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K Number
K221204
Device Name
Excipio SV Thrombectomy Device
Manufacturer
Contego Medical Inc.
Date Cleared
2022-06-23

(58 days)

Product Code
QEW
Regulation Number
870.5150
Type
Traditional
Panel
CV
Reference & Predicate Devices
K142870,K193379,K132281
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Excipio SV Thrombectory Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels.

Device Description

The Excipio SV Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The Device will be sold as a sterile, single use device.

Thrombectomy Catheter
The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (4-8mm in diameter). Proximal and distal marker bands delineate the ends of the basket component, and 4 radiopaque markers delineate the circumference of the basket component to facilitate visualization under fluoroscopy.

AI/ML Overview

The provided document describes the Excipio SV Thrombectomy Device and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical medical device (a thrombectomy device), and the testing described is standard for such a device (e.g., visual inspection, dimensional inspection, biocompatibility, animal study for thrombogenicity).

Therefore, I cannot provide the requested information for the following points as they are not applicable to this physical medical device submission:

  1. A table of acceptance criteria and the reported device performance: This document refers to meeting acceptance criteria for non-clinical lab tests (e.g., kink resistance, tensile testing) and biocompatibility, but it doesn't provide specific quantitative acceptance criteria or detailed reported performance values for these tests in a table format that would be typical for an AI/ML device. It merely states that the device "met all acceptance criteria."
  2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable to this type of device.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
  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.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 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).