Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance data focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing for decision-making or analysis.

Therapeutic

Yes

The device's intended use is for the non-surgical removal of emboli and thrombi from blood vessels and the injection/aspiration of fluids, directly addressing a medical condition (thrombosis/embolism) through a physical intervention, which aligns with the definition of a therapeutic device.

Diagnostic

No

The device is indicated for the non-surgical removal of emboli and thrombi, and for injection, infusion, and/or aspiration of fluids, which are therapeutic actions, not diagnostic ones. While it mentions fluoroscopic visualization, this is for guidance during a therapeutic procedure, not for disease detection or diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components such as catheters, retrievers, sheaths, syringes, and materials like Nitinol, stainless steel, and polymers. The performance studies also involve bench testing of physical properties and animal studies, indicating a hardware-based device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended use is the non-surgical removal of emboli and thrombi from blood vessels and the injection/infusion/aspiration of fluids into or from blood vessels. This is a therapeutic and interventional procedure performed directly on the patient's body.
Device Description: The device is a mechanical system designed to physically interact with and remove blockages within blood vessels. It involves catheters, retrievers, and aspiration mechanisms.
Lack of In Vitro Activity: An IVD is a device intended for use in the examination of specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis or testing of bodily fluids or tissues outside the body.
Anatomical Site: The device is used within the peripheral vasculature, which is inside the patient's body.

The device is clearly intended for direct therapeutic intervention within the patient's circulatory system, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Laguna Thrombectomy System is indicated for:

The non-surgical removal of emboli and thrombi from blood vessels.
Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Laguna Thrombectomy System is intended for use in the peripheral vasculature.

The Malibu Aspiration Catheter™ System is indicated for:

The non-surgical removal of emboli and thrombi from blood vessels.
Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Malibu Aspiration Catheter™ System is intended for use in the peripheral vasculature.

Product codes (comma separated list FDA assigned to the subject device)

QEW, KRA

Device Description

The Laguna Clot Retriever™ System is a single use, sterile, non-pyrogenic medical device designed for use in the peripheral vasculature. The Laguna Clot Retriever™ System is intended be used in conjunction with the Malibu Aspiration Catheter™ System. The combined use of the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System is referred to as the Laguna Thrombectomy System.

The Laguna Clot Retriever™ is used to engage and retrieve emboli and thrombi into the Malibu Aspiration Catheter™. The Laguna Clot Retriever™ is designed with a flexible pusher attached to a distal self-expanding, laser cut, closed cell design Nitinol structure. The self-expanding portion is delivered inside a delivery sheath. The flexible pusher is designed with stainless steel reinforcement and a polymer. The retriever head is designed with and without radiopaque body markers. The retriever head designed with radiopaque body markers is intended to visualize the expansion and collapse of the Laguna Clot Retriever™.

The Malibu Aspiration Catheter™ System is a single use, sterile, non-pyrogenic medical device designed for use in the peripheral vasculature. The Malibu Aspiration Catheter™ System is intended be used independently and in conjunction with the Laguna Clot Retriever™ System.

The Malibu Aspiration Catheter™ is intended for retrieving thrombi or emboli and/or infusing fluids into the peripheral vasculature. The Malibu Aspiration Catheter™ is designed with a single lumen and comprised of tubes for aspiration and infusion connected proximally to its hub. Two-way flow control valves are located at the end of aspiration and infusion tubes, respectively. The aspiration tube can be connected to a locking vacuum syringe via its two-way valve. Similarly, the infusion tube can be connected to a syringe to infuse fluids through the catheter. The Malibu Aspiration Catheter™ is designed with a radiopaque marker band at the distal tip for fluoroscopic visualization. In addition, the Malibu Aspiration Catheter™ is also available with a second marker band located proximally to the distal marker band. The Malibu Aspiration Catheter™ is supplied with a dilator and a 60cc locking syringe. The Malibu Aspiration Catheter™ incorporates a metallic reinforcement made of stainless steel, an inner liner made of polytetrafluoroethylene, and polymeric jacket material having gradient softness. The distal segment of the Malibu Aspiration Catheter™ is coated with a hydrophilic coating to optimize lubricity and reduce friction.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Data - Bench:
The Laguna Clot Retriever™ System was evaluated for the following:

Dimensional Verification
Visual Inspection
Tensile Strength
Turns to Failure
Coating Integrity
Corrosion Resistance
Kink to Failure
Liquid Leakage
Air Leakage into Hub Assembly
Radial Force
Unsheathing and Resheathing Force
Unsheathing and Resheathing Integrity
Luer Fittings .

The Malibu Aspiration Catheter™ System was evaluated for the following:

Dimensional Verification
Visual Inspection
Tensile Strength
Torque Transmission
Turns to Failure
Coating Integrity
. Corrosion Resistance
Kink to Failure
Liquid Leakage
Air Leakage into Hub Assembly
Lumen Collapse
Luer Fittings

The Laguna Thrombectomy System was evaluated for the following:

. Particulate Evaluation
Usability
. Simulated Use

Performance Data – Animal:
The radiopacity and safety of the Laguna Thrombectomy System was evaluated at acute and chronic time points in a porcine model and was conducted in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.

Performance Data – Clinical:
A determination of substantial equivalence is based upon successful completion of performance data – bench and animal.

Conclusion:
The Laguna Thrombectomy System and Malibu Aspiration Catheter™ System are substantially equivalent to the FlowTriever Retrieval/Aspiration System.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

FlowTriever Retrieval/Aspiration System (K211013)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 1, 2023

Innova Vascular, Inc. Ryan Kenney Director, Regulatory Affairs 15375 Barranca Parkway, B-101 Irvine, California 92618

Re: K223929

Trade/Device Name: Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System (Laguna Thrombectomy System) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: May 2, 2023 Received: May 4, 2023

Dear Ryan Kenney:

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Eleni
For
Whatley -S
Digitally signed by
Eleni Whatley -S
Date: 2023.06.01
20:54:07 -04'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K223929

Device Name

Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System (Laguna Thrombectomy System )

Indications for Use (Describe)

The Laguna Thrombectomy System is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Laguna Thrombectomy System is intended for use in the peripheral vasculature.

The Malibu Aspiration Catheter™ System is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Malibu Aspiration Catheter™ System is intended for use in the peripheral vasculature.

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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K223929

510(k) Summary

Date Prepared:	June 1, 2023
Device Classification Name:	Peripheral Mechanical Thrombectomy with Aspiration
Device Name:	Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System
(Laguna Thrombectomy System)
Applicant:	Innova Vascular, Inc.
15375 Barranca Pkwy Ste B101
Irvine, CA 92618
Applicant Contact:	Ryan Kenney
Director, Regulatory Affairs
Regulation Number:	870.5150
Product Code(s):	QEW, KRA
Regulation Medical Specialty:	Cardiovascular
Review Panel:	Cardiovascular
Predicate Device:	FlowTriever Retrieval/Aspiration System (K211013)

Device Description:

The Laguna Clot Retriever™ System is a single use, sterile, non-pyrogenic medical device designed for use in the peripheral vasculature. The Laguna Clot Retriever™ System is intended be used in conjunction with the Malibu Aspiration Catheter™ System. The combined use of the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System is referred to as the Laguna Thrombectomy System.

The Laguna Clot Retriever™ is used to engage and retrieve emboli and thrombi into the Malibu Aspiration Catheter™. The Laguna Clot Retriever™ is designed with a flexible pusher attached to a distal self-expanding, laser cut, closed cell design Nitinol structure. The self-expanding portion is delivered inside a delivery sheath. The flexible pusher is designed with stainless steel reinforcement and a polymer. The retriever head is designed with and without radiopaque body markers. The retriever head designed with radiopaque body markers is intended to visualize the expansion and collapse of the Laguna Clot Retriever™.

The Malibu Aspiration Catheter™ System is a single use, sterile, non-pyrogenic medical device designed for use in the peripheral vasculature. The Malibu Aspiration Catheter™ System is intended be used independently and in conjunction with the Laguna Clot Retriever™ System.

The Malibu Aspiration Catheter™ is intended for retrieving thrombi or emboli and/or infusing fluids into the peripheral vasculature. The Malibu Aspiration Catheter™ is designed with a single lumen and comprised of tubes for aspiration and infusion connected proximally to its hub. Two-way flow control valves are located at the end of aspiration and infusion tubes, respectively. The aspiration tube can be connected to a locking vacuum syringe via its two-way valve. Similarly, the infusion tube can be connected to a syringe to infuse fluids through the catheter. The Malibu Aspiration Catheter™ is designed with a radiopaque marker band at the distal tip for fluoroscopic visualization. In addition, the Malibu Aspiration Catheter™ is also available with a second marker band located proximally to the distal marker band. The Malibu Aspiration Catheter™ is supplied with a dilator and a 60cc locking

4

innova

syringe. The Malibu Aspiration Catheter™ incorporates a metallic reinforcement made of stainless steel, an inner liner made of polytetrafluoroethylene, and polymeric jacket material having gradient softness. The distal segment of the Malibu Aspiration Catheter™ is coated with a hydrophilic coating to optimize lubricity and reduce friction.

Indications for Use Statement:

The Laguna Thrombectomy System is indicated for:

. The non-surgical removal of emboli and thrombi from blood vessels.
Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Laguna Thrombectomy System is intended for use in the peripheral vasculature.

The Malibu Aspiration Catheter™ System is indicated for:

. The non-surgical removal of emboli and thrombi from blood vessels.
. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Malibu Aspiration Catheter™ System is intended for use in the peripheral vasculature.

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เทกปังค

Comparison of Technological Characteristics:

| | FlowTriever Retrieval/Aspiration System | Laguna Clot Retriever™ System/Malibu Aspiration Catheter™ System
(Laguna Thrombectomy System) |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device | Subject Device |
| 510(k) Number: | K211013 | K223929 |
| Product Code(s): | QEW, KRA | Same as K211013 |
| Indications for Use
Statement: | The FlowTriever Retrieval/Aspiration System is indicated for:
The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters. | The Laguna Thrombectomy System is indicated for:
The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Laguna Thrombectomy System is intended for use in the peripheral vasculature.

6

เททปองค

K223929

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Image /page/7/Picture/0 description: The image shows the word "innova" in a stylized font. The letters are brown, and the "o" is replaced with a brown teardrop shape with an orange circle inside. The teardrop shape is slightly taller than the other letters.

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INNOVA

Sterilization:

The Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System are ethylene oxide sterilized. The Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System met the requirements for ethylene oxide and ethylene chlorohydrin residuals per ISO 10993-7:2008/Amd1:2019. In addition, the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System met the requirements for bacterial endotoxin per AAMI/ANSI ST72:2019.

Shelf-Life:

The Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System have a shelf-life of one (1) year.

Biocompatibility:

Biocompatibility was conducted for the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System to meet the requirements of ISO 10993-1:2018 and Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1. The following biological endpoints were evaluated:

Cytotoxicity
Sensitization
Intracutaneous Reactivity ●
Acute Systemic Toxicity ●
Material-Mediated Pyrogenicity
Hemocompatibility
- o Hemolysis
- o Complement Activation
- o Thrombogenicity

Performance Data - Bench:

The Laguna Clot Retriever™ System was evaluated for the following:

Dimensional Verification ●
Visual Inspection
Tensile Strength ●
Turns to Failure ●
Coating Integrity
Corrosion Resistance
Kink to Failure ●
Liquid Leakage ●
Air Leakage into Hub Assembly
Radial Force
Unsheathing and Resheathing Force ●
Unsheathing and Resheathing Integrity
Luer Fittings .

The Malibu Aspiration Catheter™ System was evaluated for the following:

Dimensional Verification
Visual Inspection
Tensile Strength
Torque Transmission ●
Turns to Failure
Coating Integrity
. Corrosion Resistance
Kink to Failure
Liquid Leakage ●
Air Leakage into Hub Assembly ●
Lumen Collapse
Luer Fittings ●

9

innova

The Laguna Thrombectomy System was evaluated for the following:

. Particulate Evaluation
Usability
. Simulated Use

Performance Data – Animal:

The radiopacity and safety of the Laguna Thrombectomy System was evaluated at acute and chronic time points in a porcine model and was conducted in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.

Performance Data – Clinical:

A determination of substantial equivalence is based upon successful completion of performance data – bench and animal.

Conclusion:

The Laguna Thrombectomy System and Malibu Aspiration Catheter™ System are substantially equivalent to the FlowTriever Retrieval/Aspiration System.