# K232516: Sentec Digital Monitoring System (SDMS) tCOM+

- Pathway: 510(k) (Traditional)
- Applicant: Sentec AG
- Decided: May 17, 2024 after 273 days
- Product code: LKD (Monitor, Carbon-Dioxide, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 868.2480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941811 (1994). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041548: Sentec Digital Monitor Model #SDM, Sentec, Inc. (2004) Summary page 6.
- K071672: Sentec Digital Monitoring System, Sentec AG (2007) Summary page 6.
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable, Sentec AG (2010) Summary page 6.
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet, Sentec AG (2015) Summary page 6.

## Indications for use
The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation. Note: This manual uses the term "system" to refer to any combination of the tCOM+ or SDM and sensors, cables, accessories, disposables, and software. The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive. The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor, the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring. Intended patient population: tcPCO2 and tcPO2 monitoring is indicated in adult/pediatric (older than term birth plus 12 months) and neonatal (younger than term birth plus 12 months) patients. Pulse oximetry monitoring is indicated in adult/pediatric patients only. The target user population: of the Sentec Digital Monitoring System (SDMS) is professional medical personnel, e.g. nurses, physicians, and - if under clinical supervision - lay operators. The correct and safe application of tcPCO2 and tcPO2 measuring equipment require straining of the user (e.g. physiological restrictions, technical aspects such as membrane change, meaning of drift, calibration). Home care providers also require specific training to be allowed to install the SDMS in home environments and to instruct lay persons how to apply the sensors correctly. The lay operator cannot modify the tCOM+ configuration by means of its menu. Training: Professional medical personnel and instructed home care personnel are trained by Sentec or a qualified and authorized distributor. The instructed home care personnel provide the lay user with the lay user manual and explains attachment and detachment of the sensor. The instructed home care personnel also define the application site for the attachment of the sensor. Environment of use: In clinical and non-clinical settings such as hospitals, hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and - if under clinical supervision - home environments. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas. Hospital type facilities typically cover facilities such as surgical centers, special nursing facilities and sleep labs outside of the hospital. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facilities. The SDMS fulfills the requirements of a non-transit operable and portable device to be used in home environments. Caution: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K232516
Methodology: https://510kreport.com/methodology