(54 days)
The NovaSpine Powered Suction Pump PRO-I is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.
The NovaSpine Powered Suction Pump PRO-I is a lightweight, self contained, portable battery powered, aspiration pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous or intermittent negative pressure. The NovaSpine Powered Suction Pump PRO-I is available in only one model:
- Suction: 9 liters/min,
- Maximum Vacuum: 200 mmHg
- Noise: 35 dba,
- Weight: 2.8 kg
- Operation: Continuous and Intermittent
- Dimensions: 290mmX359mmX130mm
The pump is powered with a rechargeable Nickel-metal Hydride (NiMh) battery. The unit includes a port for an external power supply and/or a battery charger.
The NovaSpine Powered Suction Pump PRO-I is composed of two parts: - The pump and battery pack are all housed in a single unit. The charging unit is a separate stand alone device.
- The consumable/disposable components such as:
a. Collection canister (secretion container),
b. Related hoses (tubing)
c. Hose connectors
d. Filters
e. Other accessories as detailed in the operating manual
The NovaSpine Powered Suction Pump PRO-I is a medical device. The provided text, a 510(k) summary, describes its characteristics and regulatory clearance, but does not contain information about a study that proves the device meets specific acceptance criteria.
The 510(k) summary focuses on demonstrating "Substantial Equivalence" to other legally marketed devices, rather than presenting a performance study with detailed acceptance criteria and results. The "Device Description" section lists several specifications, which likely serve as the device's inherent design and performance characteristics, but these are not presented as "acceptance criteria" against which a study was performed.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study as requested, because the provided text does not describe such a study or associated acceptance criteria.
Here's what can be extracted from the text regarding the device specifications:
1. Table of Acceptance Criteria and Reported Device Performance:
As noted above, the document does not present explicit "acceptance criteria" tested in a study. Instead, it provides the device's technical specifications. If we interpret these specifications as the intended performance characteristics, the table would look like this:
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Suction | (Not explicitly stated as criteria, but expected performance) | 9 liters/min |
| Maximum Vacuum | (Not explicitly stated as criteria, but expected performance) | 200 mmHg |
| Noise | (Not explicitly stated as criteria, but expected performance) | 35 dba |
| Weight | (Not explicitly stated as criteria, but expected performance) | 2.8 kg |
| Operation | (Not explicitly stated as criteria, but expected performance) | Continuous and Intermittent |
| Dimensions | (Not explicitly stated as criteria, but expected performance) | 290mmX359mmX130mm |
The following information cannot be provided as it is not present in the given text:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices, which typically involves comparing technical specifications, intended use, and safety/effectiveness profiles without necessarily requiring new clinical performance studies against formal acceptance criteria for every new device. It's a common pathway for Class I and II medical devices.
§ 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.