(120 days)
The guide wire is intended to be used as a stylet inserted into the MAQUET Edi Catheter to stiffen it in order to simplify its placement in the intended patient population comprising adult, pediatric, infant and neonatal patients.
The function of the Guide wire for Edi Catheter is to provide the necessary stiffness to facilitate the clinician in the placement of the MAQUET naso-gastric feeding tube called Edi Catheter. The guide wire is inserted as a stylet into the feeding lumen of the catheter prior to insertion of the Edi Catheter in the patient and is removed right after the placement of the Edi Catheter is completed.
The Guide wire for Edi Catheter consists of symmetrical stainless steel wire surrounded by a spiral stainless steel wire which is PFTE (polytetrafluoro- ethylene) coated. It also has soft and rounded ends. A safety ribbon runs thru the length of the Guide wire and is welded at each end to contain the coil of the spring. The Guide wire for Edi Catheter is provided in a non-sterile package and is for single use only. The individually packed Guide wires are delivered to the customer in an outer plastic bag containing five (5) Guide wires.
This document describes a 510(k) premarket notification for a medical device called "Guide wire for Edi Catheter" by MAQUET Critical Care AB. It aims to establish substantial equivalence to existing legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific thresholds for metrics like accuracy, sensitivity, or specificity. This is because the device is a physical medical instrument (a guide wire/stylet) and not a diagnostic or AI-powered imaging device. Therefore, the "acceptance criteria" are related to its functional performance, safety, and equivalence to predicate devices, rather than statistical performance metrics.
The document states:
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance / Evidence |
|---|---|
| Safety and Effectiveness | "These tests have demonstrated that the device is as safe and as effective as the predicate legally marked devices." |
| Mechanical Integrity/Performance | "Performance testing which included: mechanical strain..." |
| Biocompatibility | "Performance testing which included: ...biocompatibility..." |
| Physical Properties | "Performance testing which included: ...physical properties..." |
| Equivalent Intended Use | "The indications for use are SE [substantially equivalent] with Biosearch Medical Product's stylets (K831840 . & K894857) and Sherwood Medical stylet (K960632)." |
| Equivalent Function | "The Guide wire function is SE to Biosearch Medical Product's stylets (K831840 & . K894857) and Sherwood Medical stylet (K960632)." |
| Equivalent Basic Design | "The Guide wire basic design is SE to AMCE Monaco Guide wire K920884, . Biosearch Medical Product's stylets (K831840 & K894857) and Sherwood Medical stylet (K960632)." |
| Equivalent Materials | "The Guide wire's material (Stainless steel) is SE with Biosearch Medical Product's stylets... "The Guide wire's material (PTFE- Polytetrafluoro Ethylene) is SE with ACME . Monaco Corp. Guide wire K920884." |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "performance testing which included: mechanical strain, biocompatibility, physical properties and animal testing."
- Test Set Sample Size: The exact sample sizes for each type of performance test (mechanical strain, biocompatibility, physical properties, animal testing) are not specified in this 510(k) summary.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that animal testing is mentioned, it would be prospective data collection, but details are lacking.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/not provided in the context of this device. A guide wire/stylet for catheter placement does not typically involve a "ground truth" established by experts in the same way an AI diagnostic algorithm would. The safety and effectiveness are evaluated through engineering tests and biological assessments, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like "2+1, 3+1" are typically used for establishing ground truth in human-AI performance studies, which is not relevant for this physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable/not provided. An MRMC study is relevant for AI-assisted diagnostic devices. This submission is for a physical medical instrument (guide wire).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. This device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Engineering Specifications/Standards: For mechanical strain and physical properties (e.g., stiffness, flexibility, dimensions).
- Biocompatibility Standards: For assessing material safety in biological environments.
- Animal Testing Outcomes: For evaluating the device's interaction with living tissue, though specific outcomes are not detailed.
- Comparison to Predicate Devices: The primary "ground truth" for regulatory approval is proving substantial equivalence to already legally marketed devices, demonstrating similar safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is not an AI algorithm; therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.