Search Results

Two-Way Catheter - Urethral catheterization for bladder drainage for Urological use only

Three Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only

The Well Lead Latex and Silicone Foley catheters are two-way Foley catheters which are placed in the bladder throught the urethra. The urine drains out through the catheter into a collection device attached to the catheter.

Based on the provided text, here's a detailed analysis of the acceptance criteria and the study performed for the Well Lead Silicone and Latex Foley Catheters:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided text does not specify a sample size used for a test set. It mentions conformance to an ASTM standard, which implies testing was conducted, but the details of that testing, including sample specifics, are not present. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

The document does not mention the use of experts to establish a "ground truth" in the context of typical diagnostic device studies. The performance is assessed against an engineering standard (ASTM F 623-99), not through expert consensus on medical images or diagnoses.

4. Adjudication Method:

Not applicable. This device is a medical catheter, and its performance is evaluated against engineering and manufacturing standards, not through adjudication of diagnostic outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The provided text does not describe an MRMC comparative effectiveness study. This type of study is relevant for diagnostic AI devices where human readers interpret medical data.

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

Not applicable. This device is a physical medical instrument (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is adherence to the specifications outlined in the ASTM F 623-99 standard. This standard likely covers physical dimensions, material properties, sterility, and packaging integrity. It's an engineering/manufacturing standard, not clinical pathology or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. This section is relevant for AI/ML devices that require training data. The Well Lead Foley Catheters are physical medical devices.

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

Not applicable. This section is relevant for AI/ML devices.

Summary of Device Performance Study:

The "study" cited in the document is the claim that the device "conform[s] to ASTM F 623-99." This indicates that the manufacturer has performed internal testing and quality control procedures to ensure their Foley catheters meet the established specifications of this American Society for Testing and Materials (ASTM) standard. ASTM F 623-99, titled "Standard Specification for Foley Catheter," would define the precise requirements for aspects like catheter diameter, balloon volume, material strength, leakage, and other critical performance characteristics. The document does not provide a detailed report of the specific tests conducted, the sample sizes for those tests, or the raw data, but rather states the conclusion of conformance to the standard.

Ask a specific question about this device

The Well Lead Reinforced Endotracheal Tubes are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone positiom so that a non-reinforced tracheal tube might become kinked.

Single Use. A Tracheal tube with addidional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, and oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen. The Well Lead Reinforced Endotracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric patients or when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.

The acceptance criteria and device performance for the Well Lead Reinforced Endotracheal Tube are based on conformity to the international standard ISO 5361:1999(E).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided document does not contain information regarding a specific "test set" in the context of clinical studies with human subjects or a defined set of data for performance evaluation. The device's performance is asserted by its conformity (or non-conformity in one aspect) to a manufacturing standard. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not available from this document.

3. Number of Experts and Qualifications for Ground Truth

The document does not detail any studies that involved human experts to establish ground truth for the device's performance. The "ground truth" for this device's acceptance is based on its adherence to manufacturing standards (ISO 5361:1999(E)).

4. Adjudication Method for Test Set

Since no specific test set involving expert review is described, there is no information on an adjudication method.

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

No MRMC comparative effectiveness study is mentioned or implied in the provided 510(k) summary. This type of study typically assesses the impact of AI assistance on human reader performance, which is not relevant for this device.

6. Standalone (Algorithm Only) Performance

The device is a physical medical instrument (Reinforced Endotracheal Tube), not a software algorithm. Therefore, the concept of "standalone (algorithm only) performance" does not apply.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptance is primarily based on conformance to international engineering and manufacturing standards (ISO 5361:1999(E)). This standard dictates various physical and functional properties of tracheal tubes.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI/algorithmic device, there is no "training set" in the computational context described.

9. How Ground Truth for Training Set Was Established

Similarly, since there is no training set, the method of establishing ground truth for it is not applicable.

Ask a specific question about this device

The device is intended for oral or nasal intubation and for airway management.

The tracheal tubes are made from medical grade PVC, with a connector and valve. The tracheal tubes may be cuffed or uncuffed and are for oral or nasal use.

The provided text is a 510(k) summary for an Endotracheal Tube, seeking clearance from the FDA. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the way a medical device performance study typically would. Instead, it relies on substantial equivalence to predicate devices.

However, I can extract the information that is present and highlight what is missing based on your request.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of a formal performance study with a specific number of devices tested. The submission relies on conformance to an ISO standard and comparison to predicate devices, inferring that the design and manufacturing process meet these criteria. It doesn't detail a specific test sample size for an investigative study.
• Data Provenance: N/A for a specific test set. The submission itself is from China (Well Lead Medical Instruments Ltd, Guangzhou City, China). The basis for comparison is market-cleared predicate devices.

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

• N/A. This device clearance is based on substantial equivalence to predicate devices and conformance to an international standard (ISO 5361:1999(E)), not on a clinical or performance study requiring expert ground truth establishment for a test set. The FDA's review and clearance process involves their own experts, but not in the context of establishing ground truth for a specific device efficacy or diagnostic accuracy study.

4. Adjudication method for the test set

• N/A. No specific test set requiring adjudication in this context.

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. This is a physical medical device (endotracheal tube), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• N/A. Not applicable for this type of device clearance. Instead of ground truth, the submission relies on:
  • Conformance to an International Standard: ISO 5361:1999(E)
  • Substantial Equivalence: Comparison to existing market-cleared predicate devices (Kendall - Pre-Amendment, RÜSCHELIT K961837, K993786, K961840, K931163, K93786).

8. The sample size for the training set

• N/A. Not applicable. There is no AI training set for this physical device.

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

• N/A. Not applicable. There is no AI training set for this physical device.

Summary based on the provided text:

The clearance for the Well Lead Endotracheal Tube (K042683) was based on demonstrating substantial equivalence to predicate devices and conformance to the ISO 5361:1999(E) standard for dimensions, design, material, sterility, and packaging. This is typical for Class II physical medical devices where a new clinical performance study is not required if the device is sufficiently similar to existing devices on the market. The text does not describe a clinical study with specific acceptance criteria, test sets, or ground truth establishment as would be expected for a novel diagnostic or therapeutic device requiring de novo authorization or a PMA.

Ask a specific question about this device

The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

The tracheostomy tubes are made from the raw material of PVC for medical use, with the The trachetoney wave. The tracheostomy tubes have such good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility.

The provided document is a 510(k) summary for the Well Lead Tracheostomy Tubes, which was cleared in 2005. It describes the device, its intended use, and its equivalence to a predicate device.

However, the document does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance through a clinical or performance study involving human readers or algorithmic standalone performance. This type of submission (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies for safety and effectiveness.

Here’s a breakdown of the information requested, based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not provided. This submission does not describe a clinical performance study with a test set of data. The performance claims are based on conformance to international standards (ISO 5366-1 and ISO 5366-3) and comparison to a predicate device.

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

• Not applicable / Not provided. See above. Ground truth, in the context of clinical studies for AI/algorithms, is not relevant to this type of device submission which focuses on physical and material specifications.

4. Adjudication method for the test set

• Not applicable / Not provided. See above.

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 provided. This device is a physical medical instrument (tracheostomy tube), not an AI/software-as-a-medical-device (SaMD) that would assist human readers or perform diagnostic interpretations.

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

• Not applicable / Not provided. This device is a physical medical instrument.

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

• Not applicable / Not provided. For this type of device, "ground truth" would relate to its physical and material properties meeting specified engineering and biocompatibility standards rather than diagnostic accuracy. The provided text indicates conformance to ISO standards and biocompatibility.

8. The sample size for the training set

• Not applicable / Not provided. This submission does not involve an AI algorithm with a training set.

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

• Not applicable / Not provided. This submission does not involve an AI algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily an engineering and materials conformance study against established international standards and comparison to a predicate device, rather than a clinical trial or an AI performance study.

The document states:
"The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1 and ISO 5366-3."
Additionally, claims are made about "good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility."
Finally, "The device has the same dimensions and design as the predicate device (Section 9)."

This implies that the manufacturer conducted internal testing and verification to ensure their device met the physical, material, and performance specifications outlined in the ISO standards and matched the predicate device’s characteristics. The FDA's 510(k) clearance is a determination of "substantial equivalence" based on this documentation, verifying that the new device is as safe and effective as a legally marketed predicate device.

Ask a specific question about this device