(436 days)
A non-sterile gravity medicine delivery device for use with a nasogastric or percutaneous endoscopic gastrostomy ( PEG) tube to administer crushed and diluted medications and liquids.
The FROG is functionally similar to the syringe used for delivery of "bolus feedings and medications through a nasogastric feeding tube or a "Peg" feeding tube. By adapting the tip of the syringe barrel to accommodate the secondary medication tubing, adding a cap and hanger and enlarging the barrel of the syringe to accommodate the 240cc capacity, the FROG is capable of delivering a can (240cc) of feeding or medications, hands free and accurately without spillage or waste. The FROG is made of polypropolene, latex free and dishwasher safe for home use. The drip chamber on the delivery tubing allows for back priming in the event crushed medication particles clump and cause a blockage in the flow.
The provided text describes a medical device called "The FROG" (Fluids- Rx medications- On the Go), which is a dosage vessel for indwelling feeding tubes. The 510(k) summary focuses on demonstrating substantial equivalence to existing devices rather than meeting specific performance acceptance criteria through detailed studies. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a typical AI/software device is not present in this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal, quantitative acceptance criteria in the typical sense for a medical device with measurable performance metrics (e.g., sensitivity, specificity, accuracy). The "performance" described is functional similarity to existing devices and addressing identified user pain points.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional similarity to existing syringes for bolus feedings/meds. | The FROG is functionally similar to the syringe used for delivery of "bolus feedings and medications through a nasogastric feeding tube or a "Peg" feeding tube. It adapts the syringe barrel tip to accommodate secondary medication tubing, adds a cap and hanger, and enlarges the barrel to 240cc. |
| Deliver a can (240cc) of feeding or medications. | Capable of delivering a can (240cc) of feeding or medications. |
| Deliver hands-free. | Capable of delivering hands-free. |
| Deliver accurately without spillage or waste. | Capable of delivering accurately without spillage or waste. |
| Mitigate blockages from crushed medication particles. | The drip chamber on the delivery tubing allows for back priming in the event crushed medication particles clump and cause a blockage. (This is presented as an improvement over existing syringes that don't accommodate alternatives, requiring disconnection and risking loss of medication/feeding). |
| Control flow rate. | In a single clinical test, the shortened 60cc syringe tip with secondary medication tubing provided a more controllable (using the roller clamp) flow rate. |
| Resolve reflux issues. | In subsequent non-clinical testing, the airway on the tubing, the cap, and the hanger have proven to resolve reflux issues. (Note: Initial clinical test with shortened syringe tip still had reflux problems). |
| Ease and accuracy of use; relief of anxiety over dosing. | A clinical test of the "FROG" with cap and hanger via the "BUTTON" access reported ease and accuracy of use and relief of anxiety related to fear of inaccurate dosing. (This refers to a qualitative assessment of user experience). |
| Material properties. | Made of polypropylene, latex-free, and dishwasher safe for home use. (These are material specifications rather than performance criteria in the sense of functional output, but are important for safety and usability.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- "In a single clinical test": The sample size is not explicitly stated but implies a very small number, possibly one client ("a client who was capable of giving self feedings and medications").
- "A clinical test of the 'FROG' with cap and hanger was performed via the 'BUTTON' access, popular for use in children": Again, the sample size is not explicitly stated but suggests potentially a few "children" or "clients." Given the qualitative nature of the findings ("ease and accuracy of use was reported and the level of anxiety related to fear of inaccurate dosing was relieved"), it is unlikely to be a large, statistically powered study.
- Data Provenance: Not specified, but the submission is from Branchville, NJ, USA, so it's reasonable to infer the testing took place in the USA.
- Retrospective or Prospective: The descriptions "In a single clinical test" and "A clinical test [...] was performed" suggest prospective testing, even if small in scale and scope.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a mechanical delivery system, and its "ground truth" is its functional performance and user experience, not diagnostic accuracy requiring expert consensus. The "ease and accuracy of use" and "relief of anxiety" were reported by the users or caregivers in the clinical tests, acting as the subjective "truth-tellers." No external experts for ground truth establishment are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this summary describes functional testing and user feedback, not a study requiring an adjudication method for ground truth or performance assessment.
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 or diagnostic device that involves "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is primarily based on:
- Functional observation: Does it deliver 240cc? Does it flow hands-free? Does it prevent spillage?
- User feedback/reported experience: "Ease and accuracy of use was reported" and "the level of anxiety related to fear of inaccurate dosing was relieved."
- Direct observation of physical phenomena: "The airway on the tubing, the cap and hanger have proven to resolve these issues (reflux) as well."
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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.