(130 days)
Sterile Single-use Syringe with Needle is intent fluids into or withdraw fluids from the body.
The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consists of needle tube, needle hub, needle cap. The proposed devices shall be operated manually, are not intended for use with syringe pumps. All specifications of proposed devices subject to the same design and the difference between each specification is syringe volume and needle size. The proposed devices are available in a variety combination of needle size and syringe volume.
The provided text describes a 510(k) premarket notification for a "Sterile Single-use Syringe with Needle." This document outlines the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to a predicate device.
Crucially, this document is for a medical device (syringe with needle), not an AI/ML software device. Therefore, the concepts of acceptance criteria for AI model performance, test/training sets for algorithms, ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable to this submission.
The "acceptance criteria" discussed in this document refer to adherence to established international and national standards for physical, mechanical, chemical, and biological properties of syringes, needles, and packaging. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing and biocompatibility assessments conducted according to these standards.
Here's an interpretation of the information provided within the context of a medical device submission, recognizing it does not fit the AI/ML framework:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are defined by various clauses within a range of ISO and ASTM standards. The reported device performance is that the "non-clinical tests were conducted to verify that the proposed devices met all design specifications and are Substantially Equivalent (SE) to the predicate device." The document implies that the device passed these tests, thereby meeting the acceptance criteria set by these standards.
| Acceptance Criteria (Standard Clause) | Reported Device Performance |
|---|---|
| ISO 9626:1991/AMD-1:2001 (Needle) | |
| Clause 3: Materials | Tests performed, device met design specifications. |
| Clause 4: Surface finish | Tests performed, device met design specifications. |
| Clause 5: Cleanliness | Tests performed, device met design specifications. |
| Clause 6: Limits for acidity and alkalinity | Tests performed, device met design specifications. |
| Clause 7: Size designation | Tests performed, device met design specifications. |
| Clause 8: Dimensions | Tests performed, device met design specifications. |
| Clause 9: Stiffness | Tests performed, device met design specifications. |
| Clause 10: Resistance to breakage | Tests performed, device met design specifications. |
| Clause 11: Resistance to corrosion | Tests performed, device met design specifications. |
| ISO 7864:1993 (Needle) | |
| Clause 4: Cleanliness | Tests performed, device met design specifications. |
| Clause 5: Limits for acidity or alkalinity | Tests performed, device met design specifications. |
| Clause 6: Limits for extractable metals | Tests performed, device met design specifications. |
| Clause 7: Size designation | Tests performed, device met design specifications. |
| Clause 8: Colour coding | Tests performed, device met design specifications (hub color complies with ISO 6009). |
| Clause 9: Needle hub | Tests performed, device met design specifications. |
| Clause 10: Sheath | Tests performed, device met design specifications. |
| Clause 11: Needle tube | Tests performed, device met design specifications. |
| Clause 12: Needle point | Tests performed, device met design specifications. |
| Clause 13: Performance | Tests performed, device met design specifications. |
| ISO 7886:1993 (Syringe) | |
| Clause 5: Cleanliness | Tests performed, device met design specifications. |
| Clause 6: Limits for acidity or alkalinity | Tests performed, device met design specifications. |
| Clause 7: Limits for extractable metals | Tests performed, device met design specifications. |
| Clause 8: Lubricant | Tests performed, device met design specifications. |
| Clause 9: Tolerance on graduated capacity | Tests performed, device met design specifications. |
| Clause 10: Graduated scale | Tests performed, device met design specifications. |
| Clause 11: Barrel | Tests performed, device met design specifications. |
| Clause 12: Piston/plunger assembly | Tests performed, device met design specifications. |
| Clause 13: Nozzle | Tests performed, device met design specifications. |
| Clause 14: Performance | Tests performed, device met design specifications. |
| ISO 594-1:1986 (Conical Fittings) | |
| Clause 3: Dimension | Tests performed, device met design specifications. |
| Clause 4.1: Gauging | Tests performed, device met design specifications. |
| Clause 4.2: Liquid leakage | Tests performed, device met design specifications. |
| Clause 4.3: Air leakage | Tests performed, device met design specifications. |
| Clause 4.4: Separation force | Tests performed, device met design specifications. |
| Clause 4.5: Stress cracking | Tests performed, device met design specifications. |
| ISO 594-2:1998 (Luer-Lock Fittings) | |
| Clause 4.1: Gauging | Tests performed, device met design specifications. |
| Clause 4.2: Leakage | Tests performed, device met design specifications. |
| Clause 4.3: Separation force | Tests performed, device met design specifications. |
| Clause 4.4: Unscrewing torque | Tests performed, device met design specifications. |
| Clause 4.5: Ease of assembly | Tests performed, device met design specifications. |
| Clause 4.6: Resistance to overriding | Tests performed, device met design specifications. |
| Clause 4.7: Stress cracking | Tests performed, device met design specifications. |
| Sterile Barrier Packaging Testing | |
| ASTM F88/F88-09: Seal strength | Tests performed, device met design specifications. |
| ASTM F1140/F1140M-13: Internal pressure | Tests performed, device met design specifications. |
| Sterilization and Shelf Life Testing | |
| ISO 10993-7:2008: EO residue | Tests performed, device met design specifications. |
| ISO 10993-7:2008: ECH residue | Tests performed, device met design specifications. |
| USP 36-NF 31: Bacteria Endotoxin Limit | Tests performed, device met design specifications. |
| Shelf Life Evaluation (Physical, Mechanical, Chemical, Package, Sterility) | Tests performed on real-time aging samples to verify claimed shelf life. |
| Biocompatibility Testing (ISO 10993-1) | |
| Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Hemolysis, Pyrogen | Tests performed, device met design specifications. |
Since this document is not about an AI/ML device, the remaining points are addressed as "Not Applicable" for AI/ML concepts, or reinterpreted in the context of a traditional medical device submission if relevant.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set: The document does not specify exact sample sizes for each physical, mechanical, chemical, sterility, or biocompatibility test. It indicates "tests were performed on real time aging samples" for shelf life, implying prospective testing for that aspect. Other tests are generally conducted on representative samples of the manufactured device.
- Data Provenance: The manufacturing company is JiangXi HongDa Medical Equipment Group Ltd. in China. The testing was likely performed in China, but the document does not explicitly state the country of origin for the testing data. The testing is performed on the proposed device itself, not on human data.
- Retrospective/Prospective: Shelf-life testing is prospective (real-time aging). Other tests are typically performed on newly manufactured devices, which could be considered prospective testing for that specific batch.
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)
- Not Applicable (for AI/ML ground truth): Ground truth in this context refers to the verifiable performance of the physical device against established engineering and biological standards. There are no "experts" establishing ground truth in the AI/ML sense (e.g., clinicians labeling images). The standards themselves define the ground truth, and the testing methodology is designed to objectively measure compliance. The "experts" would be the engineers and technicians performing the tests, qualified in areas of materials science, mechanical testing, chemistry, microbiology, and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (for AI/ML adjudication): This concept does not apply to the physical testing of a syringe and needle. Test results are objectively measured against defined limits in the standards.
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 a physical medical device, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth (for physical device): The "ground truth" for this device is its adherence to the predefined physical, mechanical, chemical, sterility, and biocompatibility specifications as outlined in the referenced ISO and ASTM standards. This is determined by quantitative measurements and qualitative assessments described in these standards, rather than expert consensus on a diagnostic outcome or pathology.
8. The sample size for the training set
- Not Applicable: This is a physical medical device, not an AI/ML algorithm. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable: This is a physical medical device. There is no "training set" or ground truth established for training.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).