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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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The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility.

The MALLINCKRODT DAR Heated Wire Breathing Circuit consists of the existing smooth bore breathing circuits (K942392, Airway Connectors with Flex Tube) into which a resistor has been molded into the inside of the external rib. Heating is controlled by ventilation/anesthesia breathing heaters or heater/humidifiers to which the MALLINCKRODT DAR Heated Wire Breathing Circuits are electrically connected. Some HWBC configurations may include traps for collection of the condensed moisture from patient exhalation or from humidification. Devices will be available in a variety of configurations.

The provided document (K993268) describes a 510(k) premarket notification for the MALLINCKRODT DAR Heated Wire Breathing Circuit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with acceptance criteria that would typically be seen for novel devices.

Therefore, the document does not contain information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document states:

1. Acceptance Criteria and Device Performance:

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate devices. The performance of the device is assessed through compliance with designated voluntary standards and fulfillment of product specifications, rather than specific performance metrics against clinical acceptance criteria.

The document states:
"Biocompatibility, performance, electrical safety, and electromagnetic compatibility testing demonstrate that Mallinckrodt DAR HWBC comply with designated voluntary standards and fulfill product specifications."

No specific quantifiable performance metrics or acceptance thresholds are provided in the document. The substantial equivalence claim is based on:

• Intended Use: "The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility." This is consistent with the predicate devices.
• Design: Shared characteristics with predicate devices (e.g., smooth bore, standard airway connectors, various configurations).
• Operational Characteristics: Provides a heated gas pathway, used for anesthesia and respiratory therapy, compatible with humidifiers.
• Materials of Construction: "Same materials as standard breathing circuits."
• Performance: "Meets ASTM standards" (implying standard performance criteria rather than novel device-specific criteria).

The comparison table (Table 1) highlights shared characteristics with predicate devices across Use, Sterility, Design, Materials, and Performance, indicating that the new device meets similar functional and safety attributes as the legally marketed predicate devices without defining new performance acceptance criteria.

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