(55 days)
The DV-300 is intended for general suction use in hospitals or clinics.
The DV-300 is a portable AC suction pump capable of delivering 24.4 inHg of negative pressure (vacuum) to draw fluids and small particles through tubing and into a disposable collection canister, where the suctioned fluids and particles are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, a power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, an analog pressure gauge, a microbial filter, intermediate tubing, and a disposable collection canister (≥ 800 ml) with overflow protection.
The DV-300 requires an AC input voltage of 110-120V 60Hz. Housed in ABS plastic, the DV-300 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-300 must only be used on the order of a physician.
This document describes the Cliq Aspirator DV-300, a powered suction pump, seeking 510(k) clearance. The focus of the document is on the device's substantial equivalence to a predicate device and its performance and safety testing.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| The pump shall be compliant with IEC 60601-1 requirements. | 100% Pass | Pass: 100% |
| The pump shall be compliant with IEC 60601-1-2 requirements. | 100% Pass | Pass: 100% |
| The pump shall be compliant with ISO 10079-1 requirements. | 100% Pass | Pass: 100% |
| The pump controls shall be easily identifiable by the User. | 100% Pass | Pass: 100% |
| The pump controls shall be validated for Usability. | 100% Pass | Pass: 100% |
| The DV-300 should supply uniform vacuum level for an entire case. | 100% Pass | Pass: 100% |
| The DV-300 will be a durable piece of capital equipment. | 100% Pass | Pass: 100% |
| The DV-300 should be quiet. | 100% Pass | Pass: 100% |
| After use, any blood or clot collected in the canister should be able to be removed for analysis. | 100% Pass | Pass: 100% |
| The canister should have volume reference markings. | 100% Pass | Pass: 100% |
| The canister should be able to withstand the maximum pressure delivered by the pump. | 100% Pass | Pass: 100% |
| The canister lid should include a feature to prevent excess fluid from entering the pump. | 100% Pass | Pass: 100% |
2. Sample size used for the test set and the data provenance:
The document explicitly states that "Full test reports can be found in Section 16 of this submission." However, Section 16 is not provided in the given text. Therefore, the sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) cannot be determined from the provided excerpt.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given document. The acceptance criteria largely relate to technical specifications and physical performance of the device and its components, rather than diagnostic accuracy that would typically require expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the performance tests.
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:
This is not applicable as the device (Cliq Aspirator DV-300) is a powered suction pump, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is mechanical, not an algorithm. The reported performance is standalone with respect to the device's physical attributes and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests appears to be based on engineering and physical measurements, compliance with international standards (IEC, ISO), and functional assessments against predefined technical criteria. For usability-related criteria, it would likely be based on internal testing and possibly user feedback, but the specific methodologies are not detailed.
8. The sample size for the training set:
This is not applicable as the device is a physical medical device (suction pump), not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
§ 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.