(241 days)
The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SVED, PRO Family and PRO HC devices, which are indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT system is intended for use in acute, extended and home care settings, however wound irrigation is not intended for use in a home care setting.
The Cardinal Health NPWT Irrigation Tubing Set consists of single-lumen PVC tubing, a pinch clamp, an adhesive SpeedConnect flange and a universal luer lock connector wherein the caregiver can attach the universal connector to an irrigation source obtained by the caregiver. The Cardinal Health NPWT Irrigation Delivery Set consists of single-lumen PVC tubing with an integrated irrigation solution bag (to be filled by the caregiver), tubing roller clamp and an adhesive SpeedConnect flange to provide a convenient way for caregivers to utilize the proprietary simultaneous irrigation feature with the various Cardinal Health NPWT devices. The tubing sets are supplied sterile and will be available as new accessories to the PRO HC and PRO family devices.
The provided text is a 510(k) Summary for a medical device (Cardinal Health NPWT Irrigation Tubing Set and Delivery Set). It describes the device, its intended use, and indicates that non-clinical performance data was provided to support substantial equivalence.
However, the document does not contain the detailed study information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it states:
- **"The following non-clinical performance data were provided in support of the substantial equivalence determination:
- Pressure stability testing with irrigation using a worst-case dressing set spanning the range of pressure settings
- Irrigation bag printed scale accuracy test"**
This lists the types of tests performed, but does not provide:
- A table of acceptance criteria
- The reported device performance against those criteria
- Sample sizes used for the test set or data provenance
- Information about experts establishing ground truth or adjudication methods
- Details about MRMC comparative effectiveness studies
- Confirmation of standalone algorithms
- Type of ground truth used
- Training set size or ground truth establishment for training data
The document concludes that "The non-clinical tests demonstrate that the irrigation tubing sets are compatible with the Cardinal Health NPWT PRO HC and PRO family devices, function as intended and therefore are equivalent to the predicate devices for their intended use." This is a general conclusion, not a detailed report of the study results against specific criteria.
Therefore, based only on the provided text, I cannot complete the requested tables and information. The document focuses on demonstrating substantial equivalence through non-clinical testing, rather than providing a detailed clinical or performance study report with specific acceptance criteria and outcome metrics.
§ 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.