(84 days)
Not Found
No
The document describes standard ultrasound imaging and processing techniques, including 2D/3D imaging, Doppler, and multimodal image fusion. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is an imaging system designed to generate, visualize, and record ultrasound images for diagnostic purposes and organ mapping, rather than directly treating a disease or condition.
Yes
Explanation: The device is used to generate, visualize, and record 2D and 3D ultrasound images, and specifically in the context of prostate biopsy, to process, visualize, and record 3D digital ultrasound images to map the organ. This information is used by clinicians to aid in diagnosis and intervention planning.
No
The device description explicitly lists hardware components such as a mobile workstation with a central unit, screen, mouse, touch pen, footswitch, and ultrasonic probes. While it includes software for image processing and other functions, it is not solely software.
Based on the provided information, the TRINITY® Ultrasound and Medical Imaging Processing System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- TRINITY's Function: The TRINITY system is an ultrasound and medical imaging processing system. It uses ultrasound waves to create images of internal organs within the body (in vivo). It processes and visualizes these images for diagnostic and interventional purposes.
- Intended Use: The intended use clearly states it's for generating, visualizing, and recording ultrasound images, particularly for mapping organs during procedures like prostate biopsy. This is an imaging and guidance tool, not a device for analyzing biological samples.
- Device Description: The description details the components of an ultrasound system (workstation, probes, software) and how it generates and processes ultrasound signals. There is no mention of handling or analyzing biological specimens.
Therefore, the TRINITY system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants.
The device is indicated to generate, visualize and record 2D and 3D ultrasound images.
In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ.
Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.).
Patient population: all patients requiring an ultrasound scan or ultrasound-based intervention particularly in urology.
Product codes
IYN, IYO, ITX, LLZ
Device Description
TRINITY is an electro medical system considered as a system composed of:
- A mobile workstation composed by a central unit with ultrasound beamformer, a tactile . screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
- Ultrasonic probe: 2D/3D end-fire endocavity probe. Optionally 2D probes can be delivered: linear probe and abdominal probe.
- 3D PROSTATE SUITE PROMAP software composed of the base software and PROMAP –Ty that drives the ultrasound module and perform additional measuring functions.
The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz.
Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging for body fluid flow analysis.
- B-mode imaging measures the time and waveform differences between wave emission and . wave reception to reconstruct an image.
- . Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement).
The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.
The clinician can control acoustic output intensity with the TI and MI indices provided by the system. They indicate the level of thermal and mechanical stress that the system causes to the tissues, allowing the clinician to apply an ALARA-principle based exposure reduction strategy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, MRI
Anatomical Site
Abdominal (kidneys, bladder), Small Organs (scrotum, testicles), Endocavity (prostate)
Indicated Patient Age Range
all patients
Intended User / Care Setting
clinicians and their assistants, in a clinical 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 subject of this premarket submission did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2016
KOELIS % Mrs. Laetitia Gervais Quality and Regulatory Affairs Manager 5 Avenue du Grand Sablon La Tronche 38700 FRANCE
Re: K160357 Trade/Device Name: TRINITY Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, LLZ Dated: April 13, 2016 Received: April 18, 2016
Dear Ms. Gervais:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160357
Device Name TRINITY
Indications for Use (Describe)
TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants.
The device is indicated to generate, visualize and record 2D and 3D ultrasound images.
In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ.
Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.).
Patient population: all patients requiring an ultrasound scan or ultrasound-based intervention particularly in urology.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
3
510(k) number : K160357
ANNEX: INDICATIONS FOR USE TABLES (FOUND IN SECTION 14)
The indications with clinical applications and exam types along with the modes of operation for TRINITY are recorded in the following tables.
Combinations identified "P" for the probes represents those previously cleared with this or another KOELIS Ultrasound system and those identified and "N" are new.
TRINITY
System: TRINITY
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||
|---|---|---|---|
| Clinical Application | B [4] | B+Color Doppler* [6] | Other (Notes) |
| Ophtalmic | |||
| Fetal | |||
| Abdominal [1] | N | N | |
| Intra-operative (Specify) | |||
| Intra-operative (Neuro) | |||
| Laparoscopic | |||
| Pediatric | |||
| Small Organ [2] | N | N | |
| Neonatal Cephalic | |||
| Adult Cephalic | |||
| Transrectal | N | N | [5] |
| Trans-vaginal | N | N | |
| Trans-urethral | |||
| Trans-esoph. (non-Card.) | |||
| Musculo-skeletal | |||
| (Conventional) | N | N | |
| Musculo-skeletal | |||
| (Superficial) | N | N | |
| Intravascular | |||
| Other [3] | N | N | [5] |
| Cardiac Adult | |||
| Cardiac Pediatric | |||
| Intravascular (Cardiac) | |||
| Trans-esoph. (Cardiac) | |||
| Intra-cardiac | |||
| Other |
4
510(k) number : K160357
| Clinical Application | Mode of Operation | B [4] | B+Color Doppler* [6] | Other (Notes) |
|---|---|---|---|---|
| Peripheral vessel | ||||
| Other |
- Color Doppler (CFM)
NOTE
N = New indication; P =previously cleared by the FDA
[1] Abdominal includes for instance in urology kidneys and bladder
[2] Small organ includes for instance in urology scrotum and testicles
[3] Other use includes Urology / Prostate
[4] Includes volume-swept 3D B-Mode imaging
[5] Needle guidance imaging
[6] Combined modes are B+Color Doppler
2D LINEAR PROBE (K2DLN00)
System: TRINITY
Probe: 2D Linear probe (K2DLN00)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||
|---|---|---|---|
| B | B+Color Doppler* | Other (Notes) | |
| Ophtalmic | |||
| Fetal | |||
| Abdominal [1] | |||
| Intra-operative (Specify) | |||
| Intra-operative (Neuro) | |||
| Laparoscopic | |||
| Pediatric | |||
| Small Organ [2] | N | N | |
| Neonatal Cephalic | |||
| Adult Cephalic | |||
| Transrectal | |||
| Trans-vaginal | |||
| Trans-urethral | |||
| Trans-esoph. (non-Card.) | |||
| Musculo-skeletal | |||
| (Conventional) | N | N | |
| Musculo-skeletal | |||
| (Superficial) | N | N |
5
510(k) number : K160357
| Clinical Application | Mode of Operation | ||
|---|---|---|---|
| B | B+Color Doppler* | Other (Notes) | |
| Intravascular | |||
| Other [3] | |||
| Cardiac Adult | |||
| Cardiac Pediatric | |||
| Intravascular (Cardiac) | |||
| Trans-esoph. (Cardiac) | |||
| Intra-cardiac | |||
| Other | |||
| Peripheral vessel | |||
| Other |
- Color Doppler (CFM)
NOTE
N = New indication; P =previously cleared by FDA
[1] Abdominal includes for instance in urology kidneys and bladder
[2] Small organ includes for instance in urology scrotum and testicles
[3] Other use includes Urology / Prostate
2D ABDOMINAL PROBE (K2DAB00)
System: TRINITY
Probe: 2D abdominal probe (K2DAB00)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||
|---|---|---|---|
| B | B+Color Doppler* | Other (Notes) | |
| Ophtalmic | |||
| Fetal | |||
| Abdominal [1] | N | N | |
| Intra-operative (Specify) | |||
| Intra-operative (Neuro) | |||
| Laparoscopic | |||
| Pediatric | |||
| Small Organ [2] | |||
| Neonatal Cephalic |
6
| TRADITIONAL 510(K) | ||||
|---|---|---|---|---|
| Image: KOELIS logo | 510(k) Number: | K160357 | Version: | 1.0 |
| Pr-Name: | TRINITY | Date: | 2016.02.01 |
5 510(K) SUMMARY OR 510(K) STATEMENT
510(k) Summary for TRINITY
The 510(k) summary is submitted in accordance with the requirements of.
| 510(k) Owner | KOELIS
5 avenue du Grand Sablon
38700 La Tronche
FRANCE
Phone: +33 476 637 587
Fax: +33 476 549 561 |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Ms Laetitia GERVAIS
Quality and Regulatory Affairs Manager
Mail: gervais@koelis.com
Phone: +33 476 637 587
Fax: +33 476 549 561 |
| Date Prepared | February 1st, 2016 |
Proposed Device:
| Trade Name | TRINITY |
|---|---|
| Common Name | Ultrasound and Medical Imaging Processing System |
| Classification Name | Ultrasonic Pulsed Doppler Imaging System (21CFR 892.1550) |
| Ultrasonic Pulsed Echo Imaging System (21CFR 892.1560) | |
| Diagnostic Ultrasound Probe (21CFR 892.1570) | |
| System, Image processing, Radiological - Picture archiving and | |
| communication system -21CFR 892.2050) | |
| Device Class | Class II |
| Product Code | IYN (21CFR 892.1550) |
| IYO (21CFR 892.1560) | |
| ITX (21CFR 892.1570) | |
| LLZ (21CFR 892.2050) |
Cleared Device:
The device is substantially equivalent to:
| 510(k) Number | Device Name |
|---|---|
| K141261 | LOGIQ S7 Expert and LOGIQ S7 Pro (GE Healthcare) |
| K131448 | UROSTATION - 3D PROSTATE SUITE (KOELIS) |
KOELIS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)476 637 587 www.koelis.com ©KOELIS SAS, RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenoble. Code APE 7112B
7
| Image: KOELIS logo | TRADITIONAL 510(K) | ||
|---|---|---|---|
| 510(k) Number: | K160357 | Version: | 1.0 |
| Pr-Name: | TRINITY | Date: | 2016.02.01 |
Intended Use:
TRINITY® Ultrasound and Medical Imaging Processing System and its probes are intended for diagnostic ultrasound imaging and analysis of fluids from the human body.
lt is intended to be used by clinicians who are qualified to perform ultrasound diagnoses, in a clinical setting.
TRINITY® has been optimized for use in urological applications: Abdominal (kidneys, bladder, etc.), Small Organs (scrotum, testicles, etc.), Endocavity (prostate, etc.).
Indications for Use:
TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants.
The device is indicated to generate, visualize and record 2D and 3D ultrasound images.
In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ.
Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.).
Patient population: all patients requiring an ultrasound-based intervention particularly in urology.
Device Description:
TRINITY is an electro medical system considered as a system composed of:
- A mobile workstation composed by a central unit with ultrasound beamformer, a tactile . screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
- Ultrasonic probe: 2D/3D end-fire endocavity probe. Optionally 2D probes can be delivered: linear probe and abdominal probe.
- 3D PROSTATE SUITE PROMAP software composed of the base software and PROMAP –Ty that drives the ultrasound module and perform additional measuring functions.
The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz.
Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging for body fluid flow analysis.
| OMS TITLE | Traditional 510/k) | C | FOR8302 | Dagon 11 of 00 | |||
|---|---|---|---|---|---|---|---|
| TI OFF TO F | 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 | ADDOCT M | . DD LITOR M 1 . 00 (0) 196 (00 . 00 |
KOELIS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)476 637 587 www.koelis.com ©KOELIS SAS, RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenoble. Code APE 7112B
8
| Image: KOELIS logo | TRADITIONAL 510(K) |
|---|---|
| 510(k) Number: | K160357 Version: 1.0 |
| Pr-Name: | TRINITY Date: 2016.02.01 |
- B-mode imaging measures the time and waveform differences between wave emission and . wave reception to reconstruct an image.
- . Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement).
The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.
The clinician can control acoustic output intensity with the TI and MI indices provided by the system. They indicate the level of thermal and mechanical stress that the system causes to the tissues, allowing the clinician to apply an ALARA-principle based exposure reduction strategy.
Technological Characteristics compared with the cleared device:
TRINITY employs the same fundamental scientific technology as its predicate devices.
TRINITY is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- . TRINITY and predicate TRINITY system have the same clinical intended use (TRINITY has less clinical intended use than its predicate).
- TRINITY and predicate TRINITY systems have the same imaging modes.
- TRINITY and predicate TRINITY systems probes are identical. ●
- The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- The systems have acoustic power levels which are below the applicable FDA limits.
- TRINITY and predicate TRINITY systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . TRINITY integrates the software UROSTATION 3D PROSTATE SUITE (predicate K131448), which is intended to process, visualize and record 3D digital ultrasound images of the prostate.
- TRINITY and predicate systems have been designed in compliance with approved electrical and physical safety standards.
Summary of Non-Clinical Tests
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to compliant with applicable medical device safety standards. TRINITY and its applications comply with voluntary standards:
1. AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
| QMS TITLE | Traditional 510(k) | ID FOR8302 | Page 12 of 99 |
|---|---|---|---|
| KOELIS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)476 637 587 www.koelis.com |
©KOELIS SAS, RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenoble. Code APE 7112B
9
| TRADITIONAL 510(K) | ||||||
|---|---|---|---|---|---|---|
| Contral College of Contraction of Contraction of Contraction of Contraction of Contraction of Contraction of Contraction of Contribution of Constituding Comments of Constitud | 510(k) Number: | K160357 | Version: 1.0 | |||
| Pr-Name: | TRINITY | Date: | 2016.02.01 |
-
IEC60601-1-2, Medical Electrical Equipment - Part I - 2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests
-
IEC60601-2-37, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
-
NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
-
ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing
-
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
-
ISO14971, Application of risk management to medical devices: Second edition
-
NEMA Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures are applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- . Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final Acceptance Testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification) ●
Probe materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission did not require clinical studies to support substantial equivalence.
Conclusion:
KOELIS considers TRINITY to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
| QMS TITLE | Traditional 510(k) | ID | FOR8302 | Page 13 of 99 |
|---|---|---|---|---|
| ----------- | -------------------- | ---- | --------- | --------------- |
KOELIS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)476 637 587 www.koelis.com ©KOELIS SAS, RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenoble. Code APE 7112B