(10 days)
The guide wire is intended to be used as a stylet 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 Catheters is to provide the necessary stiffness to facilitate the clinicians in the placement of the Maquet Critical Care AB nasogastric feeding tube called Edi Catheter. The guide wire is inserted as a stylet into the feeding lumen of the Edi 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 PTFE (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.
The provided text describes a 510(k) premarket notification for a medical device: "Guide wire for Edi Catheter" (K153461). The review emphasizes the device's substantial equivalence to a legally marketed predicate device (K101199).
However, the document does not contain the kind of detailed information about acceptance criteria and studies that would be typical for complex diagnostic or AI-powered devices. The device in question, a guide wire, is a relatively simple mechanical accessory. Therefore, the "study" referenced in the prompt (and expected for AI/diagnostic devices) is not present here. Instead, the "proof" of meeting acceptance criteria comes from demonstrating material and functional equivalence, as well as biocompatibility.
Here's an analysis based on the provided text, heavily constrained by the fact that it's a submission for a guide wire, not a high-tech diagnostic:
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" and "device performance" in the sense of accuracy, sensitivity, or specificity (as would be seen for diagnostic tools) are not present for this guide wire. Instead, the acceptance criteria are implicitly met by demonstrating:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance / Evidence |
|---|---|---|
| Biocompatibility | Device materials will not cause unacceptable biological reactions when in contact with the body. | Tests Performed (according to ISO 10993-1 and ODE General Program Memorandum #G95-1): |
- Cytotoxicity
- Sensitization
- Intracutaneous reactivity
(Implicitly, these tests were passed, demonstrating the device is biocompatible.) |
| Material Integrity | The guide wire maintains its structural integrity and design characteristics during intended use. | Functional Verification Activities Performed: - Fracture and Flex testing
- Corrosion resistance
- Particulate matter
(Implicitly, these tests were passed, ensuring the guide wire remains intact and functional.) |
| Functional Equivalence | The device performs its intended function (stiffening the Edi Catheter for placement) equivalently to the predicate device. | "The Guide wire for Edi Catheter has the same technical specifications and performance as the cleared Guide wire for Edi Catheters, K101199. The only difference is the updated coating process."
"The intended use for the subject device is identical with the intended use of the predicate device."
(Demonstrated through technical comparison and the lack of negative findings in other tests.) |
| Manufacturing Process | The change in manufacturing (PFOA removal) does not adversely affect safety or performance while adhering to regulatory requirements. | PFOA removed from manufacturing process due to EPA mandate. The manufacturer asserts that the "processing aid should not be present in the finished coating of the predicate device since the PFOA is completely dissipated at the point the coating is cured." The non-clinical testing (biocompatibility and functional) implicitly confirms no adverse impact from this change. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For a guide wire, "test set" would typically refer to the number of units tested for biocompatibility and functional properties. These are not clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This concept is not applicable to this device and the type of evaluation described. "Ground truth" established by experts is relevant for diagnostic or AI-driven devices where clinical interpretation is involved. For a guide wire, ground truth is based on objective physical and chemical testing (e.g., material composition, strength, corrosion resistance) and regulatory standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not part of this submission for a guide wire.
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 is not applicable. The device is a guide wire, a mechanical accessory, not an AI-powered diagnostic tool. No human reader or AI assistance is involved in its direct function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a guide wire, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Established Biocompatibility Standards: (ISO 10993-1, ODE General Program Memorandum #G95-1)
- Engineering and Material Science Principles: For fracture, flex, corrosion resistance, and particulate matter testing.
- Comparison to Predicate Device Specifications: Demonstrating equivalence in technical specifications and performance to a previously cleared device.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. There is no "training set."
Summary of Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is a series of non-clinical, laboratory-based tests and a technical comparison to a predicate device. This "study" consists of:
- Biocompatibility Testing: Cytotoxicity, Sensitization, Intracutaneous reactivity (following ISO 10993-1 and G95-1 guidelines). These tests confirm the materials are safe for patient contact.
- Functional Verification Activities: Fracture and Flex testing, Corrosion resistance, and Particulate matter testing. These tests ensure the guide wire performs its mechanical function reliably and does not degrade or shed dangerous particles.
- Technical Specification Comparison: The manufacturer asserts that the new device has "the same technical specifications and performance" as the cleared predicate device (K101199), with the only change being the PFOA-free coating process, which is considered an improvement due to regulatory mandates, and is implicitly covered by the re-performed biocompatibility and functional tests.
The conclusion is that the new guide wire is "substantially equivalent" to the predicate device because the manufacturing change (removal of PFOA) does not impact the intended use, indications for use, or fundamental technology, as supported by the non-clinical testing.
§ 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.