The MIVI Q Distal Access 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 Distal Access Catheter (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 Q Docking Station may be used to facilitate insertion and extraction of the Q Catheter through a hemostasis valve attached to the 8F guide catheter/6F guide sheath. The pin vise may be used to advance the catheter.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MIVI Q Distal Access Catheter:

The document provided is a 510(k) Summary for the MIVI Q Distal Access Catheter, which is a premarket notification to the FDA for a medical device seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than proving novel effectiveness.

Given the nature of a 510(k) submission for a catheter, the "acceptance criteria" and "device performance" in this context refer to the ability of the device to meet specified engineering and biocompatibility standards, and to perform its intended function without significant differences from the predicate. There is no clinical study in the traditional sense (e.g., patient trials with efficacy endpoints) described for this device, as it's a substantially equivalent determination based on non-clinical testing.

Here's the information extracted and organized according to your request:

Acceptance Criteria and Device Performance for MIVI Q Distal Access Catheter

1. Table of Acceptance Criteria and Reported Device Performance

For Bench Testing (Non-Clinical Performance):

Test	Acceptance Criteria	Reported Device Performance
Dimensional Verification	The device must meet dimensional specifications.	Pass
System Introduction (Simulated Use)	The device must function as intended.	Pass
Liquid Leakage under Pressure	The device must hold a hydrostatic pressure.	Pass
Tensile Strength	Tensile strength pull force minimum must be met.	Pass

For Biocompatibility Testing:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Cytotoxicity	Non-toxic to cells (determined by specific extract and cell line).	PASS
Irritation or Intracutaneous Reactivity	No significant irritation or reactivity in vivo (animal model).	PASS
Sensitization	No significant sensitization reaction (animal model).	PASS
Acute Systemic Toxicity	No acute systemic toxicity (animal model).	PASS
Pyrogenicity (Material-mediated)	Non-pyrogenic (no fever-inducing substances in vivo).	PASS
Hemolysis	No significant hemolysis (destruction of red blood cells) in vitro.	PASS
Unactivated Partial Thromboplastin Time	No significant impact on blood clotting time (in vitro).	PASS
Complement Activation	No significant complement activation (immune response) in vitro.	PASS

For Sterilization and Shelf Life:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization	Confirmed sterility of the final packaging configuration and method.	Met specification
Shelf Life and Expiration Dating	Maintain performance and integrity for the specified period.	3 years (same as predicate)

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

The document does not specify the exact sample sizes used for each individual non-clinical (bench and biocompatibility) test. Such details are typically found in the full test reports, not in the summary document.

Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting (in vitro or in animal models), not on human subjects. Therefore, there is no country of origin for human patient data. The provenance of the data is the laboratory where the tests were performed. The studies are prospective in the sense that they were designed and executed to test the characteristics of the MIVI Q Distal Access Catheter.

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

This question is not applicable to the provided document. The "ground truth" in this context is established by objective measurements and standardized test methods (e.g., ISO standards for biocompatibility, engineering specifications for bench tests), not by expert consensus on clinical data. No human "experts" were used to establish ground truth for this type of non-clinical testing.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for interpreting imaging or clinical outcomes where there might be inter-reader variability. For non-clinical bench and biocompatibility tests, results are typically objective (e.g., a tensile strength value, a cytotoxicity rating) and do not require expert adjudication in this manner.

5. If a Multi Reader Multi Case (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

This is not applicable. The MIVI Q Distal Access Catheter is a physical medical device (a catheter), not an AI algorithm, and therefore does not involve human readers interpreting output from an AI system. The submission is for substantial equivalence of a physical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. As explained above, this device is a physical catheter, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described:

Bench Testing: Ground truth is defined by engineering specifications and objective physical measurements (e.g., specified dimensions, force thresholds, pressure integrity).
Biocompatibility Testing: Ground truth is established by standardized biological assays and observation in animal models and in vitro systems, as per recognized international standards (e.g., ISO 10993 series). The results are objective measurements against defined pass/fail criteria.

8. The sample size for the training set

This is not applicable. There is no AI algorithm involved that requires a training set. The "study" here consists of non-clinical performance and biocompatibility testing of the physical catheter.

9. How the ground truth for the training set was established

This is not applicable, as there is no AI algorithm or training set.

Summary

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Image /page/0/Picture/0 description: The image shows the date December 16, 2021. The month is spelled out, followed by the day and year. The text is in a simple, sans-serif font and is left-aligned.

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MIVI Neuroscience, Inc. Janel Hurtado Director of Regulatory 6545 City West Parkway Eden Prairie, Minnesota 55344

Re: K212402

Trade/Device Name: MIVI Q Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 11, 2021 Received: November 17, 2021

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

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

For comprehensive regulatory information about mediation-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,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K212402

Device Name MIVI Q Distal Access Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 K212402

[as required by 21 CFR $807.92(c)]

Date Prepared: December 14, 2021

	510(k) Submitter	Contact
	MIVI Neuroscience, Inc.6545 City West ParkwayEden Prairie, MN 55344(952) 944-3834	Janel HurtadoRegulatory Affairs DirectorEmail: jhurtado@mivineuro.com(952) 944-3834
General Information
Trade Name	MIVI Q Distal Access Catheter
Common Name	Distal access catheter
ClassificationInformation	Device Classification: Class IICommon Name: Percutaneous catheterRegulation Number: 21 CFR 870.1250Product Code: QJP; Panel: NeurologyProduct Code: DQY; Panel: Cardiovascular
Predicate Device	MIVI Q Distal Access Catheter (K192558; April 6, 2020)

Device Description

Intended Use / Indications for Use

Substantial Equivalence Comparison

The MIVI Q Distal Access Catheter (pre-loaded with Docking Station) has identical indications, principle of operation, and similar design as the currently marketed predicate catheters.

Table 1: Comparison with Currently Marketed Predicate
Feature	Subject DeviceMIVI Q Distal Access Catheter	Predicate DeviceMIVI Q Distal Access Catheter
510(k) Holder &Manufacturer	MIVI Neuroscience, Inc.	MIVI Neuroscience, Inc.
510(k)#	K212402	K192558
Table 1: Comparison with Currently Marketed Predicate
Feature	Subject DeviceMIVI Q Distal Access Catheter	Predicate DeviceMIVI Q Distal Access Catheter
ClassificationInformation	Percutaneous catheter21 CFR 870.1250 (Class II)ProCode: QJP, DQY
Indications / Intended Use / Principle of Operation
Indications for Use	The MIVI Q Distal AccessCatheter is indicated for use withcompatible guide catheters infacilitating the insertion andguidance of microcatheters into aselected blood vessel in theperipheral, coronary and neurovascular systems.	The Q Catheter is indicated for usewith compatible guide catheters infacilitating the insertion andguidance of microcatheters into aselected blood vessel in theperipheral, coronary and neurovascular systems.
Principle ofOperation	Used to endovascularly insert and guide microcatheters under fluoroscopyduring diagnostic and/or therapeutic procedures for patients with arterialdisease or damage.
Design Information
Configuration	Distal	Single-lumen, variable stiffness, braided (5F & 6F) / coiled (3F & 4F)
	Proximal	Control (push) wire through aDocking Station assembly
	Tip	Straight
	RadiopaqueMarkers	Two (2) - Distal and Proximal
	CatheterCoating	Hydrophilic
	Catheter Sizes	3F, 4F, 5F, 6F

	3F	154	148
	4F	141	135
Total Length(cm)	5F	136	130
	6F	136	130


Extensible Length
	3F	40-42
	4F	27-29
Extensible length (cm) with:90 cm Guide	5F	22-24
	6F	22-24


	3F	35-37
	4F	22-24
95 cm Guide	5F	17-19
	6F	17-19


Control WireLength	108	104
Table 1: Comparison with Currently Marketed Predicate
Feature	Subject DeviceMIVI Q Distal Access Catheter	Predicate DeviceMIVI Q Distal Access Catheter
Pin Vise Shape	Looped shape (Pin Vise not removable)
GuidewireCompatibility(cm)	3F	0.018"
	4F	0.035"
	5F
	6F
CatheterBiomaterials	Patient contacting materials are identical between the subject and currentlymarketed predicate and accessories.
Accessories / Packaging / Sterilization / Shelf Life
Provided Accessories	9F Rotating Hemostasis Valve Y-Connector	None
Required Accessories(not provided)	8F guide catheter / 6F guide sheath 90-95 cm in length
PackageConfiguration	Catheter inserted in a plastic tube, mounted on an insert card, and sealed ina pouch. Sealed pouch packaged in carton along with Instructions for Use.
Sterile & Non-pyrogenic	Yes
Sterilization Method		Ethylene Oxide (EO)
Shelf Life		3 years

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The technological differences between the modified MIVI Q Distal Access Catheter and the currently marketed predicate do not raise new questions of safety and effectiveness.

Non-Clinical Performance Testing

Bench Testing

Bench testing was completed to assess the performance of the subject device, as shown in the following table.

Test	Test Summary	Result
DimensionalVerification	The device must meet dimensional specifications.	Pass
System Introduction (SimulatedUse)	The device must function as intended.	Pass
Liquid Leakage under Pressure	The device must hold a hydrostatic pressure.	Pass
Tensile Strength	Tensile strength pull force minimum must be met.	Pass

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Biocompatibility

Biocompatibility testing was completed to assess the subject device, as shown in the following table.

Test	Test Summary	Result
Cytotoxicity	Extracted with MEM with 10% FBS at 37 °C for 24hours and administered on mouse fibroblast L929 cells.	PASS
Irritation or IntracutaneousReactivity	Extracted with 0.9% NaCl and cottonseed oil (CSO) at37 °C for 72 hours and intracutaneously injected inrabbits.	PASS
Sensitization	Extracts: 0.9% NaCl, CSO for 72 hours at 37 °C.	PASS
Acute Systemic Toxicity	Extracted with 0.9% NaCl and CSO at 37 °C for 72hours and injected in mice.	PASS
Pyrogenicity (Material-mediated)	Extracted with 0.9% NaCl at 37 °C for 72 hours andinjected intravenously in rabbits.	PASS
Hemolysis	Extracted from PBS at 37 °C for 24 hours, administeredon rabbit blood; or directly contacting rabbit blood invitro.	PASS
Unactivated PartialThromboplastin Time	Human plasma was exposed to the test article at a ratio of6 cm2/ml for 15 minutes at 37 °C.	PASS
Complement Activation	Human plasma was exposed to the test article at aratio of 6 cm2/mL for 90 mins at 37 °C, in triplicate.	PASS

Sterilization

The sterilization method is unchanged. Confirmatory testing on the final packaging configuration was completed and met specification.

Shelf Life and Expiration Dating

The labeled shelf life of the modified device is the same as that of the predicate, 3 years from the date of sterilization. The bench testing described above was performed to support the shelflife of the modified device.

Conclusion

The modified MIVI Q Distal Access Catheter has identical indications, principle of operation, and similar design as the currently marketed MIVI Q Catheter predicate device. The technological differences between the modified Q Catheter and the currently marketed predicate do not raise new questions of safety and effectiveness. Based on the predicate comparison, risk assessment, and device testing results, the modified MIVI Q Distal Access Catheter has been shown to be appropriate for its intended use and is considered substantially equivalent to the predicate device.

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).