(352 days)
The InnerSense Esophageal Temperature/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.
Philips' InnerSense Esophageal Temperature/Feeding Tube is a disposable, single-use, sterile device designed for nasogastric placement in neonatal and pediatric patients. It is used to continuously monitor esophageal temperature, deliver oral medications, and/or provide enteral feeding to a patient for up to 30 days. It should be used only under direct supervision of a licensed physician or healthcare provider, according to the hospital standard of care. Note: the temperature probe is auto-located in the distal esophagus when device is placed in accordance with the Insertion steps provided in the Application section of the IFU.
The provided 510(k) summary for the InnerSense Esophageal Temperature / Feeding Tube ([K120815](https://www.accessdata.fda.gov/cdrh_docs/reviews/[K120815](https://510k.innolitics.com/search/K120815).pdf)) describes extensive verification of functional performance. However, it does not explicitly define specific numerical acceptance criteria with pass/fail thresholds in the same way one might find for a diagnostic algorithm's sensitivity or specificity. Instead, the document outlines categories of tests performed and attests to their successful completion.
Here's an interpretation of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the successful completion of various performance tests, aligned with established medical device standards. The "reported device performance" is the statement that these tests were successfully completed.
| Acceptance Criteria Category | Description (Implicit) | Reported Device Performance |
|---|---|---|
| Feeding Tube Attributes | ||
| Tensile Strength / Pull Cycle Testing | Device must withstand specified tensile forces and cyclic pulling without failure. | Successfully completed |
| Resistance to Liquid Leakage | Device must prevent liquid leakage under specified pressure. | Successfully completed |
| Fluid Extraction | Device must allow for appropriate fluid extraction. | Successfully completed |
| Temperature Sensor Attributes | ||
| Temperature Accuracy | Device must measure temperature within a specified deviation from a true value. | Successfully completed |
| Temperature Stability | Device's temperature measurements must remain stable over time and under conditions. | Successfully completed |
| General Safety and Biocompatibility | ||
| Biocompatibility (various ISO 10993) | Device materials must be biologically safe (no cytotoxicity, irritation, systemic toxicity, etc.). | Successfully completed |
| Electrical Safety (IEC 60601-1) | Device must meet general electrical safety requirements. | Successfully completed |
| Electromagnetic Compatibility (IEC 60601-1-2) | Device must operate safely in its electromagnetic environment without interference. | Successfully completed |
| Clinical Thermometer Performance (EN 12470-4) | Device must meet performance standards for electrical thermometers for continuous measurement. | Successfully completed |
| Small-bore Connectors (ISO 80369-1) | Device's connectors must meet specifications for small-bore connectors. | Successfully completed |
The study that proves the device meets the acceptance criteria is the "Extensive verification of functional performance" which was "successfully completed." This verification involved subjecting the device to numerous tests as outlined above and by the listed international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993 series, EN 12470-4, ISO 80369-1).
Additional Information Not Found in the Provided Text:
The provided 510(k) summary focuses on device design and in vitro performance testing against engineering standards. It does not contain information related to human user studies or AI/algorithm performance. Therefore, the following points cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not applicable in the context of in vitro device performance verification against engineering standards. The "test set" would refer to the physical units of the device that underwent testing. The document does not specify the number of devices tested, nor does it refer to data provenance in terms of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for in vitro engineering tests is established by calibrated instrumentation and adherence to standard protocols, not by expert human interpretation in the clinical sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for clinical endpoints or image interpretation, not for in vitro device performance tests.
- 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 device is a physical medical device (temperature/feeding tube), not an AI-powered diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm for diagnosis or interpretation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the in vitro performance tests, the "ground truth" would be established by the reference standards and calibrated equipment used during testing (e.g., a reference thermometer for temperature accuracy, a force gauge for tensile strength).
- The sample size for the training set: Not applicable. This device does not involve machine learning or a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the engineering and biocompatibility testing of a physical medical device, not a software algorithm or AI system. As such, many of the requested criteria related to AI/algorithm evaluation are not relevant or addressed in this submission.
§ 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.