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The Pressure Connecting Tube is for use during angiography procedures as a connecting line for the injection of liquid, such as radiopaque dye, saline, or other diagnostic fluids.

The Pressure Connecting Tube is a sterile, single use device which can withstand injection pressures to 350~1200psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors. This device is designed, like other legally marked devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The fluid such as radipoaque dye, saline, or other diagnostic fluid is then injected from the syringe, through the connecting tube, into the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe through the High Pressure Tube, into the catheter. According to the different pressure maintenance, the material of tube is PVC or PU, and the appearance is clear or braided.

Here's an analysis of the acceptance criteria and study information for the Pressure Connecting Tube (K131770):

Key Takeaways Before Diving In:

• This device is a tubing connector for angiographic procedures. It's a relatively low-risk device.
• The study described is non-clinical testing, meaning it does not involve human subjects. It focuses on device performance and safety characteristics.
• This submission relies heavily on substantial equivalence to a predicate device (K071196), meaning the manufacturer asserts that their device is as safe and effective as a previously cleared device.
• There's no AI component in this device, so questions related to AI-specific metrics like human reader improvement with AI assistance, standalone AI performance, and AI-specific ground truth establishment are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the reference to international standards and manufacturer's internal standards. The "reported device performance" is a confirmation that the device met these standards.

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

• Sample Size for Test Set: The document states that "The most complicated structure of each pressure type is selected to conduct the performance test." It does not specify an exact number of units/samples for each test. Typically, for such non-clinical tests, a statistically relevant number of samples (often 3-10, sometimes more depending on the test and risk) would be used to demonstrate consistency and robustness, but the exact number is not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. The manufacturer is based in China: Shenzhen ANT Hi-Tech Industrial Co., Ltd. The data is prospective in the sense that the tests were performed specifically for this submission to verify the device's performance against defined standards.

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

• Not Applicable. This is a non-clinical device performance and safety study involving physical and chemical testing against engineering standards (e.g., pressure, leaks, biocompatibility, sterility). There is no "ground truth" established by human experts in the way it would be for a diagnostic imaging device. The "ground truth" is defined by the objective measurement results compared to the pass/fail criteria of the referenced international and manufacturer standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical physical and chemical testing, there is no expert adjudication process like 2+1 or 3+1. The results are objective measurements against predefined acceptance criteria from standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance

• No. This device is a passive, non-AI medical device (a pressure connecting tube). MRMC studies, AI assistance, and related metrics are not relevant to this submission.

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

• No. This device is a passive, non-AI medical device. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Objective Measurements Against Industry Standards and Manufacturer Specifications: The "ground truth" for the non-clinical tests is based on the quantitative and qualitative results derived from testing the device according to established international standards (ISO, ASTM, USP) and the manufacturer's own internal standards for pressure maintenance. For example, pressure maintenance is a quantitative measurement, while sterility is determined by a pass/fail microbiological test as per USP .

8. The Sample Size for the Training Set

• Not Applicable. This is a non-AI medical device; therefore, there is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and material science, not learned from a dataset.

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

• Not Applicable. As there is no AI component or training set, this question does not apply.

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The ANT Inflation Device is intended for use during vascular procedures in conjunction with interventional device such as balloon catheters to create and monitor pressure in the balloon catheter.

The ANT Inflation Device Compact Pack:
-ANT Inflation Device: See description above.
-ANT Inflation Device Accessory Kit: The Accessory Kit is recommended for use during vascular procedures in conjunction and/or diagnostic device (e.g., balloon dilatation catheters, artherectorny devices, sent delivery systems, intravascular ultrasound devices.)

ANT Inflation Device is a single-use, sterile device used in cardiovascular procedures to inflate and deflate balloon catheters. Pressure can be monitored via a pressure gauge. The manually operation of the device is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure up to 30 ATM.

ANT Inflation Device Accessory Compact Pack contains a hemostasis valve, a torque device, and a guide wire introducer. The hemostasis valve is designed to provide a port for interventional system. The guide wire introducer is used to facilitate placement of a guide wire tip through the hemostasis valve. The torque device is designed to hold the guide wire and provide a handle for manipulating.

This document describes the ANT Inflation Device and ANT Inflation Device Compact Pack, which are intended for use during vascular procedures to create and monitor pressure in balloon catheters. The submission includes performance tests, biocompatibility tests and comparison to a predicate device to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact number of test samples used for each performance test (Accuracy of pressure gauge, Leak test, Competence test). It generally states "Completely packaged devices are chosen as the test samples" for the accuracy test and "Test samples were pressurized" for the leak test. The data provenance is not explicitly stated as retrospective or prospective, but these appear to be internal laboratory tests conducted by the manufacturer (Shenzhen ANT Hi-Tech Industrial Co., Ltd, China) for the purpose of this 510(k) submission.

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

Not applicable. The tests performed are objective performance measurements against established physical standards (calibrated pressure gauge) or pass/fail criteria (leakage, functional competence according to the device's design). No human expert interpretation of device output for medical diagnosis or treatment decisions was involved in establishing ground truth for these tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements and do not require 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. This device is a medical instrument (balloon inflation device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a manually operated mechanical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance tests consists of:

• Calibrated Measurement: For the accuracy of the pressure gauge, the ground truth was established by a "calibrated pressure gauge."
• Objective Criteria: For the leak test, the ground truth was the observable presence or absence of bubbles, indicating leakage. For the competence test, it was the observable proper functioning of the device during inflation and deflation when attached to a legally marked catheter.
• Established Standards: For biocompatibility, the ground truth was compliance with the requirements of ISO 10993-1:2003, as assessed through specific tests outlined in the standard (e.g., ISO 10993-5, 10993-10, 10993-11, 10993-4).

8. The Sample Size for the Training Set

Not applicable. This device is a medical instrument, not an AI/machine learning model that requires a training set.

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

Not applicable. As this device does not involve AI/machine learning, there is no training set or associated ground truth for it.

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The disposable pressure transducer (DPT) is intended for direct measurement and monitoring of invasive blood pressure, intrauterine pressure, urine-dynamic pressure, compartmental (intramuscular) pressure and intracranial pressure.

The proposed device, disposable pressure transducer (DPT), is an extravascular pressure transducer interfaces between an intravascular catheter and monitor by converting changes in pressure into electrical currents that can be impute into a compatible patient monitor. It is for single use; DPT mainly consists of a transducer which converting the pressure changes to electrical currents, a luer connector which can be connected to an intravascular catheter, a transducer cable that can connect to a compatible patient monitor and a stopcock for altering direction fluid flow.

This document describes a 510(k) submission for a Disposable Pressure Transducer (DPT). The submission aims to establish substantial equivalence to a predicate device, the Transpac® Disposable Straight Pressure Transducer (DSPT) (K061573).

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided text only states that "Performance testing was conducted to validate and verify that the proposed device, Disposable Pressure Transducer (DPT) met all design specifications and was substantially equivalent to the predicate device." It does not specify the actual acceptance criteria (e.g., specific accuracy ranges, drift limits, etc.) or the detailed reported performance results against those criteria. The focus of this 510(k) summary is on the conclusion of equivalence, not the granular performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for performance testing or the data provenance.

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)

This information is not applicable and not provided. The device in question is a physical measurement transducer, not one requiring expert interpretation of data to establish ground truth for testing. Performance testing for such devices typically involves comparison against calibrated reference standards, not human expert consensus.

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

This information is not applicable and not provided, as the testing does not involve human interpretation or 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

No MRMC comparative effectiveness study was done. This type of study is not relevant for a disposable pressure transducer.

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

This concept is not directly applicable to a disposable pressure transducer. The performance tests would have evaluated the device's ability to accurately convert pressure into electrical signals, without human intervention in the primary measurement process itself. The "standalone" performance here refers to the device's intrinsic accuracy and reliability. The text indicates "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," which implies standalone performance evaluation.

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

The ground truth for evaluating the performance of a pressure transducer would be established using calibrated reference pressure sources and possibly traceable measurement standards. For example, a precise pressure calibrator would be used to apply known pressures, and the DPT's output would be compared against these known values. This is not explicitly stated but is the standard practice for such devices.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided. This device is not an AI/ML algorithm.

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ANT Angiographic Syringes are syringes for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

The applicant device of ANT Angiographic Syringes are plastic, single-use, disposable syringes to be offered in 10 mL, 12 mL, 20mL, 60mL, 60ml, 65ml, 100ml, 115 ml, 125 mL, 130ml, 140ml and 200mL sizes. The syringes will be offered made of polypropylene or PET- both materials, of which, are available in current legally marketed products.

Variants: All variants include 7 series as followings: Series 1: Model 100101, Model 100103, Model 100103, Model 100202, Model 100202, Model 100203, Model 100204, Model 100301, Model 100302, Series 2: Model 200101, Model 200201, Model 200202, Model 200203, Model 200301, Series 3: Model 300101, Model 300102, Model 300202, Model 300301, Model 300302, Series 4: Model 400101, Series 5: Model 500101, Model 500102, Series 6: Model TR0012, Series 7: Model CS0010, Model CS0020,

All 8 series follow same design principle, same material, and same intended use. The only differences are volume and the connection (nozzle) to different angiography injector from different manufacturer. The connection differs to fit with US legally Market Angiographic Injectors from company Medrad. The connector difference is only to fit the injector and does not affect the performance of the syringes.

The provided document describes a 510(k) submission for ANT Angiographic Syringes. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria as might be seen for novel devices.

Therefore, the submission does not contain detailed information about acceptance criteria for a new device, a study proving the device meets these criteria, or specific performance metrics in the way a novel AI/ML device submission would. Instead, the "Effectiveness" section broadly states that "All the variant models of the applicant device are evaluated regarding the performance." without providing specific criteria or results.

The submission relies on demonstrating Substantial Equivalence to a predicate device (K051799 Disposable CT/MR Syringes for Nemoto Injectors) based on:

• Same classification
• Same intended use
• Same sterilizations
• Same performance (this is a general claim, not a specific metric)
• Same biocompatibility
• Same chemical specifications
• Similar physical and mechanical specifications (differences are stated as "too slight to influence the effectiveness and safety").

Because dedicated performance studies as would be conducted for a new device are not explicitly detailed with specific acceptance criteria and performance results, I cannot fill out the detailed table and answer all subsequent questions as requested. The available information primarily addresses the regulatory path of substantial equivalence for a medical syringe.

However, I can extract information related to the 'study' as presented within the context of a 510(k) for this type of device:

1. A table of acceptance criteria and the reported device performance:

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

• The document does not specify a sample size for a "test set" in the context of a clinical study or performance study with quantified metrics. The evaluation relies on comparing specifications and materials to a predicate, and conducting biocompatibility tests.
• Data provenance: Not applicable in this context as it's a submission for equivalence, not a clinical trial. The biocompatibility tests would have been performed in a laboratory, likely in China (country of manufacturer: Shenzhen, China).

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. This is not a study requiring expert readers to establish ground truth.

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

• Not applicable. No observer-dependent adjudication was involved.

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 MRMC study was done. This device is a syringe, not an AI-powered diagnostic tool.

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

• No standalone performance study of an algorithm was done. This is a medical device (syringe), not an algorithm.

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

• The 'ground truth' in this submission is effectively established by:
  • Predicate Device Equivalence: The specifications and performance of the legally marketed predicate device (K051799) serve as the benchmark.
  • Established Standards: Compliance with international standards like ISO 10993 for biocompatibility.
  • Material Science/Engineering: Performance "evaluation" of the syringe variants would involve engineering tests to ensure functionality (e.g., fluid delivery, structural integrity), rather than clinical 'ground truth' in the diagnostic sense.

8. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device.

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

• Not applicable. This is not a machine learning/AI device.

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