(20 days)
No
The device description and performance studies focus on mechanical and electrical components and their physical performance, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
No.
The device functions as an introducer for other catheters and a dilator/needle for vascular access, and does not provide a therapeutic effect on its own.
No
Explanation: The device is described as an introducer set designed to facilitate vascular access and position catheters within the heart. Its function is to assist in the delivery of other catheters, not to diagnose a medical condition itself. While it has an ECG adapter to monitor an ECG from the needle, this is for guidance during the procedure, not for direct diagnosis.
No
The device description clearly outlines multiple hardware components including a steerable introducer shaft, handle, dilator/needle, guidewire, and ECG adapter cable. The performance studies also focus on hardware-related testing like biocompatibility, sterilization, packaging, and mechanical performance.
Based on the provided information, the Flextra™ Steerable Introducer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to introduce various cardiovascular catheters into the heart for procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a physical tool designed for accessing and navigating within the heart. It includes components like a steerable introducer, dilator/needle, guidewire, and ECG adapter cable. These are all instruments used in vivo (within the living body).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The Flextra Steerable Introducer does not perform any such analysis of bodily specimens.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the device itself (biocompatibility, sterilization, packaging, mechanical performance, animal study comparing to a predicate device), not on the analytical performance of testing bodily fluids or tissues.
In summary, the Flextra™ Steerable Introducer is a medical device used for interventional procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
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.
The set includes the following accessories:
- Lancer™ Integrated Dilator/Needle
- J-Tip Guidewire
- ECG Adaptor
The Lancer integrated dilator/needle combines the dilator and transseptal needle into a single component. 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).
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.
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.
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:
-
- Medium Curl, 50 cm, 8.5 French
-
- Medium Curl, 65 cm, 8.5 French
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization, Intracardiac Echocardiographic Visualization
Anatomical Site
Heart, interatrial septum, vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The Flextra Steerable Introducer set underwent testing 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 real-time aging (T=12rt).
Biocompatibility Testing:
The Flextra Steerable Introducer underwent and passed the following biocompatibility tests: Hemocompatibility (Hemolysis Test, Complement Activation, Platelet and Leukocyte, Partial Thromboplastin Time (PTT), Prothrombin Time Assay (PT)), Cytotoxicity (MEM Elution), Sensitization (Guinea Pig Maximization), Irritation (Intracutaneous Reactivity Test), Pyrogenicity (Materials Mediated Pyrogenicity Test), Systemic Toxicity (Acute Systemic Toxicity Test), and In vivo thrombogenicity (4-hour Thrombogenicity; 2 canines, Flextra and Lancer separately). All tests passed, with results indicating the device is non-hemolytic, non-reactive, non-cytotoxic, non-sensitizer, non-irritant, non-pyrogenic, non-toxic, and non-thrombogenic.
Sterilization Testing:
The Flextra Steerable Introducer will be offered as sterility assurance level (SAL) by an ethylene oxide (EO) sterilization process. The sterilization protocol 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. Tests conducted include Biological Indicator Population Enumeration Testing, Bioburden Testing, Product Sterility Testing, Bacteriostasis/Fungistasis Testing, Biological Indicator Sterility Testing, and EO Residuals Testing. The device is pending sterilization, with the protocol contained in the submission.
Packaging Testing:
The devices underwent the following distribution and packaging testing: Environmental Conditioning, Distribution Simulation, Dimensional/Visual Inspection, Package Integrity/Bubble Test, and Package Integrity/Peel Strength. All samples had undergone 2x EO sterilization cycles and were subjected to environmental conditioning followed by distribution per ASTM D 4169-09, Distributions Cycle 13; Assurance Level II, and thermal conditioning per ISTA 2A (2011). The Flextra Steerable Introducer passed all distribution and packaging testing.
Shelf Life Testing:
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
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.
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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.
10025 Valley View Road
Suite 130
Eden Prairie, MN 55344 |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Jim Hassett
Phone: 952-479-7903
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 |
4
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)
5
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 ●
6
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).
7
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.
8
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
9
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
10
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.
11
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 |
| 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 | |
| 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:
-
- Medium Curl, 50 cm, 8.5 French
-
- Medium Curl, 65 cm, 8.5 French
12
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
13
14
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 | |
| Method; Direct Contact and | ||
| Extract Contact | Pass, | |
| Non- Hemolytic | ||
| Complement Activation; C3a | ||
| Assay and SC5b-9 Assay | Pass, | |
| Non-Reactive | ||
| Platelet and Leukocyte | Pass | |
| Partial Thromboplastin Time | ||
| (PTT) | Pass, Non- | |
| Activator | ||
| Prothrombin Time Assay (PT) | Pass | |
| Cytotoxicity | MEM Elution: L-929 Mouse | |
| Fibroblast Cells | Pass, | |
| Non-Cytotoxic | ||
| Sensitization | Guinea Pig Maximization (2 | |
| extracts) | Pass, | |
| Non-Sensitizer | ||
| Irritation | Intracutaneous Reactivity Test | |
| (2 extracts) | Pass, | |
| Non-Irritant | ||
| Pyrogen | Materials Mediated Pyrogenicity | |
| Test | Pass, | |
| Non- Pyrogenic | ||
| Systemic Toxicity | Acute Systemic Toxicity Test | |
| (Aqueous and Non-Aqueous | ||
| Extract) | Pass, Non-Toxic | |
| In vivo | ||
| thrombogenticity | 4-hour Thrombogenicity; 2 | |
| canines, Flextra and Lancer | ||
| separately | Pass, Non- | |
| 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
15
- 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