Search Results
Found 1 results
510(k) Data Aggregation
(443 days)
Pluski Safe 1 Safety IV Catheter is Passive anti-needle stick device for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14-22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.
Pluski Safe 1 Safety I.V. Catheter is a medical device used for inserting a catient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. The device is equipped with a safety feature intended to prevent needle stick injuries. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids and have hence been potentially contaminated with infectious agents.
The device contains different parts like Needle cover, Catheter holder, body, Cross clip safety & filterHub cover. Devices are available in winged and non-winged version.
These devices are sold in sterile form & are single use devices.
This document is a 510(k) premarket notification for the Pluski Safe 1 Safety IV Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting a clinical study proving specified acceptance criteria for algorithm performance. Therefore, most of the requested information regarding an AI model's performance study is not available in this document.
However, I can extract information related to the device's overall performance and safety standards, which are a form of acceptance criteria for medical devices.
Acceptance Criteria and Reported Device Performance (General Device Performance, not AI-specific):
The device performance of the Pluski Safe 1 Safety I.V. Catheter was demonstrated against a set of applicable international standards. These standards define the "acceptance criteria" for the device's physical, mechanical, and biological properties.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 10555-1: Intravascular catheters - Part 1: General Requirements | Device demonstrated compliance with general requirements. |
| ISO 10555-5: Intravascular catheters - Part 5: Over-needle peripheral catheters | Device demonstrated compliance with over-needle peripheral catheter requirements. |
| ISO 80369-7: Small-bore connectors for intravascular or Hypodermic Applications (Luer taper) | Device demonstrated compliance with Luer taper specifications. |
| ISO 80369-20: Common test methods for small-bore connectors | Device utilized these common test methods. |
| ISO 23908:2011: Sharps injury protection - Features for single-use hypodermic needles, introducers for catheters | Device demonstrated sharps injury protection features. |
| ISO 10993-1: Biocompatibility evaluation for short-term intravascular catheter (Externally Communicating Device, Circulating Blood, Prolonged Contact) | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic/Chronic Systemic Toxicity, Hemocompatibility, Complement Activation, Prothrombin time/Activated partial thromboplastin time, Pyrogenicity, Particulate matter testing conducted and passed. |
| Shelf life (ASTM F1980-16) | 5 years validated. |
| Package Integrity (ASTM D4169/ISTA 2A) | Testing, conditioning, and simulated shipping performed. |
| Sterile Barrier Package Testing (ASTM F88/F88M:15, ASTM F1929-15, ASTM F1886-F1886M-16) | Peel testing, Dye Penetration, Visual Inspection performed. |
Regarding AI-specific questions, the document does not contain this information as it pertains to a physical medical device, not an AI algorithm:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: 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 (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For the physical device, ground truth is based on engineering standards, material science, and biological safety testing protocols.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1