A percutaneous introducer is used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices.

Device Description

The Medtronic Vascular Input® PS Introducer is comprised of a sheath, a locking dilator, a Needle and a guide wire. This set may also contain an introducer obturator which must be left in dwelling post PTCA. Individual components within the Input® PS Introducer set are described below:

Input PS Dilator: The function of a dilator is to dilate the artery or vein to provide a less traumatic entry of the introducer sheath to a vasculature. The dilator is usually placed inside the lumen of the introducer sheath during sheath insertion.
GuideWire: The guidewire is inserted through the needle into the vessel and provides a platform over which the dilator and introducer sheath can be advanced. The guidewire is available with a maximum outer diameter of 0.038" Double Distal "J" guidewire approximately 15cm in length.
Input PS Introducer Sheath: The Input PS Introducer sheath allows for placement of various devices into the vasculature. The sheath shaft is coated with hydrophilic coating to improve ease of insertion. The Input Introducer sheath is available in two different lengths: 11cm sheath and 23cm sheath. The l 1 cm sheath is available in five different diameters measured in French size (5F, 6F, 7F, 8F and 9F). The 23cm sheath is available in four different diameters measured in French size (6F, 7F, 8F and 9F).
Needle: The needle provided with the Percutaneous Catheter Introducer Set is a standard puncture needle. The needle is used to puncture the vessel to provide route into the vessel for the guidewire.
Obturator: The Medtronic Input Introducer Obturator is inserted into an introducer sheath to provide support and help maintain sheath patency when placement of an intravascular catheter is delayed or removed.

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided text for the Medtronic Input® PS Introducer:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes material modifications to the Input® PS Introducer sheath and performance qualification testing to demonstrate substantial equivalence to the predicate device. The acceptance criteria are implicitly that the modified device's performance is similar to the predicate and meets relevant FDA guidance.

Acceptance Criterion (Test Type)	Reported Device Performance
Visual Inspections	Performed, demonstrated substantial equivalence
Coating Length	Performed, demonstrated substantial equivalence
Lubricity	Performed, demonstrated substantial equivalence
Coating Durability	Performed, demonstrated substantial equivalence
Introducer Insertability	Performed, demonstrated substantial equivalence
Particulate Evaluation	Performed, demonstrated substantial equivalence
Biocompatibility Testing	Completed per ISO 10993-1:2009, no new safety concerns

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "Bench testing was performed specific to the material modification to the Input PS Introducer sheath." It does not provide specific sample quantities for the various tests (e.g., number of sheaths tested for lubricity).
Data Provenance: The studies are described as "Bench testing" and "Biocompatibility Testing" performed by Medtronic Vascular. This indicates the testing was conducted internally or by contracted labs for the manufacturer. The country of origin for the data is not specified beyond Medtronic Vascular's address in Danvers, MA, USA, which is where the contact person is located. The tests are prospective in nature, as they are performed on the modified device to demonstrate its performance.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This device is a medical introducer, and the "testing" involves physical and chemical property evaluations rather than subjective expert assessment of images or data to establish a "ground truth" in the diagnostic sense. The evaluations are against engineering specifications and industry standards.

4. Adjudication Method

Not applicable. As noted above, the testing involves objective measurements against predefined criteria and standards, not a process requiring expert adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed on the modified device." The evaluation relies on bench testing and biocompatibility.

6. Standalone Performance (Algorithm Only)

Not applicable. This device is a physical medical instrument (catheter introducer), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the performance qualification and biocompatibility testing is based on:
- Engineering Specifications: Meeting predefined performance requirements for physical properties (coating length, lubricity, durability, insertability, particulate).
- Regulatory Standards: Compliance with relevant FDA guidance and international standards like ISO 10993-1:2009 for biocompatibility.
- Predicate Device Performance: The modified device's performance is compared to that of the predicate device to demonstrate "substantial equivalence."

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device, there is no "training set" in the context of an AI/ML algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable for the same reasons as above.

Summary

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Traditional 510(k) Summary

Submitter:	Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923,USA
Contact Person:	Nisarg ShahRegulatory Affairs Specialist37A Cherry Hill DriveDanvers, MA 01923USAPhone: (978)-739-6632Fax: (978)-750-8204Email: nisarg.g.shah@medtronic.com
Date Prepared:	April 23, 2014
Trade Name:	Input® PS Introducer
Common Name:	Catheter Introducer
ClassificationName:	Catheter introducerClass II per 21 CFR §870.1340, Product Code DYB.
Predicate Device:	USCI Input™ Introducer [K940092 clearance received onAugust 10th, 1995]; referred to as Input PS Introducer in thispremarket notification for identification purposes.
DeviceDescription:	The Medtronic Vascular Input® PS Introducer is comprised ofa sheath, a locking dilator, a Needle and a guide wire. This setmay also contain an introducer obturator which must be left indwelling post PTCA. Individual components within theInput® PS Introducer set are described below:1. Input PS Dilator: The function of a dilator is to dilatethe artery or vein to provide a less traumatic entry ofthe introducer sheath to a vasculature. The dilator isusually placed inside the lumen of the introducersheath during sheath insertion.

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K132617 510(k) Summary Page 2 of 4

1. GuideWire: The guidewire is inserted through the needle into the vessel and provides a platform over which the dilator and introducer sheath can be advanced. The guidewire is available with a maximum outer diameter of 0.038" Double Distal "J" guidewire approximately 15cm in length.

Input PS Introducer Sheath: The Input PS Introducer sheath allows for placement of various devices into the vasculature. The sheath shaft is coated with hydrophilic coating to improve ease of insertion. The Input Introducer sheath is available in two different lengths: 11cm sheath and 23cm sheath. The l 1 cm sheath is available in five different diameters measured in French size (5F, 6F, 7F, 8F and 9F). The 23cm sheath is available in four different diameters measured in French size (6F, 7F, 8F and 9F).

1. Needle: The needle provided with the Percutaneous Catheter Introducer Set is a standard puncture needle. The needle is used to puncture the vessel to provide route into the vessel for the guidewire.
1. Obturator: The Medtronic Input Introducer Obturator is inserted into an introducer sheath to provide support and help maintain sheath patency when placement of an intravascular catheter is delayed or removed.

Statement of The Medtronic Vascular Input PS Introducer is a percutaneous Intended Use: introducer used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices.

Summarv of The Medtronic Vascular Input PS Introducer sheath allows for Technological placement of various devices into the vasculature. The Input Characteristics: PS Introducer sheath assembly involves following feature:

i. Shaft (with hydrophilic coating)
ii. Hub

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K132617 510(k) Summary Page 3 of 4

iii. Strain relief
IV. Hemostatic valve
v. Sidearm tubing with a stop-cock.

Summary of Non-The device performance qualification and the biocompatibility i clinical Data: testing for the material modification was conducted in accordance with the relevant recommendations from the relevant FDA guidance to demonstrate that the modified Input PS Introducer sheath have met the acceptance criteria and performed similar to the predicate device:

Performance Qualification/ Bench Testing: Bench testing was performed specific to the material modification to the Input PS Introducer sheath. The following verification tests were performed to demonstrate the substantial equivalence of the modified Input PS Introducer Sheath to the predicate device:

i. Visual Inspections
ii. Coating length
iii. Lubricity
iv. Coating Durability
v. Introducer Insertability
vi. Particulate evaluation

Biocompatibility Testing: Pursuant to the ISO 10993-1: 2009- Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process; the biocompatibility testing for the modified Input PS Introducers was completed.

No new safety or effectiveness concerns were raised during the testing on the modified device. The performance qualification testing along with biocompatibility testing demonstrated that the modified Input PS Introducer sheath is safe, effective and substantially equivalent to the predicate device.

Summary of Clinical Data:

No clinical investigation has been performed on the modified device.

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K132617 510(k) Summary Page 4 of 4

Conclusion from Data:

Medtronic Vascular has demonstrated that the modified Input PS Introducers are substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

April 30, 2014

Medtronic, Inc. % Nisarg Shah Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, Massachusetts 01923

Re: K132617

Trade/Device Name: Medtronic Input® PS Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Percutaneous Catheter Introducer Regulatory Class: II Product Code: DYB Dated: February 27, 2014 Received: March 4, 2014

Dear Mr. Shah,

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

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Page 2 - Nisarg Shah

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.

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 yours,

Bram D. Zuckerman -S

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): K132617

Device Name: Medtronic Vascular Input® PS Introducer

Indications for Use:

Prescription Use M (Part 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)

PAGE 1 OF

Bram D. Zuckerman -S 2014.04.30 05:50:28 -04'00'

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).