MANAN GWI GUIDE WIRE INTRODUCER

• K Number: K974745
• Device Name: MANAN GWI GUIDE WIRE INTRODUCER
• Manufacturer: MEDICAL DEVICE TECHNOLOGIES, INC.
• Date Cleared: 1998-04-06 ( 108 days)
• Product Code: DRC
• Regulation Number: 870.1390
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K851834
• Predicate For: N/A

Intended Use

The Manan™ Guide Wire Introducer is intended for use as an anterior, single wall arterial percutaneous puncture.

Device Description

This introducer is made in various gauges from 16 to 21 ga, and in 3.8 or 7 cm lengths. The tip of the introducer is ground to a chisel bevel. it differs from a standard "CHIBA" needle only in the hub. The Guide Wire Introducer's hub has a funnel shaped interior configuration to facilitate introduction of the guidewire.

AI/ML Overview

The provided documentation does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria. This 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device, the Manan Medical Products Guide Wire Introducer (K851834), rather than presenting detailed performance study data against defined acceptance criteria.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable as this is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

The document states that the Manan™ Guide Wire Introducer is "made in various gauges from 16 to 21 ga, and in 3.8 or 7 cm lengths" and that "The tip of the introducer is ground to a chisel bevel." It also highlights a key differentiating feature: "The Guide Wire Introducer's hub has a funnel shaped interior configuration to facilitate introduction of the guidewire." These are descriptive features rather than performance metrics with associated acceptance criteria. The FDA's decision letter confirms that the device is "substantially equivalent" to the predicate device, implying that its performance characteristics are deemed comparable without requiring a new, detailed performance study in this context.

Regulation Number and Section

§ 870.1390 Trocar.

(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.