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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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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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PICO 7Y 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. 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 Systems are suitable for use both in a hospital and homecare setting.

PICO 7Y Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a Yshaped tube known as the "Y-Connector" to two super-absorbent, gentle adhesive dressings. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressings and fixation strips are supplied sterile and for single use. PICO 7Y was designed to deliver negative pressure wound therapy to low and moderate exudate levels of acute and chronic wound types. PICO 7Y Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

The provided text describes the PICO 7Y Single Use Negative Pressure Wound Therapy System, focusing on performance testing and regulatory clearance. It is important to note that this device is a physical medical device (a powered suction pump) and not an AI device or software. Therefore, the typical acceptance criteria and study designs associated with AI/software devices (e.g., MRMC studies, expert consensus on image interpretation, training/test set ground truth establishment for algorithms) are not applicable here.

However, I can extract the acceptance criteria and study details relevant to this physical medical device based on the information provided in the K182323 submission.

Acceptance Criteria and Device Performance for PICO 7Y Single Use Negative Pressure Wound Therapy System

Given that this is a physical medical device (a Negative Pressure Wound Therapy system) and not an AI or software product, the acceptance criteria and study focus on mechanical and performance-based metrics, rather than diagnostic accuracy or human reader improvement with AI assistance.

1. Table of Acceptance Criteria and Reported Device Performance

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