Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and mechanical function of the kit, with no mention of AI or ML.

Therapeutic

No.
The device facilitates the placement of a catheter for diagnostic or interventional procedures, but it does not directly treat a disease or condition itself.

Diagnostic

No

The device is an introducer sheath and associated components designed to facilitate the placement of a catheter into the lower extremity peripheral vasculature. It is a tool for accessing the vasculature, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a sheath, dilator, guide wire, entry needle, and guide inserter. It also mentions materials like stainless steel and nitinol, and processes like sterilization and coating. This indicates a hardware-based medical device, not a software-only one.

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 is to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature. This is a procedure performed in vivo (within the living body) for diagnostic or interventional purposes.
Device Description: The device components (sheath, dilator, needle, guide wire) are all designed for direct insertion into the patient's blood vessels.
Mechanism of Action: The device works by providing access and a conduit into the patient's circulatory system.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.

IVD devices are specifically designed to be used in vitro to test samples from the body. This device is clearly designed for in vivo use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

Product codes

DYB

Device Description

The Glidesheath Slender Tibial Pedal Kit is used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter.

During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle.

Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

The sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together.

The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy, ultrasound

Anatomical Site

lower extremity peripheral vasculature below the knee

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

Cadaver Testing: devices were tested in a simulated use situation using cadaver lower leg models to test arterial access at specific BTK (below-the-knee) arterial access sites.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Cadaver Testing: It was demonstrated that the Glidesheath Slender sheath is compatible with the insertion angles used in ultrasound guided BTK access protocols in the four BTK vessels tested. The study also demonstrated that the kit and its components are acceptable for use in BTK access. The study along with a follow-up survey confirmed that the protocols used by physicians in standard practice are equivalent to the access protocol used in the simulated use study.

Clinical Tests: summary of the PRIME Registry data. The first 71 patients treated with the Terumo Glidesheath Slender when undergoing an index endovascular procedure using a tibial access point was compared to a literature based dataset of procedures using radial and femoral access. No issues that may affect the determination of substantial equivalence were noted in the comparison.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142183

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K152173, K111606

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 3, 2018

Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, Maryland 21921

Re: K181237

Trade/Device Name: Glidesheath Slender Tibial Pedal Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 24, 2018 Received: May 10, 2018

Dear Liang Lu:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 medical devices and radiation-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,

for

Finn E.
Donaldson -S

Digitally signed by Finn E. Donaldson -
S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=20009796
73, cn=Finn E. Donaldson -S
Date: 2018.08.03 15:29:23 -04'00'

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) K181237

Device Name Glidesheath Slender Tibial Pedal Kit

Indications for Use (Describe)

The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

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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510(K) SUMMARY

A. SUBMITTER INFORMATION (807.92(a)(1))

Prepared bv:

Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079

Prepared for: Owner/Operator Terumo Medical Corporation 2101 Cottontail Lane

Somerset, NJ 08873, USA Registration Number: 2243441

Manufacturer (510(k) Applicant)

Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Registration Number: 1118880

Sterilization Facility

Steris Isomedix Services Inc. 3459 South Clinton Ave South Plainfield, NJ 07080 Registration Number: 2246552

Contact Person: Liang Lu

Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com

Date prepared: August 3, 2018

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B. DEVICE NAME (807.92(a)(2))

Proprietary Name:	Glidesheath Slender Tibial Pedal Kit
Common Name:	Introducer Sheath
Classification Name:	Catheter Introducer
Classification Panel:	Cardiovascular
Regulation:	21 CFR 870.1340
Product Code:	DYB
Classification:	Class II

C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device(s) to which substantial equivalence is claimed are:

Predicate Device: K142183 Glidesheath Slender, manufactured by Terumo . Corporation
Reference Device 1: K152173 Glidesheath, manufactured by Terumo ● Medical Corporation
Reference Device 2: K111606 - Pinnacle Precision Access System, manufactured by Terumo Medical Corporation

D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the Glidesheath Slender Tibial Pedal Kit, manufactured by Terumo Medical Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device.

E. DEVICE DESCRIPTION (807.92(a)(4))

The Glidesheath Slender Tibial Pedal Kit is used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter.

During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle.

Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

The sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

5

The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together.

The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only.

F. INDICATIONS FOR USE (807.92(a)(5))

The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

The Glidesheath Slender Tibial Pedal Kit, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device, manufactured by Terumo Medical Corporation.

A comparison of the technological characteristics is summarized on the table below.

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Table 1: Summary of Substantial Equivalence

| Device
Characteristic | New Device:
Glidesheath Slender Tibial Pedal Kit | Predicate:
Glidesheath Slender (K142183) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Medical Corporation | Terumo Corporation |
| Intended Use /
Indications for
Use | The Glidesheath Slender Tibial
Pedal Kit is indicated to facilitate
placing a catheter through the skin
into the lower extremity peripheral
vasculature below the knee. | The Glidesheath Slender is used to
facilitate placing a catheter through
the skin into the radial artery. |
| Operation
Principle | Operated manually or by a manual
process | Same |
| Design /
Construction | Sheath, Dilator,
Guide Wire, Guide Inserter, Entry
Needle | Sheath, Dilator,
Guide Wire, Guide Inserter, Entry
Needle,
Surflo IV catheter |
| Materials | Sheath assembly
Tube:
Ethylene-Tetrafluoroethylene
(ETFE) copolymer,
Bismuth trioxide, Colorant, Silicone
oil

Hydrophilic Coating: Dimethyl
acrylamide-glycidyl methacrylate
copolymer

Housing: Polypropylene

Cap: Polypropylene

Valve: Silicone Rubber

Caulking Pin: Stainless Steel

Sheath support:
Styrene-ethylene-butylene-styrene
block copolymer, Colorant

Side tube:
Polybutadiene

Three-way stopcock:
Holder: Polycarbonate;
Cock: Polyethylene;
Fastener pin: Polyethylene

Dilator assembly
Tube: Polypropylene, Bismuth
subcarbonate, Colorant, Silicone oil

Hub: Polypropylene, Colorant | Note: Sheath and Dilator are
Identical to the subject device

Sheath Assembly
Identical

Identical

Dilator Assembly
Identical

7

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H. NON-CLINICAL TESTS (807.92(b)(1)) Performance

All components of the Glidesheath Slender Tibial Pedal Kit come from the predicate device and reference devices. They are identical in materials, formulation, geometry, source (manufacturer), processing, chemicals, and intended patient exposure and utilize the same sterilization method (Ethylene Oxide) as those in the predicate devices and reference devices. All components are packaged together in a pouch, labeled, and sterilized as a finished good for the Glidesheath Slender Tibial Pedal kit. Therefore, no design verification testing was performed on the individual components to demonstrate the substantial equivalence of the proposed Glidesheath Slender Tibial Pedal kit.

Since the packaging configurations of the needle in the Glidesheath Slender Tibial Pedal Kit were different from the reference device (K152173), packaging testing was re-evaluated. The following packaging verification testing was performed to ensure the durability of the proposed Glidesheath Slender Tibial Pedal kit packaging throughout distribution:

. Visual Inspection (Post Environmental Conditioning and Distribution Simulation)

Cadaver Testing

To evaluate the clinical feasibility of the Glidesheath Slender Tibial Pedal kit, devices were tested in a simulated use situation using cadaver lower leg models to test arterial access at specific BTK (below-the-knee) arterial access sites. It was demonstrated that the Glidesheath Slender sheath is compatible with the insertion angles used in ultrasound guided BTK access protocols in the four BTK vessels tested. The study also demonstrated that the kit and its components are acceptable for use in BTK access. The study along with a follow-up survey confirmed that the protocols used by physicians in standard practice are equivalent to the access protocol used in the simulated use study. This provides confidence that the results from the testing are applicable to the broader BTK operator community. Therefore, the results of the feasibility study ensure the substantial equivalence of the proposed Glidesheath Slender Tibial Pedal kit.

Standards referenced in the testing of the proposed Glidesheath Slender Tibial Pedal kit by Terumo Medical Corporation are provided in Table 2 below.

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| Standard Designation | Standard Name | FDA
Recognition #
(if applicable) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| ISO 10993-1: 2009
Cor. 1:2010 | Biological Evaluation of Medical Devices - Part
1: Evaluation and Testing Within a Risk
Management Process | 2-220 |
| ISO 10993-7: 2008
Cor.1:2009 | Biological Evaluation of Medical Devices - Part
7: Ethylene Oxide Sterilization Residuals | 14-408 |
| USP 38 | Bacterial Endotoxins Test (Sterility) | NA |
| ISO 11135: 2014 | Sterilization Of Health-Care Products - Ethylene
Oxide - Requirements For The Development,
Validation And Routine Control Of A
Sterilization Process For Medical Devices
(Sterility) | 14-452 |
| ASTM D4169-14 | Standard Practice for Performance Testing of
Shipping Containers and Systems | NA |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks
in Porous Medical Packaging by Dye Penetration | 14-484 |
| ASTM F88/F88M-15 | Standard Test Method for Seal Strength of
Flexible Barrier Materials | 14-482 |
| ASTM F2825-10
(Reapproved 2015) | Standard Practice for Climatic Stressing of
Packaging Systems for Single Parcel Delivery | 14-344 |

			Table 2: Standards Referenced in Testing of the Glidesheath Slender Tibial Pedal Kit

Biocompatibility

Biocompatibility classification is based on the FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."

Glidesheath Slender Tibial Pedal kit is categorized as an external communicating device, circulating blood with limited contact duration (up to 24 hours). The biological evaluation of Glidesheath Slender Tibial Pedal kit was performed per EN ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1.

All components of the Glidesheath Slender Tibial Pedal kit are identical in materials, formulation, geometry, source (manufacturer), processing, chemicals, and intended patient exposure and utilize the same sterilization method (Ethylene Oxide) as those in the predicate device and reference devices. Therefore, no additional biocompatibility testing was performed, and the Glidesheath Slender Tibial Pedal kit is considered to have substantially equivalent biocompatibility for the indicated use.

Sterilization

Glidesheath Slender Tibial Pedal kit was adopted into an existing ethylene oxide sterilization process validated via the overkill half cycle approach in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization

10

process for medical devices. The microbiological and performance qualifications for the existing sterilization process used for the reference devices were leveraged to provide a Sterility Assurance Level (SAL) of 10-6.

Glidesheath Slender Tibial Pedal kit is a limited exposure device. Sterilant residual testing was performed to demonstrate that after 24 hours of heated aeration, the level of residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) do not exceed an average daily dose of 4 mg and 9 mg respectively per EN ISO 10993-7:2008.

CLINICAL TESTS (807.92(b)(2)) I.

This 510(k) included a summary of the PRIME Registry data. The first 71 patients treated with the Terumo Glidesheath Slender when undergoing an index endovascular procedure using a tibial access point was compared to a literature based dataset of procedures using radial and femoral access. No issues that may affect the determination of substantial equivalence were noted in the comparison.

J. CONCLUSION (807.92(b)(3))

In summary, the Glidesheath Slender Tibial Pedal kit, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device.