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K Number
K210681
Device Name
SiteSeal SV
Manufacturer
Ensite Vascular
Date Cleared
2021-04-06

(29 days)

Product Code
DXC
Regulation Number
870.4450
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure or the brachial artery after a transbrachial procedure.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA letter is a notification of substantial equivalence for a physical medical device (SiteSeal SV, a vascular clamp), not an AI/ML software device.

Therefore, the document does not contain any information about:

  • Acceptance criteria for software performance
  • Any study proving a device meets acceptance criteria via AI/ML methods
  • Sample sizes for test or training sets
  • Data provenance
  • Number or qualifications of experts for ground truth
  • Adjudication methods
  • MRMC studies or human reader improvement with AI
  • Standalone algorithm performance
  • Types of ground truth used for AI models
  • How ground truth was established for training data

Thus, I cannot fulfill your request as the necessary information regarding AI/ML device performance and testing is not present in the provided text.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).