(203 days)
The Kangaroo™ Enteral Feeding Syrinqe with ENFit Connector delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. The feeding syringes are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians (under the supervision of a clinician), to administer enteral nutrition. The syringe is intended for all age groups.
The Kangaroo™ Enteral Feeding Syringe with ENFit Connector consists of disposable enteral feeding syringes that deliver formula to provide nutrition for those who do not have the ability to orally ingest food. The device incorporates a female ENFit connector for connection to an enteral access device.
The provided text describes a 510(k) premarket notification for a medical device, the Kangaroo™ Enteral Feeding Syringe with ENFit Connector. It is a submission for a device that is substantially equivalent to a predicate device, focusing on non-clinical testing to demonstrate safety and effectiveness.
Here's an analysis of the provided information against your request:
1. A table of acceptance criteria and the reported device performance
The document lists several tests conducted in accordance with ISO 80369-3 and ISO 80369-20. The "acceptance criteria" are implied by the "Requirement is in:" columns, referring to specific clauses in ISO 80369-3, and the "reported device performance" is generally stated as "The testing demonstrates the proposed devices conform to the requirements of ISO 80963-3." Specific quantitative performance values are not provided in this summary.
| Test | Acceptance Criteria (ISO 80369-3 Clause) | Reported Device Performance |
|---|---|---|
| Fluid Leakage | Clause 6.2 | Conforms to requirements of ISO 80963-3 |
| Stress Cracking | Clause 6.3 | Conforms to requirements of ISO 80963-3 |
| Resistance to separation from axial load | Clause 6.4 | Conforms to requirements of ISO 80963-3 |
| Resistance to separation from unscrewing | Clause 6.5 | Conforms to requirements of ISO 80963-3 |
| Resistance to overriding | Clause 6.6 | Conforms to requirements of ISO 80963-3 |
| Disconnection by unscrewing | Clause 6.7 | Conforms to requirements of ISO 80963-3 |
| Dimensional analysis | Table B.2 of ISO 80369-3 | Conforms to Table B.2 of ISO 80963-3 |
| Minimum through diameter flow testing | (Implied performance objective) | Exceeds the performance of the predicate device |
| Biocompatibility testing | (Implied biological safety standards) | Demonstrated the biological safety of indirect contact parts |
| Stability testing | (Implied shelf-life/aging standards) | Evaluated properties after accelerated aging |
| Risk associated with misconnection | (Implied acceptable risk level) | Assessed and captured in various reports |
| Usability and human factors testing | (Implied usability/safety standards) | Conducted and captured in a validation study |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for any of the non-clinical tests (e.g., number of syringes tested for fluid leakage, stress cracking, etc.). It also does not explicitly state the data provenance (country of origin, retrospective/prospective). However, given that these are non-clinical engineering and bench tests, "data provenance" in the context of clinical studies (like patient demographics or retrospectivity) is not directly applicable. These tests would be conducted in a laboratory setting by the manufacturer, or a certified testing lab.
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)
This request is not applicable to the provided document. The study described is a non-clinical performance evaluation of a physical medical device (enteral feeding syringe) against engineering standards (ISO 80369-3/20). There is no "ground truth" in the sense of expert medical diagnosis or interpretation that would require a panel of experts. The "ground truth" here is adherence to the specified technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this involves non-clinical engineering testing against predefined standards, not a diagnostic or interpretive task requiring adjudication by experts.
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 a study involving human readers, AI, or diagnostic imaging. It is a submission for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is adherence to the specified international standards, specifically ISO 80369-3: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications and ISO 80369-20: Common test methods. This is equivalent to established, recognized engineering and safety standards.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of non-clinical device testing.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
In summary, the provided document describes a 510(k) submission for a physical medical device (enteral feeding syringe). The "study" refers to a series of non-clinical engineering and bench tests designed to demonstrate conformity to ISO standards for small-bore connectors. The questions regarding expert consensus, clinical ground truth, training/test sets, and AI/human reader performance are not applicable to the nature of this particular device approval process.
§ 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.