(122 days)
The DV-XXX aspirator provides a portable, battery-powered medical vacuum source. The DV-XXX can also be powered from a standard wall outlet with the use of an AC power adapter. It is intended for use in the home care or hospital environment.
The DV-XXX is a portable AC/DC high vacuum / high flow suction pump. The DV-XXX can be powered from a standard wall outlet or from a rechargeable battery pack. The DV-XXX creates a negative pressure (vacuum) that draws fluids through tubing and into a collection container where the fluids are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, an AC power adapter with power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, a pressure gauge, an inline filter, intermediate tubing, and a rechargeable battery pack. Optional accessories which may be included with the unit include a collection canister and suction tubing.
The DV-XXX produces a flow rate of up to 20 liters per minute, and has a maximum vacuum pressure of 620 mmHg. Housed in ABS plastic, the DV-XXX has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock.
The DV-XXX must only be used on the order of a physician.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Cliq Aspirator DV-XXX (model family)". As such, it is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the detailed performance metrics of a novel AI/ML-driven device.
Therefore, the information typically requested for acceptance criteria and studies proving the device meets those criteria, particularly for AI/ML devices (e.g., sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect sizes), is largely not present in this document.
This document describes a powered suction pump, a traditional medical device, not an AI/ML diagnostic or therapeutic device. The "performance" discussed refers to physical specifications and compliance with electrical and safety standards, not diagnostic accuracy or effectiveness in an AI context.
Here's how the provided information relates to your request, with an emphasis on what is not applicable or not found in this type of submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide specific "acceptance criteria" in the sense of a numerical threshold for clinical performance (like sensitivity/specificity for a diagnostic AI). Instead, it relies on demonstrating compliance with recognized consensus standards and substantial equivalence to a predicate device.
The "performance" metrics for this device are largely physical and electrical characteristics.
| Criterion Type | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Cliq Aspirator DV-XXX) |
|---|---|---|
| Intended Use | Portable, battery-powered medical vacuum source for homecare/hospital environment. | Portable, battery-powered medical vacuum source for homecare/hospital environment. (Equivalent) |
| Electrical Requirements | AC Adaptor: 100-240 VAC, 50-60Hz; Pump Unit: 12 VDC | AC Adaptor: 100-240 VAC, 50-60Hz; Pump Unit: 12 VDC (Equivalent) |
| Protection against electric shock | Class I or Class II with Type BF applied part | Class II with Type BF applied part (Equivalent) |
| Battery Type | Rechargeable battery (Predicate: Lead acid battery) | NiMH rechargeable battery pack (Different type, but deemed equivalent in function and safety) |
| Battery Status Indicator | Colored LED lights for fully charged/low battery status | Colored LED lights for fully charged/low battery status (Equivalent) |
| Vacuum Pressure | Max: 533 mmHg (Predicate: EasyGo Aspirator) | Max: ~620 mmHg; Vacuum adjustable; Vacuum gauge (Higher max pressure, but deemed equivalent; adjustable and with gauge like predicate) |
| Pump Type | Positive displacement reciprocating pump | Positive displacement reciprocating pump (Equivalent) |
| Flow Rate | Up to ~14 l/min (Predicate: EasyGo Aspirator) | Up to ~20 l/min (Higher flow rate, but deemed equivalent) |
| Sound Level | Not specified for predicate |
§ 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.