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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the TRINITY Ultrasound and Medical Imaging Processing System. While it provides detailed information about the device's intended use, technological characteristics, and compliance with safety standards, it explicitly states that "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria because a clinical study was not performed as part of this submission. The submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study.

Here's what can be inferred from the document regarding the information requested, based on the absence of a clinical study:

1. A table of acceptance criteria and the reported device performance:

This information is not provided because no clinical study was conducted. The document focuses on demonstrating equivalence to predicate devices based on technical specifications and non-clinical tests.

2. Sample size used for the test set and the data provenance:

Not applicable, as no clinical test set was used for a study proving device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set requiring ground truth was used for a study proving device performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set requiring adjudication was used for a study proving device performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study was performed. The device is an ultrasound system and processing software, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study comparing human readers with and without AI assistance for a specific clinical task.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The TRINITY system is an ultrasound and medical imaging processing system intended to be used by clinicians. It is not an algorithm-only standalone diagnostic tool. Its performance is inherent to the generation, visualization, and recording of ultrasound images, and processing of 3D digital ultrasound images for tasks like organ mapping (with the 3D PROSTATE SUITE SOFTWARE).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no clinical study required establishing ground truth for performance evaluation of "new" clinical results.

8. The sample size for the training set:

Not applicable, as no clinical study with a training set was performed for this submission. The device leverages existing technology and previously cleared software (UROSTATION - 3D PROSTATE SUITE, K131448).

9. How the ground truth for the training set was established:

Not applicable, as no clinical study with a training set was performed for this submission.

Summary from the document:

Basis for Approval: Substantial equivalence to predicate devices (LOGIQ S7 Expert and LOGIQ S7 Pro (GE Healthcare) K141261, and UROSTATION - 3D PROSTATE SUITE (KOELIS) K131448).
Non-Clinical Tests: Acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety were evaluated and found compliant with applicable medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set).
Clinical Studies: None were required or performed for this premarket submission to support substantial equivalence.

Summary

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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

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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: 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.

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

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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

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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

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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

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	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	KOELIS5 avenue du Grand Sablon38700 La TroncheFRANCEPhone: +33 476 637 587Fax: +33 476 549 561
Contact Name:	Ms Laetitia GERVAISQuality and Regulatory Affairs ManagerMail: gervais@koelis.comPhone: +33 476 637 587Fax: +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 andcommunication 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

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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.

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

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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.

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

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	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
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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

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.