(48 days)
The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.
The FlexCath Select Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Select Steerable Sheath can be deflected to provide additional maneuverability to catheters that are advance through the sheath and into the right or left chamber of the heart. The FlexCath Select Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application introduces FlexCath Select 10 French (10Fr) FlexCath Select Steerable Sheath (990065), which is a modification of the 12 French (12Fr) FlexCath Advance Sheath (4FC12). Modifications were made to the shaft, cap and strain relief components, hemostasis valve assembly (stopcock, valve, and hub), dilator, new adhesive material and packaging tray cavity.
This document describes a 510(k) premarket notification for the "FlexCath Select Steerable Sheath and Dilator (Model 990065)". The submission aims to establish substantial equivalence to predicate devices, namely the "FlexCath Advance Steerable Sheath & Dilator (Model 4FC12)" and the "HeartSpan Steerable Introducer (Models FST-085-00, FST-085-01, and FST-085-02)". The primary modification and expansion of indications for use revolve around the ability to introduce the catheter into the left side of the heart through the interatrial septum (transseptal puncture).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and the reported device performance" in a quantitative format with specific values for acceptance and performance. Instead, it describes a substantial equivalence comparison with predicate devices and states that "all testing demonstrated that acceptance criteria were met" and "all testing passed by meeting the established requirements".
However, we can infer some performance characteristics and implicit "acceptance criteria" from the comparative tables and descriptions:
| Characteristic/Performance Aspect | Acceptance Criteria (Implied from Predicate/Requirements) | Reported Device Performance (FlexCath Select Steerable Sheath) |
|---|---|---|
| Intended Use | Facilitates introducing various cardiovascular catheters into the heart. | Same as predicate FlexCath Advance and HeartSpan: Facilitates introducing various cardiovascular catheters into the heart. |
| Indications for Use | Similar to predicate FlexCath Advance; for transseptal puncture, similar to predicate HeartSpan. | Intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates catheter positioning. (Expanded from FlexCath Advance, equivalent to HeartSpan). |
| Contraindications | Similar to predicates, particularly regarding atrial septal issues, thrombus, and myxoma. | FlexCath Select contraindications align with predicates: intra-atrial septal patch/occluder, surgical intervention in/adjacent to septum, left atrial thrombus, known/suspected atrial myxoma. |
| Steerable Catheter Introducer | Yes | Yes |
| Unidirectional/Deflectable | Yes | Yes |
| Hemostasis valve | Yes | Yes (New Stopcock design, but functional equivalence implied) |
| Braided Shaft | Yes | Yes |
| Sheath ID (10F) | Adequate for intended catheters (implied from predicate 12F and new 10F design). | 0.131" (10F) |
| Deflection | ≥ 135° when loaded with specific balloon catheters (for FlexCath Advance, Arctic Front/Advance). | ≥ 135° when loaded with Freezor MAX CryoAblation Catheters and phased RF PVAC (different specific catheters, but same deflection performance cited). |
| Dilator OD (10F) | Adequate for transseptal puncture and sheath introduction (implied from predicate HeartSpan 8.5F and new 10F design). | 0.128" (10F) |
| Dilator Material (Stiffness) | Resistant to skiving and damage from transseptal needles (HeartSpan predicate characteristic). | Copolyester TPE (Hytrel 7246 with 40% BaSO4) - identical to predicate HeartSpan for increased stiffness, resistant to skiving/damage. |
| Dilator Guide Wire Compatibility | Up to 0.038" (HeartSpan predicate). | 0.032" to 0.035" |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Usage | Single use and disposable. | Single use and disposable. |
| Shelf Life | 2 years (FlexCath Advance); 3 years (HeartSpan). (Note: FlexCath Select has a 1-year shelf life, which is a difference but deemed acceptable) | 1 year (A difference from predicates, but not explicitly stated as failing acceptance criteria; implies it was justified and accepted by FDA for market clearance). |
| Safety and Effectiveness | No new questions of safety or effectiveness when compared to predicates. | All testing demonstrated acceptance criteria were met and device does not raise new questions of safety or effectiveness. |
| Compatibility with transseptal needles | Resistant to skiving and damage (HeartSpan predicate). | Modified dilator material identical to HeartSpan, chosen for resistance to skiving and damage. |
| Risk Assessment | Residual risks associated with transseptal procedures are acceptable. | Residual risks classified as level 2 (Medium Risk/As Reasonably Practical) based on HeartSpan predicate and internal testing, deemed acceptable. Air embolism added as potential adverse event (inherent risk of transseptal puncture). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states: "In-vitro testing was performed to demonstrate substantial equivalence with the predicate devices and also to comply with user needs and safety and effectiveness requirements." It further mentions "Non-clinical performance testing (bench testing) was performed to support substantial equivalence".
- Sample Size for Test Set: The document does not specify the sample sizes used for the various in-vitro or bench tests. It broadly refers to "all relevant key performance attributes were tested".
- Data Provenance: The data is described as "in-vitro testing" and "non-clinical performance testing (bench testing)". This inherently means the data is retrospective in the sense that it evaluates the manufactured device against pre-defined specifications. There is no mention of human subject data or clinical studies for this 510(k) submission, as it focuses on substantial equivalence through bench testing. The testing was presumably conducted by Medtronic CryoCath LP, which is based in Canada.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the ground truth for this device's performance was established through bench testing and engineering specifications against predicate devices, not through expert consensus on medical images or clinical outcomes. The "ground truth" here is the performance of the predicate devices and the established engineering requirements for safe and effective function.
4. Adjudication Method for the Test Set
This is not applicable as the evaluations were based on objective engineering and performance testing rather than subjective human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
This is not applicable. The device (FlexCath Select Steerable Sheath and Dilator) is a physical medical device, not an AI or imaging-related product. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely outside the scope of this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
This is not applicable as the device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for demonstrating substantial equivalence was primarily based on:
- Performance of Predicate Devices: The established performance characteristics, safety, and effectiveness of the FlexCath Advance Steerable Sheath & Dilator (K123591) and the HeartSpan Steerable Introducer (K132164).
- Engineering Specifications and Bench Testing: The device's ability to meet pre-defined engineering and functional requirements through mechanical and performance verification.
- Risk Assessment: Evaluation of new failure modes, particularly those related to transseptal puncture, against acceptable risk levels, often informed by clinical knowledge of procedures.
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device, there is no "training set" in the context of an AI/machine learning model. The device design and materials were developed based on engineering principles and knowledge gained from previous device designs (e.g., FlexCath Advance and HeartSpan).
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8. The "ground truth" for the device's design and functionality was established through engineering design processes, material science, and prior experience with similar devices, rather than a data-driven "training set" in the computational sense.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2015
Medtronic Cryocath Lp % Vanessa Ware Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mail Stop Mys46 Mounds View, Minnesota 55112
Re: K142684
Trade/Device Name: FlexCath Select Steerable Sheath and Dilator (Model 990065) Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA, DYB Dated: November 6, 2014 Received: November 6, 2014
Dear Vanessa Ware:
This letter corrects our substantially equivalent letter of November 6, 2014.
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.
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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.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 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 vours
Mule Jellman
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) K142684
Device Name
FlexCath Select TM Steerable Sheath and Dilator (Model 990065)
Indications for Use (Describe)
The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.
X 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) K142684 Summary of Safety and Effectiveness
5.1 General Information:
| Date Summary Prepared: | September 17, 2014 |
|---|---|
| Applicant: | Medtronic CryoCath LP9000 Autoroute TranscanadiennePointe-Claire, QuebecH9H 5Z8, CANADAEstablishment Registration No. 3002648230 |
| Contact Person: | Vanessa WarePrincipal Regulatory Affairs SpecialistMedtronic CryoCath LPCoral Sea StreetMounds View, MN 55112Telephone: 763.526.2743Fax: 763.367.9903Email: vanessa.d.ware@medtronic.com |
| Trade Name: | FlexCath® Select™ Steerable Sheath & DilatorSteerable Catheter |
| Common Name: | Steerable Sheath and Dilator |
| Classification Name: | Steerable Catheter |
| Classification & Panel: | Class II, 21 CFR § 870.1280, Cardiovascular |
| Product Code: | DRA, DYB |
| Predicate Device(s): | FlexCath® Advance™ Steerable Sheath & Dilator,Model 4FC12 (K123591)HeartSpan® Steerable Introducer, Models FST-085-00FST-085-01 and FST-085-02 (K132164). |
5.2 Device Description
The FlexCath Select Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring.
FlexCath Select Medtronic, Inc.
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The FlexCath Select Steerable Sheath can be deflected to provide additional maneuverability to catheters that are advance through the sheath and into the right or left chamber of the heart. The FlexCath Select Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath.
This application introduces FlexCath Select 10 French (10Fr) FlexCath Select Steerable Sheath (990065), which is a modification of the 12 French (12Fr) FlexCath Advance Sheath (4FC12). Modifications were made to the shaft, cap and strain relief components, hemostasis valve assembly (stopcock, valve, and hub), dilator, new adhesive material and packaging tray cavity. In addition, the Indicates for Use were expanded to include introduction into the left side of the heart through the interatrial septum (transseptal puncture). Finally the Technical Manual (Instructions for Use) and updated packaging labeling was developed for the FlexCath Select Steerable Sheath.
5.3 Intended Use
Facilitates introducing various cardiovascular catheters into the heart.
5.4 Indications for Use
The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.
The FlexCath Select Steerable Sheath and Dilator's Indications for Use is substantially equivalent to the predicate HeartSpan Steerable Introducer. In addition, the HeartSpan Steerable Introducer has an acceptable clinical performance as there are no recalls or safety alerts associated with this device.
The primary predicate. FlexCath Advance, is contraindicated for transseptal puncture because it does not support the use of the transseptal needle or transseptal puncture as it is not resistant to skiving and damage from use with a transseptal needle. The material used on the proposed dilator is stiffer compared to the dilator material on the primary predicate FlexCath Advance. The materials are identical to the predicate HeartSpan Steerable Introducer which was chosen because it is resistant to skiving and damage from use with a transseptal needle.
The modified dilator (which can be used for transseptal puncture) introduces several new failure modes that the primary predicate FlexCath Advance did not have related to the compatibility with transseptal needles and the septal wall crossing/puncture. These risks have been classified as a risk level of 2 (Medium Risk/As Reasonably Practical) based on the predicate HeartSpan dilator and our internal testing, and are all inherent to a transseptal procedures are on the left side of the heart, the FlexCath Select Steath and Dilator allows for the use of only one sheath (with the dilator) to perform both the transseptal puncture and catheter manipulation versus exchanging a sheath for the transseptal puncture and a different sheath for catheter manipulation. This is an improvement to both operators and patients and is aligned with common practices of other sheaths on the market with transseptal indication.
These residual risks associated with the use of the FlexCath Select Steerable Sheath and Dilator was deemed acceptable. Air embolism was added as a potential adverse event because it is an inherent risk associated with a transseptal puncture leading to the left side of the heart. Refer to Section 21.0 Risk Management.
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Comparison to the Predicate Device 5.4.1
The FlexCath Select Steerable Sheath and Dilator is substantially equivalent to the predicates outlined in the following comparison tables: Table 5.1: Substantial Equivalence and Comparison Primary Predicate FlexCath Advance and Table 5.2: Substantial Equivalence and Comparison - Transseptal Indication.
| Characteristic | PRIMARY PREDICATE:FlexCath Advance SteerableSheath (4FC12) K123591 | MODIFIED DEVICE:FlexCath Select Steerable Sheath(990065) |
|---|---|---|
| Instructions for Use | ||
| Intended Use | Facilitates introducing variouscardiovascular catheters into theheart. | Same |
| Indications for Use | The FlexCath Steerable Sheath isintended for percutaneous catheterintroduction into the vasculature andinto the chambers of the heart. TheSheath deflection facilitates catheterpositioning. | The FlexCath Select Steerable Sheathis intended for percutaneous catheterintroduction into the vasculature andinto the chambers of the heart,including the left side of the heartthrough the interatrial septum. Thesheath deflection facilitates catheterpositioning. |
| Contraindications | The FlexCath Advance SteerableSheath is contraindicated forplacement in the left atrium orventricle if:The patient has an intra-atrialseptal patch or has had othersurgical intervention in oradjacent to the intra-atrialseptum. The patient has had a previousembolic event from the left sideof the heart within two monthsof the procedure. The patient has known orsuspected atrial myxoma.FlexCath should not be used toperform the transseptal puncture. | The FlexCath Select Steerable Sheathis contraindicated for placement in theleft atrium or ventricle if any of thefollowing conditions apply to thepatient:The patient has an intra-atrialseptal patch or occluder, or hashad other surgical intervention inor adjacent to the intra-atrialseptum. The patient has a left atrialthrombus The patient has known orsuspected atrial myxoma. |
| Performance/Technology | ||
| Steerable catheter introducer | Yes | Same |
| Design | ||
| Characteristic | PRIMARY PREDICATE:FlexCath Advance SteerableSheath (4FC12) K123591 | MODIFIED DEVICE:FlexCath Select Steerable Sheath(990065) |
| Unidirectional | Yes | Same |
| Hemostasis valve | Yes | Same |
| Deflectable | Yes | Same |
| Side flush port tubing | Yes | Same |
| Stopcock at the end of sideport tubing | Yes | New Stopcock design in which theside port tubing is inserted inside thestopcock |
| Handle | Yes | Same |
| Braided Shaft | Yes | Same |
| Sheath OD (inches/ French) | 0.198"(15F) | 0.170" (13F) |
| Sheath ID (inches/ French) | 0.158"(12F) | 0.131" (10F) |
| Total length (cm) | 86.4 cm | Same |
| Usable length (cm) | 65cm | Same |
| Distal Flush Holes (quantity) | 3 | Same |
| Deflection | ≥ 135°, when loaded with an ArcticFront or Arctic Front Advanceballoon catheter (PMA P010010) | ≥ 135°, when loaded with the FreezorMAX CryoAblation CathetersModels 239F3. 239F5 (P010010), anda phased RF PVAC Model 990078(G120067). |
| Deflection Reach length | 5.5cm | Same |
| Guide wire | Not included in the package | Same |
| Cap ID | 0.204" | 0.178" |
| Strain Relief ID | 0.190" | 0.165" |
| Dilator OD | 0.154" | 0.128" |
| Dilator ID | 0.039" | 0.038" |
| Dilator usable length (cm) | 83.5 cm | 82.88 cm |
| Dilator total length (cm) | 87 cm | 85.74 cm |
| Dilator shape | Straight | Pre-curved 55 degree tip |
| Dilator color | Hub - WhiteShaft - Blue (Pantone 278C) | Hub - WhiteShaft - White |
| Materials | ||
| Shaft Material | Pebax with 20% Barium Sulfate,stainless steel braid and PTFE liner | Same |
| Adhesive (shaft to hub -sheath valve assembly) | Loctite 416 | Loctite 4310 |
| Hemostasis valve material | Molded silicone rubber | Medalist MD200 (ThermoplasticElastomer) |
Table 5.1: Substantial Equivalence and Comparison Primary Predicate FlexCath Advance
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| Characteristic | PRIMARY PREDICATE:FlexCath Advance SteerableSheath (4FC12) K123591 | MODIFIED DEVICE:FlexCath Select Steerable Sheath(990065) |
|---|---|---|
| Hemostasis hub and capmaterial | Polycarbonate | Hub: Calibre 2081-15FC030004(Polycarbonate)Cap: PRO-FAX 6523 (Polypropylene) |
| Hemostasis valve (stopcock) | Polycarbonate | Body: MAKROLON RX 1805 451118(Polycarbonate)Handle: HDPE HD6706.17 |
| Dilator shaft and hub material | Polyethylene | Copolyester TPE(Hytrel 7246 with 40% BaSO4)Color: White |
| Pouch material | Tyvek/nylon polyethylene pouch | Same |
| Sterility, Shelf Life | ||
| Sterilization Method | Ethylene Oxide (EtO) | Same |
| Usage | Single use and disposable | Same |
| Shelf Life | 2 years | 1 year |
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| Characteristic | PREDICATE:HeartSpan SteerableIntroducer(Models FST-085-00, FST-085-01, and FST-085-02)K132164 | MODIFIED DEVICE:FlexCath Select Steerable Sheath(Model 990065) |
|---|---|---|
| Instructions for Use | ||
| Intended Use | Facilitates introducing variouscardiovascular catheters into theheart. | Same |
| Indications for Use | The HeartSpan SteerableIntroducer Kit is indicated forintroducing variouscardiovascular catheters into theheart, including the left side ofthe heart through the interatrialseptum. | The FlexCath Select SteerableSheath is intended for percutaneouscatheter introduction into thevasculature and into the chambersof the heart, including the left sideof the heart through the interatrialseptum. The sheath deflectionfacilitates catheter positioning. |
| Contraindications | • Previous intra-atrial septalpatch.• Known or suspected atrialmyxoma.• Myocardial Infarctions withinthe last two weeks.• Unstable angina.• Recent Cerebral VascularAccident (CVA).• Patients who do not tolerateanticoagulation therapy.• Patients with an activeinfection.• Presence of atrial thrombus. | The FlexCath Select SteerableSheath is contraindicated forplacement in the left atrium orventricle if any of the followingconditions apply to the patient:• The patient has an intra-atrialseptal patch or occluder, orhas had other surgicalintervention in or adjacent orthe intra-atrial septum.• The patient has a left atrialthrombus• The patient has known orsuspected atrial myxoma. |
| Technology/Performance - Dilator | ||
| Steerable catheter introducer | Yes | Same |
| Design | ||
| Deflectable | Yes | Yes |
| Dilator OD | 0.112" (8.5 F) | 0.128" (10 F) |
| Dilator ID | 0.057" | 0.038" |
| Dilator usable length (cm) | 94.56 cm (37.23") | 82.88 cm (32.63") |
| Dilator total length (cm) | 96.19 cm (37.87") | 85.74 cm (33.755") |
| Dilator to Guide WireCompatibility | up to 0.038" | 0.032" to 0.035 |
| Materials |
Table 5.2: Substantial Equivalence and Comparison – Transseptal Indication
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| Characteristic | PREDICATE:HeartSpan SteerableIntroducer(Models FST-085-00, FST-085-01, and FST-085-02)K132164 | MODIFIED DEVICE:FlexCath Select Steerable Sheath(Model 990065) |
|---|---|---|
| Dilator shaft and hub material | 7246 Hytrel, with 40% BariumSulfate, Color: White | Same |
| Sterility, Shelf Life | ||
| Sterilization Method | Ethylene Oxide (EtO) | Same |
| Usage | Single use and disposable | Same |
| Shelf Life | 3 years | 1 year |
Technological Characteristics Comparison of Modified Device to Predicate 5.4.2 Device
The FlexCath Select Steerable Sheath and Dilator, with the modified hemostasis valve assembly (stopcock, valve, hub) and new adhesive (both transparent to the user), modified dilator (increased stiffness for transseptal puncture), modified shaft, cap and strain relief components and packaging tray cavity has the following similarities to the primary predicate device previously cleared under K123591:
- Same Intended Use ●
- Same fundamental scientific technology
- Same unidirectional deflection
- Same basic sheath design (dimensions, bullnose tip shape) ●
- Same user interface with handle (rotating actuator for deflection) ●
- Same materials ●
- Same sterilization process ●
The modified FlexCath Select Steerable Sheath and Dilator has the following similarities to the predicate device previously cleared under K132164.
- Same Intended Use ●
- Same fundamental scientific technology
- Same materials ●
Summary of Performance Data ર્સ્ડ
In-vitro testing was performed to demonstrate substantial equivalence with the predicate devices and also to comply with user needs and safety and effectiveness requirements.
Non-clinical performance testing (bench testing) was performed to support substantial equivalence between the FlexCath Select Steerable Sheath (990065) and the predicate FlexCath Steerable Sheath and Dilator (Model 4FC12) previously cleared under K123591 and HeartSpan Steerable Introducer, (Models FST-085-00. FST-085-02) previously cleared under
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K132164. All relevant key performance attributes were tested on the FlexCath Select against performance requirements, and some tests were leveraged from the predicate device and not repeated.
The FlexCath Select does not provide a new therapy and the intended use remains equivalent to that of approved predicates. However, the indications for use were expanded to include introduction into the left side of the heart through the interatrial septum (transseptal puncture) and are equivalent to that of the approved HeartSpan Steerable Introducer with known acceptable performance which is a market released and commercially available device (Models FST-085-00, FST-085-01, FST-085-02) K132164.
Testing supplied in the 510(k) Notification (Section 18) includes formal data collection, mechanical and performance verification, reliability verification, system verification, labeling and Instructions for Use (IFU) verification and validation tests.
It was determined that modifications of features to the FlexCath Steerable Sheath and Dilator had no impact on safety and performance and all testing demonstrated that acceptance criteria were met. In addition, all testing passed by meeting the established requirements for the use of the FlexCath Select Steerable Sheath and Dilator, and the testing demonstrates that the device does not raise new questions of safety or effectiveness when compared to the predicate.
5.6 Conclusion
Design verification testing was performed to verify that the performance of FlexCath Select and Dilator remains substantially equivalent to the predicate devices. All test results demonstrate that the properties and performance of the device are suitable for its intended use. There are no differences between devices or in testing which would raise new issues of safety or effectiveness.
§ 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).