(275 days)
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 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 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.
The provided text is a 510(k) summary for the Conavi Medical Inc. Novasight Hybrid System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on functional and technological comparisons and non-clinical performance testing.
The document does not include detailed acceptance criteria for standalone device performance nor does it describe a study explicitly proving the device meets said acceptance criteria in a quantitative manner with reported performance metrics, ground truth, or expert consensus.
Instead, the document states:
- "No clinical study is included in the submission. Determination of substantial equivalence Performance is based on an assessment of non-clinical data." (Page 5)
- "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." (Page 17)
Therefore, I cannot populate the table or provide specific details regarding sample sizes, ground truth establishment, or expert qualifications for performance criteria because this information is not present in the provided document. The document focuses on regulatory compliance through non-clinical testing and comparison to predicate devices, rather than a clinical performance study with defined acceptance criteria and reported outcomes for the device's diagnostic capabilities.
However, based on the non-clinical testing listed, I can infer the types of acceptance criteria the device would have met in terms of safety and technical specifications, as these are the focus of the testing mentioned.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no specific performance metrics like sensitivity, specificity, or accuracy for diagnostic tasks are provided, and no quantitative acceptance criteria for such metrics are given, this table cannot be fully populated as requested. The "reported device performance" is broadly stated as meeting "applicable requirements" of various standards.
| Acceptance Criterion Type (Inferred from non-clinical tests) | Reported Device Performance (as stated in document) |
|---|---|
| Safety and Essential Performance | |
| IEC 60601-1 (Electrical Safety) | Confirmed to meet applicable requirements |
| IEC 60601-1-2 (EMC) | Confirmed to meet applicable requirements |
| IEC 60601-1-6 (Usability) | Confirmed to meet applicable requirements |
| IEC 60825-1 (Laser Safety) | Confirmed to meet applicable requirements |
| IEC 60601-2-18 (Endoscopic Equipment) | Confirmed to meet applicable requirements |
| IEC 60601-2-37 (Ultrasonic Diagnostic Equipment) | Confirmed to meet applicable requirements |
| IEC 61161 (Ultrasonic Power Measurement) | Confirmed to meet applicable requirements |
| IEC 62127-1 (Ultrasonic Hydrophones) | Confirmed to meet applicable requirements |
| IEC 62359 (Ultrasonic Field Characterization) | Confirmed to meet applicable requirements |
| Biocompatibility | |
| ISO 10993-7 (Ethylene Oxide Residuals) | Confirmed to meet applicable requirements |
| Sterilization | |
| ISO 11607-1 (Packaging) | Confirmed to meet applicable requirements |
| ISO 11137-1/2 (Radiation Sterilization) | Confirmed to meet applicable requirements |
| Risk Management | |
| ISO 14971 (Risk Management Process) | Confirmed to meet applicable requirements |
| Software Development | |
| ANSI/AAMI/IEC 62304 (Software Lifecycle) | Confirmed to meet applicable requirements |
2. Sample size used for the test set and the data provenance:
- Not provided. The document states, "No clinical study is included in the submission." The non-clinical tests would have involved specific test samples (e.g., catheters, system components) but the "sample size" in a clinical or diagnostic performance context is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. Since no clinical performance study with ground truth establishment was conducted or submitted, this information is not available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No adjudication method is mentioned as there's no clinical test set for diagnostic 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:
- No. The document explicitly states "No clinical study is included in the submission." Therefore, no MRMC study or AI assistance improvement effect size is reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No specific standalone diagnostic performance study was reported. The device is an imaging system (hardware and software) intended for real-time guidance. Its "standalone" performance is implicitly covered by its technical specifications and compliance with safety and imaging standards (e.g., acoustic output, image resolution capability, etc., which are compared to predicates and tested non-clinically). However, this is not a diagnostic algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No ground truth for diagnostic performance assessment is mentioned, as no clinical study was performed. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
8. The sample size for the training set:
- Not applicable/Not provided. There is no mention of a training set, indicating that this submission is not for an AI/ML-based diagnostic algorithm that would typically require a training set for its development. The device is hardware and associated software.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no mention of a training set, this information is not available.
{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
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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)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 RoadNorth York, ON, Canada M3B 2V1 |
| Contact Person: | Sam MostafaviSam@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 870.1200Ultrasonic 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 HybridCatheter (K172258) | Volcano Revolution TM 45 MHzRotational Imaging Catheter(K050995) | Lightlab Ilumien Optis,Dragonfly Optis ImagingCatheter (K141453) | ||
| Classification | Class II | Class II | Class II | Same aspredicate devices |
| Regulation Name | Diagnostic Intravascular Catheter | Diagnostic Intravascular Catheter | Diagnostic IntravascularCatheter | Same aspredicate devices |
| Product code | OBJ, NQQ | OBJ | NQQ | Same aspredicate devices |
| Catheter type | Intravascular Imaging Catheter | IVUS Imaging Catheter | Intravascular OCT Catheter | Similar topredicate devices |
| Clinical data | No clinical study is included in thesubmission. Determination ofsubstantial equivalencePerformance is based on anassessment of non-clinical data. | No clinical testing is mentioned inthe performance data. | No clinical testing is mentionedin the performance data.Determination of substantialequivalence performance isbased on an assessment of non-clinical data. | Same aspredicate devices |
| Performance data | Bench-top evaluations, riskanalysis, packaging validation,biocompatibility, electrical safety, | In accordance with design controlsincluding risk analysis, andbiocompatibility test. | Electrical safety, softwareverification and validation,bench test, and pre-clinicalanimal testing | Similar topredicate devices |
Si
S
Si
Si
Catheter substa
{6}------------------------------------------------
Novasight Hybrid System
510(k) Notification
| Intended use | ||
|---|---|---|
| The Novasight Hybrid System isintended for intravascular imagingof coronary arteries and isindicated in patients who arecandidates for transluminalinterventional procedures. | The Revolution™ 45 MHzRotational IVUS ImagingCatheter is intended for theintravascular ultrasoundexamination of coronary arteries.Intravascular ultrasound imagingis indicated in patients who arecandidates for transluminalinterventional procedures. | The ILUMIEN OPTIS with C7Dragonfly, Dragonfly DUO, orDragonfly OPTIS ImagingCatheter is intended for theimaging of coronary arteries andis indicated in patients who arecandidates for transluminalinterventional procedures. TheC7 Dragonfly, Dragonfly DUO,or Dragonfly OPTIS ImagingCatheter is intended for use invessels 2.0 to 3.5 mm indiameter. The C7 Dragonfly,Dragonfly DUO, or DragonflyOPTIS Imaging Catheter is notintended for use in the left maincoronary artery or in a targetvessel which has undergone aprevious bypass procedure.The ILUMIEN OPTIS willfurther acquire radio frequencysignal outputs from both a distalintracoronary pressuretransducer and a proximal aorticpressure transducer to determinethe physiological parameter,Fractional Flow Reserve (FFR).The physician may use the FFRparameter, along withknowledge of patient history,medical expertise and clinicaljudgment to determine iftherapeutic intervention isindicated. |
| Crossing profile inimaging window(Nominal) | 2.8F | 3.2F |
| Similar to thepredicate devices |
Page 4 of 16
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Novasight Hybrid System
| Working Length | 149cm | 135cm | 135cm | Similar topredicate devices |
|---|---|---|---|---|
| CompatibleGuidewire | 0.014" | 0.014" | 0.014" | Similar topredicate devices |
| Rotational speed | 30-100 RPS | 30 RPS | 180 RPS | Similar topredicate devices |
| Pullback length | 10cm | 15cm | 7.5cm | Similar topredicate device |
| Pullback speed | 0.5mm/s to 25mm/s | 0.5 to 1mm/s | 36mm/s | Similar topredicate devices |
| Catheter preparation | Saline flush | Saline flush | Contrast flush | Similar topredicate devices |
| Minimum GuideCatheter | >=6F | >=6F | >=6F | Same aspredicate device |
| Imaging energy | Ultrasound/ Optical CoherenceTomography (IVUS/OCT)Imaging | Ultrasound Imaging | Optical Coherence Tomography(OCT) Imaging | Similar topredicate devices |
| CatheterConfiguration | Single ultrasound and opticalimaging element, mechanicallyrotated. | Single ultrasound imagingelement, mechanically rotated. | Single optical imaging element,mechanically rotated. | Similar topredicate devices |
| Ultrasound imagingfrequency | 40MHz | 45 MHz | N/A | Similar topredicate device |
| Optical wavelength | 1310nm | N/A | 1310nm | Same aspredicate devices |
| Proximal endConfiguration | Single connector, mechanical snapinto motor drive unit (referred toas PIM). | Single connector, mechanical snapinto motor drive unit (referred toas PIM). | Single connector, mechanicalsnap into motor drive unit(referred to as DOC). | Same aspredicate device |
| Acoustic output | Max Pressure: 2.96 MPaMI: 0.54 | Max Pressure: 1.9 MPaMI: 0.281 | N/A | Similar topredicate device |
| Acoustic testing | IEC 60601-2-37:2007 andequivalent analysis to NEMA UD-2 performance | IEC 60601-2-37 | N/A | Similar topredicate device |
Conavi Medical Inc
Page 5 of 16
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| Sterilization | Imaging Modes | Biocompatibility | Catheter construction | Re-usability |
|---|---|---|---|---|
| ISO 11137-2ISO 11137-1-3 | B-Mode IVUSB-Mode OCT | ISO 10993, ExternallyCommunicating Device,Circulating Blood category | Biocompatible Thermopolymersheath delivered over monorail | Single use |
| ISO 11737 | B-Mode IVUS | ISO 10993, ExternallyCommunicating Device,Circulating Blood category. | Biocompatible Thermopolymersheath delivered over monorail | Single use |
| ISO 11737 | B-Mode OCT | ISO 10993, ExternallyCommunicating Device,Circulating Blood category | Biocompatible Thermopolymersheath 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 HybridSystem (K172258) | Lightlab Ilumien Optis,Dragonfly Optis ImagingCatheter (K141453) | Volcano s5s5i Series IntravascularImaging and Pressure Systems(K071554) | Comment |
|---|---|---|---|---|
| Configuration | Mobile cart with brakingsystem | Mobile cart with braking system | Mobile cart with braking system | Same as predicatedevices |
| Product Code | NQQ, IYO | NQQ | IYO | Same as predicatedevices |
| Input | Touchscreen, touchpad, andkeyboard | Keyboard and mouse | Keyboard and trackball | Similar topredicate devices |
| Display | Dedicated image displaymonitor, images alsodisplayed on Touchscreen | Dual monitor configuration | single monitor configuration | Similar topredicate 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 editionIEC 60601-1-2:2007IEC 60601-2-37:2007IEC 60601-2-18:2009IEC 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+A1:2012EN60601-1-2:200760601-1-14IEC 60825-1 2nd Ed. 2007IEC 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 2IEC 60601-1-1:2000IEC 60601-1-2:2007IEC 60601-2-34:2000-10 Ed 2IEC 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 | ColorDoppler | Combined(Specify) | Other*(Specify) | |
| General(Track 1 Only) | Specific(Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| FetalImaging& 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 VesselCarrely 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 آهيnoth |
= 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 | |||
|---|---|---|---|---|---|---|---|
| Atsurface | Belowsurface | Atsurface | Belowsurface | ||||
| Maximum index value | 0.54 | 0.12 | 0.19 | 0.19 | |||
| Index component value | sc: 0.12ns: N/A | sc: 0.12ns: N/A | sc: 0.19ns: N/A | sc: 0.12ns: N/A | |||
| AcousticParameters | $P_{r,g} at Z_{MI}$ [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 | ||||||
| OtherInformation | $p_{rr}$ [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 | ||||||
| OperatingControl | Depth Boost | On | |||||
| Frequency | 40 MHz |
{15}------------------------------------------------
Scanning Operating Mode: IVUS + OCT
| Index Label | MI | TIS | TIB | TIC | ||||
|---|---|---|---|---|---|---|---|---|
| Atsurface | Belowsurface | Atsurface | Belowsurface | |||||
| Maximum index value | 0.54 | 0.24 | 0.36 | 0.36 | ||||
| Index component value | sc: 0.24ns: N/A | sc: 0.24ns: N/A | sc: 0.36ns: N/A | sc: 0.24ns: N/A | ||||
| AcousticParameters | $p_{ra}$ 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 | ||||||
| OtherInformation | $p_{rr}$ | [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 | ||||||
| OperatingControl | 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 |
{17}------------------------------------------------
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:
-
- IEC 60601-1:2012, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance.
-
- 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.
-
- IEC 60601-1-6:2013, Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
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- IEC 60825-1:2014 (Third Ed). Safety of laser products Part 1: Equipment classification and requirements
-
- 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.
-
- 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
-
- IEC 62359:2010, Ultrasonic Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.
-
- 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).
-
- ISO 11137-1:2006, Sterilization of healthcare products Radiation (Gamma & E-Beam Sterilization for Medical Devices).
-
- ANSI/AAMI/ISO 11137-2:2013. Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
-
- ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.
-
- ISO 14971:2012, Medical Devices Risk Management Process
-
- 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.
§ 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).