(294 days)
The Cediflo Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for patients 2 years and above which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract. Maximum duration of use: 42 days.
The Cediflo Junior Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for neonatal and pediatric patients which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.
The Cediflo and Cediflo Junior Enteral Feeding Tubes are sterile, single use devices intended for use in acute care facilities, long-term care facilities, and home. They are made from radiopaque polyurethane tubing printed with centimeter markings and bonded at the proximal end to a rigid male ENFit connector with a tethered cap. The proposed device is offered in lengths of 50 cm to 120 cm and diameters of 5 Fr (1.66 mm) to 16 Fr (5.33 mm). These tubes are supplied with or without a guidewire. The distal tip of the polyurethane tubing is closed and rounded with four side holes to allow for fluid flow.
The male ENFit connector of the proposed device is designed to comply with ISO 80369-3:2016 and allows for connection to enteral feeding specific sets and syringes while reducing the likelihood of misconnections to devices that are not intended for enteral administration. A twist on cap is tethered to the male ENFit connect via a strap.
The guidewire, when provided, of the proposed device is a stainless-steel braided wire with a rounded distal tip which is pre-loaded into the polyurethane feeding tube. The guidewire stiffens the polyurethane tubing to aide in insertion of the device. The guidewire has a lubricious coating that aids in removal of the guidewire from the feeding tube in situ. A flow through guidewire connector is attached to the proximal end of the guidewire which provides the connection between the wire and feeding tube.
The provided document (K181787) is a 510(k) premarket notification for Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes. This type of medical device is a physical tube used for nutritional support, not a software-based AI/ML device. Therefore, the questions related to AI/ML acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and training/test set data are not applicable to this document.
The document primarily relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, as well as biocompatibility testing. No clinical performance testing, animal testing, or AI/ML specific studies were conducted or required for this device.
Here's a breakdown of the relevant information provided in the document regarding how the device meets acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of "acceptance criteria" in the way one would for an AI/ML device with specific metrics like sensitivity or specificity. Instead, it demonstrates compliance with relevant international standards and performs specific mechanical and material tests.
| Criteria/Test | Acceptance Method (Implicit) | Reported Device Performance (Implicit - Pass/Fail) |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Pass (Successfully evaluated per ISO 10993-1) |
| ISO 80369-3:2016 (Small-bore connectors) | Compliance with standard, including tests for: | Pass (Designed and constructed in compliance) |
| - Fluid leakage | Meet standard requirements | Met |
| - Stress cracking | Meet standard requirements | Met |
| - Resistance to separation from axial load | Meet standard requirements | Met |
| - Resistance to separation from unscrewing | Meet standard requirements | Met |
| - Resistance to overriding | Meet standard requirements | Met |
| - Disconnection by unscrewing | Meet standard requirements | Met |
| - Dimensional verification | Meet standard requirements | Met |
| EN 1615:2000 (Feeding Tubes) | Compliance with standard, including tests for: | Pass (Designed and constructed in compliance) |
| - Leakage | Meet standard requirements | Met |
| - Tensile Strength | Meet standard requirements | Met |
| - Flow Rate (with water and commercially available enteral nutrition) | Meet standard requirements | Met |
| ISO 11070 (Guidewire - if included) | Compliance with standard, including tests for: | Pass (Testing performed) |
| - Tensile Strength | Meet standard requirements | Met |
| - Fracture Resistance | Meet standard requirements | Met |
| - Flexion Resistance | Meet standard requirements | Met |
| Tubing Kink Resistance | EN 13868:2002 | Pass (Testing performed) |
| Shelf Life | Accelerated aging conditioning | Substantiated |
| Substantial Equivalence | Comparison to predicate devices based on intended use, indications, clinical settings, target population, design characteristics, materials, and performance. | Determined as "Substantially Equivalent" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of a "test set" for an algorithm. Instead, the tests refer to a sufficient number of manufactured units or materials to validate the design and manufacturing claims (e.g., "accelerated aging conditioning" implies a batch of devices).
- Data Provenance: The testing was conducted by or for Cedic s.r.l., located in Peschiera Borromeo (MI), Italy. This is a manufacturer's internal testing or contracted testing to demonstrate compliance with standards. It is retrospective in the sense that it's done on manufactured products for regulatory submission, but not in the clinical data sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires expert-established ground truth from medical images/data. The "ground truth" for this device's performance is objective measurement against engineering standards and material properties.
4. Adjudication Method for the Test Set:
- Not applicable. No human adjudication of clinical data is involved. Performance is determined by whether the device meets quantitative and qualitative engineering and material standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not a study type relevant to an enteral feeding tube.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
- Not applicable. This is not an algorithm. The "standalone" performance here refers to the device's ability to meet its specifications independently, which is what the non-clinical tests demonstrate (e.g., flow rate, tensile strength).
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on established engineering standards (ISO, EN), material specifications, and physical measurements (e.g., flow rate, tensile strength, leakage). It's objective, quantitative data derived from laboratory testing, not medical consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" for a traditional medical device like an enteral feeding tube.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. No training set exists.
In summary, this 510(k) clearance relied on demonstrating that the Cediflo Enteral Feeding Tubes meet established performance standards and are substantially equivalent to existing predicate devices through comprehensive non-clinical (laboratory and engineering) testing, rather than clinical trials or AI/ML performance studies.
§ 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.