The Q Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Device Description

The MIVI Q Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The catheter contains a pin vise threaded on the control wire, which may be used to advance the catheter.

AI/ML Overview

Acceptance Criteria and Study for MIVI Q Distal Access Catheter

This document describes the acceptance criteria and study proving the MIVI Q Distal Access Catheter meets these criteria, based on the provided FDA 510(k) summary (K192558).

It's important to note that this device is a medical catheter and not an AI/ML powered device, so many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, data provenance) are not directly applicable in the context of this traditional medical device submission. The study focuses on bench testing (non-clinical performance testing) to demonstrate substantial equivalence to a predicate device, rather than clinical trials or AI model validation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Criterion (Pass/Fail)	Reported Device Performance (Result)
Dimensional Verification	Device meets specified dimensional requirements.	Pass
Corrosion Resistance	Exposed metallic components show no signs of corrosion.	Pass
Tensile Strength – Pin Vise	Adequate device tensile strength.	Pass
System Compatibility / Simulated Use	Successful simulated use testing with "worst case" dimensional stack up.	Pass

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

Sample Size: Not explicitly stated for each test. For medical devices undergoing bench testing, samples are typically chosen based on statistical methods to ensure representativeness and confidence in the results, though the exact numbers are not detailed in this summary.
Data Provenance: This is bench testing conducted by the manufacturer, MIVI Neuroscience, Inc., at their facilities. It is inherently prospective for the specific design verification of the modified device. Country of origin for the data is implicitly the United States, given the company's location (Eden Prairie, Minnesota).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. For this type of medical device submission focused on physical properties and performance, "ground truth" is established by engineering specifications, validated test methods, and industry standards, not by expert medical consensus on human-generated data. The "experts" would be the engineers and quality control personnel designing and executing the tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and quantitative (e.g., measuring dimensions, observing corrosion, measuring tensile strength). There is no "adjudication" in the sense of resolving disagreements between human observers. The outcomes are determined by adherence to pre-defined engineering and performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The MIVI Q Distal Access Catheter is a physical medical device (catheter) with no AI/ML components or human diagnostic interpretation associated with its direct function.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, this is not applicable. The MIVI Q Distal Access Catheter is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing is based on:

Engineering Specifications: Pre-defined dimensional requirements, material properties, and functional performance targets derived from the device's intended use and comparison to the predicate device.
Industry Standards: Relevant ISO or ASTM standards governing medical device testing (though not explicitly listed in this summary, they are implicitly followed in such submissions).
Predicate Device Performance: The established performance and safety profile of the legally marketed predicate device (MIVI Mi-EXT Extension Catheter, now branded as the MIVI Q Distal Access Catheter K163233) serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 6, 2020

MIVI Neurovascular Janel Hurtado Regulatory Affairs Director 6545 City West Parkway Eden Prairie, Minnesota 55344

Re: K192558

Device Name: MIVI O Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: March 12, 2020 Received: March 13, 2020

Dear Janel Hurtado:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192558

Device Name MIVI Q Distal Access Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Date Prepared: November 8, 2019

Table 1. General Information
510(k) Submitter	Contact
MIVI Neuroscience, Inc.6545 City West ParkwayEden Prairie, MN 55344	Randy LaBountyVice President Regulatory, Clinical and QualityEmail: rlabounty@mivineuro.com
Trade Name	MIVI Q Distal Access Catheter
Common Name	Distal access catheter
ClassificationInformation	Percutaneous catheter; 21 CFR 870.1250 (Class II)ProCode: QJP, DQY; Panel: Cardiovascular
PredicateDevice	MIVI Neuroscience, Inc. MIVI Mi-EXT Extension Catheter (nowbranded as the MIVI Q Distal Access Catheter) (K163233)

Device Description

Intended Use / Indications for Use

Substantial Equivalence Comparison

Table 2 compares the substantial equivalence of the subject and predicate devices.

Feature	Subject DeviceMIVI Q Distal Access Catheter	Currently MarketedPredicate DeviceMIVI Q Distal AccessCatheter
510(k) Holder &Manufacturer	MIVI Neuroscience, Inc.
Table 2. Comparison with Currently Marketed Predicate
Feature	Subject DeviceMIVI Q Distal Access Catheter	Currently MarketedPredicate DeviceMIVI Q Distal Access Catheter
510(k)#	K192558	K163233
ClassificationInformation	Percutaneous catheter21 CFR 870.1250 (Class II)ProCode: QJP, DQY
Indications / Intended Use	Indicated for use with compatible guide catheters in facilitating theinsertion and guidance of microcatheters into a selected blood vesselin the peripheral, coronary and neuro vascular systems.
Principle of Operation	Used to endovascularly insert and guide microcatheters underfluoroscopy during diagnostic and/or therapeutic procedures forpatients with arterial disease or damage.
Design Information
Configuration	Distal	Single-lumen, variable stiffness, braided (5F & 6F) / coiled (3F & 4F)
	Proximal	Control (push) wire through a guide catheter luer fitting
	Tip	Straight
	RadiopaqueMarkers	Two (2) - Distal and Proximal
	CatheterCoating	Hydrophilic
	Catheter Sizes	3F, 4F, 5F, 6F
Total Length(cm)	3F	148	163
	4F	135	150
	5F	130	145
	6F	130	145
Extensible Length		Range	Fixed
ExtensibleLength (cm)with:90cm Guide	3F	40-42	42
	4F	27-29	29
	5F	22-24	24
	6F	22-24	24
Table 2. Comparison with Currently Marketed Predicate
Feature			Subject DeviceMIVI Q Distal Access Catheter	Currently MarketedPredicate DeviceMIVI Q Distal AccessCatheter
	95cm Guide	3F	35-37	42
		4F	22-24	29
		5F	17-19	24
		6F	17-19	24
Control Wire Length			104 cm	119 cm
	Pin Vise Shape		Looped shape(Pin vise not removable)	Straight shape(Pin vise can be removed)
	GuidewireCompatibility(cm)	3F	0.018"
		4F	0.035"
		5F
		6F
Catheter Biomaterials			Patient contacting materials are identical between the subject andcurrently marketed predicate.
Accessories / Packaging / Sterilization / Shelf Life / Labeling
	Provided Accessories			None
Required Accessories(not provided)			8F guide catheter / 6F guide sheathwith rotating hemostasis valve with Y adapter and stopcock.	8F guide catheter / 6Fguide sheathY adapter with rotatinghemostasis valve (lengthsbetween 6-8 cm)
Package Configuration			Catheter inserted in a plastic tube, mounted on an insert card, andsealed in a pouch. Sealed pouch packaged in carton along withInstructions for Use.
Sterile & Non-pyrogenic?			Yes
Sterilization Method			Ethylene Oxide (EO)
Shelf Life			3 years
Labeling			Proposed IFU	Current IFU

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Non-Clinical Performance Testing

Bench Testing

Table 3. Design Verification Testing
Test	Test Method	Results
Dimensional Verification	Ensure device meets dimensional requirements.	Pass
Corrosion Resistance	Any exposed metallic components must not show signs of corrosion.	Pass
Tensile Strength – Pin Vise	Ensure adequate device tensile strength.	Pass
System Compatibility / Simulated Use	Simulated use testing with “worst case” dimensional stack up.	Pass

Based on the test results, the Q catheter with the described wire modification is considered verified to perform to its design specifications.

Biocompatibility

The MIVI Q Distal Access Catheter patient contacting materials are the same materials used in the currently marketed predicate MIVI Q Catheter K163233 with an identical biocontact. There is no change to colorants between the subject and predicate devices.

Sterilization

The MIVI Q Distal Access Catheter packaging configuration and packaged device density are the same for the predicate K163233 and subject device. No additional testing or validation is required for the subject device to be adopted into the existing sterilization cycles.

Shelf Life and Expiration Dating

The modified Q catheter will be labeled with an expiration date of 3 years from the date of sterilization, which is the same as the predicate K163233. The change to the length and distal feature of the control (push) wire does not introduce any new materials and does not impact the shelf life of the product.

Substantial Equivalence Summary and Conclusion

The modified MIVI Q Distal Access Catheter has identical indications, principle of operation, and a similar design to the currently marketed MIVI Q catheter predicate device. Based on the predicate comparison, risk assessment, and device testing results, the modified MIVI Q catheter has been shown to be appropriate for its intended use and is therefore considered substantially equivalent to the predicate device. The modified Q catheter raises no new questions of safety or effectiveness compared to the predicate device and is therefore substantially equivalent.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).