D'Vill Introducer

K190974 · NuMED, Inc. · DYB · May 14, 2019 · Cardiovascular

Device Facts

• Record ID: K190974
• Device Name: D'Vill Introducer
• Applicant: NuMED, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 14, 2019
• Decision: SESE
• Submission Type: Special
• 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 devices; consists of sheath with hemostasis valve, side port, and dilator. Sheath features distal imaging band for visualization. Used by physicians in clinical settings (e.g., cath lab) to maintain hemostasis while inserting balloons or catheters into vasculature. Device accommodates 0.035" guidewires. Output is the established vascular access path for subsequent interventional tools. Benefits include controlled access and reduced blood loss during procedures.

Clinical Evidence

Bench testing only. Tests included surface inspection, size designation, leakage testing (sheath and hemostasis valve), peak tensile force, strength of union between hub and dilator, kink/flexibility, and luer testing. All tests met acceptance criteria.

Technological Characteristics

Sheath: Pebax braided with stainless steel, PTFE liner, distal imaging band. Dilator: LDPE. Accommodates 0.035" guidewire. Available in 10F-14F sizes, lengths 30cm, 65cm, 85cm. Sterilization method not specified.

Indications for Use

Indicated for patients requiring introduction of balloons, catheters, or other diagnostic/interventional devices into veins or arteries during diagnostic and therapeutic procedures.

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

• D'VILL Introducer (K171206)

Submission Summary (Full Text)

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May 14, 2019

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

Re: K190974

Trade/Device Name: D'Vill Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 12, 2019 Received: April 15, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.

For

Kenneth Cavanaugh Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K190974

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.

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 K190974

| Contact<br>Information | NuMED, Inc.<br>2880 Main Street<br>Hopkinton, NY 12965<br>Telephone – [phone]<br>Contact Person: Nichelle LaFlesh, RAC |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Date summary was prepared – 05 April 2019<br><b>Trade Name:</b> D'Vill Introducer<br><b>Common Name:</b> Catheter, Introducer<br><b>Classification Name:</b> Catheter, Introducer |
| Name of<br>Predicate<br>Devices | D'VILL Introducer – K171206<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 | Special 510(K) to obtain marketing clearance for the additional size of D'Vill<br>Introducer in the 65cm length. |
| 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. |
| Device<br>Description | The NuMED D'VILL Introducer is recommended for introduction of<br>balloons, catheters and other diagnostic and interventional devices into veins<br>and/or arteries while maintaining hemostasis for a variety of diagnostic and<br>therapeutic procedures. The introducer consists of a dilator and sheath with<br>hemostasis valve and side port on the proximal end of the sheath assembly.<br>There is a single image band embedded in the distal end of the sheath tubing<br>for imaging purposes. The sheath is Pebax braided with stainless steel and a<br>PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE.<br>The D'VILL is available in 10, 12 and 14F sizes in both 30 and 85cm lengths,<br>as well as, 12 and 14F in a 65 cm length. |
| Comparison of<br>Technological<br>Characteristics<br>with the<br>predicate<br>Device | The technological characteristics of the D'Vill Introducer are identical to<br>those in the predicate in terms of the following:<br>Mode of Operation; Materials; Design; Method of delivery / packaging; Sterilization Method; Intended Use. |
| | This is the same device design as the predicate. This 510(k) is for a new size that falls in between the previously cleared sizes. |
| Performance<br>Testing | A complete list of tests performed are provided below. All tests met their acceptance criteria and specifications. Surface Inspection Size Designation – Sheath and Dilator Freedom from Leakage – Sheath and Hemostasis Valve Peak Tensile Force – 3 locations Strength of Union Between Hub and Dilator Kink / Flexibility Luer Testing (stress cracking, resistance to separation and overriding) |
| Bio-<br>compatibility | All materials used to manufacture the new size of D'Vill Introducer are identical to the predicate device. There have been no changes to the materials or the processing / manufacturing of the device. |

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# 510(k) Summary K190974

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