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The intended use of this device is for the removal of 90 degree winged infusion sets, manufactured by Harmac Medical Products and having a 1-1/2" needle or shorter, from implanted ports and the containment of the used needle until placed in an appropriate sharps container. When used in this manner this device is intended to aid in the prevention of needle stick injuries.

The Harmac Medical Huber Needle Safety Device is designed as an accessory to Harmac Huber Needle Infusion Sets to assist in the removal and containment of ninety-degree Huber needles from implanted IV ports. The device consists of a single injection molded plastic component incorporating a stabilizing foot and an internal design to capture the proprietary needle hub of the Harmac Medical Infusion Set as it is slid up a receiving slot in one side. Only one version of the device will be marketed and will accommodate a range of Harmac Huber needles up to 19 gauge, 1-1/2" in length. The Huber Needle Safety Device is used by placing the open slot over the hub of the Harmac Infusion Set needle and using the foot of the device to stabilize the patient's skin via downward pressure with one hand. The other hand is used to grasp the wings of the Huber needle and draw it upward into the Safety Device. As the Huber needle reaches the top of the device the proprietary head locks into place. As the needle is drawn upwards it is also turned slightly to the side to keep the needle from protruding through the receiving slot. This method of operation requires two hands but eliminates the rebound reflex by locking the needle hub and keeping the other hand behind the device at all times. The Huber Needle Safety Device is provided as a sterile accessory packaged only with Harmac Infusion Sets. It is provided as a disposable, single use device.

The Harmac Huber Needle Safety Device's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Bench Testing: The document does not specify an exact sample size (number of devices or tests performed) for the Instron tester measurements, but it refers to "bench studies," implying multiple tests were conducted to determine average forces and standard deviations.
• Simulated Clinical Studies: Over 480 safety devices were tested.
• Data Provenance: The studies were conducted retrospectively as part of the design control phase at Harmac Medical Products, Inc. The location of the test (Harmac facilities) does not specify country of origin for data, but implies the studies were conducted internally for product development.

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

• Number of Experts: The simulated clinical studies involved "health care professionals familiar with the intended use of the device as well as the predicate device." The exact number of individual health care professionals is not specified, only that "health care professionals" participated.
• Qualifications of Experts: They were "health care professionals familiar with the intended use of the device as well as the predicate device." No further specific qualifications (e.g., years of experience, specific medical roles) are provided. They received "in-service training."

4. Adjudication Method for the Test Set:

• The document does not explicitly state an adjudication method (such as 2+1 or 3+1) for the simulated clinical studies. The health care professionals filled out a "detailed evaluation form during the study," implying direct observation and reporting of events (needle sticks, problems with safety feature) by these professionals, rather than a separate adjudication process of their findings. The outcome of 0 needle stick injuries and 0 significant problems suggests a clear-cut result rather than a need for complex 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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a mechanical safety accessory, not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the typical sense of medical imaging or clinical decision support. The study focused on the device's ability to prevent needle stick injuries during its intended use.

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

• N/A. This device is a physical safety accessory, not an algorithm. Its function inherently involves human interaction (removing a needle). The bench testing could be considered a "standalone" mechanical performance test in a highly controlled environment, but the simulated clinical studies involved human users.

7. The Type of Ground Truth Used:

• Bench Testing: Engineering measurements (force to engage/disengage from Instron tester).
• Simulated Clinical Studies: Direct observation and self-reporting by health care professionals regarding the occurrence of needle stick injuries and functional problems with the safety device during simulated use on port trainers. This is essentially empirical, real-world (simulated) outcome data on injury prevention and device function.

8. The Sample Size for the Training Set:

• None applicable in the context of an AI training set. This is a physical medical device, not an AI model. Therefore, there is no "training set" in the machine learning sense. The "design control phase" involves iterative design, prototyping, and testing, which refine the product but are not "training" an algorithm.

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

• N/A. As there is no AI training set, there is no ground truth established for such a set.

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The Balloon Wedge Pressure catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure and pulmonary artery wedge pressure). In the case of anatomical cardiac defect or situations requiring left transseptal access, this catheter may be used in any chamber which can be entered from the right heart.

Harmac Balloon Wedge Pressure Catheter

This document is a 510(k) clearance letter from the FDA for a medical device -- Harmac Balloon Wedge Pressure Catheter. It does not contain sections on acceptance criteria or performance studies. Therefore, I cannot provide the information requested.

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The Balloon Angiographic catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be used to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart.

Harmac Balloon Angiographic Catheter

This document is a 510(k) clearance letter from the FDA for a medical device (Harmac Balloon Angiographic Catheter). It does not contain any information about acceptance criteria, device performance reporting, or a study that proves the device meets acceptance criteria.

The letter explicitly states that the FDA has reviewed the Section 510(k) notification of intent to market the device and determined it is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory pathway for medical devices that are similar to existing legally marketed devices, and often does not require new clinical studies demonstrating safety and effectiveness compared to devices undergoing a Premarket Approval (PMA) pathway.

Therefore, I cannot extract the requested information from the provided text. The document is solely a regulatory clearance for market entry based on substantial equivalence, not a performance study report.

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The Balloon Temporary Pacing catheter is indicated for use in temporary transvenous ventricular cardiac pacing when impulse formation or conduction is impaired.

Harmac Temporary Pacing Catheter with Balloon

This document is an FDA 510(k) clearance letter for the Harmac Temporary Pacing Catheter with Balloon. It confirms substantial equivalence to a predicate device and provides information on indications for use. However, it does not include details about specific acceptance criteria or a study proving the device meets them.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired.

Harmac Temporary Pacing Catheter with Stylet

This document is a 510(k) clearance letter from the FDA for a medical device, the Harmac Temporary Pacing Catheter with Stylet. It is not a study report or a technical performance document for an AI/ML powered device. As such, it does not contain the requested information regarding acceptance criteria or a study proving device performance against such criteria.

The letter primarily states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and outlines the regulatory framework for its marketing.

Specifically, the requested information cannot be found in this document:

1. A table of acceptance criteria and the reported device performance: Not present. This document only includes the Indications for Use.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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 present. This is a traditional medical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a traditional medical device, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

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The Balloon Thermodilution catheter is indicated for use in measuring cardiac output by the thermodilution method. In addition, this balloon thermodilution catheter can be used to measure right atrial pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary capillary wedge pressure.

Harmac Thermodilution Catheter

I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Harmac Medical Products, Inc. for their Thermodilution Catheter. This document is primarily an administrative letter confirming substantial equivalence and outlining regulatory compliance.

It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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Mapping of electrical signals of the His bundle and also used to stimulate the myocardium to depolarize at a rate higher than the intrinsic heart rate or at a rate sufficient to maintain adequate cardiac output until definitive treatment can be instituted.

Harmac Quadpolar MappingPacing Catheter with Stylet

The provided document is limited to a 510(k) clearance letter for the Harmac Quadpolar Mapping Pacing Catheter with Stylet. This type of document primarily confirms that the device is substantially equivalent to a predicate device and is cleared for marketing. It does not contain the detailed information required to describe acceptance criteria, the specific study design, or device performance metrics as requested in your prompt.

Therefore, I cannot provide the information requested in your prompt based on the provided text. The document refers to "indications for use" but does not elaborate on performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.

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