Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter

K192558 · Mivi Neurovascular · DQY · Apr 6, 2020 · Cardiovascular

Device Facts

• Record ID: K192558
• Device Name: Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
• Applicant: Mivi Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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 Story

Single-lumen, variable stiffness catheter; used for endovascular insertion and guidance of microcatheters under fluoroscopy. Features radiopaque markers for visualization; hydrophilic coating to reduce friction; stainless-steel control (push) wire; pin vise for advancement. Introduced via 8F guide catheter/6F guide sheath over guidewire/microcatheter. Used by physicians in clinical settings during diagnostic/therapeutic procedures. Output is physical guidance of microcatheters to target vessels; enables delivery of therapeutic devices or diagnostic agents. Benefits patient by facilitating access to complex arterial anatomy.

Clinical Evidence

Bench testing only. Testing included dimensional verification, corrosion resistance, tensile strength of the pin vise, and system compatibility/simulated use testing with worst-case dimensional stack-up. All tests passed.

Technological Characteristics

Single-lumen, variable stiffness catheter; stainless-steel control wire; hydrophilic coating; radiopaque markers. Sizes: 3F, 4F, 5F, 6F. Sterilization: Ethylene Oxide (EO). Shelf life: 3 years. No electronic components or software.

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 for patients with arterial disease or damage.

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 Mi-EXT Extension Catheter (now branded as the MIVI Q Distal Access Catheter) (K163233)

Submission Summary (Full Text)

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

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.

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

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## 510(K) SUMMARY

#### Date Prepared: November 8, 2019

| Table 1. General Information | |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | Contact |
| MIVI Neuroscience, Inc.<br>6545 City West Parkway<br>Eden Prairie, MN 55344 | Randy LaBounty<br>Vice President Regulatory, Clinical and Quality<br>Email: [e-mail] |
| Trade Name | MIVI Q Distal Access Catheter |
| Common Name | Distal access catheter |
| Classification<br>Information | Percutaneous catheter; 21 CFR 870.1250 (Class II)<br>ProCode: QJP, DQY; Panel: Cardiovascular |
| Predicate<br>Device | MIVI Neuroscience, Inc. MIVI Mi-EXT Extension Catheter (now<br>branded as the MIVI Q Distal Access Catheter) (K163233) |

#### 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.

#### Intended Use / Indications for Use

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.

#### Substantial Equivalence Comparison

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

| Feature | Subject Device<br>MIVI Q Distal Access Catheter | Currently Marketed<br>Predicate Device<br>MIVI Q Distal Access<br>Catheter | | |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| 510(k) Holder &<br>Manufacturer | MIVI Neuroscience, Inc. | | | |
| Table 2. Comparison with Currently Marketed Predicate | | | | |
| Feature | Subject Device<br>MIVI Q Distal Access Catheter | Currently Marketed<br>Predicate Device<br>MIVI Q Distal Access Catheter | | |
| 510(k)# | K192558 | K163233 | | |
| Classification<br>Information | Percutaneous catheter<br>21 CFR 870.1250 (Class II)<br>ProCode: QJP, DQY | | | |
| Indications / Intended Use | Indicated for use with compatible guide catheters in facilitating the<br>insertion and guidance of microcatheters into a selected blood vessel<br>in the peripheral, coronary and neuro vascular systems. | | | |
| Principle of Operation | Used to endovascularly insert and guide microcatheters under<br>fluoroscopy during diagnostic and/or therapeutic procedures for<br>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<br>Markers | Two (2) - Distal and Proximal | | |
| | Catheter<br>Coating | Hydrophilic | | |
| | Catheter Sizes | 3F, 4F, 5F, 6F | | |
| Total Length<br>(cm) | 3F | 148 | 163 | |
| | 4F | 135 | 150 | |
| | 5F | 130 | 145 | |
| | 6F | 130 | 145 | |
| Extensible Length | | Range | Fixed | |
| Extensible<br>Length (cm)<br>with:<br>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 Device<br>MIVI Q Distal Access Catheter | Currently Marketed<br>Predicate Device<br>MIVI Q Distal Access<br>Catheter |
| | 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<br>(Pin vise not removable) | Straight shape<br>(Pin vise can be removed) |
| | Guidewire<br>Compatibility<br>(cm) | 3F | 0.018" | |
| | | 4F | 0.035" | |
| | | 5F | | |
| | | 6F | | |
| Catheter Biomaterials | | | Patient contacting materials are identical between the subject and<br>currently marketed predicate. | |
| Accessories / Packaging / Sterilization / Shelf Life / Labeling | | | | |
| | Provided Accessories | | | None |
| Required Accessories<br>(not provided) | | | 8F guide catheter / 6F guide sheath<br>with rotating hemostasis valve with Y adapter and stopcock. | 8F guide catheter / 6F<br>guide sheath<br>Y adapter with rotating<br>hemostasis valve (lengths<br>between 6-8 cm) |
| Package Configuration | | | Catheter inserted in a plastic tube, mounted on an insert card, and<br>sealed in a pouch. Sealed pouch packaged in carton along with<br>Instructions for Use. | |
| Sterile & Non-<br>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.