(191 days)
The extriCARE® NPWT foam kit is intended to be used in conjunction with the extriCARE® 2400 NPWT pump. The extriCARE® 2400 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE Negative Pressure Wound Therapy System is indicated for the following wound types: chronic. acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The extriCARE® Negative Pressure Wound Therapy (NPWT) System consists of extriCARE® NPWT Pump, canister, connection tubing, and dressing kit. In operation, the dressing is attached to an extriCARE® Negative Pressure Wound Therapy pump via the tubing. The pump is used to provide the negative pressure to the system. Pressure and mode selections are digitally programmable.
The extriCARE NPWT foam dressing kit is a new accessory to the NPWT system. The foam dressing kit is designed to be an alternative solution to the bandage dressing kit in the original system. The foam dressing kit consists one of each of the following: polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp. The single-use foam dressing kit is packed in Paper/poly peel pouch bag, which is sterilized using ETO. The foam is used to pack the wound.
The extriCARE® NPWT foam dressing kit can be sold alone or as a part of the extriCARE 2400 system. The associated accessories include:
- . Large foam dressing kit
- . Medium foam dressing kit
- . Small foam dressing kit
The provided text describes a 510(k) premarket notification for the extriCARE 2400 NPWT System with extriCARE 2400 NPWT pump and extriCARE NPWT Foam Dressing Kit. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a diagnostic or AI device.
Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, MRMC studies, standalone performance) are not applicable to the information contained in this document, as it pertains to a medical device approval that is based on demonstrating equivalence rather than a clinical performance study with defined thresholds.
Here's an attempt to extract the relevant information based on your request, with an understanding that the context is a 510(k) submission for a non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format of a typical performance study for diagnostic AI. Instead, the "acceptance criteria" are implied by the need for the device's performance to be comparable to or meet the functional requirements of the predicate devices. The performance tests conducted aimed to verify that the device design met its function and performance requirements.
| Test Conducted | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| extriCARE 2400 Performance Test with extriCARE Foam Dressing | Device performs as intended with the foam dressing, consistently with the predicate devices. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is safe and effective." |
| Pressure Accuracy Test | The device maintains pressure accuracy within acceptable limits for Negative Pressure Wound Therapy. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is safe and effective." |
| Pressure Maintenance Over Time Test | The device effectively maintains the set negative pressure over the duration of typical use. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is safe and effective." |
| Extended Continuous Exudates Removal Test | The device effectively removes wound exudate, infectious materials, and tissue debris continuously over an extended period. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is safe and effective." |
| Biocompatibility (for Foam Dressing Kit) | Components in contact with the patient are biocompatible (non-cytotoxic, non-sensitizing, non-irritating). | "The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation." |
| Sterilization (for Foam Dressing Kit) | The single-use foam dressing kit is effectively sterilized and maintains sterility. | "Sterilization has been done for the extriCARE NPWT Foam Dressing Kit. Aged samples are used for sterilization and testing." |
| Electrical Safety and EMC (for NPWT pump) | Meets electrical safety and electromagnetic compatibility standards. | Omitted because electrical parts are the same as predicate (K110078). |
| Software Verification and Validation | Software functions as intended and does not pose a risk of serious injury. | "Software verification and validation were conducted and documentation was provided." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic data, nor does it provide sample sizes for the performance tests mentioned. The testing was conducted on "aged samples" of the device itself (pump and foam dressing kit).
Data provenance (country of origin, retrospective/prospective) is not applicable or provided for this type of device and submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" in the context of diagnostic accuracy or AI performance is not relevant for this medical device submission, which focuses on functional performance and substantial equivalence.
4. Adjudication Method
Not applicable, as no ground truth for a diagnostic performance test was established.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical device (pump and dressing kit), not an algorithm or AI system for standalone performance evaluation in the diagnostic sense.
7. Type of Ground Truth Used
Not applicable. As mentioned, the concept of "ground truth" for diagnostic or predictive purposes is not relevant for this device's submission. The "truth" for this submission revolves around the device's functional integrity, safety, and performance characteristics as measured by engineering tests.
8. Sample Size for the Training Set
Not applicable. This document describes a physical medical device and its accessories, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
§ 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.