(407 days)
The VOLTERA Powered Suction Pump, S1001-3 Series is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VOLTERA Powered Suction Pump is indicated for removal of exudate from traumatic, dehisced wounds, partial thickness burns, chronic wounds such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, acute wounds, and flaps and grafts.
The VOLTERA Powered Suction Pump, S1001-3 Series is a lightweight, suction device intended for wound management via application of continual or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery.
The provided text describes a 510(k) submission for the VOLTERA Powered Suction Pump S1001-3 Series. This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, not on a study proving the device meets specific acceptance criteria in a clinical setting with human-in-the-loop performance.
Here's an analysis of the provided information relative to your request:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed reported performance alongside those criteria in a table format. Instead, it states that "All the test results demonstrate the performance of VOLTERA Powered Suction Pump meets the requirements of its pre-defined acceptance criteria and intended uses." This implies that the device successfully met internal criteria for various tests.
However, the "Substantial Equivalence Determination" section (excerpt 2) provides a comparison chart of specifications between the proposed device and two predicate devices. While not "acceptance criteria" in the traditional sense of a clinical study, these specifications serve as performance benchmarks for demonstrating equivalence.
| Item | Acceptance Criteria (Predicate Device K062456 / K112458) | Reported Device Performance (VOLTERA S1001-3 Series) |
|---|---|---|
| Intended Use | Similar scope for wound management, fluid removal, and promotion of healing. | Matched |
| Indications for Use | Management of chronic, acute, traumatic, sub-acute, dehisced wounds, partial thickness burns, ulcers (diabetic, pressure), flaps and grafts. | Matched |
| Contraindications | Similar list including necrotic tissue, unexplored fistulas, untreated osteomyelitis, malignancy, exposed arteries/veins/organs. | Similar list (minor variations in wording). |
| Maximum Vacuum | -200 mmHg | -200 mmHg |
| Noise | 35 dba | 30dba at 190 cm |
| Weight | 2.8 kg (PRO-I), 1.8~2.8 kg (PRO-I, PRO-II, PRO-III) | 1.35 kg |
| Voltage | 100-240V / 50-60Hz | 100-240V / 50-60Hz |
| Operation | Continuous and Intermittent | Continuous and Intermittent |
| Battery Operation | 24~48hrs depending on use | 24~48hrs depending on use |
| Consumable/Disposable components | Collection canister, related hoses, hose connectors, filters, other accessories. | Matched |
| Suction | 9 liters/min | 2.5 liters/min |
| Dimensions | 290359130 mm | 17016090 mm |
Note on "Acceptance Criteria" for Medical Devices: For 510(k) submissions, "acceptance criteria" often refer to the successful completion of specific predefined non-clinical tests (e.g., electrical safety, electromagnetic compatibility, risk management, mechanical performance) to demonstrate that the device performs as intended and is as safe and effective as a legally marketed predicate device. The document explicitly states these types of tests were performed and met requirements.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided text does not mention a "test set" in the context of clinical data for performance evaluation. The testing described is "in vitro and in vivo preclinical physical and mechanical tests." These are likely engineering and lab tests, not clinical studies with human subjects. Therefore, sample size and data provenance in terms of human subjects are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. Given the nature of the non-clinical testing described, the "ground truth" would be established by technical specifications, established test methods, and industry standards, rather than expert clinical consensus on images or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set with human subject data and expert adjudication is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a powered suction pump, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a physical powered suction pump. The concept of "standalone algorithm performance" (without human-in-the-loop) typically applies to software or AI-driven devices. While the pump operates independently (standalone in a functional sense), this question is usually framed in the context of AI/software. If interpreting "standalone performance" as the device operating independently without constant human intervention, then yes, the pump is designed to operate in a standalone manner to apply negative pressure. However, this is not performance of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests would be defined by the specifications and performance standards set by relevant international standards (IEC 60601-1-1, IEC 60601-1-2, ISO 14971:2007) and the performance of the predicate devices. For example, if a test was to measure maximum vacuum, the "ground truth" would be the required -200 mmHg, and the device's output would be compared against that.
8. The sample size for the training set:
Not applicable. This submission concerns a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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.