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510(k) Data Aggregation
(296 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. 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, twindiaphragm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump, 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 programmed 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 PICO Single Use Negative Pressure Wound Therapy System's acceptance criteria and studies focused on demonstrating biocompatibility and electrical/software safety rather than a comparative effectiveness study with human readers or standalone algorithm performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (ISO 10993 Series) | ||
| Cytotoxicity (Dressing) | ISO 10993-5 (Minimum Essential Medium elution assay) standards for non-cytotoxicity. | N to 1:16, all non-cytotoxic (Grade 0) |
| Cytotoxicity (Fixation Strips) | ISO 10993-5 (elution assay with L-929 mouse fibroblast cells) standards for non-cytotoxicity. | N to 1:16, all non-cytotoxic (Grade 0) |
| Sensitization (Dressing) | ISO 10993-10 (Guinea Pig Maximisation Test) standards for non-sensitizing. | Non-sensitizing |
| Sensitization (Fixation Strips) | ISO 10993-10 (Guinea pig maximisation test) standards for non-sensitizing. | Non-sensitizing |
| Irritation (Dressing) | ISO 10993-10 standards for negligible irritancy. | PII SC = 0.0 (Negligible irritant) |
| Irritation (Fixation Strips) | ISO 10993-10 standards for negligible irritancy (e.g., Primary Irritation Index below a certain threshold). | PII SC = 0.1; 0.9% NaCl extract: Primary Irritation Index: 0.11 (Negligible) |
| Ethylene Oxide Residuals (Dressing & Fixation Strips) | ISO 10993-7 requirements for allowable residual limits for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) for permanent and tolerable contact. | Permanent contact limits: Ethylene Oxide <0.1mg/day (Complies), Ethylene Chlorohydrin <0.4mg/day (Complies). Tolerable contact limits: Ethylene Oxide 10µg²/cm/day (Complies), Ethylene Chlorohydrin 5mg/cm²/day (Implied Complies, as it follows the EO compliance) |
| Electrical Safety | Compliance with IEC / UL 60601-1; General Requirements for Safety of Electrical Medical Equipment. | Test results conform to IEC / UL 60601-1. |
| Electromagnetic Safety | Compliance with IEC 60601-1-2; Electromagnetic Safety Requirements For Electrical Medical Equipment. | Test results conform to IEC 60601-1-2. |
| Software Validation | Compliance with IEC 62304 Software for Medical Devices. | Software validation completed in accordance with IEC 62304. |
| Substantial Equivalence | Device is substantially equivalent to predicate devices (NPD 1000, Renasys Go, PICO K111170) in design characteristics, functions, intended use, indications, and instructions for use, raising no new safety/effectiveness issues. | The subject device was found substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not detail a "test set" in the context of clinical performance or algorithm evaluation with human data. The tests described are primarily non-clinical bench and lab-based studies focused on biocompatibility and safety.
- Biocompatibility Tests: These involved laboratory samples of the PICO dressing and secondary fixation strips. The specific "sample sizes" (e.g., number of animals for sensitisation, number of cell cultures for cytotoxicity) are not explicitly stated in the summary, but the methods were conducted in accordance with ISO 10993 standards.
- Electrical, Electromagnetic, and Software Tests: These involve testing the physical device and its software, not human data.
Data Provenance: Not applicable in the context of human data. The biocompatibility tests are lab-based, not involving human subjects or real-world clinical data from specific countries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for these non-clinical tests is established by adhering to international recognized standards (e.g., ISO, IEC protocols) and achieving predefined outcomes (e.g., "non-sensitising," "Grade 0 Cytotoxicity," compliance with electrical safety limits). These are objective measurements rather than expert consensus on a subjective output.
4. Adjudication Method for the Test Set
Not applicable. As the tests are objective measurements against established standards (biocompatibility, electrical safety), an adjudication method for conflicting expert opinions is not relevant.
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 comparative effectiveness study was done as this device is a medical device (Negative Pressure Wound Therapy System), not an AI-driven diagnostic or interpretative tool designed to assist human readers. The regulatory submission focuses on the safety and efficacy of the physical device itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The PICO system is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is defined by:
- International Standards: Compliance with specific ISO (e.g., 10993 for biocompatibility) and IEC (e.g., 60601 for electrical safety, 62304 for software) standards.
- Objective Laboratory Measurements: Results from cytotoxicity assays, sensitization tests (e.g., Guinea Pig Maximisation Test), irritation tests, and residual analyses, all yielding quantitative or qualitative results that are evaluated against pre-defined acceptable limits within the standards.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" of data or associated ground truth.
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