(30 days)
The V.A.C. Therapy 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
The V.A.C.® ATS Large (1000 mL) Canister With Gel is a sterile, single use canister that is inserted into the V.A.C.® ATS Therapy Unit to collect wound exudates. The V.A.C.® ATS 1000 mL Canister has volume graduations every 100 mL and contains two gel packs (isolyzers) for solidification of wound exudates. The 1000 mL canister is identical to the 500 mL canister cleared under K032310 except for volume capacity, the number of gel packs within the canister, and labeling.
This 510(k) summary describes a negative pressure wound therapy device, the V.A.C.® ATS Large (1000 mL) Canister With Gel. It is important to note that this document does not contain details about a clinical study or performance data based on acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (the 500 mL V.A.C.® ATS Canister With Gel, K032310).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets specific performance criteria. The information requested regarding sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are all absent from this summary.
The document primarily states that:
- The device is a sterile, single-use, 1000 mL canister for collecting wound exudates, containing two gel packs for solidification.
- It is "identical to the 500 mL canister cleared under K032310 except for volume capacity, the number of gel packs within the canister, and labeling."
- The intended use has not changed from the predicate device.
Key takeaway: This 510(k) submission relies on the concept of substantial equivalence to a predicate device rather than presenting new performance data from a specific study against acceptance criteria for this particular device. Therefore, it does not fit the framework of a study proving acceptance criteria.
§ 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.