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.

AI/ML Overview

The provided document describes the predicate device and the studies conducted to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. The device in question is the "MC3 Vascular Access Kit 21030," which consists of physical components like dilators, guidewires, needles, and scalpels for vessel cannulation. It is not an AI/ML device.

Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this physical medical device submission.

However, I can extract the relevant information regarding the acceptance criteria and the performance for this device based on the non-clinical testing performed.

Updated Information based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Test	Description (Acceptance Criteria Implicit in Description)	Reported Device Performance
Dilator Buckling	Dilator body strength testing with objective acceptance criteria. (Implicitly, the device should not buckle under expected forces.)	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. (Implicitly, the device should withstand pulling forces without breaking or deforming excessively.)	All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application.
Guidewire Fit	0.038" guidewire fits through dilator. (Implicitly, the internal lumen of the dilator must be patent and of sufficient size for the specified guidewire.)	All test articles met acceptance criteria.
Tip Cracking/Kinking	Splitting or cracking testing with objective acceptance criteria. (Implicitly, the dilator tip should not split or kink during use.)	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. (Implicitly, the materials should not cause adverse biological reactions.)	Under conditions of the study, the dilator materials are not cytotoxic, are not a sensitizer and not an irritant.
Packaging Integrity	Not explicitly described, but generally involves ensuring the sterile barrier and physical protection of the device.	"Verification and validation testing was used to establish the performance characteristics... Packaging Integrity" - Results implicitly met acceptance criteria as it was used to support substantial equivalence.
Transportation Integrity	Not explicitly described, but generally involves ensuring the device's integrity after transportation simulations.	"Verification and validation testing was used to establish the performance characteristics... Transportation Integrity" - Results implicitly met acceptance criteria as it was used to support substantial equivalence.
Sterilization Validation	Not explicitly described, but generally involves confirming the efficacy of the sterilization process.	"Verification and validation testing was used to establish the performance characteristics... Sterilization Validation" - Results implicitly met acceptance criteria as it was used to support substantial equivalence.
Functional Testing	Not explicitly described, but generally involves testing the device's ability to perform its intended function.	"Verification and validation testing was used to establish the performance characteristics... Functional Testing" - Results implicitly met acceptance criteria as it was used to support substantial equivalence.

2. Sample size used for the test set and the data provenance:
For the non-clinical tests (Buckling, Tensile Strength, Guidewire Fit, Tip Cracking/Kinking, Biocompatibility), the document states "All test articles met acceptance criteria." This implies a sample size was used for each test, but the exact number for each specific test is not explicitly stated in the provided text.
The data provenance is from non-clinical laboratory testing conducted by the manufacturer, MC3 Incorporated. It is not patient data (retrospective or prospective) from specific countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This criterion is not applicable as the studies were in-vitro/lab-based non-clinical tests, not involving expert interpretation of data or images.

4. Adjudication method for the test set:
Not applicable for these types of non-clinical tests.

5. If a multi-reader multicase (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is not an AI/ML device.

7. The type of ground truth used:
For the mechanical and physical tests, the "ground truth" was established by objective engineering specifications and measurement standards. For biocompatibility, it was based on internationally recognized standards (ISO-10993).

8. The sample size for the training set:
Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable as this is not an AI/ML device.

Summary

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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.

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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

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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)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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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:

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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 objectiveacceptance criteria.	All test articles met acceptancecriteria. Mechanical integrity ismore than adequate for the intendedapplication.
Dilator TensileStrength	Pull test with objective acceptance criteria.	All test articles met acceptancecriteria. Mechanical integrity ismore than adequate for the intendedapplication.

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K182914 Page 3 of 3

Test	Description	Results
Guidewire Fit	0.038" guidewire fits through dilator.	All test articles met acceptancecriteria.
TipCracking/Kinking	Splitting or cracking testing with objectiveacceptance criteria.	All test articles met acceptancecriteria.
Biocompatibility	Testing per ISO-10993 for an externalcommunicating device in contact withcirculating blood for limited duration less than24 hours.	Under conditions of the study, thedilator materials are not cytotoxic, arenot 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.

Regulation Number and Section

§ 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).