Novasight Hybrid System

K172258 · Conavi Medical, Inc. · OBJ · Apr 27, 2018 · Cardiovascular

Device Facts

• Record ID: K172258
• Device Name: Novasight Hybrid System
• Applicant: Conavi Medical, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Apr 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

Device Story

The Novasight Hybrid System provides real-time, minimally-invasive guidance for transluminal interventional procedures. It utilizes a 3Fr single-use sterile catheter to perform simultaneous ultrasound (IVUS) and optical coherence tomography (OCT) imaging of coronary arteries. The system consists of a cart-based console with an Acquisition and Display Module (ADM) and a Patient Interface Module (PIM). The catheter contains a single imaging element that is mechanically rotated to acquire data. The system produces co-registered 2D side-viewing images and post-processed rendered longitudinal images of vessel anatomy, including healthy tissue and stent struts. It is used in a cath lab setting by physicians and technologists. The physician controls image acquisition via the PIM, while the technologist manages the system software via touchscreen, trackpad, or keyboard. The output allows clinicians to visualize vessel features, device spatial relationships, and complications like perforation, aiding in procedural decision-making and potentially improving patient outcomes during interventions.

Clinical Evidence

No clinical data included. Substantial equivalence is based on non-clinical performance data, including bench-top evaluations, risk analysis, packaging validation, biocompatibility, and electrical safety testing.

Technological Characteristics

Hybrid IVUS/OCT imaging system. Catheter: 3Fr, single-use, sterile, thermopolymer sheath, monorail delivery. Imaging: 40MHz ultrasound and 1310nm optical wavelength. Mechanical rotation of imaging element. Connectivity: DICOM and native format storage. Electrical safety: IEC 60601-1, IEC 60601-2-37. Sterilization: Radiation (ISO 11137). Software: Version 2.0 (2.0.6607.31062).

Indications for Use

Indicated for intravascular imaging of coronary arteries in patients who are candidates for transluminal interventional procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Volcano Corporation, Revolution™ 45 MHz Rotational Imaging Catheter (K050995)
• Lightlab Imaging, Ilumien Optis, Dragonfly Optis Imaging Catheter (K141453)
• Volcano s5s5i Series Intravascular Imaging and Pressure Systems (K071554)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are displayed side-by-side.

April 27, 2018

Conavi Medical Inc. Sam Mostafavi Director of Regulatory 293 Lesmill Road North York, ON, Canada M3B 2V1

Re: K172258

Trade/Device Name: Novasight Hybrid System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, NQQ, IYO Dated: March 24, 2018 Received: March 26, 2018

Dear Sam Mostafavi:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

M.A. Hillebrenner

for, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K172258

Device Name Novasight Hybrid System

### Indications for Use (Describe)

The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

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

| <span style="font-size:12px">☒ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) Summarv

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## 510(k) Number: K172258

## Applicant Information:

| Date Prepared: | March 16, 2018 |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Name: | Conavi Medical Inc. |
| Address: | 293 Lesmill Road<br>North York, ON, Canada M3B 2V1 |
| Contact Person: | Sam Mostafavi<br>[e-mail] |
| Mobile Number: | [phone] |
| Office Number: | [phone] |
| Facsimile Number: | [phone] |
| Device Information: | |
| Trade/Proprietary Name: | Novasight Hybrid System |
| Common Name: | Novasight Hybrid System |
| Classification Name: | Diagnostic Intravascular Catheters, 21 CFR 870.1200<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560 |
| Product Code | OBJ, NQQ, IYO |
| Class: | Class II |
| Panel: | Division of Cardiovascular Devices |

## Predicate Device:

## Primary:

- · Volcano Corporation, Revolution™ 45 MHz Rotational Imaging Catheter K050995
## Secondary:

- Lightlab Imaging, Ilumien Optis, Dragonfly Optis Imaging Catheter K141453
- · Volcano s5s5i Series Intravascular Imaging and Pressure Systems K071554

## Device Description

The Novasight™ Hybrid System is intended for real-time, minimally-invasive guidance of transluminal interventional procedures. The system provides image information of coronary vessel anatomic features, spatial relationships of other devices within the coronary

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arteries, and intra-procedural complications such as perforation.

The system is comprised of a catheter and a cart based console. The console includes the Acquisition and Display Module (ADM) for image acquisition, display and manipulation as well as the Patient Interface Module (PIM) which the catheter connects to. The ADM has two monitors to allow for ease of image view and review for both the technologist and the physician users. The technologist user is able to control the system software via an easy to use interface using multiple methods of input including a trackpad, keyboard and/or a touch screen. Casters on the ADM allow easy movement of the system throughout a cath lab which can have a small footprint as well as small obstacles to cross. The PIM has a user interface for the physician to have control over the acquisition. It is also compact such that it can be moved and handled by an able-bodied user. The system includes software build version 2.0 (2.0.6607.31062).

The catheter is a 3Fr single use, sterile device, which is able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. The imaging system is able to resolve features within coronary arteries such as healthy tissue and stent struts. The physician user has the ability to manually position the imaging sensor as well as perform pullback (automatically or manually trigger) for defined regions of interest.

## Indications for Use

The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

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## nctional and Technological Compar

ables 1 and 2 below include functional and technological comparison between Conavi Medical Novasigh Hybrid System and FDA a
arketed systems.

1 provides functional and technological comparison of Conavi Medical Novasight Fronton Corporation, Revolution™
Rotational Imaging Catheter (K050995), and Lightlab Imaging, I

rovides functional and technological comparison of Conavi Medical Novasight Hybrid System (Console and PIM) to the Volcano s5
ravascular Imaging and Pressure Systems (K071554

| Component | Subject Device | Predicate Devices | Comments | |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| | Conavi Novasight Hybrid<br>Catheter (K172258) | Volcano Revolution TM 45 MHz<br>Rotational Imaging Catheter<br>(K050995) | Lightlab Ilumien Optis,<br>Dragonfly Optis Imaging<br>Catheter (K141453) | |
| Classification | Class II | Class II | Class II | Same as<br>predicate devices |
| Regulation Name | Diagnostic Intravascular Catheter | Diagnostic Intravascular Catheter | Diagnostic Intravascular<br>Catheter | Same as<br>predicate devices |
| Product code | OBJ, NQQ | OBJ | NQQ | Same as<br>predicate devices |
| Catheter type | Intravascular Imaging Catheter | IVUS Imaging Catheter | Intravascular OCT Catheter | Similar to<br>predicate devices |
| Clinical data | No clinical study is included in the<br>submission. Determination of<br>substantial equivalence<br>Performance is based on an<br>assessment of non-clinical data. | No clinical testing is mentioned in<br>the performance data. | No clinical testing is mentioned<br>in the performance data.<br>Determination of substantial<br>equivalence performance is<br>based on an assessment of non-<br>clinical data. | Same as<br>predicate devices |
| Performance data | Bench-top evaluations, risk<br>analysis, packaging validation,<br>biocompatibility, electrical safety, | In accordance with design controls<br>including risk analysis, and<br>biocompatibility test. | Electrical safety, software<br>verification and validation,<br>bench test, and pre-clinical<br>animal testing | Similar to<br>predicate devices |

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# Catheter substa

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Novasight Hybrid System

510(k) Notification

| Intended use | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Novasight Hybrid System is<br>intended for intravascular imaging<br>of coronary arteries and is<br>indicated in patients who are<br>candidates for transluminal<br>interventional procedures. | The Revolution™ 45 MHz<br>Rotational IVUS Imaging<br>Catheter is intended for the<br>intravascular ultrasound<br>examination of coronary arteries.<br>Intravascular ultrasound imaging<br>is indicated in patients who are<br>candidates for transluminal<br>interventional procedures. | The ILUMIEN OPTIS with C7<br>Dragonfly, Dragonfly DUO, or<br>Dragonfly OPTIS Imaging<br>Catheter is intended for the<br>imaging of coronary arteries and<br>is indicated in patients who are<br>candidates for transluminal<br>interventional procedures. The<br>C7 Dragonfly, Dragonfly DUO,<br>or Dragonfly OPTIS Imaging<br>Catheter is intended for use in<br>vessels 2.0 to 3.5 mm in<br>diameter. The C7 Dragonfly,<br>Dragonfly DUO, or Dragonfly<br>OPTIS Imaging Catheter is not<br>intended for use in the left main<br>coronary artery or in a target<br>vessel which has undergone a<br>previous bypass procedure.<br>The ILUMIEN OPTIS will<br>further acquire radio frequency<br>signal outputs from both a distal<br>intracoronary pressure<br>transducer and a proximal aortic<br>pressure transducer to determine<br>the physiological parameter,<br>Fractional Flow Reserve (FFR).<br>The physician may use the FFR<br>parameter, along with<br>knowledge of patient history,<br>medical expertise and clinical<br>judgment to determine if<br>therapeutic intervention is<br>indicated. |
| Crossing profile in<br>imaging window<br>(Nominal) | 2.8F | 3.2F |
| | | Similar to the<br>predicate devices |

Page 4 of 16

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## Novasight Hybrid System

| Working Length | 149cm | 135cm | 135cm | Similar to<br>predicate devices |
|---------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------|
| Compatible<br>Guidewire | 0.014" | 0.014" | 0.014" | Similar to<br>predicate devices |
| Rotational speed | 30-100 RPS | 30 RPS | 180 RPS | Similar to<br>predicate devices |
| Pullback length | 10cm | 15cm | 7.5cm | Similar to<br>predicate device |
| Pullback speed | 0.5mm/s to 25mm/s | 0.5 to 1mm/s | 36mm/s | Similar to<br>predicate devices |
| Catheter preparation | Saline flush | Saline flush | Contrast flush | Similar to<br>predicate devices |
| Minimum Guide<br>Catheter | >=6F | >=6F | >=6F | Same as<br>predicate device |
| Imaging energy | Ultrasound/ Optical Coherence<br>Tomography (IVUS/OCT)<br>Imaging | Ultrasound Imaging | Optical Coherence Tomography<br>(OCT) Imaging | Similar to<br>predicate devices |
| Catheter<br>Configuration | Single ultrasound and optical<br>imaging element, mechanically<br>rotated. | Single ultrasound imaging<br>element, mechanically rotated. | Single optical imaging element,<br>mechanically rotated. | Similar to<br>predicate devices |
| Ultrasound imaging<br>frequency | 40MHz | 45 MHz | N/A | Similar to<br>predicate device |
| Optical wavelength | 1310nm | N/A | 1310nm | Same as<br>predicate devices |
| Proximal end<br>Configuration | Single connector, mechanical snap<br>into motor drive unit (referred to<br>as PIM). | Single connector, mechanical snap<br>into motor drive unit (referred to<br>as PIM). | Single connector, mechanical<br>snap into motor drive unit<br>(referred to as DOC). | Same as<br>predicate device |
| Acoustic output | Max Pressure: 2.96 MPa<br><br>MI: 0.54 | Max Pressure: 1.9 MPa<br><br>MI: 0.281 | N/A | Similar to<br>predicate device |
| Acoustic testing | IEC 60601-2-37:2007 and<br>equivalent analysis to NEMA UD-<br>2 performance | IEC 60601-2-37 | N/A | Similar to<br>predicate device |

Conavi Medical Inc

Page 5 of 16

K172258

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| Sterilization | Imaging Modes | Biocompatibility | Catheter construction | Re-usability |
|------------------------------|---------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------|
| ISO 11137-2<br>ISO 11137-1-3 | B-Mode IVUS<br>B-Mode OCT | ISO 10993, Externally<br>Communicating Device,<br>Circulating Blood category | Biocompatible Thermopolymer<br>sheath delivered over monorail | Single use |
| ISO 11737 | B-Mode IVUS | ISO 10993, Externally<br>Communicating Device,<br>Circulating Blood category. | Biocompatible Thermopolymer<br>sheath delivered over monorail | Single use |
| ISO 11737 | B-Mode OCT | ISO 10993, Externally<br>Communicating Device,<br>Circulating Blood category | Biocompatible Thermopolymer<br>sheath delivered over monorail | Single use |
| Similar to predicate devices | | | | Similar to predicate devices |
| Similar to predicate devices | | | | Same as predicate derives |
| Similar to predicate devices | | | | Same as predicate derives |

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## able-2: Console Comparison Table

| Component | Subject Device:<br>Conavi Novasight Hybrid<br>System (K172258) | Lightlab Ilumien Optis,<br>Dragonfly Optis Imaging<br>Catheter (K141453) | Volcano s5s5i Series Intravascular<br>Imaging and Pressure Systems<br>(K071554) | Comment |
|---------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------|
| Configuration | Mobile cart with braking<br>system | Mobile cart with braking system | Mobile cart with braking system | Same as predicate<br>devices |
| Product Code | NQQ, IYO | NQQ | IYO | Same as predicate<br>devices |
| Input | Touchscreen, touchpad, and<br>keyboard | Keyboard and mouse | Keyboard and trackball | Similar to<br>predicate devices |
| Display | Dedicated image display<br>monitor, images also<br>displayed on Touchscreen | Dual monitor configuration | single monitor configuration | Similar to<br>predicate devices |

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Jovasight Hybrid System

| Intended use | | | | | | | | | | | | | | | | | | | | | | | Similar to predicate devices |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. | | | | | | | | | | | | | | | | | | | | | | The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.<br>ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.<br>The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.<br>Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm. | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| The ILUMIEN OPTIS with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. | | | | | | | | | | | | | | | | | | | | | | | |

Page 8 of 16

Conavi Medical Inc

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## Novasight Hybrid System

| Data storage | Footprint | Electrical safety | Sterile barrier interface | Max optical output power (measured at Motor Drive unit) |
|--------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| DICOM and native format | 502 x 502mm (centre to centre distance of casters) | IEC 60601-1 3rd edition<br>IEC 60601-1-2:2007<br>IEC 60601-2-37:2007<br>IEC 60601-2-18:2009<br>IEC 60825-1:2014 | Motor Drive Unit (referred to as Patient Interface Module) encapsulated in single use disposable sterile bag | 23.3mW |
| DICOM and native format | 610 x 710 mm (total footprint) | IEC 60601-1:2005+A1:2012<br>EN60601-1-2:2007<br>60601-1-14<br>IEC 60825-1 2nd Ed. 2007<br>IEC 60601-2-18:2009 | Motor Drive Unit (referred to as Drive-motor and Optical Controller) | 22.6mW |
| DICOM and native format | 559 x 838 mm (total footprint) | IEC 60601-1:2005, Ed 2<br>IEC 60601-1-1:2000<br>IEC 60601-1-2:2007<br>IEC 60601-2-34:2000-10 Ed 2<br>IEC 60601-2-37:2007 Ed 2 | Motor Drive Unit (referred to as Patient Interface Module) encapsulated in single use disposable sterile bag | Not applicable |
| Same as predicate device | Similar to predicate devices | Similar to predicate devices | Same as predicate devices | Similar to predicate |

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## System:
Transducer: Transducer:

Novasight Hybrid System
Novasight Hybrid Catheter
Visualization of human anatomy by means of ultrasound imaging:

| Intended Use: Visualization of human anatomy by means of ultrasound imaging: | | | | Mode of Operation | | | | |
|------------------------------------------------------------------------------|---------------------------------|---|---|-------------------|-----|------------------|-----------------------|---------------------|
| Clinical Application | | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| Fetal<br>Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | N |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |

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| Peripheral Vessel<br>Carrely Controller Company Company Company Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Co | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -<br>I Peripher | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | راندا آهي<br>noth | | | |

= new indication; P = previously cleared by FDA; E = added under this appendix

\ — new indication; P — previously cleared by FDA; E = added under this appendix
* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging,

facturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, please refer to EXT-02 evidence of system compliance to guidance provided in Guidance for Industry and FDA Staff - Information ght Hybrid System Compliance to FDA Guidance for Diagnostic Ultrasound Systems and Transduc

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## Scanning Operating Mode: IVUS ONLY

| Index Label | MI | TIS | | TIB | | TIC | |
|------------------------|------------------------------------------------------------------|---------------------|---------------------|---------------------|---------------------|------|------|
| | | At<br>surface | Below<br>surface | At<br>surface | Below<br>surface | | |
| Maximum index value | 0.54 | 0.12 | | 0.19 | | 0.19 | |
| Index component value | | sc: 0.12<br>ns: N/A | sc: 0.12<br>ns: N/A | sc: 0.19<br>ns: N/A | sc: 0.12<br>ns: N/A | | |
| Acoustic<br>Parameters | $P_{r,g} at Z_{MI}$ [MPa] | 2.96 | | | | | |
| | P [mW] | | 0.73 | | 0.73 | | 0.73 |
| | P1x1 [mW] | | 0.73 | 0.73 | 0.73 | 0.73 | |
| | $Z_s$ [cm] | | | 0.18 | | | |
| | $Z_b$ [cm] | | | | | 0.18 | |
| | $Z_{MI}$ [cm] | 0.18 | | | | | |
| | $Z_{pll, \alpha}$ [cm] | 0.18 | | | | | |
| | $f_{awt}$ [MHz] | 31.25 - 45.00 | | | | | |
| Other<br>Information | $p_{rr}$ [KHz] | 24.39 | | | | | |
| | $s_{rr}$ [Hz] | 30 or 100 | | | | | |
| | $n_{pps}$ | 1 | | | | | |
| | $I_{pa, \alpha} @ Z_{pll, \alpha}$ [W/cm²] | 65.95 | | | | | |
| | $I_{spta, \alpha} @ Z_{pll, \alpha} or Z_{sll, \alpha}$ [mW/cm²] | 23.58 | | | | | |
| | $I_{spta} @ Z_{pil} or Z_{sll}$ [mW/cm²] | 36.42 | | | | | |
| | $p_r @ Z_{pil}$ [MPa] | 3.19 | | | | | |
| Operating<br>Control | Depth Boost | On | | | | | |
| | Frequency | 40 MHz | | | | | |

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## Scanning Operating Mode: IVUS + OCT

| Index Label | | | MI | TIS | | TIB | | TIC |
|------------------------|--------------------------------------|----------|---------------|---------------------|---------------------|---------------------|---------------------|------|
| | | | | At<br>surface | Below<br>surface | At<br>surface | Below<br>surface | |
| Maximum index value | | | 0.54 | 0.24 | | 0.36 | | 0.36 |
| Index component value | | | | sc: 0.24<br>ns: N/A | sc: 0.24<br>ns: N/A | sc: 0.36<br>ns: N/A | sc: 0.24<br>ns: N/A | |
| Acoustic<br>Parameters | $p_{ra}$ at $Z_{MI}$ | [MPa] | 2.96 | | | | | |
| | P | [mW] | | 1.42 | | 1.42 | | 1.42 |
| | $P_{1x1}$ | [mW] | | 1.42 | 1.42 | 1.42 | 1.42 | |
| | $Z_s$ | [cm] | | | 0.18 | | | |
| | $Z_b$ | [cm] | | | | | 0.18 | |
| | $Z_{MI}$ | [cm] | 0.18 | | | | | |
| | $Z_{pll,",alpha}$ | [cm] | 0.18 | | | | | |
| | $f_{avt}$ | [MHz] | 31.25 - 45.00 | | | | | |
| Other<br>Information | $p_{rr}$ | [KHz] | 47.62 | | | | | |
| | $s_{rr}$ | [Hz] | 30 or 100 | | | | | |
| | $O_{ppa}$ | | 1 | | | | | |
| | $I_{pa,",alpha} @ Z_{pll,",alpha}$ | [W/cm²] | 129.2 | | | | | |
| | $I_{spta,",alpha} @ Z_{pll,",alpha}$ | [mW/cm²] | 46.19 | | | | | |
| | $I_{spta} @ Z_{pll}$ | [mW/cm²] | 71.34 | | | | | |
| | $p_r @ Z_{pll}$ | [MPa] | 3.19 | | | | | |
| Operating<br>Control | Depth Boost | | On | | | | | |
| | Frequency | | 40 MHz | | | | | |

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| fawf | ACOUSTIC WORKING FREQUENCY |
|--------|------------------------------------------------------|
| Ipa, | ATTENUATED PULSE-AVERAGE INTENSITY |
| Ispta | SPATIAL-PEAK, TEMPORAL-AVERAGE INTENSITY (in Water) |
| Ispta, | ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY |
| MI | MECHANICAL INDEX |
| P | OUTPUT POWER (in Water) |
| P1x1 | BOUNDED-SQUARE OUTPUT POWER (in Water per 1cm x 1cm) |
| Pr, | ATTENUATED PEAK-RAREFACTIONAL ACOUSTIC PRESSURE |
| Pr | PEAK-RAREFACTIONAL ACOUSTIC PRESSURE (in water) |
| Npps | NUMBER OF PULSES PER ULTRASONIC SCAN LINE |
| Prr | PULSE REPETITION RATE |
| Srr | SCAN REPETITION RATE |
| TIB | BONE THERMAL INDEX |
| TIC | CRANIAL-BONE THERMAL INDEX |
| TIS | SOFT-TISSUE THERMAL INDEX |
| SC | SCANNING MODE |
| ns | NON-SCANNING MODE |
| Zb | DEPTH FOR TIB |
| Zpii | DEPTH FOR PEAK PULSE-INTENSITY INTEGRAL |
| ZMI | DEPTH FOR MECHANICAL INDEX |
| Zpii,a | DEPTH FOR PEAK ATTENUATED PULSE INTENSITY INTEGRAL |
| z | DEPTH FOR TIS |

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## Non Clinical Performance Testing

Verification and validation test were performed in accordance with the following standards, and test results confirm that results demonstrate that Novasight Hybrid System demonstrate as intended meeting the applicable requirements. Standards include:

- 1. IEC 60601-1:2012, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance.
- 2. IEC 60601-1-2:2007 (Ed3.0), Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility.
- 3. IEC 60601-1-6:2013, Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
- 4. IEC 60825-1:2014 (Third Ed). Safety of laser products Part 1: Equipment classification and requirements
- 5. IEC 60601-2-18:2009 (Third Ed) for use in conjunction with IEC 60601-1:2005, Medical Electrical Equipment - Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment.
- IEC 60601-2-37:2007 & A1:2015, for use in conjunction with IEC 60601-1:2005, Medical 6. Electrical Equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- 7. IEC 61161:2013, Ultrasonic Power measurement Radiation force balances and performance requirements.
- IEC 62127-1:2013, Ultrasonic Hydrophones Part 1: Measurement and characterization of 8. medical ultrasonic fields up to 40 MHz
- 9. IEC 62359:2010, Ultrasonic Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.
- 10. ISO 11607-1:2006, Packaging for terminally sterilized medical device. Part 1: requirements for materials, sterile barrier systems and packaging systems (2006 Amendment 1, 2014).
- 11. ISO 11137-1:2006, Sterilization of healthcare products Radiation (Gamma & E-Beam Sterilization for Medical Devices).
- 12. ANSI/AAMI/ISO 11137-2:2013. Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
- 13. ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.
- 14. ISO 14971:2012, Medical Devices Risk Management Process
- 15. ANSI/AAMI/IEC 62304:2006, Software development lifecycle

{18}------------------------------------------------

## Conclusion:

Conavi Novasight Hybrid System, the subject device, and predicate devices have very similar intended use, principles of operational and technological characteristics. The subject device and predicate devices are intended for intravascular imaging use. Minor technological differences do not raise any new safety and effectiveness risk or concerns. Additionally, non-clinical test results confirm that Novasight Hybrid System meets the intended use and the requirements of applicable standards. Therefore, it is the conclusion of Conavi Medical that Conavi Novasight Hybrid System is substantially equivalent to the cited predicate devices.