(25 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.
Here's an analysis of the provided text regarding the PICO Single Use Negative Pressure Wound Therapy System, focusing on acceptance criteria and supporting studies.
Based on the provided K172519 FDA 510(k) summary, the device PICO Single Use Negative Pressure Wound Therapy System is stated to be substantially equivalent to a previously cleared predicate device (K163387). The core of this submission is not about proving new clinical effectiveness or performance claims for a novel device, but demonstrating continued compliance with updated safety and performance standards for an existing design.
Therefore, many of the requested points related to clinical studies (sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this specific submission. The submission focuses on engineering and regulatory compliance testing, rather than clinical performance evaluation.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Compliance Status) |
|---|---|
| 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) | Demonstrated compliance |
| IEC60601-1-2 Edition 4 (2014) (Electromagnetic compatibility - Requirements and tests) | Demonstrated compliance |
| IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability. | Demonstrated compliance |
| IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment. | Demonstrated compliance |
Explanation: The "acceptance criteria" in this context are the updated versions of international safety and performance standards for medical electrical equipment. The "reported device performance" is the assertion by the manufacturer, accepted by the FDA for substantial equivalence, that the device meets these updated standards. No specific numerical performance metrics (e.g., suction pressure, battery life, etc.) are explicitly detailed as "acceptance criteria" distinct from the standards themselves in this document, as the core device design is unchanged from the predicate.
Regarding Clinical Performance Studies:
The document states, "The subject device and the predicate device are the same. The only difference between the subject device and the predicate device is the compliance against the requirements of IEC60601." This means the submission does not include new clinical performance studies to establish efficacy or clinical acceptance criteria beyond what was demonstrated for the predicate device. The focus is on updated safety and usability standards. Therefore, the following points are largely not applicable (N/A) in the context of this specific 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission focuses on engineering and regulatory compliance testing rather than clinical performance testing with human subjects. The device itself was retested against updated standards, not a clinical "test set" of patients or 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)
- N/A. No clinical "ground truth" was established as part of this submission, as it's not a clinical performance study. The "ground truth" here is the adherence to technical standards, validated by testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical "test set" requiring adjudication methods was used.
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
- N/A. This is not an AI-enabled device and no MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device does not involve an algorithm or AI that would require standalone performance evaluation in that sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A (for clinical ground truth). The "ground truth" for this submission refers to the specifications and requirements defined by the international medical device standards (e.g., IEC60601 series). Testing houses (CSA Group and Intertek Testing Service NA, Inc) performed evaluations to confirm the device met these technical requirements.
8. The sample size for the training set
- N/A. No training set was used as this is not an AI/ML device or a clinical study requiring data training.
9. How the ground truth for the training set was established
- N/A. No training set and thus no ground truth for a training set was established for this submission.
§ 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.