Glidesheath

K152173 · Terumo Medical Corporation · DYB · Dec 1, 2015 · Cardiovascular

Device Facts

• Record ID: K152173
• Device Name: Glidesheath
• Applicant: Terumo Medical Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Glidesheath™ is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

Device Story

Glidesheath is a manual catheter introducer system used by clinicians to gain vascular access. The system comprises a sheath, dilator, and accessories (mini guide wire, entry needle, guide wire inserter, flushing syringe). The sheath features a hydrophilic coating to reduce frictional resistance during insertion and removal. The sheath and dilator contain bismuth for fluoroscopic visibility. The clinician uses the entry needle to access the vessel, inserts the guide wire, and then advances the sheath/dilator assembly over the wire. Once the sheath is positioned, the dilator and guide wire are removed, allowing for the insertion of an appropriate catheter. The device is used in clinical settings to facilitate diagnostic or interventional procedures, potentially benefiting the patient by providing a secure, lubricated pathway for catheter delivery into the vasculature.

Clinical Evidence

No clinical data.

Technological Characteristics

Materials include ETFE copolymer, bismuth trioxide, polypropylene, stainless steel, silicone rubber, styrene-ethylene-butylene-styrene, polybutadiene, polycarbonate, polyethylene, nickel-titanium alloy, and polyurethane. Features hydrophilic coating. Manual operation. Sterilized via ethylene oxide (ISO 11135:2014) to SAL 10^-6. Complies with ISO 11070, ISO 594, and ISO 10993 standards.

Indications for Use

Indicated for patients requiring catheter placement into a vein or artery, including the radial artery, to facilitate vascular 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™ (K082644)

Reference Devices

• Surflo (SR) IV catheter (K891087)
• Glidesheath (K102008)

Submission Summary (Full Text)

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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 features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

December 01, 2015

Terumo Medical Corporation Erin Doyle Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921

Re: K152173

Trade/Device Name: Glidesheath™ Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 29, 2015 Received: October 30, 2015

Dear Mr. Doyle:

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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand
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)

Device Name Glidesheath™

Indications for Use (Describe)

The Glidesheath™ is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to 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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Image /page/3/Picture/1 description: The image shows the Terumo company logo. The logo features a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.

# SECTION 5 – 510(K) SUMMARY

A summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.

# Section Contents

| A. SUBMITTER INFORMATION (807.92(a)(1)) | 41 |
|------------------------------------------------------|----|
| B. DEVICE NAME (807.92(a)(2)) | 42 |
| C. PREDICATE DEVICE (807.92(a)(3)) | 42 |
| D. REASON FOR 510(k) SUBMISSION | 42 |
| E. DEVICE DESCRIPTION (807.92(a)(4)) | 43 |
| F. INDICATIONS FOR USE (807.92(a)(5)) | 46 |
| G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) | 46 |
| H. NON CLINICAL TESTS (807.92(b)(1)) | 48 |
| I. CLINICAL TESTS (807.92(b)(2)) | 56 |
| J. CONCLUSION (807.92(b)(3)) | 56 |

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Image /page/4/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 curved and positioned above the left side of the word.

# 510(K) SUMMARY

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

Prepared by: Erin Michael Doyle Regulatory Affairs Specialist Terumo Medical Corporation Tel. [phone] Fax [phone]

#### Prepared for: Owner/Operator

Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873, USA Registration Number: 2243441

# Manufacturer (Applicant)

Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 Registration Number: 2246552

# Sterilization Facility

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

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Image /page/5/Picture/1 description: The image shows the logo for Terumo. 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 "TERUMO". The font of the word "TERUMO" is bold and sans-serif.

Contact Person: Erin Michael Doyle Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 Tel. [phone] Fax [phone] E-mail: [e-mail]

Date prepared: July 31, 2015

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

| Proprietary Name: | Glidesheath™ |
|-----------------------|----------------------|
| Common Name: | Introducer Sheath |
| Classification Name: | Introducer, Catheter |
| 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/are claimed is/are:

- K082644, Glidesheath™ manufactured by manufactured by Terumo ● Corporation, Japan.
# D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted due to the addition of a new manufacturing site for the Glidesheath™ (K082644) currently manufactured by Terumo Corporation (Ashitaka, Japan facility). The GlidesheathTM design, technology, and manufacturing is being transferred from its current manufacturing site, Terumo Corporation (Ashitaka, Japan facility) to Terumo Medical Corporation (Elkton, Maryland facility). The Ashitaka facility of Terumo Corporation will continue to manufacture the Glidesheath.

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Image /page/6/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 letters "TE". The font is bold and sans-serif. The red curved line is positioned above the left side of the word.

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

#### Principle of Operation Technology

The proposed Glidesheath™ manufactured by Terumo Medical Corporation (TMC) and the predicate Glidesheath (K082644) manufactured by Terumo Corporation (TC) are operated manually or by a manual process.

# Design/Construction

The Glidesheath consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. 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 entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The entry needle is offered in either stainless steel (SS) version or the Surflo (SR) IV catheter (which includes a needle) (K891087). There are two different types of stainless steel entry needles that are available in various gauges and lengths.

The mini guide wire is inserted through the cannula into the patient's blood vessel and is used for placement of the sheath and dilator into the vein or artery. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. The mini guide wire is offered in three versions, either a stainless steel spring coil model (stainless steel), a nitinol model with palladium tipped (nitinol) or a polyurethane plastic model with a nitinol core (plastic).

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 flushing syringe is used to prime the dilator with heparinized saline.

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Image /page/7/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The swoosh is curved and points to the right. The word "TERUMO" is in a bold, sans-serif font.

The entry needle, the mini guide wire, the guide wire inserter and flushing syringe, are all accessories to the Glidesheath. Depending on the product code, certain accessories may or may not be contained within the kit. All of the accessories for a given product code are provided in an individual package with the Glidesheath and sterilized together.

#### Materials

Table 5.1 below provides an overview of the materials of the proposed TMC Glidesheath.

| | Glidesheath Component | Material |
|-------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------|
| | Tube | Ethylene-Tetrafluoroethylene (ETFE) copolymer, Bismuth<br>Trioxide |
| | Hydrophilic<br>Coating | Dimethyl acrylamide-glycidyl methacrylate copolymer |
| | Housing | Polypropylene |
| | Caulking Pin | Stainless Steel |
| Sheath | Cap | Polypropylene |
| | Valve | Silicone Rubber |
| | Sheath<br>Support | Styrene-ethylene-butylene-styrene block copolymer |
| | Side Tube | Polybutadiene |
| | 3-Way<br>Stopcock | Polyethylene, Polypropylene, Polycarbonate |
| | Tube | Polypropylene,<br>Bismuth subcarbonate |
| Dilator | Hub | Polypropylene |
| | Caulking Pin | Stainless Steel |
| | Plastic Jacketed Guide Wires | Nickel-Titanium alloy,<br>Tungsten, Polyurethane |
| | Stainless Steel Straight and J-<br>Tip Guide Wires | Stainless Steel |
| | Nitinol Guide Wire | Nickel-Titanium alloy, Palladium |
| | Guide Wire Inserter | Polyethylene |
| TPC<br>Stainless<br>Steel Entry<br>Needle | Cannula | Stainless Steel |
| | Hub | Polycarbonate |

Table 5.1: Proposed TMC Glidesheath Materials

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Image /page/8/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 dynamic and recognizable brand symbol.

| | Glidesheath Component | Material |
|-------------------------------------------|-----------------------|---------------------------------------------------------------|
| TRI<br>Stainless<br>Steel Entry<br>Needle | Cannula | Stainless Steel |
| | Hub | Styrene-butadiene |
| | | |
| Surflo IV<br>Catheter | Catheter tube | Ethylene-Tetrafluoroethylene (ETFE) copolymer, Barium sulfate |
| | Hub | Polypropylene |
| | Caulking Pin | Stainless Steel |
| | Filter Cap | Polystyrene, Polyester-Chlorinated polyvinyl chloride |
| | Adapter | Polypropylene |
| | Needle<br>Cannula | Stainless Steel |
| | Needle Hub | Polycarbonate |
| Flushing<br>Syringe | Barrel | Polypropylene |
| | Plunger | Polypropylene |
| | Gasket | Rabalon |

## Specifications

Table 5.2 below provides an overview of the device specifications for the proposed TMC Glidesheath.

| Component | Parameter | Specification | | |
|---------------------------------|---------------------|------------------------------------------|------------------------|-----------------------------|
| Sheath | Size | 4Fr | 5Fr | 6Fr |
| Sheath | Length | 10,16, 25 (cm) | | |
| Sheath | Hydrophilic coating | 10,16, 25 (cm) - entire length of sheath | | |
| Dilator | Applicable to GW | 0.021, 0.025 (inch) | | 0.021,0.025<br>0.035 (inch) |
| Dilator | Length | 15.7, 21.7, 30.7cm | | |
| Guide Wire (Stainless<br>Steel) | Outer Diameter | 0.021 (inch) | 0.021, 0.025<br>(inch) | 0.021,0.025<br>0.035(inch) |
| | Length | 45, 80 (cm) | | |
| Guide Wire (Nitinol) | Outer Diameter | n/a | 0.021 (inch) | |
| Guide Wire (Nitinol) | Length | n/a | 45 (cm) | |
| Guide Wire (Plastic) | Outer Diameter | 0.021, 0.025 (inch) | | |
| Guide Wire (Plastic) | Length | 45 (cm) | 45, 80 (cm) | |
| Surflo IV Catheter | Type | 20, 22 (G) | | |
| Surflo IV Catheter | Length | 25,32 (mm) – 1, 11/4 (inch) | | |
| Surflo IV Catheter | | (20G x 32mm, 22G x 25mm) | | |
| Surflo IV Catheter | Type | n/a | 20, 21 (G) | |

Table 5.2: Proposed TMC Glidesheath Specifications

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Image /page/9/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is curved and tapers to a point on the left side of the logo.

| TPC Stainless Steel<br>Entry Needle | Length | n/a | 35 (mm)<br>(1 2/5") |
|-------------------------------------|--------|-------|---------------------|
| TRI Stainless Steel<br>Entry Needle | Type | n/a | 21 (G) |
| TRI Stainless Steel<br>Entry Needle | Length | n/a | 38 (mm)<br>(1 1/2") |
| Flushing Syringe | Volume | 2.5mL | |

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

The Glidesheath is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

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

The proposed Glidesheath manufactured by Terumo Medical Corporations, 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 Glidesheath, manufactured by Terumo Corporation.

Table 5.3 below provides a summary comparison of the proposed TMC Glidesheath and the predicate TC Glidesheath (K082644).

| Device<br>Characteristic | Proposed TMC Glidesheath | Predicate TC Glidesheath<br>(K082644) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Medical Corporation (Elkton,<br>MD) | Terumo Corporation<br>(Ashitaka, Japan) |
| Intended Use /<br>Indications for<br>Use | The Glidesheath is indicated to<br>facilitate placing a catheter through the<br>skin into a vein or artery including but<br>not limited to the radial artery. | The Glidesheath is used to<br>facilitate placing a catheter<br>through the skin into a vein or<br>artery including but not limited to<br>the radial artery.<br>The Mini Guide Wire is an<br>accessory device which is used<br>for placement of the sheath into<br>the vein or artery including but<br>not limited to the radial artery.<br>The Radifocus Obturator is also<br>an accessory device which is used |
| Device<br>Characteristic | Proposed TMC Glidesheath | Predicate TC Glidesheath<br>(K082644) |
| | | by placing it into the sheath to<br>create an occlusion and further<br>provide support to the wall of the<br>indwelling sheath while it remains<br>in place within the vein or artery,<br>including but not limited to the<br>radial artery, after removal of a<br>catheter. |
| Operation<br>Principle | Manual | same |
| Design /<br>Specifications | Introducer (4,5,6 Fr):<br>• Hydrophilic Sheath<br>• Dilator<br>Accessories:<br>• Guide Wires - 0.021,0.025<br>0.035 (inch)<br>• Needles – 20G, 21G, 22G<br>• Flushing Syringe – 2.5mL<br>• Guide Wire Inserter | same |
| Performance | The proposed TMC Glidesheath<br>design and performance specifications<br>are based off of the same internal and<br>external standards as the predicate TC<br>Glidesheath (K082644) | same |
| Materials | Sheath<br>ETFE copolymer, Bismuth<br>Trioxide,<br>Dimethyl acrylamide-<br>glycidyl methacrylate<br>copolymer, Polypropylene,<br>Stainless Steel, Silicone<br>Rubber, Styrene-ethylene-<br>butylene-styrene block<br>copolymer, Polybutadiene,<br>Polycarbonate,<br>Polyethylene | same |
| | Dilator<br>Polypropylene, Bismuth<br>subcarbonate, Stainless<br>Steel | |
| | Plastic<br>Jacket<br>Guide<br>Wire<br>Nickel-Titanium alloy,<br>Polyurethane, Tungsten | |
| | SS<br>Stainless Steel | |
| Device<br>Characteristic | Proposed TMC Glidesheath | Predicate TC Glidesheath<br>(K082644) |
| Wire | | |
| Nitinol<br>Guide<br>Wire | Nitinol, Palladium, Epoxy | Wire not available in kits for<br>predicate TC Glidesheath<br>(K082644). Identical wire<br>included in kit for reference<br>Glidesheath (K102008). |
| Guide<br>Wire<br>Inserter | High Density Polyethylene | same |
| SR<br>Catheter | ETFE copolymer, Barium<br>sulfate, Polypropylene,<br>Stainless Steel, Polystyrene,<br>Polyester-Chlorinated<br>polyvinyl chloride,<br>Polycarbonate | same |
| SS<br>Needle | Stainless Steel,<br>Polycarbonate | same |
| Silicon-<br>zed SS<br>Needle | Stainless Steel, styrene-<br>butadiene | Needle not available in kits for<br>predicate Glidesheath (K082644).<br>Identical needle included kit for<br>reference Glidesheath (K102008) |
| Syringe | Polypropylene, Resin:<br>Rabalon | same |
| Packaging | Tyvek, Polyester-polyethylene<br>laminated film, High Impact<br>Polystyrene | same |
| Sterilization<br>Method | Ethylene oxide sterilization (validated<br>in accordance with ISO 11137-1 to<br>achieve SAL 10-6) | same |

Table 5.3: Summary of Substantial Equivalence

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Image /page/10/Picture/1 description: The image features the word "TERUMO" in a bold, green sans-serif font. Above the word, there is a red, curved shape that resembles a swoosh or a stylized checkmark. The red shape starts thin on the left and gradually thickens as it curves over the word "TERUMO".

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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 company name, which is written in green, block letters. The font is sans-serif and the letters are bolded.

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

#### Performance

Performance testing was conducted to ensure the proposed TMC Glidesheath 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. Tables 5.4 – 5.9 below provide a list of the performance tests that were performed on the proposed TMC Glidesheath.

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Image /page/12/Picture/1 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is curved and points to the right.

# Table 5.4: Summary of Sheath Performance Testing

| Component | Test<br>Description | Standard |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Sheath | Visual Inspection – Extraneous<br>matter | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection - Process and<br>surface defects | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection – Lubricant on<br>external surfaces | ISO 11070: 1998, Sect. 4.3 |
| | Corrosion Resistance | ISO 11070: 1998, Sect. 4.4 & Annex B |
| | Radiodetectability | ISO 11070: 1998, Sect. 4.5 /<br>ASTM F640-12 |
| | Liquid leakage through sheath | ISO 11070:1998, Sect. 7.3 & Annex D |
| | Liquid leakage through valve | ISO 11070:1998, Sect. 7.4 & Annex E |
| | Sheath to housing joint strength | ISO 11070: 1998, Sect. 7.6 |
| | Sheath tubing tensile strength | ISO 11070: 1998, Sect. 7.6 |
| | Kink resistance | ISO 11070:1998, Annex A Section A.1 |
| | Sheath side tube to housing joint<br>strength | ISO 11070: 1998, Annex C<br>*ISO 11070 does not require test on<br>side tube Ref. for test method only |
| | 3WSC to side tube joint strength | ISO 11070: 1998, Annex C<br>*ISO 11070 does not require test on<br>side tube Ref. for test method only |
| | Visual Inspection – housing color | Internal |
| | Penetration of Sheath, Dilator<br>System in thin film, Sheath Tip<br>Cracks | Internal |
| | Housing to cap joint strength | Internal |
| | Assembled side tube length | Internal |
| | Side tube burst | Internal |
| | Sheath housing to support joint<br>strength | Internal |
| | Sheath Length | Internal |
| Visual Inspection – Suture Eye | Internal | |
| Catheter insertion through valve | Internal | |
| Aspiration & injection through<br>side tube | Internal | |
| External Lubricity | Internal | |
| Particulate & Coating Integrity<br>Testing<br>Note: Test conducted using whole<br>kit | FDA PTCA<br>Guidance /USP788 | |

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Image /page/13/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 is positioned above and to the left of the word.

| | | | Table 5.5: Summary of Dilator Performance Testing | |
|--|--|--|---------------------------------------------------|--|
|--|--|--|---------------------------------------------------|--|

| Component | Test # /<br>Description | Standard |
|----------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------|
| Dilator | Visual Inspection – Extraneous matter | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection – Process and surface<br>defects | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection – Lubricant on<br>external surfaces | ISO 11070: 1998, Sect. 4.3 |
| | Corrosion Resistance | ISO 11070: 1998, Sect. 4.4 &<br>Annex B |
| | Radiodetectability | ISO 11070: 1998, Sect. 4.5 |
| | Dilator tubing to hub joint strength | ASTM F640-12 |
| | Gauge Luer Taper | ISO 11070: 1998, Sect. 9.3.3 &<br>Annex C |
| | Liquid Leakage from fitting assembly<br>under pressure | ISO 594-1:1986, Sect. 5.1 |
| | Air leakage into the fitting assembly<br>during aspiration | ISO 594-2: 1998, Sect. 5.2 |
| | Separation force of fitting assembly | ISO 594-2: 1998, Sect. 5.3 |
| | Unscrewing torque of fitting assembly | ISO 594-2:1998,Sect. 5.4 |
| | Ease of assembly | ISO 594-2:1998, Sect. 5.5 |
| | Resistance to overriding | ISO 594-2:1998, Sect. 5.6 |
| | Stress cracking | ISO 594-2: 1998, Sect. 5.7 |
| | Visual Inspection – hub color | ISO 594-2: 1998, Sect. 5.8 |
| | Dilator hub to sheath housing fitting<br>strength | Internal |
| | Dilator OD at Sheath Tip interface &<br>shaft OD; Sheath tip ID | Internal |
| | Dilator Length | Internal |
| Dilator tip ID | Internal | |
| Penetration of Dilator System in thin<br>film | Internal | |
| Pass wire through dilator to check for<br>blockage | Internal | |

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Image /page/14/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the word "TERUMO", which is written in a bold, green sans-serif font. The arc is positioned above and slightly to the left of the word "TERUMO".

| Guide<br>Wires | Visual Inspection – Extraneous matter | ISO 11070: 1998, Sect. 4.3 |
|-----------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------|
| | Visual Inspection – Process and surface defects | ISO 11070: 1998, Sec. 4.3 |
| | Visual Inspection – Lubricant on external surfaces | ISO 11070: 1998, Sec. 4.3 |
| | Corrosion Resistance | ISO 11070: 1998, Sect. 4.4 & Annex B |
| | Radiodetectability | ISO 11070: 1998, Sec. 4.5 |
| | | ASTM F640-12 |
| | Test for fracture of guide wires | ISO 11070: 1998, Annex F |
| | Test for resistance of guide wires to damage by flexing | ISO 11070: 1998, Annex G |
| | Guide Wire Tensile | ISO 11070: 1998, Annex H |
| | Guide Wire OD | Internal |
| | Guide Wire length | Internal |
| | Tip buckling (Tip butt resistance) test | Internal |
| | Insertion against flashback | Internal |
| | Removal through standard 21G needle (Nitinol Wire only) | Internal |
| | | |
| Entry Needles (including Surflo (SR) I.V. Catheter) | Visual Inspection – Extraneous matter | ISO 11070: 1998, Sect. 4.3 |
| | Visual Inspection – Process and surface defects | ISO 11070: 1998, Sec. 4.3 |
| | Visual Inspection – Lubricant on external surfaces | ISO 11070: 1998, Sec. 4.3 |
| | Corrosion Resistance | ISO 11070: 1998, Sect. 4.4 & Annex B |
| | Radiodetectability | ISO 11070: 1998, Sec. 4.5 |
| | Visual Inspection – Needle Point | ASTM F640-12 |
| | Distance from heel of needle to catheter tip (Surflo Needle test only) | ISO11070:1998, Section 5.3 |
| | Catheter to hub joint strength (Surflo Catheter test only) | ISO 11070: 1998, section 6.2 |
| | Needle to hub joint strength | ISO 11070:1998, Annex C |
| | Gauge Luer Taper | ISO/ FDIS 11070: 2014, Annex I |
| | Liquid Leakage from fitting assembly under pressure | ISO 594-1:1998, Sect. 5.1 |
| | Air leakage into the fitting assembly during aspiration | ISO 594-2: 1998, Sect. 5.2 |
| | Separation force of fitting assembly | ISO 594-1: 1986, Sect. 5.2 for SR Needles only |
| | Unscrewing torque of fitting assembly (SR needles not included) | ISO 594-2: 1998, Sect. 5.3 |
| | Ease of assembly (SR needles not included) | ISO 594-1: 1986, Sect. 5.3 for SR Needles only |
| | Resistance to overriding (SR needles not included) | ISO 594-2: 1998, Sect. 5.4 |
| | Stress cracking | ISO 594-1: 1986, Sect. 5.4 for SR Needles only |
| | Visual Inspection – hub color | ISO 594-2:1998, Sect. 5.5 |
| | Visual Inspection – SR Catheter hub | ISO 594-2:1998, Sect. 5.6 |
| | Needle Length | ISO 594-2: 1998, Sect. 5.7 |
| | Needle bevel indicator position | ISO 594-2: 1998, Sect. 5.8 |
| | Needle bevel indicator Visibility | ISO 594-1: 1986, Sect. 5.5 for SR Needles only |
| | Wire can pass through insertion device provided in kit (needles only) | ISO 6009:1992, Sect. 2 |
| | Needle I.D. | Internal |
| | Needle Flashback | Internal |
| | Surflo I.V. Catheter Penetration | Internal |
| | Needle Penetration | Internal |
| | Gauge Luer Taper | ISO 594-1:1986, Sect. 5.1 |
| | Liquid Leakage from fitting assembly<br>under pressure | ISO 594-1:1986, Sect. 5.2 |
| | Air leakage into the fitting assembly<br>during aspiration | ISO 594-1:1986, Sect. 5.3 |
| | Separation force of fitting assembly | ISO 594-1:1986, Sect. 5.4 |
| | Stress Cracking | ISO 594-1:1986, Sect. 5.5 |
| | Barrel finger grips – Flash and Sharp<br>edges | ISO 7886-1: 1993, Sect. 11.2 |
| Syringe | Barrel finger grips - Rolling | ISO 7886-1: 1993, Sect. 11.2 |
| | Plunger length past finger grips | ISO 7886-1: 1993, Sect. 12.1 |
| | Fit of the piston in the barrel | ISO 7886-1: 1993, Sect. 12.2 |
| | Piston/Plunger Assembly – One-<br>Handed Design | ISO 7886-1: 1993, Sect. 12.1 |
| | Separation force of fitting assembly | ISO 7886-1: 1993, Sect. 12.1 |
| | Visual Inspection - lubricant inside of<br>syringe barrel | ISO 7886-1: 1993, Sect. 8 |
| | Visual Inspection - Glidesheath Access<br>Kit w/ SR and Syringe | Internal |

## Table 5.6: Summary of Guide Wire Performance Testing

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Image /page/15/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.

## Table 5.7: Summary of Entry Needles Performance Testing

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Image /page/16/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 curved and positioned above the left side of the word. The word "TERUMO" is in a bold, sans-serif font.

## Table 5.8: Summary of Syringe Performance Testing

#### Table 5.9: Summary of 3-Way Stopcock Performance Testing

| 3-Way<br>Stopcock | Gauge Luer Taper | ISO 594-1:1986, Sect. 5.1 |
|-------------------|------------------------------------------------------------|---------------------------|
| | Liquid Leakage from fitting assembly<br>under pressure | ISO 594-2:1998 Sec. 5.2 |
| | Air leakage into the fitting assembly<br>during aspiration | ISO 594-2:1998 Sec. 5.3 |
| | Separation force of fitting assembly | ISO 594-2:1998 Sec. 5.4 |
| | Unscrewing torque of fitting assembly | ISO 594-2:1998 Sec. 5.5 |
| | Ease of assembly | ISO 594-2:1998 Sec. 5.6 |
| | Resistance to overriding | ISO 594-2:1998 Sec. 5.7 |
| | Stress cracking | ISO 594-2:1998 Sec. 5.8 |

The components tested met the predetermined acceptance criteria and results support a determination of substantial equivalence

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Image /page/17/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". The word "TERUMO" is written in a bold, sans-serif font.

#### Biocompatibility

The individual components of the Glidesheath were categorized according to the following:

- FDA General Program Memorandum #G95-1 (5/1/95): Use of . International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"
- EN ISO 10993-1. .

Table 5.10 below provides the categorization of each of the Glidesheath components. Tests were then selected based upon these categorizations.

| Device | Body Contact | Contact Duration |
|-----------------------------------------------------|--------------------------------------------------|---------------------|
| Introducer Sheath<br>(Sheath and Dilator) | Externally communicating,<br>Circulating Blood | Limited (<24 hours) |
| Guide Wires | | |
| Plastic Jacketed Guide Wire | Externally communicating,<br>Circulating Blood | Limited (<24 hours) |
| Stainless Steel Guide Wires<br>(Straight and J-tip) | Externally communicating,<br>Circulating Blood | Limited (<24 hours) |
| Nitinol Guide Wire | Externally communicating,<br>Circulating Blood | Limited (<24 hours) |
| Entry Needles | | |
| TRI Stainless Steel Entry<br>Needle | Externally communicating,<br>Circulating Blood | Limited (<24 hours) |
| TPC Stainless Steel Entry<br>Needle | Externally communicating,<br>Circulating Blood | Limited (<24 hours) |
| Surflo IV Catheter | Externally communicating,<br>Circulating Blood | Limited (<24 hours) |
| Syringe | | |
| Flushing Syringe | Externally communicating, Blood<br>Path Indirect | Limited (<24 hours) |

Table 5.10: The Glidesheath Blood/Body Contacting Components and Categorization

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Image /page/18/Picture/1 description: The image shows the logo for Terumo, a medical device company. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word "TERUMO", giving the logo a dynamic and modern look. The logo is simple, clean, and easily recognizable.

Table 5.11 provides a list of the Biocompatibility test conducted on the proposed TMC Glidesheath introducer (sheath & dilator) and accessories.

| Table 3.II: Summary of ISO 10993 Biocompatibility Testing |
|-----------------------------------------------------------|
| Non-aged, whole device (finished, sterile) |
| Cytotoxicity |
| Hemocompatibility (Hemolysis and Thrombogenicity) |
| Sensitization |
| Intracutaneous reactivity (acute) |
| Systemic toxicity (acute) |
| Pyrogenicity |
| Physicochemical |
| Accelerated-aged (12m), whole device (finished, sterile) |
| Cytotoxicity |
| Hemolysis |
| Physicochemical |

Table 5.11: Summary of ISO 10993Biocompatibility Testing

In addition to testing defined above, Extractables and Acidity/Alkalinity testing was performed on the needles per ISO 7864: 1993, Sterile hypodermic needles for single use (Annex A). All tests results met requirements.

All of the blood/body contacting materials present in the proposed TMC Glidesheath, including all accessories, have been tested for biocompatibility. The testing, conducted on the whole devices (finished, sterile), demonstrate that all test articles of the proposed TMC Glidesheath, including accessories, are biocompatible; furthermore, the screening tests demonstrate that biocompatibility of the device is maintained throughout its shelf life.

#### Sterilization

The sterility of the device is assured using a sterilization method validated in accordance with EN ISO 11135: 2014, Sterilization of Health Care Products- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The device is sterilized to provide a Sterility Assurance Level (SAL) of 106 using the overkill half cycle approach.

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Image /page/19/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. The word "TERUMO" is written in a bold, sans-serif font.

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

This 510(k) does not include data from clinical tests.

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

In summary, the proposed Glidesheath manufactured by Terumo Medical Corporation, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device(s):

K082644 – Glidesheath manufactured by Terumo Corporation