Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image acquisition, display, and processing, but does not mention any AI or ML capabilities. The performance studies listed are standard for medical devices and do not indicate AI/ML validation.

Therapeutic

No
The device is described as an "intravascular imaging system" that provides "image information of coronary vessel anatomic features" and helps in "minimally-invasive guidance of transluminal interventional procedures." Its function is to provide real-time imaging and guidance, not to directly treat a condition or disease.

Diagnostic

Yes

Explanation: The device is intended for "intravascular imaging of coronary arteries" and provides "image information of coronary vessel anatomic features, spatial relationships of other devices within the coronary arteries, and intra-procedural complications such as perforation." This information is used for "real-time, minimally-invasive guidance of transluminal interventional procedures," which inherently involves assessing the condition of the coronary arteries to inform treatment, thus performing a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system is comprised of a catheter and a cart-based console, which are hardware components. The software is part of the console, but the system as a whole is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Novasight Hybrid System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "intravascular imaging of coronary arteries" and "guidance of transluminal interventional procedures." This describes a device used within the body for imaging and procedural guidance, not a device used to test samples outside the body.
Device Description: The description details a system with a catheter inserted into the body and a console for image acquisition and display. This is consistent with an in-vivo imaging system.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device provides imaging information of the vessel itself.

IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Novasight Hybrid System does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OBJ, NQQ, IYO

Device Description

The Novasight(TM) 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 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound/Optical Coherence Tomography (IVUS/OCT) Imaging

Anatomical Site

coronary arteries

Indicated Patient Age Range

Adults

Intended User / Care Setting

Physician, technologist / cath lab

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)

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.

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.

K050995, K141453

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.

K071554

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

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

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
North York, ON, Canada M3B 2V1
Contact Person:	Sam Mostafavi
Sam@Conavi.com
Mobile Number:	(650) 670-6972
Office Number:	(416) 483-0100
Facsimile Number:	(416) 483-0101
Device Information:
Trade/Proprietary Name:	Novasight Hybrid System
Common Name:	Novasight Hybrid System
Classification Name:	Diagnostic Intravascular Catheters, 21 CFR 870.1200
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

4

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.

5

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

Si

S

Si

Catheter substa

6

Novasight Hybrid System

510(k) Notification

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.	The Revolution™ 45 MHz
Rotational IVUS Imaging
Catheter is intended for the
intravascular ultrasound
examination of coronary arteries.
Intravascular ultrasound imaging
is indicated in patients who are
candidates for transluminal
interventional procedures.	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.
Crossing profile in
imaging window
(Nominal)	2.8F	3.2F
		Similar to the
predicate devices

Page 4 of 16

7

Novasight Hybrid System

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

MI: 0.54 | Max Pressure: 1.9 MPa

MI: 0.281 | N/A | Similar to
predicate device |
| Acoustic testing | IEC 60601-2-37:2007 and
equivalent analysis to NEMA UD-
2 performance | IEC 60601-2-37 | N/A | Similar to
predicate device |

Conavi Medical Inc

Page 5 of 16

K172258

8

Sterilization	Imaging Modes	Biocompatibility	Re-usability
ISO 11137-2
ISO 11137-1-3	B-Mode IVUS
B-Mode OCT	ISO 10993, Externally
Communicating Device,
Circulating Blood category	Biocompatible Thermopolymer
sheath delivered over monorail	Single use
ISO 11737	B-Mode IVUS	ISO 10993, Externally
Communicating Device,
Circulating Blood category.	Biocompatible Thermopolymer
sheath delivered over monorail	Single use
ISO 11737	B-Mode OCT	ISO 10993, Externally
Communicating Device,
Circulating Blood category	Biocompatible Thermopolymer
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

9

able-2: Console Comparison Table

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

10

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.
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.
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.
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

11

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
IEC 60601-1-2:2007
IEC 60601-2-37:2007
IEC 60601-2-18:2009
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
EN60601-1-2:2007
60601-1-14
IEC 60825-1 2nd Ed. 2007
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
IEC 60601-1-1:2000
IEC 60601-1-2:2007
IEC 60601-2-34:2000-10 Ed 2
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

12

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
Doppler	Combined
(Specify)	Other*
(Specify)
General
(Track 1 Only)	Specific
(Tracks 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
Fetal
Imaging
& 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)

13

System


Hybrid





Novasight

| Peripheral Vessel
Carrely Controller Company Company Company Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Co | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
I Peripher | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | راندا آهي
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

14

Scanning Operating Mode: IVUS ONLY

Index Label	MI	TIS		TIB		TIC
		At
surface	Below
surface	At
surface	Below
surface
Maximum index value	0.54	0.12		0.19		0.19
Index component value		sc: 0.12
ns: N/A	sc: 0.12
ns: N/A	sc: 0.19
ns: N/A	sc: 0.12
ns: N/A
Acoustic
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
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
Control	Depth Boost	On
	Frequency	40 MHz

15

Scanning Operating Mode: IVUS + OCT

Index Label			MI	TIS		TIB		TIC
				At
surface	Below
surface	At
surface	Below
surface
Maximum index value			0.54	0.24		0.36		0.36
Index component value				sc: 0.24
ns: N/A	sc: 0.24
ns: N/A	sc: 0.36
ns: N/A	sc: 0.24
ns: N/A
Acoustic
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
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
Control	Depth Boost		On
	Frequency		40 MHz

16

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.
1. 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.
1. IEC 60601-1-6:2013, Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
1. IEC 60825-1:2014 (Third Ed). Safety of laser products Part 1: Equipment classification and requirements
1. 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.
1. 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
1. IEC 62359:2010, Ultrasonic Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.
1. 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).
1. ISO 11137-1:2006, Sterilization of healthcare products Radiation (Gamma & E-Beam Sterilization for Medical Devices).
1. ANSI/AAMI/ISO 11137-2:2013. Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
1. ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.
1. ISO 14971:2012, Medical Devices Risk Management Process
1. 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.