R2P Destination Slender Guiding Sheath

K171491 · Terumo Medical Corporation · DYB · Oct 5, 2017 · Cardiovascular

Device Facts

• Record ID: K171491
• Device Name: R2P Destination Slender Guiding Sheath
• Applicant: Terumo Medical Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

R2P™ Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including but not limited to the radial artery.

Device Story

Low-profile guiding sheath; functions as both guiding catheter and introducer sheath. Input: manual insertion into peripheral vasculature. Operation: manual; coil-reinforced tubing with radiopaque tip and hydrophilic coating; includes dilator and hemostatic valve. Output: provides access channel for interventional/diagnostic devices. Used in clinical settings by physicians. Benefits: facilitates minimally invasive peripheral vascular procedures via radial or other access sites.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical integrity (tensile, torque, bend), leakage, lubricity, biocompatibility, and simulated use testing.

Technological Characteristics

Coil-reinforced sheath; materials: PTFE (inner), stainless steel (middle coil), nylon (outer), tungsten-loaded nylon (tip), polyvinylpyrrolidone-based hydrophilic coating. Dimensions: 6Fr, 119cm/149cm lengths. Sterilization: Ethylene Oxide (ISO 11135). Manual operation. No software/electronics.

Indications for Use

Indicated for patients requiring introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities via an access site (e.g., radial artery).

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

• Destination Carotid Guiding Sheath (K052185)

Reference Devices

• R2P SlenGuide (K161546)

Submission Summary (Full Text)

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October 5, 2017

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

Re: K171491

Trade/Device Name: R2PTM Destination Slender™ Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 6, 2017 Received: September 7, 2017

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 (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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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) K171491

Device Name

R2PTM Destination Slender™ Guiding Sheath

Indications for Use (Describe)

R2P™ Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including tut 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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# K171491 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 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. [phone] Fax [phone] E-mail: [e-mail]

Date prepared: May 11, 2017

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

| Proprietary Name: | R2PTM Destination Slender™ Guiding Sheath |
|-----------------------|-------------------------------------------|
| Common Name: | Guiding 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:

- . Primary Predicate Device: K052185 - Destination Carotid Guiding Sheath, manufactured by Terumo Medical Corporation, USA
- Reference Device: K161546 R2P SlenGuide, manufactured by Terumo . Corporation

## D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the R2P™ Destination Slender™ Guiding Sheath, 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 R2PTM Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated and is available in 6Fr with a length of 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.

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

R2P™ Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including but not limited to the radial artery.

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

The R2PTM Destination Slender™ Guiding Sheath, 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.

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Image /page/5/Picture/1 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.

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

| Device<br>Characteristic | New Device:<br>R2PTM Destination<br>Slender™ Guiding<br>Sheath | Primary Predicate:<br>Destination Carotid<br>Guiding Sheath<br>(K052185) | Reference Device:<br>R2P SlenGuide<br>(K161546) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Medical<br>Corporation | Terumo Medical<br>Corporation | Terumo Corporation |
| Intended Use /<br>Indications for<br>Use | R2PTM Destination<br>Slender™ Guiding<br>Sheath is indicated to<br>be used for the<br>introduction of<br>interventional and<br>diagnostic devices in<br>the lower extremities of<br>the peripheral<br>vasculature through an<br>access site, including<br>but not limited to the<br>radial artery. | The Destination®<br>Guiding Sheath is<br>designed to be used for<br>the introduction of<br>interventional and<br>diagnostic devices into<br>the human vasculature<br>including but not<br>limited to the carotid<br>arteries. | The R2P (radial to<br>peripheral)<br>SlenGuide is<br>designed for the<br>introduction of<br>interventional and<br>diagnostic devices<br>into the<br>peripheral<br>vasculature of<br>the lower extremities |
| Operation<br>Principle | Operated manually or<br>by a manual<br>process; | Same | Same |
| Design /<br>Construction | Sheath, Dilator,<br>Hemostatic Valve with<br>side tube and three-way<br>stopcock | Same | Guiding Catheter,<br>Inner Guide |

#### Table 12.1: Summary of Substantial Equivalence

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Image /page/6/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The font is sans-serif and bolded.

| Materials | Sheath Assembly | Sheath Assembly | Guiding Catheter: |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| | Tubing: | Tubing: | Outer layer: |
| | Inner Layer: PTFE | Inner Layer: PTFE | Polyamide elastomer<br>(Nylon) |
| | Middle Coil Layer: | Middle Coil Layer: | Middle Braid Layer: |
| | Stainless Steel | Stainless Steel | Stainless steel |
| | Outer Layer: Nylon | Outer Layer: Nylon | Inner layer: |
| | | | Polytetrafluoroethylene |
| | Radiopaque Tip: Nylon<br>with Tungsten | Tip: Nylon<br>Radiopaque Band:<br>Gold | Radiopaque Tip:<br>Polyamide Elastomer<br>(Nylon) with Tungsten |
| | Hydrophilic Coating:<br>Polyvinylpyrrolidone-<br>based coating | Hydrophilic Coating:<br>Polyvinylpyrrolidone-<br>based coating | Hydrophilic Coating:<br>Dimethyl acrylic amide<br>- glycidyl methacrylate |
| | Hub: Nylon | Hub: Nylon | Hub: Polyamide 12 |
| | Anti-kink protector:<br>Nylon | | Anti-kink protector:<br>Polyester Elastomer |
| | Dilator Assembly<br>Tubing: Polypropylene<br>Hub: Polypropylene/<br>/Thermoplastic<br>Elastomer Blend<br>Coating: Silicone<br>Caulking Pin: Stainless<br>steel | Dilator Assembly<br>Same | Inner Guide:<br>Shaft: Polyester<br>Elastomer with<br>Tungsten<br>Hub: Polyamide<br>Lock Adaptor:<br>polycarbonate |

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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 font is sans-serif and bold.

| | Cross Cut Valve | Cross Cut Valve | None |
|---------|------------------------|---------------------|-----------------|
| | Valve Assembly: | Valve Assembly: | |
| | Housing: | Same | |
| | Polypropylene | | |
| | Cap: Polypropylene | | |
| | Luer Lock Collar: | | |
| | Polycarbonate | | |
| | Valve: Silicone Rubber | | |
| | Elastomer | | |
| | Sidetube: | | |
| | polybutadiene | | |
| | Silicone: Non-reactive | | |
| | silicone oil 1000cst | | |
| | Side Tube Assembly: | Side Tube Assembly: | |
| | Body: Polybutadiene | Same | |
| | 3Way (3WSC) | 3Way (3WSC) | |
| | Stopcock Assembly: | Stopcock Assembly: | |
| | Body: Polycarbonate | Same | |
| | Locking | | |
| | Pin: Polyethylene | | |
| | Cap: Polyethylene and | | |
| | Colorant | | |
| | Handle: Polyethylene | | |
| | and Colorant | Tuohy-Borst Valve | |
| | Lock Adaptor: | Similar material as | |
| | Polycarbonate | Cross Cut Valve | |
| Package | Unit Pouch | Unit Pouch | Unit Pouch |
| | Shelf Box | Shelf Box | Shelf Box |
| | Shipping Carton | Shipping Carton | Shipping Carton |

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Image /page/8/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red arc above the letters "TE". The font is bold and sans-serif. The logo is simple and modern.

| Specifications | Sheath Size: 6 Fr. | Sheath Size: 6-7 Fr. | Catheter Size: 7Fr |
|--------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------|
| | Sheath ID/OD<br>(nominal): | Sheath ID/OD<br>(nominal): | I.D.: 2.20 mm (0.087") |
| | 6Fr.: 0.087"/0.100"<br>(2.2mm /2.5mm) | 6Fr.: 0.087"/0.111"<br>7Fr.: 0.100"/0.122" | O.D.: 2.37 mm<br>(0.093") |
| | | | |
| | Sheath Length:<br>119cm, 149cm | Sheath Length:<br>80-110cm | Effective lengths:<br>120cm, 150cm |
| | Hydrophilic Coating:<br>full effective length | Hydrophilic Coating:<br>Distal 15cm | |
| | Distal Shape: Straight | Distal Shapes: Straight,<br>Angled (40 degrees) | |
| | Dilator ID/OD<br>(nominal): | Dilator ID/OD<br>(nominal): | Inner Guide<br>Accepts guide wire<br>diameter: 0.035" |
| | 0.039"/0.086" | 6Fr.: 0.045”/0.084"<br>7Fr.: 0.045”/0.097" | |
| | Dilator Extended<br>Length: 5cm | Dilator Extended<br>Length: 5cm | |
| Sterilization | Ethylene Oxide<br>(validated in<br>accordance with ANSI<br>/ AAMI / ISO 11135-1<br>to achieve SAL 10-6) | Same | Same |
| Shelf life | 30 months | Same | 36 months |
| Disposable<br>Single Use | Yes | Same | Same |

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

# Performance

Performance testing was conducted to ensure that the R2P™ Destination Slender™ Guiding Sheath 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 provides a list of the performance tests that were performed on the proposed R2P™ Destination Slender™ Guiding Sheath.

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Image /page/9/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The font is bold and sans-serif. The logo is simple and modern.

| Table 5.4: Summary of Performance Testing | | |
|--------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------|
| Test Item | Reference | Component<br>(Sheath,<br>Dilator, CCV<br>Assembly) |
| Three-Point Bend | In-house standard | Sheath |
| Hub Joint Strength | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| Tubing Tensile Strength | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| Tip Tensile Strength | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| Ovalization | In-house standard | Sheath |
| Lubricity and Durability | In-house standard | Sheath |
| Uncoated Length | In-house standard | Sheath |
| Corrosion Resistance | ISO 11070:2014 | Sheath, Dilator |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| Gauging | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| | ISO 594-1:1986 | |
| Liquid Leakage of Luer<br>under Pressure | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| | ISO 594-2:1998 | |
| Air Leakage | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| | ISO 594-2:1998 | |
| Separation Force | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| | ISO 594-2:1998 | |
| Unscrewing Torque | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| | ISO 594-2:1998 | |
| Ease of Assembly | ISO 11070:2014 | Sheath |
| | ISO 10555-1:2009 | |
| | ISO 10555-1:2013 | |
| Test Item | Reference | Component<br>(Sheath,<br>Dilator, CCV<br>Assembly) |
| | ISO 594-2:1998 | |
| Resistance to Overriding | ISO 11070:2014<br>ISO 10555-1:2009<br>ISO 10555-1:2013 | Sheath |
| Stress Cracking | ISO 594-2:1998<br>ISO 11070:2014<br>ISO 10555-1:2009<br>ISO 10555-1:2013<br>ISO 594-2:1998 | Sheath |
| Simulated Use and<br>Particulate* | FDA Guidance Doc 1608 | Sheath, Dilator,<br>CCV |
| Radiodetectability | ISO 11070:2014<br>ISO 10555-1:2013 | Sheath, Dilator |
| Visual Inspection of<br>External Surface | ISO 11070:2014<br>ISO 10555-1:2009<br>ISO 10555-1:2013 | Sheath, Dilator |
| Sheath Tip Inner Diameter | In-house standard | Sheath |
| Sheath Hub Inner Diameter | In-house standard | Sheath |
| Dilator Bump Inner<br>Diameter | In-house standard | Dilator |
| Outer Diameter<br>Measurement | In-house standard | Sheath, Dilator |
| Effective Length | In-house standard | Sheath, Dilator |
| Coating Integrity | FDA Guidance Doc 1608 | Sheath |
| Liquid Leakage of the<br>Sheath | ISO 11070:2014 | Sheath |
| Liquid Leakage Through<br>Hemostasis Valve | ISO 11070:2014 | CCV |
| Torque Strength | FDA Guidance Doc 1608 | Sheath |
| Dilator Tip Inner Diameter | In-house standard | Dilator |
| Dilator Tip Penetration | In-house standard | Dilator |

#### Table 5.4: Summary of Performance Testing

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The R2P™ Destination Slender™ Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence. Based on the results of the performance testing, the proposed R2PTM Destination Slender™ Guiding Sheath is substantially equivalent.

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Image /page/11/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The word "TERUMO" is in a bold, sans-serif font.

#### 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."

The R2PTM Destination Slender™ Guiding Sheath is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours).

The following tests are recommended by FDA and ISO 10993-1 to be performed per this device classification:

- 1. Cytotoxicity
- 2. Sensitization
- 3. Intracutaneous Reactivity
- 4. Systemic Toxicity (Acute)
- 5. Pyrogenicity
- 6. Hemocompatibility
- 7. Thrombogenicity
- 8. Complement Activation (Immunology)
- 9. Physiochemical Testing

Results of the testing demonstrate biocompatibility of the finished R2PTM Destination Slender™ Guiding Sheath.

#### Sterilization

The sterility of the device is assured using a sterilization method validated in accordance with 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.

The sterilization process was validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.

R2P™ Destination Slender™ Guiding Sheath is a limited exposure device. 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.

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

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

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Image /page/12/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green, block letters. The red line appears to be a stylized representation of a blood vessel or a medical device.

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

In summary, the R2PTM Destination Slender™ Guiding Sheath, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device(s):

- Primary Predicate Device: K052185 Destination Carotid Guiding Sheath, ● manufactured by Terumo Medical Corporation, USA
- Reference Device: K161546 R2P SlenGuide, manufactured by Terumo . Corporation