Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI or ML.

Therapeutic

Yes
The device is indicated for the "removal of fresh, soft emboli and thrombi in the peripheral arterial system," which describes a therapeutic action to treat a medical condition.

Diagnostic

No.
The device is indicated for the removal of emboli and thrombi, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (catheter, tubing) and mentions bench and animal testing of these physical attributes, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
Device Description and Intended Use: The Merlin Aspiration System is a medical device used within the body (in the peripheral arterial system) to physically remove blood clots (emboli and thrombi). It does not analyze samples taken from the body.
Lack of IVD Characteristics: The description focuses on the physical components, their function in a surgical procedure, and performance testing related to mechanical properties and aspiration effectiveness. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.

Therefore, the Merlin Aspiration System is an invasive medical device used for therapeutic purposes, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

QEZ

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).

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

fluoroscopy

Anatomical Site

peripheral arterial system

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

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:
Coating Particulate Testing - Met established criteria
Coating Adhesion - Met established criteria
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.

Key Metrics

Not Found

Predicate Device(s)

Penumbra INDIGOTM Aspiration System (K161523)

Reference Device(s)

MIVI Q Distal Access Catheter (K192558)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

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.

1

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

2

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
Merlin Aspiration
System	Predicate Device
INDIGO Aspiration
System	Reference Device
MIVI Q Distal Access
Catheter
510(k) Holder &
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
Use	Merlin Aspiration
Catheter
As a part of the Merlin
Aspiration System, the
Merlin Aspiration	INDIGO Aspiration
Catheters
and Separators
As part of the Penumbra
Embolectomy Aspiration
System	Q Distal Access Catheter is
indicated for use with
compatible guide catheters in
facilitating the insertion
and guidance of
microcatheters into a selected
Table-3: Comparison with Predicate Device
Feature	Subject Device
Merlin Aspiration
System	Predicate Device
INDIGO Aspiration
System	Reference Device
MIVI Q Distal Access
Catheter
	Catheter is indicated for
the removal of fresh, soft
emboli and thrombus in
the peripheral arterial
systems.

High Flow Tubing
As a part of the Merlin
Aspiration System, the
HFT 110 High Flow
Tubing is indicated to
connect the guide
catheter to an aspiration
pump. | (INDIGOTM Aspiration
System),
the INDIGO Aspiration
Catheters
and Separators are
indicated for
the removal of fresh, soft
emboli
and thrombi from vessels
of the
peripheral arterial and
venous
systems.

INDIGO Aspiration
Tubing
As part of the Penumbra
Embolectomy Aspiration
System
(INDIGOTM Aspiration
System),
the INDIGO Sterile
Aspiration
Tubing is indicated to
connect the
INDIGO Aspiration
Catheters to
the Penumbra Pump
MAX.

5

6

7

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

9

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.