GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ

K122980 · Terumo Medical Corporation · DYB · Dec 11, 2012 · Cardiovascular

Device Facts

• Record ID: K122980
• Device Name: GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
• Applicant: Terumo Medical Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Indications for Use

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

Device Story

Introducer sheath system used to facilitate catheter placement into radial artery. Components include introducer sheath, dilator, entry needle, and mini guide wire. Sheath and dilator contain bismuth for fluoroscopic visibility; hydrophilic coating on sheath reduces frictional resistance during insertion/removal. Operated manually by clinicians in clinical settings. Entry needle gains arterial access; guide wire assists sheath/dilator placement. System enables safe catheter introduction into vasculature, minimizing vessel trauma through lubricious coating and optimized design.

Clinical Evidence

Bench testing only. Performance verified against ISO 11070 standards for surface, corrosion resistance, radiodetectability, dimensional accuracy, leakage, force at break, and sheath-to-dilator fit. Internal standards used for insertion/penetration resistance and coating integrity. Biocompatibility evaluated per ISO 10993-1. No clinical data presented.

Technological Characteristics

Materials: ETFE, bismuth, polypropylene, silicone rubber, stainless steel, NiTi, tungsten, polyurethane. Hydrophilic coating: dimethyl acrylamide-glycidyl methacrylate copolymer. Sensing/Actuation: Manual. Energy: None. Connectivity: None. Sterilization: Ethylene oxide (ANSI/AAMI/ISO 11135). Form factor: 6Fr sheath, 10/16cm lengths. Radiopaque components included.

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 (K082644)

Reference Devices

• Surflo IV catheter (K891087)

Submission Summary (Full Text)

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**510(K) SUMMARY**

## DEC 1 1 2012

ﺩ \ ﻣﻤﺴ

K122980 P

#### A. Device Name

| Proprietary Name | Glidesheath Slender |
|---------------------|---------------------------------------|
| Classification Name | Catheter Introducer (as per 870.1340) |
| Common Name | Introducer Sheath |
| Product Code | DYB |

#### B. Intended Use

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

#### C. Predicate Device

Terumo Corporation, Glidesheath (K082644)

#### D. Device Description

The Glidesheath Slender consists of an introducer sheath and a dilator which are packaged together with an entry needle and mini guide wire. The Glidesheath Slender is 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 two versions, either a stainless steel needle or a Surflo IV catheter (K891087).

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.

A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.

#### E. Principle of Operation

The Glidesheath Slender is operated manual process. This is the same principle of operation of the predicate Glidesheath device.

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## F. Technological/Design Comparison

- §¡ႁ̣̣ The Giligẹsheath Slender submitted in this 510(k) and the Glidesheath cleared under K082644 contain the same basic components. Specification differences do not raise any new issues of safety and effectiveness.
KI2298

| Specification | Glidesheath<br>(K082644) | Glidesheath Slender |
|-----------------------------------|--------------------------|--------------------------|
| Sheath Sizes | 4, 5 and 6Fr | 6Fr |
| Sheath Tip ID (6Fr) | 2.10mm | 2.10mm |
| Sheath OD (6Fr) | 2.62mm | 2.46mm |
| Sheath Length | 10, 16 and 25cm | 10 and 16cm |
| Sheath Coating | Hydrophilic | Hydrophilic |
| | (entire length of shaft) | (entire length of shaft) |
| Dilator Length | 15.5cm - 30.5cm | 15.5cm - 21.5cm |
| Stainless Steel Guide Wire OD | .021" - . 038" | .018" - .035" |
| Stainless Steel Guide Wire Length | 10cm -180cm | 45cm - 80cm |
| Plastic Guide Wire OD | .021" - . 038" | .018" - 035" |
| Plastic Guide Wire Length | 45cm - 80cm | 45cm - 80cm |
| Metallic Entry Needle Size | 20G - 21G | 20G - 22G |
| Metallic Entry Needle Length | 1.5" | 1.5" |
| Surflo IV Catheter Size | 16G - 22G | 18G - 22G |
| Surflo IV Catheter Length | 1" -- 2.5" | l" – 2.5" |

### G. Materials Comparison

The Glidesheath Slender submitted in this 510(k) and the Glidesheath cleared under K082644 are manufactured from identical materials.

| Component | Glidesheath<br>(K082644) | Glidesheath<br>Slender |
|---------------------|--------------------------------------------------------|--------------------------------------------------------|
| Sheath Tubing | ETFE, Bismuth | ETFE, Bismuth |
| Hydrophilic Coating | Dimethyl acrylamide-glycidyl<br>methacrylate copolymer | Dimethyl acrylamide-glycidyl<br>methacrylate copolymer |
| Sheath Housing | Polypropylene | Polypropylene |
| Sheath Caulking Pin | Stainless Steel | Stainless Steel |
| Sheath Cap | Polypropylene | Polypropylene |
| Sheath Valve | Silicone Rubber | Silicone Rubber |
| Sheath Support | Styrene-ethylene-butylene-<br>styrene block copolymer | Styrene-ethylene-butylene-<br>styrene block copolymer |
| Side Tube | Polybutadiene | Polybutadiene |
| 3-Way Stopcock | Polyethylene, Polypropylene,<br>Polycarbonate | Polyethylene, Polypropylene,<br>Polycarbonate |
| Dilator Tube | Polypropylene | Polypropylene |

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K122980 Page 3 of 6

| Dilator Hub | Polypropylene | Polypropylene |
|--------------------------|------------------------------|------------------------------|
| Dilator Caulking Pin | Stainless Steel | Stainless Steel |
| Plastic Guide Wire | NiTi, Tungsten, Polyurethane | NiTi, Tungsten, Polyurethane |
| Metallic Guide Wire | Stainless Steel | Stainless Steel |
| Guide inserter | Polyethylene | Polyethylene |
| Metallic Needle | Stainless Steel | Stainless Steel |
| Metallic Needle Hub | Styrene-butadiene copolymer | Styrene-butadiene copolymer |
| IV Catheter Tube | ETFE, Barium sulfate | ETFE, Barium sulfate |
| IV Catheter Hub | Polypropylene | Polypropylene |
| IV Catheter Caulking Pin | Stainless Steel | Stainless Steel |
| IV Catheter Filter Cap | Polystyrene, Polyester- | Polystyrene, Polyester- |
| | Chlorinated polyethylene | Chlorinated polyethylene |
| IV Catheter Adapter | Polypropylene | Polypropylene |
| IV Catheter Needle | Stainless Steel | Stainless Steel |
| IV Catheter Needle Hub | Polycarbonate | Polycarbonate |

## H. Performance Testing

The following bench tests were performed to verify that the subject device is substantially equivalent to the predicate device and that there are no new issues regarding the safety and effectiveness of the device:

| Performance Testing<br>Sheath | Method |
|--------------------------------------------|-----------------------|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification | ISO 11070 Sec. 7.2 |
| Freedom from leakage (sheath) | ISO 11070 Sec. 7.3 |
| Freedom from leakage (hemostasis valve) | ISO 11070 Sec. 7.4 |
| Force at break (sheath) | ISO 11070 Sec. 7.6 |
| Force at break (sheath to hub) | ISO 11070 Sec. 7.6 |
| Sheath to dilator fit | ISO 11070 Sec. A.1 |
| Rollback test | ISO 11070 Sec. A.1 |
| Puncture model test | ISO 11070 Sec. A.1 |
| Flexibility (kink angle) | ISO 11070 Sec. A.1 |
| Flexibility (radius of curvature) | ISO 11070 Sec. A.1 |
| Catheter insertion resistance | Internal Standard |
| Penetration resistance | Internal Standard |
| External surface sliding performance | Internal Standard |
| Hydrophilic coating separation resistance | Internal Standard |
| Hydrophilic coating particulate evaluation | FDA Guidance', USP788 |

¹ Class II Special Controls Guidance Document for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters

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| Performance Testing<br>Dilator | Method |
|------------------------------------|----------------------|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Dimensional verification | ISO 11070 Sec. 9.2 |
| Conical fitting | ISO 11070 Sec. 9.3.2 |
| | ISO 594-1 |
| Strength of union (dilator to hub) | ISO 11070 Sec. 9.3.3 |

| Performance Testing<br>Stainless Steel Needle | Method |
|-----------------------------------------------|---------------------------------|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification | ISO 11070 Sec. 5.2 |
| Needle point | ISO 11070 Sec. 5.3 |
| Conical fitting | ISO 11070 Sec. 5.4.1, ISO 594-1 |
| Strength of union (needle tube to hub) | ISO 11070 Sec. 5.4.2 |

| Performance Testing<br>Surflo IV Needle | Method |
|-----------------------------------------|---------------------------------|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification | ISO 11070 Sec. 5.2 |
| Needle point | ISO 11070 Sec. 5.3 |
| Conical fitting | ISO 11070 Sec. 5.4.1, ISO 594-1 |
| Strength of union (needle tube to hub) | ISO 11070 Sec. 5.4.2 |

| Performance Testing<br>Surflo IV Catheter | Method |
|-------------------------------------------|-------------------------------|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Catheter to needle fit | ISO 11070 Sec. 6.2 |
| Strength of union (catheter to hub) | ISO 11070 Sec. 6.3 |
| Conical fitting | ISO 11070 Sec. 6.4, ISO 594-1 |
| Dimensional verification | ISO 11070 Sec. 6.5 |

| Performance Testing<br>Plastic Guide Wire | Method |
|-------------------------------------------|--------------------|
| Surface | ISO 11070 Sec. 4.3 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification · | ISO 11070 Sec. 8.2 |
| Test for fracture of guide wire | ISO 11070 Sec. 8.4 |
| Resistance to damage by flexing | ISO 11070 Sec. 8.5 |

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| Performance Testing<br>Stainless Steel Guide Wire | Method |
|---------------------------------------------------|--------------------|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification | ISO 11070 Sec. 8.2 |
| Test for fracture of guide wire | ISO 11070 Sec. 8.4 |
| Resistance to damage by flexing | ISO 11070 Sec. 8.5 |
| Strength of union of safety wire and coil | ISO 11070 Sec. 8.6 |
| Strength of union of core wire and coil | ISO 11070 Sec. 8.7 |

#### I. Biocompatibility

Biocompatibility of Glidesheath Slender was evaluated based on ISO10993-1 : 2009. The Glidesheath Slender including Sheath, Dilator, Guidewire, and Entry needle are classified as Externally Communicating Devices, Circulating Blood, Limited Contact (<24 hrs). This is the same classification as the predicate Glidesheath (K082644).

All of the materials and manufacturing processes used to fabricate the Glidesheath Slender are identical to the Glidesheath predicate device cleared in K082644.

Glidesheath Slender has the same body contact, contact duration, blood contacting materials, manufacturing processes and sterilization method as the Glidesheath predicate device (K082644). Additionally, the Glidesheath product line has a demonstrated history of safe and effective use. We conclude therefore that the Glidesheath Slender is biocompatible for its intended use.

#### J. Sterilization

Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135. Sterilization of Health Care Products- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals will meet requirements for limited exposure devices (contact up to 24 hours) prior to use, based on ISO 10993-7. Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device.

#### K. Additional Safety Information

The Glidesheath Slender is certified to be non-pyrogenic in the unopened and undamaged package. Kinetic Turbidimetric Limulus Amebocyte Lysate (LAL) test is performed on each lot of production in accordance with the United States Pharmacopoeia (USP) <85> Bacterial Endotoxins Test. Validation was performed in accordance with FDA published "Guideline on

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Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices"; 1987.

13122880

Potential release of TiO2 particles from the Glidesheath Slender was evaluated using both nonpolar and polar extracts in accordance with ISO10993-12. Results demonstrated that potential release of titanium dioxide per product was much lower than the tolerable intake calculated from the No Observable Adverse Effect Level (NOAEL) and therefore, does not raise a safety concern.

#### L. Substantial Equivalence

The Glidesheath Slender is substantially equivalent in intended use, principles of operation, design/technology, materials and performance to the predicate device the Glidesheath (K082644). Differences between the devices do not raise any new concerns of safety or effectiveness.

#### M. Submitter Information

| Prepared By: | Mr. Daniel R. Plonski, RAC<br>Sr. Regulatory Affairs Specialist |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation<br>950 Elkton Blvd.<br>Elkton, MD 21921<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

Date Prepared: September 25, 2012

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Image /page/6/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a stylized representation of a bird or wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEC 1 1 2012

Terumo Medical Co. Daniel Plonski, Senior Regulatory Affairs Specialist 950 Elkton Blvd Elkton, MD 21921

Re: K122980

Trade/Device Name: Glidesheath Slender introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 25, 2012 Received: September 26, 2012

Dear Daniel Plonski,

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Matthew G. Hillebrenner

for

Bram Zuckerman, M.D. Director -Division of Cardiac Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): _ K/22 980

Glidesheath Slender™ Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Prescription Use X (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)

Cmgsttllle

on of Cardiovascular Devices

510(k) Number K122980