Merlin Aspiration System
Device Facts
| Record ID | K213771 |
|---|---|
| Device Name | Merlin Aspiration System |
| Applicant | Mivi Neurovascular, Inc. |
| Product Code | DXE · Cardiovascular |
| Decision Date | Jan 27, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Merlin Aspiration Catheter As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombus in the peripheral arterial system. High Flow Tubing As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
Device Story
Merlin Aspiration System comprises Merlin Aspiration Catheter and High Flow Tubing; used for endovascular removal of fresh, soft emboli/thrombi from peripheral arterial system. Catheter introduced via guide catheter/sheath over guidewire to occlusion site under fluoroscopic guidance. High Flow Tubing connects catheter to external aspiration pump; includes flow valve for physician control of vacuum. System provides mechanical aspiration; no active electronic sensing or automated processing. Used in clinical settings by physicians. Benefits include effective thrombus removal, restoring blood flow in peripheral vasculature.
Clinical Evidence
No clinical data. Bench testing included coating particulate/adhesion/uniformity, surface integrity, tip inspection, leakage, dimensional verification, kink resistance, push/track, suction flow rate, thromboemboli aspiration, tensile strength, torque, and burst testing. Animal testing performed in porcine carotid, renal, and subclavian vasculature (n=8).
Technological Characteristics
Single lumen, coiled, variable stiffness catheter; radiopaque markers; hydrophilic coating. High Flow Tubing: PVC with end fittings and flow valve. Sterilization: Ethylene Oxide (EO) per ISO 11135-1:2014. Biocompatibility per ISO 10993-7. Manual operation; no software or electronic components.
Indications for Use
Indicated for removal of fresh, soft emboli and thrombi in the peripheral arterial system. High Flow Tubing indicated to connect guide catheter to aspiration pump.
Regulatory Classification
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Predicate Devices
- Penumbra INDIGO Aspiration System (K161523)
Reference Devices
- MIVI Q Distal Access Catheter (K192558)
Submission Summary (Full Text)
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January 27, 2022
MIVI Neurovascular, Inc. Janel Hurtado Regulatory Affairs Director 6545 City West Parkway Eden Prairie, Minnesota 55443
Re: K213771
Trade/Device Name: Merlin Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: November 24, 2021 Received: December 2, 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.
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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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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)
K213771
Device Name Merlin Aspiration System
Indications for Use (Describe)
· Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system.
· High Flow Tubing
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
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
| Date Prepared: January 24, 2022 | | | | |
|---------------------------------|---------------------------------------------------|-------------------------------|--|--|
| Table 1. General Information | | | | |
| 510(k) Submitter | | Contact | | |
| MIVI Neuroscience, Inc. | | Janel Hurtado | | |
| 6545 City West Parkway | | Regulatory Affairs Director | | |
| Eden Prairie, MN 55344 | | Email: jhurtado@mivineuro.com | | |
| | | | | |
| General Information | | | | |
| Trade Name | Merlin Aspiration System | | | |
| Common Name | Catheter, Embolectomy | | | |
| Classification | Percutaneous catheter; 21 CFR 870.5150 (Class II) | | | |
| Information | ProCode: QEZ | | | |
| | Panel: Cardiovascular | | | |
| Predicate | Penumbra INDIGOTM Aspiration System (K161523) | | | |
| Device | | | | |
| Reference | MIVI Q Distal Access Catheter (K192558) | | | |
| Device | | | | |
## Device Description
The Merlin Aspiration System is comprised of two devices:
- Merlin Aspiration Catheter
- High Flow Tubing
The Merlin Aspiration Catheter is introduced through a guide catheter or long sheath into the peripheral vasculature and guided over a guidewire to the site of primary occlusion. The Merlin Aspiration Catheter is used in conjunction with an aspiration pump, which is connected to High Flow Tubing. These devices are visible under fluoroscopy.
#### Merlin Aspiration Catheter
The Merlin Aspiration Catheter consists of single lumen, coiled construction, variable stiffness shaft with radiopaque markers on distal and proximal end of the catheter portion for angiographic visualization. The Merlin Aspiration Catheter is identical in design to the MIVI Q Distal Access Catheter (K192558).
| Table 2: Device Information | |
|--------------------------------|--------------|
| Device Description | Model Number |
| Merlin Aspiration Catheter, 3F | M3-36 |
| Merlin Aspiration Catheter, 4F | M4-43 |
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| Merlin Aspiration Catheter, 5F | M5-57 |
|--------------------------------|---------|
| Merlin Aspiration Catheter, 6F | M6-69 |
| High Flow Tubing | HFT 110 |
#### High Flow Tubing
The MIVI High Flow Tubing is a sterilized and disposable (onetime use) product consisting of high-pressure PVC tubing with end fittings and an on/off switch. The MIVI High Flow Tubing connects an aspiration pump to a reperfusion catheter, providing a means for introducing vacuum during procedures. The MIVI High Flow Tubing has a flow valve that allows the physician to start and stop the flow of aspiration.
#### Intended Use / Indications
#### ● Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombus in the peripheral arterial system.
- High Flow Tubing ●
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
#### Substantial Equivalence Comparison
Table 3 compares the substantial equivalence of the subject, predicate and reference devices.
| Table-3: Comparison with Predicate Device | | | |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Subject Device<br>Merlin Aspiration<br>System | Predicate Device<br>INDIGO Aspiration<br>System | Reference Device<br>MIVI Q Distal Access<br>Catheter |
| 510(k) Holder &<br>Manufacturer | MIVI Neuroscience, Inc. | Penumbra, Inc. | MIVI Neuroscience, Inc. |
| 510(k)# | K213771 | K161523 | K192558 |
| Product Code | QEZ | QEW | DQY |
| Regulatory Class | Class II | | |
| Regulatory Number | 21 CFR 870.5150 | | |
| Regulatory Name | Percutaneous Catheter | | |
| | Indications / Intended Use / Principle of Operation | | |
| Indications / Intended<br>Use | Merlin Aspiration<br>Catheter<br>As a part of the Merlin<br>Aspiration System, the<br>Merlin Aspiration | INDIGO Aspiration<br>Catheters<br>and Separators<br>As part of the Penumbra<br>Embolectomy Aspiration<br>System | Q Distal Access Catheter is<br>indicated for use with<br>compatible guide catheters in<br>facilitating the insertion<br>and guidance of<br>microcatheters into a selected |
| Table-3: Comparison with Predicate Device | | | |
| Feature | Subject Device<br>Merlin Aspiration<br>System | Predicate Device<br>INDIGO Aspiration<br>System | Reference Device<br>MIVI Q Distal Access<br>Catheter |
| | Catheter is indicated for<br>the removal of fresh, soft<br>emboli and thrombus in<br>the peripheral arterial<br>systems.<br><br>High Flow Tubing<br>As a part of the Merlin<br>Aspiration System, the<br>HFT 110 High Flow<br>Tubing is indicated to<br>connect the guide<br>catheter to an aspiration<br>pump. | (INDIGOTM Aspiration<br>System),<br>the INDIGO Aspiration<br>Catheters<br>and Separators are<br>indicated for<br>the removal of fresh, soft<br>emboli<br>and thrombi from vessels<br>of the<br>peripheral arterial and<br>venous<br>systems.<br><br>INDIGO Aspiration<br>Tubing<br>As part of the Penumbra<br>Embolectomy Aspiration<br>System<br>(INDIGOTM Aspiration<br>System),<br>the INDIGO Sterile<br>Aspiration<br>Tubing is indicated to<br>connect the<br>INDIGO Aspiration<br>Catheters to<br>the Penumbra Pump<br>MAX.<br><br>Penumbra Pump MAX<br>The Penumbra Pump<br>MAX is<br>indicated as a vacuum<br>source for<br>the Penumbra Aspiration<br>System. | blood vessel in the<br>peripheral, coronary and<br>neuro vascular systems. |
| Aspiration Catheter | | | |
| Tip | Straight | Straight | Straight |
| Marker band | Radiopaque | Radiopaque | Radiopaque |
| Catheter Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Guidewire<br>compatibility | Yes | Yes | Yes |
| Catheter Sizes | 3F, 4F, 5F, 6F | 3.4F, 5F, 6F, 8F | 3F, 4F, 5F, 6F |
| Table-3: Comparison with Predicate Device | | | |
| Feature | Subject Device<br>Merlin Aspiration<br>System | Predicate Device<br>INDIGO Aspiration<br>System | Reference Device<br>MIVI Q Distal Access<br>Catheter |
| Total Length (cm) | 148cm,135cm,130cm,130cm | 150cm, 132cm, 135cm, 85cm | 148cm,135cm,130cm,130cm |
| Catheter Biomaterials | Patient contacting<br>materials are listed in<br>Table 11-3 in Section<br>11.7 | Biocompatible,<br>commonly utilized for<br>interventional devices | Same as Merlin Aspiration<br>Catheter |
| Principle of Operation | The principle of operation<br>is for removal of fresh,<br>soft emboli and thrombi<br>in the peripheral arterial<br>system, using an<br>endovascular<br>approach, under<br>fluoroscopy.<br>Contrast is often used<br>during catheter<br>placement. | The principle of operation<br>is for removal of fresh,<br>soft emboli and thrombi<br>in the peripheral arterial<br>and venous system, using<br>an endovascular<br>approach, under<br>fluoroscopy. Contrast is<br>often used during catheter<br>placement. | Used to endovascularly insert<br>and guide microcatheters<br>under fluoroscopy<br>during diagnostic and/or<br>therapeutic procedures for<br>patients with arterial<br>disease or damage |
| Aspiration Tubing | | | |
| Materials | The materials list is<br>provided in listed in<br>Table 11-3 in Section<br>11.7 | Biocompatible,<br>commonly utilized for<br>interventional devices | N/A |
| Inner Diameter (ID) | 0.110 +/- .003 inches | 0.071"- 0.110" [1.8mm –<br>2.8mm] | N/A |
| Length | 112 +/- 3 inches | 112.0 [284.5cm] | N/A |
| Principle of Operation | The High Flow Tubing is<br>a suction tube used to<br>pass fluids from a<br>catheter to a retention<br>canister based on vacuum<br>applied by a pump. It is<br>connected between a<br>commercially available<br>aspiration catheter and a<br>chosen source of<br>vacuum. | Tubing consists of a short<br>tubing segment with an<br>inline filter, and<br>connectors on each end to<br>facilitate attachment to<br>the pump's vacuum port.<br>The tubing is provided<br>pre-attached to the<br>canister reservoir lid. | N/A |
| Accessories / Packaging / Sterilization / Shelf Life / Labeling | | | |
| Provided Accessories | Not provided with any<br>accessories. | Torque Device and<br>Introducer Sheath | Not provided with any<br>accessories |
| Table-3: Comparison with Predicate Device | | | |
| Feature | Subject Device<br>Merlin Aspiration<br>System | Predicate Device<br>INDIGO Aspiration<br>System | Reference Device<br>MIVI Q Distal Access<br>Catheter |
| Required Accessories | 9F Rotating<br>hemostasis<br>valve Y-<br>Connector 8F guide<br>catheter / 6F<br>guide sheath 90-<br>95 cm in length<br>(Required<br>Accessory) | None | 9F Rotating<br>hemostasis valve Y-<br>Connector 8F guide catheter /<br>6F guide sheath 90-<br>95 cm in length<br>(Required<br>Accessory) |
| Package Configuration | Catheter inserted in a<br>plastic tube, mounted on<br>an insert card, and sealed<br>in a pouch. Sealed pouch<br>packaged in carton along<br>with Instructions for Use.<br>High Flow Tubing is<br>placed in a sealed,<br>labeled Tyvek pouch<br>packaged in a labeled<br>box. | Commonly utilized for<br>interventional devices | Catheter inserted in a plastic<br>tube, mounted on an insert<br>card, and sealed in a pouch.<br>Sealed pouch packaged in<br>carton along with Instructions<br>for Use. |
| Sterile & Non-<br>pyrogenic? | Yes | | |
| Sterilization Method | Ethylene Oxide (EO) | | |
| Shelf Life | 3 years | | |
| Single use | Yes | Yes | Yes |
| Labeling | Proposed IFU | Current IFU | Current IFU |
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#### Performance Testing
#### Bench Testing
The Merlin Aspiration System is identical to the MIVI Q Distal Access Catheter (K192558), which has been evaluated through risk analysis and design verification testing, which confirmed the device met design specifications.
Testing includes:
| Table 4: Design Verification Testing | | | |
|--------------------------------------|--------------------------|--|--|
| Merlin Aspiration Catheter | | | |
| Test | Result | | |
| Coating Particulate Testing | Met established criteria | | |
| Coating Adhesion | Met established criteria | | |
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| Coating Uniformity | Met established criteria |
|---------------------------------------------------|--------------------------|
| Surface Integrity | Met established criteria |
| Tip Inspection | Met established criteria |
| Liquid Leakage under Pressure | Met established criteria |
| Dimensional Verification | Met established criteria |
| Kink Resistance | Met established criteria |
| Push/Track | Met established criteria |
| Suction Flow Rate | Met established criteria |
| System Introduction / Aspiration of Thromboemboli | Met established criteria |
| Tensile Strength-Push Wire | Met established criteria |
| Tensile Strength-Distal Section | Met established criteria |
| Catheter Torque Testing | Met established criteria |
| Catheter Burst Testing | Met established criteria |
| High Flow Tubing | |
| Dimensional Verification | Met established criteria |
| Vacuum Pressure | Met established criteria |
| Flow Rate | Met established criteria |
| Degree of Collapse | Met established criteria |
| Simulated Use | Met established criteria |
| Leak Test | Met established criteria |
| Distal Male Luer Tubing Tensile Strength | Met established criteria |
| Female Luer Tubing Tensile Strength | Met established criteria |
| Proximal Male to Tubing Tensile Strength | Met established criteria |
| Connector to Tubing Tensile Strength | Met established criteria |
## Animal Testing
The Animal Testing data was performed in the porcine carotid, renal, and subclavian vasculature of 8 animals to ensure that there are no new questions of safety and effectiveness.
#### Biocompatibility
The MIVI Merlin Aspiration System patient contacting materials are the same materials used in the currently marketed reference device with an identical bio-contact. There is no change to colorants between the subject and reference devices.
#### Sterilization
Each Merlin Aspiration Catheter and High Flow Tubing device meets EO and ECH limits specified in the ISO 10933-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (2008).
The sterilization validation for Merlin Aspiration Catheter and High Flow tubing was validated in accordance with ISO 11135-1: 2014 Sterilization of healthcare product- Ethylene oxide -Part 1: Requirements for development validation and routine control of a sterilization process for medical devices (2014).
## Shelf-life and Expiration Dating
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The Merlin Aspiration System will be labeled with an expiration date of 3 years from the date of sterilization, which is same as predicate and reference devices. There is no change in materials used and this does not impact the shelf-life of the product.
#### Substantial Equivalence Summary and Conclusion
The Merlin Aspiration System and the predicate device, the INDIGO Aspiration System, have identical indications, principles of operation, and a comparable design, but the Merlin catheter is indicated only for peripheral arterial use. While there are technological differences between the Merlin Aspiration System and the predicate device which are related to exclusion of separators, product labeling, and size matrix (3-6F and 130-148 cm lengths for the Merlin catheter, 3.4-8F and 85-150 cm lengths for the INDIGO aspiration catheter, 0.110+/- 0.003 inches ID and 112+/-3 inches length for High Flow Tubing, 0.071-0.110 inches ID and 112.0 inches length for INDIGO Aspiration Tubing), the Merlin Aspiration catheter is identical to currently marketed Q Distal Access catheter reference device in design and materials, and the scope of the change includes an indication change and rebranding. Therefore, the Merlin Aspiration Catheter has been evaluated through risk analysis and design verification testing (DVT). The testing verified the device met the design specifications and is sufficiently robust and suitable for its intended use as the predicate device. Based on the predicate device comparison, risk assessment, and DVT information provided in this 510(k), the subject device has been shown to be appropriate for its intended use and is therefore considered substantially equivalent to the predicate device.
