Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical aspects of a steerable sheath and does not mention any AI or ML components or functionalities.

Therapeutic

No
This device is an introducer sheath designed to facilitate the placement of other catheters into the heart and vasculature. It does not provide any therapeutic effect itself.

Diagnostic

No.
Explanation: The device is an introducer sheath designed to facilitate the positioning of catheters within the heart and vasculature, not to perform diagnostic measurements or analyses. Its functions include blood loss minimization, infusion, injection, flushing, aspiration, blood sampling, and pressure monitoring, all of which support interventional procedures rather than providing a diagnostic output.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical medical device (sheath, valve, side port, dilator, handle, deflection mechanism, deflection wire, catheter shaft) and describes bench testing of its physical properties and performance. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "percutaneous catheter introduction into the vasculature and into the chambers of the heart." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
Device Description: The description details a physical device used for introducing and manipulating catheters within the body. It doesn't mention any components or functions related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents or assays

The FlexCath Select Steerable Sheath is a medical device used for facilitating a medical procedure (catheterization), not for performing an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.

Product codes

DYB

Device Description

The Medtronic FlexCath™ Select Steerable Sheath is a sterile, single-use, percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and exchange 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. A dilator is packaged with the FlexCath Select. The handle incorporates a deflection mechanism and a deflection wire that is integrated into the catheter shaft. This allows the sheath to be deflected to provide additional maneuverability to catheters that are advanced through the 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench testing was completed to support the proposed 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

Key Metrics

Not Found

Predicate Device(s)

K142684

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 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.

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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" (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

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

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Date Summary Prepared:	November 16, 2016
Applicant:	Medtronic CryoCath LP
9000 Autoroute Transcanadienne
Pointe-Claire, Quebec
H9R 5Z8, Canada
Establishment Registration No. 3002648230
Official Correspondent:	Natalie Sadeghi
Senior Requlatory Affairs Specialist
Medtronic CryoCath LP
8200 Coral Sea Street
Mounds View, MN 55112
Telephone: 763.526.1035
Fax: 763.367. 9903
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
(K142684)
Device Description:	The Medtronic FlexCath™ Select Steerable Sheath is a sterile,
single-use, percutaneous catheter introducer fitted with a
valve to allow for introduction, withdrawal, and exchange 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. A dilator is packaged with
the FlexCath Select.
The handle incorporates a deflection mechanism and a
deflection wire that is integrated into the catheter shaft. This
allows the sheath to be deflected to provide additional
maneuverability to catheters that are advanced through the

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	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. This is the same intended use as previously cleared for the original FlexCath Select Steerable Sheath and Dilator, predicate device (K142684).
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 indications for use are the same as previously cleared for the original FlexCath Select Steerable Sheath and Dilator, predicate device (K142684).
Comparison of
Technological
Characteristics :	The FlexCath Select Steerable Sheath and Dilator has the following similarities to the predicate device: Same intended useSame indications for useSame fundamental scientific technologySame unidirectional deflectionSame basic sheath and dilator designSame user interfaceSame materials of constructionSame sterilization processSame packaging configurationSame device shelf life The differences between the modified FlexCath Select and the predicate device consist of the following: Minor dimensional changes to hemostasis valve assembly components Modified molding process temperature for the valve seal component Added silicone oil to the entire length of the dilator component; this silicone oil was present on the predicate device hemostasis valve

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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
DEVICE:
FlexCath Select
Steerable Sheath
(Model 990065)
K142684	SUBJECT
DEVICE:
FlexCath Select
Steerable
Sheath (Model

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7

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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.