The Wedge XL Delivery Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

Device Description

The Wedge XL Delivery Catheter is a single lumen catheter designed to be introduced over a steerable quidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Radiopaque markers at the distal end facilitate fluoroscopic visualization. A larger diameter distal segment helps provide stability for navigation. The distal 110 cm outer surface of the Wedge XL Delivery Catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Wedge XL Delivery Catheter hub is used for the attachment of accessories.

AI/ML Overview

This document describes the regulatory approval of the MicroVention, Inc. Wedge XL Delivery Catheter (K232542) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and performance data in the typical format of a clinical trial for an AI/software device.

The information provided confirms that the device is a percutaneous catheter, not an AI/software as a medical device (SaMD). Therefore, the questions regarding acceptance criteria and performance studies specifically for AI/Software (e.g., test set, ground truth, expert adjudication, MRMC studies) are not directly applicable in the format requested.

However, I can extract the information relevant to the device's performance testing and general acceptance:

The submission demonstrates the device meets acceptance criteria through a series of bench testing and an animal study, alongside biocompatibility evaluation and sterilization information. The overall acceptance criterion is substantial equivalence to the predicate device (Wedge Microcatheter K172014) and a reference device (Delivery Catheter of the Route 92 Medical 088 Access System K200121).

Here's a breakdown of the provided information within the context of a medical device submission:

Acceptance Criteria and Reported Device Performance (Table Format - Adapted for a Non-AI Device):

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria Met / Reported Performance
Bench Performance	Physical Attributes	All tests passed pre-determined acceptance criteria.
	Surface Contamination	All tests passed pre-determined acceptance criteria.
	Coating Lubricity and Durability	All tests passed pre-determined acceptance criteria.
	Simulated Use (Preparation/Ease of Assembly, Introducer Sheath Insertion, Tracking With/Without Guidewire, Delivery Catheter/Guidewire Lock Up, Catheter Ovalization, Lubricity/Durability of Hydrophilic Coating, Guide Catheter Tracking over Wedge XL Delivery Catheter, Particle Testing)	All tests passed pre-determined acceptance criteria.
	Dynamic Burst Pressure	All tests passed pre-determined acceptance criteria.
	Freedom from Air Leakage	All tests passed pre-determined acceptance criteria.
	Freedom from Liquid Leakage	All tests passed pre-determined acceptance criteria.
	Static Burst Pressure	All tests passed pre-determined acceptance criteria.
	Force at Break	All tests passed pre-determined acceptance criteria.
	Catheter Flexural Fatigue	All tests passed pre-determined acceptance criteria.
	Catheter Particle Testing	All tests passed pre-determined acceptance criteria.
	Kink Resistance	All tests passed pre-determined acceptance criteria.
	Torque Strength	All tests passed pre-determined acceptance criteria.
	Luer-Connector Dimensions and Performance (ISO 80369-7)	All tests passed pre-determined acceptance criteria.
	Radiopacity	Yes (Previously conducted on an equivalent test article).
	Corrosion Resistance	Yes (Previously conducted on an equivalent test article).
Biocompatibility	Cytotoxicity (ISO MEM Elution Test)	Non-cytotoxic (slight reactivity, grade 1).
	Sensitization (ISO Guinea Pig Maximization Test)	Non-sensitizer (no sensitization observed).
	Irritation Reactivity (ISO Intracutaneous Reactivity Test)	Non-irritant (no irritation observed).
	Material Mediated Pyrogenicity (ISO/USP)	Non-pyrogenic (no temperature rise).
	Systemic Toxicity (ISO Acute Systemic Toxicity Test)	No systemic toxicity (no weight loss, mortality, or evidence of systemic toxicity).
	Hemocompatibility (Hemolysis Assay - Extract and Direct Methods, ASTM)	Non-hemolytic (1.2% hemolysis in direct, 0.0% in indirect).
	Hemocompatibility (Complement Activation Assay, ISO)	Non-activator (no activation of SC5b-9).
	Hemocompatibility (Partial Thromboplastin Time (PTT) Test, ASTM)	Non-activator (no significant difference from control).
	Hemocompatibility (Heparinized Blood Platelet and Leukocyte Count Assay, ASTM)	Non-activator (no significant difference from control).
	Hemocompatibility (In-Vitro Blood Loop Assay, ISO)	Thromboresistant (minimal thrombus formation observed).
Animal Study	Safety & Performance (Porcine model, tracking with SOFIA 88 Catheter vs. predicate with SOFIA 6F Catheter)	Performed equally; no remarkable gross findings; comparable histological impact; results consistent with routine catheterization and did not raise safety concerns. Deemed equivalent.

For the points specifically pertaining to AI/ML device studies, the following is direct or inferred from the document:

Sample sizes used for the test set and the data provenance:
- This is not an AI/ML device. For bench testing, samples are typically physical units. For the animal study, it mentions a "porcine model," implying a number of animals were used, but the specific count is not provided. The study followed GLP (Good Laboratory Practice) Regulation (21 CFR Part 58), indicating a controlled, prospective study. The origin is a "porcine model," which is not human data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device. Ground truth for device performance would be established through physical measurements, chemical analyses, and histopathological evaluation by trained personnel (e.g., lab technicians, pathologists) in the animal study, but the specific number and qualifications are not detailed beyond "Good Laboratory Practice (GLP)".
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device.
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 not an an AI-driven or diagnostic device that involves human reader interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For bench testing: Physical measurements, performance metrics based on engineering and material science standards.
- For biocompatibility: Laboratory assays with established controls and reference standards.
- For the animal study: Pathology (histological impact on arterial sections, postmortem examination for gross findings), and outcomes data (safety and performance of catheter tracking, vascular response to device use).
The sample size for the training set:
- Not applicable as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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May 16, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized caduceus symbol. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

MicroVention, Inc. Alick Tan, Ph.D. Associate Principal, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656

Re: K232542

Trade/Device Name: Wedge XL Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: April 15, 2024 Received: April 15, 2024

Dear Alick Tan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Naira Muradyan -S

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

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Indications for Use

510(k) Number (if known) K232542

Device Name Wedge XL Delivery Catheter

Indications for Use (Describe)

The Wedge XL Delivery Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Owner	MicroVention, Inc.35 EnterpriseAliso Viejo, CA 92656Establishment Registration No: 3013556777
Contact Person	Alick Tan, PhDAssociate Principal, Regulatory AffairsTelephone: 949-615-2603Email: alick.tan@microvention.com
Date SummaryPrepared	May 14, 2024
Trade Name	Wedge XL Delivery Catheter
Common Name	Percutaneous Catheter
Classification	Class II, QJP
Predicate Device	Wedge Microcatheter (K172014)
Reference Device	Delivery Catheter of the Route 92 Medical 088 Access System(K200121)

Device Description

Indications for Use

The Wedge XL Delivery Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

Comparison to the Predicate Device

Substantial equivalence of the Wedge XL Delivery Catheter to the predicate device Wedge Microcatheter and to the reference device Delivery Catheter of the Route 92 Medical 088 Access System was established through an evaluation of the intended use, indications for use, principles of operation, device design, materials of construction, and an assessment of usability, safety, and effectiveness via bench and animal studies.

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The Wedge XL Delivery Catheter and the predicate device Wedge Microcatheter (K172014)

have similar intended use,
. use the same principle of operation,
incorporate the same basic design, .
use similar construction and materials, and
are ethylene oxide (EtO)-sterilized and packaged using the same processes. •

Device Comparison Table

	Delivery Catheter ofthe Route 92 Medical088 Access System(K200121)	WedgeMicrocatheter(K172014)	Wedge XL DeliveryCatheter(K232542)
	Reference Device	Predicate Device	Subject Device
Indications forUse	The Route 92 Medical088 Access System,110 cm, is indicatedfor use withcompatible guidecatheters in facilitatingthe insertion andguidance ofmicrocatheters into aselected blood vesselin the neurovascularsystem.	The WedgeMicrocatheter isintended for generalintravascular use,including theperipheral, coronaryand neuro vasculaturefor the infusion ofdiagnostic agents,such as contrastmedia, and to assist inthe delivery ofinterventional devices,such as the SOFIA 6FCatheter, in theneurovasculature.	The Wedge XLDelivery Catheter isintended to assist inthe delivery ofinterventional devices,such as distal accesscatheters, in theneurovasculature.
DeviceClassification	Class IIQJP21 CFR 870.1250	Class IIDQY21 CFR 870.1250	Class IIQJP21 CFR 870.1250
Inner Diameter (ID)	0.019 in.	0.021 in.	Same as predicate(K172014)
Outer Diameter(OD)	Distal 0.080 in.Proximal 0.062 in.	0.028 - 0.034 in.	Distal Tip 0.056 in.Proximal 0.065 in.

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	Delivery Catheter ofthe Route 92 Medical088 Access System(K200121)	WedgeMicrocatheter(K172014)	Wedge XL DeliveryCatheter(K232542)
	Reference Device	Predicate Device	Subject Device
Shapeable Tip	No	Shapeable	No
DistalSegment/Bulb	Yes	Yes	Yes
Bulb OD	0.080 in.	0.064 – 0.068 in.	0.083 in.
Effective/WorkingLength	151 cm	158 – 160 cm	160 cm
Coating	Hydrophilic coating	Hydrophilic coating	Same
Method of Supply	Sterile and single use	Sterile and single use	Same
Method ofSterilization	Ethylene oxide	Ethylene oxide	Same

Performance Testing - Bench

The following bench performance testing was performed to support the design of the Wedge XL Delivery Catheter and demonstrate that it performs as intended. All tests passed the pre-determined acceptance criteria.

Physical Attributes ●
Surface Contamination ●
Coating Lubricity and Durability ●
Simulated Use ●
- Preparation/Ease of Assembly o
- Introducer Sheath Insertion O
- Tracking With/Without Guidewire O
- Delivery Catheter/Guidewire Lock Up O
- Catheter Ovalization O
- Lubricity/Durability of Hydrophilic Coating o
- Guide Catheter Tracking over Wedge XL Delivery Catheter o
- Particle Testing o
Dynamic Burst Pressure ●
Freedom from Air Leakage ●
Freedom from Liquid Leakage ●
Static Burst Pressure ●
Force at Break ●
Catheter Flexural Fatigue ●
Catheter Particle Testing ●
Kink Resistance
. Torque Strength
Luer-Connector Dimensions and Performance Testing per ISO 80369-7 ●

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Radiopacity testing and corrosion resistance testing were previously conducted on a test article that was equivalent to the Wedge XL Delivery Catheter in all aspects relevant to the testing performed, therefore it was deemed unnecessary to repeat the testing for Wedge XL Delivery Catheter.

Biocompatibility Evaluation

Test	Test Summary	Results
Cytotoxicity(ISO MEM ElutionTest)	The test article extract exhibited slight reactivity(grade 1).	Non-cytotoxic
Sensitization (ISOGuinea PigMaximization Test)	No sensitization was observed in the testedanimals.	Non-sensitizer
Irritation Reactivity(ISO IntracutaneousReactivity Test)	No irritation was observed in the testedanimals.	Non-irritant
Material MediatedPyrogenicity(ISO/USP MaterialMediated PyrogenicityTest)	No single animal showed a temperature rise of0.5 °C or more above its baseline temperature.	Non-pyrogenic
Systemic Toxicity (ISOAcute SystemicToxicity Test)	No weight loss, mortality, or evidence ofsystemic toxicity in the tested animals.	No systemic toxicity
HemocompatibilityHemolysis Assay -Extract and DirectMethods(ASTMHemolysis Assay)	The test article demonstrated 1.2% hemolysisin direct contact and 0.0% hemolysis inindirect contact.	Non-hemolytic
HemocompatibilityComplementActivation Assay(ISOHemocompatibility:ComplementActivation Assay(SC5b-9))	The human serum exposed to the test articlefor 60 minutes was found not to activateSC5b-9.	Non-activator

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Test	Test Summary	Results
HemocompatibilityPartial ThromboplastinTime (PTT) Test(ASTMHemocompatibility:Partial ThromboplastinTime (PTT) Assay)	The average clotting time of the test articleshowed no significant difference from thecontrol.	Non-activator
HemocompatibilityHeparinized BloodPlatelet and Leukocyte(ASTMHemocompatibility:Heparinized BloodPlatelet andLeukocyte CountAssay)	The average leukocyte and platelet counts ofthe test article showed no significantdifference from the control.	Non-activator
HemocompatibilityIn-Vitro Blood LoopAssay(ISO In-vitro BloodLoop Assay withComparison Article)	The worst-case sample thrombus observedon the test article showed minimal thrombusformation.	Thromboresistant

Animal Study

Acute, subacute, and chronic animal testing was conducted in accordance with Good Laboratory Practice (GLP) Regulation (21 CFR Part 58) comparing the Wedge XL Delivery Catheter to the predicate Wedge Microcatheter (K172014). The study was designed to assess the safety and performance of catheter tracking in a porcine model. The porcine model was chosen because the vessel sizes allow the insertion and navigation of standard-sized catheters used in humans. Animals were survived to subacute (3 days) and chronic (30 days) time points after procedures to evaluate the vascular response to device use. The study results demonstrated that use of the subject Wedge XL Delivery Catheter with the SOFIA 88 Catheter (K214024) and Wedge Microcatheter with the SOFIA 6F Catheter (K172014, K150366) performed equally in all animal testing. During postmortem examination there were no remarkable gross findings in any of the vessels evaluated with either test or control devices. There was a comparable histological impact of device use on arterial sections in which test and control devices were used. Artery sections subjected to the stiffest segment of the Wedge XL Delivery Catheter exhibited similar tissue responses as to control devices. Overall, the histologic findings were consistent with routine catheterization procedures, which are commonly observed after interventional procedures in porcine models. The results of the animal study did not raise any safety concerns with either the test Wedge XL Delivery Catheter or control Wedge Microcatheter. The devices are deemed equivalent.

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Conclusion

MicroVention concludes based upon the comparison of the device intended use, indications for use, operating principles, technological characteristics, and the review of the performance bench testing, animal study assessments, sterility, and biocompatibility evaluation that the Wedge XL Delivery Catheter is substantially equivalent to the predicate Wedge Microcatheter and performs as intended. Any differences between the subject device and the predicate device do not raise new or different questions of safety and effectiveness.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

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