MIVI Q Distal Access Catheter

K212402 · Mivi Neuroscience, Inc. · QJP · Dec 16, 2021 · Cardiovascular

Device Facts

• Record ID: K212402
• Device Name: MIVI Q Distal Access Catheter
• Applicant: Mivi Neuroscience, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Dec 16, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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 Story

Single-lumen, variable stiffness catheter; used to facilitate insertion/guidance of microcatheters into peripheral, coronary, or neurovascular vessels. Input: manual manipulation by physician under fluoroscopic guidance. Operation: catheter introduced via 8F guide catheter/6F guide sheath; advanced over guidewire/microcatheter; stainless-steel control wire and docking station facilitate movement; hydrophilic coating reduces friction. Output: physical placement of microcatheter at target vessel site. Used in clinical settings (e.g., cath lab) by physicians. Benefits: enables access to distal vasculature for diagnostic/therapeutic interventions.

Clinical Evidence

Bench testing only. Testing included dimensional verification, simulated use (system introduction), liquid leakage under pressure, and tensile strength. Biocompatibility testing included cytotoxicity, irritation/intracutaneous reactivity, sensitization, acute systemic toxicity, pyrogenicity, hemolysis, unactivated partial thromboplastin time, and complement activation. All tests passed.

Technological Characteristics

Single-lumen, variable stiffness catheter; stainless-steel control wire; hydrophilic coating; radiopaque markers (distal/proximal). Sizes: 3F, 4F, 5F, 6F. Sterilization: Ethylene Oxide (EO). Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring endovascular insertion and guidance of microcatheters into peripheral, coronary, or neurovascular vessels during diagnostic or therapeutic procedures for 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 Q Distal Access Catheter (K192558)

Submission Summary (Full Text)

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

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.

**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.<br>6545 City West Parkway<br>Eden Prairie, MN 55344<br>[phone] | Janel Hurtado<br>Regulatory Affairs Director<br>Email: [e-mail]<br>[phone] |
| General Information | | |
| Trade Name | MIVI Q Distal Access Catheter | |
| Common Name | Distal access catheter | |
| Classification<br>Information | Device Classification: Class II<br>Common Name: Percutaneous catheter<br>Regulation Number: 21 CFR 870.1250<br>Product Code: QJP; Panel: Neurology<br>Product Code: DQY; Panel: Cardiovascular | |
| Predicate Device | MIVI Q Distal Access Catheter (K192558; April 6, 2020) | |

## 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.

### Intended Use / Indications for Use

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.

### 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 Device<br>MIVI Q Distal Access Catheter | Predicate Device<br>MIVI Q Distal Access Catheter | |
| 510(k) Holder &<br>Manufacturer | MIVI Neuroscience, Inc. | MIVI Neuroscience, Inc. | |
| 510(k)# | K212402 | K192558 | |
| Table 1: Comparison with Currently Marketed Predicate | | | |
| Feature | Subject Device<br>MIVI Q Distal Access Catheter | Predicate Device<br>MIVI Q Distal Access Catheter | |
| Classification<br>Information | Percutaneous catheter<br>21 CFR 870.1250 (Class II)<br>ProCode: QJP, DQY | | |
| Indications / Intended Use / Principle of Operation | | | |
| Indications for Use | The MIVI Q Distal Access<br>Catheter is indicated for use with<br>compatible guide catheters in<br>facilitating the insertion and<br>guidance of microcatheters into a<br>selected blood vessel in the<br>peripheral, coronary and neuro<br>vascular systems. | The Q Catheter is indicated for use<br>with compatible guide catheters in<br>facilitating the insertion and<br>guidance of microcatheters into a<br>selected blood vessel in the<br>peripheral, coronary and neuro<br>vascular systems. | |
| Principle of<br>Operation | Used to endovascularly insert and guide microcatheters under fluoroscopy<br>during diagnostic and/or therapeutic procedures for patients with arterial<br>disease or damage. | | |
| Design Information | | | |
| Configuration | Distal | Single-lumen, variable stiffness, braided (5F & 6F) / coiled (3F & 4F) | |
| | Proximal | Control (push) wire through a<br>Docking Station assembly | |
| | Tip | Straight | |
| | Radiopaque<br>Markers | Two (2) - Distal and Proximal | |
| | Catheter<br>Coating | Hydrophilic | |
| | Catheter Sizes | 3F, 4F, 5F, 6F | |
| | | | |
| | 3F | 154 | 148 |
| | 4F | 141 | 135 |
| Total Length<br>(cm) | 5F | 136 | 130 |
| | 6F | 136 | 130 |
| | | | |
| | | | |
| Extensible Length | | | |
| | 3F | 40-42 | |
| | 4F | 27-29 | |
| Extensible length (cm) with:<br>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 Wire<br>Length | 108 | 104 | |
| Table 1: Comparison with Currently Marketed Predicate | | | |
| Feature | Subject Device<br>MIVI Q Distal Access Catheter | Predicate Device<br>MIVI Q Distal Access Catheter | |
| Pin Vise Shape | Looped shape (Pin Vise not removable) | | |
| Guidewire<br>Compatibility<br>(cm) | 3F | 0.018" | |
| | 4F | 0.035" | |
| | 5F | | |
| | 6F | | |
| Catheter<br>Biomaterials | Patient contacting materials are identical between the subject and currently<br>marketed predicate and accessories. | | |
| Accessories / Packaging / Sterilization / Shelf Life | | | |
| Provided Accessories | 9F Rotating Hemostasis Valve Y-Connector | None | |
| Required Accessories<br>(not provided) | 8F guide catheter / 6F guide sheath 90-95 cm in length | | |
| Package<br>Configuration | Catheter inserted in a plastic tube, mounted on an insert card, and sealed in<br>a pouch. Sealed pouch packaged in carton along with Instructions for Use. | | |
| Sterile & Non-<br>pyrogenic | Yes | | |
| Sterilization Method | | Ethylene Oxide (EO) | |
| Shelf Life | | 3 years | |

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# P a g e | 2

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# Page | 3

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 |
|----------------------------------------|--------------------------------------------------|--------|
| Dimensional<br>Verification | The device must meet dimensional specifications. | Pass |
| System Introduction (Simulated<br>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 |

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### Page | 4

### 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 24<br>hours and administered on mouse fibroblast L929 cells. | PASS |
| Irritation or Intracutaneous<br>Reactivity | Extracted with 0.9% NaCl and cottonseed oil (CSO) at<br>37 °C for 72 hours and intracutaneously injected in<br>rabbits. | 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 72<br>hours and injected in mice. | PASS |
| Pyrogenicity (Material-<br>mediated) | Extracted with 0.9% NaCl at 37 °C for 72 hours and<br>injected intravenously in rabbits. | PASS |
| Hemolysis | Extracted from PBS at 37 °C for 24 hours, administered<br>on rabbit blood; or directly contacting rabbit blood in<br>vitro. | PASS |
| Unactivated Partial<br>Thromboplastin Time | Human plasma was exposed to the test article at a ratio of<br>6 cm2/ml for 15 minutes at 37 °C. | PASS |
| Complement Activation | Human plasma was exposed to the test article at a<br>ratio 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.