The ZelanteDVT™ Thrombectomy Set 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 Set 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.

Device Description

The ZelanteDVTT™ Thrombectomy Set is one component of the AngioJet® Ultra Thrombectomy System (AngioJet Ultra System). The other component, packaged and sold separately, is the multiple-use AngioJet® Ultra Console. The ZelanteDVT Thrombectomy Set can only be used in conjunction with the AngioJet Ultra Console.

The ZelanteDVT Thrombectomy Set uses 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 collection bag for ultimate disposal.

The 105 cm ZelanteDVT Thrombectomy Catheter is introduced through an 8F introducer sheath and tracks and operates over a 0.035" (0.89 mm) guidewire. The manifold is equipped with a port with an attached stopcock. This port can be used to inject contrast media and other fluids into the bloodstream.

AI/ML Overview

This document is a 510(k) premarket notification for the ZelanteDVT™ Thrombectomy Set. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, this document does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria in the format requested.

Here's an analysis of what is available and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Missing. The document lists various nonclinical tests performed (biocompatibility and in vitro performance tests) such as "Hemolysis Ratio", "Clot Removal", "Net Evacuation", etc., but it does not provide specific quantitative acceptance criteria (e.g., "Hemolysis Ratio < X%") or the numerical results achieved by the device for these tests. It only states that the tests 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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Partially available/Missing. The document mentions "Acute and Chronic GLP studies were performed to evaluate the safety and performance of the ZelanteDVT Thrombectomy Set in peripheral veins." "GLP studies" implies prospective animal (in vivo) studies conducted under Good Laboratory Practice regulations, which would include a test set. However, the specific sample size for these studies is not provided. The provenance would be animal studies, but no country of origin is specified.
For the in vitro performance tests, the "test set" would typically refer to the number of devices or test articles subjected to each test. This is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Missing. This question is typically relevant for studies involving human interpretation of medical images or clinical outcomes. The studies mentioned are nonclinical (biocompatibility, in vitro performance, animal GLP studies). Therefore, there would not be "experts" in the sense of radiologists establishing ground truth from images. The "ground truth" for these types of studies would be objective measurements or observations during the lab or animal testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Missing. Similar to point 3, adjudication methods are typically used in clinical trials or studies where human interpretation or subjective assessment is involved, often to resolve discrepancies between readers. This is not mentioned or relevant for the nonclinical tests described.

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

Not applicable / Missing. The device is a thrombectomy set (a physical medical device), not an AI algorithm or an imaging device requiring human interpretation for diagnosis. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

Not applicable / Missing. This question pertains to the performance of an AI algorithm on its own. The ZelanteDVT Thrombectomy Set is a physical medical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Partially available. For the nonclinical in vitro tests, the ground truth would be objective measurements obtained through standardized laboratory procedures (e.g., measuring clot removal percentage, fluid flow rates, tensile strength, hemolysis ratio).
For the Acute and Chronic GLP animal studies, the ground truth would be direct observation of physiological effects, pathological examination of tissues, or other objective measures of safety and performance (e.g., absence of signs of thrombus, vessel integrity). The document does not go into detail on the specific endpoints used for "safety and performance" in these animal studies.

8. The sample size for the training set

Not applicable / Missing. This question is relevant for machine learning or AI models, which require a "training set." This document describes a traditional medical device, not an AI product.

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

Not applicable / Missing. As above, this pertains to AI models.

In summary, the provided document is a regulatory submission for a physical medical device, and as such, it focuses on demonstrating substantial equivalence through nonclinical testing (biocompatibility, in vitro performance, and animal studies). It does not provide the kind of detailed clinical study results, particularly those related to human reader performance or AI, that your questions anticipate. For a comprehensive answer matching your request, you would typically need a clinical trial report or a more detailed technical report which would accompany such a 510(k) submission, but is not included in this FDA letter and summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them that resemble hair or a stylized representation of the human spirit.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 21, 2015

Boston Scientific Corporation c/o Ms. Anne V. Rossi Regulatory Affairs Manager One Scimed Place Maple Grove. MN 55311

Re: K151313

Trade/Device Name: ZelanteDVT Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Embolectomy Regulatory Class: Class II Product Code: DXE, KRA Dated: August 21, 2015 Received: August 24, 2015

Dear Ms. Rossi:

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. 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); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

of Surveillance and Biometrics/Division of Postmarket Surveillance.

Sincerely yours,

Kenneth J. Cavanaugh -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151313

Device Name ZelanteDVT™ Thrombectomy Set

Indications for Use (Describe)

The ZelanteDVT™ Thrombectomy Set 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.

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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510(k) Summary

per 21 CFR §807.92

Date Prepared	15 May 2015
Submitter's Name andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact Name andInformation	Anne V. RossiRegulatory Affairs FellowPhone: 763-494-1094Fax: 763-494-2222Email: Anne.Rossi@bsci.com
Trade Name(s)	ZelanteDVT™ Thrombectomy Set
Common or Usual Name	Catheter, Embolectomy
Product Code	DXE
Secondary ProductCode	KRA (Catheter, Continuous Flush)
Classification of Device	Class 2 according to 21 CFR 870.5150
Predicate Device(s)	Solent™ Omni Thrombectomy Set K111182 24 May 2011

Device Description

Intended Use

The ZelanteDVT™ Thrombectomy Set is intended for the removal of thrombus from and infusion of fluids into the peripheral vasculature.

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Indications for Use

The ZelanteDVTT™ Thrombectomy Set 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.

Comparison of Required Technological Characteristics

The ZelanteDVT Thrombectomy Set incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate AngioJet Solent Omni Thrombectorny Set (K111182).

Summary of Nonclinical Tests

Nonclinical testing was performed on the ZelanteDVT Thrombectomy Set to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing.

The following biocompatibility tests were completed on the ZelanteDVT Thrombectomy Set:

Cytotoxicity	Acute Systemic Toxicity	In Vivo Thromboresistance
Sensitization	Direct Contact Hemolysis	Materials Mediated Pyrogenicity
Intracutaneous Reactivity	In Vitro Hemocompatibility	USP Physicochemical

The following in vitro performance tests were completed with the ZelanteDVT Thrombectomy Set:

Shaft Outer Diameter	Hemolysis Ratio	Device Tensile
Effective Length	Contrast Injection	Tip Compression
Guidewire Compatibility	Extended Use	Manifold Torque
Operating Pressure	Thermal Dose	Torsional Buckling Strength
Net Evacuation	Torque Transference	Proximal Saddle Torque
Infusion Rate	Corrosion & FM	Manifold Fluid Immersion
Particulate	Freedom from Leaks	U-Bend
Clot Removal	Guidewire Lumen Leak	Distal Pressure Test
		Packaging Bubble and Peel Tests

Additionally Acute and Chronic GLP studies were performed to evaluate the safety and performance of the ZelanteDVT Thrombectomy Set in peripheral veins.

Conclusion

Based on the indications for use, technological characteristics, safety and performance testing, the ZelanteDVT Thrombectomy Set is appropriate for the intended use and is considered to be substantially equivalent to the AngioJet Solent Omni Thrombectomy Set (K111182).

Regulation Number and Section

§ 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).