(30 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.
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 both in a hospital and homecare setting.
PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use. PICO was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.
This submission K172521 is for a PICO Single Use Negative Pressure Wound Therapy System. The submission states that "The only difference between the subject device and the predicate device is the compliance against the requirements of IEC60601." This means that the device itself has not changed, only the testing and certifications for electrical safety and electromagnetic compatibility to updated standards. Therefore, there are no "acceptance criteria" or "reported device performance" in the typical sense of a clinical or analytical study, as the device's functional performance and efficacy are assumed to be the same as the predicate device.
Instead, the "acceptance criteria" for this submission are related to compliance with updated electrical and usability standards, and the "study" proving it meets these is the retesting and certification by a new testing house.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Certification) |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 and . A2:2010/(R)2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance) | Tested and certified by Intertek Testing Service NA, Inc (USA) |
| . IEC60601-1-2 Edition 4 (2014) (Medical Electrical Equipment - Electromagnetic Disturbances - Requirements and Tests) | Tested and certified by Intertek Testing Service NA, Inc (USA) |
| IEC 60601-1-6 Edition 3.1 2013-10 (Medical Electrical Equipment - Usability) | Tested and certified by Intertek Testing Service NA, Inc (USA) |
| IEC 60601-1-11 Edition 2.0 2015-01 (Medical Electrical Equipment - Home Healthcare Environment) | Tested and certified by Intertek Testing Service NA, Inc (USA) |
2. Sample size used for the test set and the data provenance
This information is not applicable as this is not a study involving patient data or a test set in the clinical/performance sense. The "test set" here refers to the device itself being subjected to engineering tests for compliance with electrical and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth, in the context of clinical or diagnostic studies, is not relevant here. The "ground truth" for compliance with electrical standards is the standard itself, and the experts are the personnel at the testing and certification body (Intertek Testing Service NA, Inc (USA)) who conducted and verified the tests. Their qualifications would be in electrical engineering, biomedical engineering, and regulatory compliance, but specific numbers and detailed qualifications are not provided in this document.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or image interpretation. Here, the "adjudication" is the formal process of testing and certifying by a recognized body (Intertek) against defined standards.
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
This information is not applicable. An MRMC study is relevant for AI-powered diagnostic devices. This device is a negative pressure wound therapy system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained above, "ground truth" in the typical clinical context is not applicable. The "ground truth" for this submission is compliance with the specified electrical safety, EMC, usability, and home healthcare environment standards (AAMI / ANSI ES60601-1, IEC60601-1-2, IEC 60601-1-6, IEC 60601-1-11).
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.