(364 days)
XLR8 Abdominal Wound Dressing Kit is indicated for use in conjunction with Genadyne NPWT System's XLR8+ for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome. XLR8 Abdominal Wound dressing Foam is used for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. It is intended for use in acute hospital setting(trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
XLR8 Abdominal Wound dressing is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and transport exudates from the wound. Abdominal Foam is a fully reticulated hydrophobic polyurethane foam made with polyether resin.
XLR8 Abdominal Wound dressing Kit along with Genadyne XLR8+ Negative Pressure Wound therapy Pump and its accessories is a complete negative pressure system for managing open abdomens. This dressing kit is intended for use in acute hospital settings and should ideally be applied in the operating theatre.
The dressing kit consists of one Oval Green Abdominal Foam, one Organ Contact Layer, four transparent dressing, two XLR8 port pad. Each foam is individually packaged in a medical grade Tyvek pouch (1073B Tyvek and a polyester/polyethylene laminate with a 0.375″ side and chevron seals.)
XLR8 Abdominal Wound Dressing Foam is for prescription use only.
The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device to a legally marketed predicate device. This type of submission focuses on comparing the new device's features to an existing one, rather than presenting a clinical study proving its performance against specific acceptance criteria for a diagnostic AI.
Therefore, the document does not contain the information requested about acceptance criteria, a study proving device performance against those criteria, or details related to AI/MRMC studies, ground truth establishment, or training set specifics.
Specifically, the document includes:
- Device Name: XLR8 Abdominal Wound Dressing Kit
- Predicate Device: Avance Abdominal Dressing Kit (K161939)
- Regulation Number: 21 CFR 878.4780 (Powered suction pump)
- Device Description: It's a negative pressure wound therapy device, an abdominal dressing kit used with a negative pressure wound therapy pump. The foam material is fully reticulated hydrophobic polyurethane.
- Indications for Use: Temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required, for patients with open abdominal wounds with exposed viscera and organs, including abdominal compartment syndrome. Intended for use in acute hospital settings and ideally applied in the operating theatre.
- Technological Characteristics Comparison Table: This table compares various attributes of the XLR8 Abdominal Wound Dressing Kit to its predicate, such as company, device name, 510(k) number, single use/reusable, sterile, indications for use, foam material, kit components, kit component material, contraindications, packaging, and shelf life.
- Discussion of Non-Clinical and Clinical Testing: This section briefly mentions that biocompatibility tests were performed to support limited contact exposure and bench tests were conducted on performance (pressure precision, absorbance, alert, and dimension). It states that "The results were within the acceptable limit of the criteria that were set prior the experiment." However, it does not list these specific criteria or their measured values.
Missing Information (critical for addressing the prompt):
The document does not provide any of the following:
- A table of acceptance criteria and reported device performance linked to a specific study.
- Sample size used for a "test set" (as it's a non-AI device, there isn't a "test set" in the context of AI model evaluation). The testing mentioned is bench testing for physical properties, not a clinical trial to prove efficacy or safety against quantitative metrics in human patients with a specific sample size.
- Data provenance, expert numbers, qualifications, or adjudication methods. These are relevant for AI/diagnostic studies, not for this type of device's 510(k) submission.
- MRMC comparative effectiveness study details.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size or ground truth establishment for a "training set."
In conclusion, the provided FDA 510(k) document is for a physical medical device (wound dressing kit) and does not describe the kind of performance study, acceptance criteria, or AI model evaluation metrics relevant to the prompt. The "acceptance criteria" mentioned are for internal bench tests confirming physical properties, not clinical performance or diagnostic accuracy.
§ 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.