(176 days)
The Sterile Hypodermic Syringe for Single Use With/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The sterile Insulin Syringe for single use with needle is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Retractable Auto-Disable Syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
| Device Name | Intended Use | Nozzel | Volume | Material | Remark |
|---|---|---|---|---|---|
| Sterile Hypodermic | |||||
| Syringe for single use | The Sterile Hypodermic Syringe for Single Use | ||||
| With/without needle is intended to be used for medical | |||||
| purposes to inject fluid into or withdraw fluid from | |||||
| body. | Luer Slip | 1,2,3,5,10,20,30,50,100 | |||
| (ml) | PP | With or Without | |||
| Needle | |||||
| Sterile Insulin | |||||
| Syringe for single use | The sterile Insulin Syringe for single use with needle is | ||||
| a device intended for medical purposes for the manual | |||||
| aspiration of insulin, and for the injection of insulin into | |||||
| parts of the body below the surface skin. | Fixed | 0.5,1 | |||
| (ml) | PP | With Fixed Needle | |||
| Retractable | |||||
| Auto-Disable Syringe | |||||
| for single use | The Retractable Auto-Disable Syringe for single use | ||||
| with/without needle is intended to be used for medical | |||||
| purposes to inject fluid into or withdraw fluid from | |||||
| body. Its secondary intended use is to retract inside the | |||||
| safety barrel, contain the contaminated needle and aid in | |||||
| the prevention of accidental needle stick injuries. | Luer Lock | 3,5,10 | |||
| (ml) | PP | With or Without | |||
| Needle | |||||
| Sterile Hypodermic | |||||
| Needle for single use | The Sterile Hypodermic Needle for single use is | ||||
| intended for use with syringes and injection devices for | |||||
| general purpose fluid injection/aspiration | Luer Slip | ||||
| Luer Lock | 16G,18G,19G,20G, | ||||
| 21G,22G,23G,24G, | |||||
| 25G,26G,27G,29G | Stainless | ||||
| Steel |
The provided 510(k) summary for K072739 describes Jierui Syringes and Needles, which are mechanical devices, not AI/ML-driven software. Therefore, the questions regarding acceptance criteria and studies typical for AI/ML performance evaluation (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and data provenance) are not applicable in this context.
Instead, the document details the substantial equivalence determination to predicate devices based on regulatory classification, intended use, sterilization specifications, performance, biocompatibility, chemical specifications, and physical/mechanical specifications.
Here's an overview of the "effectiveness and safety considerations" relevant to this medical device:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for Jierui Syringes and Needles are primarily based on achieving substantial equivalence to predicate devices and compliance with established performance standards and biological evaluation tests. The device's performance is reported in terms of meeting these standards for effectiveness and safety.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate devices |
| Sterilization Specifications | Same as predicate devices |
| Performance | Equivalent to predicate devices; all variant models evaluated regarding performance |
| Biocompatibility | In compliance with ISO 10993 "Biological Evaluation of Medical Devices" |
| - Cytotoxicity | |
| - Sensitization | |
| - Irritation or Intracutaneous Reactivity | |
| - Systemic Toxicity (Acute) | |
| - Haemo-compatibility | |
| Chemical Specifications | Same as predicate devices |
| Physical and Mechanical Specs | Similar to predicate devices, with slight variants deemed not to influence effectiveness and safety |
| Safety Aspects | Compliance with ISO 10993 standards and substantial equivalence to predicate devices |
2. Sample Size and Data Provenance
Not applicable. This information is relevant for AI/ML performance studies, not for the substantial equivalence demonstration of mechanical medical devices like syringes and needles described here. The evaluation is based on compliance to standards and comparison to predicate devices, not on data sets.
3. Number of Experts and their Qualifications for Ground Truth
Not applicable. This information is relevant for AI/ML performance studies. For this device, "ground truth" is established by adherence to recognized standards (e.g., ISO 10993) and comparison to the characteristics of legally marketed predicate devices.
4. Adjudication Method
Not applicable. This is a concept related to reviewing discrepancies in expert opinions for AI/ML ground truth establishment.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a MRMC study was not done. This type of study is typically performed to evaluate the impact of AI assistance on human reader performance, which is not relevant for this mechanical device.
6. Standalone Performance Study (Algorithm Only)
No, a standalone performance study was not done. This concept is for AI algorithms, not for physical medical devices.
7. Type of Ground Truth Used
The "ground truth" for this submission is implicitly defined by:
- Compliance with recognized international standards: e.g., ISO 10993 for biological evaluation.
- Characteristics of legally marketed predicate devices: The Jierui Syringes and Needles are compared against previously cleared predicate devices (K070936, K071630, K053519, K070440) to establish substantial equivalence in terms of design, materials, intended use, and performance outputs.
8. Sample Size for the Training Set
Not applicable. This refers to AI/ML models.
9. How the Ground Truth for the Training Set was Established
Not applicable. This refers to AI/ML models.
In summary, the K072739 submission for Jierui Syringes and Needles demonstrates safety and effectiveness through a substantial equivalence argument, supported by compliance with relevant performance and biocompatibility standards, rather than through empirical studies involving human readers or AI algorithms on specific datasets.
§ 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).