(85 days)
The needle is used to access surgically implanted vascular ports.
Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.
In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.
Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle.
The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B and Type C), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.
The provided text describes a 510(k) premarket notification for the Promisemed Safety Huber Needle. This document focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device (Surecan Safety II, K170897) rather than providing a detailed study proving the device meets specific acceptance criteria for a novel technology.
The 510(k) clearance process does not typically involve a comparative effectiveness study (MRMC) with human readers or standalone AI performance studies, as it's for devices demonstrating substantial equivalence to pre-existing products, not necessarily for proving the clinical utility or superiority of a new diagnostic algorithm.
Therefore, the requested information about acceptance criteria and a study proving device performance in a clinical diagnostic context (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies) is not applicable to this type of device and submission. The "performance" discussed in this document refers to the adherence to engineering and safety standards.
However, I can extract the relevant "acceptance criteria" and "device performance" in the context of this 510(k) submission, which focuses on various engineering, material, and safety tests to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided document, noting where aspects are not applicable (N/A) due to the nature of a 510(k) submission for a physical medical device like a needle:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Compliance) |
|---|---|
| ISO 8536-4:2019 (Infusion sets for single use, gravity feed) | Complied |
| ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications) | Complied |
| ISO 23908:2011 (Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling) | Complied (Specifically addresses sharps protection feature for Type B safety mechanism) |
| ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods) | Complied |
| ISO 7864:2016 (Sterile hypodermic needles for single use Requirements and test methods) | Complied |
| ANSI/AAMI CN27:2021 (General Requirements For Luer Activated Valves (LAVs) Incorporated Into Medical Devices For Intravascular Applications) | Complied |
| ASTM F3212-16 (Coring Testing of Huber Needles) | Complied |
| Power injection flow rate testing (non-standardized test) | Verified flow rate under 330 psi; 19, 20 gauge - 5mL/s; 22 gauge - 2 mL/s |
| USP Bacterial Endotoxin Test | Complied (Pyrogen: Non pyrogenic) |
| Biocompatibility (ISO 10993 Series): | |
| ISO 10993-1: Classification | External communicating device, in contact with circulating blood with prolonged duration |
| ISO 10993-5:2009 (Tests for in Vitro Cytotoxicity) | No cytotoxicity |
| ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization) | No evidence of skin irritation, No evidence of sensitization |
| ISO 10993-11:2017 (Tests for systemic toxicity - Acute and Subchronic systemic toxicity) | No systemic toxicity |
| ISO 10993-3:2014 (Tests for genotoxicity, carcinogenicity and reproductive toxicity - Genotoxicity Test) | No evidence of mutagenicity |
| ISO 10993-4:2017 (Selection of tests for interactions with blood) | No evidence of hemolysis |
| ISO 10993-6:2016 (Tests for local effects after implantation) | No abnormal symptoms at the implantation site |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Complied |
| USP NF 2021 chapter (Pyrogen Test) | Non pyrogenic |
| USP (Particulate matter in injections) | Complied |
| Sterilization, Shipping, and Shelf-Life: | |
| ISO 11135:2014 (Sterilization of health-care products Ethylene oxide) | EO Sterilization, SAL = 10-6 (Complied) |
| Sterile Barrier Packaging Testing (Seal strength ASTM F88/F88-15) | Complied |
| Sterile Barrier Packaging Testing (Dye penetration ASTM F1929-15) | Complied |
| Sterility test USP39 | Complied |
| Shelf life validation (ASTM F1980-16) | 3 years shelf life validated |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test. For medical device testing against standards (like ISO or ASTM), sample sizes are generally specified by the standard or determined through a statistical rationale to ensure confidence in the results. This is common for bench testing.
- Data Provenance: The tests are "bench testing," meaning they were conducted in a laboratory setting. The manufacturer is Promisemed Hangzhou Meditech Co., Ltd. in Hangzhou City, Zhejiang, China. The data would be prospective, as these are tests performed on the manufactured device models to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information is not relevant to the type of device and submission. "Ground truth" established by experts (e.g., radiologists interpreting images) is specific to diagnostic AI/imaging devices. For a physical device like a needle, performance is assessed against engineering standards and material properties, not clinical expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable as there is no "adjudication" in the context of testing a physical device against engineering specifications. The results are physical measurements or observations of compliance.
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:
- N/A. No MRMC comparative effectiveness study was done. This type of study is specifically for evaluating the impact of a diagnostic aid (often AI) on human reader performance, which doesn't apply to a Huber needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. No standalone algorithm performance was done. This device is a physical medical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" and "acceptance criteria" are defined by established international and national standards (e.g., ISO, ASTM, USP) for medical device design, manufacturing, safety, and performance. The performance tests yield objective measurements and observations (e.g., "No cytotoxicity," "Complied with ISO 23908") which serve as the "ground truth" of compliance with these standards.
8. The sample size for the training set:
- N/A. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for a physical medical device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).