(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard introducer sheath and dilator, with no mention of AI or ML capabilities.
No
The device is described as an introducer for other diagnostic and interventional devices, which are used in therapeutic procedures but the introducer itself is not described as providing a therapeutic effect. It facilitates the introduction of other devices, but doesn't perform therapy itself.
No
The device is an introducer sheath designed to facilitate the introduction of other diagnostic and interventional devices, rather than performing a diagnostic function itself.
No
The device description clearly outlines physical components made of materials like Pebax, stainless steel, PTFE, and LDPE, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for introducing other devices into veins and/or arteries for diagnostic and therapeutic procedures. This is an in vivo application, meaning it's used within the living body.
- Device Description: The description details a physical device (sheath, dilator, valves) designed for insertion into the vascular system. This aligns with an interventional or surgical device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used in laboratories or point-of-care settings to perform tests on specimens.
Therefore, the NuMED D'VILL Introducer is an interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins and/or arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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
Information | NuMED, Inc.
2880 Main Street
Hopkinton, NY 12965
Telephone – (315) 328-4491
Contact Person: Nichelle LaFlesh, RAC |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General
Provisions | Date summary was prepared – 05 April 2019
Trade Name: D'Vill Introducer
Common Name: Catheter, Introducer
Classification Name: Catheter, Introducer |
| Name of
Predicate
Devices | D'VILL Introducer – K171206
Class II, 21 CFR 870.1340 – Product Code DYB |
| Classification | Class II, 21 CFR 870.1340 – Product Code DYB, Cardiovascular Panel |
| 510(K) Type
and Reason for
Submission | Special 510(K) to obtain marketing clearance for the additional size of D'Vill
Introducer in the 65cm length. |
| 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
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. |
| Comparison of
Technological
Characteristics
with the
predicate
Device | The technological characteristics of the D'Vill Introducer are identical to
those 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. |
| Performance
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-
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
5
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.