Flextra Steerable Introducer
Device Facts
| Record ID | K170373 |
|---|---|
| Device Name | Flextra Steerable Introducer |
| Applicant | Rhythm Xience, Inc. (Rxi) |
| Product Code | DYB · Cardiovascular |
| Decision Date | Feb 27, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The Flextra Steerable Introducer is introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Device Story
Flextra Steerable Introducer set facilitates vascular access to heart and variable catheter positioning. Set includes steerable introducer, integrated vessel dilator/transseptal needle (Lancer), guidewire, and ECG adapter cable. Introducer features proximal handle with rotating actuator for +/- 180° distal tip deflection; hemostasis valve; sideport for aspiration/infusion/pressure monitoring; platinum radiopaque tip marker. Lancer combines dilator and transseptal needle; needle remains retracted until manually advanced via slider button. ECG adapter allows monitoring of electrograms from needle during transseptal puncture. Used in clinical settings by physicians. Device provides transseptal access to left atrium; integrated needle design improves component alignment and efficiency compared to predicate. Benefits include reduced manual steps and enhanced procedural convenience.
Clinical Evidence
Animal study performed at American Preclinical Services, Inc. compared Flextra to the predicate Agilis NxT. Study evaluated access, fluoroscopic/echocardiographic visualization, fossa ovalis localization/puncture, ECG monitoring, and overall performance. Results demonstrated performance substantially equivalent to the predicate. No human clinical data provided.
Technological Characteristics
Materials: Pebax, Vestamid, PTFE, Polyethylene terephthalate, Platinum, Polycarbonate, HDPE, PVC, Polyisoprene, Buna-N, 304 Stainless Steel, ABS, Silicone. Principle: Mechanical deflection via rotating actuator. Energy: Passive (mechanical). Dimensions: 8.5 French ID, 50/65 cm lengths. Connectivity: ECG adapter cable (DIN 0.080 inch touchproof connectors). Sterilization: Ethylene Oxide (ISO 11135). Standards: ISO 10993, ISO 10555, ISO 11070, ASTM F640, IEC 60601-1.
Indications for Use
Indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Predicate Devices
- Agilis™ NxT Steerable Introducer (K061363)
Reference Devices
- St. Jude Medical BRK™ Transseptal Needle (K072278)
- Boston Scientific Peri Vac Pericardiocentesis Kit (K032050)
- Lake Region Medical Guidewire (K935170)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three heads, each in profile, facing to the right. The eagle's body is represented by flowing lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2017
Rhythm Xience, Inc. c/o Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K170373
Trade/Device Name: Flextra Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 4, 2017 Received: February 7, 2017
Dear Mr. Job:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Willhemen
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)
Device Name FLEXTRA™ STEERABLE INTRODUCER
Indications for Use (Describe)
The Flextra™ Steerable Introducer is introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Type of Use (Select one or both, as applicable)
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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#### 5.0 510(k) SUMMARY AS REQUIRED BY 21CFR 807.92
510(k) Number: K__________________or TBD [X]
Date Prepared: January 24, 2017
#### Table 5.1 Submitter Information
| Submitter: | Rhythm Xience, Inc.<br>10025 Valley View Road<br>Suite 130<br>Eden Prairie, MN 55344 |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Jim Hassett<br>Phone: 952-479-7903<br>Email: jimhassett@rhythm-xience.com |
| Establishment registration: awaiting 510(k) clearance prior to initial registration/listing | |
| Trade Name | Flextra Steerable Introducer |
|----------------------------|------------------------------|
| Common Name | Catheter Introducer |
| Classification Name | Introducer, Catheter |
| Regulation /Product Code | 21 CFR 870.1340 |
| Product Code | DYB |
| Regulatory Classification: | Class II |
| Device Panel: | Cardiovascular |
The RXI Flextra Steerable Introducer is substantially equivalent to the previously cleared predicate, St. Jude Medical (SJM) Agilis™ NxT Steerable Introducer, K061363.
#### Table 5.3 Predicate Device
| Predicate Device | Manufacturer | FDA 510(k) |
|----------------------------------|------------------------|------------|
| Agilis™ NxT Steerable Introducer | St. Jude Medical, Inc. | K061363 |
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## 5.1 Device Description
The Flextra Steerable Introducer set contains a steerable introducer, integrated vessel dilator/transseptal needle (component branded as Lancer"), guidewire, and ECG adapter cable. The set is designed to facilitate vascular access to the heart and then provide variable catheter positioning within the cardiac anatomy (see Figure 5.1).
Image /page/4/Figure/2 description: The image shows a Flextra Introducer Kit. The kit includes a Flextra introducer, a Lancer dilator/needle, an ECG adapter, and a guidewire. The components are arranged in a white tray against a black background. The kit appears to be sterile and ready for use.
Figure 5.1 Flextra Steerable Introducer Set
The Flextra introducer is an elongated shaft with central lumen capable of accepting the Lancer dilator/needle as well as various cardiac catheters. The shaft has a proximal handle with a rotating actuator that allows the user to change the degree of curvature on the distal tip of the shaft (referred to as steerable tip, deflectable tip, or dynamic tip). Rotating the actuator can deflect the tip, in a planar fashion, +/- 180°. The handle is also fitted with a hemostasis valve to minimize blood loss during catheter introduction, and/or exchange, as well as a sideport with 3way stopcock to allow blood aspiration, fluid infusion, and pressure monitoring. The introducer shaft features distal side holes to facilitate aspiration and prevent cavitation plus an embedded platinum radiopaque tip marker to facilitate fluoroscopic visualization. (See Figures 5.2-5.3)
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Image /page/5/Figure/0 description: The image contains two panels, labeled A and B, showing different views of a medical device. Panel A shows two top-down views of the device, one labeled "Neutral" and the other "Deflected", indicating different states of the device's tip. Panel B presents two perspective views of the device, highlighting components such as the "Shaft", "Sideport", "Hemostasis valve", and "Rotating actuator", providing a detailed look at its design and functionality.
Figure 5.2 Panel A is profile technical drawing depicting the tip response to actuator rotation. Panel B illustrates the handle features.
Image /page/5/Figure/2 description: The image shows a diagram of a medical device with dimensional specifications. The handle of the device is labeled as 22 cm in length. The effective length of the device is labeled as 50 and 65 cm. The inner diameter (ID) at the tip is .114", .110", and the outer diameter (OD) at the tip is .158", .140".
Figure 5.3 Flextra Steerable Introducer Dimensional Specifications
The set includes the following accessories (see Figure 5.4):
- Lancer™ Integrated Dilator/Needle ●
- J-Tip Guidewire ●
- ECG Adaptor ●
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Image /page/6/Picture/0 description: The image shows medical equipment laid out on a white surface. The equipment includes a blue Lancer dilator/needle, a guidewire arranged in a loop and held together with blue and white clips, and a red ECG adapter. The guidewire is made of a thin, silver-colored wire and is arranged in a circular pattern.
Figure 5.4 Flextra Steerable Introducer Accessories
The Lancer integrated dilator/needle combines the dilator and transseptal needle into a single component (see Figures 5.5 - 5.7). The needle is used to puncture the interatrial septum to gain access to the left atrium similar to the St. Jude Medical BRK™ Transseptal Needle (K072278). The Lancer consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire in a similar fashion to conventional dilators. The lumen of the Lancer is fitted with a hollow stainless steel transseptal needle and both the shaft and needle are connected to the same proximal handle. The needle lumen will accept guidewire sizes up to 0.032 inches in diameter. Inside the Lancer handle, the needle is affixed to a spring-tensioned actuator that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector to monitor an ECG from the needle while in the heart, utilizing the ECG adapter cable. This is done in a similar manner as pericardiocentesis kits whereby electrocardiograms are monitored from the needle during use (reference Figure 5.8, Boston Scientific Peri Vac Pericardiocentesis Kit, K032050).
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Image /page/7/Figure/0 description: The image contains two panels, labeled A and B, showing different views of a medical device. Panel A is a schematic diagram illustrating the internal components, including the internal needle, push button, Luer fitting, tension spring, electrical pin plug, and dilator shaft. Panel B presents a product view of the device, highlighting features such as the ECG adapter cable, electrical connector for ECG monitoring, dilator shaft, proximal Luer fitting, male interlock for mating with the introducer hub, and a spring-tensioned push button for needle extension.
Figure 5.5 Lancer™ integrated dilator/needle. Panel A is a profile technical drawing depicting the internal components of the handle. Panel B illustrates the handle features.
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Image /page/8/Figure/0 description: The image shows a medical device, specifically a needle inside the lumen of a dilator shaft. The needle is positioned within the dilator shaft, which appears to be a hollow tube. The device also includes a handle, which is likely used to control the movement of the needle and dilator shaft. The image provides a detailed view of the device's components and their arrangement.
Figure 5.6 Lancer™ with inset depicting internal needle in baseline retracted position
Image /page/8/Figure/2 description: The image shows a medical instrument with various measurements labeled. The handle of the instrument is 9 cm long. The effective lengths of the instrument are listed as 191.9 cm, 229.2 cm, 153.8 cm, and 191.9 cm. The needle at the tip has an inner diameter of .035" and an outer diameter of .042".
Figure 5.7 Lancer dimensional specifications
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The distal end of the Lancer handle and the proximal end of the Flextra handle are designed with male/female surfaces to mate the components together into a snap-fit closure (see Figures 5.9 -5.10).
Image /page/9/Picture/1 description: The image shows a medical device, possibly a lancing device used for blood sampling. The device is two-toned, featuring light blue and gray colors. The bottom part of the device has the word "Lancer" printed on it vertically, along with an arrow pointing upwards. The top part of the device has an image of an arrow that is curved.
Figure 5.9 Flextra and Lancer Mating Side-view
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Image /page/10/Picture/0 description: The image shows a diagram of the Lancer to Flextra male/female interface. The Lancer is on the left side of the image, and the Flextra is on the right side of the image. The interface is located in the center of the image. The text "Lancer to Flextra male/female interface" is written below the interface.
Figure 5.10 Flextra and Lancer Snap-fit Closure Mating Feature
The guidewire included in the kit is manufactured by Lake Region Medical (K935170) and is supplied in a polypropylene retainer coil with a J-straightener and Luer fitting. The Luer fitting is compliant to ISO 594-1 and ISO 594-2. The ECG adapter cable included is manufactured by Bioconnect (RF Industries, Inc.), is one (1) meter long, and has male/female DIN 0.080 inch touchproof connectors on the ends.
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The patient-contacting materials used in the Flextra Steerable Introducer set are listed in Table 5.4. A detailed listing of all materials used in the set is provided in this submission.
| Component | Materials |
|------------------------------|-----------------------------------------------------------------------------|
| Flextra Steerable Introducer | |
| Shaft | Pebax (63D, 55D, 35D) and Vestamid with Barium Sulfate<br>and gray colorant |
| | Polytetrafluoroethylene (PTFE) |
| | Polyethylene terephthalate |
| | Ethyl Cyanoacrylate |
| | Siloxane Lubricant (Nusil MED-4162) |
| | Platinum |
| Sideport | Polycarbonate, High Density Polyethylene (HDPE) |
| | Polyvinyl Chloride (PVC) |
| | UV Adhesive |
| Hemostasis Valve<br>Assembly | |
| | Polyisoprene |
| | Buna-N, Durometer Shore A50 |
| | 304 Stainless Steel |
| | Acrylonitrile butadiene styrene (ABS) with white colorant |
| | Acrylic UV Curable |
| | Silicone, Nusil Med-420 |
| | Ethyl Cyanoacrylate |
| Lancer Dilator/Needle | |
| Shaft | Polyethylene Hexene Copolymer |
| | Ethylene Homopolymer |
| | Barium Sulfate with blue colorant |
| Hypotube | 304 Stainless Steel |
| Needle | 304 Stainless Steel |
| Luer fitting | Polycarbonate |
| Guidewire | |
| Guidewire | Polytetrafluoroethylene (PTFE) coated stainless steel |
Table 5.4 Flextra Steerable Introducer List of Materials
There are two (2) models of the Flextra Steerable Introducer set based on useable length (the Lancer component is length-matched to the Flextra introducer). All have an inner diameter of 8.5 French. These include:
- 1. Medium Curl, 50 cm, 8.5 French
- 2. Medium Curl, 65 cm, 8.5 French
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### 5.2 Indications for Use
The Flextra Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart. including the left side of the heart through the interatrial septum.
# 5.3 Summary of Testing
The Flextra Steerable Introducer set underwent the tests listed in Table 5.5. Testing was conducted at three different time intervals: 1) Baseline - 2x sterilization, environmental conditioning and distribution simulation (T=0); 2) Accelerated aging - 2x sterilization and 12month accelerated aging (T=12aa); and 3) Real-time aging - 2x sterilization and 12-month realtime aging (T=12rt). The testing was performed by the following vendors and locations:
- Biocompatibility testing and an Animal Study were performed at American Preclinical Services, LLC., (APS) located in Minneapolis, MN.
- Sterilization testing was performed by Steris Isomedix, located in Minneapolis, MN. ●
- . Environmental Conditioning, Distribution Simulation Testing, Accelerated Aging, Peel Strength and Bubble Leak Testing were performed by Distribution Dynamic Labs, Inc (DDL), Eden Prairie, MN.
- Particulate testing was performed at Nelson Labs located in Salt Lake City, UT. ●
- . Electrical testing was performed at Medical Equipment Compliance Associates, LLC (MECA) located in Franklin, WI.
- . All other tests were performed by CRI-Devices, Maple Grove, MN.
| Test Type | Test Name |
|------------------------|----------------------------------------------------------|
| Biocompatibility | Hemocompatibility |
| | Cytotoxicity |
| | Sensitization |
| | Irritation |
| | Pyrogenicity |
| | Systemic Toxicity |
| | Thrombogenicity |
| | Sterilization Validation |
| Bioburden | |
| EO residuals | |
| Packaging | Environmental Conditioning |
| | Distribution Simulation –Post Environmental Conditioning |
| | Visual Evaluation - Post Environmental Conditioning/ |
| | Distribution Simulation |
| | Bubble Test - Post Environmental Conditioning/ |
| | Distribution Simulation/ Visual Evaluation |
| | Seal Strength- Post Environmental Conditioning/ |
| | Distribution Simulation/ Visual Evaluation/ Bubble Leak |
| Shelf Life | 12 Month Accelerated Aging |
| | 12 Month Real Time Aging |
| Inspection | Corrosion Resistance |
| | Surface Inspection |
| | Tip Deflection |
| Test Type | Test Name |
| | Tip Curve Retention |
| | Dimensional Verification |
| Functional Testing | Pushability/Trackability |
| | Sheath Compatibility (Insertion/Withdrawal Force) |
| | System Leak (Hemostasis, Luer, Aspiration) |
| | Coating Integrity (Particulate, Friction) |
| | Radiopacity |
| | Needle Actuation |
| | Electrical Continuity Pin-Needle |
| Mechanical | Kink Resistance |
| | Torque Resistance |
| | Tip/Marker band Tensile |
| | Sheath to Hemostasis Valve Tensile |
| | Shaft to Handle Tensile |
| | Needle to Button Tensile |
| | Luer to Hypo. Tensile |
| | Flushing Tubing to Stopcock Tensile |
| | Flushing Tubing to Hemostasis Valve Tensile |
| Electrical | Electrical Safety IEC 60601 |
| Animal Study | Access from packaging |
| Comparing to Predicate | Visual Inspection |
| Device | Preparation |
| | Preliminary Device Function |
| | Advancement of Guidewire to Superior Vena Cava |
| | Fluoroscopic Visualization |
| | Intracardiac Echocardiographic Visualization |
| | Fossa Ovalis Localization |
| | Maintenance of component orientation |
| | ECG Monitoring |
| | Fossa Ovalis Puncture |
| | Needle Lumen Function |
| | Dilator Crossing of Fossa Ovalis |
| | Sheath Crossing of Fossa Ovalis |
| | Removal of Device |
| | Overall Performance |
| | Device Function -Aspirate, Flush, Transduce and Deflect |
Table 5.5 Summary of Testing
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### 5.3.1 Biocompatibility
The Flextra Steerable Introducer underwent the following biocompatibility tests as shown in Table 5.6. All testing completed passed with the results listed.
| Test type | Test name | Result |
|-----------------------------|----------------------------------------------------------------------------|----------------------------|
| Hemocompatibility | Hemolysis Test; ASTM F756<br>Method; Direct Contact and<br>Extract Contact | Pass,<br>Non- Hemolytic |
| | Complement Activation; C3a<br>Assay and SC5b-9 Assay | Pass,<br>Non-Reactive |
| | Platelet and Leukocyte | Pass |
| | Partial Thromboplastin Time<br>(PTT) | Pass, Non-<br>Activator |
| | Prothrombin Time Assay (PT) | Pass |
| Cytotoxicity | MEM Elution: L-929 Mouse<br>Fibroblast Cells | Pass,<br>Non-Cytotoxic |
| Sensitization | Guinea Pig Maximization (2<br>extracts) | Pass,<br>Non-Sensitizer |
| Irritation | Intracutaneous Reactivity Test<br>(2 extracts) | Pass,<br>Non-Irritant |
| Pyrogen | Materials Mediated Pyrogenicity<br>Test | Pass,<br>Non- Pyrogenic |
| Systemic Toxicity | Acute Systemic Toxicity Test<br>(Aqueous and Non-Aqueous<br>Extract) | Pass, Non-Toxic |
| In vivo<br>thrombogenticity | 4-hour Thrombogenicity; 2<br>canines, Flextra and Lancer<br>separately | Pass, Non-<br>Thrombogenic |
Table 5.6 Biocompatibility Testing Summary
#### Results
The Flextra Steerable Introducer passed all biocompatibility testing. The full protocols and results for each test are contained in the submission.
#### 5.3.2 Sterilization
The Flextra Steerable Introducer will be offered as sterility assurance level (SAL) by an ethylene oxide (EO) sterilization process. The device will undergo EO sterilization at STERIS Isomedix, located at 380 90th Ave NW, Minneapolis, MN 55433. The sterilization protocol provided by STERIS Isomedix establishes the procedures for validation of an ethylene oxide sterilization process for this device. The performance qualifications were executed using the overkill approach as referenced in the international standard, ANSVA AMI/ISO 11135.
The following tests are conducted to assess the product sterilization:
Rhythm Xience
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- Biological Indicator Population Enumeration Testing ●
- Bioburden Testing ●
- Product Sterility Testing
- Bacteriostasis/Fungistasis Testing
- Biological Indicator Sterility Testing
- EO Residuals Testing ●
#### Results
The Flextra Steerable Introducer is pending sterilization. The protocol is contained in the submission.
## 5.3.3 Packaging
The Flextra Steerable Introducer sets are situated on a thermoformed high-density polyethylene (HDPE) backer card and are shipped sterile in a sealed Tyvek® pouch placed inside a cardboard shelf box and labeled as single use only. The devices underwent the following distribution and packaging testing:
- Environmental Conditioning ●
- Distribution Simulation ●
- Dimensional/Visual Inspection
- Package Integrity/Bubble Test
- Package Integrity/Peel Strength ●
Prior to the testing, all samples had undergone 2x EO sterilization cycles at STERIS Isomedix. The sterilized units were packaged into shippers. The units/shippers were subjected to environmental conditioning followed by the distribution per ASTM D 4169-09, Distributions Cycle 13; Assurance Level II, and thermal conditioning per ISTA 2A (2011). Testing was performed by Distribution Dynamic Labs, Inc. (DDL, Inc.) located at 10200 Valley View Road, Eden Prairie, MN 55344.
#### Results
The Flextra Steerable Introducer passed all distribution and packaging testing. The full protocols and results are contained in the submission.
#### 5.3.4 Shelf Life
The Flextra Steerable Introducer will be labeled with a 12-month shelf life. The device was subjected to 12-month accelerated aging and 12 -month real-time aging (on-going at time of submission). The test devices were subjected to accelerated aging environmental conditions of 55°C ± 2°C and <20% RH for 38 days to simulate the equivalent of 12 months of real-time aging as guided by ASTM F 1980-07 (2011). The Flextra Steerable Introducer passed all baseline and accelerated aging testing while maintaining its sterile barrier.
#### 5.3.5 Performance Testing
Mechanical and functional testing of the Flextra Steerable Introducer with associated Lancer Integrated Dilator/Transseptal Needle, and associated kit accessories including the guidewire and
Rhythm Xience
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ECG extension lead wire, were tested post-sterilization: immediately after manufacturing (t=0), after twelve months accelerated aging (t=12aa). Test samples have been manufactured and reserved for testing after twelve months of real-time aging has occurred (t=12rt).
Tests include:
- Product Inspection/Dimensional Verification
- Surface Inspection
- Label Legibility ●
- Label Adhesion
- Sheath Compatibility (Insertion/Withdrawal) ●
- Pushability/Trackability ●
- Tip Deflection
- Tip Curve Retention
- System Leak -Liquid Leak and Hemostasis
- System Leak - Luer
- System Leak – Aspiration
- Coating Integrity / Particulate Evaluation
- Coating Integrity / Friction Reduction
- Kink Resistance
- Torque Resistance
- Tip / Markerband Tensile ●
- Sheath to Hemostasis Valve Tensile
- Shaft to Handle Tensile
- Needle to Button Tensile ●
- Luer to Hypotube Tensile
- Needle Actuation ●
- Flush Tubing to Stopcock Tensile
- Flush Tubing to Hemostasis Valve Tensile
- Electrical Safety
- Electrical Continuity Pin-Needle
- Corrosion Resistance
- Package Integrity - Bubble Leak
- Package Integrity Peel Strength ●
- Radiopacity
#### Results
All protocol requirements/specifications were met. The full protocols and results for each test are contained in the submission.
# 5.3.6 Animal Study
As part of Design Validation, animal testing was performed at American Preclinical Services, Inc. (APS), located in Minneapolis, MN. APS is USDA registered to conduct research in animals and is AAALAC accredited. All testing followed the requirements for Good Laboratory Practices per 21 CFR 58 as well as ISO 10993 for Biologic Evaluation of Medical Devices.
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A single animal study was performed that combined the evaluation of another device that is being submitted under a separate file by RXI. This was decided due to ethical concerns to limit the number of animals required. This study compared the Flextra Steerable Introducer device to the predicate device listed in Table 5.3.
# Results
This study indicates that the Flextra Steerable Introducer performed for the selected parameters substantially equivalent to the commercially available SJM Agilis NxT Steerable Catheter Introducer (K061363). The full report and results are included in the submission.
### 5.4 Comparison to the Predicate Device
The Flextra Steerable Introducer and St. Jude Agilis NxT are made with similar medical-grade polymers and internal mechanical componentry. Both have a rotating actuator on the proximal handle that causes deflection of the distal tip. The handles of each also contain a hemostasis valve and sideport tube with stopcock. Each set also includes a vessel dilator and guidewire to facilitate introduction into the vasculature and advancement to the heart.
In order to gain transseptal access to the left side of the Agilis NxT requires the use of a separate transseptal needle.
The primary difference with the Flextra is that the needle is integrated into the vessel dilator for convenience. Feature benefits of this integrated dilator/needle include proper alignment of components when assembled, length-matched needle, automatic needle tip retraction within dilator, and the ability to obtain an electrogram from the needle via an ECG adapter. Each of these functions must be performed manually with the Agilis NxT device.
These differences provide convenience and efficiency over the predicate device and do not impact the intended use.
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# 5.5 Summary of Standards Utilized in Testing
The standards used in the testing of the device are outlined in Table 5.7.
| Table 5.7 Standards Utilized | | | | |
|------------------------------|-----------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Standards No. | Standards<br>Organization | Standards Title | Version |
| 1 | 10993-1 | ISO | Biological Evaluation of Medical Devices | 2009 |
| 2 | 11135-1 | ISO | Sterilization of health care products –<br>Ethylene oxide - Requirements for<br>development, validation, and routine control<br>of a sterilization process for medical<br>devices | 2014 |
| 3 | 10555-1 | ISO | Sterile, Single-Use Intravascular Catheters | 2013 |
| 4 | F2096-11 | ASTM | Standard Test Method for Detecting Gross<br>Leaks in Porous Medical Packaging by<br>Internal Pressurization (Bubble Leak) | 2014 |
| 5 | D4169-14 | ASTM | Performance Testing of Shipping<br>Containers and Systems Distribution<br>Simulation Testing | 2014 |
| 6 | F756-13 | ASTM | Standard Practice for Assessment of<br>Hemolytic Properties of<br>Materials | 2013 |
| 7 | 60601-<br>1:2005/(R)2012<br>and A1:2012 | AAMI/ANSI<br>ES | Medical electrical equipment - Part 1:<br>General requirements for basic<br>safety and essential performance | 2012 |
| 8 | 11607-1 | ISO | Packaging for Terminally Sterilized<br>Medical Devices - Part 1: Requirements for<br>Materials, Sterile Barrier Systems and<br>Packaging Systems | 2006 |
| 9 | 11607-2 | ISO | Packaging for Terminally Sterilized<br>Medical Devices - Part 2: Validation<br>Requirements for Forming, Sealing and<br>Assembly Processes | 2006 |
| 10 | 14971 | ISO | Medical Device: Application of Risk<br>Management | 2012 |
| 11 | 594-1 | ISO | Conical fittings with 6% (Luer) taper- Part<br>1: General requirements | 1986 |
| 12 | 594-2 | ISO | Conical fittings with 6% (Luer) taper- Part<br>2: Lock Fittings | 1998 |
| 13 | F88/F88M-15 | ASTM | Standard Test Method for Seal Strength of<br>Flexible Barrier Materials | 2009 |
| 14 | F2394-07(2013) | ASTM | Standard Guide for Measuring Securement<br>of Balloon Expandable Vascular Stent<br>Mounted on Delivery System | 2013 |
| 15 | F2888-13 | ASTM | Standard Test Method for Platelet<br>Leukocyte Count | 2013 |
| | Table 5.7 Standards Utilized | | | |
|-----------------------------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | | | | |
| Standards No. | Standards Organization | Standards Title | Version | |
| 16 11135-1:2007 | ISO | Sterilization of Healthcare products –<br>Ethylene oxide – Part 1: Requirements for<br>Development, Validation, and Routine<br>Control of a Sterilization Process for<br>Medical Devices. | 2007 | |
| 17 14:2009 | AAMI TIR | Contract Sterilization Using Ethylene Oxide | 2009 | |
| 18 16:2009(R)2013 | AAMI TIR | Microbiological Aspects of Ethylene Oxide<br>Sterilization | 2013 | |
| 19 11135-2:2008 | ISO | Sterilization of Healthcare Products –<br>Ethylene Oxide – Part 2: Guidance on the<br>Application of ISO 11135-1 | 2008 | |
| 20 10993-<br>7:2008(R)2012 | ISO | Biological Evaluation of Medical Devices -<br>Part 7: Ethylene Oxide Sterilization<br>Residuals | 2012 | |
| 21 10993-<br>04:2002(R)2013 | ISO | Biological Evaluation of Medical Devices -<br>Part 4: Selection of Tests for Interaction<br>with Blood | 2013 | |
| 22 10993-05:2009<br>(R)2014 | ISO | Biological Evaluation of Medical Devices -<br>Part 5 Tests for In Vitro Cytotoxicity | 2014 | |
| 23 10993-<br>11:2006(R)2010 | ISO | Biological Evaluation of Medical Devices -<br>Part 11: Tests for Systemic Toxicity | 2010 | |
| 24 10993-12 | ISO | Biological Evaluation of Medical Devices -<br>Part 12: Sample Preparation and Reference<br>Materials | 2012 | |
| 25 10993-10 | ISO | Biological Evaluation of Medical Devices -<br>Part 10: Tests for Irritation and Skin<br>Sensitization | 2012 | |
| 26 13485:2016 | ISO | Medical Devices --Quality Management<br>System—Requirements for Regulatory<br>Purposes | 2016 | |
| 27 F2382-04 | ASTM | Standard Test Method for Assessment of<br>Intravascular Medical Device Materials on<br>Partial Thromboplastin Time (PTT) | 2010 | |
| 28 11070:2014 | ISO | Sterile Single-use Intravascular Introducers,<br>Dilators and Guidewires | 2014 | |
| 29 F1980-07 | ASTM | Standard Guide for Accelerated Aging of<br>Sterile Barrier Systems for Medical Devices | 2011 | |
| 30 F640-12 | ASTM | Standard Test Methods for Determining<br>Radiopacity for Medical Use | 2012 | |
| 31 2A | ISTA | Packaged Products 150lbs or less | 2011 | |
| 32 60601-1-2 | IEC | Medical electrical equipment - Part 1-2:<br>General Requirements for Basic Safety and<br>Essential Performance - Collateral<br>Standard:<br>Electromagnetic Compatibility -<br>Requirements and Tests | 2014 | |
| | Standards No. | Standards Organization | Standards Title | Version |
| 33 | 10555-5 | ISO | Intravascular Catheters-Sterile, single-use intravascular catheters- Part 5: Over Needle Peripheral Catheters | 2013 |
| 34 | ST72:2011 | ANSI/AAMI | Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | 2011 |
| 35 | 33 | USP | Transfusion and Infusion Assemblies and Similar medical devices | 2010 |
| 36 | F1886 | ASTM | Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection | 2016 |
| 37 | 15223-1 | ISO | Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements | 2016 |
{19}------------------------------------------------
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## 5.6 Conclusions
The Flextra Steerable Introducer has similar design, materials, and technical requirements as the predicate device. The Flextra Steerable Introducer performs as intended, and presents no unacceptable risks to the intended patient population or end user.
The conclusion drawn from the nonclinical tests, summarized in this submission, demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device listed in Table 5.3.
The Flextra Steerable Introducer is substantially equivalent to the predicate device, the SJM Agilis NxT Steerable Catheter Introducer (K061363).
