FlexCath Select Steerable Shealth and Dilator

{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 stylized eagle or bird-like symbol with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 2, 2017 Medtronic CryoCath LP Natalie Sadeghi Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE, Mail Stop MVS46 Mounds View, Minnesota 55112 Re: K163268 Trade/Device Name: FlexCath™ Select Steerable Sheath and Dilator Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 18, 2016 Received: November 21, 2016 Dear Natalie Sadeghi: 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 devicerelated 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" (21 CFR 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. incerery, 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) K163268 Device Name FlexCath™ Select Steerable Sheath and Dilator 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. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------| | <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Date Summary Prepared: | November 16, 2016 | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Medtronic CryoCath LP<br>9000 Autoroute Transcanadienne<br>Pointe-Claire, Quebec<br>H9R 5Z8, Canada<br>Establishment Registration No. 3002648230 | | Official Correspondent: | Natalie Sadeghi<br>Senior Requlatory Affairs Specialist<br>Medtronic CryoCath LP<br>8200 Coral Sea Street<br>Mounds View, MN 55112<br>Telephone: 763.526.1035<br>Fax: 763.367. 9903<br>Email: natalie.t.sadeghi@medtronic.com | | Device Trade Name: | FlexCath™ Select Steerable Sheath and Dilator | | Common Name: | Steerable Sheath and Dilator | | Classification Name: | Introducer, Catheter | | Classification & Panel: | Class II, 21 CFR 870.1340, Cardiovascular | | Product Code: | DYB | | Predicate Device: | FlexCath® Select™ Steerable Sheath & Dilator<br>(K142684) | | Device Description: | The Medtronic FlexCath™ Select Steerable Sheath is a sterile,<br>single-use, percutaneous catheter introducer fitted with a<br>valve to allow for introduction, withdrawal, and exchange of<br>catheters and wires while minimizing blood loss. A side port<br>with stopcock is integrated to allow continuous drip infusion,<br>injection through the center lumen, flushing, aspiration, blood<br>sampling and pressure monitoring. A dilator is packaged with<br>the FlexCath Select.<br>The handle incorporates a deflection mechanism and a<br>deflection wire that is integrated into the catheter shaft. This<br>allows the sheath to be deflected to provide additional<br>maneuverability to catheters that are advanced through the | {4}------------------------------------------------ | | sheath into the right or left chamber of the heart. The FlexCath Select sheath is comprised of two (2) main sections: the shaft and the handle. | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | Facilitates introducing various cardiovascular catheters into the heart. <p>This is the same intended use as previously cleared for the original FlexCath Select Steerable Sheath and Dilator, predicate device (K142684). </p> | | 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. <p>The indications for use are the same as previously cleared for the original FlexCath Select Steerable Sheath and Dilator, predicate device (K142684). </p> | | Comparison of<br>Technological<br>Characteristics : | The FlexCath Select Steerable Sheath and Dilator has the following similarities to the predicate device: <ul><li>Same intended use</li><li>Same indications for use</li><li>Same fundamental scientific technology</li><li>Same unidirectional deflection</li><li>Same basic sheath and dilator design</li><li>Same user interface</li><li>Same materials of construction</li><li>Same sterilization process</li><li>Same packaging configuration</li><li>Same device shelf life</li></ul> <p>The differences between the modified FlexCath Select and the predicate device consist of the following: </p> <ul><li>Minor dimensional changes to hemostasis valve assembly components </li><li>Modified molding process temperature for the valve seal component </li><li>Added silicone oil to the entire length of the dilator component; this silicone oil was present on the predicate device hemostasis valve </li></ul> | {5}------------------------------------------------ These changes do not constitute a change in the fundamental scientific technology for the proposed device; the differences between the modified FlexCath Select and the predicate do not raise new or different questions of safety and effectiveness. The FlexCath Select does not provide a new therapy, and the intended use and indications for use remain equivalent to that of the predicate. The modified FlexCath Select described in this Traditional 510(k) submission is substantially equivalent to the predicate device, reference Table 1. | Table 1. Substantial Equivalence for FlexCath Select | | | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Characteristic | PREDICATE<br>DEVICE:<br>FlexCath Select<br>Steerable Sheath<br>(Model 990065)<br>K142684 | SUBJECT<br>DEVICE:<br>FlexCath Select<br>Steerable<br>Sheath (Model<br>990065) | | | Intended Use | | | Intended Use | Facilitates<br>introducing various<br>cardiovascular<br>catheters into the<br>heart. | Same | | Indications for Use | The FlexCath Select<br>Steerable Sheath is<br>intended for<br>percutaneous<br>catheter<br>introduction into<br>the vasculature and<br>into the chambers<br>of the heart,<br>including the left<br>side of the heart<br>through the<br>interatrial septum.<br>The sheath<br>deflection facilitates<br>catheter<br>positioning | Same | | Contraindications | The FlexCath Select<br>Steerable Sheath is<br>contraindicated for<br>placement in the<br>left atrium or<br>ventricle if any of<br>the following<br>conditions apply to<br>the patient:<br>• The patient has<br>an intra-atrial<br>septal patch or<br>occluder, or has<br>had other<br>surgical<br>intervention in or<br>adjacent to the<br>intra-atrial<br>septum.<br>• The patient has a<br>left atrial<br>thrombus.<br>The patient has<br>known or<br>suspected atrial<br>myxoma. | Same | | | | | | Technology | | | | Steerable catheter<br>introducer | Yes | Same | | | | | | Design | | | | Unidirectional | Yes | Same | | Hemostasis valve | Yes | Same | | Deflectable | Yes | Same | | Side flush port<br>tubing | Yes | Same | | Stopcock at the end<br>of side port tubing | Yes | Same | | Handle | Yes | Same | | Braided Shaft | Yes | Same | | Sheath OD (inches/<br>French) | 0.170" (13F) | Same | | Sheath ID (inches/<br>French) | 0.131" (10F) | Same | | Total length (cm) | 81 cm | Same | | Usable length (cm) | 65 cm | Same | | Distal Flush Holes<br>(quantity) | 3 | Same | | Deflection | ≥ 135°, when loaded<br>with the Freezor<br>MAX CryoAblation<br>Catheters – Models<br>239F3. 239F5<br>(P010010), or a<br>phased RF PVAC<br>Model 990078<br>(G120067). | Same | | Deflection Reach<br>length | 5.5cm | Same | | Guidewire | Not included in<br>package | Same | | Valve seal volume | 0.645cm3 | 0.584cm3 | | Valve cap ID | 0.171" | 0.140" | | Valve hub distal ID | 0.412" | 0.420" | | Strain Relief ID | 0.165" | Same | | Dilator OD | 0.128" | Same | | Dilator ID | 0.038" | Same | | Dilator usable<br>length (cm) | 82.88 cm (32.63") | Same | | Dilator total length<br>(cm) | 85.74 cm (33.755" ) | Same | | Dilator shape | Pre-curved 55° tip | Same | | Dilator color | Hub – White<br>Shaft – White | Same | | Materials | | | | Sheath shaft | Pebax with 20%<br>Barium Sulfate,<br>stainless steel braid<br>and PTFE liner | Same | | Adhesive (shaft to<br>hub -sheath valve<br>assembly) | Loctite 4310 | Same | | Hemostasis valve<br>material (seal) | Medalist MD200,<br>Nusil MED-400<br>silicone fluid | Same | | Hemostasis hub<br>and cap material | Hub: Calibre 2081-<br>15 FC030004 (Poly<br>Carbonate)<br>Cap: PRO-FAX 6523<br>(Polypropylene) | Same | | | | | | Hemostasis valve<br>(stopcock) | Body: MAKROLON<br>RX 1805 451118<br>(Polycarbonate)<br>Handle:HDPE<br>HD6706.17<br>Extension Tube:<br>Polyurethane<br>(Pellethane 2363-<br>80A) | Same | | Dilator shaft and<br>hub material | Copolyester TPE<br>(Hytrel 7246 with<br>40% BaSO4) | Copolyester TPE<br>(Hytrel 7246 with<br>40% BaSO4)<br>Coating: NuSil<br>MED-400<br>Silicone oil fluid | | Pouch material | Tyvek/nylon<br>polyethylene pouch | Same | | | <b>Sterility, Shelf Life</b> | | | Sterilization<br>Method | Ethylene Oxide<br>(EtO) | Same | | Usage | Single use and<br>disposable | Same | | Shelf Life | 2 years | Same | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Bench testing was completed to support the proposed Performance Data: modifications to the FlexCath Select. Performance testing verified that the subject device performs as designed and is suitable for the intended use. Testing included: - Leak/air ingress performance - Hemostasis valve - Valve performance following insertion/removal cycling -. sheath/valve - Dilator insertion/removal force - Bond pull force sheath/hub ● - . Compatibility verification Design verification testing was performed to verify that the Conclusion: performance of the modified FlexCath Select remains substantially equivalent to the predicate device. All results demonstrate that the properties and performance of the modified FlexCath Select are suitable for the intended use. There are no differences between devices identified in testing that raised new questions of safety or effectiveness.