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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:

1. Addition of new needle lengths (16mm, 17mm, 20mm) for Type D and Type E needles.
2. 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."

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.

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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

• 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.

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