(57 days)
The device is indicated 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.
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The enteral feeding syringe consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male tapered connector. There are 2 types of the syringe: Side connector tapered syringe and central connector tapered syringe. The sizes of the central connector tapered syringe range from 0.5ml to 3ml; and side connector tapered syringe range from 6ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
The provided text is a 510(k) Summary for an Oral/Enteral Syringe, which is a medical device for dispensing and transferring fluids. It outlines the regulatory process for clearance and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Crucially, this document describes physical, mechanical, chemical, and biocompatibility testing of a physical medical device (a syringe), not a software or AI-based device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to software performance (e.g., sensitivity, specificity, F1 score for an AI model) are not relevant here.
The document discusses performance purely in terms of the physical characteristics of the syringe.
However, I can extract the information related to the physical device's "acceptance criteria" and the "study" (non-clinical tests) that proves it, as per the format you requested, but adapted for a physical device:
Acceptance Criteria and Study Proving Device Meets Criteria (for a Physical Medical Device)
The device in question is an Oral/Enteral Syringe. The acceptance criteria and the studies (non-clinical tests) proving the device meets these criteria are related to its physical properties, material safety, and functionality as a fluid delivery device.
1. Table of Acceptance Criteria and Reported Device Performance
| Item/Parameter | Acceptance Criteria (Standard Reference) | Reported Device Performance/Conclusion |
|---|---|---|
| General Physical Requirements | ISO 7886-1:2017 Clause 5 (General requirements) | The device complies with the general requirements of ISO 7886-1:2017. |
| Extraneous Matter | ISO 7886-1:2017 Clause 6 (Extraneous matter) | The device complies with the requirements for extraneous matter. |
| Lubricant | ISO 7886-1:2017 Clause 7 (Lubricant) | The device complies with the requirements for lubricant. |
| Tolerance on Graduated Capacity | ISO 7886-1:2017 Clause 8 (Tolerance on graduated capacity) | The device complies with the tolerance requirements for graduated capacity. |
| Graduated Scale | ISO 7886-1:2017 Clause 9 (Graduated scale) | The device complies with the requirements for the graduated scale. |
| Barrel | ISO 7886-1:2017 Clause 10 (Barrel) | The device complies with the requirements for the syringe barrel. |
| Piston/Plunger Assembly | ISO 7886-1:2017 Clause 11 (Piston/ plunger assembly) | The device complies with the requirements for the piston/plunger assembly. |
| Nozzle | ISO 7886-1:2017 Clause 12 (Nozzle) | The device complies with the requirements for the nozzle. |
| Performance (General) | ISO 7886-1:2017 Clause 13 (Performance) | The device complies with the general performance requirements. |
| Connector Incompatibility | ISO 80369-1:2018 (General Requirements for small-bore connectors) | The proposed device was unable to connect with devices specified in ISO 80369-1:2010 (e.g., intravenous, hypodermic, breathing systems, urethral/urinary, etc.), demonstrating incompatibility and mitigating misconnection risks. |
| Fluid Leakage | ISO 80369-3:2016 Clause 6.1 (Fluid leakage) | The device complies with the fluid leakage requirements. |
| Stress Cracking | ISO 80369-3:2016 Clause 6.2 (Stress cracking) | The device complies with the stress cracking requirements. |
| Resistance to Separation (Axial) | ISO 80369-7:2016 Clause 6.3 (Resistance to separation from axial load) | The device complies with the resistance to separation from axial load requirements. |
| Disconnection by Unscrewing | ISO 80369-7:2016 Clause 6.6 (Disconnection by unscrewing) | The device complies with the requirements for disconnection by unscrewing. |
| Sterilization & Shelf Life | ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | EO ECH residue did not exceed the limit of ISO 10993-7. Shelf life test results showed the device maintains performance during the claimed three-year shelf life. |
| Seal Strength (Packaging) | ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Packaging maintained integrity. |
| Dye Penetration (Packaging) | ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging) | Packaging maintained integrity. |
| Biocompatibility | ISO 10993-5:2009 (Tests for in Vitro Cytotoxicity) | No negative impacts from materials; results showed no cytotoxicity. |
| ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization) | No negative impacts from materials; results showed no irritation and no sensitization. | |
| Dose Accuracy | Accurate to ±10% when syringe is filled with a minimum dose of 20% of overall syringe capacity (simulating clinical conditions) | The test results show that enteral syringes are accurate to ±10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity. |
| Dimensional Verification | Acceptance standard for tapered tip dimensions (specific standard not named) | The test results show that the tapered tip dimensional meets the acceptance standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample sizes" (i.e., number of syringes tested) for each non-clinical test. It broadly states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
- Data Provenance: The tests were conducted internally by or for Ningbo Tianyi Medical Appliance Co., Ltd. The data is from prospective non-clinical laboratory testing of the manufactured device. The country of origin of the data would be China, where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the "ground truth" for a physical device like a syringe is established by objective engineering and laboratory measurements against internationally recognized standards (e.g., ISO, ASTM). There is no "expert consensus" in the sense of medical image interpretation for ground truth.
The "experts" involved would be qualified laboratory technicians and engineers with expertise in medical device testing and quality control.
4. Adjudication Method for the Test Set
Not applicable. As described above, the verification involves objective measurements against established technical standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document pertains to a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm. The "standalone performance" is equivalent to the results of the non-clinical tests demonstrating compliance with physical, mechanical, and biocompatibility standards.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established international and national standards (e.g., ISO 7886-1, ISO 80369 series, ISO 10993 series, ASTM F88/F88M, ASTM F1929) for medical device design, manufacturing, and safety. This involves objective measurements and assessments rather than clinical outcomes or expert consensus in an interpretative medical sense.
8. The Sample Size for the Training Set
Not applicable. This is for a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for a physical 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.