Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath

K172995 · Terumo Medical Corporation · DYB · Nov 21, 2017 · Cardiovascular

Device Facts

• Record ID: K172995
• Device Name: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
• Applicant: Terumo Medical Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries. The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach. The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.

Device Story

Destination Guiding Sheath functions as guiding catheter and introducer sheath; facilitates access for interventional/diagnostic devices into human vasculature. Device comprises 3-layer tubing (PTFE, stainless-steel coil, Nylon Pebax), hemostatic valve, radiopaque marker, and hydrophilic coating. Used in clinical settings by physicians; inserted into vasculature to provide conduit for secondary devices. Output is physical access path; enables delivery of therapeutic/diagnostic tools. Benefits include improved navigation and device delivery within target vessels.

Clinical Evidence

No clinical data. Bench testing only, including lubricity, durability, simulated use, particulate evaluation, and biocompatibility testing per ISO 10993-1.

Technological Characteristics

3-layer tubing (PTFE, stainless-steel coil, Nylon Pebax); hydrophilic coating (polyvinylpyrrolidone-based); radiopaque gold marker. Sterilized via Ethylene Oxide (ISO 11135:2014) to SAL 10^-6. Manual operation. Components include sheath, dilator, hemostatic valve, and dilator retaining clip.

Indications for Use

Indicated for introduction of interventional and diagnostic devices into human vasculature, including carotid, renal, and peripheral arteries (e.g., lower extremity access via contralateral approach).

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)
• Destination® Peripheral Guiding Sheath (K091329)
• Destination® Renal Guiding Sheath (K081045)

Submission Summary (Full Text)

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

November 21, 2017

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

Re: K172995

Trade/Device Name: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 19, 2017

Received: September 27, 2017

Dear Mr. 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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)

#### K172995

Device Name Destination® Carotid Guiding Sheath Destination® Peripheral Guiding Sheath Destination® Renal Guiding Sheath

Indications for Use (Describe)

The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.

| 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 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: July 20, 2017

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

| Proprietary Name: | Destination® Carotid Guiding Sheath |
|-----------------------|----------------------------------------|
| | Destination® Peripheral Guiding Sheath |
| | Destination® Renal 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:

- Predicate Device: K052185 Destination® Carotid Guiding Sheath, ● manufactured by Terumo Medical Corporation
- . Predicate Device: K091329 - Destination® Peripheral Guiding Sheath, manufactured by Terumo Medical Corporation
- . Predicate Device: K081045 - Destination® Renal Guiding Sheath, manufactured by Terumo Medical Corporation

The primary predicate device is K052185.

## D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the Destination® 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 Destination® Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Destination® Guiding Sheath is a 3-layer tubing with a Stainless-Steel coil reinforcement sandwiched between layers of PTFE Teflon and Nylon Pebax, a hemostatic valve at the proximal end, a radiopaque marker near the distal end, and a hydrophilic coating on the distal portion of the tubing of varying lengths based on the product code. The sheath is available in multiple French sizes, useable lengths and distal shape configurations. The Destination® Guiding Sheaths are packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (only available with codes that contain the Tuohy-borst valve).

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

The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.

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

The Destination® 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.

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

Table 5.1: Summary of Substantial Equivalence

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| Device<br>Characteristic | New Device:<br>Destination® Guiding<br>Sheath (Carotid,<br>Peripheral and Renal) | Primary Predicate:<br>Destination® Carotid<br>Guiding Sheath | Predicate:<br>Destination® Peripheral<br>Guiding Sheath | Predicate:<br>Destination® Renal<br>Guiding Sheath |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | None | K052185 | K091329 | K081045 |
| Manufacturer | Terumo Medical<br>Corporation | Same | Same | Same |
| Intended Use /<br>Indications for<br>Use | Carotid: Same<br>Peripheral: Same<br>Renal: Same | The Destination® Carotid<br>Guiding Sheath is<br>designed to be used for<br>the introduction of<br>interventional and<br>diagnostic devices into the<br>human vasculature,<br>including but not limited<br>to the carotid arteries. | The Destination®<br>Peripheral Guiding Sheath<br>is designed to be used for<br>the introduction of<br>interventional and<br>diagnostic devices into the<br>human vasculature,<br>including but not limited<br>to lower extremity access<br>via a contralateral<br>approach. | The Destination® Renal<br>Guiding Sheath is<br>intended for the<br>introduction of<br>interventional and<br>diagnostic devices into<br>the human vasculature<br>including but not limited<br>to the renal arteries. |
| Operation<br>Principle | Operated manually or by<br>a manual<br>process; | Same | Same | Same |
| Design /<br>Construction | Sheath, Dilator,<br>Hemostatic Valve with<br>side tube and three-way<br>stopcock, and Dilator<br>Retaining Clip | Same | Same | Same |
| Device<br>Characteristic | New Device:<br>Destination® Guiding<br>Sheath (Carotid,<br>Peripheral and Renal) | Primary Predicate:<br>Destination® Carotid<br>Guiding Sheath | Predicate:<br>Destination® Peripheral<br>Guiding Sheath | Predicate:<br>Destination® Renal<br>Guiding Sheath |
| Materials | Sheath Assembly<br>Same except for the<br>materials grade changes | Sheath Assembly<br>Tubing: PTFE – SSL coil –<br>Nylon<br>Tip: Nylon<br>Hydrophilic Coating:<br>Polyvinylpyrrolidone-based<br>coating<br>Hub: Nylon<br>Radiopaque Band:Gold | Sheath Assembly<br>Same | Sheath Assembly<br>Same |
| | Dilator Assembly<br>Same | Dilator Assembly<br>Tubing: Polypropylene/<br>Thermoplastic Elastomer Blend<br>Hub: Polypropylene<br>Coating:<br>Reactive Silicone<br>Caulking Pin:<br>Stainless steel | Dilator Assembly<br>Same | Dilator Assembly<br>Same |
| | Tuopy-Borst Valve<br>(TBV):<br>Same | Tuopy-Borst Valve<br>(TBV):<br>Y-Connector Assembly:<br>Polycarbonate,<br>Silicone<br>Side Tube/3-Way Stopcock<br>Assembly:<br>Polybutadiene,<br>Polycarbonate,<br>High Density Polyethylene<br>Base Resin and HDPE<br>colorants,<br>Polypropylene | Tuopy-Borst Valve<br>(TBV):<br>Same | Tuopy-Borst Valve<br>(TBV):<br>Same |
| | | | | |
| Device | New Device: | Primary Predicate: | Predicate: | Predicate: |
| Characteristic | Destination® Guiding | Destination® Carotid | Destination® Peripheral | Destination® Renal |
| | Sheath (Carotid, | Guiding Sheath | Guiding Sheath | Guiding Sheath |
| | Peripheral and Renal) | | | |
| | Cross Cut Valve | Cross Cut Valve (CCV): | Cross Cut Valve (CCV): | Cross Cut Valve |
| | (CCV): | Valve Assembly: | Same | (CCV): |
| | Same | Polypropylene, | | Same |
| | | Polycarbonate, | | |
| | | Silicone Rubber | | |
| | | Elastomer, | | |
| | | Non-reactive silicone oil | | |
| | | 1000cst | | |
| | | Side Tube/3-Way Stopcock | | |
| | | Assembly: | | |
| | | Same as TBV | | |
| | Dilator Retaining Clip | Dilator Retaining Clip | Dilator Retaining Clip | Dilator Retaining Clip |
| | Same | LDPE | Same | Same |
| Package | Unit Pouch | Same | Same | Same |
| | Shelf Box | | | |
| | Shipping Carton | | | |
| Device<br>Characteristic | New Device:<br>Destination® Guiding<br>Sheath (Carotid,<br>Peripheral and Renal) | Primary Predicate:<br>Destination® Carotid<br>Guiding Sheath | Predicate:<br>Destination® Peripheral<br>Guiding Sheath | Predicate:<br>Destination® Renal<br>Guiding Sheath |
| Specifications | Carotid: Same<br>Peripheral: Same<br>Renal: Same | Sheath Size: 6-7Fr.<br>Nominal ID/OD:<br>6Fr.: 0.087"/0.111" 7Fr.:<br>0.101"/0.122"<br>Sheath Length:<br>80-110 cm<br>Hydrophilic Coating:<br>Distal 15 cm<br>Distal Shapes: ST, MP<br>Dilator ID/OD (nominal):<br>6Fr.: 0.045"/0.084" 7Fr.:<br>0.045"/0.097"<br>Dilator Extended Length:<br>5cm | Sheath Size: 5-8 Fr.<br>Nominal ID/OD:<br>5Fr.: 0.076"/0.098"<br>6Fr.: (45cm):<br>0.087"/0.109"<br>6Fr.: (65cm, 90cm):<br>0.087"/0.111"<br>7Fr.: 0.101"/0.122"<br>8Fr.: 0.115"/0.136"<br>Sheath Length:<br>45-110 cm<br>Hydrophilic Coating:<br>Distal 15-60 cm<br>Distal Shapes: ST<br>Dilator ID/OD (nominal):<br>5Fr.: 0.045"/0.072"<br>6Fr.: 0.045"/0.084"<br>7Fr.: 0.045”/0.097"<br>8Fr.: 0.045"/0.111"<br>Dilator Extended Length:<br>2.5 cm for sheaths lengths<br>up to 75cm,<br>5 cm for sheaths longer<br>than 75cm | Sheath Size: 5-7 Fr.<br>Nominal ID/OD:<br>5Fr.: 0.076"/0.098"<br>6Fr.: 0.087"/0.109"<br>7Fr.: 0.101" /0.122"<br>Sheath Length:<br>45-55 cm<br>Hydrophilic Coating:<br>Distal 5 cm<br>Distal Shapes: ST, HS,<br>MP, RDC, LIMA<br>Dilator ID/OD (nominal):<br>5Fr.: 0.045”/0.072"<br>6Fr.: 0.045"/0.084"<br>7Fr.: 0.045”/0.097"<br>Dilator Extended Length:<br>2 cm |
| Device<br>Characteristic | New Device:<br>Destination® Guiding<br>Sheath (Carotid,<br>Peripheral and Renal) | Primary Predicate:<br>Destination® Carotid<br>Guiding Sheath | Predicate:<br>Destination® Peripheral<br>Guiding Sheath | Predicate:<br>Destination® Renal<br>Guiding Sheath |
| Sterilization | Ethylene Oxide<br>(validated in accordance<br>with ANSI / AAMI / ISO<br>11135-1 to achieve SAL<br>10-6) | Same | Same | Same |
| Shelf life | 6 months | 30 months | 30 months | 30 months |
| Disposable<br>Single Use | Yes | Same | Same | Same |

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

Performance testing was conducted to ensure that the Destination® 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 Destination® Guiding Sheath.

| Test Item | Reference | Component |
|-----------------------------------------------|-----------------------|----------------------------|
| Lubricity and<br>Durability/Adhesion | In-house standard | Sheath |
| Simulated Use and<br>Particulate | FDA Guidance Doc 1608 | Sheath,<br>Dilator,<br>CCV |
| Simulated Use Coating<br>Integrity Evaluation | FDA Guidance Doc 1608 | Sheath |

Table 5.2: Summary of Performance Testing

The Destination® 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 Destination® Guiding Sheath is substantially equivalent for its intended use.

## Biocompatibility

The Destination Guiding Sheaths were evaluated for biological safety based on its body contact and duration per FDA Guidance on Use of International Standard ISO 10993-1 and EN ISO 10993-1.

The Destination 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 for 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

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*Complement activation tests are not a requirement for ISO 10993-4 for external communicating devices, circulating blood with limited exposure (<24 hours). This testing was completed since FDA has previously requested this testing for similar devices. ISO 10993-4/Amd 1: 2006 indicated complement activation testing should be evaluated for devices with prolonged exposure (>24 hours).

Results of the testing demonstrate biocompatibility of the finished Destination® 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 - Ethvlene 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.

Destination® 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.

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

In summary, the Destination® 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):

- . Predicate Device: K052185 - Destination® Carotid Guiding Sheath, manufactured by Terumo Medical Corporation
- Predicate Device: K091329 Destination® Peripheral Guiding Sheath, ● manufactured by Terumo Medical Corporation
- . Predicate Device: K081045 - Destination® Renal Guiding Sheath, manufactured by Terumo Medical Corporation