(278 days)
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.
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.
The provided text describes the performance data and substantial equivalence arguments for the SavvyWire™ and OptoMonitor 3 with TAVI, rather than detailing specific acceptance criteria and the results of a study designed to prove the device meets those criteria in a quantitative table. The document focuses on demonstrating substantial equivalence to existing predicate devices through various tests and studies.
Based on the provided text, a direct table of acceptance criteria and reported device performance with specific quantitative thresholds and met/not met status cannot be fully constructed as this information is not presented in that format. However, I can infer the general nature of the acceptance criteria from the tests conducted and the stated conclusions.
Here's a breakdown of the requested information based on the document, with inferred acceptance criteria where explicit quantitative values are not given:
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Test Goals) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Equivalence (Overall System) | The SavvyWire™ and OptoMonitor 3 with TAVI are shown to perform in a manner equivalent to the predicate devices with the same intended use. All substantial equivalence requirements were met. |
| Safety and Effectiveness (Risk Management) | "All acceptance criteria were met regarding risks and device functionality." "No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities." "The risks related to all applicable hazards which were identified for the SavvyWire™ have been reduced to the acceptable level by mitigation...all residual risks post-mitigation have been deemed acceptable for this design." The device is shown to be at least as safe and effective as the predicate device. |
| Sterilization, Packaging, Shelf-life | Equivalence to specified ISO and ASTM standards (ISO 11135-1, ISO 11607-1, ASTM F1980-07) was utilized. Devices subjected to accelerated aging equivalent to 2 years ("TO" = no aging) were tested. (Specific results are not detailed, but adherence to standards implies meeting criteria). |
| Biocompatibility | Evaluation conducted in accordance with FDA guidance Use of International Standard ISO 10993-1. All listed tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Hemocompatibility, Pyrogenicity, SC5b-9 complement) were completed. (Specific results are not detailed, but completion implies meeting criteria for classification as "External communicating device – circulating blood" with "limited exposure"). |
| Electrical Safety & EMC | The OptoMonitor 3 with TAVI Software complies with applicable requirements of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-34 when used with SavvyWire™. Certain applicable portions of ISO 14708 are also applied. (Compliance implies meeting criteria). |
| Mechanical Performance (e.g., Guide Wire Properties) | Design Verification was conducted based on FDA Guidance Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling. All Design Requirements were verified. "Verification testing includes: Rapid Pacing Testing, Mechanical Testing, Functional Testing, FOIC Testing." "Design Specification Verification and ISO 11070 Compliance were completed by documentation check." (Meeting design requirements and compliance implies success). |
| Pacing Functionality (Equivalence to Bipolar Pacing Catheters) | The pacing of the SavvyWire™ (unipolar) was "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." (Successful equivalence demonstration). Animal performance testing "validated device functionality and to provide comparison data to the predicate devices." Clinical study demonstrated "use of the SavvyWire™ guidewire in the LV for rapid ventricular pacing...is substantially equivalent to other marketed devices." |
| Pressure Measurement Performance (Accuracy, Range, Drift, etc. for OptoMonitor 3) | Pressure Range: -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). Thermal Zero Shift: <0.3 mmHg/deg C. Zero Drift: <1 mmHg/h. (These are performance specifications listed for the OptoMonitor 3, which is updated for TAVI use, implying they are the acceptance criteria for its pressure measurement functionality and are met). The OptoMonitor 3 (with TAVI) maintains the same pressure measurement specifications as the predicate OptoMonitor 3. |
| Guidewire Introduction & Positioning (for TAVR) | Clinically confirmed in a single-arm study: "use of the SavvyWire™ guidewire in the LV for...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." |
Here's the rest of the requested information:
2. Sample sizes used for the test set and the data provenance:
-
Clinical Study (Test Set for Clinical Performance):
- Sample Size: 20 patients. Twenty-one (21) devices were used (one per patient except the first patient needed two).
- Data Provenance: Single-arm, two-center, prospective study. The document does not specify the country of origin for the clinical study data, but it is an FDA submission, implying compliance with US regulatory standards for clinical data. Given the context of the company (Opsens Inc. in Quebec, Canada) and a US consultant, the study might be multicenter, potentially including sites in the US or Canada.
-
Animal Studies:
- Sample Size: Not specified quantitatively.
- Data Provenance: Animal performance testing (prospective).
-
Design Verification (Mechanical, Electrical, etc.):
- Sample Size: Not specified quantitatively, but tests were conducted. "Design Specification Verification and ISO 11070 Compliance were completed by documentation check and therefore did not use any SavvyWire™ product." implying some tests were document-based, while others (mechanical, functional, FOIC, rapid pacing) involved physical devices.
- Data Provenance: Laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical or animal studies.
- For a clinical study involving TAVR procedures, it is implied that the procedures were performed and outcomes assessed by qualified interventional cardiologists or cardiac surgeons. The "ground truth" for success in TAVR procedures and pacing would typically be established by established clinical protocols and expert medical judgment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify any formal adjudication method (e.g., 2+1, 3+1 for imaging or clinical endpoints) for the clinical study. It describes a single-arm clinical study for TAVR procedures.
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 MRMC or AI-assisted human reader study was conducted or described. This device is a physical medical device (guidewire and monitor), not an AI-powered diagnostic imaging tool that would typically involve human-in-the-loop performance studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is a physical guidewire with pressure sensing and pacing capabilities, used with a monitor. The "performance" described is the device's functional and safety performance, not an algorithmic diagnostic output. Therefore, the concept of "standalone (algorithm only)" doesn't directly apply here in the typical sense of AI/software performance. However, aspects like "Pressure Accuracy," "Thermal Zero Shift," and "Zero Drift" for the OptoMonitor 3 are standalone device performance metrics, independent of human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Study: The ground truth for the clinical performance (e.g., successful pacing, successful THV advancement/positioning) was established by clinical observation and outcomes during actual TAVR procedures in patients. This falls under outcomes data and clinical observation/judgment by the treating physicians.
- Animal Study: Ground truth was based on direct observation of device functionality in animal models, comparison to predicate devices, and findings from necropsy and histopathology.
- Design Verification: Ground truth for mechanical, electrical, and biocompatibility tests derived from engineering specifications, established medical device standards (ISO, ASTM, IEC), and laboratory test results.
8. The sample size for the training set:
- This device is not an AI/machine learning model, so there is no "training set" in the sense of data used to train an algorithm. The development of such a device involves engineering design, prototyping, and testing, rather than data-driven machine learning.
9. How the ground truth for the training set was established:
- As above, there is no "training set" in the context of an AI/ML model for this device. Ground truth for the underlying engineering design values would be based on established physics, biomedical engineering principles, and performance requirements derived from clinical needs and predicate device capabilities.
{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) |
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."
{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 ™ | ||||||
|---|---|---|---|---|---|---|
| ProposedDevice | Predicate 1(PrimaryPredicate) | Predicate 2 | Reference Device | Predicate 3 | ||
| Regulatory Information | Name | SavvyWire™ | Pre-FormedGuidewire(BSC Safari2) | OptoWire III | Pacel BipolarPacing Catheters | Wattson TemporaryPacing 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™ | ||||||
| ProposedDevice | Predicate 1(Primary Predicate) | Predicate 2 | Reference Device | Predicate 3 | ||
| RegulationNumber | 870.1330,870.2870,870.3680 | 870.2870 | 870.1330,870.2870 | 870.3680 | 870.1330, 870.3680 | |
| RegulationGeneric 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 | |
| RegulationIntended Use | Coiled wirefits inside apercutaneouscatheter forthe purposeof directingthe catheterthrough ablood vessel.Catheter tiptransmitsmechanical orelectricalpropertychanges inrelation tochanges inbloodpressure toaccessoryequipment forprocessing.The device isused totransmit apacingelectricalstimulus fromthe pulsegenerator tothe heartand/or totransmit theelectricalsignal of theheart to thepulse | Coiled wirefits inside apercutaneouscatheter forthe purposeof directingthe catheterthrough ablood vessel. | Coiled wire fitsinside apercutaneouscatheter forthe purpose ofdirecting thecatheterthrough ablood vessel.Catheter tiptransmitsmechanical orelectricalpropertychanges inrelation tochanges inblood pressureto accessoryequipment forprocessing. | The device is usedto transmit apacing electricalstimulus from thepulse generator tothe heart and/orto transmit theelectrical signal ofthe heart to thepulse generator. | Coiled wire fits inside apercutaneous catheterfor the purpose ofdirecting the catheterthrough a blood vessel.The device is used totransmit a pacingelectrical stimulus fromthe pulse generator tothe heart and/or totransmit the electricalsignal of the heart tothe pulse generator. | |
| SavvyWire ™ | ||||||
| ProposedDevice | Predicate 1(PrimaryPredicate) | Predicate 2 | Reference Device | Predicate 3 | ||
| Indications | TheSavvyWire™is intendedfor use tointroduce andpositioninterventionaldeviceswithin thechambers ofthe heart,includingthose usedfortranscatheteraortic valveprocedures,whilemeasuringthe pressurewithin theheartallowingcalculation ofhemodynamicparameters.Additionally,theSavvyWire™can be usedfor temporaryintracardiacpacing bytransmittingan electricalsignal from anexternal pulsegenerator tothe heart. | The Pre-Formedguidewiresare intendedto facilitatetheintroductionandplacement ofinterventionaldeviceswithin thechambers ofthe heartincludingthose usedwithintranscatheteraortic valveprocedures. | To measurepressure inblood vesselsincluding bothcoronary andperipheralvessels, duringdiagnosticangiographyand/or otheranyinterventionalprocedures.Bloodpressuremeasurementsprovidehemodynamicinformation,such asfractional flowreserve, forthe diagnosisand treatmentof blood vesseldisease. | The St. JudeMedical Pacel™Bipolar PacingCatheters areintended foruse in theintracardiacpacing and/orECG recording | The Wattson temporarypacing guidewire isintended to introduceand position cathetersand otherinterventionaldevices within thechambers of the heart, including those usedwithin transcatheteraortic valvereplacement (TAVR)procedures and balloonaortic valvuloplasty(BAV), whiletransmitting anelectrical signal from anexternal pulsegenerator to the heart.The temporary pacingguidewire is notintended to remain inplace following theclinical procedure. | |
| SavvyWire™ | ||||||
| ProposedDevice | Predicate 1(PrimaryPredicate) | Predicate 2 | Reference Device | Predicate 3 | ||
| Contraindications | Cerebralvasculature &absence ofanti-coagulationtherapy | Cerebralvasculature | Cerebralvasculature | Patients withrecurrent sepsisor with ahypercoagulablestate should notbe consideredcandidates fortransvenouscatheters sincethe catheter couldserve as a focalpoint for septic orbland thrombusformation. Inaddition, patientswith a mechanicaltricuspid valveshould not beconsidered forventricular pacing. | The guidewire iscontraindicated for usein the coronary arteriesand in thecerebrovascular. | |
| Prescription Use | Rx Only | Rx Only | Rx Only | Rx Only | Rx Only | |
| SystemComponents | Sterile,disposableguidewire | Sterile,disposableguidewire | Sterile,disposableguidewire | Sterile, disposablecatheter | Sterile, disposablecatheter | |
| Pressure Sensing& SignalTransmissionTechnology | Fiberopticsensor & fiberbundleembedded inguidewire. | None. | Fiberopticsensor & fiberbundleembedded inguidewire. | None | None | |
| Sterile, SingleUse PatientContactComponent? | Yes | Yes | Yes | Yes | Yes | |
| Guidewire OD | 0.035" | 0.035" | 0.014" | Multiple cathetersizes available. | 0.035" | |
| GuidewireLength | 280 cm | 275 cm | 180 cm | 110 cm | 280 cm | |
| Guidewire ShaftMaterial | Stainless steel | Stainless steel | Stainless Steel,Nitinol | Stainless steel | Stainless Steel | |
| Technological Characteristics | Tip Coating | None(Stainlesssteel) | Teflon spraycoating(PTFE) | None(Platinum-Tungstenalloy) | None (Stainlesssteel) | None (Stainless steel) |
| Shaft Coating | Teflon (PTFE) | Teflon (PTFE) | Teflon (PTFE) | Proprietary blend | Fluropolymer outer | |
| IntermediateSection Coating | Teflon (PTFE) | Teflon (PTFE) | PET +Hydrophiliccoating | of polyurethanecoating(hemocompatible) | Jacket (FEP) withSilicone Oil Lubricant | |
| Tip Configuration | Spiral (XS OD3.2 cm,S OD 4.2 cm) | Spiral (XS OD3.2 cm, S OD4.2 cm) | Straight | Various L and Jcurves available | Spiral (OD is 3.0 cm) | |
| Guidewire TipDesign | Coiled | Coiled | Coiled | Solid Core | Coiled | |
| Guidewire TipLength | XS: 2.9 cmS: 3.8 cm | XS: 2.9 cmS: 4.2 cm | 3.0 cm | Various lengths | Not specified | |
| SavvyWire ™™ | ||||||
| ProposedDevice | Predicate 1(PrimaryPredicate) | Predicate 2 | Reference Device | Predicate 3 | ||
| Radiopaque Tip? | Yes | Yes | Yes | Yes | Yes | |
| Pressure SensorLocation | XS: 2.9 cmS: 3.8 cm | N/A | 3.0 cm fromdistal tip | N/A | N/A | |
| Electrode | Unipolar | N/A | N/A | Bipolar | Bipolar | |
| External PulseGeneratorConnection | Alligatorclamp(negativelead) isconnected toone of theSavvyWirepacingconnectionzones | N/A | N/A | Pins areconnected tonegative andpositive terminals. | Removable guidewireadapter terminating intwo shroudedpositive/negativeconnectors | |
| Pulse Generatorcompatibility | Compatiblewith standardexternal pulsegenerators | N/A | N/A | Compatible withstandard externalpulse generators | Compatible withstandard external pulsegenerators |
Table 1: SavvyWire™
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
TABLE 2:OPTOMONITOR 3 WITH TAVI
-OntoMonitor Swith TAVI
| OptoMonitor 3 with TAVI | |||
|---|---|---|---|
| OptoMonitor 3 (with TAVI) | OptoMonitor 3 (Predicate Device 4) | ||
| RegulatoryInformation | 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 tomeasure cardiovascular bloodpressure, including in heartchambers, coronary vessels andperipheral vessels, duringinterventional procedures.Blood pressure measurementsprovide hemodynamic information,such as fractional flow reserve forthe diagnosis and treatment ofblood vessels and such as valvegradients during transcatheteraortic valve procedures. | The OptoMonitor 3 is intended tomeasure pressure in blood vesselsincluding both coronary andperipheral vessels, during diagnosticangiography and/or other anyinterventional procedures.Blood pressure measurementsprovide hemodynamic information,such as fractional flow reserve, forthe diagnosis and treatment of bloodvessel disease. |
| Prescription Use | Rx Only | Rx Only | |
| TechnologicalCharacteristics | System Components / devicematerials | Reusable signal processor /monitorEmbedded softwareConnecting cables | Reusable signal processor / monitorEmbedded softwareConnecting cables |
| System Capabilities | Measurement of intravascularblood pressure including FFR andmeasurement inside left ventricle | Measurement of intravascular bloodpressure including FFR. | |
| OptoMonitor 3 with TAVI | OptoMonitor 3 (with TAVI) | OptoMonitor 3 (Predicate Device 4) | |
| Pressure Sensing & SignalTransmission Technology | Fiberoptic sensor & fiber bundleembedded in guidewire. MonitorSenses pressure from Fiberopticsensor. | Fiberoptic sensor & fiber bundleembedded in guidewire. MonitorSenses pressure from Fiberopticsensor. | |
| 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 (pressurerange 50 to 300mmHg) | +/- 1 mmHg plus +/- 1% of reading(pressure range -30 to 50 mmHg) or+/- 3% of reading (pressure range 50to 300mmHg) | |
| Thermal Zero Shift | <0.3 mmHg/deg C | <0.3 mmHg/deg C | |
| Zero Drift | <1 mmHg/h | <1 mmHg/h | |
| Electrical Isolation | Class 2 (double isolation) | Class 2 (double isolation) | |
| User Interface | TouchscreenControl room: yes | TouchscreenControl room: yes | |
| Auto-zeroing | Yes | Yes | |
| Real Time Curves | Aortic instantaneous pressure,aortic mean pressure, pressurewire instantaneous pressure, distalmean pressure | Aortic instantaneous pressure, aorticmean pressure, distal instantaneouspressure, distal mean pressure | |
| Real Time Numerical Values | Mean aortic pressure, meanpressure wire pressure, meanPd/mean Pa; FFR, dPR. Averagedpulse rate, systolic/diastolic values,gradients, left ventricular end ofdiastole pressure | Mean aortic pressure, mean distalpressure, mean Pd/mean Pa; FFR, dPR | |
| Recording Values | Instantaneous Pa, pressure wireand Pd/Pa; mean Pa; mean Pd;mean Pd/mean Pa; FFR, dPR. pulserate, systolic/diastolic values | Instantaneous Pa, Pd and Pd/Pa;mean Pa; mean Pd; mean Pd/meanPa; FFR, dPR | |
| Display Monitor | LCD | LCD | |
| OptoMonitor 3 with TAVI | |||
| OptoMonitor 3 (with TAVI) | OptoMonitor 3 (Predicate Device 4) | ||
| Aortic Input | Low Level (5μV/V/mmHg) | Low Level (5μV/V/mmHg) | |
| Pressure wire Input | OptoWire™ (optical) andSavvyWire™ (optical) | OptoWire (optical) | |
| AUX Input | High Level (100 mmHg/V) | High Level (100 mmHg/V) | |
| Distal pressure output | Low Level (5μV/V/mmHg) | Low Level (5μV/V/mmHg) | |
| Hardware components | Signal Conditioner Unit (SCU), theDisplay Unit (DU), The Handle Unit(HU) and accessories (cables,power supply, etc) | Signal Conditioner Unit (SCU), theDisplay Unit (DU), The Handle Unit(HU) and accessories (cables, powersupply, etc) | |
| Connected devices | OptoWire™SavvyWire™ | OptoWire™SavvyWire™ |
{11}------------------------------------------------
{12}------------------------------------------------
PERFORMANCE DATA 7.
Risk Based Approach
The Risk Management Report was prepared to document the evaluations and decisions made as well as necessary safety measures in the design and the manufacturing of the SavvyWire™. A full set of new risk management documents in accordance with ISO 14971 have been created for the SavvyWire™ including a Risk Management Plan, Hazard and risk analysis, FMEAs, and a Risk Management Report. Risk Management documentation as well as all testing associated with the OptoMonitor 3 with TAVI are included in the software risk management file as the OptoMonitor 3 device is a currently marketed device and the only changes are software related (addition of TAVI).
The risks related to all applicable hazards which were identified for the SavvyWire™ have been reduced to the acceptable level by mitigation. The SavvyWire™ is shown to be at least as safe and effective as the predicate device and the inherent risks are believed to be overcome by the benefits of the device use as indicated. Therefore, all residual risks post-mitigation have been deemed acceptable for this design.
Sterilization, Packaging, Shelf-life Testing:
The following standards are utilized to show equivalence of Sterilization, Packaging, and Shelf life:
- ISO 11135-1 (2014) Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
- . ISO 11607-1 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging systems [including: amendment 1 (2014)]. (Sterility)
- . ASTM F1980-07 (Reapproved 2011), standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
Biocompatibility testing:
The biocompatibility evaluation was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Attachment A) published June 16, 2016. This device is
{13}------------------------------------------------
categorized in ISO 10993-1:2018 as "External communicating device – circulating blood" per section 5.2.3 c). The device will have limited exposure, a cumulative sum of single, multiple or repeated duration of contact up to 24 h. Testing completed on this device includes:
- Cytotoxicity
- Sensitization
- . Intracutaneous reactivity
- . Systemic toxicity (acute)
- Hemocompatibility
- . Pyrogenicity
- SC5b-9 complement
Design Verification Pre-Conditioning:
The SavvyWire™ devices were exposed to EtO and Simulated Distribution prior to the execution of testing as pre-conditioning. Additionally, testing with the indicator "T2" was completed on devices subjected to accelerated aging the equivalent of 2 years ("TO" = no aging).
Electrical Safety:
The OptoMonitor 3 with TAVI Software complies with applicable requirements of IEC 60601-1 safety standard, IEC 60601-1-2 EMC standard, and IEC 60601-2-34 safety and performance standard when used in combination with the SavvyWire™. Certain applicable portions of ISO 14708 are also applied.
Design Verification:
Testing was conducted based on requirements of the latest FDA guidance document on guidewires: FDA Guidance Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff October 2019. All Design Requirements were verified for the SavvyWire™ device.
Design Specification Verification and ISO 11070 Compliance were completed by documentation check and therefore did not use any SavvyWire™ product.
Verification testing includes:
- . Rapid Pacing Testing
- . Mechanical Testing
- Functional Testing
- . FOIC Testing
No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities.
Animal studies:
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.
{14}------------------------------------------------
All acceptance criteria were met regarding risks and device functionality.
Clinical Studies
A single-arm, two-center, prospective study. The SavvyWire™ guidewire was used in eligible subject for rapid pacing runs, valve delivery and for pressure measurements pre- and post-THV deployment. The study included 20 patients; male and female subjects were eligible for this study if they were ≥18 years of age and were undergoing a TAVR procedure due to severe symptomatic aortic stenosis. 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.
CONCLUSIONS 8.
The results from these tests mentioned above demonstrate that the technological and performance characteristics of the SavvyWire™ is comparable to the predicate and reference devices, supports the substantial equivalence of the device that is the subject of this 510(k), and ensures the subject device can perform in a manner equivalent to the predicate device with the same intended use.
The results of the verification/validation tests and the risk analysis have demonstrated that the SavvyWire™ and OptoMonitor 3 with TAVI does not raise any new questions of safety and is therefore substantially equivalent to the legally marketed predicate devices (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
§ 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.