(278 days)
No
The summary describes a guidewire with pressure and pacing capabilities and a monitor for pressure measurement. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as introducing and positioning interventional devices, measuring pressure within the heart for hemodynamic parameters, and providing temporary intracardiac pacing, all of which contribute to the diagnosis and treatment of conditions, fitting the definition of a therapeutic device.
Yes
The SavvyWire™ and OptoMonitor 3 are used to measure pressure within the heart, calculate hemodynamic parameters, and measure cardiovascular blood pressure, including fractional flow reserve for diagnosis and valve gradients. These actions provide information for the diagnosis and treatment of conditions, which is characteristic of a diagnostic device.
No
The device description clearly states that the SavvyWire™ is a "new Catheter guidewire" which is a physical hardware component. While it interacts with software (OptoMonitor 3), the device itself is not software-only.
Based on the provided text, the SavvyWire™ and OptoMonitor 3 are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The SavvyWire™ and OptoMonitor 3 are used within the body during interventional procedures. They measure pressure directly within the heart chambers and blood vessels, and the SavvyWire™ also provides structural support and temporary pacing.
- Intended Use: Their intended use is to facilitate and monitor procedures performed on the patient, not to analyze samples taken from the patient.
Therefore, these devices fall under the category of in vivo medical devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters.
Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX, DXO, LDF
Device Description
The proposed SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name.
SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers of the heart, coronary vessels, peripheral vessels.
Indicated Patient Age Range
=18 years of age
Intended User / Care Setting
Not Found
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)
Animal performance testing was completed to validate device functionality and to provide comparison data to the predicate devices. The use of the device is compared to the TAVI Guidewire: Safari', Boston Scientific (Lake Region Medical Pre-Formed Guidewire K151244) (predicate device) and the Rapid Pacing Wire: Pacel™ Bipolar Pacing Catheter, St-Jude Medical (K161873). Necropsy and Histopathology was also performed. All acceptance criteria were met regarding risks and device functionality.
A single-arm, two-center, prospective study. The SavvyWire™ guidewire was used in eligible subjects for rapid pacing runs, valve delivery and for pressure measurements pre- and post-THV deployment. The study included 20 patients. Twenty one (21) devices were used; one per patient except the first patient needed two. All substantial equivalence requirements were met. The experience reported here shows that the use of the SavvyWire™ guidewire in the LV for rapid ventricular pacing and appropriate advancement and positioning of the THV system during TAVR with both balloon expandable and self-expandable valves is substantially equivalent to other marketed devices as indicated in the identified predicates of section 3.
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.
K151244, K191907, K192454, K202943
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.
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2022
Opsens Inc. % Christina Henza Consultant Ultra Lifescience Solutions, Inc. 2811 Milton Ave, #409 Janesville, Wisconsin 53545
Re: K213854
Trade/Device Name: SavvyWire™ and OptoMonitor 3 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO, LDF Dated: August 9, 2022 Received: August 9, 2022
Dear Christina Henza:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K213854
Device Name SavvyWire™
Indications for Use (Describe)
The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters.
Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
| 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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3
Indications for Use
510(k) Number (if known)
K213854
Device Name OptoMonitor 3
Indications for Use (Describe)
The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers,
coronary vessels and peripheral vessels, during interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary SavvyWire™
SUBMITTER । .
Address: Opsens, Inc.
750, Boulevard du Parc Technologique
Quebec (Quebec) G1P 4S3
Phone: 418.781.0333 ext 3408
Fax Number: 418-781-0024
Contact Person: Marc Chaunet, Regulatory Affairs and Quality System Director
Email: marc.chaunet@opsens.com
Date Prepared: September 13, 2022
2. DEVICE
Name of Device: SavvyWire™ and OptoMonitor 3
Common or Usual Name: structural wire with pacing and pressure sensing
Classification name: Wire, guide, catheter; Transducer, pressure, catheter tip, electrode, pacemaker, temporary
Regulatory Class: II
Product Code: DQX, DXO, LDF
PREDICATE DEVICE ന്
The proposed SavvyWire™ is substantially equivalent to the Opsens existing pressure guidewire, OptoWire III cleared in K191907 on 01/02/2020 (Primary Predicate), and the Wattson Temporary Pacing Guidewire cleared in K192454 on 01/15/2020 [Secondary predicate], with the Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) cleared in K151244 on 06/11/2015 used as a primary reference device.
The primary and secondary predicates (Predicate #2) are included to support the pressure sensing and pacing indications / technologies as indicated below in accordance with the multiple predicates example 4 for a multi-parameter device from FDA guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued on: July 28, 2014.
The Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) cleared in K151244 on 06/11/2015 is used as a reference #1) for the mechanical testing performed on the SavvyWire to demonstrate substantial equivalence. The Pacel™ Bipolar Pacing
5
Catheters cleared in K152784 on 10/22/2015 is used as a secondary reference #2) device to support the pacing function. Bundled together with this new device is a minor change to the OptoMonitor 3 software included in K202943 cleared on 11/24/2020 (Predicate #3) which expands the software to include a separate TAVI interface for use with the new wire. The predicate and reference devices have not been subject to a design-related recall.
DEVICE DESCRIPTION 4.
The proposed SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name.
SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update.
ട. INDICATIONS FOR USE
SawyWire™: The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters.
Additionally, the SavyWire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
OptoMonitor 3: The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during transcatheter aortic valve procedures.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed SavvyWire™ is substantially equivalent to the Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) cleared in K151244 on on 06/11/2015 [primary predicate], Opsens existing pressure guidewire, OptoWire III cleared in K191907 on 01/02/2020 [Secondary Predicate], and the Wattson Temporary Pacing Guidewire cleared in K192454 on 01/15/2020 [Tertiary predicate]. The Pacel™ Bipolar Pacing Catheters cleared in K152784 on 10/22/2015 is used as a reference device to support the pacing function. The secondary and tertiary predicates are included to support the pressure sensing and pacing indications / technologies as indicated below in accordance with the multiple predicates example 4 for a multi-parameter device from FDA guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued on: July 28, 2014. Bundled together with this new device is a minor change to the OptoMonitor 3 software included in K202943 cleared on 11/24/2020 (Predicate 4) which expands the software to include a separate TAVI
6
interface for use with the SavvyWire™. It is appropriate to bundle the two devices because they are intended to be used together as a system during a therapeutic or diagnostic procedure.
The proposed SavvyWire™ indications for use are a blend of the three predicate devices since the proposed device includes functionalities supported by each of these. The OptoMonitor 3 indications were updated slightly to encompass the new modality including addition of pressure measurements in heart chambers and addition of measurements such as aortic valve gradients during transcatheter aortic valve replacement procedures.
The technological characteristics of the proposed SawyWire™ encompass the functionalities of the predicate and reference devices including functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart). Each of these functions is fully supported by the relevant predicate/reference devices. Beyond the major difference of combining these functionalities, there is a slight difference in the pacing wire. The SavvyWire™ is unipolar where the reference device and predicate device 3 are bipolar. This necessitates the use of a separate patient electrode for the positive connection to the external pulse generator. The pacing of the SavvyWire™ is tested to be equivalent to that of the reference device, Pacel™ Bipolar Pacing Catheters in an animal study comparing the two devices and clinical performance is also confirmed via a clinical study. No new questions of safety and effectiveness were identified during the execution of Verification and Validation activities.
Therefore, the proposed devices, SavvyWire™ and OptoMonitor 3 with TAVI meet substantial equivalence requirements with regards to the legally marketed predicate 1) the Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) cleared in K151244, (Predicate 2) OptoWire III cleared in K191907, (Predicate 3) Watson Temporary Pacing Guidewire cleared in K192454 on 01/15/2020, (Predicate OptoMonitor 3 cleared in K202943 and the reference device, Pacel™ Bipolar Pacing Catheters cleared in K152784.
For detailed comparison, refer to the Substantial Equivalence tables on the following pages. Note that the comparison of the SavvyWire™ is included in Table 1: SavvyWire™ while the comparison for the OptoMonitor 3 is included in Table 2:OptoMonitor 3 with TAVI.
| SavvyWire ™ | ||||||
|---|---|---|---|---|---|---|
| Proposed | ||||||
| Device | Predicate 1 | |||||
| (Primary | ||||||
| Predicate) | Predicate 2 | Reference Device | Predicate 3 | |||
| Regulatory Information | Name | SavvyWire™ | Pre-Formed | |||
| Guidewire | ||||||
| (BSC Safari2) | OptoWire III | Pacel Bipolar | ||||
| Pacing Catheters | Wattson Temporary | |||||
| Pacing Guidewire | ||||||
| 510(k)# | K213854 | K151244 | K191907 | K152784 | K192454 | |
| Predicates | K151244, | |||||
| K191907 | K130798 | K152991 | K875059 | K181001, K800298 | ||
| Product Code | DQX, DXO, | |||||
| LDF | DQX | DQX, DXO | LDF | DQX, LDF | ||
| Class | 2 | 2 | 2 | 2 | 2 | |
| SavvyWire™ | ||||||
| Proposed | ||||||
| Device | Predicate 1 | |||||
| (Primary Predicate) | Predicate 2 | Reference Device | Predicate 3 | |||
| Regulation | ||||||
| Number | 870.1330, | |||||
| 870.2870, | ||||||
| 870.3680 | 870.2870 | 870.1330, | ||||
| 870.2870 | 870.3680 | 870.1330, 870.3680 | ||||
| Regulation | ||||||
| Generic Name | Wire, guide, | |||||
| catheter; | ||||||
| Transducer, | ||||||
| pressure, | ||||||
| catheter tip, | ||||||
| electrode, | ||||||
| pacemaker, | ||||||
| temporary | Wire, guide, | |||||
| catheter; | Wire, guide, | |||||
| catheter; | ||||||
| Transducer, | ||||||
| pressure, | ||||||
| catheter tip | Electrode, | |||||
| pacemaker, | ||||||
| temporary | Wire, guide, catheter; | |||||
| Electrode, pacemaker, | ||||||
| temporary | ||||||
| Regulation | ||||||
| Intended Use | Coiled wire | |||||
| fits inside a | ||||||
| percutaneous | ||||||
| catheter for | ||||||
| the purpose | ||||||
| of directing | ||||||
| the catheter | ||||||
| through a | ||||||
| blood vessel. |
Catheter tip
transmits
mechanical or
electrical
property
changes in
relation to
changes in
blood
pressure to
accessory
equipment for
processing.
The device is
used to
transmit a
pacing
electrical
stimulus from
the pulse
generator to
the heart
and/or to
transmit the
electrical
signal of the
heart to the
pulse | Coiled wire
fits inside a
percutaneous
catheter for
the purpose
of directing
the catheter
through a
blood vessel. | Coiled wire fits
inside a
percutaneous
catheter for
the purpose of
directing the
catheter
through a
blood vessel.
Catheter tip
transmits
mechanical or
electrical
property
changes in
relation to
changes in
blood pressure
to accessory
equipment for
processing. | The device is used
to transmit a
pacing electrical
stimulus from the
pulse generator to
the heart and/or
to transmit the
electrical signal of
the heart to the
pulse generator. | Coiled wire fits inside a
percutaneous catheter
for the purpose of
directing the catheter
through a blood vessel.
The device is used to
transmit a pacing
electrical stimulus from
the pulse generator to
the heart and/or to
transmit the electrical
signal of the heart to
the pulse generator. |
| SavvyWire ™ | | | | | | |
| | Proposed
Device | Predicate 1
(Primary
Predicate) | Predicate 2 | Reference Device | Predicate 3 | |
| | Indications | The
SavvyWire™
is intended
for use to
introduce and
position
interventional
devices
within the
chambers of
the heart,
including
those used
for
transcatheter
aortic valve
procedures,
while
measuring
the pressure
within the
heart
allowing
calculation of
hemodynamic
parameters.
Additionally,
the
SavvyWire™
can be used
for temporary
intracardiac
pacing by
transmitting
an electrical
signal from an
external pulse
generator to
the heart. | The Pre-
Formed
guidewires
are intended
to facilitate
the
introduction
and
placement of
interventional
devices
within the
chambers of
the heart
including
those used
within
transcatheter
aortic valve
procedures. | To measure
pressure in
blood vessels
including both
coronary and
peripheral
vessels, during
diagnostic
angiography
and/or other
any
interventional
procedures.
Blood
pressure
measurements
provide
hemodynamic
information,
such as
fractional flow
reserve, for
the diagnosis
and treatment
of blood vessel
disease. | The St. Jude
Medical Pacel™
Bipolar Pacing
Catheters are
intended for
use in the
intracardiac
pacing and/or
ECG recording | The Wattson temporary
pacing guidewire is
intended to introduce
and position catheters
and other
interventional
devices within the
chambers of the heart
, including those used
within transcatheter
aortic valve
replacement (TAVR)
procedures and balloon
aortic valvuloplasty
(BAV), while
transmitting an
electrical signal from an
external pulse
generator to the heart.
The temporary pacing
guidewire is not
intended to remain in
place following the
clinical procedure. |
| SavvyWire™ | | | | | | |
| | | Proposed
Device | Predicate 1
(Primary
Predicate) | Predicate 2 | Reference Device | Predicate 3 |
| | Contraindications | Cerebral
vasculature &
absence of
anti-
coagulation
therapy | Cerebral
vasculature | Cerebral
vasculature | Patients with
recurrent sepsis
or with a
hypercoagulable
state should not
be considered
candidates for
transvenous
catheters since
the catheter could
serve as a focal
point for septic or
bland thrombus
formation. In
addition, patients
with a mechanical
tricuspid valve
should not be
considered for
ventricular pacing. | The guidewire is
contraindicated for use
in the coronary arteries
and in the
cerebrovascular. |
| | Prescription Use | Rx Only | Rx Only | Rx Only | Rx Only | Rx Only |
| | System
Components | Sterile,
disposable
guidewire | Sterile,
disposable
guidewire | Sterile,
disposable
guidewire | Sterile, disposable
catheter | Sterile, disposable
catheter |
| | Pressure Sensing
& Signal
Transmission
Technology | Fiberoptic
sensor & fiber
bundle
embedded in
guidewire. | None. | Fiberoptic
sensor & fiber
bundle
embedded in
guidewire. | None | None |
| | Sterile, Single
Use Patient
Contact
Component? | Yes | Yes | Yes | Yes | Yes |
| | Guidewire OD | 0.035" | 0.035" | 0.014" | Multiple catheter
sizes available. | 0.035" |
| | Guidewire
Length | 280 cm | 275 cm | 180 cm | 110 cm | 280 cm |
| | Guidewire Shaft
Material | Stainless steel | Stainless steel | Stainless Steel,
Nitinol | Stainless steel | Stainless Steel |
| Technological Characteristics | Tip Coating | None
(Stainless
steel) | Teflon spray
coating
(PTFE) | None
(Platinum-
Tungsten
alloy) | None (Stainless
steel) | None (Stainless steel) |
| | Shaft Coating | Teflon (PTFE) | Teflon (PTFE) | Teflon (PTFE) | Proprietary blend | Fluropolymer outer |
| | Intermediate
Section Coating | Teflon (PTFE) | Teflon (PTFE) | PET +
Hydrophilic
coating | of polyurethane
coating
(hemocompatible) | Jacket (FEP) with
Silicone Oil Lubricant |
| | Tip Configuration | Spiral (XS OD
3.2 cm,
S OD 4.2 cm) | Spiral (XS OD
3.2 cm, S OD
4.2 cm) | Straight | Various L and J
curves available | Spiral (OD is 3.0 cm) |
| | Guidewire Tip
Design | Coiled | Coiled | Coiled | Solid Core | Coiled |
| | Guidewire Tip
Length | XS: 2.9 cm
S: 3.8 cm | XS: 2.9 cm
S: 4.2 cm | 3.0 cm | Various lengths | Not specified |
| SavvyWire ™™ | | | | | | |
| | | Proposed
Device | Predicate 1
(Primary
Predicate) | Predicate 2 | Reference Device | Predicate 3 |
| | Radiopaque Tip? | Yes | Yes | Yes | Yes | Yes |
| | Pressure Sensor
Location | XS: 2.9 cm
S: 3.8 cm | N/A | 3.0 cm from
distal tip | N/A | N/A |
| | Electrode | Unipolar | N/A | N/A | Bipolar | Bipolar |
| | External Pulse
Generator
Connection | Alligator
clamp
(negative
lead) is
connected to
one of the
SavvyWire
pacing
connection
zones | N/A | N/A | Pins are
connected to
negative and
positive terminals. | Removable guidewire
adapter terminating in
two shrouded
positive/negative
connectors |
| | Pulse Generator
compatibility | Compatible
with standard
external pulse
generators | N/A | N/A | Compatible with
standard external
pulse generators | Compatible with
standard external pulse
generators |
Table 1: SavvyWire™
7
8
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TABLE 2:OPTOMONITOR 3 WITH TAVI
-OntoMonitor Swith TAVI
| OptoMonitor 3 with TAVI | |||
|---|---|---|---|
| OptoMonitor 3 (with TAVI) | OptoMonitor 3 (Predicate Device 4) | ||
| Regulatory | |||
| Information | Device Name | OptoMonitor 3 | OptoMonitor 3 |
| 510(k)# | K213854 | K202943 | |
| Product Code | DXO | DXO | |
| Class | 2 | 2 | |
| Regulation Number | 870.2870 | 870.2870 | |
| Regulation Generic Name | transducer, pressure, catheter tip | transducer, pressure, catheter tip | |
| Intended use | Indications for Use | The OptoMonitor 3 is intended to | |
| measure cardiovascular blood | |||
| pressure, including in heart | |||
| chambers, coronary vessels and | |||
| peripheral vessels, during | |||
| interventional procedures. |
Blood pressure measurements
provide hemodynamic information,
such as fractional flow reserve for
the diagnosis and treatment of
blood vessels and such as valve
gradients during transcatheter
aortic valve procedures. | The OptoMonitor 3 is intended to
measure pressure in blood vessels
including both coronary and
peripheral vessels, during diagnostic
angiography and/or other any
interventional procedures.
Blood pressure measurements
provide hemodynamic information,
such as fractional flow reserve, for
the diagnosis and treatment of blood
vessel disease. |
| | Prescription Use | Rx Only | Rx Only |
| Technological
Characteristics | System Components / device
materials | Reusable signal processor /
monitor
Embedded software
Connecting cables | Reusable signal processor / monitor
Embedded software
Connecting cables |
| | System Capabilities | Measurement of intravascular
blood pressure including FFR and
measurement inside left ventricle | Measurement of intravascular blood
pressure including FFR. |
| OptoMonitor 3 with TAVI | | OptoMonitor 3 (with TAVI) | OptoMonitor 3 (Predicate Device 4) |
| Pressure Sensing & Signal
Transmission Technology | Fiberoptic sensor & fiber bundle
embedded in guidewire. Monitor
Senses pressure from Fiberoptic
sensor. | Fiberoptic sensor & fiber bundle
embedded in guidewire. Monitor
Senses pressure from Fiberoptic
sensor. | |
| Operating Temperature
(Monitor) | 15°C to 30°C | 15°C to 30°C | |
| Transport Temperature
(Monitor) | -25°C to 60°C | -25°C to 60°C | |
| Operating Relative Humidity
(Monitor) | 10% to 85% non-condensing | 10% to 85% non-condensing | |
| Storage Temperature
(Monitor) | Room Temperature | Room Temperature | |
| Operating Pressure | 70 to 106 kPa | 70 to 106 kPa | |
| Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg | |
| Pressure Accuracy | +/- 1 mmHg plus +/- 1% of reading
(pressure range -30 to 50 mmHg)
or +/- 3% of reading (pressure
range 50 to 300
mmHg) | +/- 1 mmHg plus +/- 1% of reading
(pressure range -30 to 50 mmHg) or
+/- 3% of reading (pressure range 50
to 300
mmHg) | |
| Thermal Zero Shift |