(267 days)
No
The device description and performance studies focus on the mechanical aspects of the thrombectomy device and do not mention any AI or ML components.
Yes
The device is designed for the non-surgical removal of emboli and thrombi from peripheral blood vessels to restore blood flow, which is a therapeutic intervention.
No
The NeVa™ PV Thrombectomy Device is intended for the non-surgical removal of emboli and thrombi to restore blood flow, making it a therapeutic device rather than a diagnostic one.
No
The device description clearly outlines a physical medical device consisting of a nitinol basket, core pusher wire, and radiopaque markers. The performance studies also detail physical and mechanical testing, not software validation.
Based on the provided information, the NeVa™ PV Thrombectomy Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NeVa™ PV Thrombectomy Device is a physical device used within the body to remove clots from blood vessels.
- The intended use and device description clearly state its function is to physically remove emboli and thrombi from peripheral blood vessels. This is an interventional procedure performed directly on the patient, not a test performed on a sample outside the body.
- The device description focuses on its mechanical properties and how it interacts with the blood vessels and clots. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the NeVa™ PV Thrombectomy Device is a medical device used for therapeutic purposes (removing clots to restore blood flow), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeVa™ PV Thrombectomy Device is indicated for:
- · The non-surgical removal of emboli and thrombi from peripheral blood vessels.
- · Temporary use in peripheral vessel occlusion.
- · Use with aspiration and with the injection or infusion of contrast media and other fluids.
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA
Device Description
The NeVa™ PV Thrombectomy Device is a sterile, single-use thrombectomy device designed to for use in the peripheral vasculature to restore blood flow via non-surgical removal of emboli and thrombi from peripheral vessels in the vasculature. The NeVa™ PV device consists of a self-expanding nitinol basket attached to a core pusher wire that can be delivered through a micro catheter, deployed across a clot, and then removed with the clot to enable revascularization of the occluded vessel. To aid in fluoroscopic visualization, radiopaque markers are positioned at the distal end, proximal end, and along the nitinol basket of the NeVa™ PV device. A flexible atraumatic soft tip attached to the distal end of the nitinol basket is radiopaque for enhanced fluoroscopic visualization.
The NeVaTM PV device is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used. No accessories are provided with the NeVaTM PV device. The device is intended to be used in conjunction with the appropriately sized microcatheter as indicated in the proposed Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral blood vessels, peripheral vessels
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)
Comprehensive design verification and validation testing was performed on the NeVa™ PV Thrombectomy Device. Results from bench and animal testing demonstrated substantial equivalence to the predicate. Testing performed included a combination of the following:
- Physical and Dimensional Inspection ●
- Tensile Strength ●
- Af Temperature ●
- Radial Forces
- Torque Strength / Torsion ●
- Delivery / Retrieval Forces ●
- Multiple Re-sheathing Durability ●
- Navigation/Steerability ●
- Flexibility/Kink Resistance
- Tip Deflection
- Radiopacity ●
- Corrosion Resistance ●
- Clot Retrieval Testing
- Physician Usability Testing ●
- Biocompatibility Testing (ISO 10993-1)
- Sterilization Validation (ISO 11137-1) ●
- Packaging Validation (ISO 11607-1 and -2) ●
- GLP Animal Study
Overall, testing confirms that the NeVa™ PV Thrombectomy Device can be used according to its intended use and in an equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
January 15, 2021
Vesalio Sigi Caron Regulatory and Clinical Consultant Biologics and Medical Device Consulting Group PO Box 7605 Mammoth Lakes, California 93546
Re: K201085
Trade/Device Name: NeVa™ PV Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: December 15, 2020 Received: December 17, 2020
Dear Sigi Caron:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
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
2
Indications for Use
510(k) Number (if known) K201085
Device Name NeVa PV Thrombectomy Device
Indications for Use (Describe)
The NeVa™ PV Thrombectomy Device is indicated for:
- · The non-surgical removal of emboli and thrombi from peripheral blood vessels.
- · Temporary use in peripheral vessel occlusion.
- · Use with aspiration and with the injection or infusion of contrast media and other fluids.
| 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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3
1. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(K) NUMBER | K201085 |
|---|---|
| DATE PREPARED | January 13, 2021 |
| APPLICANT | Vesalio |
| Gustavo R. Prado, PhD | |
| gprado@vesalio.com | |
| 3200 West End Ave, Ste 500 | |
| Nashville, TN 37203 | |
| OFFICIAL | |
| CORRESPONDENT | Sigi Caron, MBA RAC |
| Biologics and Medical Device Consulting Group | |
| 4260 Paul Sweet Rd. | |
| Santa Cruz, CA 95065 | |
| Tel: (310) 614-3120 | |
| Fax: (888) 295-1535 | |
| sigi@BioMDG.com | |
| TRADE NAME | NeVa™ PV Thrombectomy Device |
| COMMON NAME | Embolectomy Catheter |
| DEVICE CLASSIFICATION | Product Codes: |
| QEW - Catheter, Embolectomy (21 CFR §870.5150) | |
| KRA - Catheter, Continuous Flush (21 CFR) §870.1210) | |
| Class: II | |
| PREDICATE DEVICE | ReVive™ PV Thrombectomy Device (K132281) |
| REFERENCE DEVICE | Trevo Provue Thrombus Retriever (K122478) |
| Solitaire Platinum Revascularization Device (K160641) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The NeVa™ PV Thrombectomy Device is a sterile, single-use thrombectomy device designed to for use in the peripheral vasculature to restore blood flow via non-surgical removal of emboli and thrombi from peripheral vessels in the vasculature. The NeVa™ PV device consists of a self-expanding nitinol basket attached to a core pusher wire that can be delivered through a micro catheter, deployed across a clot, and then removed with the clot to enable revascularization of the occluded vessel. To aid in fluoroscopic visualization, radiopaque markers are positioned at the distal end, proximal end, and along the nitinol basket of the NeVa™ PV device. A flexible
4
atraumatic soft tip attached to the distal end of the nitinol basket is radiopaque for enhanced fluoroscopic visualization.
The NeVaTM PV device is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used. No accessories are provided with the NeVaTM PV device. The device is intended to be used in conjunction with the appropriately sized microcatheter as indicated in the proposed Instructions for Use.
INDICATIONS FOR USE:
The NeVa™ PV Thrombectomy Device is indicated for:
- The non-surgical removal of emboli and thrombi from peripheral blood vessels. ●
- Temporary use in peripheral vessel occlusion.
- Use with aspiration and with the injection or infusion of contrast media and other fluids. ●
SUBSTANTIALLY EQUIVALENT TO:
The NeVa™ PV Thrombectomy Device is substantially equivalent in intended use and technological features to the ReVive™ PV Thrombectomy Device (K132281).
SUMMARY OF TECHNOLOGICAL CHARACTERISTIC SIMILARITIES / DIFFERENCES:
The NeVa™ PV Thrombectomy Device and the predicate ReVive™ PV Thrombectomy Device are both sterile, single-use thrombectomy devices intended to restore blood flow via non-surgical removal of emboli and thrombi from peripheral vessels. Both the NeVa™ PV and the ReVive™ PV use a self-expanding nitinol basket to capture emboli and thrombotic material in occluded vessels. Both devices have a soft distal tip, integrated radiopaque markers for fluoroscopic visualization during the procedure, and are constructed of equivalent materials. Both devices are introduced by being loaded in an insertion sheath that is then delivered via a compatible microcatheter to the target vessel location for deployment.
The only notable difference between two the devices is that the NeVa™ PV Thrombectomy Device uses a different cell design (net pattern) in the nitinol basket structure. The NeVa PV incorporates a proprietary drop zone pattern to optimize capture of emboli and thrombotic material. The diameter of the basket remains similar in size, and the method of clot capture (entrapment) remains the same. There are no other technological differences between the two devices.
The NeVa™ PV device will also be offered in a range of configurations and sizes in order to provide more options to the interventionalist and to accommodate clot removal in different anatomical locations..
5
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The NeVa™ PV Thrombectomy Device is substantially equivalent to the ReVive™ PV with respect to indications for use (intended use) and technical characteristics. The following table compares the features of the proposed NeVa™ PV device to its predicate.
| Element | New Device:
NeVa™ PV Thrombectomy Device | Primary Predicate:
ReVive™ PV Thrombectomy Device |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K201085 | K132281 |
| Indications for Use | The non-surgical removal of
emboli and thrombi from
peripheral blood vessels. Temporary use in peripheral
vessel occlusion. Use with aspiration and with the
injection or infusion of contrast
media and other fluids. | The non-surgical removal of emboli
and thrombi from peripheral blood
vessels. Temporary use in peripheral
vessel/graft occlusion. Use with aspiration and with the
injection or infusion of contrast
media and other fluids. The non-surgical removal of
thrombi from synthetic grafts. |
| Design Features | | |
| Use of basket to capture
clot? | Yes | Yes |
| Vessel Diameter Range | 2.0 - 6.0 mm | 1.5 - 5.0 mm |
| Basket Type | Self-Expanding Closed Cell Basket | Self-Expanding Closed Cell Basket |
| Basket Material | Nitinol | Nitinol |
| Basket - Maximum
Available Diameters | 4.0, 4.5, and 6.0 mm | 4.5 mm |
| Basket - Working
Lengths | 22 – 46 mm | 22 - 28 mm |
| Basket Radiopaque
Markers | Yes | Yes |
| Soft Distal Tip | Yes | Yes |
| Distal Tip Length | 5 mm | 6 mm |
| Distal /Proximal
Radiopaque Markers | Yes | Yes |
| Radiopaque Marker
Material | Platinum | Platinum |
| Core Pusher Wire | Yes | Yes |
| Pusher Wire Material | Nitinol | Nitinol |
| Compatible
Microcatheter Sizes | 0.021", 0.027" | 0.027" |
| Element | New Device:
NeVa™ PV Thrombectomy Device | Primary Predicate:
ReVive™ PV Thrombectomy Device |
| Loaded into Introducer
Sheath? | Yes | Yes |
| Provided Sterile? | Yes | Yes |
| Single Use? | Yes | Yes |
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PERFORMANCE STANDARDS:
No performance standards have been established by the Agency to date that apply to this device.
SUMMARY OF NONCLINICAL TESTING:
Comprehensive design verification and validation testing was performed on the NeVa™ PV Thrombectomy Device. Results from bench and animal testing demonstrated substantial equivalence to the predicate. Testing performed included a combination of the following:
- Physical and Dimensional Inspection ●
- Tensile Strength ●
- Af Temperature ●
- Radial Forces
- Torque Strength / Torsion ●
- Delivery / Retrieval Forces ●
- Multiple Re-sheathing Durability ●
- Navigation/Steerability ●
- Flexibility/Kink Resistance
- Tip Deflection
- Radiopacity ●
- Corrosion Resistance ●
- Clot Retrieval Testing
- Physician Usability Testing ●
- Biocompatibility Testing (ISO 10993-1)
- Sterilization Validation (ISO 11137-1) ●
- Packaging Validation (ISO 11607-1 and -2) ●
- GLP Animal Study
Overall, testing confirms that the NeVa™ PV Thrombectomy Device can be used according to its intended use and in an equivalent manner to the predicate device.
CONCLUSION:
7
Based on the above information, Vesalio believes that the substantial equivalence of the NeVaTM PV Thrombectomy Device to the ReVive™ PV Thrombectomy Device has been demonstrated.