The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.

Device Description

The Sentrant Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments. The dilator is radiopaque and has a tapered, flexible tip that facilitates atraumatic tracking through the vasculature. A female luer taper fitting is located on the distal end of the dilator grip. The proximal end of the dilator grip is threaded to allow the dilator to be secured to the sheath seal housing. The introducer sheath is comprised of a hydrophilic, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension with a 3way valve is attached to the seal housing. A radiopaque markerband is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.

AI/ML Overview

This acceptance criteria and study information is for the Sentrant Introducer Sheath with Hydrophilic Coating (K123990).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the performance criteria as "predetermined acceptance criteria" which were all met. The specific quantitative values for these criteria are not detailed in the summary. However, the types of tests performed indicate the areas of performance evaluated.

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance
Physical Dimensions	OD of Sheath Tubing	All predetermined acceptance criteria were met and results passed.
	OD of Dilator	All predetermined acceptance criteria were met and results passed.
	Sheath Working Length	All predetermined acceptance criteria were met and results passed.
	Dilator Working Length	All predetermined acceptance criteria were met and results passed.
	Hydrophilic Coating Length	All predetermined acceptance criteria were met and results passed.
Functional / Mechanical Performance	Guidewire Acceptance	All predetermined acceptance criteria were met and results passed.
	Grip to Dilator Tensile Strength	All predetermined acceptance criteria were met and results passed.
	Seal Housing to Sheath Tubing Tensile Test	All predetermined acceptance criteria were met and results passed.
	Seal Cap to Seal Housing Tensile Strength	All predetermined acceptance criteria were met and results passed.
	Atraumatic Tip (A-Tip) Lamination Tensile Strength	All predetermined acceptance criteria were met and results passed.
	Sideport Torque Test	All predetermined acceptance criteria were met and results passed.
	Leak Test	All predetermined acceptance criteria were met and results passed.
	Kink Test	All predetermined acceptance criteria were met and results passed.
	Test for Liquid Leakage Under Pressure	All predetermined acceptance criteria were met and results passed.
Biocompatibility	ISO MEM Elution, Cytotoxicity	All predetermined acceptance criteria were met and results passed.
	ISO Maximization Sensitization	All predetermined acceptance criteria were met and results passed.
	ISO Intracutaneous Reactivity	All predetermined acceptance criteria were met and results passed.
	ISO Acute Systemic Toxicity	All predetermined acceptance criteria were met and results passed.
	USP Material Mediated Pyrogen	All predetermined acceptance criteria were met and results passed.
	ASTM In-vitro Hemolysis	All predetermined acceptance criteria were met and results passed.
	Complement Activation C3a and SC5b-9	All predetermined acceptance criteria were met and results passed.
	ASTM Partial Thromboplastin Time	All predetermined acceptance criteria were met and results passed.
	In-vivo Thromboresistance	All predetermined acceptance criteria were met and results passed.
	Inductively Coupled Plasma Spectroscopy	All predetermined acceptance criteria were met and results passed.

Study Proving Device Meets Acceptance Criteria

The study described is a series of bench testing and biocompatibility testing.

The type of study: Bench Testing and Biocompatibility Testing. The purpose was to evaluate its performance and verify that it meets the required performance specifications, and to assess biological compatibility per ISO10993-1.

Outcome: "All of the predetermined acceptance criteria were met and results passed."

Additional Information:

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (N-numbers) for each individual bench test or biocompatibility test.
- Data Provenance: The tests were conducted by Medtronic Vascular, the device manufacturer. No information is provided regarding data country of origin, or if the data is retrospective or prospective, though bench testing is inherently prospective for device clearance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the study involves physical, mechanical, and biological testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation (e.g., image analysis). The "ground truth" for these tests would be the established scientific and engineering principles, and the protocols defined by international standards (e.g., ISO, ASTM, USP).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as the study does not involve subjective assessment or interpretation requiring adjudication by multiple readers/experts. The tests are objective measurements against predefined specifications.
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:
- This is not applicable. This device is an introducer sheath, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a physical medical device, not an algorithm or software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" is defined by the predetermined performance specifications and acceptance criteria that typically align with engineering standards, material science principles, and functional requirements for such devices.
- For biocompatibility testing, the "ground truth" is established by adherence to recognized international standards such as ISO 10993-1 and other specific standards (e.g., ASTM, USP) for evaluating biological responses to medical devices.
The sample size for the training set:
- This is not applicable as the study does not involve an AI model or machine learning, and thus no "training set."
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device evaluation.

Summary

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510(k) Summary Page 1 of 3 +

510(k) Summary – K123990

Submitter:	Medtronic Vascular3576 Unocal PlaceSanta Rosa, CA 95403(707) 591-2091(707) 566-1432	APR 26 2013
Contact Person:	Kelley LamkeRegulatory Affairs Specialist3576 Unocal PlaceSanta Rosa, CA 95403(707) 543-5043(707) 566-1245kelley.lamke@medtronic.com
Date Prepared:	December 21, 2012
Device Trade Name:	Sentrant Introducer Sheath with HydrophilicCoating
Device Classification:	Class II
Classification Name:	Catheter Introducer
Regulation Number:	21 CFR 870.1340
Classification Product Code:	DYB
Classification Panel:	Cardiovascular
Predicate Devices:	Cook Extra Large Check-Flo® Introducer (K902469)GORE Dry Seal Sheath (K093791)

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Device Description:

The dilator is radiopaque and has a tapered, flexible tip that facilitates atraumatic tracking through the vasculature. A female luer taper fitting is located on the distal end of the dilator grip. The proximal end of the dilator grip is threaded to allow the dilator to be secured to the sheath seal housing.

The introducer sheath is comprised of a hydrophilic, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension with a 3way valve is attached to the seal housing. A radiopaque markerband is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.

Statement of Intended Use:

Substantial Equivalence:

The documentation provided includes mechanical test results that demonstrate the Sentrant Sheath is substantially equivalent to the Cook Extra Large Check-Flo Introducer (K902469) and the GORE Dry Seal Sheath (K093791).

Bench Testing Performance Data:

The Sentrant Sheath was tested through a series of physical, mechanical and bench tests, listed below, to evaluate its performance and verify that it meets the required performance specifications. All of the predetermined acceptance criteria were met and results passed.

OD of Sheath Tubing ●
OD of Dilator .
. Sheath Working Length
. Dilator Working Length
. Hydrophilic Coating Length .
. Guidewire Acceptance
. Grip to Dilator Tensile Strength
. Seal Housing to Sheath Tubing Tensile Test
Seal Cap to Seal Housing Tensile Strength
. Atraumatic Tip (A-Tip) Lamination Tensile Strength
Sideport Torque Test ●
. Leak Test
Kink Test .
. Test for Liquid Leakage Under Pressure

Medtronic Vascular Sentrant Introducer Sheath with Hydrophilic Coating K123990 Traditional 510(k) Submission

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510(k) Summary K123990, Page 3 of 3

Biocompatibility Testing:

The following Biocompatibility testing was performed on the Sentrant Sheath per the requirements of ISO10993-1. All of the predetermined acceptance criteria were met and results passed.

. ISO MEM Elution, Cytotoxicity
ISO Maximization Sensitization .
. ISO Intracutaneous Reactivity
ISO Acute Systemic Toxicity .
. USP Material Mediated Pyrogen
. ASTM In-vitro Hemolysis
Complement Activation C3a and SC5b-9 .
ASTM Partial Thromboplastin Time .
. In-vivo Thromboresistance
Inductively Coupled Plasma Spectroscopy .

Conclusion:

The Sentrant Introducer Sheath is substantially equivalent in intended use, technological characteristics and performance of the predicate introducer catheters, the Cook Extra Large Check-Flo® Introducer (K902469) and the GORE DrySeal Sheath (K093791).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 26, 2013

Medtronic Vascular C/O Kelley Lamke, Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, CA 95403

Re: K123990

Trade/Device Name: Sentrant Introducer Sheath with Hydrophilic Coating Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: March 12, 2013 Received: March 13, 2013

Dear Ms. Kelley Lamke:

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 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.

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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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Matthew G Hillebrenner

Bra

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: K123990

Device Name: Sentrant Introducer Sheath with Hydrophilic Coating

Indications for Use:

Prescription Use X

(21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matthew G퀘咖lebrenner

Page 1 of 1

Medtronic Vascular Sentrant Introducer Sheath K123990 Traditional 510(k)

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).