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This closed suction system is indicated for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.

Ty-Care is a suction catheter system that is designed to connect to the endotracheal tube or tracheostomy tube of the patient and remains in place up to 48 hours ("fixed" version). Ty-Care exel is a detachable system and features a suction catheter that must be replaced after 24 hours while the angled connector (elbow) may be replaced after 72 hours of use. If the patient is on mechanical ventilation, this device allows the attending health professional to suction the patient's tracheobronchial secretions without disconnecting the ventilator. Ty-Care exel offers all the advantages of Ty-Care system with the added feature of a rotating patient-access valve.

The provided text describes the 510(k) summary for the MALLINCKRODT DAR Ty-Care™ / Ty-Care™ exel Closed Suction System, claiming substantial equivalence to predicate devices. However, it does not contain the detailed information required to fill out a table of acceptance criteria and a study that proves the device meets those criteria, specifically regarding performance metrics, sample sizes, expert involvement, or comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on intended use, design, operational characteristics, and materials of construction compared to predicate devices. It briefly mentions "Biocompatibility and performance testing demonstrate that MALLINCKRODT DAR Ty-Care™ / Ty-Care Closed Suction System complies with designated voluntary standards and fulfills product specifications. Verification and validation testing demonstrates that the increased duration of use raises no new issues of safety or effectiveness." This is a general statement and lacks the specific details requested in your prompt.

Therefore, most of the requested information cannot be extracted from this document.

Here's how much of your request can be answered based solely on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document does not mention experts involved in establishing ground truth for performance testing.

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

• Not specified.

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 is a medical device (closed suction system), not an AI-powered diagnostic or imaging device for which MRMC studies comparing human readers with and without AI assistance would be relevant.

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 (expert consensus, pathology, outcomes data, etc)

• Not specified. The document only generally mentions "biocompatibility and performance testing" and "verification and validation testing" against "designated voluntary standards and product specifications." It does not detail how the "truth" or success of these tests was established.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a "training set."

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

• Not applicable.

Summary:
The provided 510(k) summary is designed to demonstrate substantial equivalence to predicate devices based on design and intended use, rather than presenting a detailed performance study with specific acceptance criteria and results in the format requested. Information regarding specific testing methodologies, sample sizes, ground truth establishment, or expert involvement in performance criteria is absent from this document.

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Ambu Suction Pump is intended for quick suction of fluids from the nose and mouth of children and adult as well as for amnionic fluids from the newborn.

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This is a 510(k) clearance letter from the FDA for a medical device. It does not include information on acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not the clearance letter.

Therefore, I cannot provide the requested information based only on the provided text. The document confirms the device is substantially equivalent to a predicate device, which is the basis for its market clearance, but doesn't detail performance studies or acceptance criteria it might have undergone.

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The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

The provided 510(k) summary for the "DUAL PURPOSE CLOSED CATHETER" does not include specific acceptance criteria or detailed results from the performance testing. Instead, it makes a general statement about substantial equivalence.

Here's a breakdown of the information that is available and what is missing for your specific questions:

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

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: Not explicitly enumerated in the provided text beyond the general statement of "substantially equivalent."

The document states: "Based on the results of performance testing conducted at HAUSER Laboratories the Spirit Medical Systems. Inc. DUAL PURPOSE CLOSED CATHETER is substantially equivalent to the Jinotti™ Closed Suction/Oxygen Catheter Systems manufactured and distributed by MedCare Medical Group, Inc." This indicates that performance testing was done, but the details of what was tested, the specific metrics, and the acceptance thresholds are not included in this summary.

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

• Sample Size: Not specified.
• Data Provenance: The testing was "conducted at HAUSER Laboratories," but details regarding the type of samples (e.g., in vitro, animal, human), their origin, or whether the study was retrospective or prospective are not provided. Given the nature of a catheter, it's highly likely this involved in-vitro and/or animal studies rather than human clinical trials for a 510(k) submission, especially from this era.

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

• This question is largely irrelevant for a device of this type (a physical catheter) undergoing performance testing for substantial equivalence. The "ground truth" would likely be objective measurements from laboratory tests, rather than expert interpretation of images or other diagnostic data. Therefore, no information is provided.

4. Adjudication method for the test set

• Not applicable/provided for the reasons stated in point 3.

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

• MRMC Study: No.
• Effect Size: Not applicable. This device is a physical catheter, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

• While not explicitly stated, for a physical medical device like a catheter seeking substantial equivalence, the "ground truth" for performance testing (likely flow rates, suction efficiency, material compatibility, strength, etc.) would be established through objective laboratory measurements and engineering standards, not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices. The comparison is made against the predicate device's established performance characteristics.

8. The sample size for the training set

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

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

• Not applicable/provided.

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The intended use of the NI-MED suction catheter kit is for the physician to aspirate liquids or semi-solids from a patient's upper airway.

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This document is a 510(k) clearance letter from the FDA for a medical device: a Suction Catheter Kit. This type of letter generally does not contain detailed information about acceptance criteria or specific study results that prove a device meets those criteria. The 510(k) process primarily demonstrates "substantial equivalence" to a predicate device, focusing on similar intended use and technological characteristics, rather than extensive clinical efficacy studies in many cases, especially for Class I devices like this one.

Therefore, most of the information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details) is typically not found in a 510(k) clearance letter for a Class I device.

Here's what can be inferred or explicitly stated from the provided text, and what cannot:

What can be inferred or explicitly stated:

• Device Name: Suction Catheter Kit
• Intended Use: "for the physician to aspirate liquids or semi-solids from a patient's upper airway."
• Regulatory Class: I (one)
• Product Code: 73 BSY
• Device Manufacturer: Ni-Med, Inc.

Information NOT available in this document and therefore cannot be provided:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific performance criteria (e.g., flow rate, suction pressure, material integrity over time) or the results of tests against such criteria. The FDA review focuses on substantial equivalence to a predicate, not necessarily detailed performance metrics for this specific device.
2. Sample size used for the test set and the data provenance: No information about a "test set" in the context of clinical studies is provided. The 510(k) submission would have included technical specifications and comparisons to a predicate device, but not detailed study design for a performance test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is described in this regulatory letter.
4. Adjudication method: Not applicable.
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 device is a physical medical device (suction catheter), not an AI-driven diagnostic or imaging device. Therefore, MRMC studies and AI-related metrics are entirely irrelevant and not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as detailed performance studies with a "ground truth" are not described. The "ground truth" for a Class I device in a 510(k) context is often compliance with established standards, biocompatibility, and manufacturing quality, rather than clinical efficacy against a "ground truth" outcome.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory clearance for marketing, not a scientific publication detailing performance studies. For a Class I device like a suction catheter, the "study" proving it meets acceptance criteria typically refers to engineering tests, material compatibility tests, and comparison to a legally marketed predicate device, rather than extensive clinical trials or AI performance evaluations.

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This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions. This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.

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This document is a marketing clearance letter from the FDA for the "Hi-Care Closed Suction System." It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide the requested information. The provided text is a regulatory approval document, not a clinical study report or a performance evaluation.

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Amsino Suction Catheter, tracheobronchial, is to be used to aspirate liquids or semisolids from a patient's upper airway.

AMSINO® Suction Catheter

The provided text is a 510(k) clearance letter from the FDA for a device called "AMSINO® Suction Catheter." This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the letter does not contain any information regarding acceptance criteria or a study proving the device meets those criteria. The content is purely administrative, focusing on the regulatory clearance process.

Therefore, I cannot provide the requested information from the given text.

To be clear:

1. Table of acceptance criteria and reported device performance: Not available.
2. Sample size and data provenance: Not available.
3. Number and qualifications of experts for ground truth: Not available.
4. Adjudication method for test set: Not available.
5. MRMC comparative effectiveness study: Not available.
6. Standalone performance study: Not available.
7. Type of ground truth used: Not available.
8. Sample size for training set: Not available.
9. How ground truth for training set was established: Not available.

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The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.

The Argyle® ASPR-Care™ Closed Suction System consists of three discreet components: a dual swivel T-piece, a sheathed suction catheter, and a suction control valve. When connected together, these components form a closed system suction catheter similar in form and function to the closed system catheters available from Ballard and Concord/Portex.

This document is a 510(k) summary for the Argyle® ASPR-Care™ Closed Suction System, not a study evaluating acceptance criteria against reported device performance as might be found for AI/ML-driven medical devices. Therefore, much of the requested information (e.g., sample sizes, expert qualifications, MRMC studies, training set details) is not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can extract the general acceptance criteria in terms of "substantial equivalence" and the types of tests performed.

1. Table of Acceptance Criteria and Reported Aevice Performance

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

• This document does not specify a "test set" in the context of AI/ML performance evaluation. The "testing" referred to is for device performance characteristics and biocompatibility.
• For performance, "Sherwood Medical has conducted a battery of tests comparing the performance of the Argyle® ASPR-Care™ Closed Suction System and ancillary components with those devices to which we are claiming substantial equivalence." No sample sizes or data provenance (country, retrospective/prospective) are mentioned for these tests in this summary.
• For biocompatibility, the tests were conducted according to ISO 10993 Part 1. Specific sample sizes for these biological tests (e.g., number of animals for systemic toxicity, number of cell cultures for cytotoxicity) are not provided in this summary, nor is the provenance of the samples.

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

• Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.

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

• Not applicable.

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 is not an AI-assisted device.

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 (expert consensus, pathology, outcomes data, etc.):

• For biocompatibility: Ground truth is typically based on laboratory assay results (e.g., cell viability for cytotoxicity, skin reaction for irritation, systemic effects in animal models).
• For performance: Ground truth would be based on engineering specifications, physical measurements (e.g., airflow, pressure integrity, suction flow rates), and functional testing against design requirements and comparison to predicate devices. The summary indicates that testing was "conducted to ensure Sherwood's device provides a safe and effective conduit for ventilator qases and allows efficient tracheal and oral suctioning capabilities," implying functional validation.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable.

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