Glidesheath Slender

K173831 · Terumo Medical Corporation · DYB · May 8, 2018 · Cardiovascular

Device Facts

• Record ID: K173831
• Device Name: Glidesheath Slender
• Applicant: Terumo Medical Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: May 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.

Device Story

Glidesheath Slender is a catheter introducer system used to facilitate radial artery access during diagnostic or interventional catheterization. The system includes a sheath, dilator, entry needle, mini guide wire, and guide wire inserter. The sheath features a hydrophilic coating to reduce friction and contains bismuth for fluoroscopic visibility. Operation involves a physician inserting the mini guide wire through a cannula into the radial artery, followed by the sheath and dilator. Once positioned, the dilator and guide wire are removed, allowing catheter insertion through the sheath. The device is intended for single-use in a clinical setting. It provides a pathway for catheters, potentially improving procedural efficiency and patient outcomes during vascular access.

Clinical Evidence

No clinical data included. Substantial equivalence is supported by non-clinical bench testing, including fluoroscopic visibility, mechanical integrity (tensile, kink, pressure, leak tests), lubricity, and biocompatibility (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, and hemocompatibility) per ISO 10993-1.

Technological Characteristics

Materials: ETFE, bismuth trioxide, polypropylene, silicone oil, stainless steel, nitinol, polyurethane, polycarbonate. Sensing: Fluoroscopic visibility (ASTM F640-12). Energy: None (manual operation). Connectivity: None. Sterilization: Ethylene Oxide (ISO 11135). Form factor: 5-7 Fr sheath sizes, 10-16 cm lengths.

Indications for Use

Indicated for patients requiring catheter placement into the radial artery via percutaneous access.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Glidesheath Slender (K142183)

Reference Devices

• Glidesheath (K152173)

Submission Summary (Full Text)

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May 8, 2018

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

## Re: K173831

Trade/Device Name: Glidesheath Slender Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 13, 2018 Received: April 16, 2018

Dear Liang Lu:

We have reviewed vour 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 (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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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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Kenneth J. Cavanaugh - S

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)

K173831

Device Name Glidesheath Slender

Indications for Use (Describe)

The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.

Type of Use (Select one or both, as applicable)

X 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 by:

Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation Tel. [phone] Fax [phone]

Prepared for: Owner/Operator Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873, USA Owner/Operator Number: 9003933

#### Manufacturer (510(k) Applicant)

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

#### Sterilization Facility

STERIS AST 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. [phone] Fax [phone] E-mail: [e-mail]

Date prepared: April 27, 2018

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

Proprietary Name: Common Name: Classification Name: Classification Panel: Regulation: Product Code: Classification:

Glidesheath Slender Introducer Sheath Introducer, Catheter Cardiovascular 21 CFR 870.1340 DYB 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, Japan
- Reference Device: K152173 Glidesheath, manufactured by Terumo Medical . Corporation. USA

# D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the Glidesheath Slender, 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 consists of an introducer (sheath and a dilator), which are packaged together with an entry needle, mini guide wire and guide wire inserter. The Glidesheath Slender devices (all sheath sizes) are used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in either the stainless steel (SS) entry needle version or the Surflo (SR) IV catheter (which includes a needle). There are two different types of stainless-steel entry needles that are available in various gauges and lengths. The two needle types are referenced in the documentation as TPC and TRI. These initials are only used in internal Terumo documents.

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in three versions made out of three materials, either a stainless-steel spring coil model (stainless steel), a nitinol model with palladium tip (nitinol) or a polyurethane plastic model with a nitinol core (plastic).

During either a diagnostic or interventional catheterization procedure, a physician will perform the following procedure. The mini guide wire is inserted through a cannula placed in the patient's blood vessel. A guide wire inserter is provided to assist

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in insertion of the mini guide wire into the cannula. 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 entry needle, the mini guide wire and the guide wire inserter are all accessories to the Glidesheath Slender sheath/dilator. The accessories for a given product code are provided with the Glidesheat Slender sheath/dilator in an individual package and sterilized together.

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

The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.

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

The Glidesheath Slender, 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 Corporation.

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

Table 5.1: Summary of Substantial Equivalence

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| Device Characteristic | Subject Device: | Predicate Device: |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Glidesheath Slender | Glidesheath Slender (K142183) |
| Manufacturer | Terumo Medical Corporation (Elkton, MD) | Terumo Corporation, (Ashitaka, Japan) |
| Intended Use /<br>Indications for Use | The Glidesheath Slender is indicated to facilitate placing a<br>catheter through the skin into the radial artery | Same |
| Operation Principle | Operated manually or by a manual<br>process: | Same |
| Design / Construction | Sheath,<br>Dilator,<br>Guide Wires (Plastic, Stainless Steel, Nitinol),<br>Surflo IV Catheter,<br>Stainless Steel Entry Needle | Same, except for:<br>Guide Wire (Nitinol) and TRI Stainless Steel Entry Needle of<br>the proposed device are not available in kits for the predicate<br>TC Glidesheath Slender (K142183), they are identical to the<br>Guide Wire (Nitinol) and TRI Stainless Steel Entry Needle<br>used in the reference Glidesheath (K152173). |
| Materials | Sheath Assembly:<br>Ethylene-Tetrafluoroethylene(ETFE) copolymer<br>Bismuth trioxide<br>Colorant<br>Dimethylacrylamide-glycidyl methacrylate copolymer<br>Silicone oil<br>Polypropylene<br>Silicone Rubber<br>Stainless Steel<br>Styrene-ethylene-butylene-styrene block copolymer<br>Polybutadiene<br>Polycarbonate<br>Polyethylene<br>Colorant<br><br>Dilator Assembly:<br>Polypropylene<br>Bismuth subcarbonate<br>Colorant<br>Silicone oil<br>Stainless Steel | Same, except for:<br>3WSC and Silicone Lubricant of the proposed device have<br>same material types with minor differences, but they are<br>identical to the 3WSC and Silicone Lubricant used in the<br>reference Glidesheath (K152173).<br><br>Same, except for:<br>Silicone Lubricant of the proposed device has same material<br>types with minor differences, but it is<br>identical to the Silicone Lubricant used in the reference<br>Glidesheath (K152173). |
| Device Characteristic | Subject Device: | Predicate Device: |
| | Glidesheath Slender | Glidesheath Slender (K142183) |
| | Guide Wire (Plastic Jacket): | Same |
| | Nickel-Titanium alloy | |
| | Polyurethane | |
| | Tungsten | |
| | Silicone oil | |
| | | |
| | Guide Wire (Stainless Steel): | Same |
| | Stainless Steel | |
| | Guide Wire (Nitinol): | Guide Wire (Nitinol) of the proposed device is not available |
| | Nickel-Titanium alloy | in kits for the predicate TC Glidesheath Slender (K142183), |
| | Palladium | but it is identical to the Guide Wire (Nitinol) used in the |
| | Epoxy adhesive | reference Glidesheath (K152173). |
| | Guide Wire Inserter: | Same |
| | Polyethylene | |
| | Colorant | |
| | Surflo IV Catheter: | Same |
| | Ethylene-Tetrafluoroethylene (ETFE) copolymer | |
| | Colorant | |
| | Barium sulfate | |
| | Dispersant | |
| | Silicone oil | |
| | Polypropylene | |
| | Stainless Steel | |
| | Sorbitan fatty acid ester | |
| | Polycarbonate<br>Polystyrene<br>Polyester-Chlorinated polyvinyl chloride | |
| | Entry Needle (TPC): | Same |
| | Stainless Steel | |
| | Silicone oil | |
| | Polycarbonate<br>Acrylic resin containing colorant | |
| Device Characteristic | Subject Device:<br>Glidesheath Slender | Predicate Device:<br>Glidesheath Slender (K142183) |
| | Entry Needle (TRI): | Same, except for: |
| | Stainless Steel<br>Silicone oil<br>Styrene-buadiene<br>Acrylic resin heat transcription foil | TRI Stainless Steel Entry Needle (21G x 38mm) of the<br>proposed device is not available in kits for the predicate TC<br>Glidesheath Slender (K142183), but it is identical to the<br>entry needle used in the reference Glidesheath (K152173). |
| Package | Tyvek, Polyester-polyethylene laminated film,<br>High Impact Polystyrene | Same |
| Specifications | Sheath | Sheath |
| | Size: 5, 6, 7 Fr.<br>Length: 10, 16 cm | Same |
| | Dilator<br>Size (Applicable to GW Outer Diameter):<br>0.021, 0.025 inch<br>Length: 15.7, 21.7 cm | Dilator<br>Size (Applicable to GW Outer Diameter):<br>0.018, 0.021, 0.025, 0.035 inch<br>Length: 15.5, 21.5 cm |
| | Guide Wire (Plastic)<br>OD: 0.021, 0.025 inch<br>Guide Wires Length: 45, 80 cm | Guide Wire (Plastic)<br>OD: 0.018, 0.021, 0.025, 0.035 inch<br>Guide Wires Length: Same |
| | Guide Wire (Stainless Steel)<br>OD: 0.021, 0.025 inch<br>Guide Wires Length: 45, 80 cm | Guide Wire (Stainless Steel)<br>OD: 0.018, 0.021, 0.025, 0.035 inch<br>Guide Wires Length: Same |
| | Guide Wire (Nitinol)<br>OD: 0.021 inch<br>Guide Wires Length: 43 cm | Guide Wire (Nitinol)<br>None |
| | Surflo IV Catheter<br>Type: 20, 22 G<br>Length: 25, 32 mm (1", 1 1/4") | Surflo IV Catheter<br>Type: 18, 20, 22 G<br>Length: 25, 32, 51, 64 mm (1", 1 1/4", 2", 2 1/2") |
| Device Characteristic | Subject Device: | Predicate Device: |
| | Glidesheath Slender | Glidesheath Slender (K142183) |
| | Entry Needle (TPC) | Entry Needle (TPC) |
| | Type: 20, 21 G | Same |
| | Length: 35 mm | |
| | | |
| | Entry Needle (TRI) | Entry Needle (TRI) |
| | Type: 21 G | None |
| | Length: 38 mm | TRI Stainless Steel Entry Needle (21G x 38mm) of the |
| | | proposed device is not available in kits for the predicate TC |
| | | Glidesheath Slender (K142183), but it is identical to the |
| | | entry needle used in the reference Glidesheath (K152173). |
| Sterilization | Ethylene Oxide (validated in accordance with ANSI / AAMI / ISO 11135-1 to achieve SAL 10-6) | Same |
| | | |
| Shelf life | 30 months | Same |
| Disposable Single Use | Yes | Same |

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Image /page/7/Picture/1 description: The image shows the Terumo logo. The logo consists of a red curved line above the word "TERUMO" in green. The red curved line is positioned above and to the left of the word "TERUMO", creating a sense of motion or direction.

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Image /page/8/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word, creating a dynamic and modern look.

Terumo Medical Corporation, USA

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Image /page/9/Picture/1 description: The image shows the Terumo logo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word, creating a sense of motion or progress.

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Image /page/10/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red curved line above the word. The red curved line starts above the "T" and extends to the right, above the "E".

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

## Performance

Performance testing was conducted to ensure that the Glidesheath Slender met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.

The following Table 5.2 provides a list of the performance tests that were performed on the proposed Glidesheath Slender.

| Component | Test Item | Reference |
|-----------|---------------------------------------------|----------------------------------------------------|
| Sheath | Fluoroscopy | ISO 11070:2014, Section 4.5<br>ASTM F640-12 |
| | Sheath visual inspection | In-house standard |
| | Sheath Effective Length | In-house standard |
| | Side Tube Length | In-house standard |
| | Sheath Tip ID | In-house standard |
| | Sheath, Hemostatic Valve Leak | ISO 11070:2014, Annex E |
| | Sheath Pressure Test | ISO 11070:2014, Annex D<br>ISO 11070:2013, Annex C |
| | Sheath Penetration | In-house standard |
| | Visual inspection after penetration testing | ISO 11070:2014 - Annex A section A3 |
| | Sheath Tip Rollback Test | ISO 11070:2014 - Annex A section A3 |
| | Dilator Hub to Sheath Hub Snap Fit Strength | In-house standard |
| | Valve Mobility Resistance | In-house standard |
| | Sheath Kink resistance | ISO 11070:2014 Annex A section A.1 |
| | Sheath Tubing/Housing Joint Strength | ISO 11070:2014, Section 7.6 |
| | Cap to Housing Joint Strength | In-house standard |
| | Sheath Support to Housing Strength | In-house standard |
| | Sheath Tubing Tensile Strength | ISO 11070:2014, Section 7.6 |
| | Sheath Lubricity and Durability | In-house standard |
| | Particle capture during simulated use | FDA PTCA Guidance |
| | Coating integrity after simulated use | In-house standard |
| Dilator | Fluoroscopy | ISO 11070:2014, Section 4.5<br>ASTM F640-12 |
| | Dilator visual inspection | In-house standard |
| | Dilator Useable Length | In-house standard |
| | Dilator Tip ID | In-house standard |
| | Dilator OD at Sheath Tip | In-house standard |
| | Dilator Penetration | In-house standard |
| | Visual inspection after penetration testing | ISO 11070:2014 - Annex A section A3 |
| | Dilator Tip Rollback Test | ISO 11070:2014 - Annex A section A3 |
| | Dilator to Hub Tensile | ISO 11070:2014, Annex C<br>ISO 11070:2013, Annex B |
| | Dilator Hub to Sheath Hub Snap Fit Strength | In-house standard |
| | Particle capture during simulated use | FDA PTCA Guidance |

Table 5.2: Summary of Performance Testing

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Image /page/11/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh appears to be a stylized representation of movement or progress.

The Glidesheath Slender tested met the predetermined acceptance criteria and results support a determination of substantial equivalence. There are no new issues of safety and effectiveness in the performance of the device.

## Biocompatibility

Glidesheath Slender is categorized as an external communicating device, circulating blood with limited contact duration (up to 24 hours). The biological evaluation of Glidesheath Sl…