(58 days)
Single use O-ring gasket syringe with ENFit connector (provided sterile and non-sterile):
The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical settings by users ranging from clinicians to laypersons in all age groups.
Reusable O-ring gasket syringe with ENFit connector-(provided non-sterile):
The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
The proposed device is manual feeding syringe, used as a dispenser, a measuring device, and a fluid transfer device. And it is used to deliver fluids into the body orally or enterally in clinical and non-clinical settings.
There are 2 types of connector for proposed device: Low dose tip ENFit connector(1ml to 6ml) and Standard ENFit connector(12ml to 60ml). The proposed device is standard piston syringe consisting of a plastic hollow barrel with female ENFit connector of ISO 80369-3, plunger, 0-ring piston, Connector of 1ml and 3ml syringe situated centrally, connector of other syringe situated eccentrically. All connectors are compatible only with enteral access or accessories having male ENFit connector of ISO 80369-3. The proposed syringes are available in transparent barrel and amber barrel.
The proposed device is provided sterile or non-sterile, single use or reusable. The sterile device is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life. The reusable device is for single patient use only.
The proposed device is made with polypropylene and Silica gel. No DEHP, BPA and Natural Rubber Latex are added in the proposed device. The proposed device also has an optional syringe tip cap.
The provided document is a 510(k) Premarket Notification for a medical device (O-ring gasket syringe with ENFit connector). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving a device meets specific acceptance criteria through a large-scale clinical study or AI performance evaluation.
Therefore, the information typically requested in your prompt regarding AI/algorithm performance, ground truth establishment for training and test sets, multi-reader multi-case (MRMC) studies, expert opinions, and sample sizes for AI model development is not present in this document.
The document demonstrates compliance with performance standards for a physical medical device. Here's what can be extracted and inferred based on the document's content:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of "acceptance criteria" in a quantitative sense as might be found for algorithm performance (e.g., minimum accuracy). Instead, it lists the standards the device was tested against and states that the test results "demonstrated that the proposed device complies with the following standards." Compliance with these standards is the acceptance criterion for a physical device in this context.
| Acceptance Criteria (Standards Complied With) | Reported Device Performance |
|---|---|
| ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals, AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019) | Complies |
| ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity | Complies |
| ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | Complies |
| ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Complies |
| ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | Complies |
| USP-NF Pyrogen Test | Complies |
| ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration. | Complies |
| ASTM F88/F88M-21 standard method for seal strength of flexible barrier materials | Complies |
| ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | Complies |
| USP-NF Bacterial Endotoxins Test | Complies |
| ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | Complies |
| ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications | Complies |
| ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods | Complies |
| Microbial Enumeration and Specified Microorganisms Tests report | Complies |
| Cleaning instructions verification | Complies |
| Re-use cycle parameters study | Complies |
| Microbial study in simulation using | Complies |
| Risk assessment in accordance to ISO 14971 | Complies |
| Dosing Accuracy Testing | Complies |
| Additional Acceptance Criteria for Reusable Devices (implied): | |
| Ability of immediate package to maintain sterility for 5 years | Validated (in accordance with ASTM F1886/F1886M-16, ASTM F88/F88M-21, ASTM F1929-15) |
| Performance after 5 years accelerated aging | Complies with ISO7886-1 and ISO 80369-3 |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. These would be determined by the specific requirements of each ISO/ASTM standard (e.g., how many units are tested for seal integrity or biocompatibility).
- Data Provenance: The tests were "Non-clinical tests" conducted to verify compliance with international standards. The country of origin for the testing itself is not specified, but the applicant (Jiangsu Caina Medical Co., Ltd.) is from China. These are laboratory-based compliance tests, not data collected from human subjects.
- Retrospective or Prospective: Not applicable, as these are technical performance tests, not clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The "ground truth" for the device's physical performance is established by the definitions and methodologies within the cited international standards (ISO, ASTM, USP-NF). The tests are designed to objectively measure properties and assess compliance according to these universally accepted procedures, not through expert consensus in the way a medical image diagnosis might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for subjective assessments (like medical image interpretation). For compliance testing against engineering and biological standards, the results are typically quantitative measurements that either meet or fail a predefined specification.
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:
- No. This type of study (MRMC, human readers, AI assistance) is relevant for AI-powered diagnostic devices. The device in question is a physical syringe, not an AI diagnostic tool.
- The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for proving performance is adherence to established international and national engineering and biological standards. This involves:
- Validated test methods: e.g., the specific procedures for pyrogen testing (USP-NF ), seal integrity (ASTM F88/F88M-21), or material biocompatibility (ISO 10993 series).
- Defined acceptance limits/specifications: e.g., allowable residuals of ethylene oxide, specified ranges for dosing accuracy, or criteria for passing cytotoxicity tests.
8. The sample size for the training set:
- Not applicable. This is not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.