(172 days)
The XLR8 Plus (XLR8+) Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
The XLR8 Plus (XLR8+) Wound Vacuum System is a portable, rechargeable battery powered wound suction pump with the intention to generate negative pressure to remove exudate from the wound.
This document describes a 510(k) premarket notification for the Genadyne XLR8 Plus (XLR8+) Negative Pressure Wound Therapy device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device or a PMA.
Therefore, the typical metrics and study designs associated with proving a device meets specific acceptance criteria via a study (especially for AI/ML-driven devices with performance metrics like sensitivity, specificity, or AUC) are not present in this document. The "acceptance criteria" here are primarily met by demonstrating comparable performance and characteristics to the predicate device.
Here's an analysis based on the provided text, addressing your points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device (A4-XLR8 Wound Vacuum System, K090638). The new device, XLR8 Plus, aims to be substantially equivalent. The table provided is a comparative table, not a pure acceptance criteria table with a "pass/fail" for an independent study.
Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (New Device) |
|---|---|---|
| Suction Capacity | 3.5 liters per minute | > 5 liters per minute |
| Max Vacuum | 230 mmHg | 230 mmHg |
| Power Requirements | 30W | 30W |
| Battery Type | Rechargeable Li-Ion | Rechargeable Li-Ion |
| Dimensions / Weight | 5.9" x 4" x 2.4" / 1.5 lbs | 5.9" x 4" x 3.4" / 1.65 lbs |
| Canister Sizes | 200, 400, 600, 800 ml | 200, 400, 600, 800 & 1100 ml |
| Reusable | No | No |
| Sterile | Non Sterile | Non Sterile |
| Indications for Use | Substantially similar | Substantially similar |
| Contraindications | Identical list | Identical list |
| Precautions | Identical list | Identical list |
| Compliance | IEC 60601-1, 3rd Edition | IEC 60601-1, IEC 60601-1-2 |
| Storage/Transport | -18°C to +43°C, 10-95% RH, 700-1060 mbar | Identical |
| Operation | 18°C to 34°C, 10-95% RH, 700-1060 mbar | Identical |
Note: For the 510(k) process, the new device can be better than the predicate in some aspects (like suction capacity or additional canister size) as long as it doesn't raise new questions of safety or effectiveness.
2. Sample Size for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of an AI/ML device validating performance on a dataset of patient cases. The testing conducted for this device is focused on engineering verification and validation (e.g., measuring suction, power, verifying dimensions, and confirming compliance with electrical safety standards). These tests are typically performed on a small number of production or pre-production units.
- Sample Size: Not specified in terms of patient data or clinical cases, as this is not an AI/ML driven device requiring such clinical validation. Laboratory (bench) testing of the device itself would likely involve a small number of units (e.g., 3-10).
- Data Provenance: Not applicable in the context of patient data. The provenance for the device's technical specifications would be from internal engineering and manufacturing. This is a physical medical device, not a software device processing patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a negative pressure wound therapy system, not an imaging analysis or diagnostic AI/ML device requiring expert interpretation for ground truth establishment.
4. Adjudication Method
Not applicable. There is no expert review or adjudication process outlined for this type of device submission. Performance is based on engineering specifications and bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML diagnostic or assistive device that would participate in an MRMC study to compare human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not a standalone algorithm.
7. Type of Ground Truth Used
Not applicable. Ground truth for an AI/ML context doesn't apply here. The "truth" for this device lies in its adherence to engineering specifications, safety standards, and functional performance metrics (like creating negative pressure). Bench testing and electrical safety compliance form the basis of "truth."
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set for an AI/ML model is involved.
§ 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.