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510(k) Data Aggregation
(385 days)
Medline Luer-Lock Syringes are intended for use by healthcare professionals for general purpose fluid aspiration/ injection. Intended for manual use.
Medline Luer Lock Syringes are Rx, sterile, non-pyrogenic, single use syringes intended to inject fluids into or withdraw fluids from, the body. The syringe consists of a luer lock tip, graduated barrel, a plunger rod and stopper. The barrel has gradient markings (mL) and the male luer lock tip allows the user to attach to a hypodermic needle or administration line. The plunger is pulled back to aspirate fluids or depressed to inject or expel fluids. Medline Luer Lock Syringes are available in 3mL, 5mL, 20mL, 30mL and 60mL.
The document describes the Medline Luer Lock Syringes, which are sterile, non-pyrogenic, single-use syringes intended for general purpose fluid aspiration/injection by healthcare professionals for manual use. The device's substantial equivalence to a predicate device (BD Plastipak Syringe, K182589) was established through non-clinical performance testing and biocompatibility assessments, rather than clinical studies or those involving AI.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|---|
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10093-4, ASTM F756-17 | Testing performed in accordance with FDA guidance and standards, indicating compliance (implied by 510(k) clearance) |
| Performance (Syringe) | ISO 7886-1:2017 (Sterile hypodermic syringes for single use - Part 1) | Testing performed for compliance with this standard, indicating compliance (implied by 510(k) clearance) |
| Performance (Connectors) | ISO 80369-7:2016 (Small-Bore Connectors for Liquids and Gasses - Part 7) | Testing performed for compliance with this standard, indicating compliance (implied by 510(k) clearance) |
| Particulate Matter | USP Particulate Matter in Injections | Testing performed in accordance with USP , indicating compliance (implied by 510(k) clearance) |
| Bacterial Endotoxin | USP Bacterial Endotoxin Testing (Limulus Amebocyte Lysate (LAL)) | Testing performed in accordance with USP Bacterial Endotoxin Testing, indicating compliance (implied by 510(k) clearance) |
| Shelf Life | N/A (Comparison to predicate, 5 years) | 5 years shelf life (same as predicate) |
| Sterility Assurance Level | $10^{-6}$ | $10^{-6}$ (same as predicate) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test mentioned (e.g., number of syringes tested for flow rate, leakage, etc.). It only states that "Performance testing on the Medline Luer Lock Syringes was conducted for compliance with the below standards."
Regarding data provenance, the studies are non-clinical (bench testing and biocompatibility), so "country of origin of the data" and "retrospective or prospective" are not applicable in the typical sense of clinical or real-world data studies. The testing was conducted internally or by contracted labs to demonstrate compliance with international standards.
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. The evaluations are based on established engineering standards (e.g., ISO, USP) and laboratory testing protocols, not expert consensus on ground truth in a diagnostic or interpretive sense.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies involving human interpretation (e.g., medical imaging), which is not the case for device performance testing against defined engineering standards.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not applicable to a piston syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance evaluation was not done. This is also relevant for AI/software devices, not for a physical medical device like a syringe.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this device is based on established international and national engineering standards (e.g., ISO 7886-1, ISO 80369-7), biocompatibility guidelines (ISO 10993), and pharmacopeial monographs (USP). Compliance with these standards defines the acceptable performance and safety criteria for the device.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
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