AMSINO I.V. START KIT

• K Number: K050654
• Device Name: AMSINO I.V. START KIT
• Manufacturer: AMSINO INTERNATIONAL, INC.
• Date Cleared: 2005-05-02 ( 49 days)
• Product Code: LRS
• Regulation Number: 880.5200
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The AMSINO® I.V. Start Kit is intended for use in performing, and assisting in performing, I.V. start procedures.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding the AMSINO® I.V. Start Kit. This letter does not contain information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical studies with specified acceptance criteria as might be seen for novel devices or those undergoing a PMA (Premarket Approval) process.

Therefore, I cannot extract the requested information from this document.

Specific reasons why the requested information is not available in the document:

1. Acceptance Criteria and Reported Device Performance: This document is an FDA clearance letter, not a study report or a summary of performance data. It states that the device is "substantially equivalent" to a predicate device, which is the regulatory standard for 510(k) clearance. It does not list specific performance metrics or acceptance criteria.
2. Sample Size, Data Provenance, Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size, and Training Set Ground Truth: All these items pertain to the design and results of a clinical or performance study. The provided document does not contain any details about studies of this nature. It primarily focuses on the regulatory decision of substantial equivalence.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).