(187 days)
The SmartLink Wireless system's primary function is to transfer 12 lead and other vital signs data from a Welch Allyn PIC50 Defibrillator/Monitor at a remote location to a personal computer station, and to display the data on the computer's monitor. The data is intended to be used by Emergency Room staff for patient assessment prior to arrival of the patient at the Emergency Room, in order to reduce the delay in treating the patient upon arrival.
The SmartLink Wireless system can be used to:
- Provide users of Welch Allyn PIC 50 products in the field the capability of transmitting patient vitals using wireless technology to a remote location. At the remote location the information will be used for diagnostic purposes by trained medical personnel. Patient's vitals may include 12 lead data, IBP, NIBP, ETCO2, Respiratory rate, Heart rate, Temperature, SPO2, and optional single lead ECG snapshot.
- Send automatic pager notification when a new patient record is received at the personal computer station.
- Forward the patient data to any number of e-mail address at remote computers or personal digital assistants.
The SmartLink Wireless system is not intended to be used as a primary alarm source. Patient information received by the SmartLink Wireless system should not be examined for the purpose of generating alarms.
Not Found
This document [K033642] is a 510(k) clearance letter from the FDA for the Welch Allyn Medical Research Laboratories (MRL) Inc. SmartLink Wireless Monitoring System, dated May 25, 2004. It
determines that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
The document only states the device's indications for use:
- To transfer 12-lead ECG and other vital signs data from a Welch Allyn PIC50 Defibrillator/Monitor at a remote location to a personal computer station.
- To display this data on the computer's monitor for Emergency Room staff to use for patient assessment prior to arrival, aiming to reduce treatment delays.
- To provide users of Welch Allyn PIC 50 products the capability of transmitting patient vitals wirelessly to a remote location for diagnostic purposes by trained medical personnel. Vitals may include 12-lead data, IBP, NIBP, ETCO2, Respiratory rate, Heart rate, Temperature, SPO2, and optional single lead ECG snapshot.
- To send automatic pager notifications when new patient records are received.
- To forward patient data to multiple email addresses at remote computers or PDAs.
It also explicitly states that the system is not intended to be used as a primary alarm source and received patient information should not be examined for the purpose of generating alarms.
Therefore, based solely on the provided text, I cannot answer any of the specific questions about acceptance criteria or study details. This information would typically be found in the 510(k) submission itself or in supporting clinical or performance data not included in this FDA clearance letter.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.