(211 days)
The 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 stick.
The Safety Needle is intended for use with a 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 needle stick.
The proposed devices are provided in two types of configurations; one type is a syringe with safety needle contained in a sterility maintenance package, the other is one safety needle contained in a sterility maintenance package.
The Syringe with Safety Needle is available in various combination of syringe volume and needle size. The proposed device is operated manually. The liquid is aspiration into the syringe by pulling the plunger manually and injected into the body by pushing the plunger manually. When the needle is pulled out from the body, push the safety shield to cover the needle.
The proposed devices are 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 document is a 510(k) premarket notification for a medical device (Syringe with Safety Needle, Safety Needle). It primarily demonstrates substantial equivalence to a predicate device rather than presenting a de novo study proving a device meets specific clinical acceptance criteria through a novel study design. Therefore, much of the requested information regarding clinical study setup (sample size, ground truth, expert opinions, MRMC studies) is not applicable to this type of submission.
The document focuses on non-clinical performance data and a simulated clinical study for the safety mechanism.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria are generally based on compliance with international and ASTM standards (e.g., ISO 10993 series for biocompatibility, ISO 7864 for hypodermic needles, ISO 7886-1 for syringes, ISO 23908 for sharps injury protection, ASTM standards for packaging integrity). The reported device performance is stated as meeting these standards. Specific numerical acceptance criteria or performance metrics for each test are not explicitly detailed in a single table, but rather implied by the statement "The test results demonstrated that the proposed device complies with the following standards" and "The test results show that the device meets the requirements of related standards."
Non-Clinical Acceptance Criteria (Implied by Standards Compliance):
| Test Category | Standard / Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5: No cytotoxicity | No cytotoxicity |
| Irritation | ISO 10993-10: No intracutaneous reactivity | No intracutaneous reactivity |
| Sensitization | ISO 10993-10: No skin sensitization | No skin sensitization |
| Systemic Toxicity | ISO 10993-11: No systemic toxicity | No systemic toxicity |
| Hemolysis | ISO 10993-4, ASTM F756-17: No Hemolysis | No Hemolysis |
| Pyrogen (Endotoxin) | USP : Endotoxin Limit : Within limits for injections | (Tested, outcome implied compliant) |
| Device Performance | (Based on various ISO standards listed on page 12) | |
| Needle Characteristics | ISO 7864 (Cleanliness, Acidity/Alkalinity, Metals, Size, Color Coding, Hub, Cap, Tube, Point, Bond, Patency) | Meets requirements of related standards |
| Needle Tubing | ISO 9626 (Surface, Cleanliness, Acidity/Alkalinity, Size, Dimensions, Stiffness, Resistance to Breakage/Corrosion) | Meets requirements of related standards |
| Connectors | ISO 80369-7 (Fluid leakage, Sub-atmospheric air leakage, Stress cracking, Resistance to separation (axial/unscrewing), Overriding) | Meets requirements of related standards |
| Syringe Characteristics | ISO 7886-1 (General req., Extraneous matter, Lubricant, Capacity tolerance, Scale, Barrel, Piston/plunger, Nozzle, Performance) | Meets requirements of related standards |
| Packaging & Shelf Life | ||
| Shelf Life | Verified through aging samples, maintains performance during claimed shelf life | Maintains performance during 5-year claimed shelf life |
| Package Integrity | ASTM F1886/F1886M-16 (Visual), ASTM F88/F88M-15 (Seal Strength), ASTM F1929-15 (Dye Penetration) | Can maintain its integrity |
| Safety Feature | FDA Guidance (Medical Device with Sharps Injury Prevention Feature, Aug 2005), ISO 23908:2011 | Met pre-established criteria |
2. Sample size used for the test set and the data provenance
- Non-Clinical/Bench Testing: The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications" and "Physical. Mechanical, Chemical testing listed in following table were performed on the proposed device." Specific sample sizes for each non-clinical test (e.g., biocompatibility lot sizes, mechanical test numbers) are not provided in this summary.
- Simulated Clinical Study: "A simulated clinical study was performed... to evaluate the safety mechanism of the proposed device." Similarly, the specific sample size for this simulated study is not provided.
- Data Provenance: The manufacturer is Jiangsu Caina Medical Co., Ltd in China. The testing was conducted internally or by contract labs consistent with international standards. The document does not specify country of origin for any "data" beyond the manufacturer's location. The studies are by nature prospective (testing the new device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as there was no clinical study involving expert interpretation of patient data to establish ground truth. The "ground truth" for the non-clinical tests is adherence to established international and ASTM standards.
- For the "Simulated Clinical Study," the ground truth would be objectively measured performance against the safety mechanism's functional requirements as per FDA guidance and ISO 23908:2011. No human expert interpretation with ground truth labels is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical study with human readers/interpreters requiring adjudication of results.
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 device is a physical medical instrument (syringe/needle), not an AI-enabled diagnostic device. 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)
- The "ground truth" for this submission are the performance specifications and acceptance criteria outlined in recognized industrial and medical device standards (ISO, ASTM, USP), as well as relevant FDA guidance documents for sharps injury prevention. For the simulated clinical study, the ground truth was the objective performance of the safety mechanism against pre-established criteria based on these standards and guidance.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
Summary of what the document does provide regarding acceptance:
The acceptance of this device for 510(k) clearance is primarily based on:
- Demonstration of Substantial Equivalence (SE) to a legally marketed predicate device (K170651 for "Sterile Disposable Syringe with Safety Needle" and "Sterile Disposable Safety Needle"). The "Indications for Use" are shown to be the same.
- Compliance with recognized consensus standards (listed on page 12-14) for biocompatibility, sterility, physical/mechanical performance, packaging, and sharps injury prevention.
- Non-clinical testing results affirming that the proposed device performs comparably to the predicate device and meets the performance requirements of applicable standards.
- A Simulated Clinical Study (details not provided beyond its existence and outcome) to evaluate the safety mechanism's compliance with FDA guidance and ISO 23908:2011, demonstrating it "met the pre-established criteria."
- A Safety Feature Test comparing the proposed device to the predicate, showing "the test data of the proposed device is very close to the test data of the predicate device."
No human clinical trials or complex multi-reader studies were required or conducted, as indicated by "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).