(445 days)
PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe 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.
PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body the surface of the skin. The device consists of a calibrated barrel (cylinder) with plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. At the distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. Attached needle has covered by the protective cap which is intended to provide physical protection to the needle tube. Attached needle may have safety guard that protect the user after use. This product is packed by sterile paper and sterilized by EO gas, and single-use device.
This document describes the regulatory approval for a medical device, specifically a Low Dead Volume (LDV) Sterile Syringe (PLPT LDV LC/LL Sterile Syringe). The provided text is an FDA 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or clinical superiority through extensive comparative clinical trials.
Therefore, the information about acceptance criteria and study proving the device meets those criteria will be focused on bench testing and biocompatibility assessments demonstrating equivalence to established standards and predicate devices, rather than complex multi-reader, multi-case studies typically seen for AI/ML devices.
Here's the breakdown based on the provided text:
Device: PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe and PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe.
Indications for Use: Intended for use by healthcare professionals for general purpose aspiration of fluid from vials, ampoules, and liquid injection below the surface of the skin.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established international standards for medical devices and comparison to predicate devices. The device's performance is demonstrated through adherence to these standards and the fulfillment of specific regulatory requirements.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard / Test Method / Limit) | Reported Device Performance (Compliance / Result) |
|---|---|---|
| Mechanical Performance | ISO 7886-1:2017 Sterile hypodermic syringes for single use (Syringe performance) | Complies with ISO 7886-1:2017 |
| ISO 7864:2016 Sterile hypodermic needles for single use (Needle performance) | Complies with ISO 7864:2016 | |
| ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices | Complies with ISO 9626:2016 | |
| ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications (Connector performance) | Complies with ISO 80369-7:2021 | |
| Biocompatibility | ISO 10993-1:2018 (Body contact: External communication device – Blood path indirect; Duration: Limited (, Bacterial Endotoxins Test) | Satisfied requirements |
| Particulate Matter Injection (USP ) | Satisfied requirements | |
| Sterility | ISO 11135:2014 Ethylene Oxide (EO) Sterilization Validation (Parameters: EO 30%, CO2 70%; Temp: 50 ±7°C; Exposure: 5 hours) | Validated and deemed acceptable. |
| Sterility Test (ISO 11737-2) | Complied | |
| EO Residual Test (ISO 10993-7:2008) | Met test requirements | |
| Sterility Assurance Level (SAL) | 10⁻⁶ | |
| Endotoxin Limit | 20 EU per device | |
| Low Dead Volume | Syringe Dead Space: ≤ 0.023 mL | ≤ 0.023 mL (Same as predicate) |
| Needle Dead Space: , USP ). |
These standards define the acceptable performance characteristics for syringes and needles.
8. The sample size for the training set:
Not applicable. This device is a physical product and does not involve AI/ML requiring a "training set" in the computational sense.
9. How the ground truth for the training set was established:
Not applicable for the same reason as above.
§ 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).