FlexCath Advance Steerable Sheath and Dilator

K183174 · Medtronic Cryocath, LP · DRA · Nov 26, 2018 · Cardiovascular

Device Facts

• Record ID: K183174
• Device Name: FlexCath Advance Steerable Sheath and Dilator
• Applicant: Medtronic Cryocath, LP
• Product Code: DRA · Cardiovascular
• Decision Date: Nov 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1280
• Device Class: Class 2

Intended Use

The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

Device Story

FlexCath Advance is a sterile, single-use percutaneous introducer sheath and dilator; used for introducing, withdrawing, and swapping cardiovascular catheters and wires into heart chambers. Features integrated valve to minimize blood loss; side-port with stopcock for continuous drip infusion, injection, flushing, aspiration, blood sampling, and pressure monitoring. Sheath shaft is deflectable to improve catheter maneuverability. Operated by physicians in clinical settings. Device facilitates precise catheter placement during cardiac procedures; benefits patient by enabling access to heart chambers for diagnostic or therapeutic interventions. Subject device represents an update to Instructions for Use (IFU) only; design, technology, and performance remain identical to predicate.

Clinical Evidence

No clinical data or performance testing (bench or animal) was required for this submission; existing performance data from K123591 remains valid.

Technological Characteristics

Sterile, single-use steerable sheath and dilator. Features deflectable shaft and handle. Includes integrated valve and side-port with stopcock for fluid management/monitoring. Mechanical device; no software or energy source.

Indications for Use

Indicated for percutaneous catheter introduction into the vasculature and heart chambers to facilitate catheter positioning.

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• FlexCath Advance Steerable Sheath and Dilator (K123591)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

November 26, 2018

Medtronic CryoCath LP Natalie Sadeghi Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE MVS 46 Mounds View, Minnesota 55112

## Re: K183174

Trade/Device Name: FlexCath Advance Steerable Sheath and Dilator Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: November 15, 2018 Received: November 16, 2018

## 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

M.A. Wilhelm
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)

### K183174

Device Name

FlexCath Advance TM Steerable Sheath and Dilator

Indications for Use (Describe)

The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CER 801 Subpart C) </span> </div> |

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# 5.0 510(k) Summary

| Date Summary Prepared: | November 12, 2018 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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>Principal Regulatory Affairs Specialist<br>Medtronic CryoCath LP<br>8200 Coral Sea Street<br>Mounds View, MN 55112<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Trade Name: | FlexCath Advance™ Steerable Sheath and Dilator |
| Common Name: | Steerable Sheath and Dilator |
| Classification Name: | Steerable Catheter |
| Classification & Panel: | Class II, 21 CFR 870.1280, Cardiovascular |
| Product Code: | DRA |
| Predicate Device: | FlexCath Advance™ Steerable Sheath and Dilator<br>(K123591) |
| Device Description: | The FlexCath Advance Steerable Sheath is a sterile, single use<br>percutaneous introducer fitted with a valve to allow for<br>introduction, withdrawal and swapping of catheters and wires<br>while minimizing blood loss. A side-port with stopcock is<br>integrated to allow continuous drip infusion, injection through<br>the center lumen, flushing, aspiration, blood sampling and<br>pressure monitoring.<br><br>The FlexCath can be deflected to provide additional<br>maneuverability to catheters that are advanced through the<br>sheath and into the right or left chamber of the heart. The<br>FlexCath Advance Steerable Sheath is comprised of two (2) |
| | main sections: the shaft and the handle. A dilator is included with each sheath. |
| | This premarket notification presents proposed updates to the Instructions for Use (IFU) manual; changes resulting in the subject device are limited to these IFU updates only. All other aspects of the device (design/technology, performance specifications, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance originally cleared under K123591. |
| Intended Use: | Facilitates introducing various cardiovascular catheters into the heart. |
| | The intended use is unchanged with the proposed IFU update and remains the same as previously cleared under K123591. |
| Indications for Use: | The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning. |
| | The indications for use is unchanged with the proposed IFU update and remains the same as previously cleared under K123591. |
| Comparison of<br>Technological<br>Characteristics: | There are no changes to the predicate device specifications or technological characteristics associated with the proposed IFU update. Compared to the predicate, the subject device features the: |
| | Same intended use Same indications for use Same fundamental scientific technology Same unidirectional deflection Same sheath and dilator design Same user interface Same materials of construction Same sterilization process Same packaging configuration and labels The differences between the subject device and the predicate device are limited to the IFU content only. The updates to the |
| | US IFU were proposed to align with recent updates for the |
| | across the global labeling. The subject device design<br>technology, performance characteristics, materials, shelf life<br>and sterilization process are all unchanged with this IFU<br>update. |
| | The proposed IFU updates do not constitute a change in the<br>fundamental scientific technology for the proposed device<br>and do not raise new or different questions of safety and<br>effectiveness. The subject device does not provide a new<br>therapy, and the intended use and indications for use remain<br>unchanged and identical to the predicate. The FlexCath<br>Advance featuring the updated IFU as described in this 510(k)<br>submission is substantially equivalent to the predicate device. |
| Performance Data: | No performance testing (bench, animal or clinical) was<br>required to support the proposed IFU updates. The existing<br>performance data previously submitted under K123591<br>remains valid and applicable for this subject device. |
| Conclusion: | This premarket notification is limited to updates to the<br>FlexCath Advance Instructions for Use manual, to align the<br>global labeling for the FlexCath Advance sheath. There are no<br>changes to the device specifications or technological<br>characteristics. The IFU update for the subject device does<br>not raise any new questions of safety or effectiveness as<br>compared to the device as previously cleared under K123591. |

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# 510(k) Summary of Safety and Effectiveness

-FlexCath Advance Japan package insert to ensure consistency

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# 510(k) Summary of Safety and Effectiveness