Q Distal Access Catheter

K222948 · Mivi Neuroscience, Inc. · QJP · Sep 19, 2023 · Cardiovascular

Device Facts

• Record ID: K222948
• Device Name: Q Distal Access Catheter
• Applicant: Mivi Neuroscience, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Sep 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Indications for 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 Story

Single-lumen, variable stiffness catheter; stainless-steel control wire proximal; coiled/braided shaft distal; hydrophilic coating. Used endovascularly to insert/guide microcatheters under fluoroscopy during diagnostic/therapeutic procedures for arterial disease/damage. Operated by physicians in clinical settings. Introduced via 8F guide catheter/6F guide sheath over guidewire/microcatheter; pin vise used for advancement; syringe/flush tool provided for flushing. Radiopaque markers at distal/proximal ends allow visualization. Facilitates access to target vessels, aiding clinical decision-making by enabling delivery of therapeutic/diagnostic devices.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included design verification (label integrity, bubble leak, seal strength, coating particulate, dimensional verification, tip inspection, surface integrity, heat shrink inspection, coating uniformity, simulated use, coating adhesion, push/track, kink resistance, liquid leak, static burst, tensile strength) and biocompatibility (cytotoxicity, hemolysis).

Technological Characteristics

Single-lumen, variable stiffness catheter; stainless-steel proximal control wire; coiled/braided distal shaft; hydrophilic coating. Radiopaque markers. Sizes 3F-6F. Sterilized via Ethylene Oxide (ISO 11135:2014). Biocompatibility per ISO 10993-7, USP 24 Chapter 85, and ASTM F756. No software or electronic components.

Indications for Use

Indicated for use with compatible guide catheters to facilitate insertion and guidance of microcatheters into selected blood vessels in peripheral, coronary, and neurovascular systems.

Regulatory Classification

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.

Predicate Devices

• MIVI Q Distal Access Catheter (K192558)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K222948

Device Name Q Distal Access Catheter

Indications for Use (Describe)

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.

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.<br>6545 City West Parkway<br>Eden Prairie, MN 55344 | Srija Reddy Bandari<br>Regulatory Affairs Specialist<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name | Q Distal Access Catheter |
| Common Name | Q Distal Access Catheter |
| Classification Information | Percutaneous catheter; 21 CFR 870.1250 (Class II)<br>ProCode: QJP, DQY<br>Panel: Cardiovascular |
| Predicate Device | MIVI Q Distal Access Catheter (K192558) |

#### 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.

#### 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.

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

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## 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<br>legible after environmental conditioning, distribution simulation<br>and aging. | Pass | |
| Bubble Leak | Device packaging was evaluated to detect gross leaks in<br>packaging. | Pass | |
| Pouch Seal<br>Strength | Pouch was evaluated for the mechanical strength of the seal. | Pass | |
| Coating<br>Particulate | The number and size of particles generated during simulated use<br>were measured. | Pass | |
| Dimensional<br>Verification | Dimensional specifications were verified to ensure device meets<br>all the requirements. | Pass | |
| Tip Inspection | Catheter tip was evaluated to ensure the complete retrieval of tip<br>during its removal. | Pass | |
| Surface Integrity | Device visually inspected to ensure surface is free of defects<br>that can cause tissue trauma. | Pass | |
| Heat shrink<br>Inspection | To ensure heat shrink identifier remains intact and legible after<br>environmental conditioning, distribution simulation and aging. | Pass | |
| Coating<br>Uniformity | To evaluate the devices for uniform coating. | Pass | |
| Simulate Use/<br>Compatibility | The catheter performance was evaluated when used in<br>conjunction with other devices used in standard procedures<br>without sustaining damage or kinks and without causing<br>damage to the other devices. | Pass | |
| Coating<br>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 | |

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## 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<br>10% FBS at 37°C<br>for 24 hours and<br>administered on mouse<br>fibroblast L929 cells. | Biological reactivity Grade 0 on the<br>test article after 48 hrs. incubation<br>with mouse fibroblast. The response<br>on the positive and negative control<br>article extracts confirmed the<br>suitability of the tests. The test article<br>(TA) is considered non-cytotoxic. | Pass |

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