(57 days)
The ZelanteDVT™ Thrombectomy System, which includes the ZelanteDVT™ Thrombectomy Set and the ClotHunter™ Helical Rotation Device, is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
· Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
· Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy System is also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The AngioJet™ ZelanteDVT Thrombectomy System is a component of the AngioJet Ultra Thrombectomy System (AngioJet Ultra System or System). The ZelanteDVT Thrombectomy System can only be used in conjunction with the AngioJet Ultra Console. The AngioJet ZelanteDVT Thrombectomy System is comprised of the single-use ZelanteDVT Thrombectomy Set and the single-use ClotHunter Helical Rotation Device. Both components are packaged and sold separately. The ClotHunter Helical Rotation Device can only be used in conjunction with the ZelanteDVT Thrombectomy Set.
The Thrombectomy Set uses this pressurized, high-velocity saline to create a low-pressure zone at the Catheter tip. Thrombus is drawn into the Catheter where it is fragmented by the jets and evacuated from the body. The waste tubing transports the thrombus debris from the Catheter to the waste bag for ultimate disposal.
The ClotHunter Helical Rotation Device consists of a distal helical-shaped wire portion attached to a control handle that is used with the ZelanteDVT Thrombectomy Set. The Helical Rotation Device deflects the distal tip of the Catheter and improves clot removal due to increased luminal coverage. The ClotHunter Helical Rotation Device extends beyond the distal tip of the Catheter to provide a transition between the Catheter and the vessel wall.
The provided text describes a 510(k) premarket notification for the ZelanteDVT™ Thrombectomy System. This submission focuses on demonstrating substantial equivalence to a predicate device through bench, animal, and biocompatibility testing, rather than clinical studies involving human patients or complex AI-based performance metrics like sensitivity/specificity.
Therefore, the information requested in your prompt related to the acceptance criteria for an AI device, sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, and human reader performance improvement is not applicable to this specific device submission as described in the provided document.
The document states:
- "Bench, animal, and biocompatibility testing were performed to support a determination of substantial equivalence."
- "No new safety or performance issues were raised during the testing."
This indicates that the acceptance criteria and study design for this device revolved around engineering performance, material compatibility, and biological safety, as opposed to diagnostic accuracy or AI algorithm performance typically seen with AI-powered medical devices.
Summary of what can be extracted and what is N/A:
-
A table of acceptance criteria and the reported device performance:
- N/A. The document lists the types of tests performed (biocompatibility, in-vitro performance, GLP animal study), but it does not specify quantitative acceptance criteria or detailed numerical results for these tests. It broadly states that the results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised."
-
Sample sized used for the test set and the data provenance:
- N/A (for human clinical data). The studies are described as "Bench, animal, and biocompatibility testing." There's no mention of a human test set in the context of device performance data, thus no data provenance or sample size for human data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the context of diagnostic accuracy established by human experts is not relevant here as the testing is not for diagnostic performance of an AI.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable as there is no diagnostic test set requiring adjudication.
-
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:
- N/A. This applies to AI-assisted diagnostic devices. The ZelanteDVT™ Thrombectomy System is a mechanical thrombectomy device, not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. There is no algorithm to test standalone performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. Not applicable in the context of a mechanical thrombectomy device's performance testing. The "ground truth" for this device would be established by direct measurement during bench testing (e.g., clot removal efficiency, wire whip force), and observations during animal studies.
-
The sample size for the training set:
- N/A. No AI training set is mentioned or required for this type of device.
-
How the ground truth for the training set was established:
- N/A. No AI training set.
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October 2, 2020
Boston Scientific Corporation Vanessa Fowler Senior Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311
Re: K202218
Trade/Device Name: ZelanteDVT™ Thrombectomy System ZelanteDVT™ ClotHunter™ Helical Rotation Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: August 5, 2020 Received: August 6, 2020
Dear Vanessa Fowler:
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,
Gregory O'Connell 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) K202218
Device Name
ZelanteDVT™ Thrombectomy System ZelanteDVT™ ClotHunter™ Helical Rotation Device
Indications for Use (Describe)
The ZelanteDVT Thrombectomy System, which includes the ZelanteDVT Thrombectomy Set and the ClotHunter Helical Rotation Device, is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
· Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
· Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy System is also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Sponsor | Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA |
|---|---|
| Contact Name andInformation | Vanessa FowlerSr Regulatory Affairs Specialist3 Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2537Fax: 763-494-2222e-mail: Vanessa.Fowler@bsci.com |
| Date Prepared | August 5, 2020 |
| Proprietary Name | ZelanteDVT™ Thrombectomy SystemZelanteDVT™ ClotHunter™ Helical Rotation Device |
| Common Name | Catheter, Embolectomy; Catheter, Continuous Flush |
| Product Code | QEW, KRA |
| Classification | Class II, 21 CFR Part 870.5150 |
| Predicate Device | ZelanteDVT Thrombectomy Set (K151313), cleared 21 September 2015 |
| Reference Device | Amplatz Super Stiff Guidewire (K843012), cleared 29 November 1984 |
| Device Description | The AngioJet™ ZelanteDVT Thrombectomy System is a component of theAngioJet Ultra Thrombectomy System (AngioJet Ultra System or System).The ZelanteDVT Thrombectomy System can only be used in conjunction withthe AngioJet Ultra Console. The AngioJet ZelanteDVT ThrombectomySystem is comprised of the single-use ZelanteDVT Thrombectomy Set andthe single-use ClotHunter Helical Rotation Device. Both components arepackaged and sold separately. The ClotHunter Helical Rotation Device canonly be used in conjunction with the ZelanteDVT Thrombectomy Set.The Thrombectomy Set uses this pressurized, high-velocity saline to create alow-pressure zone at the Catheter tip. Thrombus is drawn into the Catheterwhere it is fragmented by the jets and evacuated from the body. The wastetubing transports the thrombus debris from the Catheter to the waste bag forultimate disposal.The ClotHunter Helical Rotation Device consists of a distal helical-shapedwire portion attached to a control handle that is used with the ZelanteDVTThrombectomy Set. The Helical Rotation Device deflects the distal tip of theCatheter and improves clot removal due to increased luminal coverage. TheClotHunter Helical Rotation Device extends beyond the distal tip of theCatheter to provide a transition between the Catheter and the vessel wall. |
| Intended Use ofDevice | The ZelanteDVT™ Thrombectomy System is intended for removal ofthrombus from and infusion of fluids into the peripheral vasculature |
| Indications for Use | The ZelanteDVT Thrombectomy System, which includes the ZelanteDVTThrombectomy Set and the ClotHunter Helical Rotation Device, is intendedfor use with the AngioJet Ultra Console to break apart and remove thrombus,including deep vein thrombus (DVT), from:• Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and• Upper extremity peripheral veins ≥ 6.0 mm in diameter.The ZelanteDVT Thrombectomy System is also intended for use with theAngioJet Ultra Power Pulse technique for the controlled and selective infusionof physician specified fluids, including thrombolytic agents, into the peripheralvascular system |
510(k) Summary for K202218 Per 21 CFR §807.92
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| Comparison ofTechnologicalCharacteristics | The ZelanteDVT Thrombectomy System incorporates substantially equivalentdevice materials and design, packaging materials and design, fundamentaltechnology, manufacturing processes, sterilization process and intended useas those featured in the ZelanteDVT Thrombectomy Set (K151313). |
|---|---|
| Performance Data | Bench, animal, and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. Nonew safety or performance issues were raised during the testing.The following biocompatibility tests were completed on the ZelanteDVTClotHunter Helical Rotation Device or leveraged from the reference device,the Amplatz Super Stiff Guidewire:Cytotoxicity Extract and Direct Contact Hemolysis Sensitization Complement Activation Intracutaneous Reactivity Partial Thromboplastin Time Acute Systemic Toxicity In Vitro Hemocompatibility Materials Mediated Pyrogenicity Platelet and Leukocyte Counts The following in-vitro performance tests were completed for the ZelanteDVTThrombectomy System.Clot Removal Wire Whip Force (Wire Torque) Catheter Withdrawal Infused Volume Handle Attach/Detach Radiopacity Distal Emboli Particulate Evaluation Catheter Advance Rotator Disengagement Force Insertion Force Rotational Fatigue Rotation Force Exposed Wire Length Wire Tip Tensile Wire Shape Retention Wire to Handle Torsional Force Trapped Wire Rotation Handle / Wire Tensile Strength Thumbwheel Breakage Gear Slip Force Column Strength Corrosion Handle Function Post Fluid Exposure Coating Integrity Additionally a GLP animal study was performed to evaluate the safety and |
AddRonally, a Jan ZelanteDVT Thrombectomy System.
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| Conclusion | Based on the indications for use, technological characteristics, and safety andperformance testing, the ZelanteDVT Thrombectomy System, consisting ofthe ZelanteDVT Thrombectomy Set and the ZelanteDVT ClotHunter HelicalRotation Device, has been shown to be appropriate for its intended use and isconsidered to be substantially equivalent to the ZelanteDVT ThrombectomySet (K151313). |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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).