Sentrant Introducer Sheath with Hydrophilic Coating

K171866 · Medtronic Vascular, Inc. · DYB · Dec 20, 2017 · Cardiovascular

Device Facts

• Record ID: K171866
• Device Name: Sentrant Introducer Sheath with Hydrophilic Coating
• Applicant: Medtronic Vascular, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 20, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.

Device Story

Single-use, disposable, hydrophilic-coated catheter system; includes dilator and introducer sheath. Used in vascular procedures to provide conduit for diagnostic/endovascular devices; minimizes blood loss via hemostatic valve. Operated by clinicians in clinical settings. Dilator features flexible tapered tip for tracking; sheath features coil-reinforced catheter, radiopaque marker band, and sideport extension. System accommodates 0.035 in guidewire; available in 28/64 cm lengths and 12-26 Fr sizes. Clinician inserts device into vasculature; provides access for secondary devices; hemostatic valve prevents blood loss during insertion/exchange. Benefits patient by facilitating minimally invasive endovascular access.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including design verification, sterilization validation, biocompatibility, packaging verification, and shelf-life testing.

Technological Characteristics

Materials: HDPE, LDPE, BaSO4, Orevac, Pebax, stainless steel coil. Sensing/Actuation: Mechanical hemostatic valve (silicone seals). Energy: None. Dimensions: 12-26 Fr, 28/64 cm lengths. Connectivity: None. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 11135 (sterilization), ISO 10993-1 (biocompatibility), ISO 11607-1 (packaging).

Indications for Use

Indicated for patients requiring a vascular conduit for the insertion of diagnostic or endovascular devices while minimizing blood loss.

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

• Sentrant Introducer Sheath with Hydrophilic Coating (K123990)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

December 20, 2017

Medtronic Vascular, Inc. Wee Wen Leow Senior Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, California 95403

Re: K171866

Trade/Device Name: Sentrant Introducer Sheath with Hydrophilic Coating Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 20, 2017 Received: November 21, 2017

Dear Wee Wen Leow:

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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#### Page 2 - Wee Wen Leow

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) K171866

#### Device Name

Sentrant Introducer Sheath with Hydrophilic Coating

Indications for Use (Describe)

The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.

| 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 - K171866

| Submitter: | Medtronic Vascular, Inc.<br>3576 Unocal Place<br>Santa Rosa, CA 95403<br>[phone]<br>[phone] |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Wee Wen Leow<br>Sr. Regulatory Affairs Specialist<br>3576 Unocal Place<br>Santa Rosa, CA 95403<br>[phone]<br>[phone]<br>[e-mail] |
| Date Prepared: | June 21, 2017 |
| Device Trade Name: | Sentrant™ Introducer Sheath with Hydrophilic<br>Coating |
| Device Classification: | Class II |
| Classification Name: | Catheter Introducer |
| Regulation Number: | 21 CFR 870.1340 |
| Classification Product Code: | DYB |
| Classification Panel: | Cardiovascular |
| Predicate Device: | Sentrant Introducer Sheath with Hydrophilic<br>Coating (K123990) |

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## Device Description:

The Sentrant Introducer Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments.

The dilator is radiopaque and has a flexible tapered tip that facilitates atraumatic tracking through the vasculature. There is a dilator grip at the proximal end of the dilator shaft. The dilator grip has a female Luer taper fitting on the proximal end to allow flushing of the device, and a threaded-feature at the distal end to allow the dilator to be secured to the sheath seal housing (dilator locking mechanism).

The introducer sheath is comprised of a hydrophilic-coated, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension assembly with a 3-way valve is attached to the seal housing. A radiopaque (RO) marker band is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.

## Intended Use:

The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.

#### Comparison of Technical Characteristics:

The Sentrant Introducer Sheath with Hydrophilic Coating, sterilized via Ethylene Oxide, has the same fundamental technological characteristics as the predicate device. Sentrant Introducer Sheath with Hydrophilic Coating, sterilized via E-beam irradiation. The form, fit, function, and principles of operation are the same.

| Description | Predicate Device<br>(K123990) | Subject Device<br>(in comparison with predicate) |
|-------------------------|----------------------------------------------------------|--------------------------------------------------|
| Condition of Use | Single use | Same |
| Sheath Diameters | 12 Fr to 26 Fr (2 Fr increments) | Same |
| Sheath Working Length | 28 cm<br>64 cm | Same |
| Guidewire Compatibility | 0.035" | Same |
| Hydrophilic Coating | Yes | Same |
| Radiopacity | Dilator- fully radiopaque<br>Sheath - marker band at tip | Same |
| Hemostasis Technology | Silicone Seals | Same |
| Device Materials | Dilator:<br>HDPE or HDPE/LDPE Blend,<br>BaSO4 | Same |

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| Description | Predicate Device<br>(K123990) | Subject Device<br>(in comparison with predicate) |
|----------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | Sheath:<br>Composite structure composed of<br>HDPE, Orevac and Pebax with an<br>encapsulated stainless steel coil | |
| Sterility | Sterile to the SAL of 10-6 | Same |
| Sterilization Method | E-beam | Ethylene Oxide |
| Shelf Life | 1 year | 2 years |

#### Substantial Equivalence to K123990:

The assessment of non-clinical performance data demonstrates that the Sentrant Introducer Sheath with Hydrophilic Coating, sterilized via Ethylene Oxide (EtO), is substantially equivalent to the Sentrant Introducer Sheath with Hydrophilic Coating, sterilized via E-beam irradiation.

#### Non-Clinical Performance Data:

The following tests were performed on the subject device to demonstrate that the device meets performance requirements for its intended use. All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence.

- . Design Verification Testing
- Sterilization Validation per requirements of ISO 11135 .
- Biocompatibility Testing per the requirements of ISO 10993-1 .
- . Packaging Design Verification Testing per requirements of ISO 11607-1
- . Shelf Life Testing

#### Conclusion:

The Sentrant Introducer Sheath with Hydrophilic Coating, sterilized via Ethylene Oxide (Et(), is substantially equivalent in intended use, technological characteristics, and performance to the previously cleared Sentrant Introducer Sheath (K123990). The subject device has the same fundamental technological characteristics, principles of operation, and applications as the predicate device.