(136 days)
It is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
A sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both). It is made of stainless steel needle, plastic and silicone materials, and is manually operated. It is intended for various medical applications and is not dedicated to medication administration.
It is intended be used by health-care personnel (doctors, nurses, etc.). The needle is lubricated with silicone. Product is sterile and sterilization process is validated according to ISO 11135:2014.
This document is a 510(k) Premarket Notification for Promisemed Sterile Hypodermic Syringes and Verifine Sterile Hypodermic Syringes. It is not a study proving the device meets acceptance criteria for an AI/ML powered device. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (Sol-M TB Syringe K153537) for a standard medical device (syringes).
Therefore, the requested information about acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, and training set details are not applicable to this document.
The document primarily focuses on:
- Device Description: Sterile hypodermic syringes with a fixed needle.
- Intended Use: To inject or withdraw fluids from the body for medical purposes.
- Substantial Equivalence: Comparison to a predicate device (Sol-M TB Syringe K153537) in terms of intended use, technological characteristics, and performance.
- Performance Testing: Bench testing according to recognized ISO standards (ISO 7886-1, ISO 9626, ISO 7864) and USP for bacterial endotoxin, along with sterility, package integrity, shelf-life, and biocompatibility testing per ISO 10993 series. These tests confirm the physical and biological safety of the device, not the performance of an AI algorithm.
Summary of Device Performance (from the document), adapted to fit a "performance" concept for a non-AI device:
| Acceptance Criteria (Bench Test Standards) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7886-1:2017 (Sterile hypodermic syringes for manual use) | Complied |
| ISO 9626:2016 (Stainless steel needle tubing) | Complied |
| ISO 7864:2016 (Sterile hypodermic needles for single use) | Complied |
| **USP ** (Bacterial Endotoxin Test - limit ** (Pyrogen Test) | Non pyrogenic |
| **USP ** (Particulate matter in injections) | Complied |
| ISO 10993-4:2017 (Interactions with blood) | Complied (No evidence of hemolysis) |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Within limit |
The remaining questions are not applicable as this is a traditional medical device submission, not an AI/ML device:
- Sample sized used for the test set and the data provenance: Not applicable. Performance is based on bench testing of device characteristics, not a clinical test set from patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for diagnostic or prognostic purposes is established. Device performance is determined by objective physical and chemical tests against recognized standards.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. Performance is based on compliance with established engineering and biocompatibility standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).