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PLPT LDV (Low Dead Volume) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
A sterile device consisting of a calibrated barrel (cylinder) with plunger 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); a needle is not included. It is intended for various medical applications and is not dedication administration. At the distal end of the barrel is a Luer-lock connector for the attachment to a hypodermic needle or an administration set. This is a single-use device.
The PLPT LDV (Low Dead Volume) Sterile Syringe is designed to reduce the fluid waste because of its plunger design.
The provided FDA 510(k) summary for the PLPT LDV (Low Dead Volume) Sterile Syringe describes its performance testing but does not contain information typically associated with studies for AI/algorithm-driven medical devices.
This document describes a traditional medical device (a syringe) and focuses on engineering, material, and biological compatibility testing, not on algorithm performance, human reader studies, or ground truth establishment for AI.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be answered from the provided text.
Here's a breakdown of the relevant and irrelevant information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Dead space specification (ISO 7886-1 compliant) | ≤ 0.023mL with 95% confidence/95% reliability |
| Cytotoxicity (ISO 10993-5) | Conformed (Met acceptance criteria) |
| Sensitization (ISO 10993-10) | Conformed (Met acceptance criteria) |
| Irritation (ISO 10993-10) | Conformed (Met acceptance criteria) |
| Acute Systemic Toxicity (ISO 10993-11) | Conformed (Met acceptance criteria) |
| Material-Mediated Pyrogenicity (ISO 10993-11 for systemic toxicity) | Conformed (Met acceptance criteria) |
| Hemocompatibility (ISO 10993-4, ASTM F756-17) | Conformed (Met acceptance criteria) |
| Particulate Matter (USP ) | Met USP acceptance criteria |
| Sterility (USP 39, , ISO 11135:2014) | Sterilization process deemed acceptable (validated) |
| Bacterial Endotoxins (USP 39, ) | (Implied met, as part of ISO 10993-4/11 or general biocompatibility) |
| Shelf-life (3 years) (ISO 11607-1:2006 and ISO 11607-2:2006) | Validated |
| Small-bore connectors (ISO 80369-7:2016) | (Implied met, as listed as conformed standard) |
| General requirements for sterile hypodermic syringes (ISO 7886-1) | (Implied met, as listed as conformed standard) |
| Biological evaluation of medical devices (ISO 10993-1:2018) | Conformed (Relevant parts tested and met criteria) |
| Ethylene Oxide sterilization residuals (ISO 10993-7:2008) | (Implied met, as part of overall sterilization validation) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This information is for AI/algorithm studies. The document describes bench testing for a physical device. While specific sample sizes for tests like dead space measurement, biocompatibility, or sterility validation would have been used, they are not detailed in this summary.
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)
- Not applicable / Not provided. This information is for AI/algorithm studies. The "ground truth" for a physical device is typically established through direct measurement against established standards or validated laboratory methods, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. This information is for AI/algorithm studies involving human readers or interpretation.
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. This is not an AI-assisted device. The device is a physical syringe.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / No. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance testing of this physical device relied on established international and national standards, laboratory methods, and physical measurements. For example:
- Dead space: Measured directly against the specified quantitative limit.
- Biocompatibility: Evaluated through laboratory tests like cytotoxicity, sensitization, and irritation following ISO standards.
- Sterility: Determined through microbiological testing according to USP and ISO standards.
- Particulate Matter: Measured using methods described in USP .
8. The sample size for the training set
- Not applicable / Not provided. This information is for AI/algorithm studies. This document describes a physical medical device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This information is for AI/algorithm studies.
§ 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).