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 Description

The FlexCath Advance 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 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 can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The 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.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic CryoCath LP FlexCath Advance Steerable Sheath and Dilator. However, this submission (K183174) is specifically for updates to the Instructions for Use (IFU) manual only.

The document explicitly states:

"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."
"No performance testing (bench, animal or clinical) was required to support the proposed IFU updates. The existing performance data previously submitted under K123591 remains valid and applicable for this subject device."

Therefore, this specific 510(k) (K183174) does not contain information on acceptance criteria or a study proving the device meets those criteria, as its purpose was not to establish device performance from scratch but rather to update labeling based on an already cleared device (K123591).

To answer your questions, one would need to refer to the original 510(k) submission (K123591) for the FlexCath Advance Steerable Sheath and Dilator. Since that document is not provided, I cannot fulfill your request for details about acceptance criteria and the study proving the device meets them from the given text.

In summary, based only on the provided document (K183174):

1. A table of acceptance criteria and the reported device performance: Not available in this document. This submission is for IFU updates, not performance data.
2. Sample sized used for the test set and the data provenance: Not applicable to this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to this submission.
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 is a medical device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable to this submission.
8. The sample size for the training set: Not applicable to this submission.
9. How the ground truth for the training set was established: Not applicable to this submission.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

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5.0 510(k) Summary

Date Summary Prepared:	November 12, 2018
Applicant:	Medtronic CryoCath LP9000 Autoroute TranscanadiennePointe-Claire, QuebecH9R 5Z8, CanadaEstablishment Registration No. 3002648230
Official Correspondent:	Natalie SadeghiPrincipal Regulatory Affairs SpecialistMedtronic CryoCath LP8200 Coral Sea StreetMounds View, MN 55112Telephone: 763.526.1035Fax: 763.367.9903Email: natalie.t.sadeghi@medtronic.com
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(K123591)
Device Description:	The FlexCath Advance Steerable Sheath is a sterile, single usepercutaneous introducer fitted with a valve to allow forintroduction, withdrawal and swapping of catheters and wireswhile minimizing blood loss. A side-port with stopcock isintegrated to allow continuous drip infusion, injection throughthe center lumen, flushing, aspiration, blood sampling andpressure monitoring.The FlexCath can be deflected to provide additionalmaneuverability to catheters that are advanced through thesheath and into the right or left chamber of the heart. TheFlexCath 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 ofTechnologicalCharacteristics:	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 designtechnology, performance characteristics, materials, shelf lifeand sterilization process are all unchanged with this IFUupdate.
	The proposed IFU updates do not constitute a change in thefundamental scientific technology for the proposed deviceand do not raise new or different questions of safety andeffectiveness. The subject device does not provide a newtherapy, and the intended use and indications for use remainunchanged and identical to the predicate. The FlexCathAdvance featuring the updated IFU as described in this 510(k)submission is substantially equivalent to the predicate device.
Performance Data:	No performance testing (bench, animal or clinical) wasrequired to support the proposed IFU updates. The existingperformance data previously submitted under K123591remains valid and applicable for this subject device.
Conclusion:	This premarket notification is limited to updates to theFlexCath Advance Instructions for Use manual, to align theglobal labeling for the FlexCath Advance sheath. There are nochanges to the device specifications or technologicalcharacteristics. The IFU update for the subject device doesnot raise any new questions of safety or effectiveness ascompared 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

Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).