(30 days)
Not Found
No
The summary describes a mechanical embolic protection system and does not mention any AI or ML components or functionalities.
No
The device is described as an embolic protection system used to contain and remove embolic material, which is a supportive function during medical procedures rather than a direct therapeutic treatment itself.
No
Explanation: The device, WIRION®, is described as an "embolic protection system" used to contain and remove embolic material during atherectomy procedures. Its stated function is protective and therapeutic, not diagnostic. It does not analyze patient data or provide information for diagnosis.
No
The device description clearly states it is a "temporary Embolic Protection System" and describes physical components like a "pre-crimped filter" and its use with "0.014" guide wires," indicating it is a hardware device.
Based on the provided information, the WIRION® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body during a medical procedure (atherectomy in lower extremities) to capture embolic material. This is an in vivo application.
- Device Description: The description of a temporary Embolic Protection System (EPS) with a filter basket further supports its use within the circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples of human origin (blood, tissue, etc.) outside the body to provide diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The WIRION®'s function is purely mechanical and interventional within the body.
N/A
Intended Use / Indications for Use
The WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION® may be used with commercially available 0.014" guide wires.
Product codes
NTE
Device Description
WIRION® is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and Safety Testing: Biocompatibility testing was performed to verify the changed materials and processes are acceptable. In addition, simulated use, bond and torque strength testing, and package testing were also performed to confirm pre-determined device specifications were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K200198 – WIRION™ Embolic Protection System
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 3, 2021
Cardiovascular Systems Inc. Erika Huffman Regulatory Affairs Manager 1225 Old Hwy 8 NW St. Paul, Minnesota 55112
Re: K210282
Trade/Device Name: WIRION Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: January 29, 2021 Received: February 1, 2021
Dear Erika Huffman:
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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or
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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 (QS) 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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.
Finn Donaldson 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) K210282
Device Name WIRION® Embolic Protection System
Indications for Use (Describe)
The WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION® may be used with commercially available 0.014" guide wires.
| 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
| Submitter: | Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Erika Huffman, MS, RAC
Regulatory Affairs Manager
Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
St. Paul, MN 55112
Ph: 651-259-1608
ehuffman@csi360.com |
| Date Prepared: | January 29, 2021 |
| Trade Name: | WIRION® Embolic Protection System |
| Common Name: | Embolic Protection System |
| Regulation Number: | 870.1250, Percutaneous Catheter |
| Classification: | Class II |
| Product Code: | NTE |
| Predicate Device(s): | K200198 – WIRION™ Embolic Protection System |
| Device Description: | WIRION® is a temporary Embolic Protection System (EPS),
filtering distal to the intervention site. The system is a rapid
exchange, pre-crimped filter that can be used with any
commercially available 0.014" guide wires. |
| Intended Use: | The WIRION® is indicated for use as an embolic protection system
to contain and remove embolic material (thrombus/debris) while
performing atherectomy in calcified lesions of the lower
extremities. The diameter of the vessel at the site of filter basket
placement should be between 3.5mm to 6.0mm. WIRION® may be
used with commercially available 0.014" guide wires. |
| Comparison to
Predicate Device: | The modified WIRION device is identical to the predicate device as
follows:
Same regulation number, product code and classification Same intended use and indications for use Same vessel diameter range and anatomic location of use Same filter design and materials Same principles of operation |
| Same guidewire rapid exchange (RX) design Same 0.014" guidewire compatibility Same filter delivery and retrieval methods Same filter dimensions and pore size Same filter function and placement within the vessel Same filter fluoroscopy markers for visualization Same sterilization method and SAL Same number of uses per device (single use) The modified WIRION device is different from the predicate device as follows: Longer Retrieval Catheter RX guidewire lumen (RX port moved proximal) Longer shipping mandrel Retrieval Catheter tip material and color Larger sterile barrier pouch (Retrieval Catheter) Different pouch seal locations Branding New RX guidewire lumen tie-layer material Smaller nominal diameter of activating wire New syringe New tamper-evident seal on shelf box Clarified flushing step in Instructions for Use | |
| Functional and Safety Testing: | Biocompatibility testing was performed to verify the changed materials and processes are acceptable. In addition, simulated use, bond and torque strength testing, and package testing were also performed to confirm pre-determined device specifications were met. |
| Conclusion: | No new questions of safety or effectiveness were identified compared to the predicate device and the device is expected to perform as intended under the specified use conditions. |
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