(472 days)
Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.
Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle cap.
All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume.
The provided text describes the 510(k) summary for a Disposable Sterile Syringe (K221777) and its substantial equivalence to a predicate device. This document is a regulatory submission for a medical device that does not involve AI or complex software, and therefore, many of the requested details regarding acceptance criteria, study methodologies for AI/software performance (e.g., sample size for test sets, expert adjudication, MRMC studies, standalone performance, ground truth for AI), and training set information are not applicable.
The device is a simple, physical product (a syringe) and its "performance" is assessed through adherence to established international and ASTM standards for physical, chemical, and biological properties, as well as sterility and packaging integrity. The acceptance criteria for such a device are primarily defined by these international standards.
Here's an attempt to address the points based on the provided document, highlighting what is applicable and what isn't:
Device: Disposable Sterile Syringe (K221777)
Purpose: Intended to inject fluids into or withdraw fluids from the body.
This device is a traditional medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to compliance with recognized standards and biocompatibility testing, rather than performance metrics like sensitivity, specificity, or AUC for an AI algorithm.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are its compliance with various ISO and ASTM standards. The "reported device performance" is essentially that the device "meets the requirements of related standards" and that "there are no negative impacts from the materials that are used in the proposed device."
| Item / Test Category | Standard / Acceptance Criteria (Derived from document) | Reported Device Performance (Summary from document) |
|---|---|---|
| Physical/Mechanical Performance | ||
| Cleanliness | ISO 7864:2016 Clause 4.3; ISO 9626:2016 Clause 5.3 | Meets requirements (Implied by "complies with") |
| Acidity/Alkalinity | ISO 7864:2016 Clause 4.4; ISO 9626:2016 Clause 5.4 | Meets requirements |
| Extractable Metals | ISO 7864:2016 Clause 4.5 | Meets requirements |
| Size Designation | ISO 7864:2016 Clause 4.6; ISO 9626:2016 Clause 5.5 | Meets requirements |
| Color Coding | ISO 7864:2016 Clause 4.7; ISO 6009:2016 | Meets requirements |
| Needle Hub | ISO 7864:2016 Clause 4.8 | Meets requirements |
| Sheath | ISO 7864:2016 Clause 4.9 | Meets requirements |
| Needle Tube | ISO 7864:2016 Clause 4.10 | Meets requirements |
| Needle Point | ISO 7864:2016 Clause 4.11 | Meets requirements |
| Bond (hub/tube) | ISO 7864:2016 Clause 4.12 | Meets requirements |
| Patency of Lumen | ISO 7864:2016 Clause 4.13 | Meets requirements |
| Surface Finish | ISO 9626:2016 Clause 5.1 | Meets requirements |
| Dimensions | ISO 9626:2016 Clause 5.6 | Meets requirements |
| Stiffness | ISO 9626:2016 Clause 5.7 | Meets requirements |
| Resistance to Breakage | ISO 9626:2016 Clause 5.8 | Meets requirements |
| Resistance to Corrosion | ISO 9626:2016 Clause 5.9 | Meets requirements |
| Extraneous Matter | ISO 7886-1:2017 Clause 6 | Meets requirements |
| Lubricant | ISO 7886-1:2017 Clause 7 | Meets requirements |
| Graduated Capacity Tolerance | ISO 7886-1:2017 Clause 8 | Meets requirements |
| Graduated Scale | ISO 7886-1:2017 Clause 9 | Meets requirements |
| Barrel | ISO 7886-1:2017 Clause 10 | Meets requirements |
| Piston/Plunger Assembly | ISO 7886-1:2017 Clause 11 | Meets requirements |
| Nozzle | ISO 7886-1:2017 Clause 12 | Meets requirements |
| General Performance | ISO 7886-1:2017 Clause 13 | Meets requirements |
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 | No cytotoxicity / No negative impacts |
| Irritation | ISO 10993-10:2010 | No intracutaneous reactivity / No negative impacts |
| Sensitization | ISO 10993-10:2010 | No skin sensitization / No negative impacts |
| Systemic Toxicity | ISO 10993-11:2017 | No systemic toxicity / No negative impacts |
| Hemolysis | ISO 10993-4:2017 | No Hemolysis / No negative impacts |
| Pyrogen | Performed (Result is "No Pyrogen" listed in Table 2) | No Pyrogen / No negative impacts |
| Sterilization & Packaging | ||
| EO residue | ISO 11737-2:2019 | Did not exceed the limit |
| Endotoxin limit | Not specified standard, but a limit of 20EU/device | Did not exceed 20EU/device |
| Visual Inspection | ASTM F1886/F1886M-16 | Package can maintain its integrity |
| Seal Strength | ASTM F88/F88M-15 | Package can maintain its integrity |
| Dye Penetration Test | ASTM F1929-15 | Package can maintain its integrity |
| Shelf-Life | Physical, Mechanical, Chemical, Package Tests | Device can maintain its performance during claimed shelf life |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for each test. For medical device testing, samples are typically chosen according to relevant standard methods (e.g., lot-based sampling conforming to AQL – Acceptable Quality Level).
- Data Provenance: Not explicitly stated regarding country of origin for the non-clinical test data. The tests were performed by "Weihai Shengjie Medical Technology Co., Ltd." in China, where the manufacturing entity is located. The tests are "nonclinical" (laboratory-based) and are implicitly prospective for the purpose of demonstrating compliance.
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. This is a physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is provided by the universally recognized and standardized test methods and their defined acceptance limits (e.g., ISO, ASTM standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human interpretation or adjudication of case data is involved for this type of device submission. Compliance is determined by objective physical, chemical, and biological test results against predefined standard thresholds.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this medical device's performance is compliance with established international and national standards (ISO, ASTM). These standards define the acceptable physical, mechanical, chemical, and biological properties for the device. For example, for biocompatibility, the ground truth is "no cytotoxicity" as per ISO 10993-5, determined by validated laboratory methods.
8. The sample size for the training set
- Not Applicable. This device uses traditional manufacturing and testing, not machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant.
§ 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).