The Flextra™ Steerable Introducer is introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

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 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. 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. 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 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.

AI/ML Overview

The provided document describes the predicate device and the new device being submitted for 510(k) clearance, the Flextra Steerable Introducer. It focuses on demonstrating substantial equivalence to the predicate device through various non-clinical tests.

Since this document describes a medical device undergoing premarket notification (510(k)) for substantial equivalence, the "acceptance criteria" are generally established regulatory standards and the "study that proves the device meets the acceptance criteria" refers to the comprehensive non-clinical testing performed to show the device functions as intended and is safe, effective, and performs as well as or better than the predicate device.

Here's a breakdown of the requested information based on the provided text, recognizing that it pertains to a device, not an AI algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

For a medical device, "acceptance criteria" are typically defined by recognized standards and performance specifications derived from these standards or from the predicate device's performance. The "reported device performance" are the results of tests against these criteria.

Test Type	Test Name	Acceptance Criteria (Implicit from "Pass" result and standards)	Reported Device Performance (Result)
Biocompatibility	Hemolysis Test (ASTM F756)	Non-Hemolytic	Pass, Non-Hemolytic
	Complement Activation (C3a Assay, SC5b-9 Assay)	Non-Reactive	Pass, Non-Reactive
	Platelet and Leukocyte	Acceptable levels	Pass
	Partial Thromboplastin Time (PTT)	Non-Activator	Pass, Non-Activator
	Prothrombin Time Assay (PT)	Acceptable levels	Pass
	Cytotoxicity (MEM Elution: L-929 Mouse Fibroblast Cells)	Non-Cytotoxic	Pass, Non-Cytotoxic
	Sensitization (Guinea Pig Maximization)	Non-Sensitizer	Pass, Non-Sensitizer
	Irritation (Intracutaneous Reactivity Test)	Non-Irritant	Pass, Non-Irritant
	Pyrogenicity (Materials Mediated Pyrogenicity Test)	Non-Pyrogenic	Pass, Non-Pyrogenic
	Acute Systemic Toxicity Test (Aqueous and Non-Aqueous Extract)	Non-Toxic	Pass, Non-Toxic
	4-hour Thrombogenicity (2 canines)	Non-Thrombogenic	Pass, Non-Thrombogenic
Sterilization	Biological Indicator Population Enumeration Testing	Meeting SAL requirements (ANSVA AMI/ISO 11135 overkill approach)	Protocol for EO sterilization provided in submission, status "pending sterilization" at time of summary, but implied successful validation by "Results" section.
	Bioburden Testing	Meeting SAL requirements	Protocol for EO sterilization provided in submission, status "pending sterilization" at time of summary, but implied successful validation by "Results" section.
	Product Sterility Testing	Meeting SAL requirements	Protocol for EO sterilization provided in submission, status "pending sterilization" at time of summary, but implied successful validation by "Results" section.
	Bacteriostasis/Fungistasis Testing	Meeting SAL requirements	Protocol for EO sterilization provided in submission, status "pending sterilization" at time of summary, but implied successful validation by "Results" section.
	Biological Indicator Sterility Testing	Meeting SAL requirements	Protocol for EO sterilization provided in submission, status "pending sterilization" at time of summary, but implied successful validation by "Results" section.
	EO Residuals Testing	Acceptable levels (ISO 10993-7)	Protocol for EO sterilization provided in submission, status "pending sterilization" at time of summary, but implied successful validation by "Results" section.
Packaging	Environmental Conditioning	Maintain integrity after environmental conditions	Passed
	Distribution Simulation (ASTM D 4169-09, Cycle 13; ISTA 2A)	Maintain integrity after distribution simulation	Passed
	Visual Evaluation	No damage/defects	Passed
	Bubble Test (ASTM F2096-11)	Maintain seal integrity	Passed
	Seal Strength (ASTM F88/F88M-15)	Maintain seal strength	Passed
Shelf Life	12 Month Accelerated Aging (ASTM F 1980-07)	Device function and sterile barrier maintained	Passed at 12 months accelerated aging
	12 Month Real Time Aging	Device function and sterile barrier maintained	On-going at time of submission, but implies positive initial results.
Performance Testing	Product Inspection/Dimensional Verification	Conform to specifications	All protocol requirements/specifications met
	Surface Inspection	No defects	All protocol requirements/specifications met
	Label Legibility & Adhesion	Legible and adhered	All protocol requirements/specifications met
	Sheath Compatibility (Insertion/Withdrawal)	Acceptable force	All protocol requirements/specifications met
	Pushability/Trackability	Acceptable performance	All protocol requirements/specifications met
	Tip Deflection	Meet specified deflection range	All protocol requirements/specifications met
	Tip Curve Retention	Maintain curve	All protocol requirements/specifications met
	System Leak (Liquid, Hemostasis, Luer, Aspiration)	No leaks	All protocol requirements/specifications met
	Coating Integrity (Particulate, Friction)	Acceptable integrity	All protocol requirements/specifications met
	Kink Resistance	Resist kinking	All protocol requirements/specifications met
	Torque Resistance	Resist twisting	All protocol requirements/specifications met
	Tip/Markerband Tensile	Withstand tensile forces	All protocol requirements/specifications met
	Sheath to Hemostasis Valve Tensile	Withstand tensile forces	All protocol requirements/specifications met
	Shaft to Handle Tensile	Withstand tensile forces	All protocol requirements/specifications met
	Needle to Button Tensile	Withstand tensile forces	All protocol requirements/specifications met
	Luer to Hypotube Tensile	Withstand tensile forces	All protocol requirements/specifications met
	Needle Actuation	Proper function	All protocol requirements/specifications met
	Flush Tubing to Stopcock Tensile	Withstand tensile forces	All protocol requirements/specifications met
	Flush Tubing to Hemostasis Valve Tensile	Withstand tensile forces	All protocol requirements/specifications met
	Electrical Safety (IEC 60601)	Meet safety standards	All protocol requirements/specifications met
	Electrical Continuity Pin-Needle	Maintain continuity	All protocol requirements/specifications met
	Corrosion Resistance	Resist corrosion	All protocol requirements/specifications met
	Package Integrity - Bubble Leak	Maintain integrity	All protocol requirements/specifications met
	Package Integrity Peel Strength	Maintain strength	All protocol requirements/specifications met
	Radiopacity (ASTM F640-12)	Visible under fluoroscopy	All protocol requirements/specifications met
Animal Study	Performance (compared to predicate)	Substantially equivalent performance for selected parameters	Performed substantially equivalent to SJM Agilis NxT Steerable Catheter Introducer (K061363)

2. Sample size used for the test set and the data provenance

Biocompatibility: Various numbers per test, e.g., "2 canines" for thrombogenicity.
Sterilization, Packaging, Shelf Life, Performance Testing: The document refers to "samples" or "test devices" but does not specify the exact number of units used for each test. For accelerated aging, it mentions "test devices."
Animal Study: "A single animal study was performed that combined the evaluation of another device... to limit the number of animals required." The thrombogenicity test also used "2 canines."
Data Provenance: The tests were conducted by various vendors and labs primarily in the USA (Minneapolis, MN; Salt Lake City, UT; Franklin, WI; Eden Prairie, MN). The studies are prospective evaluations of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable to this type of device submission. The "ground truth" for device performance is established by objective measurements against engineering specifications and validated test methods (e.g., ASTM, ISO standards), or by comparison to a predicate device in an animal model. There is no mention of human experts establishing ground truth in the context of diagnostic performance or image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if disagreement) are typically used in clinical studies or diagnostic performance evaluations for subjective assessments. This document describes objective engineering tests and an animal study.

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

Not applicable. This device is a steerable introducer catheter, not an AI algorithm for diagnostic interpretation. Therefore, no MRMC study or AI-assisted human reader improvement assessment was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical medical instrument, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by:

Compliance with recognized international and national standards (e.g., ISO, ASTM IEC) for physical, mechanical, chemical, and biological properties.
Direct measurement and verification against pre-defined engineering specifications.
Comparison to a legally marketed predicate device (SJM Agilis™ NxT Steerable Introducer, K061363) in an animal model for functional and performance aspects, demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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.10025 Valley View RoadSuite 130Eden Prairie, MN 55344
Contact Person:	Jim HassettPhone: 952-479-7903Email: 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

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 Sulfateand 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 ValveAssembly
	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
1. 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 F756Method; Direct Contact andExtract Contact	Pass,Non- Hemolytic
	Complement Activation; C3aAssay 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 MouseFibroblast Cells	Pass,Non-Cytotoxic
Sensitization	Guinea Pig Maximization (2extracts)	Pass,Non-Sensitizer
Irritation	Intracutaneous Reactivity Test(2 extracts)	Pass,Non-Irritant
Pyrogen	Materials Mediated PyrogenicityTest	Pass,Non- Pyrogenic
Systemic Toxicity	Acute Systemic Toxicity Test(Aqueous and Non-AqueousExtract)	Pass, Non-Toxic
In vivothrombogenticity	4-hour Thrombogenicity; 2canines, Flextra and Lancerseparately	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

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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.	StandardsOrganization	Standards Title	Version
1	10993-1	ISO	Biological Evaluation of Medical Devices	2009
2	11135-1	ISO	Sterilization of health care products –Ethylene oxide - Requirements fordevelopment, validation, and routine controlof a sterilization process for medicaldevices	2014
3	10555-1	ISO	Sterile, Single-Use Intravascular Catheters	2013
4	F2096-11	ASTM	Standard Test Method for Detecting GrossLeaks in Porous Medical Packaging byInternal Pressurization (Bubble Leak)	2014
5	D4169-14	ASTM	Performance Testing of ShippingContainers and Systems DistributionSimulation Testing	2014
6	F756-13	ASTM	Standard Practice for Assessment ofHemolytic Properties ofMaterials	2013
7	60601-1:2005/(R)2012and A1:2012	AAMI/ANSIES	Medical electrical equipment - Part 1:General requirements for basicsafety and essential performance	2012
8	11607-1	ISO	Packaging for Terminally SterilizedMedical Devices - Part 1: Requirements forMaterials, Sterile Barrier Systems andPackaging Systems	2006
9	11607-2	ISO	Packaging for Terminally SterilizedMedical Devices - Part 2: ValidationRequirements for Forming, Sealing andAssembly Processes	2006
10	14971	ISO	Medical Device: Application of RiskManagement	2012
11	594-1	ISO	Conical fittings with 6% (Luer) taper- Part1: General requirements	1986
12	594-2	ISO	Conical fittings with 6% (Luer) taper- Part2: Lock Fittings	1998
13	F88/F88M-15	ASTM	Standard Test Method for Seal Strength ofFlexible Barrier Materials	2009
14	F2394-07(2013)	ASTM	Standard Guide for Measuring Securementof Balloon Expandable Vascular StentMounted on Delivery System	2013
15	F2888-13	ASTM	Standard Test Method for PlateletLeukocyte Count	2013

	Table 5.7 Standards Utilized

Standards No.	Standards Organization	Standards Title	Version
16 11135-1:2007	ISO	Sterilization of Healthcare products –Ethylene oxide – Part 1: Requirements forDevelopment, Validation, and RoutineControl of a Sterilization Process forMedical Devices.	2007
17 14:2009	AAMI TIR	Contract Sterilization Using Ethylene Oxide	2009
18 16:2009(R)2013	AAMI TIR	Microbiological Aspects of Ethylene OxideSterilization	2013
19 11135-2:2008	ISO	Sterilization of Healthcare Products –Ethylene Oxide – Part 2: Guidance on theApplication of ISO 11135-1	2008
20 10993-7:2008(R)2012	ISO	Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide SterilizationResiduals	2012
21 10993-04:2002(R)2013	ISO	Biological Evaluation of Medical Devices -Part 4: Selection of Tests for Interactionwith Blood	2013
22 10993-05:2009(R)2014	ISO	Biological Evaluation of Medical Devices -Part 5 Tests for In Vitro Cytotoxicity	2014
23 10993-11:2006(R)2010	ISO	Biological Evaluation of Medical Devices -Part 11: Tests for Systemic Toxicity	2010
24 10993-12	ISO	Biological Evaluation of Medical Devices -Part 12: Sample Preparation and ReferenceMaterials	2012
25 10993-10	ISO	Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and SkinSensitization	2012
26 13485:2016	ISO	Medical Devices --Quality ManagementSystem—Requirements for RegulatoryPurposes	2016
27 F2382-04	ASTM	Standard Test Method for Assessment ofIntravascular Medical Device Materials onPartial Thromboplastin Time (PTT)	2010
28 11070:2014	ISO	Sterile Single-use Intravascular Introducers,Dilators and Guidewires	2014
29 F1980-07	ASTM	Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices	2011
30 F640-12	ASTM	Standard Test Methods for DeterminingRadiopacity for Medical Use	2012
31 2A	ISTA	Packaged Products 150lbs or less	2011
32 60601-1-2	IEC	Medical electrical equipment - Part 1-2:General Requirements for Basic Safety andEssential Performance - CollateralStandard:Electromagnetic Compatibility -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

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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).

Regulation Number and Section

§ 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).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

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

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

8. The sample size for the training set

9. How the ground truth for the training set was established

Indications for Use

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

5.0 510(k) SUMMARY AS REQUIRED BY 21CFR 807.92

Table 5.1 Submitter Information

Table 5.3 Predicate Device

5.1 Device Description

5.2 Indications for Use

5.3 Summary of Testing

5.3.1 Biocompatibility

Results

5.3.2 Sterilization

Results

5.3.3 Packaging

Results

5.3.4 Shelf Life

5.3.5 Performance Testing

Results

5.3.6 Animal Study

Results

5.4 Comparison to the Predicate Device

5.5 Summary of Standards Utilized in Testing

5.6 Conclusions

§ 870.1340 Catheter introducer.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW