(26 days)
Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).
[Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.
The provided FDA 510(k) clearance letter and summary for the "Cary" device ([K251111](https://510k.innolitics.com/search/K251111)) primarily discuss non-clinical performance testing to demonstrate substantial equivalence to a predicate device. This document does not describe a clinical study (e.g., MRMC or standalone human-in-the-loop study) involving human readers or expert panels for establishing ground truth, as would typically be seen for AI/ML-driven diagnostic devices. Instead, the testing focuses on the physical and functional performance of the suction pump itself against recognized consensus standards.
Therefore, many of the requested points regarding clinical study design, expert panels, ground truth, and MRMC studies are not applicable based on the provided text.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical tests with implied or explicit acceptance criteria based on industry standards and comparison to the predicate device.
| Test Category | Acceptance Criteria (Implied/Explicit from Standards/Predicate) | Reported Device Performance |
|---|---|---|
| Operating Position | Ability to operate in any spatial orientation. | Confirmed. |
| Protection Devices | Compliance with overfill protection and reverse flow protection. | Results within acceptance criteria. |
| Noise Level | Unspecified standard, implied safe/acceptable level. | 70.5 dB. "Within the acceptance criteria apart from 0.5dB excess when the suction tip was blocked. This is considered as an acceptable deviation from the standard requirement as it does not decrease the safety or effectiveness of the subject device when compared to the predicate device." |
| Air Leakage | As per standard requirements for general use suction equipment. | Results within acceptance criteria. |
| Vacuum Levels & Free Air Flow | Within acceptance criteria for High vacuum/high flow and Low vacuum/low flow (similar to predicate: High vacuum |
§ 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.