METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000

• K Number: K051042
• Device Name: METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000
• Manufacturer: ANGIOMETRX INC.
• Date Cleared: 2005-08-05 ( 102 days)
• Product Code: LIT
• Regulation Number: 870.1250
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for:

• Balloon dilatation of the stenotic portion of an arterial lesion
• Post-delivery expansion of balloon expandable stents
• Measurement of arterial lumen cross sectional area and diameter proximal to a lesion, or within a stented section of artery.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Metricath Gemini-P System. It is a regulatory document and does not contain information on acceptance criteria or a study proving device performance against such criteria. Therefore, I cannot provide the requested information based solely on the provided text.

Specifically, the document:

• States that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices.
• Lists the indications for use of the device: balloon dilatation, post-delivery expansion of balloon expandable stents, and measurement of arterial lumen cross-sectional area and diameter.
• Provides regulatory details such as regulation number, name, class, and product code.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or adjudication methods for a test set.
4. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
5. A standalone performance study of the algorithm (as this is a medical device, not an AI/algorithm-based one in the context of typical standalone performance studies for AI).
6. The type of ground truth used.
7. Sample size for a training set.
8. How ground truth for a training set was established.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).