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The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:

• Antimicrobial gauze dressing
• Avance Transparent Film or Avance Film with Safetac technology
• Avance ViewPad

This document is a 510(k) premarket notification for "Avance Gauze Dressing Kits," which are line additions to an existing Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the information typically associated with a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, expert involvement, and ground truth establishment) is not fully present in the document in the format you've requested for an AI model.

However, I can extract the relevant information regarding acceptance criteria and general statements about testing from the provided text:

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

The document states that "all predefined acceptance criteria were met" for the bench testing. However, the specific quantitative acceptance criteria are not detailed in this summary.

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 specify the sample sizes used for the bench testing. No clinical data was required or submitted, so there is no information on data provenance relating to clinical studies. The testing described is "non-clinical bench testing."

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 testing described is bench testing, which typically relies on established engineering and materials science principles, not expert human assessment of images or patient data to establish ground truth.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers, which this submission did not include.

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 not an AI-assisted diagnostic tool; it is a medical dressing kit for Negative Pressure Wound Therapy.

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

This is not applicable as the device is not an algorithm or AI. The bench testing performed would be considered "standalone" in the sense that it evaluated the device's physical performance independently.

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

For biocompatibility, the ground truth would be established by the requirements of ISO 10993. For fluid transport and pressure delivery, the ground truth would be engineering specifications and functional parameters for NPWT systems, where "as intended" means meeting these predefined technical requirements.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dressing kits) and its non-clinical bench testing, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

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Venturi™ Gauze Wound Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.

NPWT is contraindicated for patients with:

1. Malignancy in the wound
2. Untreated osteomyelitis
3. Non-enteric and unexplored fistulas
4. Wounds with difficult haemostasis
5. Necrotic tissue with eschar present
6. Exposed vasculature, bone, nerves, or organs.

With the exception of the Portal Drain, there are no changes to the components in the currently marketed gauze dressing kits cleared in 510(K) K080897. The wound care sets connect to Negative Pressure Wound Therapy (NPWT) suction pumps to carry exudate from the wound.

The Venturi™ Gauze Wound Care Sets with Portal Drain consist of the following components:

Venturi™ Gauze Wound Care Set: Kerlix Antimicrobial gauze wound filler, adhesive film dressing, Portal Drain Assembly; 20ml saline solution and comes with measuring tape and instructions for use. These are supplied as sterile and single use.

The Venturi™ MINO Gauze Wound Care sets are have identical contents with the addition of a canister that attaches to the Venturi™ MINO NPWT device to contain the exudate.

The Portal Drain assembly is consist of the portal drain which is adhered to a window dressing and is connected to the drain tube which connects at the other end to the NPWT pump via the canister connector assembly. There is a 90° drain tube guide and pinch clamp at the pump end of the assembly for additional safety.

The window dressing end of the Portal Drain Assembly is self-adhesive and a small hole is cut in the adhesive film dressing directly over the gauze and the Portal Drain Assembly is placed over the adhesive window dressing ensuring the portal drain is lined up with the hole. The other end of the tubing attaches to the pump to carry exudate from the wound.

The provided text describes a 510(k) premarket notification for the "Venturi Gauze Wound Care Sets With Portal Drain" and the FDA's determination of substantial equivalence. This document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance.

The device in question is a medical dressing kit for Negative Pressure Wound Therapy (NPWT), and its substantial equivalence was determined based on its similarity to existing predicate devices and bench testing, not clinical or AI-related studies.

Therefore, I cannot provide the requested information as it pertains to AI acceptance criteria and study details. However, I can extract information about the predicate devices and the general testing approach for this non-AI medical device:

Device: Venturi™ Gauze Wound Care Sets with Portal Drain (K151263)

Predicate Devices:

• Venturi™ NPWT v.II Advanced Vacuum System (K080897) - Manufacturer: Talley Group
• Avance® Foam Dressing Kits (K122132) - Manufacturer: Mölnlycke Health Care US, LLC

Testing Approach Summary (for this non-AI device):
The device's substantial equivalence was established through:

• Comparison of intended use, design, and technological characteristics to predicate devices.
• Confirmation that the new component (Portal Drain Assembly) performs the same function as equivalent components in predicate devices.
• Bench testing to demonstrate that the device does not introduce any additional risks and meets its intended use.

Specific answers to your questions based on the provided text (and why most cannot be answered for an AI device):

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

   • Cannot provide this for AI. The document states "The bench testing has demonstrated that the device does not introduce any additional risks when undertaking Negative Pressure Wound Therapy and meeting the intended use." No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, AUC) are listed because it's a physical device, not an AI algorithm.

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

   • Cannot provide this for AI. This device underwent "bench testing." Details about the sample size or provenance of data for bench tests are not provided in this summary.

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 was bench testing for a physical device, not expert-adjudicated ground truth for an AI algorithm.

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

   • Not applicable. This was bench testing for a physical device.

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 was not done. This is a physical wound care device, not an AI system. The document explicitly states "No clinical data was required."

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable for AI. For the physical device, conformity to established engineering standards and functional performance during bench testing served as the "ground truth" to show safety and effectiveness.

8. The sample size for the training set:

   • Not applicable. As this is a physical device, there is no "training set" in the context of machine learning.

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

   • Not applicable. There is no training set for an AI algorithm here.

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The Avance® NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject device of this submission, the Avance Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad™ and Mepitel® is an offering of components developed for negative pressure wound therapy. These dressing kits which are intended for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac ViewPad™ and Mepitel® is a combination of different components developed and arranged to meet the needs of the clinician for specific size and types of wounds.

The provided document is a 510(k) summary for the Avance® Foam Dressing Kits. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance criteria for a novel device. As such, it does not contain the information requested in points 1-9 of your prompt.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, nor data provenance details.
3. Information on experts used to establish ground truth.
4. Details on any adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Results from a standalone algorithm-only performance study.
7. Details on the type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for a training set.
9. How ground truth for a training set (if any) was established.

Instead, the document states:

• Performance Data: "The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac® ViewPad™and Mepitel® perform in the same manner as the predicate device kits (K122132) and are compatible with a similar type of pump. The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior. The fluid was efficiently transported from the wound model without lockage or problems. The system was tested over the time period of 73 hours without any problems or errors."
• Clinical Testing: "No clinical data was required."
• Conclusion: The device is substantially equivalent to the predicate device(s) identified with respect to intended use, materials (with the exception of ViewPad™ Materials), design and technological characteristics.

To obtain the detailed information requested regarding acceptance criteria and specific study results (especially for performance metrics, sample sizes, and ground truth establishment), you would typically need to consult a full 510(k) submission or a scientific publication related to the device, which are not provided in this excerpt. This document is a summary designed to state substantial equivalence, not to provide deep technical validation details.

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The portable Medela Invia Endure Negative Pressure Wound Therapy (NPWT) system is indicated to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing, edema, promoting granulation tissue formation, and by removing exudates and infectious material. It is intended for the use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with chronic, acute, subacute, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropethic, pressure or venous insufficiency), flaps and grafts.

The Medela Invia Endure Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Endure NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The Invia Endure is also compatible with separately cleared Avance NPWT kits manufactured by Mölnlyke Healthcare (K122132).

The Invia Endure NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Acoustic and optical signals are triggered for variances from the set values as well as for faults. The Invia Endure NPWT pump is intended for a single patient's entire therapy for continuous or intermittent operation. It has lifetime of at least three years.

The Invia Endure NPWT system is intended for use in a home or other health care facility by medical personnel or trained lay users adhering to the instructions for use. The user may not be hard of hearing or deaf and must have normal visual acuity. The Invia Endure NPWT pump is portable and can be operated independent of the electrical power supply via its rechargeable battery.

This document is a 510(k) premarket notification for the "Invia Endure Negative Pressure Wound Therapy System". It explicitly states that no clinical testing was performed. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the section "SUMMARY OF CLINICAL TESTS:" on page 5 states: "The Invia Endure has not been the subject of clinical testing."

Since no clinical study was performed, none of the requested information regarding acceptance criteria, sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies can be provided from this document.

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