(142 days)
The KCI NPWT Gauze Dressing is intended to be used with the following KCI Therapy Units (ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™, V.A.C. ® Freedom, V.A.C. ATS® and V.A.C.Ulta™ Therapy Systems). The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Wound types include chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The KCI NPWT Gauze Dressing is not intended for use with instillation therapy, intermittent therapy or over closed incisions.
The KCI NPWT Gauze Dressing is a convenience kit that consists of the following currently marketed products:
• One Kerlix AMD Roll, identical to predicate (antimicrobial gauze wound dressing)
• One V.A.C. SensaT.R.A.C.™ Pad (connection to KCI NPWT source)
• Two V.A.C. Drapes
• One wound measuring ruler
The currently marketed sterile products are kitted in a non-sterile package. The kit is provided in one size and is intended to be single use.
The KCI NPWT Gauze Dressing is a convenience kit for Negative Pressure Wound Therapy (NPWT). The 510(k) summary (K123507) outlines non-clinical tests to demonstrate substantial equivalence to a predicate device, Smith and Nephew's RENASYS™ Gauze NPWT Wound Dressing Kit with Softport (K110647).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the KCI NPWT Gauze Dressing were primarily focused on performance specifications related to negative pressure delivery and exudate removal. These were evaluated through non-clinical validation tests.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Delivers negative pressure within specification to the top of the wound site for a period of 72 hours. | The KCI NPWT Gauze Dressing, when used with KCI V.A.C. Negative Pressure Wound Therapy Units, delivers negative pressure within specification to the top of the wound site for a period of 72 hours. |
| Removes exudate from the wound for a period of 72 hours. | The KCI NPWT Gauze Dressing, when used with KCI V.A.C. Negative Pressure Wound Therapy Units, removes exudate from the wound for a period of 72 hours. |
| Does not contribute to false blockage alarms when used with KCI V.A.C. Negative Pressure Wound Therapy Units. | The KCI NPWT Gauze Dressing, when used with the V.A.C. Negative Pressure Wound Therapy Units, do not contribute to false blockage alarms. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The provided document does not specify the sample size for the non-clinical tests (design verification and validation). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These were laboratory-based performance tests, not human subject studies.
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" in this context refers to engineering and performance specifications for negative pressure delivery and exudate removal, rather than clinical diagnoses or interpretations that would require expert consensus. The non-clinical tests would have been designed and evaluated by engineers and testing personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to establish a ground truth. For these non-clinical performance tests, the outcome would be determined by objective measurements against predefined engineering specifications.
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. This is a medical device (wound dressing kit) and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a medical dressing kit and does not involve an "algorithm" in the sense of software for diagnosis or image analysis. The "standalone performance" refers to the dressing kit's ability to, for example, maintain negative pressure and remove exudate independently, which was indeed evaluated in the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these tests was based on engineering specifications and scientific principles related to negative pressure wound therapy. This would involve:
- Physical measurements: Quantifying negative pressure exerted, volume of exudate removed.
- Functional performance: Observing the absence of false blockage alarms.
- Comparison to predicate: Demonstrating that the performance is comparable to the legally marketed predicate device (RENASYS™ Gauze NPWT Wound Dressing Kit).
8. The sample size for the training set
Not applicable. This device is a physical medical dressing kit and does not require a "training set" in the context of machine learning. The components are pre-existing, legally marketed products that are kitted together. The evaluation focused on the performance of the combined kit.
9. How the ground truth for the training set was established
Not applicable. As the device does not employ machine learning or AI, there is no "training set" or corresponding ground truth establishment process in that regard.
§ 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.