(29 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 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, Type D and Type E), 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.
This submission is new design primarily involve changes to addition of new needle lengths and specifications.
The provided FDA 510(k) clearance letter and summary for the Promisemed Safety Huber Needles details a medical device that is a physical product (a needle), not a software-based AI/ML medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) does not apply to this specific device.
The 510(k) submission for the Promisemed Safety Huber Needles focuses on demonstrating substantial equivalence to a predicate device (K243332) primarily through non-clinical performance testing for physical and mechanical properties, and a comparison of technological characteristics.
Here's a breakdown of the relevant information provided in the document:
Device Description and Purpose:
The Promisemed Safety Huber Needle is a non-coring intravascular infusion set with a right-angle needle and a manually activated needle-stick prevention safety mechanism. It is used to access surgically implanted vascular ports and, for the high-pressure resistant model, can be used for high-pressure injection of contrast media for CT imaging. It is for adult use only.
Nature of This Submission:
This 510(k) submission is for a device modification that primarily involves:
- Addition of new needle lengths (16mm, 17mm, 20mm) for Type D and Type E needles.
- Addition of a new specification: "without lubrication" for the needle tip.
The manufacturer asserts that these changes "do not introduce new risks as the fundamental technology and operation remain the same" and that the device remains "substantially equivalent" to its predicate device.
Acceptance Criteria and Study for This Device:
Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are based on meeting established performance specifications and international standards for hypodermic needles and infusion sets. The "study" that proves the device meets these criteria is the suite of non-clinical (bench) tests performed.
1. A table of acceptance criteria and the reported device performance:
The document lists the types of tests performed and the standards they adhere to, implying that the acceptance criteria are successful completion according to these standards. It does not provide specific quantitative acceptance thresholds (e.g., "puncture force must be X-Y Newtons") nor the raw performance data, but rather states that "All verification and validation tests passed without deviations."
| No. | Test Item | Standard | Reported Device Performance |
|---|---|---|---|
| 1. | Appearance and cleanliness | ISO 7864:2016 | Passed without deviations. Conforms to specified appearance and cleanliness requirements. |
| 2. | Dimension of needle tube | ISO 9626:2016 | Passed without deviations. Conforms to specified dimensional tolerances. |
| 3. | Needle point | ISO 7864:2016 | Passed without deviations. Conforms to specified needle point characteristics. |
| 4. | Fragment | ASTM F3212-16 | Passed without deviations. No fragments detected. |
| 5. | Needle sheath and cap | / (Internal) | Passed without deviations. Conforms to specified design and functionality. |
| 6. | Puncture force of needle | ISO 7864:2016 | Passed without deviations. Conforms to specified puncture force requirements. |
| Overall | Verification & Validation | Various / Internal | All verification and validation tests passed without deviations, confirming that the subjective device meet the necessary design specifications and regulatory requirements. 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 the data provenance:
- Sample Size: Not explicitly stated in the 510(k) summary. For physical device performance testing, sample sizes are typically determined by statistical methods based on specified confidence levels or are prescribed by the testing standards themselves (e.g., a certain number of units per lot).
- Data Provenance: The tests were conducted by Promisemed Hangzhou Meditech Co., Ltd. in China ("Promisemed Hangzhou Meditech Co., Ltd. completed the following non-clinical tests"). This is a retrospective collection of data for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This concept applies to AI/ML device ground truth establishment, often involving clinical image interpretation. For a physical device like a needle, "ground truth" is established by adherence to engineering specifications and international standards, tested by qualified engineers and technicians using calibrated equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept relates to human expert consensus in clinical data annotation for AI/ML validation. Physical device testing relies on objective measurements against defined criteria.
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. An MRMC study is for evaluating the impact of AI assistance on human diagnostic performance. This device is a physical medical instrument, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This pertains to AI algorithm performance. The device here is a standalone physical needle.
7. The type of ground truth used:
- Engineering Specifications and International Standards: For a physical device, "ground truth" is adherence to predefined engineering specifications (e.g., dimensions, material properties, force resistance) and compliance with internationally recognized standards (like ISO 7864, ISO 9626, ASTM F3212). The testing confirms that the device's physical properties and functionality meet these established objective benchmarks.
8. The sample size for the training set:
- N/A. This concept is relevant for AI/ML model development. This device does not involve a "training set" in the computational sense.
9. How the ground truth for the training set was established:
- N/A. As above, this applies to AI/ML.
Summary of Key Takeaways from the Document:
The 510(k) submission successfully demonstrated substantial equivalence by confirming through non-clinical testing that the modified Promisemed Safety Huber Needles:
- Maintain the same intended use, technological characteristics, and principle of operation as the predicate device.
- The added needle lengths and the "without lubrication" option do not introduce new safety or effectiveness risks.
- All required performance tests (appearance, dimensions, needle point, fragment, sheath/cap, puncture force) passed without deviations, confirming adherence to relevant ISO and ASTM standards.
- No clinical testing was deemed necessary for this type of modification, reinforcing that the changes were not considered to impact fundamental safety or effectiveness parameters requiring human clinical data.
§ 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).