Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056011
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-28
First Post:
2023-09-19
Brief Title:
Timmy3 Module Clinical Accuracy ISO 80601-2-562017 A1 2018
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
TIMMY3 80601-2-562017 A1 2018 Clinical Accuracy Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module integrated into host device CVSM according to ISO 80601-2-562017 A1 2018
Detailed Description:
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module integrated into host device CVSM according to 80601-2-562017 A1 2018
This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms Testing will be performed with a production equivalent CVSM modified to use TIMMY3 TIMMY3 investigational device running the SureTemp Plus algorithms The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as but not limited to the Connex Spot Monitor and Spot 4400 The process described below will be followed in accordance with the method called out in ISO 80601-2-562017 A12018
This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms Testing will be performed with a production equivalent CVSM modified to use TIMMY3 TIMMY3 investigational device running the SureTemp Plus algorithms The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as but not limited to the Connex Spot Monitor and Spot 4400 The process described below will be followed in accordance with the method called out in ISO 80601-2-562017 A12018
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None