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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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PowerLoc™ Max Power Injectable Infusion Set:

The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.

For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.

SafeStep™ Huber Needle Set:

The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

These devices may be used in any patient population with an implanted vascular port.

Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non-pyrogenic, for single use only.

The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site.

SafeStep™ Huber Needle Set:

The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

These devices may be used in any patient population with an implanted vascular port.

Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

This document describes the premarket notification for the "PowerLoc™ Max Power Injectable Infusion Set" and "SafeStep™ Huber Needle Set". The study presented focuses on demonstrating substantial equivalence to a predicate device (K171735) through performance testing, rather than a standalone clinical study to establish new acceptance criteria. Therefore, much of the requested information regarding clinical studies, expert-established ground truth, and training data is not applicable in this context.

Here's a breakdown of the available and applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implied by the "All testing passed the predetermined acceptance criteria" statement. Specific quantitative acceptance criteria or detailed performance results are not provided in this summary. Instead, the document lists the type of test conducted and the standard it references, indicating compliance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes used for each individual performance test. It broadly states "All testing passed the predetermined acceptance criteria."
• Data Provenance: The studies were conducted "by or for Bard Access Systems (BD)". The data is presumably from laboratory testing, not patient data (retrospective or prospective), given the nature of the device and the tests performed. The country of origin for the data is not specified, but the applicant's address is in Salt Lake City, Utah, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The device's substantial equivalence was established through engineering and performance testing against recognized standards, not through clinical trials requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

This information is not applicable, as no clinical study with human observers or adjudication committees was performed.

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

This is not applicable. This is a medical device (infusion set and Huber needle set), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests would be the established requirements and limits defined by the referenced ISO standards, USP standards, and internal protocols for a device of this type. For example, for "Assembly Burst," the ground truth is that the device must withstand a certain pressure without bursting, as defined by ISO 10555-1.

8. The Sample Size for the Training Set

This is not applicable. There is no AI component or training set involved in the assessment of this physical medical device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set. The "ground truth" for the device's acceptable performance is derived from established international and national standards for medical devices and internal quality control protocols.

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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 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:

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.

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The Intera Non-coring (Huber) Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.

Specifically,

• the Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;

• the Special Bolus Needles are indicated for delivering bolus injections through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;

• the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump prior to implantation.

The Intera Refill Needle is a straight 22 gauge stainless steel non-coring needle with hub and needle cap. The Refill Needle is available in 1", 1 ½", and 2" lengths and is used to empty and fill the reservoir of a subcutaneously implanted infusion pump through the pump septum. The Refill Needle is provided sterile and is intended for single patient use.

The Intera Special Bolus Needle is a straight 20 gauge stainless steel non-coring needle with hub and needle cap. A tubing extension set is integrated with the needle hub. The Special Bolus Needle is available in 1 3/8" and 2" lengths and is used to deliver infusate through the pump septum to the pump catheter. The Special Bolus Needle is provided sterile and is intended for single patient use.

The Intera OR Prep Kit contains the accessories used to prep and fill the pump prior to implantation and is assembled as a convenience to the end-user with the following sterile, single-use items:

• One (1) 22g non-coring (Huber) Refill Needle
• One (1) 20g non-coring (Huber) Special Bolus Huber Needle with attached tubing, clamp, and female luer
• One (1) 33cm (13") tubing set with clamp and female luer assembled to an empty syringe barrel

The empty syringe barrel acts as a liquid waste receptacle to hold the fluid that is passively drained from the infusion pump during pump preparation prior to implantation. The empty syringe barrel and drained fluid are discarded after use and have no direct patient contact. The empty syringe barrel does not include a piston and does not function as a piston syringe.

The provided text is a 510(k) summary for the Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special Bolus Needles, and OR Prep Kit. It describes the device, its intended use, and a comparison to a predicate device, along with summary of testing conducted to demonstrate substantial equivalence.

However, the request asks for specific information related to acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered device. The submitted document pertains to a medical device that is a set of needles and an OR Prep Kit, not an AI/ML-powered medical device.

Therefore, the requested information elements (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable to this type of device and are not present in the provided document.

The document focuses on bench performance tests, sterilization validation, biocompatibility, and shelf-life validation to demonstrate substantial equivalence to a predicate device, which is typical for non-AI medical devices.

Here's the table of acceptance criteria and reported device performance from the document, which are performance criteria for the physical device components, not an AI algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

As the device is not an AI/ML device, the following points are not applicable and cannot be answered from the provided document:

2. Sample size used for the test set and the data provenance: Not applicable (no AI test set). For the physical device, testing was conducted on "samples" that were real-time aged, but specific sample sizes for each test are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable (no AI ground truth).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (no AI test set requiring adjudication).
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: Not applicable (not an AI device).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable (no AI ground truth).
8. The sample size for the training set: Not applicable (no AI training set).
9. How the ground truth for the training set was established: Not applicable (no AI training set).

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Huber Needle Infusion Set: The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

Safety Huber Needle Infusion Set: The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

The Huber Needle Infusion Set and Safety Huber Needle Infusion Set non-coring angled needle are single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Huber Needle Infusion Set and Safety Huber Needle Infusion Set are available in different gauge sizes (25G, 24G, 22G, 20G, 19G) and length (0.5", 0.75", 1.0", 1.24", 1.5"). The 19G-22G needles of device are suitable for power injection of contrast media into the central venous system only through an implanted port that is indicated for power injection at a maximum pressure of 325psi. For power injection of contrast media, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G and 2ml/s for 22G.The 24G and 25G needles of device should not be used with power injectors. The Huber Needle Infusion Set is available in five models (S-1, S-2, Y-1, Y-2, D-1), and the Safety Huber Needle Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s). The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.

The provided text describes a 510(k) premarket notification for a medical device, the Huber Needle Infusion Set and Safety Huber Needle Infusion Set. This document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.

The provided text does not contain information about an AI/ML powered medical device. Therefore, the specific details requested regarding acceptance criteria and study proving an AI/ML device meets acceptance criteria (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not present in this document.

The document focuses on the physical and functional equivalence of the Huber Needle Infusion Set to its predicate device through a series of non-clinical tests (performance testing and biocompatibility testing).

Here's what can be extracted, interpreted based on the provided document, and why the other AI/ML related questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance (Focus: Non-AI/ML Physical Device)

The document primarily outlines performance tests and biocompatibility tests to prove substantial equivalence of a physical medical device (Huber needle). It doesn't explicitly list "acceptance criteria" in a table format with "reported device performance" in the way one might for an AI/ML algorithm's effectiveness metrics (e.g., sensitivity, specificity thresholds). Instead, it states that tests were conducted to verify that the proposed device met all design specifications and test results demonstrated compliance with related standards requirements.

However, we can infer some "acceptance criteria" based on the tests performed:

Regarding AI/ML specific questions:

2. Sample size used for the test set and data provenance:

• Not applicable for AI/ML. This document describes testing of a physical medical device. The "test set" here refers to physical samples of the device and test media (e.g., liquids for flow rate, materials for penetration/coring). No medical imaging or patient data is involved.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable for AI/ML. Ground truth for a physical device is established through verified measurement techniques and standardized testing protocols, not expert consensus on medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for AI/ML. Adjudication relates to resolving disagreements among experts for ground truth labeling in AI/ML studies. For physical device performance, tests are objective and measurable against established standards.

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:

• No. This device is a physical infusion set, not an AI/ML algorithm intended to assist human readers (e.g., radiologists). Therefore, no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable for AI/ML diagnostic/interpretive purposes. For this physical device, "ground truth" is defined by the established physical, chemical, and biological properties of the materials and function of the device as measured by validated laboratory methods and adherence to international standards (e.g., ISO, ASTM, USP).

8. The sample size for the training set:

• Not applicable for AI/ML. This refers to a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable for AI/ML. See point 8.

In summary: The provided document is a 510(k) submission for a non-AI/ML medical device (Huber Needle Infusion Set). The "acceptance criteria" discussed are performance and material standards for the physical device, and the "study" consists of a comprehensive suite of non-clinical, laboratory-based tests to demonstrate compliance with these standards and substantial equivalence to a predicate device. None of the questions specifically pertaining to AI/ML device validation are addressed because the device is not an AI/ML product.

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The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient's surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.

The Infusion Safety Products, Inc. ISP Safety Huber Needle Infusion Set is a non-coring safety IV administration set used to access a patient's surgically implanted vascular port. The Safety Huber Needle Infusion Set is constructed with a 90°, non-coring Huber needle that is available in 19ga, 20ga and 22ga and in ½", ¾", 1″ and 1½" lengths. It is offered in various model numbers. The device is lipid resistant and contains non-latex containing products. The PVC Tubing is non-DEHP, with a flow rate of approximately 5cc per sec. max / CT rated to 300 psi. The Safety Huber Needle Infusion Set is packaged in a semi-rigid form fill and seal package with a 1059B Tyvek® lid. The sets are sterilized using a validated ethylene oxide method. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or withdraw blood through the implanted vascular port (not included with the ISP Safety Huber Needle Infusion Set device is offered in the following configurations, each with various needle gauges and needle lengths: 1. Huber needle in a needle holder in a safety wing, a 7.50" length of PVC Tubing, ratchet clamp, female luer lock and vented-protector cap. Approximate Priming Volume: 0.25cc. 2. Huber needle in a needle holder in a safety wing, a 4.12″ length of PVC tubing with a ratchet clamp attached to a Y port with a non-vented cap, a second 4.12″ length of PVC off the Y port with a ratchet clamp, a female luer lock and non-vented protector cap. Approximate Priming Volume: 0.35cc. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needles by encapsulating the needle within the wing to help prevent needle stick injuries when using the device for vascular port access. The safety mechanism is engaged when the needle is removed from the access port. As the set is removed from the patient, the wing encapsulates the needle, making an audible click when secure, to prevent needle sticks to the clinician.

The provided text describes the non-clinical performance data for the ISP Safety Huber Needle Infusion Set, which is a medical device. This information is typically found in a 510(k) premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:

Acceptance Criteria and Reported Device Performance

The device's performance is compared against internal requirements, national standards, international standards, and the predicate device (Millennium Huber Plus Safety Infusion Set, K993848).

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The Surecan Safety II power-injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Surecan Safety II safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.

For power injection of contrast media, the maximum flow rates at 325 psi are 5mL/s for 19 gauge and 20 gauge needles and 2mL/s for the 22 gauge needles.

The Surecan Safety II power-injectable safety non-coring needle is a single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. This device contains a non-coring angled needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle tip during removal. The intended patient population is for patients with implanted intravenous access ports.

The Surecan Safety II needles are available in different sizes from 19 gauge to 22 gauge and have an overall needle length ranging from 0.5-1.5 inches (12mm-38mm). The Surecan Safety II needles will be available in two configurations:
-with a Y-site and a preconnected Caresite luer access device
-without Y-site or Caresite luer access device

When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.

The Surecan Safety II is designed with flexible wings which allow the user to securely hold the device for insertion and removal of the needle. The base and bottom plate are made of clear plastic that allow the user to visualize placement of the needle. A foam pad is present on the patient-contacting side of the safety mechanism. The overall assembly has a low profile to assist with the placement of a securement dressing following insertion of the needle into the port.

The provided document describes the Surecan Safety II, a power-injectable safety non-coring needle. The document states that the device has met all established acceptance criteria for performance testing and design verification testing. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted. For most of these, the "reported device performance" is implicitly that the device met the criteria, as stated in the "CONCLUSION" section: "The Surecan Safety II has met all established acceptance criteria for performance testing and design verification testing." Specific quantitative values for acceptance criteria or performance numbers are generally not provided in this summary, but rather the type of test and the standard referenced.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each performance test. It only lists the types of tests performed. The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These are typical of a device rather than software premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable and not provided in the document. The tests performed are engineering and biocompatibility tests on a physical device, not related to medical image analysis or clinical interpretation needing expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The tests are objective measurements and evaluations against established standards, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or similar AI applications, not for a physical medical device like a hypodermic needle.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

No, this is not applicable. The device is a physical medical device, not an algorithm. Performance tests directly evaluated the physical characteristics and safety features of the device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance tests are the established standards and specifications for various physical and biological properties. For example, for "Freedom from leakage," the ground truth is "no part of the set leaks when connected to 150kPa of water pressure for 15 minutes." For biocompatibility, the ground truth refers to the acceptance criteria within the referenced ISO standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As stated above, there is no "training set" for this type of device.

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The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.

The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The Safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.

PowerLoc® MAX Power-Injectable Infusion Set
The PowerLoc® MAX Power-Injectable Infusion Set 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 shielding the needle. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.
The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Set is offered with and without a Y-site.

SafeStep® Huber Needle Set
The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a needlestick prevention feature, designed for use with a vascular access infusion system. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.

Stabilization accessory
The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization accessory is then discarded per hospital protocol.

This document is a 510(k) Premarket Notification from the FDA regarding the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set. It establishes substantial equivalence to existing predicate devices, indicating that no new clinical study was required to prove safety and effectiveness for a new medical device. Instead, the submission focuses on demonstrating that the new packaging configurations and additional kit components of the subject devices do not alter their fundamental safety and performance characteristics compared to the previously cleared predicate devices.

Therefore, the typical acceptance criteria and study design for proving the performance of a novel AI-powered medical device are not applicable in this context. This submission is for a conventional medical device (infusion sets and needles) and relies on bench testing, material comparisons, and risk management rather than clinical performance studies with AI.

However, I can extract information related to the acceptance criteria for this specific submission, which pertains to the device's substantial equivalence and safety/performance after changes, rather than a de novo AI device.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable to this submission):

For this 510(k) submission, the "acceptance criteria" are not related to a specific performance metric of an AI model (like accuracy, sensitivity, specificity). Instead, they revolve around demonstrating that the new configurations and kit components of the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set maintain the same safety and performance profiles as their cleared predicate devices.

The document implicitly states that for the original devices (the predicates), their performance was deemed acceptable for their stated indications. For this new submission, the acceptance criteria are met by demonstrating "substantial equivalence" based on:

• Product Code
• Review Branch
• Intended Use
• Indications for Use
• General Device Description
• Y-Site presence
• Duration of Use
• Device Materials
• Sterility Method (Ethylene Oxide)
• Sterility Assurance Level (SAL 10-6)
• Number of Uses (Single-use)
• Anatomical Site Use
• Principle of Operation
• Safety Infusion Set Device Components
• Sizes (Needle Gauge, Needle Length)
• Needle OD
• Tubing Dimensions (ID, OD, Length)
  Note: The addition of new kit components is acknowledged but they are themselves legally marketed, cleared devices. |
  | Safety and Performance After Changes: The new packaging configurations and additional kit components do not negatively impact the biological safety or functional efficacy of the devices. | Met: "Testing was performed to show that the kit components maintain their biological safety and functional efficacy after ethylene oxide (EO) sterilization. The kit components met all predetermined acceptance criteria. Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Risk Management for Medical Devices. The risks were analyzed, mitigated and reduced to an acceptable level, and re-evaluation showed that the remaining risks are outweighed by the benefits of the device, and that the device is acceptable for its intended use." (Page 14) |

2. Sample Size Used for the Test Set and Data Provenance:

• This 510(k) submission does not involve a "test set" in the context of an AI model's performance on clinical data.
• The evaluation is based on "safety and performance tests" (Page 15) conducted on the physical devices and their components. The document does not specify the sample sizes for these bench tests, but it states that the "kit components met all predetermined acceptance criteria" and that a "risk management" process was followed.
• Data provenance is not applicable in the sense of patient data from specific countries or retrospective/prospective studies. The "data" here refers to engineering and biocompatibility test results.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This is not applicable as there is no "ground truth" in the context of clinical images or patient data being interpreted by AI.
• The ground for proving substantial equivalence relates to regulatory standards, engineering specifications, and established biocompatibility principles. The FDA review team acts as the expert body for evaluating this submission.

4. Adjudication Method for the Test Set:

• Not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This submission is for physical medical devices (infusion sets/needles), not an AI algorithm assisting human readers. Therefore, there is no AI assistance component to measure improvement.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is not an AI algorithm.

7. Type of Ground Truth Used:

• The "ground truth" in this submission is the accepted safety and performance of the predicate devices and the physical/chemical characteristics of the materials and design, verified through bench testing and adherence to recognized standards (e.g., sterilization, biocompatibility, risk management according to ISO 14971:2012).

8. Sample Size for the Training Set:

• Not applicable. There is no AI model or training set involved.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable for the reasons stated above.

In summary, this FDA 510(k) document demonstrates substantial equivalence for conventional medical devices after a minor change (new packaging/kit components), rather than proving the performance of a novel AI-powered medical device through clinical studies. The "acceptance criteria" here refer to meeting regulatory requirements for substantial equivalence and ensuring that the modified devices maintain their established safety and functional efficacy through engineering and biocompatibility testing.

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