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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System (Laguna Thrombectomy System). It details the device's indications for use, device description, comparison to a predicate device, and performance data from bench and animal studies to support substantial equivalence.

However, the document does not contain information about clinical studies with human subjects, acceptance criteria in the context of clinical performance, sample sizes for test sets in human studies, data provenance, expert adjudication for ground truth, MRMC studies, standalone algorithm performance, or details on training sets. The document explicitly states: "A determination of substantial equivalence is based upon successful completion of performance data – bench and animal." This means clinical performance data from human studies or AI performance metrics are not part of this submission for substantial equivalence.

Therefore, many of the requested details, particularly those related to human clinical performance and AI algorithm validation, cannot be extracted from this document.

Here's what can be gathered from the provided text:

Reported Device Performance (from bench and animal studies):

The document lists various performance evaluations conducted for the device. These are primarily related to physical and mechanical characteristics and initial safety in an animal model.

Acceptance Criteria (Implied by testing done)	Reported Device Performance (Summary of testing performed)
Sterilization requirements per ISO 10993-7:2008/Amd1:2019 (Ethylene Oxide and Ethylene Chlorohydrin residuals) and AAMI/ANSI ST72:2019 (Bacterial Endotoxin)	Met the requirements for ethylene oxide and ethylene chlorohydrin residuals. Met the requirements for bacterial endotoxin.
Shelf-life stability (1 year)	Device has a shelf-life of one (1) year.
Biocompatibility per ISO 10993-1:2018 and FDA guidance	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity) were evaluated and presumably met standards. (No specific numerical results provided)
Mechanical and physical performance (Laguna Clot Retriever™ System)	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 were evaluated. (No specific numerical results or pass/fail stated explicitly, only that they were "evaluated").
Mechanical and physical performance (Malibu Aspiration Catheter™ System)	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 were evaluated. (No specific numerical results or pass/fail stated explicitly, only that they were "evaluated").
System-level performance (Laguna Thrombectomy System)	Particulate Evaluation, Usability, Simulated Use were evaluated. (No specific numerical results or pass/fail stated explicitly, only that they were "evaluated").
Radiopacity and safety in vivo	Evaluated at acute and chronic time points in a porcine model; conducted in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies. (No specific numerical results or detailed findings provided).

Information Not Available in the Document:

Given that the determination of substantial equivalence was based solely on bench and animal performance data, the following questions cannot be answered from the provided text:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No human clinical test set data is mentioned. The animal study was done in a porcine model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no human clinical test set or AI performance data requiring expert ground truth is presented.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device (catheter/retriever system), not an AI diagnostic algorithm, and no human clinical effectiveness study is described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the animal study, the ground truth would be based on ex-vivo analysis of the animal tissue/vessels and potentially imaging, but not "expert consensus" in the diagnostic sense or pathology for human disease.
The sample size for the training set: Not applicable, as this is hardware, not an AI algorithm.
How the ground truth for the training set was established: Not applicable.

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

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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 (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 B101Irvine, CA 92618
Applicant Contact:	Ryan KenneyDirector, 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:

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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 UseStatement:	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.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™ is intended for use in the peripheral vasculature
	FlowTriever Catheter/Laguna Clot Retriever™ System – Dimensional
Size(Vessel Diameter Range)	S (6 – 10 mm)M (11 – 14 mm)L (15 – 18 mm)XL (19 – 25 mm)	10 mm (≥ 6 mm)14 mm (≥ 10 mm)
Outer Diameter	4 mm	10 mm: 3.1 mm14 mm: 4 mm
	FlowTriever Retrieval/Aspiration System	Laguna Clot Retriever™ System/Malibu Aspiration Catheter™ System(Laguna Thrombectomy System)
	Predicate Device	Subject Device
Usable Length	115 cm	10 mm: 127 cm14 mm: 119 cm
Guidewire Compatibility	0.035"	Same
	FlowTriever Catheter/Laguna Clot Retriever™ System - Material
Self-Expanding NitinolRetriever	Yes	Same
Polymeric DeliverySheath	Yes	Same
	FlowTriever Catheter/Laguna Clot Retriever™ System - Supplied
Non-Pyrogenic	Yes	Same
Sterile	Ethylene Oxide	Same
Single Use	Yes	Same
	Triever Aspiration Catheter/Malibu Aspiration Catheter™ System - Dimensional
Outer Diameter	16 Fr	12 Fr
	20 Fr	16 Fr
	24 Fr	20 Fr
		24 Fr
Usable length	16 Fr: 107 cm20 Fr: 90 cm24 Fr: 90 cm	12 Fr: 115 cm16 Fr: 107 cm20 Fr: 100 cm24 Fr: 90 cm
Guidewire Compatibility	0.035"	Same
	Triever Aspiration Catheter/Malibu Aspiration Catheter™ System - Material
Polymeric Jacket withMultiple Durometers	Yes	Same
Metallic Reinforcement	Yes	Same
Liner	Yes	Same
	Triever Aspiration Catheter/Malibu Aspiration Catheter™ System - Packaged With
Dilator	Yes	Same
Syringe	Yes	Same
	FlowTriever Retrieval/Aspiration System	Laguna Clot Retriever™ System/Malibu Aspiration Catheter™ System(Laguna Thrombectomy System)
	Predicate Device	Subject Device
Triever Aspiration Catheter/Malibu Aspiration Catheter™ System - Supplied
Non-Pyrogenic	Yes	Same
Sterile	Ethylene Oxide	Same
Single Use	Yes	Same

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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 ●

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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.

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).