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Longterm NPWT Foam Dressing Kit is intended to be used along with VCare 1000 -300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Longterm NPWT foam dressing kit is for use in professional healthcare facilities only.

Longterm NPWT Foam dressing kit is an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit is composed of black foam dressing, polyurethane (PU) film drape and suction bell.

The foam dressing is used to pack the wound bed, the PU film drape is used to cover the packed wound bed and peri-wound area to create and maintain a sealed environment, the suction bell is served as a conduit between the wound bed and the negative pressure pump to transfer the wound fluid to the canister attached to the pump.

Longterm NPWT Foam dressing kit consists of hydrophobic, reticulated Polyurethane foam, polyurethane film drape coated with acrylic adhesive, suction bell composed of a polyvinyl chloride (PVC) drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent polyurethane film coated with acrylic adhesive. Each component is individually packaged and sterilized. The foam dressing should be changed every 2-3 days depending on the wound condition or according to the local protocol.

The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive.

Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium (18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm.

This document describes the premarket notification (510(k)) for the Longterm NPWT Foam Dressing Kit, which is an accessory to a Negative Pressure Wound Therapy (NPWT) pump. The FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for an AI/ML device. This 510(k) is for a medical device (wound dressing kit) and not an AI/ML product. Therefore, the "acceptance criteria" discussed are related to the performance characteristics of the physical device as tested in a bench and animal study, demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical testing summary, we can infer the tested parameters and their implied acceptance criteria (meeting expectations for safe and effective wound management when used with the pump).

Inferred Performance and Acceptance Criteria (from Non-Clinical Testing Summary):

Regarding the other requested information, which typically applies to AI/ML devices, it's important to clarify that this 510(k) is for a physical medical device (NPWT Foam Dressing Kit), not an AI/ML product. Therefore, many of the requested points are not applicable to this submission.

Here's a breakdown of the requested points in the context of this device:

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

   • Test Set:
     • Biocompatibility: The sample sizes would be specific to each ISO standard for material testing (e.g., number of test specimens, number of animals in acute/subacute toxicity studies). The document does not specify these numbers, but implies compliance with the referenced ISO standards.
     • Bench Testing: The document lists the types of tests performed (e.g., foam dimension, fluid removal rate, pressure distribution). The sample size for these tests (e.g., number of foam dressing kits tested) is not specified.
     • Animal Testing: A "Porcine wound healing study" was conducted. The number of animals used is not specified in this summary.
   • Data Provenance: Not explicitly stated, but the testing would typically be conducted at certified labs either within the manufacturer's facility or at contract research organizations.
   • Retrospective or Prospective: These terms are generally more relevant to clinical studies. Biocompatibility and bench testing are typically prospective experiments designed to evaluate specific device properties. The porcine study would be a prospective animal study.

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

   • This is not applicable as there is no "ground truth" in the AI/ML sense (e.g., image annotation for disease detection). The "truth" is established by the physical and functional properties of the device meeting pre-defined engineering and safety standards.
   • The "experts" involved would be the engineers, scientists, and veterinarians conducting and overseeing the biocompatibility, bench, and animal studies. Their qualifications would be in their respective fields (e.g., toxicologists for biocompatibility, mechanical engineers for bench testing, veterinarians for animal studies).

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

   • Not applicable. Adjudication methods are typically used in clinical studies or expert labeling tasks for AI/ML validation. Device testing results are typically objectively measured against defined criteria.

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 device is not an AI/ML product and does not involve human readers interpreting data or assisting with diagnosis.

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

   • Not applicable. This is not an algorithm. Bench testing evaluates the standalone performance of the physical device components and their functionality when integrated with the pump.

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

   • The 'ground truth' for this device's performance is established by:
     • Standardized material and performance tests (bench testing): Adherence to ISO standards for biocompatibility and specific engineering specifications for foam dimensions, fluid removal rate, pressure distribution, and mechanical properties.
     • Animal study outcomes: For the porcine wound healing study, the outcomes would be assessed based on observed wound healing parameters (e.g., wound size reduction, tissue granulation, infection status), which serve as a proxy for clinical performance.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable.

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Innomed NPWT Silicone Foam Dressing is intended to be used along with VCare 1000- 300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.

When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types:

• Chronic
• Acute
• · Traumatic
• Subacute and dehisced wounds
• · Partial-thickness burns,
• · Ulcers (such as diabetic or pressure)
• · Flaps and grafts

The device is for use in professional healthcare facilities only.

Innomed NPWT Silicone foam dressing is a single-use device, as an accessory to VCare-1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The NPWT Silicone foam dressing consists of silicone adhesive coated foam dressing attached with a suction bell and fixation film strips.

The silicone foam dressing is comprised of PU film, absorbent pad consisting of polyurethane (PU) foam, absorbent fibre and polyester fabric, a layer silicone adhesive is coated onto the entire surface.

The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a polypropylene luer taper, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive. The suction bell is attached on the silicone foam dressing surface.

Fixations film strips is composed of PU film coated with acrylic adhesive.

Machnism of Action: The silicone adhesive coated foam dressing is used to pack the wound bed and cover periwound area, and the fixation film strips are applied over the outside edges of the dressing to facilitate hold the silicone foam dressing in place and seal the wound bed area. The other end of the attached suction bell is connected to a canister attached to the negative pressure pump, VCare 1000-300S pump, and served as a conduit to transfer the wound exudate to the canister under negative pressure when the pump is turned on.

Innomed NPWT Silicone Foam Dressing is available in 10 sizes: SNPWT-1010 ( 10cm X 10cm ), SNPWT-1020 (10cm X 20cm ), SNPWT-1030 (10cm X 30cm ), SNPWT-1040( 10cm X 40cm ), SNPWT-1515(15cm X 15cm ), SNPWT-1520 (15cm X 20cm ), SNPWT-1530 (15cm X 30cm ), SNPWT-2020 (20cm X 20cm ), SNPWT-2025(20cm X 25cm ), SNPWT-2525(25cm X 25cm )

The provided text describes the "Innomed NPWT Silicone Foam Dressing," an accessory for negative pressure wound therapy (NPWT). This device is cleared for marketing based on a 510(k) submission, meaning it was found substantially equivalent to existing predicate devices rather than requiring de novo approval or a PMA that would necessitate extensive clinical trials.

Therefore, the study design and acceptance criteria are evaluated against the substantial equivalence paradigm, not a traditional clinical trial proving efficacy against specific numerical thresholds in a clinical population. The performance is assessed by demonstrating similarity to predicate devices through non-clinical testing.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are generally understood as demonstrating functional equivalence or similarity to predicate devices through a series of bench tests and biocompatibility assessments. The "reported device performance" refers to the results of these non-clinical tests for the subject device and the predicates.

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

The document does not specify a "test set" in the context of a clinical study with human subjects. The testing performed was non-clinical (bench and biocompatibility). Therefore, there is no information on human sample size or data provenance in terms of country of origin or retrospective/prospective nature. The tests involved material samples and simulated environments.

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

Not applicable. As this was a non-clinical study, there was no "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" for non-clinical tests comes from standardized testing methods and specifications (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring human expert adjudication.

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

No. A MRMC study is a clinical study involving human readers interpreting medical cases. This submission is for a medical device (dressing) and relies on non-clinical testing.

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

Not applicable. This device is a physical dressing used in conjunction with a pump, not an AI algorithm.

7. The type of ground truth used

For biocompatibility testing, the "ground truth" is derived from the established standards (e.g., ISO 10993 series) which define acceptable ranges or outcomes for various biological responses. For bench testing, the "ground truth" is typically defined by engineering specifications, performance requirements, and comparison to the predicate devices. There is no pathology or patient outcomes data directly determining "ground truth" for the device's performance in this 510(k) submission.

8. The sample size for the training set

Not applicable. The description is for a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable.

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LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns.

LT Antibacterial Alginate with Silver Dressing is intended for external use only.

LT Antibacterial Alginate with Silver Dressing is an advanced wound care dressing composed of calcium alginate and silver salt (3.5%). The dressing forms a gel when absorbs wound fluid to provide a moist environment and allows intact removal. When in contact with wound fluid, silver ions within the dressing inhibit bacterial growth in the dressing. LT Antibacterial Alginate with Silver Dressing is available in pad and ribbon configurations and various sizes. The pad is used to cover and protect the wound bed and the ribbon is used to pack the wound with cavity.

LT Antibacterial Alginate with Silver Dressing can be cut and layered for various wound shapes and types.

This document describes the FDA 510(k) clearance for the LT Antibacterial Alginate with Silver Dressing. Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) process for this device relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than explicit acceptance criteria and performance against those criteria in a typical clinical trial sense. The performance is assessed through non-clinical (bench and animal) testing and similarity to the predicate device.

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

• Sample Size for Non-Clinical Tests: Not specified in the document for individual tests (e.g., number of samples for AATCC 100, number of animals for the porcine study). The various configurations of the dressing (different sizes) would likely have been tested.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location (Zhejiang, China) and common industry practices, it's highly likely the non-clinical testing was conducted in laboratories, possibly in China or by contract research organizations.

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

• This information is not provided in the document. For non-clinical studies (bench and animal), specific "experts" establishing ground truth in the sense of clinical adjudication are typically not involved. Results are measured objectively according to standard protocols (e.g., ISO, AATCC).

4. Adjudication Method for the Test Set

• None as described in a clinical context. Non-clinical tests follow established protocols and measurement techniques for objective results.

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 a wound dressing, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.

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

• Not applicable. This device is a wound dressing, not a software algorithm.

7. The Type of Ground Truth Used

• Objective Test Results and Animal Models:
  • Bench Testing: Ground truth is established by standardized laboratory methods and measurements (e.g., bacterial count reduction for antibacterial activity, physical properties like tensile strength, chemical assays for silver content).
  • Biocompatibility Testing: Ground truth is determined by standardized biological response assessments according to ISO 10993 series.
  • Animal Testing: Ground truth is established by observational and histological assessments in a controlled animal model (porcine wound healing study).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical wound dressing; it does not involve machine learning or a "training set" in the computational sense.

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

• Not applicable. As there is no training set for a machine learning model, there is no ground truth established for it.

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The dressing kit is intended to be used along with VCare 1000-300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT foam dressing kit is for use in professional healthcare facilities only.

Longterm NPWT dressing kit is a single use device as an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit consists of hydrophobic, reticulated Polyurethane foam, polyurethane film drape coated with acrylic adhesive, suction bell composed of a polyvinyl chloride (PVC) drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent polyurethane film coated with acrylic adhesive. Each component is individually packaged and sterilized.

The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive.

Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium (18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm.

The foam dressing is used to pack the wound bed, the film drape is used to cover the packed wound bed and peri-wound area to create and maintain a sealed environment, the suction bell is served as a conduit between the wound bed and the suction pump to transfer the wound fluid to the canister attached to the suction pump.

The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with the VCare 1000-300S pump after 24 hours.

The provided document describes a 510(k) Premarket Notification for the Longterm NPWT Foam Dressing Kit, which is an accessory to the VCare 1000-300S pump. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the information provided focuses on comparative performance and compliance with relevant standards.

Here's an analysis of the requested information based on the document:

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

For a 510(k) submission, "acceptance criteria" and "reported device performance" are often framed in terms of meeting established standards and demonstrating equivalence to predicate devices, rather than achieving specific numerical thresholds for effectiveness (like sensitivity/specificity). The document details several non-clinical tests performed to support substantial equivalence.

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

The document lists "non-clinical testing" including biocompatibility and bench testing. These tests typically involve material samples or simulated environments, not patient data in the sense of a clinical test set.

• Sample Size for Test Set: Not applicable in the context of clinical patient data. The tests involved material samples (foam, drape, suction bell components) and possibly multiple units for bench testing, but specific quantities are not provided in this summary.
• Data Provenance: The manufacturer is "Zhejiang Longterm Medical Technology Co., LTD" located in Deqing, Zhejiang, CHINA. The testing would have been conducted to support a US FDA submission, implying adherence to relevant international standards (e.g., ISO) which might be carried out by various certified labs.

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 is not applicable as no clinical test set involving human experts to establish ground truth was conducted for this 510(k) submission. The document explicitly states: "No clinical testing was required to support substantial equivalence."

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

Not applicable, as there was no clinical test set requiring expert 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

Not applicable. This device is a medical dressing and accessory; it does not involve AI or human readers for diagnostic interpretation. No MRMC study was conducted.

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

Not applicable, as this device does not involve an algorithm or AI.

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

For the non-clinical tests:

• Biocompatibility: Ground truth is established by adherence to recognized international standards (e.g., ISO 10993 series) and specific test methodologies that define what constitutes "non-cytotoxic," "non-irritant," etc.
• Bench Testing: Ground truth is established by engineering specifications, performance requirements for negative pressure wound therapy systems, and comparison to the performance characteristics of the predicate device (VCare 1000-300S pump, which this dressing kit is an accessory to). The "Conclusion" states "The non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as the legally marked predicate devices," implying a comparison to the predicate's established performance.

8. The sample size for the training set

Not applicable, as this device does not involve AI or machine learning that would require a training set.

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

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

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