(96 days)
The syringe without needle is used to inject fluids into, or withdraw fluids from, the body.
The Slip Tip and Eccentric Tip Syringe without Needle is a sterile, single-use, standard 3 piece piston. The device is packed individually and EO sterilized with 10-6 SAL.
The proposed device includes different specifications:
1ml Slip Tip Syringe without Needle
3ml Slip Tip Syringe without Needle
5ml Slip Tip Syringe without Needle
10ml Slip Tip Syringe without Needle
20ml Slip Tip Syringe without Needle
30ml Slip Tip Syringe without Needle
60ml Slip Tip Syringe without Needle
10ml Eccentric Tip Syringe without Needle
20ml Eccentric Tip Syringe without Needle
60ml Eccentric Tip Syringe without Needle
The provided document is a 510(k) summary for a medical device called "Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle." It outlines the device, its intended use, comparison to a predicate device, and non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information as requested:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are based on compliance with several international and industry standards for medical devices, particularly those related to syringes and their components. The reported device performance indicates compliance with these standards.
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ISO 7886-1:2017 (Sterile hypodermic syringes for manual use) | Complied with ISO 7886-1 |
| ISO 80369-7:2021 (Small-bore connectors for intravascular or hypodermic application) | Complied with ISO 80369-7 |
| ISO 80369-20:2015 (Common test methods for small-bore connectors) | Complied with ISO 80369-20 |
| ISO 10993-1:2018 (Biological evaluation - Risk management) | Complied with ISO 10993-1 |
| ISO 10993-4:2017 (Biological evaluation - Interaction with blood) | Complied with ISO 10993-4 |
| ISO 10993-5:2009 (Biological evaluation - In vitro cytotoxicity) | Complied with ISO 10993-5 |
| ISO 10993-7:2008 (Biological evaluation - Ethylene oxide sterilization residuals) | Complied with ISO 10993-7 |
| ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization) | Complied with ISO 10993-10 |
| ISO 10993-11:2017 (Biological evaluation - Systemic toxicity) | Complied with ISO 10993-11 |
| USP (Particulate Matter for injection) | Complied with USP |
| ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide) | Complied with ISO 11135 |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Complied with ASTM F88/F88M-15 |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Complied with ASTM F1929-15 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to compliance with international standards through non-clinical performance testing. It does not provide specific details on sample sizes for each non-clinical test conducted. The tests evaluate the physical, mechanical, chemical, and biological properties of the syringe. Given the nature of these tests, they are typically conducted in a controlled laboratory environment (prospective testing) to ensure adherence to the specified standards for medical devices. The country of origin of the data is not explicitly stated in this FDA submission document.
3. 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)
This information is not applicable as the submission describes non-clinical performance testing against established engineering and biological standards, not clinical studies requiring expert consensus on medical conditions or interpretations. The "ground truth" here is adherence to specified parameters within recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials where expert readers independently review medical images or patient data, and discrepancies are resolved. This submission details non-clinical laboratory testing.
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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." This device is a basic medical syringe, and such studies are not typically required for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument (syringe), not an AI algorithm or software. Therefore, there's no "standalone" algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" is defined by the specifications and acceptable limits established within the cited international and industry standards. For example, for ISO 7886-1, the ground truth would be the defined force required for plunger operation, or the leakage limits. For biological compatibility tests, the ground truth would be the absence of toxicity or irritation as per ISO 10993 series.
8. The sample size for the training set
This information is not applicable. This is a submission for a physical medical device (syringe), not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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).