(233 days)
No reference devices were used in this submission
No
The device description and performance studies focus on the mechanical components and clinical outcomes of an embolic protection system, with no mention of AI or ML technologies.
Yes
The device is described as an Embolic Protection System (EPS) which is used to contain and remove embolic material during angioplasty and stenting procedures, directly treating a medical condition.
No
This device is an embolic protection system designed to capture and remove dislodged debris during interventional procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a guidewire, filter, delivery catheter, and retrieval catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used during a medical procedure (angioplasty and stenting) to physically capture and remove embolic material from the carotid arteries. This is a therapeutic and interventional use, not a diagnostic one.
- Device Description: The description details a physical device (filter, wires, catheters) designed for mechanical action within the body. This aligns with a medical device used for treatment or intervention, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, tissue, etc.) to provide diagnostic information about a patient's condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on a physical intervention within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
NTE
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries
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
Performance Data:
- Sterilization validation
- EO residuals
- Package integrity (visual inspection, dye penetration, and seal strength)
- Shelf-life
- Biocompatibility per ISO 10993-1
- Mechanical testing: Dimensional verification, Deployment/retrieval force, EPD retrieval test, Peel away test, Tensile strength, Torque test, Buckle test, Tracking/kink resistance, Particulate capture, Coating adherence, Radial force, Filter capacity, Simulated use
Animal Study:
- Study Type: In vivo performance and safety evaluation.
- Sample Size: 6 porcine animals.
- Data Source: Porcine model.
- Protocol: Devices were explanted 30 days post-operatively (4 animals) or 180 days post-operatively (2 animals). Evaluated performance characteristics during intervention: preparation and introduction, tracking, deployment force, radiopacity, wall apposition, blood flowrate, device stability, retrieval force, vessel irregularities, and post intervention cine time. Post-intervention, evaluated thrombus formation, particulate capture, filter/stent damage, and neurological dysfunction. Histology performed to evaluate impact on local tissues.
- Key Results: EPD performs as intended. Performance scores met or exceeded acceptance criteria in both intervention groups. All animals met acceptance criteria for neurological assessments at both timepoints. Histological analysis showed negligible vessel injury, inflammation, and neointimal response where the EPD was deployed.
Clinical Study (CONFIDENCE study):
- Study Type: Multicenter, single-arm, interventional study.
- Sample Size: 256 patients with qualifying carotid artery stenosis.
- Data Source: Patients requiring carotid revascularization, considered at high risk for adverse events from carotid endarterectomy (CEA).
- Protocol: Evaluated safety and effectiveness of the Casper™ Carotid Artery Stent used in conjunction with the EmPro™/Nanoparasol™ EPS.
- Primary Endpoint: Major Adverse Event (MAE) composite of death, stroke, or MI within 30 days of the index procedure plus ipsilateral stroke between 31 days and 12 months.
- Secondary Endpoints: Procedure success and technical success of the Casper™ Roadsaver™ Carotid Artery Stent and EmPro™/Nanoparasol™ EPS technical success.
- Key Results:
- 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, MAE rate was 6.2% (16/256).
- Upper limit of the 95% exact binomial CI for MAE was 9.22%, which was below the PG of 13.9%. Thus, the primary endpoint was met.
- EmPro™/Nanoparasol™ EPS technical success was achieved in 98.8% (253/256) of subjects.
- General safety results: One patient had an SAE (Nervous System Disorder (Cerebrovascular Accident)) most likely due to a strong relationship to the device.
Key Metrics
Clinical Study (CONFIDENCE study):
- MAE Rate (ITT Population): 5.9% (95% exact binomial CI: 3.89, 10.69)
- MAE Rate (ITT analysis with multiple imputations): 6.2% (16/256)
- EmPro™/Nanoparasol™ EPS technical success: 98.8% (253/256)
- 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
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
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,
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
2
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)
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.
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
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:
4
-
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 | Catalogue
Number | Labeled
Filter
Size
(mm) | Unconstrained
Filter OD (mm) | Filter
Length (in) | Reference
Vessel
Diameter
(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
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.
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 Protection
Device is indicated for use as a
guidewire and embolic protection system
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 3.0mm and 7.0mm. | 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 Classification | Class II, Temporary Carotid Catheter for
Embolic Capture | Class II, Temporary Carotid Catheter
for 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 and
retrieval | separate catheter for delivery and
retrieval |
| Embolic Protection
Device (Filter) Design
and Materials | Nitinol mesh filter with 23 gauge blunt
tip needle mounted on a 0.014" PTFE
coated stainless steel guidewire | Nitinol mesh filter with an atraumatic
distal tip built on an integrated .014"
PTFE coated stainless steel capture
delivery wire. |
| Filter Configuration | Eccentric | Concentric |
| Average Pore Size (mm) | 245 | 177 |
| Filter Basket
Unconstrained 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 RX | ||
| Section Length (cm) | 25 | 30 |
| Delivery Catheter | ||
| Working Length (cm) | 140 | 150 |
| Retrieval Catheter OD | ||
| (Fr) | 4.2 | 5.0 |
| Retrieval Catheter RX | ||
| Section Length (cm) | 25 | 30 |
| Retrieval Catheter | ||
| Working 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.
8
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 Performance
Analysis | ITT Population
N=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.