(28 days)
The Corflo cuBBy LPGD is designed to allow for the administration of feeding solutions directly into the stomach of patients who are unable to take oral feedings but whose alimentary tracts are otherwise intact. It may also be used for gastric drainage with the aid of a decompression tube.
Corflo cuBBy™ Low Profile Gastrostomy Device (LPGD)
Here's an analysis of the provided text regarding acceptance criteria and device studies:
Assessment of Provided Information
The provided text does not contain any information about the acceptance criteria or studies used to prove the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the Corflo cuBBy™ Low Profile Gastrostomy Device (LPGD). This letter primarily states that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices.
The document includes:
- A formal FDA clearance letter.
- The device name and 510(k) number (K990127).
- The regulatory class (Class II) and procode (78 KNT).
- Indications for Use for the Corflo cuBBy LPGD.
- Instructions for marketing the device and regulatory compliance.
Missing Information:
The 510(k) clearance letter document itself does not include the detailed study methodology, results, or acceptance criteria that would have been part of the manufacturer's submission to the FDA. Such information is typically found in the 510(k) summary or the full submission, which is not provided here.
Therefore, I cannot populate the requested table and answer the questions based solely on the provided text.
To illustrate what a comprehensive answer would look like if the information were available, here's a template outlining what would be needed:
Hypothetical Example (if detailed study information were provided):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| [e.g., Device durability against specified force] | [e.g., Withstood X Newtons, exceeding criteria of Y Newtons] |
| [e.g., Flow rate through the device for feeding solutions] | [e.g., Maintained flow rate of Z mL/min, meeting criteria of A mL/min minimum] |
| [e.g., Biocompatibility as per ISO 10993 standards] | [e.g., Passed all cytotoxicity, sensitization, and irritation tests] |
| [e.g., Insertion/removal force within ergonomic range] | [e.g., Average insertion force BN, removal force CN (within D-EN range)] |
| [e.g., Leakage prevention under pressure] | [e.g., No leakage observed up to X kPa (criteria: no leakage up to Y kPa)] |
2. Sample Size for Test Set and Data Provenance
- Sample Size (Test Set): [e.g., 50 devices for mechanical durability, 10 for flow rate, 12 animals for biocompatibility]
- Data Provenance: [e.g., Bench testing conducted in a US laboratory; Animal study conducted in a reputable contract research organization in Europe; Clinical data (if any) was retrospective, collected from 3 hospitals in the USA and Canada.]
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: [e.g., 3 experts (for a human factors study, if applicable)]
- Qualifications: [e.g., Board-certified gastroenterologists with an average of 15 years of experience in managing enteral feeding patients.]
4. Adjudication Method (Test Set)
- *[e.g., N/A for bench/animal testing. If clinical: 2+1 (two experts independently assessed, with a third expert resolving disagreements).] *
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? [e.g., No, this is a physical medical device, not an AI/imaging diagnostic device.]
- Effect Size: N/A
6. Standalone Performance Study (Algorithm Only)
- Was it done? [e.g., No, this is a physical medical device, not an AI algorithm.]
7. Type of Ground Truth Used
- General Rationale: For a physical medical device like a gastrostomy device, ground truth would typically be established by established engineering standards, in-vitro test methods, and potentially animal or human clinical outcomes for safety and function.
- Examples: [e.g., Mechanical load cell readings (for force/durability), calibrated flow meters (for flow rate), histological analysis (for tissue reaction in biocompatibility studies), direct observation of device function in animal models.]
8. Sample Size for Training Set
- [e.g., N/A for a non-AI physical device. If design iterations involved prototypes, then data from earlier prototypes might be considered "training data" for design refinement, but not in the AI sense.]
9. How Ground Truth for Training Set was Established
- [e.g., N/A. (If applicable: In design and development, performance targets were based on industry standards, clinical literature, and predicate device performance. Prototypes were iteratively tested against these targets.)]
Conclusion:
The provided FDA letter (K990127) serves as the regulatory approval document but does not contain the detailed technical and clinical study data required to answer your specific questions about acceptance criteria and study methodologies. That information would be in the detailed 510(k) submission itself.
§ 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.