(88 days)
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.
| Characteristic | Predicate Device (PICO 7) | Subject Devices (PICO 7, 7Y, 14, Fluid Management Pack) | Comparison/ "Performance" |
|---|---|---|---|
| Indications For Use | Indicated for patients who would benefit from a suction device (NPWT) 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 (diabetic or pressure), Flaps and grafts, Closed surgical incisions. Suitable for use both in a hospital and homecare setting. | Same as predicate, extended to PICO 7 (K180698), PICO 7Y (K182323), PICO 14 (K191760) and PICO Fluid Management Pack. | Same |
| Environment of use | Hospital, home | Hospital, home | Same |
| Patient Population | Patients who would benefit from a suction device (negative pressure wound therapy) | Patients who would benefit from a suction device (negative pressure wound therapy) | Same |
| Materials | PU Plastic pump casing | PU Plastic pump casing | Same |
| Single-use or Reusable | Single use | Single use | Same |
| Method of Sterilization | Pump, dressing, and fixation strips sterilized by ethylene oxide | Pump, dressing, and fixation strips sterilized by ethylene oxide | Same |
| Biocompatibility | Dressing complies with ISO 10993 | Dressing complies with ISO 10993 | Same |
| Type of Pump | Custom designed "voice-coil" pump controlled by microprocessor | Custom designed "voice-coil" pump controlled by microprocessor | Same |
| Electrical Safety Testing | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Same |
| Instructions for Use | Old text for magnet warning, no MRI warning. | Updated/added text for magnet warning and MRI warnings ("MR Unsafe. You must remove the PICO 7 pump from the dressing before entering the MRI suite. Do not bring PICO 7 into the MRI scan room. The device presents a projectile hazard."). Text amended in "Important Information Section" and "Glossary of Symbols" regarding magnet proximity warnings, specifically removing language about "death" and adding "As with all electrical medical equipment, failure to maintain appropriate distance may disrupt the operation of nearby medical devices." | Changed (supported by additional testing) |
| Warning Label on front of Pump | Present | No warning label on the front of the pump. | Removed (supported by analysis) |
| Magnetic Field Strength | (Implied to be similar or stronger than current) | Bench testing demonstrated that the average magnetic field strength of PICO Family pump is weaker than multiple everyday devices (e.g. laptops, phones, tablets, and headphones). | Assessed (Supported changes) |
| Post Market and Risk Analysis | N/A | Systematic literature review of IMDs and magnetic interference conducted, confirming risk not as high as originally assessed. Comprehensive review of over 60,000 records from MAUDE database and company complaint data confirmed literature review outcome (no reported deaths/serious harms related to magnetic interference from PICO devices). | Assessed (Supported changes) |
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.
§ 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.