D'Vill Introducer

K171206 · NuMED, Inc. · DYB · Oct 20, 2017 · Cardiovascular

Device Facts

• Record ID: K171206
• Device Name: D'Vill Introducer
• Applicant: NuMED, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Device Story

D'Vill Introducer facilitates percutaneous access for diagnostic and interventional procedures; device consists of sheath with hemostasis valve, side port, and dilator; sheath features stainless steel braided Pebax construction with PTFE liner and distal imaging band; accommodates 0.035" guidewire; available in 10F, 12F, 14F sizes and 30cm/85cm lengths; used by clinicians in clinical settings to introduce interventional devices into vasculature; maintains hemostasis during procedure; benefits patient by enabling minimally invasive access for therapeutic/diagnostic interventions.

Clinical Evidence

Bench testing only. Testing included surface inspection, size designation, leakage testing, peak tensile force, hub/dilator union strength, dimensional requirements, luer hub testing, kink/flexibility testing, sterilization validation, biocompatibility evaluation (short duration < 24 hours), and shelf life testing. All tests met acceptance criteria.

Technological Characteristics

Materials: Pebax, stainless steel braid, PTFE liner, LDPE dilator. Design: Sheath with hemostasis valve, side port, and distal imaging band. Sterilization: Ethylene Oxide (EtO). Single-use. Dimensions: 10F-14F, 30cm/85cm lengths. Connectivity: None.

Indications for Use

Indicated for patients requiring the introduction of balloons, catheters, and other diagnostic or interventional devices into the venous or arterial systems while maintaining hemostasis.

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

• Gore Dryseal Introducer Sheath (K160254, K121234)

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, and then the word "ADMINISTRATION" in a smaller font size below that.

October 20, 2017

NuMED, Inc. Nichelle LaFlesh Regulatory Affairs Manager, Compliance Officer 2880 Main Street Hopkinton, New York 12965

### Re: K171206

Trade/Device Name: D'Vill Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 15, 2017 Received: September 18, 2017

### Dear Nichelle LaFlesh:

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 (OS) 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) K171206

Device Name D'Vill Introducer

Indications for Use (Describe)

Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

| | 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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# K171206

# 510(k) Summary

| Contact<br>Information | NuMED, Inc.<br>2880 Main Street<br>Hopkinton, NY 12965<br>Telephone – [phone]<br>Contact Person: Nichelle LaFlesh, RAC |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date summary was prepared – 21 April 2017 |
| General<br>Provisions | Trade Name: D'Vill Introducer |
| | Common Name: Catheter, Introducer |
| | Classification Name: Catheter, Introducer |
| Name of<br>Predicate<br>Devices | Gore Dryseal Introducer Sheath – K160254, K121234<br>Class II, 21 CFR 870.1340 – Product Code DYB |
| Classification | Class II, 21 CFR 870.1340 – Product Code DYB, Cardiovascular Panel |
| 510(K) Type<br>and Reason for<br>Submission | Traditional 510(K) to obtain marketing clearance for the D'Vill Introducer. |
| Intended Use | Recommended for introduction of balloons, catheters and other diagnostic<br>and interventional devices into veins and/or arteries while maintaining<br>hemostasis for a variety of diagnostic and therapeutic procedures. |
| | Continued on next page |

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## 510(k) Summary, Continued

| Device Description | The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices. The introducer consists of a dilator, and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes and 30 and 85cm lengths. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | All materials used to manufacture the D'Vill Sheath are similar to those used on other commercially available devices. The biocompatibility for the D'Vill Sheath and Dilator was assessed through a combination of testing and a risk assessment. |
| Performance Testing | A complete list of tests performed are provided below. All tests met their acceptance criteria and specifications. <ul><li>Surface Inspection</li><li>Size Designation – Sheath and Dilator</li><li>Freedom from Leakage – Sheath and Hemostasis Valve</li><li>Peak Tensile Force - 3 locations</li><li>Strength of Union Between Hub and Dilator</li><li>Dimensional Requirements – Sheath, Stopcock, and Dilator</li><li>Luer Hub Testing</li><li>Kink/Flexibility Testing – Sheath and Dilator</li><li>Sterilization Testing</li><li>Biocompatibility Evaluation – Short duration contact with circulating blood (&lt; 24 hours)</li><li>Shelf Life Testing</li></ul> |

Continued on next page

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Comparison of The technological characteristics of the D'Vill Introducer are similar to those Technological in the predicate in terms of the following: Characteristics with the Mode of Operation; ● predicate

- Materials:
- Design;

Device

- Performance testing; ●
- Method of delivery; ●
- Sterilization Method. .

The technological characteristics of the D'Vill Introducer is substantially equivalent in intended use, sterilization, and size range to those in the predicate device.

Both devices are for introduction of devices into the patient. The predicate device is specific to endovascular devices, whereas, the D'Vill Introducers are for interventional devices.

Both devices are provided sterilized via EtO sterilization and are for single use only.

Both devices include a sheath as well as a dilator. The predicate device also has a syringe that comes with it, whereas, the D'Vill does not.

Both devices are similar in the size ranges being offered. The D'Vill includes 10Fr - 14Fr sizes, and the predicate device has a much larger size range of 12Fr - 26Fr.

The D'Vill Introducer has been tested and/or compared to the predicate Conclusions device listed herein. All data gathered demonstrate the D'Vill Introducer is substantially equivalent.