(11 days)
Not Found
No
The device description focuses on physical components and mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to assist in vessel cannulation by dilating the vessel, which is a preparatory step for other medical procedures, and not for treating a disease or condition itself.
No
Explanation: The device is intended to assist in vessel cannulation by dilating vessels, which is a procedural/interventional function, not a diagnostic one. It does not gather information about a patient's condition to help diagnose a disease or condition.
No
The device description explicitly details physical components made of materials like PVC and stainless steel, and the performance studies focus on the mechanical and material properties of these physical components. There is no mention of software as a component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to assist in vessel cannulation." This is a procedure performed directly on a patient's body to access a blood vessel.
- Device Description: The device components are physical tools used for a medical procedure (needles, guidewires, dilators, scalpel, syringe). They are used to physically manipulate and access the vasculature.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are designed for testing samples in a laboratory or similar setting.
The device is clearly intended for a surgical or interventional procedure performed in vivo (within the living body), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Intended for single use by a trained physician to assist in vessel cannulation.
Product codes
DRE
Device Description
The MC3 Vascular Access Kit consists of component devices that are already cleared by FDA, as well as various sized dilator devices. The subject devices include dilators that are 13, 16, 20, 24, 26, and 28 French (FR). These dilators are all made of Colorite PVC, 9566M-RAD14. The MC3 logo and size indicator are legibly printed at the hub end of the dilator using NAZDAR VF111 Black Ink with NAZDAR VF190 Ink Thinner. These dilators are packaged together in the MC3 Vascular Access Kit with other devices already cleared by FDA in accordance with the FDA convenience kit guidance. All kit contents are sterile (EtO), nonpyrogenic, and single use only.
The current FDA cleared devices of the kit include a stainless steel Guidewire; a Stepped Dilator, starting at 8Fr. on the tip transitioning to 10Fr.; a singlewall introducer needle, with protector, that is designed to introduce up to a 0.038" guidewire into the vasculature; a long handle, disposable #11 safety scalpel used for incisions during operational procedures; and a 10ml silicone double seal stopper syringe with luer slip.
Peripheral access to the vein is gained using the needle, syringe, and scalpel. The guidewire is then inserted into the vessel through the needle is removed. A dilator is then chosen by the physician and inserted over the guidewire into the vessel. The dilator is then removed and the next sized dilator is inserted in the same manner until the desired dilation is achieved. The single-use devices are then disposed after use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Verification and validation testing was used to establish the performance characteristics of the dilators that are provided in the Vascular Access Kit as follows: Biocompatibility, Packaging Integrity, Transportation Integrity, Sterilization Validation, Functional Testing.
Summary of Non-clinical Testing:
Dilator Buckling: Dilator body strength testing with objective acceptance criteria. All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application.
Dilator Tensile Strength: Pull test with objective acceptance criteria. All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application.
Guidewire Fit: 0.038" guidewire fits through dilator. All test articles met acceptance criteria.
Tip Cracking/Kinking: Splitting or cracking testing with objective acceptance criteria. All test articles met acceptance criteria.
Biocompatibility: Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours. Under conditions of the study, the dilator materials are not cytotoxic, are not a sensitizer and not an irritant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
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October 29, 2018
MC3 Incorporated % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K182914
Trade/Device Name: MC3 Vascular Access Kit 21030 Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: October 16, 2018 Received: October 18, 2018
Dear Mr. Yungvirt:
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Misti L. Malone -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182914
Device Name MC3 Vascular Access Kit 21030
| Indications for Use (Describe) |
|---|
| Intended for single use by a trained physician to assist in vessel cannulation. |
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Registration Use (Part 21 CFR 201.2 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201.2 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------- | ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary MC3 Vascular Access Kit
Date Prepared:
October 15, 2018
Sponsor Information:
| Owner/Applicant/Submitter: | MC3 Incorporated |
|---|---|
| 2555 Bishop Circle West | |
| Dexter, MI 48130 | |
| 1-734-995-9089 | |
| 1-734-995-0840 Fax | |
| Registration number: 3011468686 | |
| Contact Person: | Adam W. Viitala |
| Regulatory Affairs Manager | |
| 2555 Bishop Circle West | |
| Dexter, MI 48130 | |
| 734.995.9089, Extension 324 |
Device Names/Classification:
| Device Trade Name: | MC3 Vascular Access Kit 21030 |
|---|---|
| Device Common Name: | Dilator |
| Classification Name: | Vessel dilator for percutaneous catheterization |
| Regulation Number: | 21 CFR 870.1310 |
| Product Code: | DRE |
Predicate Device:
Avalon Elite Vascular Access Kit (K081940)
Indications for Use:
Intended for single use by a trained physician to assist in vessel cannulation.
Device Description:
The MC3 Vascular Access Kit consists of component devices that are already cleared by FDA, as well as various sized dilator devices. The subject devices include dilators that are 13, 16, 20, 24, 26, and 28 French (FR). These dilators are all made of Colorite PVC, 9566M-RAD14. The MC3 logo and size indicator are legibly printed at the hub end of the dilator using NAZDAR VF111 Black Ink with NAZDAR VF190 Ink Thinner.
4
These dilators are packaged together in the MC3 Vascular Access Kit with other devices already cleared by FDA in accordance with the FDA convenience kit guidance. All kit contents are sterile (EtO), nonpyrogenic, and single use only.
The current FDA cleared devices of the kit include a stainless steel Guidewire; a Stepped Dilator, starting at 8Fr. on the tip transitioning to 10Fr.; a singlewall introducer needle, with protector, that is designed to introduce up to a 0.038" guidewire into the vasculature; a long handle, disposable #11 safety scalpel used for incisions during operational procedures; and a 10ml silicone double seal stopper syringe with luer slip.
Peripheral access to the vein is gained using the needle, syringe, and scalpel. The guidewire is then inserted into the vessel through the needle is removed. A dilator is then chosen by the physician and inserted over the guidewire into the vessel. The dilator is then removed and the next sized dilator is inserted in the same manner until the desired dilation is achieved. The single-use devices are then disposed after use.
Supporting Data:
Verification and validation testing was used to establish the performance characteristics of the dilators that are provided in the Vascular Access Kit as follows:
- . Biocompatibility
- Packaging Integrity
- . Transportation Integrity
- Sterilization Validation
- . Functional Testing
Comparison to Predicate Device:
A comparison of the subject device to the predicate device, Avalon Elite Vascular Access Kit (K081940), indicates the following similarities:
- . Same intended use/indications
- Same operating principle
- Same fundamental technological characteristics
- . Same overall design and performance
- Same materials
- Same packaging materials .
- Same sterilization requirements
- . Similar size range
Summary of Non-clinical Testing:
| Test | Description | Results |
|---|---|---|
| Dilator Buckling | Dilator body strength testing with objective | |
| acceptance criteria. | All test articles met acceptance | |
| criteria. Mechanical integrity is | ||
| more than adequate for the intended | ||
| application. | ||
| Dilator Tensile | ||
| Strength | Pull test with objective acceptance criteria. | All test articles met acceptance |
| criteria. Mechanical integrity is | ||
| more than adequate for the intended | ||
| application. |
5
K182914 Page 3 of 3
| Test | Description | Results |
|---|---|---|
| Guidewire Fit | 0.038" guidewire fits through dilator. | All test articles met acceptance |
| criteria. | ||
| Tip | ||
| Cracking/Kinking | Splitting or cracking testing with objective | |
| acceptance criteria. | All test articles met acceptance | |
| criteria. | ||
| Biocompatibility | Testing per ISO-10993 for an external | |
| communicating device in contact with | ||
| circulating blood for limited duration less than | ||
| 24 hours. | Under conditions of the study, the | |
| dilator materials are not cytotoxic, are | ||
| not a sensitizer and not an irritant. |
Conclusion:
The information and non-clinical data included in the 510(k) Application demonstrate that the MC3 dilators supplied in the MC3 Vascular Access Kit is as safe, as effective, and performs as well as the predicate device; therefore, it is substantially equivalent to the predicate device.