(56 days)
The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.
Profoject™ Enteral Feeding Syringe provided in a variety of sizes from 0.5mL to 60mL. It consists of plunger, plunger stopper, barrel, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector.
The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10⁻⁶ and supplied sterility maintenance package. The shelf life of both sterile and non-sterile proposed devices has been validated as 5 years.
This looks like a 510(k) clearance letter for a medical device that is NOT an AI/ML device. Therefore, the questions related to AI/ML device evaluations (such as test set, ground truth, expert qualifications, MRMC studies, and training set) are not applicable.
The document describes the non-clinical test conclusions for the Profoject™ Enteral Feeding Syringe.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was evaluated against several ISO and ASTM standards, as well as USP-NF monographs. The acceptance criteria are implicitly those defined by these standards, and the reported performance is that the device "Complied with" these standards.
| Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 20695 (Enteral feeding systems - Design and testing) | Complied with: ISO 20695 |
| Compliance with ISO 7886-1 (Sterile hypodermic syringes for single use - Part 1) | Complied with: ISO 7886-1 |
| Compliance with ISO 80369-1 (Small-bore connectors for liquids and gases - Part 1) | Complied with: ISO 80369-1 |
| Compliance with ISO 80369-3 (Connectors for enteral applications) | Complied with: ISO 80369-3 |
| Compliance with ISO 80369-20 (Common test methods for small-bore connectors) | Complied with: ISO 80369-20 |
| Compliance with ISO 11737-1 (Microbiological methods - Population determination) | Complied with: ISO 11737-1 |
| Compliance with USP - NF (Microbiological Examination of Nonsterile Products) | Complied with: USP - NF |
| Compliance with ASTM F1886/F1886M-16 (Seal integrity of flexible packaging) | Complied with: ASTM F1886/F1886M-16 |
| Compliance with ASTM F1140/F1140M-13 (Internal pressurization failure resistance) | Complied with: ASTM F1140/F1140M-13 |
| Compliance with ASTM F88/F88M-23 (Seal Strength of flexible barrier materials) | Complied with: ASTM F88/F88M-23 |
| Compliance with ASTM F1929-23 (Detecting seal leaks by dye penetration) | Complied with: ASTM F1929-23 |
| Compliance with USP - NF (Sterility Tests) | Complied with: USP - NF |
| Compliance with ISO 10993-7 (Ethylene oxide sterilization residuals) | Complied with: ISO 10993-7 |
| Compliance with ISO 11135 (Ethylene oxide sterilization processes) | Complied with: ISO 11135 |
| Compliance with ISTA 3A: 2018 (Packaged-Products for Parcel Delivery System Shipment) | Complied with: ISTA 3A: 2018 |
| Compliance with Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and FDA Staff | Complied with: (Implicitly, as it's listed under performance testing) |
| Dose accuracy: ±10% when filled with a minimum of 20% of overall syringe capacity | Dose accuracy testing conducted, results implicitly met criteria |
| Biocompatibility: No Cytotoxicity (per ISO 10993-5) | No Cytotoxicity |
| Biocompatibility: No Sensitivity (per ISO 10993-10) | No Sensitization |
| Biocompatibility: No Irritation (per ISO 10993-23) | No Irritation |
| Sterility Assurance Level (SAL) of 10⁻⁶ for sterile devices | EO Sterilization to SAL=10⁻⁶ |
| Shelf life validation | Validated as 5 years |
2. Sample size used for the test set and the data provenance
The document indicates that non-clinical verification was performed. This typically involves laboratory testing on device prototypes or production samples. The specific sample sizes for each test are not provided in this summary. Data provenance would be from laboratory testing conducted by or for CMT Health PTE. Ltd. (Singapore), likely in a controlled, prospective manner as part of the device development and validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical medical device (enteral feeding syringe), not an AI/ML device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for non-clinical performance and safety relates to adherence to recognized standards and specifications, which are typically evaluated by engineers and quality assurance professionals, not clinical experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies for AI/ML algorithms. This document describes non-clinical performance and biocompatibility testing.
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, and no MRMC study was conducted or is relevant.
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 non-clinical testing of a physical device, the "ground truth" is defined by the technical specifications, performance limits, and safety requirements outlined in the referenced ISO, ASTM, and USP standards. For example, for dose accuracy, the ground truth is the specified ±10% accuracy. For sterility, it's the SAL of 10⁻⁶. For biocompatibility, it's the absence of cytotoxicity, irritation, or sensitization as defined by the ISO 10993 series. These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data in the usual sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.