(253 days)
Safety Needles: The safety needles are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Sterile Syringe: The sterile syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Syringe with Safety Needle: The sterile syringe with safety needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
Sterile Syringe with Needle: The sterile syringe with needle is intended for use the aspiration of fluids for medical purpose.
Hypodermic Needles for Single Use: The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration of fluids for medical purpose.
(1)Safety Needles: The Safety Needles are intended for manual and single use only. They consist of a needle cap, needle tube and hub with protector. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
(2)Sterile Syringe: The Sterile Syringe is intended for manual and single use only. It consists of a Barrel, Plunger, and Piston. The syringes are available with luer slip and luer lock connector types and are available in different sizes. They are intended to be connected to a safety/hypodermic needle.
(3)Sterile Syringe with Safety Needle: This product is intended for manual and single use only. The Sterile Syringe with Safety Needle consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
(4)Sterile Syringe with Needle: The Sterile Syringe with Needle is intended for manual and single use only. It consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes.
(5)Hypodermic Needles for Single Use: The Hypodermic Needle is intended for manual and single use only. It consists of a hub, needle tube, needle cap. The proposed device is compatible for use with a luer slip or luer lock syringe.
The provided document is a 510(k) Premarket Notification from Jiangsu Micsafe Medical Technology Co., Ltd. for various sterile syringe and needle products. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its "safety and effectiveness" through clinical trials as is typically done for novel devices.
Therefore, the document does not contain the kind of acceptance criteria, study details, and performance metrics typically associated with AI/ML-enabled medical devices that would involve a "test set," "ground truth," "expert adjudication," or "MRMC comparative effectiveness studies." The acceptance criteria and "study" described in this document relate to demonstrating substantial equivalence through non-clinical bench testing to established international standards for medical devices like needles and syringes, and biocompatibility.
Here's an analysis based on the information provided in the document, framed to address the prompt's categories where applicable, and noting where the information is not present or not relevant to the prompt's context (which often implies AI/ML or diagnostic performance studies):
Acceptance Criteria and Device Performance (based on provided document):
The document defines acceptance criteria by adhering to established ISO and ASTM standards for medical devices. The "performance" is the successful demonstration of conformity to these standards.
| Acceptance Criteria (Standard & Requirement) | Reported Device Performance |
|---|---|
| Biocompatibility (per ISO 10993 series & ASTM F756-17): |
- No Cytotoxicity
- No Irritation to Skin
- No significant evidence of sensitization
- No systemic toxicity
- No Hemolysis
- Non pyrogenic | Conforms to the requirement of ISO 10993 series Standards:
- No Cytotoxicity
- No Irritation to Skin
- No significant evidence of sensitization
- No systemic toxicity
- No Hemolysis
- Non pyrogenic |
| Safety Needles Performance (per ISO 7864 & ISO 9626, and ISO 23908:2011 for safety feature): - Force to activate safety mode: NMT 10N
- Force to disengage safety mode: NLT 20N
- Force to separate safety feature from needle hub: NLT 50N | Conforms with the requirements of ISO 7864 and ISO 9626.
Needle Safety Feature: Testing conducted per ISO 23908:2011. - Force to activate safety mode: NMT 10N
- Force to disengage safety mode: NLT 20N
- Force to separate safety feature from needle hub: NLT 50N |
| Sterile Syringe Performance (per ISO 7886 & ISO 80369-7): - Cleanliness
- Limits for acidity or alkalinity
- Lubricant
- Tolerance on graduated capacity
- Scale, etc. | Conforms with the requirements of ISO 7886 and ISO 80369-7. (Specific values not provided in summary table, but implied by conformity statement) |
| Sterile Syringe with Safety Needle Performance (per ISO 7864, ISO 9626, ISO 7886, ISO 80369-7, and ISO 23908:2011 for safety feature): - Same as individual components. | Conforms with the requirements of ISO 7864, ISO 9626, ISO 7886, and ISO 80369-7.
Needle Safety Feature: Testing conducted per ISO 23908:2011. - Force to activate safety mode: NMT 10N
- Force to disengage safety mode: NLT 20N
- Force to separate safety feature from needle hub: NLT 50N |
| Sterile Syringe with Needle Performance (per ISO 7864, ISO 9626, ISO 7886, ISO 80369-7): - Same as individual components. | Conforms with the requirements of ISO 7864, ISO 9626, ISO 7886, and ISO 80369-7. (Specific values not provided in summary table, but implied by conformity statement) |
| Hypodermic Needles for Single Use (per ISO 7864 & ISO 9626): - Cleanliness
- Limits for acidity or alkalinity
- Limits for extractable metals
- Color coding
- Conical fitting, etc. | Conforms with the requirements of ISO 7864 and ISO 9626. (Specific values not provided in summary table, but implied by conformity statement) |
| Particulate Testing (per USP ): | Performed (Result of conformity implied by overall conclusion of substantial equivalence). |
Regarding the prompt's specific questions:
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A table of acceptance criteria and the reported device performance:
- See table above. The "performance" is reported as conformance to the specified ISO/ASTM standards and the specific thresholds for the safety features.
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Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify exact sample sizes for each non-clinical bench test. The testing is described as complying with the requirements of the listed ISO/ASTM standards, which typically prescribe sample sizes for such tests.
- Data Provenance: The tests were conducted by the manufacturer, Jiangsu Micsafe Medical Technology Co., Ltd. (China). The data would be specific to their manufactured devices, and these are non-clinical, bench-top tests, not human subject data.
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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 submission is for physical medical devices (needles, syringes), not AI/ML software or diagnostic devices that require expert review of ground truth in the context of images or clinical data. The "ground truth" for these devices is defined by the performance specifications of the international standards themselves (e.g., a needle must meet certain force requirements, be free from defects, etc.). The experts involved are likely engineers or quality control specialists who conduct and verify the bench tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. This concept is not relevant to non-clinical bench testing of physical medical devices. Adjudication methods are typically used in clinical studies, especially those involving subjective interpretations (e.g., by radiologists) to establish a consensus ground truth.
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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 is specifically for evaluating the impact of AI/ML algorithms on human reader performance, typically in diagnostic imaging. It is not relevant to the evaluation of sterile syringes and needles.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This concept pertains to the performance of an AI/ML algorithm by itself. The devices described (needles and syringes) are physical instruments for manual use, not software algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For these devices, "ground truth" is established by adherence to globally recognized technical standards (ISO 7864, ISO 9626, ISO 7886, ISO 80369-7, ISO 23908, ISO 10993 series, USP , ASTM F756-17). These standards specify the physical, chemical, and biological properties and performance requirements for the devices. The "ground truth" is objective measurement and verification against these specified parameters, not subjective expert consensus on complex clinical cases or pathology.
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The sample size for the training set:
- Not applicable. This document describes the testing of a medical device, not the development or validation of an AI/ML model that would use training data.
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How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML model or "training set," this question is not relevant.
Summary with respect to the 510(k) submission's purpose:
The document focuses on demonstrating substantial equivalence to an existing predicate device (K170651) by showing that the new devices meet the same safety and performance standards through non-clinical bench testing and biocompatibility assessments. The differences between the subject device and the predicate device (e.g., differences in available sizes, slight variations in luer connections, and specific safety feature force values) were addressed by demonstrating compliance with the relevant international standards. The FDA's clearance (K183665) indicates that the agency agreed that this non-clinical data was sufficient to establish substantial equivalence for these types of medical devices.
§ 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).