(233 days)
PICO 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.
Product Codes: 66800862, 66800863,66800865 and 66800866 are indicated for use on low and moderately exuding wounds.
Examples of appropriate wound types include:
- Chronic .
- Acute .
- Traumatic .
- Subacute and dehisced wounds
- Partial-thickness burns .
- Ulcers (such as diabetic or pressure) ●
- Flaps and grafts .
- Closed surqical incisions .
PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.
PICO 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 levels of exudate and infectious materials.
Product Codes: 66800864, 66800867,66800868 and 66800869 are indicated for use on low exuding wounds,
Examples of 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 Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.
PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of a electric motor driven, twindiaphraqm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump is supplied non-sterile and single use, the dressing and secondary fixations strips are supplied sterile and single use. The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place. When the suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing. The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (7 days) of battery life depending upon leak rate. The batteries can be replaced if required. The pump is designed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with new batteries. Negative pressure will not be applied at this point. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. A carry bag is not provided with the system however will be available to order separately.
The provided document describes the PICO Single Use Negative Pressure Wound Therapy System and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in terms of performance metrics. The document focuses on demonstrating safety and general functionality through non-clinical testing.
Here's an analysis of the provided information based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Cytotoxicity: All non-cytotoxic (Grade 0) for PICO Dressing and Secondary Fixation Strips (tested per ISO 10993-5). |
| Sensitization: Non-sensitizing for PICO Dressing and Secondary Fixation Strips (tested per ISO 10993-10). | |
| Irritation: PII SC = 0.0 and PII SC = 0.1 (Negligible irritant) for PICO Dressing; Primary Irritation Index: 0.11 (Negligible) for Secondary Fixation Strips (tested per ISO 10993-10). | |
| Electrical Safety | Testing completed in accordance with IEC / UL 60601-1 (General Requirements for Safety of Electrical Medical Equipment) and IEC 60601-1-2 (Electromagnetic Safety Requirements). |
| Software Validation | Completed in accordance with IEC 62304 (Software for Medical Devices). |
| Battery Life | Up to 168 hours (7 days) depending upon leak rate. |
| Operational Lifetime | Pump designed to stop working after 168 hours (7 days) of use and not re-start. |
| Wound Contact Layer Effects | Assessed during a wound healing study on ALLEVYN Gentle Border dressings (which have the same wound contact layer as PICO). (Specific results are not provided in this summary, only that it was assessed). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance or a machine learning model. The testing described (biocompatibility, electrical safety, software validation) generally involves material samples, device prototypes, and software code, not a patient-based test set or an imaging dataset. Therefore, information about sample size and data provenance (country, retrospective/prospective) related to a clinical or AI-based test set is not applicable to this 510(k) summary as presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical testing for safety and electrical/software compliance, not a study involving human interpretation of data where ground truth would be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as points 2 and 3.
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
An MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. The PICO device is a physical, mechanical negative pressure wound therapy system, not an AI-assisted diagnostic or interpretative tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI system.
7. The Type of Ground Truth Used
For the biocompatibility tests:
- Cytotoxicity, Sensitization, Irritation: The "ground truth" is established by the standardized methods of ISO 10993-5 and ISO 10993-10, which provide criteria for classifying materials as cytotoxic, sensitizing, or irritating. The results (e.g., "Grade 0," "Non-sensitizing," "Negligible irritant") are determined by adherence to these established biological assessment protocols.
For the electrical safety and software validation:
- Electrical Safety: Compliance is judged against the requirements specified in IEC / UL 60601-1 and IEC 60601-1-2. The "ground truth" is conformance to these international and national standards.
- Software Validation: Compliance is judged against IEC 62304. The "ground truth" is conformance to this software standard.
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as this is not an AI/machine learning device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.