Edwards eSheath Introducer Set

K162184 · Edward Lifesciences · DYB · Sep 2, 2016 · Cardiovascular

Device Facts

• Record ID: K162184
• Device Name: Edwards eSheath Introducer Set
• Applicant: Edward Lifesciences
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 2, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Entry of interventional devices into the vascular system

Device Story

The Edwards eSheath Introducer Set facilitates the introduction of the SAPIEN 3 Transcatheter Heart Valve and Commander Delivery System into the human vasculature. The system comprises a sheath, two dilators, and a loader. The sheath features an expandable seam design, allowing temporary diameter expansion during device insertion, and a hydrophilic coating to aid vessel entry. Hemostasis is maintained via three internal seals and a tapered strain relief. The loader includes a disc valve and a scored perforation for removal. Used in clinical settings by physicians, the device provides a stable conduit for interventional tools, minimizing vascular trauma and ensuring hemostasis during transcatheter procedures.

Clinical Evidence

Bench testing only. Testing included loader peel tests, bond strength, biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility), material verification, USP physico-chemical tests, sterilization validation, packaging integrity, and shelf-life verification.

Technological Characteristics

Materials: HDPE/TecoFlex coextruded outer layer, PTFE liner. Features: Expandable seam for diameter expansion, hydrophilic coating, radiopaque markers. Hemostasis: 3-valve housing. Dimensions: 14F and 16F inner diameters. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None (mechanical device).

Indications for Use

Indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve in patients requiring vascular intervention.

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

• Edwards eSheath Introducer Set (K152225)

Submission Summary (Full Text)

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

September 2, 2016

Edwards Lifesciences LLC Yi Gao Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K162184

Trade/Device Name: Edwards eSheath Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 3, 2016 Received: August 4, 2016

Dear Yi Gao:

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 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,

# Brian D. Pullin -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) K162184

Device Name Edwards eSheath Introducer Set

Indications for Use (Describe)

The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10px;">Prescription Use (Part 21 CFR 201 Subpart D)</span> |
|-----------------------------------------------------------------------------------|
| <span style="font-size:10px;">Over-The-Counter Use (21 CFR 201 Subpart C)</span> |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## K162184 510(K) Summary

| Submitter: | Edwards Lifesciences, LLC<br>One Edwards Way<br>Irvine, CA 92663 |
|-------------------|------------------------------------------------------------------|
| Contact: | Yi Gao<br>Phone: [phone]<br>Fax: [phone] |
| Prepared: | August 30, 2016 |
| Trade Name: | Edwards eSheath Introducer Set |
| Common Name: | Catheter, Introducer |
| Classification: | Catheter Introducer<br>21 CFR 870.1340, Product Code DYB |
| Predicate Device: | Edwards eSheath Introducer Set (K152225) |

#### Device Description:

The Edwards eSheath Introducer Set consists of a sheath and two dilators packaged together, and one loader packaged with the Commander delivery system. The Edwards eSheath Introducer Set is available in two sizes: model 914ES (14F inner diameter) and model 916ES (16F inner diameter). The 14F eSheath introducer set is used to facilitate introduction of the 20mm, 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16F eSheath introducer set is used to facilitate introduction of the 29mm SAPIEN 3 THV and Commander Delivery System into the vasculature.

The sheath shaft is comprised of 2 layers of material (HDPE/TecoFlex coextruded outer layer and PTFE liner). The outer and inner layer are folded, creating a seam which allows the distal region of the sheath to temporarily expand in diameter when a device is inserted. A tapered strain relief at the proximal end of the sheath shaft helps provide hemostasis when the sheath is inserted. The sheath shaft exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a radiopaque marker, and the shaft mates proximally with a housing that contains three valves (seals) to provide hemostasis, an extension tube for flushing, and suture holes on the exterior.

Two dilators are provided to aid in the introduction of the sheath into the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The dilators are radiopaque and feature a tapered tip and guidewire lumen.

The loader features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

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#### Intended Use:

Entry of interventional devices into the vascular system

#### Indication:

The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.

#### Comparison to Predicate:

A table comparing the proposed device to the predicate devices is provided below.

| | Predicate Device | Subject Device |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | Edwards eSheath Introducer Set | Edwards eSheath Introducer Set<br>(with Loader) |
| Manufacturer | Edwards Lifesciences | Identical |
| 510(k) | K152225 | K162184 |
| Device Classification | Class II, DYB<br>(21 CFR 870.1340)<br>Catheter Introducer | Identical |
| Intended Use | Entry of interventional devices into the<br>vascular system | Identical |
| Indication for Use | The Edwards eSheath Introducer Set is<br>indicated for the introduction and removal<br>of devices used with the Edwards<br>SAPIEN 3 Transcatheter Heart Valve. | Identical |
| Target Population | Patients requiring vascular intervention<br>with the SAPIEN 3 Transcatheter Heart<br>Valve | Identical |
| Anatomical Sites | Human vasculature | Identical |
| Model Numbers | 914ES, 916ES | Identical |
| Sizes available (French) | 14F, 16F inner diameter | Identical |
| Package Contents | 1- Sheath<br>2- Introducer (dilator) | 1 - Sheath<br>2 - Dilators<br>1 - Loader (packaged with the<br>Commander delivery system) |
| Working Length | 36.5 cm | Identical |
| Guidewire Compatibility | 0.035" guidewire | Identical |
| Radiopaque elements | Sheath, Dilators | Identical |
| Sheath<br>Hemostasis Control | 3 hemostasis seals | Identical |
| Expansion Mechanism | Expandable seam | Identical |
| Hydrophilic coating | Sheath, Dilators | Identical |
| Sterilization Method /<br>Re-use | Ethylene Oxide<br>Single use only | Identical |
| Sterility Assurance<br>Level | 10-6 or better | Identical |

### Summary of Non-Clinical Testing:

Non-clinical testing was completed to demonstrate that the performance characteristics of the Edwards eSheath Introducer Set are equivalent to the predicates, and to verify that design

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requirements are satisfied. Specifically, the following design verification and validation testing was successfully completed:

- Loader Peel Test ●
- Bond Strength Test
- Biocompatibility Tests: ●
- Cytotoxicity ၊
- Sensitization ।
- -Irritation/Intracutaneous Toxicity
- Systemic Toxicity -
- Hemocompatibility -
- Material Verification -
- -USP Physico-Chemical Test for Plastic Closures

#### Conclusion:

Based upon device testing and descriptive characteristics, the Edwards eSheath Introducer Set is substantially equivalent to the predicate device and performance testing has demonstrated that safety and efficacy are not adversely impacted.

- . Sterilization Validation
- Packaging Integrity
- Shelf Life Verification .