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 Description

The NuMED D'VILL Introducer is 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. 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 in both 30 and 85cm lengths, as well as, 12 and 14F in a 65 cm length.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "D'Vill Introducer." This submission is a "Special 510(k)" to obtain marketing clearance for an additional size (65cm length) of an already cleared device, the D'VILL Introducer – K171206.

The crucial information to understand here is that a Special 510(k) is typically used for modifications to a manufacturer's own legally marketed device where the modification does not alter the fundamental scientific technology of the device and does not raise new questions of safety and effectiveness. This often means that the performance testing is focused on demonstrating that the new modification performs equivalently to the existing device within the established parameters, rather than proving the overall safety and effectiveness of a completely new device from scratch.

Therefore, the "acceptance criteria" and "study" described in this document are not a clinical study with human patients, but rather bench testing to demonstrate that the new size performs similarly to the predicate device.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for the D'Vill Introducer (New 65cm Length)

The device in question is an additional size (65cm length) of an already cleared product. The performance testing focused on demonstrating substantial equivalence to the predicate device rather than establishing entirely new safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Name	Reported Device Performance
Surface Inspection	All tests met their acceptance criteria and specifications.
Size Designation – Sheath and Dilator	All tests met their acceptance criteria and specifications.
Freedom from Leakage – Sheath and Hemostasis Valve	All tests met their acceptance criteria and specifications.
Peak Tensile Force – 3 locations	All tests met their acceptance criteria and specifications.
Strength of Union Between Hub and Dilator	All tests met their acceptance criteria and specifications.
Kink / Flexibility	All tests met their acceptance criteria and specifications.
Luer Testing (stress cracking, resistance to separation and overriding)	All tests met their acceptance criteria and specifications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the precise number of units tested for each performance test. It only states, "A complete list of tests performed are provided below. All tests met their acceptance criteria and specifications."
Data Provenance: This is bench testing of a medical device, not a human study. The data is prospective, generated from testing newly manufactured devices. The country of origin for the testing is not explicitly stated, but given the FDA submission, it would typically be conducted in a controlled environment, often by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the ground truth for this type of device modification (addition of a new size) is established through engineering and materials testing standards, not clinical expert consensus. The "ground truth" is adherence to established physical and mechanical performance specifications.

4. Adjudication Method for the Test Set

Not applicable. Bench testing results are typically measured against predetermined specifications, not adjudicated by experts in the context of diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data. This device is a catheter introducer, a physical medical device, and its performance is evaluated through engineering and materials testing, not diagnostic accuracy by human readers.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for this type of device is based on engineering specifications, material properties, and established industry standards for the performance of introducer catheters. This includes measurements of physical dimensions, force tolerance, leak resistance, and biocompatibility (by equivalence to predicate materials).

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm or a diagnostic tool that requires a "training set" in the machine learning sense. The "training" for the device's development involves engineering design, material selection, and manufacturing processes honed over time, implicitly incorporating knowledge from previous designs and testing.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8. The "ground truth" (or design principles) for manufacturing such a device is established through biomedical engineering principles, regulatory standards (like ISO standards for medical devices), and a history of manufacturing similar devices.

Summary of the Study:

The "study" was a series of in-vitro (bench) performance tests designed to demonstrate that the new 65cm length of the D'Vill Introducer performs equivalently to the existing, predicate D'Vill Introducer (K171206). The tests covered physical dimensions, mechanical strength, and functional integrity (e.g., leakage, kink resistance). All tested parameters met the prespecified acceptance criteria, leading to the conclusion of substantial equivalence for the new size. Biocompatibility was addressed by stating that the materials and manufacturing processes are identical to the predicate device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

ContactInformation	NuMED, Inc.2880 Main StreetHopkinton, NY 12965Telephone – (315) 328-4491Contact Person: Nichelle LaFlesh, RAC
GeneralProvisions	Date summary was prepared – 05 April 2019Trade Name: D'Vill IntroducerCommon Name: Catheter, IntroducerClassification Name: Catheter, Introducer
Name ofPredicateDevices	D'VILL Introducer – K171206Class II, 21 CFR 870.1340 – Product Code DYB
Classification	Class II, 21 CFR 870.1340 – Product Code DYB, Cardiovascular Panel
510(K) Typeand Reason forSubmission	Special 510(K) to obtain marketing clearance for the additional size of D'VillIntroducer in the 65cm length.
Intended Use	Recommended for introduction of balloons, catheters and other diagnosticand interventional devices into veins and/or arteries while maintaininghemostasis for a variety of diagnostic and therapeutic procedures.
DeviceDescription	The NuMED D'VILL Introducer is recommended for introduction ofballoons, catheters and other diagnostic and interventional devices into veinsand/or arteries while maintaining hemostasis for a variety of diagnostic andtherapeutic procedures. The introducer consists of a dilator and sheath withhemostasis 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 tubingfor imaging purposes. The sheath is Pebax braided with stainless steel and aPTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE.The D'VILL is available in 10, 12 and 14F sizes in both 30 and 85cm lengths,as well as, 12 and 14F in a 65 cm length.
Comparison ofTechnologicalCharacteristicswith thepredicateDevice	The technological characteristics of the D'Vill Introducer are identical tothose in the predicate in terms of the following: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.
PerformanceTesting	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-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.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).