The EmPro™ EPS/Nanoparasol™ EPS is indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the filter placement should be between 3.0 and 6.5 mm.

Device Description

MicroVention's Embolic Protection System (EPS) is marketed under two names: EmPro™ Embolic Protection System and Nanoparasol™ Embolic Protection System. The Embolic Protection System (EPS) is designed to capture and remove dislodged debris during a carotid interventional procedure. It consists of three basic components and additional accessories:

An Embolic Protection Device (EPD) consisting of a nitinol braided mesh filter with an atraumatic distal tip built on an integrated .014" PTFE coated stainless steel capture delivery wire.
A 3.5F delivery catheter with 150 cm length.
A 5F retrieval catheter with 150 cm working length. Accessories include a wire introducer, EPD loading cover, sheath introducer and a torque device. Catheters are provided in two separate dispenser coils.

AI/ML Overview

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the EmPro™ EPS/Nanoparasol™ EPS. This device is an embolic protection system indicated for use as a guidewire to contain and remove embolic material during angioplasty and stenting procedures in carotid arteries.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (EmPro™/Nanoparasol™ EPS)
Primary Endpoint: Major Adverse Event (MAE) rate (Death, Stroke, or MI within 30 days of index procedure + ipsilateral stroke 31-365 days after procedure) upper limit of 95% exact binomial CI below PG of 13.9%	MAE rate: 5.9% (95% exact binomial CI: 3.89, 10.69); p=0.0014. Upper limit of 95% CI was 9.22%, which was below the PG of 13.9%.
Embolic Protection System (EPS) technical success	98.8% (253/256) of subjects.
EPS successfully inserted	99.6% (255/256)
EPS successfully deployed in subject	98.8% (253/256)
EPS successfully retrieved	99.6% (255/256)
Vessel dissection at EPS filter site	0
Neurological assessments (in animal study)	All animals met the acceptance criteria for neurological assessments at both timepoints (30 and 180 days post-operatively).
Histological analysis of local tissues (in animal study)	Showed negligible vessel injury, inflammation, and neointimal response where the EPD was deployed.
Performance scores (in animal study)	Met or exceeded acceptance criteria in both intervention groups.

2. Sample size used for the test set and the data provenance

Sample Size for Clinical Study (Test Set): 256 patients (n=256) in the Intent-To-Treat (ITT) population.
Data Provenance: The study was a "multicenter, single-arm, interventional study" called the CONFIDENCE study (IDE G140249). While the specific countries are not mentioned, FDA submissions typically involve studies conducted in the US or under equivalent international standards. The study design is prospective.
Sample Size for Animal Study: 6 animals (porcine model).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study's endpoint definitions (MAE, technical success). Clinical trials typically involve a clinical events committee (CEC) composed of expert physicians to independently adjudicate events like death, stroke, and MI, but this level of detail is not provided in this regulatory summary.

For the animal study, the document mentions "histological analysis" and "neurological assessments" were performed, implying expert evaluation, but the number and specific qualifications of the experts are not detailed.

4. Adjudication method for the test set

The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the clinical study's primary and secondary endpoints. For a multi-center clinical study with composite endpoints like MAE, it is standard practice to have a Clinical Events Committee (CEC) adjudicate events, often with multiple readers and a pre-defined adjudication process, but the specifics are not provided here.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an embolic protection system, not an AI-powered diagnostic tool, so such a study would not be applicable. The performance evaluated relates to the mechanical and clinical outcomes of the device itself and its ability to capture emboli, not human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (an embolic protection system), not an algorithm or AI system. Its performance is evaluated in vivo (animal and human clinical studies) and in vitro (bench testing), not as a standalone algorithm.

7. The type of ground truth used

Clinical Study (CONFIDENCE study): The ground truth for the primary endpoint (MAE) was based on clinical outcomes: death, stroke, and myocardial infarction (MI), confirmed by medical records and follow-up. For secondary endpoints like technical success (e.g., EPS successfully inserted, deployed, retrieved), the ground truth would be based on procedural observations and documentation. This represents outcomes data and procedural success data.
Animal Study: Ground truth was established through direct observation during intervention (e.g., tracking, deployment, retrieval), post-intervention assessment (thrombus formation, particulate capture, device damage, neurological dysfunction), and post-explantation histopathology/histology to evaluate tissue response.

8. The sample size for the training set

This document does not describe a "training set" in the context of an AI/ML model. The studies described are for the validation and performance evaluation of a physical medical device. Therefore, a training set sample size, as understood in AI/ML development, is not applicable or provided.

9. How the ground truth for the training set was established

As there is no mention of a "training set" for an AI/ML model, this question is not applicable. The device's design and engineering would have been informed by a vast amount of existing medical knowledge, material science, and prior device development, rather than a specific "training set" with established ground truth in the AI/ML sense.

Summary

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April 27, 2023

MicroVention, Inc. Sapna Singh Director, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656

Re: K222694

Trade/Device Name: EmPro EPSTM (EP4514C-190, EP6514C-190): NanoparasolTM EPS (PNP4514C-190,PNP6514C-190) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: March 27, 2023 Received: March 28, 2023

Dear Ms. Singh:

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,

Digitally signed by Finn E. Finn E. Donaldson -S Donaldson -S Pate: 2023.04.27 14:30:34 -04'00'

For Misti Malone 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) K222694

Device Name

EmPro™ EPS (EP4514C-190 and EP6514C-190); Nanoparasol™ EPS (NP4514C-190 and NP6514C-190)

Indications for Use (Describe)

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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510(k) Summary

I. SUBMITTER

MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 Establishment Registration No: 3013556777

Contact Person: Sapna Singh Regulatory Affairs, Director Telephone: (714)-247-8162 Email: sapna.singh(@microvention.com Date Prepared: March 27, 2023

II. DEVICE

Trade Names: EmPro™ Embolic Protection System (EP4514C-190, EP6514C-190); Nanoparasol™ Embolic Protection System (PNP4514C-190, PNP6514C-190)

Common Name: Embolic Protection System

Classification Name: 21 CFR 870.1250

Regulatory Class: II

Product Code: NTE

III. PREDICATE DEVICE

SpiderFX® Embolic Protection Device, K063204, EV3, Inc.

No reference devices were used in this submission

IV. DEVICE DESCRIPTION

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An Embolic Protection Device (EPD) consisting of a nitinol braided mesh filter with an atraumatic distal tip built on an integrated .014" PTFE coated stainless steel capture delivery wire.
A 3.5F delivery catheter with 150 cm length.
A 5F retrieval catheter with 150 cm working length. Accessories include a wire introducer, EPD loading cover, sheath introducer and a torque device. Catheters are provided in two separate dispenser coils.

The EmPro/Nanoparasol EPS is used in conjunction with a primary .014" compatible wire (not included in package) with the rapid exchange port to gain access across the .014" integrated Capture delivery wire is used as the primary guidewire for interventional devices such as a stent or PTA balloon catheter compatible with a .014" or .018" wire. The EPD loading cover protects the filter, is used to flush and load the filter into the delivery catheter.

Subject Device	CatalogueNumber	LabeledFilterSize(mm)	UnconstrainedFilter OD (mm)	FilterLength (in)	ReferenceVesselDiameter(mm)
EmPro™ EPS	EP4514C-190	4.5	5.2	0.42	3.5 – 4.5
EmPro™ EPS	EP6514C-190	6.5	7.2	0.52	4.5 - 6.5
Nanoparasol™ EPS	NP4514C-190	4.5	5.2	0.42	3.5 - 4.5
Nanoparasol™ EPS	NP6514C-190	6.5	7.2	0.52	4.5 – 6.5

Table 1: Device Information

V. INDICATIONS FOR USE

VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Substantial equivalence of the EmPro™ EPS/Nanoparasol™ EPS to the SpiderFX® Embolic Protection Device was established through comparison of technological characteristics in terms of intended use, principle of operation, and fundamental design, comparative bench testing including functional and performance testing between subject and predicate devices and via animal and clinical studies.

The testing demonstrated demonstrates the technological similarity and equivalency of the subject and predicate devices. The devices have intended use, use the same principle of operation, incorporate the same basic design, use similar construction and material, and are EtO-sterilized (Table 2).

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Table 2: Device Comparison Table

	SpiderFX® Embolic Protection Device(K063204)	EmPro™ EPS/Nanoparasol™ EPS
	Predicate Device	Subject Device
Indications for Use	The SpiderFX® Embolic ProtectionDevice is indicated for use as aguidewire and embolic protection systemto contain and remove embolic material(thrombus/debris) while performingangioplasty and stenting procedures incarotid arteries. The diameter of theartery at the site of the filter placementshould be between 3.0mm and 7.0mm.	The EmPro™ EPS/Nanoparasol™ EPSis indicated for use as a guidewire tocontain and remove embolic material(thrombus/debris) while performingangioplasty and stenting procedures incarotid arteries. The diameter of theartery at the site of the filter placementshould be between 3.0 and 6.5 mm.
Device Classification	Class II, Temporary Carotid Catheter forEmbolic Capture	Class II, Temporary Carotid Catheterfor Embolic Capture
	NTE	NTE
	21 CFR 870.1250	21 CFR 870.1250
Device Components	embolic protection device (EPD)	embolic protection device (EPD)
	dual ended catheter for delivery andretrieval	separate catheter for delivery andretrieval
Embolic ProtectionDevice (Filter) Designand Materials	Nitinol mesh filter with 23 gauge blunttip needle mounted on a 0.014" PTFEcoated stainless steel guidewire	Nitinol mesh filter with an atraumaticdistal tip built on an integrated .014"PTFE coated stainless steel capturedelivery wire.
Filter Configuration	Eccentric	Concentric
Average Pore Size (mm)	245	177
Filter BasketUnconstrained OD(mm)	3.0,4.0,5.0,6.0 and 7.0	5.2 and 7.2
Filter Basket Length(cm)	2.7	2.0 and 2.3
Wire OD (in)	.014	.014
Overall Length (cm)	190 or 320	194
Wire Coating	PTFE	PTFE
Radiopaque Markers	Yes	Yes

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Delivery Catheter Type	Rapid exchange	Peel away, rapid exchange
Delivery Catheter OD(Fr)	3.1	3.5
Delivery Catheter RXSection Length (cm)	25	30
Delivery CatheterWorking Length (cm)	140	150
Retrieval Catheter OD(Fr)	4.2	5.0
Retrieval Catheter RXSection Length (cm)	25	30
Retrieval CatheterWorking Length (cm)	140	150
Accessories	Introducer sheath and shaping mandrel	- wire introducer- EPD loading cover- sheath introducer- torque device
Method of Supply	Sterile and single use	Sterile and single use
Sterilization Method	Ethylene oxide	Ethylene oxide

VII. PERFORMANCE DATA

The following performance data were provided to demonstrate substantial equivalence:

Sterilization validation .
. EO residuals
. Package integrity (visual inspection, dye penetration, and seal strength)
. Shelf-life
Biocompatibility per ISO 10993-1 ●
. Mechanical testing
- o Dimensional verification
- Deployment/retrieval force o
- o EPD retrieval test
- 0 Peel away test
- Tensile strength O
- Torque test O
- Buckle test о

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Tracking/kink resistance O
Particulate capture o
Coating adherence o
Radial force o
Filter capacity o
Simulated use o

Animal Study

The in vivo performance and safety of the EPD was evaluated in the porcine model. Six (6) animals were subjected to interventional treatment and devices were explanted 30 days post-operatively (4 animals) or 180 days post-operatively (2 animals). The following performance characteristics were evaluated during the intervention: preparation and introduction, tracking, deployment force, radiopacity, wall apposition, blood flowrate, device stability, retrieval force, vessel irregularities, and post intervention cine time. Postintervention, thrombus formation, particulate capture, filter/stent damage, and neurological dysfunction were evaluated. In addition, histology was performed to evaluate impact of product use on local tissues. Results of the study demonstrate that the EPD performs as intended. The performance scores met or exceeded acceptance criteria is both intervention groups and all animals met the acceptance criteria for neurological assessments at both timepoints. Histological analysis of local tissues showed negligible vessel injury, inflammation, and neointimal response where the EPD was deployed.

Clinical Study

The CONFIDENCE study (IDE G140249) was a multicenter, single-arm, interventional study designed to evaluate the safety and effectiveness of the Casper™ Carotid Artery Stent used in conjunction with the EmPro™Manoparasol™ EPS in patients at high risk for adverse events from carotid endarterectomy (CEA) who required carotid revascularization. All patients with qualifying carotid artery stenosis (n = 256) were treated with the devices. The primary endpoint was the Major Adverse Event (MAE) composite consisting of death, stroke, or MI within 30 days of the index procedure plus ipsilateral stroke between 31 days and 12 months. The secondary endpoints included procedure success and technical success of the Casper™ Roadsaver™ Carotid Artery Stent and EmPro™/Nanoparasol™ EPS technical success.

In the Intent-To-Treat (ITT) population, the mean (SD) age was 69.6 (6.8) years, and the majority of the subjects were male (65.2% [n=167]). 95.3% [n=244] of subjects were not of Hispanic or Latino; 4.7% of subjects identified themselves as Hispanic or Latino. 91% [n=233] of subjects were white; 4.3% (n=11) identified themselves as Black or African American. Overall, these demographic characteristics are consistent with a typical cohort of subjects with carotid artery stenosis at high operative risk for CEA.

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The primary endpoint was MAE, a composite measure of death, stroke, or MI within 30 days of the index procedure plus ipsilateral stroke 31-365 days after the procedure In the ITT population, 15 patients (5.9% [95% exact binomial CI: 3.89, 10.69]; p=0.0014) experienced a MAE. In the ITT analysis using multiple imputations for subjects who discontinued prematurely, the MAE rate was 6.2% (16/256). The upper limit of the 95% exact binomial CI was 9.22%, which was below the PG of 13.9%. Thus, the primary endpoint of the study was met.

Secondary endpoints include technical success and procedure success of the stent and embolic protection device technical success. EmPro™Nanoparasol™ EPS technical success was achieved in 98.8% (253/256) of subjects.

Table 3: EmPro™/Nanoparasol™ EPS PerformanceAnalysis	ITT PopulationN=256(%)
EPS successfully inserted	255 (99.6%)
EPS successfully deployed in subject (Technical Success)	253 (98.8%)
EPS successfully retrieved	255 (99.6%)
Vessel dissection at EPS filter site	0

General safety results: With respect to the EmPro™Nanoparasol™ EPS, one patient had an SAE most likely due to a strong relationship to the device. This SAE was a Nervous System Disorder (Cerebrovascular Accident).

VIII. CONCLUSION

MicroVention concludes through a review of the non-clinical studies, the comparison of the device classification, indications for use, operating principle, and technological characteristics, that the subject device, EmPro™ EPS/Nanoparasol™ EPS is substantially equivalent to the predicate, SpiderFX® Embolic Protection Device. Any differences between the subject device and the predicate device do not raise 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).