, K150533) and associated predicate transducers (Terason 4V2A, 12L5A, 15L4, 8EC4A) are legally marketed. The new system and associated transducers have the same intended use as the predicate system and devices. The Terason uSmart3200T and associated transducers represent a new implementation of familiar technology and therefore possess new technological characteristics that are validated in this filing.