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The Versatile 1 EZCare™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

The product is a portable suction pump that may promote wound healing when used with accessory wound sealing kits.

This 510(k) summary describes a device that is a Versatile 1 EZCare™ Wound Vacuum System, a portable suction pump intended to promote wound healing. The submission focuses on demonstrating substantial equivalence to a predicate device (Versatile 1™ Wound Vacuum System, K042134 and K052456) rather than clinical performance against specific acceptance criteria for a new clinical claim. Therefore, the provided document does not contain the requested detailed information about acceptance criteria and a study proving the device meets those criteria in a clinical context.

Here's what can be extracted based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative acceptance criteria for clinical performance that would typically be seen in a study proving a device meets a specific efficacy threshold. Instead, it relies on demonstrating substantial equivalence to a predicate device.

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

The document does not mention a "test set" in the context of clinical performance data. The "performance testing" referred to is likely engineering and bench testing to demonstrate the device functions as intended and is comparable to the predicate. There is no information on sample size or data provenance (country of origin, retrospective/prospective) for clinical data.

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

Not applicable. The document does not describe a clinical study requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, the document does not mention an MRMC study or any study comparing human readers with and without AI assistance. This device is a wound vacuum system, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical device (a wound vacuum system), not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not applicable, as no clinical study with ground truth establishment is described. The "ground truth" for this type of submission is typically based on the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe a training set for an algorithm or AI model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of what the document does communicate regarding evidence for the device:

The document is a 510(k) Summary for a Class II medical device (Powered Suction Pump). The primary method of demonstrating approval is through substantial equivalence to a legally marketed predicate device (Versatile 1™ Wound Vacuum System).

• Evidence for Equivalence: BlueSky Medical states they "evaluated the indications for use, materials, technology, product specifications, and energy requirements of the system."
• Performance Testing: "Performance testing has been completed to demonstrate the safe and effective use of the Versatile 1 EZCare™ Wound Vacuum System for the intended use." This likely refers to bench testing, engineering verification, and validation to ensure the device meets its design specifications and operates safely and effectively, consistent with the predicate device.
• Conclusion: "Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use."

The provided information is typical for a 510(k) submission where the device is not novel in its mechanism or intended use, but rather a modification or new version of an existing cleared device. It relies on a comparison to a predicate device rather than de novo clinical trial data establishing new efficacy claims against specific, quantitative acceptance criteria.

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The BlueSky VISTA™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

The product is a portable suction pump that may promote wound healing when used with accessory wound sealing kits.

The provided text K061367 is a 510(k) summary for the BlueSky VISTA™ Wound Vacuum System, which is a portable suction pump. This document describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the 510(k) summary does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device. The product described is a physical medical device (a wound vacuum system), not an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies. These concepts are not applicable to the type of medical device described in the provided text.

The 510(k) states: "Performance testing has been completed to demonstrate the safe and effective use of the BlueSky VISTA™ Wound Vacuum System for the intended use." and "Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use."

This indicates that some performance testing was done, but the details of that testing, including specific acceptance criteria and detailed results, are not included in this summary document. For a traditional medical device, this performance testing typically involves engineering bench testing, biocompatibility, electrical safety, and sometimes limited clinical testing, but not the AI-specific metrics you've requested.

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The Versatile 1 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patients airway or respiratory support system either during surgery or at the patients bedside.

The product is a portable suction pump for general purpose drainage or for the promotion of wound healing when used with various accessory wound sealing kits.

This 510(k) submission (K052456) is a Special 510(k) for a modification to an already cleared device, the Versatile 1™ Wound Vacuum System (predicate K042134).

Therefore, the submission does not present a new clinical study to prove the device meets acceptance criteria. Instead, it relies on the principle of substantial equivalence to its predicate device. This means the manufacturer is asserting that the modifications made do not significantly affect the safety or efficacy of the device, and thus, the device still meets the criteria previously established for the predicate device.

Here's an analysis based on the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the Special 510(k) submission for K052456. Since it's a modification, the acceptance criteria would have been established and met during the clearance of the original predicate device (K042134). The current submission states that "The proposed modifications in materials and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device." This implicitly means the modified device is expected to perform at the same level as the predicate in meeting its original acceptance criteria.

• Sample size used for the test set and the data provenance: Not applicable. No new clinical or performance studies using a test set are presented in this Special 510(k). The modifications were related to "materials and labeling."

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth establishment was used.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

• 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. The device is a wound vacuum system, not an AI-assisted diagnostic tool.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a wound vacuum system, not a standalone algorithm.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for K052456. The original predicate device's clearance would have relied on appropriate testing (e.g., bench testing, biocompatibility, electrical safety) to demonstrate its performance relative to its intended use.

• The sample size for the training set: Not applicable. This is not an AI/machine learning device.

• How the ground truth for the training set was established: Not applicable.

Summary:

This 510(k) is a Special 510(k), which is used for modifications to a manufacturer's own legally marketed device. The core of such a submission is to demonstrate that the modifications do not significantly affect the safety or effectiveness of the device. Therefore, it does not typically involve new extensive clinical studies or the establishment of new acceptance criteria. The claim is that the device, with the modifications, still meets the safety and effectiveness profile established during the clearance of its predicate device (K042134). The specific acceptance criteria and the studies that originally proved the predicate device met them would be found in the documentation for K042134.

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The Versatile 1 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from a patients airway or respiratory support system either during surgery or at the patients bedside.

The BlueSky Versatile 1 WVS is a portable suction device that can be powered by an internal battery pack, wall current or 12 Volt input via optional cigarette lighter adaptor. The pump can be used for removal of surgical fluids, tissue, gases, bodily fluids or infected materials during surgery or from a patients airway or respiratory support system. The pump can also be used to create localized topical negative pressure when used with the Chariker-Jeter® accessory kits to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister.

The BlueSky versatile 1 Wound Vacuum System (V1 WVS) consists of a medium sized housing that contains a vacuum pump and control system with a location for a fluid canister system. Accessories include are a vehicle power adaptor and a Mobil Stand. A variety of disposables are available from a number of medical device manufacturers depending on the pump application. For the expanded indication of use for wound healing the Chariker -Jeter® accessory kits would be available from BlueSky Medical. This kit consists of individually reviewed medical components that have added instructions for use.

The Versatile 1 Wound Vacuum system is an ideal pump for military use and triage use. By combining a unit that can be used for wound resolution as well as tracheal use or for use in the operating theatre a minimum of products can be used for maximum versatility. The BlueSky V1 WVS is 15 inches by 11.2 inches by 6.7 inches and weighs 11.2 pounds. The battery will last for 30-45 minutes when not plugged in. the Pump can additionally be powered by a 12 volt source such as a cigarette lighter adaptor.

Switching the power switch to either continuous or intermittent suction turns on the pump. Pressing inwards on the suction control knob and then turning the knob in the desired direction adjust the level of suction. The knob will lock when it is not pressed to avoid accidental changes. The operator will view the suction gauge and when proper suction is reached the knob can be released.

Canisters
The pump includes a 250ml reusable polysulfone canister that can be autoclaved. The canister includes a mechanical overflow float to prevent backups into the pump itself. The canister can be autoclaved in a standard hospital autoclave for 134 degrees Celsius for 10 minutes. The pump also includes a 800ml liter disposable canister that has a mechanical overflow float. This canister is non-sterile and is designed by be discarded when full or partially full.

Single Use Disposables
Marketed as part of the VI Wound Vacuum System is a disposable kit. This kit is named after the pioneers in the field Katherine Jeter and Dr. Mark Chariker who popularized this technique of wound drainage, which caused wounds to heal more rapidly. "From the days of drainage through ostomy pouches to the current use of suction systems there has evolved a closed suction system incorporating moist wound management principals with the benefits of an inert silicone drain to maximize wound healing" "

The Chariker-Jeter wound vacuum system accessory kit. These kits consist of products from existing manufacturers that have met the regulatory requirements of the FDA. They include an additional set of instructions for use. The Kits include:

1. Silicone or Wound drain
2. Connecting tubing
3. Impregnated gauze
4. Gauze fill Material
5. Polyurethane Cover dressing

Here's a breakdown of the acceptance criteria and study information based on the provided documents. Please note that this document is a 510(k) summary for a medical device (a wound vacuum system) and primarily establishes substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and results as one might expect for a novel high-risk device or AI model.

The document focuses on demonstrating that the "Versatile 1 Wound Vacuum System" is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" here are generally related to the device's functional specifications being comparable to the predicate devices and its ability to meet its stated indications for use. There isn't a "study that proves the device meets acceptance criteria" in the sense of a clinical trial with specific performance metrics and statistical analysis in this document, but rather a description of the device's design and intended use aligning with existing, approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Powered suction pump functionality
• Ability to create localized topical negative pressure | Versatile 1 Wound Vacuum System (V1 WVS) Description:
• Portable suction device
• Powered by internal battery, wall current, or 12V adaptor
• Used for removal of surgical fluids, tissue, gases, bodily fluids, or infected materials.
• Can also be used to create localized topical negative pressure when used with Chariker-Jeter® accessory kits to promote wound healing and drainage of fluids/infected materials.
• Pump includes a control system, suction gauge, and mechanisms to adjust suction level which locks to avoid accidental changes. |
  | Dimensions & Weight Comparable to Predicate Devices | V1 WVS Dimensions & Weight:
• 15 inches by 11.2 inches by 6.7 inches
• Weighs 11.2 pounds |
  | Battery Life & Power Options | V1 WVS Battery Life & Power Options:
• Battery lasts 30-45 minutes when not plugged in.
• Can be powered by a 12-volt source (e.g., cigarette lighter adaptor). |
  | Canister System & Sterilization | V1 WVS Canister System:
• Includes a 250ml reusable polysulfone canister that can be autoclaved (134 degrees Celsius for 10 minutes).
• Includes an 800ml disposable canister that is non-sterile and designed to be discarded.
• Both canisters have mechanical overflow floats to prevent backups into the pump. |
  | Compatibility with Accessories/Disposables | V1 WVS Accessories:
• Vehicle power adaptor and Mobil Stand.
• For wound healing, uses Chariker-Jeter® accessory kits, consisting of: Silicone or Wound drain, Connecting tubing, Impregnated gauze, Gauze fill Material, Polyurethane Cover dressing. These kits are composed of existing, regulatory-compliant medical components. |
  | Intended Indications for Use | V1 WVS Indications for Use:
• For patients who would benefit from a suction device, particularly as the device may promote wound healing.
• For aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside. |
  | Contraindications and Precautions | V1 WVS Contraindications for Wound Healing Application:
• Presence of Necrotic tissue
• Untreated Osteomyelitis
• Malignancy (except terminal patients for quality of life issues)
• Untreated malnutrition
• Use on exposed arteries, veins, or organs
  V1 WVS Precautions:
• Patients on anticoagulations or difficult hemostasis
• Non-Compliant patients
• Health care provider must evaluate patient to ensure appropriate use. |

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

This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a new clinical study with a "test set" in the typical sense of a de novo approval or a performance study for an AI/CAD system.

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary as no specific test set data is presented for a new device performance study. The equivalence is based on comparing the design and function of the new device to existing predicate devices.
• Data Provenance: Not applicable for a traditional test set. The 'data' effectively consists of the specifications and performance characteristics of the predicate devices (V.A.C.® Plus and Medela Vario) and the design description of the Versatile 1 Wound Vacuum System.

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

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/CAD system requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No "test set" in the context of human interpretation requiring adjudication is mentioned.

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 a submission for a physical medical device, not an AI or CAD system.

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

Not applicable. This is a submission for a physical medical device, not an AI or CAD system.

7. The Type of Ground Truth Used

The "ground truth" for the Versatile 1 Wound Vacuum System's approval is the established safety and effectiveness of its predicate devices:

• V.A.C.® Plus (510(k) No. 945062)
• Medela Vario (510(k) No. 983552)

The new device is deemed acceptable because its technological characteristics, intended use, and performance are substantially equivalent to these already legally marketed and safe/effective devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" of data points would be used to develop an algorithm.

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

Not applicable. As above, this document describes a physical medical device, not an AI/ML system, so there is no training set or ground truth derived in that manner. The "ground truth" for the predicate devices would have been established through their original regulatory reviews and market experience.

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