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K Number
K220383
Device Name
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
Manufacturer
Okami Medical
Date Cleared
2022-04-29

(78 days)

Product Code
KRD
Regulation Number
870.3300
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated ( e.g. joint areas, superficial vasculature).

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the LOBO Vascular Occlusion System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to an AI/machine learning device.

The document is a standard FDA clearance letter for a medical device (a vascular occlusion system), confirming that the device is substantially equivalent to legally marketed predicates. It briefly describes the indications for use but does not delve into performance studies, acceptance criteria, sample sizes, expert adjudication, or any details relevant to AI/ML device testing as described in your request.

Therefore, I cannot fulfill your request using the provided text. To answer your query about acceptance criteria and study details for an AI/ML device, you would need to provide a document that specifically details such a study, for example, a clinical study report or a 510(k) summary for an AI/ML-driven device.

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).