(141 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 needle-stick prevention 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, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Yinjection 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.
This submission is new design primarily involve changes to the type C name, the addition of new needle lengths and new type E.
The FDA 510(k) submission document for the Promisemed Safety Huber Needles details the device's characteristics and its substantial equivalence to a predicate device (K230715). The document does not describe a study involving an AI/software device that requires extensive acceptance criteria, an MRMC study, or the establishment of ground truth by multiple experts.
The provided document is a 510(k) premarket notification for a Class II medical device, specifically a hypodermic single lumen needle. This type of device approval primarily relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than a clinical study with complex AI performance metrics.
Therefore, many of the requested details, such as the number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training sets, are not applicable to the content of this document.
However, based on the non-clinical testing described, we can extract information relevant to the device's acceptance criteria and how its performance was verified.
Here's an interpretation based on the provided document:
Acceptance Criteria and Device Performance for Promisemed Safety Huber Needles
The acceptance criteria for this device are primarily based on meeting established industry standards and design specifications, ensuring the new design (specifically Type D and Type E, and changes in needle lengths for Type D) is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Industry Standards/Design Specifications) | Reported Device Performance (Verification and Validation Activities) |
|---|---|
| Name and Labeling Compliance | Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 7864. Result: Complied. |
| Needle Dimensions (Type D) | The needle's dimensions, including outer diameter and length, were measured. Result: Complied with drawing requirements. This implies that the new needle lengths (13mm, 15mm, 19mm, 25mm, 32mm, 38mm) for Type D, previously Type C, and for the newly added Type E, met their specified dimensions. |
| Performance (Type E - newly added type) |
- Appearance
- Dimension
- Safety mechanism operation | Full performance was tested, including appearance, dimension, safety mechanism, etc., and found to comply with:
- ISO 7864 (Sterile hypodermic needles for single use)
- ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)
- ASTM F3212-16 (Standard Test Method for Performance of Safety Mechanism on Needles Used for Accessing Implanted Ports)
- ISO 23908 (Sharps injury protection features for single-use containers, sharps disposal containers and medical sharps)
Result: Complied with all specified standards. |
| No New Risks (Safety and Effectiveness) | The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of needles) used for each non-clinical test (visual inspections, dimensional measurements, and performance tests). It generally states "verification and validation tests passed without deviations."
- Data Provenance: The document implies that the testing was conducted by Promisemed Hangzhou Meditech Co., Ltd. in China ("No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China."). The testing is described as "Nonclinical test," which typically refers to laboratory-based evaluations rather than human subject data. These tests are retrospective in the sense that they are performed on manufactured devices to prove compliance, not prospective data collection from clinical use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is not an AI/software device requiring human expert annotation or ground truth determination based on clinical interpretation. The "ground truth" here refers to compliance with engineering specifications and recognized international standards (ISO, ASTM).
4. Adjudication Method for the Test Set
- Not applicable. As noted above, this isn't a study involving human interpretation or AI output that would require adjudication. Compliance is determined against quantitative and qualitative engineering specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- Not applicable. This is a physical medical device (needle), not an AI algorithm. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on adherence to international consensus standards (ISO, ASTM) and the manufacturer's internal design specifications and drawing requirements. This includes:
- Dimensional accuracy (e.g., outer diameter and length of needles).
- Functional performance of the safety mechanism.
- Material properties and biocompatibility (implied by compliance with standards for medical devices).
- Labeling accuracy.
8. The Sample Size for the Training Set
- Not applicable. There is no concept of a "training set" for a physical medical device in this context, as no AI model is being trained.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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).