(247 days)
The Low Profile Non-Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma.
The Low Profile Non-Balloon Feeding Device is used to provide nutrition, medication, and decompression access into the stomach through a secured (initial placement) or formed (replacement) stoma. The device may be placed using one of two insertion methods including an 'obturator' insertion method and a 'capsule' insertion method.
Capsule Insertion Method: The internal bolster of the device is encased by water dissolvable capsule. The capsule technology provides a low-profile option that is delivered by lubricating the capsule with lubricant, inserting the device through the stoma site, and pulling on a pull tab that pulls a suture through the capsule and deploys the internal dome. Once the capsule is deployed, the internal dome returns to its uncompressed shape and the device is held in place.
Obturator Insertion Method: A T-Handle and ratcheting obturator rod (Snap Arm Assembly) is used to extend the internal dome, decreasing the outer profile of the dome. When the dome is fully elongated, the internal dome maintains a narrow profile that can easily be inserted into the stoma site with proper lubrication. Once inserted into the stoma site, the ratcheting rod and T-handle are removed and device is held in place by the internal bolster.
Once placed, both devices provide access to nutrition, medication, and decompression into the stomach via a Mini ONE® feeding port. Both devices are identical after placement regardless of the insertion method chosen.
Removal of feeding device can be performed by using a removal tool assembly (Snap Arm and T-handle with removal tool reinforcer). Removal is done by elongating the internal bolster to reduce the outer diameter of the dome, providing for an easier removal process. The Low Profile Non-Balloon Feeding Device will be offered in several different diameters including14 Fr, 18 Fr, 20 Fr, and 24 Fr and will be available in stoma lengths ranging from 1.0 cm to 4.4 cm.
The Low Profile Non-Balloon Feeding Device is provided sterile for single use only. The molded body of the Non-Balloon feeding device is made of medical silicone. The Low Profile Non-Balloon Feeding Device consists of an external bolster, feeding catheter, and internal retention bolster similar to the predicate devices. The external bolster consists of a feeding port for access to the stomach through the tubing of the device and a strap with a plug to close the feeding port while not in use. In addition, an anti-reflux valve is included in the feeding port area to prevent backflow of stomach contents while not in use. The feeding catheter is inserted into the stomach through a stoma and is held in place with the internal retention bolster. There are two different insertion methods for the proposed device, the 'capsule' and the 'obturator' method. The 'capsule' version includes a tapered capsule enclosing the internal bolster at one end that allows ease of insertion and an obturator rod is pre-loaded in to the shaft prior to use. The 'obturator' version uses a T-Handle and snap arm assembly for controlled insertion and elongation through the device shaft. The Low Profile Non-Balloon Feeding Device and the predicate devices are provided in a number of sizes to accommodate different stoma diameters and lengths.
The provided text describes the 510(k) summary for the "Low Profile Non-Balloon Feeding Device." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, supported by performance testing. However, the document does not contain the level of detail typically found in a study description for an AI/ML device, especially regarding acceptance criteria directly linked to a specific study with statistical results.
The document discusses performance testing in general terms for a medical device (a feeding tube), but not for an AI/ML component. Therefore, much of the requested information regarding AI/ML study specifics (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this text.
Here's a breakdown of what can and cannot be extracted based on your request and the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text lists various performance tests conducted for the device. It states, "Testing found that all components and materials met or exceeded design specifications established by AMT." However, it does not explicitly state quantitative acceptance criteria for each test, nor does it provide the specific numerical results for each test. Instead, it offers a general statement of compliance.
| Acceptance Criteria (Not explicitly stated quantitatively in the document) | Reported Device Performance (Summary statement) |
|---|---|
| Design specifications established by AMT (specifics not provided) | All components and materials met or exceeded design specifications. |
| (Implicitly, the device must function as intended without leakage, with appropriate flow rates, and withstand various forces) | - Stoma Pullout Force: Met specifications. |
- Tip Poke-Through Force: Met specifications.
- Snap Arm Body to Rod Attachment Force: Met specifications.
- Snap Arm to T-Handle Snap Engagement Force: Met specifications.
- T-Handle Tooth Shear Strength: Met specifications.
- Interlock Pullout: Met specifications.
- Time to Capsule Rupture: Met specifications.
- Suture Deployment Force: Met specifications.
- Ripcord Tensile Strength: Met specifications.
- Pull Tab-to-Suture Bond Strength: Met specifications.
- Liquid Leakage Test: Met specifications.
- Flow Rate Test (Water and Viscous Fluid): Met specifications.
- Tube Tensile Test: Met specifications.
- Obturator Bond Strength Test: Met specifications.
- Duckbill Flow and Backflow Test: Met specifications.
- Obturator Poke-Through Evaluation: Met specifications.
- Obturator Push-Through Force Test: Met specifications. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "samples of the Low Profile Non-Balloon Feeding Device" were used for bench tests, but no specific number of samples is provided for any test.
- Data Provenance: Not applicable in the context of clinical data. These are bench tests conducted on physical device samples. The company conducting the tests is Applied Medical Technology, Inc. (AMT), based in Brecksville, OH, USA. The tests are prospective in the sense that they were conducted for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the performance testing described is for a physical medical device (feeding tube) through bench testing, not for an AI/ML algorithm requiring expert interpretation of data for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for physical bench testing. The results would be based on direct measurement or observation against predetermined specifications by test engineers.
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
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench tests, the "ground truth" would be the engineering design specifications and expected physical properties and performance characteristics of each component and the assembled device. These are objective measurements rather than expert consensus on clinical data.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device. While presumably, some prototypes or earlier versions of the device would have been tested during development, the concept of a "training set" for an algorithm does not apply.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
In summary, the provided document details the regulatory submission for a physical medical device. It confidently states that the device met its design specifications through various bench tests, but it does not delve into the specifics of AI/ML performance evaluation as requested in the prompts.
§ 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.