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The 3M™ V.A.C.® Peel and Place Dressing is intended to be applied in an acute, extended, or home care setting where product application is conducted by or under the supervision of a qualified healthcare professional. It is an accessory to the 3M™ Negative Pressure Wound Therapy System.

When used on open wounds, the system is intended 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 perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The 3M™ V.A.C. ® Peel and Place Dressing Kit is a sterile, single use all in one dressing comprised of a semi-occlusive drape and foam dressing kitted together with a SensaTRAC Pad and Tubeset. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the periwound and the silicone layer primarily provides a seal for negative pressure. The polyurethane foam assists with manifolding negative pressure across the wound and periwound.

The one-piece all-in-one dressing and drape are similar to the Dermatac Drape and Granufoam Dressing, most recently cleared under 510(k) K212320, which are provided in a two piece design.

This document, a 510(k) premarket notification for the 3M™ V.A.C. ® Peel and Place Dressing Kit, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving independent device performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert adjudication methods, and MRMC studies for an AI/CAD-like device is not present in this document.

The document primarily describes a medical wound care dressing and focuses on non-clinical testing (bench testing, biocompatibility, simulated-use) to show it functions as intended and is equivalent to previously cleared devices. There is no AI or software component described that would necessitate studies with ground truth, expert readers, or performance metrics like sensitivity/specificity for a diagnostic or AI-assisted system.

However, based on the provided text, I can infer and summarize the relevant information as follows, highlighting what is included and what is explicitly stated as not applicable or not done:

Acceptance Criteria and Device Performance (as inferred for a non-AI medical device):

Since this is a wound care dressing, "acceptance criteria" here refer to demonstrating that the device performs its intended physical functions and is safe and effective, similar to its predicate. The "performance" is measured through various non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding AI-specific criteria (which are not relevant to this traditional medical device):

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

• Not applicable as this is not an AI/diagnostic device. The "test set" here refers to the physical samples used in bench testing and simulated-use. Specific sample sizes for these tests are not provided in the document, but the tests performed are listed. Data provenance (country, retrospective/prospective) is not relevant for this type of physical device testing.

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

• Not applicable. There is no "ground truth" in the AI/diagnostic sense. Simulated-use testing involved "users representative of the use specification," implying qualified healthcare professionals, but the number and specific qualifications are not detailed beyond "qualified healthcare professional" for product application.

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

• Not applicable. No expert adjudication process similar to AI model evaluation is described.

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. No MRMC study was performed.

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 consensus, pathology, outcomes data, etc.):

• Not applicable. No "ground truth" as understood in AI/diagnostic validation. The "ground truth" for this device's performance is adherence to engineering specifications, physical properties, and biological safety standards as determined by laboratory and simulated-use testing.

8. The sample size for the training set:

• Not applicable. This device does not have a "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 or machine learning model involved.

Summary of Conclusions from the Document:

The document concludes that the "minor differences in technology do not raise any new questions of safety" and that the "performance data established by the predicate, including biocompatibility, shelf-life testing and bench testing demonstrate substantial equivalence to the predicate." It explicitly states, "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence," indicating that the non-clinical tests performed were deemed sufficient for this 510(k) submission.

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PICO Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

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

When used on closed surgical incisions, PICO Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

• Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
• Post-operative seroma
• Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore. Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 7 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

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

When used on closed surgical incisions, PICO 7 Single Use Negative Wound Therapy System is intended to aid in reducing the incidence of:

• Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
• Post-operative seroma
• Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 7Y Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

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

When used on closed surgical incisions, PICO 7Y Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

• Superficial incisional surgical site infections for high risk patients in Class I wounds
• Post-operative seroma
• Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class II (Clean/ Contaminated), Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 14 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

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

When used on closed surgical incisions for up to 7 days, PICO 14 Single Use Negative Pressure Wound Therapy is intended to aid in reducing the incidence of:

• Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
• Post-operative seroma
• Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

The PICO Family of devices, PICO (cleared under K163387), PICO 7 (cleared under K180698), PICO 7Y (cleared under K182323), PICO 14 (cleared under K191760) all have the same main function of management of fluid through dressing absorbency and evaporation with added benefit of negative pressure. The pump provides a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. The PICO Single Use Negative Therapy Systems consist of:

• PICO Pump
• Dressing (s)
• Fixation strips
• Batteries
• Connection tubing
• Instructions for Use

The system is a canister-less system - fluid is managed by the dressing. The pump that delivers the NPWT is a portable, battery-powered, software-controlled system that can provide continuous application of negative pressure to the wound as a delivery pressure at a nominal value of -80mmHg. The PICO Systems are designed to be used at home or within a healthcare setting by an appropriate healthcare professional.

The PICO family of devices (PICO, PICO 7, PICO 7Y, and PICO 14) are Negative Pressure Wound Therapy Systems intended for use in wound treatment.

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

The provided document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it demonstrates the device's effectiveness through a systematic literature review and meta-analyses, aiming to show a "statistically significant reduction" in the incidence of certain wound complications compared to standard care. The reported device performance is presented as Odds Ratios (OR) with 95% Confidence Intervals (CI). A favorable effect is suggested by an OR less than 1.

Here's a summary of the meta-analysis results as reported:

| Outcome | Device Performance (Odds Ratio [95% CI]) | Interpretation (Favorable Effect if OR

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The Negative Pressure Surgical Incision Management System (npSIMS)™ is indicated for patients who may benefit from wound management via application of negative pressure, as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The npSIMS is indicated for removal of small amounts of exudate from closed surgical incisions.

The npSIMS Negative Pressure Surgical Incision Management System™ by Aatru Medical, LLC is a single-use medical device consisting of a non-sterile vacuum chamber and sterile dressing and tubing kit. The npSIMS is intended for use with closed incisions with low exudate up to 10ml, or over a period of up to 7 days. The disposable vacuum chamber initially generates a peak negative pressure of -100±5mmHg at the wound surface, and maintains a continuous, linear rate of pressure decline to -60mmHg over 7 days (nominally, 80mmHg ± 20mmHg). Wound exudate is managed by the absorptive dressing technology. The tubing can be cut to length based upon patient needs. Making use of a fully pre-assembled wound contact dressing, the npSIMS operates silently without the use of an external electromechanical pump nor collection canister, enabling discrete patient portability. The duration of treatment is dependent upon the recommendation of the treating physician. After use, all components of the npSIMS are disposed of as clinical waste in accordance with local protocols and regulations.

The provided text is a 510(k) summary for the npSIMS Negative Pressure Surgical Incision Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device through technological characteristic comparisons and non-clinical performance testing against recognized consensus standards.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete "acceptance criteria" table with corresponding "reported device performance" values for a clinical study comparing an AI device against a specific benchmark. Instead, it refers to non-clinical tests that ensure the device meets product performance specifications and complies with FDA Recognized Consensus Standards.

Important Note: The provided text is for a non-powered medical device (npSIMS Negative Pressure Surgical Incision Management System), not an AI or software as a medical device (SaMD). Therefore, many of the subsequent questions related to AI device evaluation (sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies) are not applicable to this document. The study described is primarily a set of non-clinical functional and safety performance tests.

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

• Not applicable. The document describes non-clinical in vitro performance tests and compliance with recognized standards, not a clinical study with human subjects or a test set of data in the context of AI.

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. Ground truth in the context of expert consensus is relevant for diagnostic AI/imaging devices. This document describes the performance of a physical medical device. The "ground truth" here would be the physical and chemical properties of the device and its operational parameters, assessed against engineering specifications and regulatory standards.

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

• Not applicable. Adjudication methods like 2+1 are used for resolving discrepancies among human readers in interpreting data for ground truth establishment, which is not described for this device's evaluation.

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 or software assistance tool for human readers. It's a wound care system.

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

• Not applicable. This is a physical non-powered medical device, not an algorithm.

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

• For the non-clinical performance tests, the "ground truth" is defined by engineering specifications, established physical and chemical principles, and the requirements of the referenced FDA Recognized Consensus Standards (e.g., ISO, ASTM standards). For biocompatibility, this involves laboratory tests with established protocols. For negative pressure delivery, it's about meeting specified pressure ranges.

8. The sample size for the training set

• Not applicable. This document describes the evaluation of a physical medical device, not an AI model that requires a training set.

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

• Not applicable. As described above, there is no AI training set for this device.

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PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System. PICO 14 Single Use Negative Pressure Wound Therapy System. and the PICO Fluid Management Pack are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.

Appropriate wound types include:

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

PICO 7, PICO 7 Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use in both a hospital and homecare setting.

All of the PICO devices (PICO 7 (K180698), PICO 7Y (K182323), and PICO 14 (K191760) are canister-free single-use Negative Pressure Wound Therapy (NPWT) Systems and use an absorbent dressing connected to a small NPWT pump by a tubing and port. The dressing manages wound exudate by a combination of absorption and evaporation. The pump provides for a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. PICO Fluid Management Pack are packs of 5 individually packaged PICO Dressings designed for use with PICO devices.

The provided text is a 510(k) premarket notification for a medical device, specifically the PICO Single Use Negative Pressure Wound Therapy System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study on its performance in treating wounds.

Therefore, the information typically found in a clinical study report proving device performance against acceptance criteria (such as sample size, expert adjudication, MRMC studies, ground truth establishment for training, etc.) is not present in this type of regulatory submission. The document explicitly states:

"Performance data provided in previously cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack) continue to support substantial equivalence."

Instead of a new clinical performance study, the document focuses on:

• Comparison of Technological Characteristics: Demonstrating that the subject device's features, indications for use, environment of use, patient population, materials, sterilization methods, biocompatibility, pump type, and electrical safety testing methods are the same as the predicate device.
• Minor Changes and Supporting Data: Addressing specific minor changes in the device (updated magnet warning text, removal of pump warning label) and providing additional data to support these changes. This additional data includes:
  • Bench testing: For magnetic field strength.
  • Analysis of postmarket surveillance: Including a systematic literature review on IMDs and magnetic interference, and a review of MAUDE database and company complaint data.
  • Risk analysis: Updating the risk assessment based on the above.

Based on the provided text, here's what can be extracted and what information is not available:

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

The document does not present a table of acceptance criteria in the traditional sense of a clinical trial (e.g., Sensitivity X%, Specificity Y%). Instead, the "acceptance" for this 510(k) is based on demonstrating substantial equivalence to the predicate device for various technical and clinical characteristics. The "performance" is primarily demonstrated by showing that the characteristics are identical or that any changes do not raise new questions of safety or effectiveness.

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

• Test Set (for the current K202157 submission):
  • Magnetic Field Testing: This was bench testing, not involving human subjects. The sample size for devices tested is not specified, but it implies a measurement on the PICO Family pumps.
  • Post Market and Risk Analysis: Reviewed over 60,000 records from the MAUDE database (USA, retrospective) and Smith +Nephew PICO devices complaint data (provenance not specified, but likely global, retrospective).
• Provenance: MAUDE data is from the United States. The literature review is not geographically specified but typically covers international publications. Smith +Nephew complaint data is likely global. All are retrospective analyses.
• The document states that clinical performance data was provided in previously cleared 510(k)s. This suggests the initial clinical data was obtained for those initial clearances, not for this specific submission which focuses on minor labelling changes and supporting evidence for those changes through non-clinical data.

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 to this 510(k) submission. This is not a study assessing diagnostic or clinical performance against expert ground truth. The "ground truth" for the current changes is based on:
  • Bench testing results (magnetic field strength)
  • Regulatory requirements (for labeling updates)
  • Analysis of real-world adverse event data (MAUDE database, company complaints) and scientific literature review. This analysis would have been performed by internal regulatory/safety/scientific experts, but the specifics of their number or qualifications are not provided as it's not a reader study.

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

• Not applicable. This document describes a substantial equivalence claim for a physical medical device, not an AI/imaging algorithm requiring adjudication of interpretations. The analysis of post-market data and literature would involve methods of synthesizing evidence and risk assessment, but not "adjudication" in the context of clinical interpretation.

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 Negative Pressure Wound Therapy System, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its clearance.

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 software or an algorithm with standalone performance metrics.

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

• For the magnetic field testing, the "ground truth" is measured physical properties based on calibrated equipment.
• For the post-market surveillance and risk analysis, the "ground truth" is derived from:
  • Reported adverse events/complaints (MAUDE database, company data). These are real-world reported events, which serve as evidence of actual outcomes (or lack thereof).
  • Published scientific literature on magnetic interference with implantable medical devices. This represents the established scientific understanding and reported cases in medical literature.

8. The sample size for the training set

• Not applicable. This device does not use machine learning where a "training set" would be relevant.

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

• Not applicable.

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