K Number

Device Name

Q Distal Access Catheter

Manufacturer

MIVI Neuroscience, Inc

Date Cleared

2023-09-19

(357 days)

Product Code

QJP DQY

Regulation Number

870.1250

Intended Use

The 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 Q Distal Access 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 proximal portion of the device is a stainless-steel control wire. The distal portion of the device is a coiled/braided catheter shaft with hydrophilic coating along the entire length to reduce friction during use. The Q Distal Access 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 pin vise may be used to advance the catheter. The syringe and flush tool components may aid in the flushing of the Q Distal Access Catheter.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K192558

Reference Devices

K192558

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities.

Therapeutic

No
The device facilitates the insertion and guidance of other devices; it does not directly treat a disease or medical condition.

Diagnostic

No
The device is used to facilitate the insertion and guidance of microcatheters, not to make a diagnosis.

SaMD (Software as a Medical Device)

The device description clearly describes a physical catheter with various material components (stainless-steel, coiled/braided shaft, hydrophilic coating) and accessories (pin vise, syringe, flush tool), indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used to facilitate the insertion and guidance of other catheters within the vascular system. This is a procedural device used in vivo (within the body) during medical procedures.
Device Description: The description details a physical catheter designed for insertion into blood vessels. It mentions components like a control wire, catheter shaft, and radiopaque markers for visualization during a procedure.
Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. This device does not perform any such analysis of biological samples.
Input Imaging Modality: The input imaging modalities (angiographic visualization, fluoroscopy) are used to guide the device during a procedure, not to analyze biological samples.
Anatomical Site: The anatomical sites mentioned (peripheral, coronary, and neuro vascular systems, arterial vasculature) are where the device is used within the body.

In summary, the Q Distal Access Catheter is a medical device used for interventional procedures within the body, not for the in vitro examination of biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

QJP, DQY

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral, coronary and neuro vascular systems.

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

The modified Q Distal Access Catheter has been evaluated through design verification testing, which confirmed the device met the design specifications as summarized in Table 3 below. The modified Q Distal Access Catheter in the new packaging is sterilized using Sustainable Ethylene Oxide (EO) sterilization process. Sterilization was performed in accordance with ISO 11135:2014 to qualify the reduced EO sterilization process developed by Steris AST which is an optimized cycle using less EO sterilant while still achieving the 10 ° sterility assurance level (SAL) as an acceptable means of sterilization. The EO residual, limulus amoebocyte lysate (LAL), and bioburden testing were performed in accordance with standards listed below: ISO 10993-7 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide ● Sterilization Residuals. The USP 24 chapter 85 "Bacterial Endotoxins Test" and FDA guidance, "Pyrogen and ● Endotoxins Testing: Questions and Answers, " June 2012.

Key Metrics

Not Found

Predicate Device(s)

MIVI Q Distal Access Catheter (K192558)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

September 19, 2023

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

MIVI Neuroscience, Inc. Srija Reddy Bandari Regulatory Affairs Specialist 6545 City West Parkway Eden Prairie, Minnesota 55344

Re: K222948

Trade/Device Name: Q Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: August 18, 2023 Received: August 21, 2023

Dear Srija Reddy Bandari:

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 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 -S

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

Indications for Use

510(k) Number (if known) K222948

Device Name 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 K222948

Date Prepared: 09-18-2023

Table 1. General Information
510(k) Submitter	Contact
MIVI Neuroscience, Inc.
6545 City West Parkway
Eden Prairie, MN 55344	Srija Reddy Bandari
Regulatory Affairs Specialist
Email: sbandari@mivineuro.com
Phone: (612) 447-2897
Fax: (952)-944-3488
Trade Name	Q Distal Access Catheter
Common Name	Q Distal Access Catheter
Classification Information	Percutaneous catheter; 21 CFR 870.1250 (Class II)
ProCode: QJP, DQY
Panel: Cardiovascular
Predicate Device	MIVI Q Distal Access Catheter (K192558)

Device Description

Intended Use / Indications for Use

The O 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.

Substantial Equivalence Comparison

Table 2 compares the intended use and technological characteristics of the subject and predicate devices.

Table 2: Comparison with Currently Marketed Predicate
Feature	Subject Device
Q Distal Access Catheter	Currently Marketed Predicate
Device
MIVI Q Distal Access Catheter
510(k) Holder &
Manufacturer	MIVI Neuroscience, Inc.	MIVI Neuroscience, Inc.
510(k)#	K222948	K192558
Classification
Information	Percutaneous catheter
21 CFR 870.1250 (Class II)
ProCode: QJP, DQY; Panel: Cardiovascular
Indications / Intended Use / Principle of Operation
Indications /
Intended Use	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.
Principle of
Operation	Used to endovascularly insert and guide microcatheters under
fluoroscopy during diagnostic and/ or therapeutic procedures for patients
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
	Radiopaque
Markers	Two (2)- Distal and Proximal
	Catheter
Coating	Hydrophilic
	Catheter Sizes	3F, 4F, 5F, 6F
Catheter
Lengths	3F	148 cm	148 cm
	4F	135 cm and 145 cm	135 cm
	5F	130 cm and 140 cm	130 cm
Table 2: Comparison with Currently Marketed Predicate
Feature	Subject Device
Q Distal Access Catheter	Currently Marketed Predicate Device
MIVI Q Distal Access Catheter
	6F
130 cm and 135 cm	130 cm
Guidewire
Compatibility
(cm)	3F
0.018"
	4F
	5F
0.035"
	6F
Guide Catheter /
Sheath
Compatibility (ID)	0.088"- 0.091"	0.088"- 0.090"
Guide Catheter/
Sheath Length
Range (cm)	90-100	90-95
Catheter
Biomaterials	Patient contacting materials are identical between the subject and currently marketed predicate.
Accessories / Packaging / Sterilization / Shelf Life / Labeling
Provided
Accessories	Syringe (5 mL)
Flush tool (4F/5F)	None
Required
Accessories (not
provided)	Compatible Y adapter with
rotating hemostasis valve (lengths
between 6-8 cm)	Same
Package
Configuration	Catheter inserted in a plastic tube,
placed in PETG tray with lid, and
sealed in new Tyvek pouch with
improved chevron. Sealed pouch
packaged in labeled carton with
Instructions for Use.	Catheter inserted in a plastic tube,
mounted on an insert card, and
sealed in a pouch. Sealed pouch
packaged in carton box along with
Instructions for Use.
Sterile & Non-
pyrogenic?		Yes
Sterilization
Method	Ethylene Oxide (sustainable)	Ethylene Oxide
Shelf Life		3 years

Non-Clinical Performance Testing

Bench Testing

The modified Q Distal Access Catheter has been evaluated through design verification testing, which confirmed the device met the design specifications as summarized in Table 3 below.

Table 3: Design Verification Testing
Test	Test Method Summary	Results
Label Integrity	Device labels were evaluated to ensure labels are intact and
legible after environmental conditioning, distribution simulation
and aging.	Pass
Bubble Leak	Device packaging was evaluated to detect gross leaks in
packaging.	Pass
Pouch Seal
Strength	Pouch was evaluated for the mechanical strength of the seal.	Pass
Coating
Particulate	The number and size of particles generated during simulated use
were measured.	Pass
Dimensional
Verification	Dimensional specifications were verified to ensure device meets
all the requirements.	Pass
Tip Inspection	Catheter tip was evaluated to ensure the complete retrieval of tip
during its removal.	Pass
Surface Integrity	Device visually inspected to ensure surface is free of defects
that can cause tissue trauma.	Pass
Heat shrink
Inspection	To ensure heat shrink identifier remains intact and legible after
environmental conditioning, distribution simulation and aging.	Pass
Coating
Uniformity	To evaluate the devices for uniform coating.	Pass
Simulate Use/
Compatibility	The catheter performance was evaluated when used in
conjunction with other devices used in standard procedures
without sustaining damage or kinks and without causing
damage to the other devices.	Pass
Coating
Adhesion	To visually categorize the integrity of coating on the device.	Pass
Push/Track	To ensure device is able to be tracked without kink under normal conditions in tortuous anatomy.	Pass
Kink Resistance	The distal shaft of the device was evaluated for kink resistance when subjected to a bend radius of 1.0 cm.	Pass
Liquid Leak Under Pressure	To ensure device does not exhibit leakage of liquid under a minimum pressure of 44 psi for a minimum of 30 seconds.	Pass
Static Burst	To ensure device withstands a minimum pressure of 100 psi prior to burst.	Pass
Tensile Strength - Push Wire	To ensure device meets the required tensile strength between the push wire and catheter body: 15 N pull force minimum.	Pass
Tensile Strength - Distal Section	To ensure device meets the required tensile strength of the distal section of the shaft: 5N pull force minimum.	Pass

Biocompatibility

The Q Distal Access Catheter patient contacting materials are the same materials used in the currently marketed predicate MIVI Q Distal Access Catheter K192558 with the same patient contact classification. A summary of the additional biocompatibility testing conducted to support the device modifications is included in Table 4 below.

Table 4: Summary of Biocompatibility Testing
Test	Test Method	Conclusion	Result
Cytotoxicity	Extracted with MEM with
10% FBS at 37°C
for 24 hours and
administered on mouse
fibroblast L929 cells.	Biological reactivity Grade 0 on the
test article after 48 hrs. incubation
with mouse fibroblast. The response
on the positive and negative control
article extracts confirmed the
suitability of the tests. The test article
(TA) is considered non-cytotoxic.	Pass

| Hemolysis
(Direct and Indirect) | ASTM F756, Standard
Practice for Assessment of
Hemolytic Properties of
Materials. | The test article in direct contact with
blood had a hemolytic index of 0.3%,
and the test article extract had a
hemolytic index of 0.2%. Both the test
article in direct contact with blood and
the test article extract were non-
hemolytic. | Pass |

------------------------------------	--------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------

Sterilization

The modified O Distal Access Catheter in the new packaging is sterilized using Sustainable Ethylene Oxide (EO) sterilization process. Sterilization was performed in accordance with ISO 11135:2014 to qualify the reduced EO sterilization process developed by Steris AST which is an optimized cycle using less EO sterilant while still achieving the 10 ° sterility assurance level (SAL) as an acceptable means of sterilization.

The EO residual, limulus amoebocyte lysate (LAL), and bioburden testing were performed in accordance with standards listed below:

ISO 10993-7 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide ● Sterilization Residuals.
The USP 24 chapter 85 "Bacterial Endotoxins Test" and FDA guidance, "Pyrogen and ● Endotoxins Testing: Questions and Answers, " June 2012.

Shelf-life

The modified O Distal Access Catheter will be labelled with an expiration date of 3 years from the date of sterilization, which is same as for the predicate device K192558.

Conclusions

The modified Q Distal Access Catheter has the same indications for use, principle of operation, and design concept as the currently marketed MIVI Q Distal Access Catheter predicate device. The technological differences between the subject device and the currently marketed predicate device include the catheter dimensions, increased compatibility range with the guide catheter/sheath, addition of the syringe and flush tool accessory components to the packaging configuration, packaging, sterilization, and product labeling updates. The subject device has been evaluated through risk analysis and testing. The differences do not raise new questions of safety or effectiveness. The testing verified the device met the design specifications. Based on the predicate comparison, risk assessment, and device testing information provided in this 510(k) submission, the subject device has been shown to be appropriate for its intended use and is therefore considered substantially equivalent to the predicate device.