(328 days)
1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
The proposed Syringes include 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle.
Each of the 1ml Luer Slip or Luer Lock Syringe, Safety Syringe with permanently attached needle. have one kind of product configuration, and the Syringe with permanently attached needle has two kinds of product configurations (Type A and Type B).
The proposed syringes are available in different combination of syringe volumes and/or needle sizes (refer to Table 1).
The proposed Syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
The provided text describes a 510(k) premarket notification for three types of syringes. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets acceptance criteria through a clinical study or performance evaluation in the typical sense of AI/medical imaging device submissions.
Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission, as it's a conventional medical device and not an AI-powered one. The submission relies on non-clinical performance testing against established international standards to show equivalency in safety and efficacy.
Here's a breakdown of the available information based on your request, with an emphasis on what is and isn't present in this specific 510(k) summary:
Acceptance Criteria and Device Performance (Non-Clinical)
The acceptance criteria for these devices are defined by adherence to various international and national standards for medical syringes and needles. The "reported device performance" is a statement that the device complies with these standards, indicating successful non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not present a single "acceptance criteria table" with specific numerical thresholds and corresponding "reported performance values" in the way one might see for an AI algorithm's sensitivity/specificity. Instead, the performance is demonstrated by compliance with the referenced standards.
| Acceptance Criteria (Governing Standard/Requirement) | Reported Device Performance (Compliance Statement) |
|---|---|
| Piston Syringe Performance (General) | Complies with ISO 7886-1:2017 |
| Small-bore Connectors (Intravascular/Hypodermic) | Complies with ISO 80369-7:2016 |
| Common Test Methods for Small-bore Connectors | Complies with ISO 80369-20:2015 |
| Stainless Steel Needle Tubing | Complies with ISO 9626:2016 |
| Sterile Hypodermic Needles (Requirements & Test Methods) | Complies with ISO 7864:2016 |
| Sterilization Residuals (Ethylene Oxide) | Complies with ISO 10993-7:2008 |
| Bacterial Endotoxin Limit | Complies with USP 41-NF36:2018 (20 EU per device) |
| Seal Strength of Flexible Barrier Materials (Sterility) | Complies with ASTM F88/F88M-15 |
| Detecting Seal Leaks in Porous Medical Package | Complies with ASTM F1929-15 |
| Integrity of Seals for Flexible Packaging by Visual Inspection | Complies with ASTM F1886/F1886M-16 |
| Sharps Injury Protection Features | Complies with ISO 23908:2011 & FDA Guidance, demonstrated through internal safety feature performance specs (see below) |
| Biocompatibility | Conforms to ISO 10993 series standards (via reference device K150758) |
| Sterility Assurance Level (SAL) | Meets 10⁻⁶ SAL (EO Sterilized) |
| Labeling | Complies with 21 CFR part 801 |
| Safety Feature Performance Specifications (for Safety Syringe) | The torque to lock: 20 N·cm |
Study Details (Non-Clinical Performance Testing)
2. Sample size used for the test set and data provenance
- Sample Size: Not explicitly stated in the provided text. The document refers to compliance with standards, which typically involve specific sample sizes for their respective tests, but these are not enumerated here.
- Data Provenance: The tests were non-clinical performance tests conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd. The country of origin for the data is China, implicitly, as that is the manufacturer's location. The tests are prospective in the sense that they were performed to support this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a conventional medical device, typically manufactured and tested according to engineering standards. "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant for proving substantial equivalence of a syringe. Compliance with ISO and ASTM standards is the "truth" here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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/imaging device. No MRMC study was conducted.
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 consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is its adherence to established engineering, manufacturing, and performance standards for syringes and needles (e.g., ISO, ASTM). Biocompatibility is confirmed by referencing a previously cleared device with identical patient-contact materials (K150758).
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical device, not an AI model.
Summary of Approach:
The provided K192551 document demonstrates substantial equivalence based on:
- Direct comparison of the proposed devices' characteristics (e.g., configuration, materials, volume, needle size, performance standards) to legally marketed predicate devices.
- Non-clinical performance testing to ensure compliance with relevant international and national consensus standards (ISO, ASTM, USP). The "acceptance criteria" are the thresholds and requirements defined within these standards.
- Biocompatibility assessment by referencing a previously cleared device (K150758) that uses identical patient-contact materials.
No clinical studies or expert-driven evaluations of performance (like those for AI/imaging devices) were part of this submission, as stated clearly: "No clinical study is included in this submission."
§ 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).