(213 days)
No
The document describes a monitoring system with sensors and software for data display and analysis, but there is no mention of AI or ML being used in the data processing or interpretation.
No.
This device is for continuous, noninvasive patient monitoring of physiological parameters like carbon dioxide tension, oxygen saturation, and pulse rate, not for providing therapy or treatment.
Yes
The device continuously monitors physiological parameters like carbon dioxide tension, oxygen saturation, and pulse rate, which are used to assess a patient's medical condition. The "Intended Use" section explicitly states it's for "continuous, noninvasive patient monitoring."
No
The device description explicitly states that the system consists of a standalone monitor (SDM), digital sensors, connecting cables, and accessories, in addition to the optional V-STATS PC software. This indicates the presence of significant hardware components beyond just software.
Based on the provided text, the SenTec Digital Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- SenTec System Function: The SenTec Digital Monitoring System is described as a non-invasive patient monitoring system. It measures physiological parameters (carbon dioxide tension, oxygen saturation, and pulse rate) directly from the patient's body surface (earlobe, forehead, cheek, upper arm, back). It does not analyze samples taken from the body.
Therefore, the SenTec Digital Monitoring System falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories - is indicated for continuous, noninvasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in clinical and non-clinical settings such as hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and - if under clinical supervision-home environments. The SenTec Digital Monitoring System is for prescription use only.
The V-Sign Sensor 2, model VS-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of V-Sign Sensor 2 is indicated for carbon dioxide tension monitoring only.
The OxiVenT Sensor, model OV-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension as well as oxygen saturation and pulse rate are required for adult and pediatric patients. In neonatal patients the use of OxiVenT Sensor is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
SenTec's Ear Clip, model EC-MI, is intended for use with the V-Sign Sensor 2 when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring and with the OxiVenT Sensor when continuous, noninvasive carbon dioxide and oxygen tension monitoring as well as oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach the V-Sign Sensor 2 or OxiVenT Sensor to the earlobe of the patient. The use of the Ear Clip is contraindicated for patients whose earlobes are too small to ensure adequate sensor application.
SenTec's Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach V-Sign Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, noninvasive carbon dioxide tension monitoring is required for adult, pediatic, and neonatal patients. The Multi-Site Attachment Rings, model MAR-MI, are intended to attach the OxiVenT Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninvasive carbon doxide and/or oxygen tension monitoring is required for adult, pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-MI, are intended to attach the V-Sign Sensor 2 or the OxiVenT Sensor to the forehead, cheek, upper arm as well as on the back above the shoulder blade. The Multi-Site Attachment Rings, model MAR-MI, are for single use.
SenTec's Staysite Adhesive pad for MAR, model SA-MAR, is an optional, single-use adhesive pad which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF, if more secure attachment is required. The Staysite Adhesive pad for MAR, model SA-MAR, is for single use.
V-STATS is an optional PC-based software which is indicated for use with the SenTec Digital Monitor (SDM) when remote monitoring and/ or trend reporting and statistical analysis of data measured by the SDM is required. V-STATS is not intended to provide diagnosis; it is intended to supplement and not to replace any part of the SDM monitoring procedures.
Product codes (comma separated list FDA assigned to the subject device)
LKD, DPZ, DQA, KLK, LPP
Device Description
The SenTec Digital Monitoring System (SDMS) as listed under K101690 is a device consisting of a standalone monitor [SenTec Digital Monitor (SDM)], the digital sensors V-Sign™ Sensor (model VS-A/P) and its successor V-Sign™ Sensor 2 (model VS-A/P/N), connecting cables, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR) using the ear lobe, forehead or cheek as monitoring site in adult and pediatric patients. It is furthermore designed for PCO2-only monitoring in adult, pediatric and neonatal patients using conventional PCO2 measurement sites. V-STATS™ is an optional PC software application for remote monitoring and/or trend reporting and statistical analysis of the data measured with the SDMS.
The additions and expanded indications of the SenTec Digital Monitoring System (SDMS) introduced by this new 510(k) submission are summarized below:
- This new 510(k) submission expands the intended use of the SDMS by introducing non- invasive, transcutaneous oxygen (tcPO2) by measuring the oxygen partial pressure (PO2) as new monitoring parameter to the SDMS. Introducing the tcPO2 parameter includes updated firmware versions of the existing SenTec Digital Monitor (SDM) and the introduction of a new digital sensor (OxiVenT™ Sensor, see below).
- This new 510(k) submission introduces SenTec's OxiVenT™ Sensor, model OV-A/P/N. The - OxiVenT™ Sensor is a combined sensor for the continuous measurement of transcutaneous oxygen (tcPO2), as well as the previously cleared measurement of transcutaneous carbon dioxide (tcPCO2), oxygen saturation (SpO2) and pulse rate (PR).
- V-Sign™ Sensor 2 (model VS-A/P/N) has been cleared under K101690. This new 510(k) submission expands the intended use by introducing new SpO2/PR measurement sites in adult and pediatric patients: Next to the already existing measurement sites on the forehead and cheek, new the upper arm and area on the back above the shoulder blade are added.
- This new 510(k) submission expands the intended use of the Multi-Site Attachment Rings, models MAR-MI and MAR-SF, approved under K101690 and K071672. to attach the new OxiVenT™ Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninyasive carbon dioxide and/or oxygen tension monitoring is required for adult. pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-MI, are intended to attach the V-Sign™ Sensor 2 or the new OxiVenT™ Sensor to the forehead, cheek, as well as the new pulse oximetry (SpO2/PR) measurement sites upper arm as well as on the shoulder blade.
- This new 510(k) submission introduces the Staysite™ Adhesive pad (REF SA-MAR), an additional adhesive pad that can be used optionally if more secure attachment is required – the pad is attached on top off the Multi-Site Attachment Rings (MAR-SF/MI).
- The V-STATS™ PC software for trend data reporting and remote monitoring (cleared in K101690) has been updated to version 4.00 in order to incorporate download and display of the new PO2 parameter.
In total, the modifications, additions, and enhancements described above represent the step-wise evolution of the SenTec Digital Monitoring System (SDMS) to provide improved monitoring as well as expanded measurement and reporting capabilities. A traditional 510(k) has been selected instead of a special 510(k) because some of the changes affect the indications for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear lobe, forehead, cheek, upper arm, back above the shoulder blade
Indicated Patient Age Range
Adult, pediatric, neonatal
Intended User / Care Setting
Clinical and non-clinical settings such as hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and - if under clinical supervision-home environments. Prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies were performed using the SenTec Digital Monitoring System (SDMS) with healthy adult volunteer subjects who were subjected to progressive induced hypoxia against arterial hemoglobin oxygen saturation determined from arterial blood samples with a CO-Oximeter as reference. The results from the clinical studies show for all supported sensors and claimed monitoring sites that the reported saturation values from the SDMS meet specified accuracy requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: For all approved sites: V-Sign™ Sensor 2: 70 - 100%: ± 2% (Arms); OxiVenT™ Sensor: 70 - 100%: ± 2.25% (Arms);
§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2015
SenTec AG % Mr. Stephen Gorski Regulatory Consultant Imagenix, Inc. S65 W35739 Piper Road Eagle, WI 53119
Re: K151329
Trade/Device Name: SenTec Digital Monitoring System (SDMS) Regulation Number: 21 CFR 868.2480 Regulation Name: Cutaneous carbon dioxide (PcCO2) monitor Regulatory Class: Class II Product Code: LKD. DPZ. DOA. KLK. LPP Dated: November 22, 2015 Received: November 24, 2015
Dear Mr. Gorski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151329
Device Name SenTec Digital Monitoring System (SDMS)
Indications for Use (Describe)
The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories - is indicated for continuous, noninvasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in clinical and non-clinical settings such as hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and - if under clinical supervision-home environments. The SenTec Digital Monitoring System is for prescription use only.
The V-Sign Sensor 2, model VS-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of V-Sign Sensor 2 is indicated for carbon dioxide tension monitoring only.
The OxiVenT Sensor, model OV-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension as well as oxygen saturation and pulse rate are required for adult and pediatric patients. In neonatal patients the use of OxiVenT Sensor is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
SenTec's Ear Clip, model EC-MI, is intended for use with the V-Sign Sensor 2 when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring and with the OxiVenT Sensor when continuous, noninvasive carbon dioxide and oxygen tension monitoring as well as oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach the V-Sign Sensor 2 or OxiVenT Sensor to the earlobe of the patient. The use of the Ear Clip is contraindicated for patients whose earlobes are too small to ensure adequate sensor application.
SenTec's Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach V-Sign Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, noninvasive carbon dioxide tension monitoring is required for adult, pediatic, and neonatal patients. The Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the OxiVenT Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninvasive carbon doxide and/or oxygen tension monitoring is required for adult, pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-MI, are intended to attach the V-Sign Sensor 2 or the OxiVenT Sensor to the forehead, cheek, upper arm as well as on the back above the shoulder blade. The Multi-Site Attachment Rings, model MAR-MI, are for single use.
SenTec's Staysite Adhesive pad for MAR, model SA-MAR, is an optional, single-use adhesive pad which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF, if more secure attachment is required. The Staysite Adhesive pad for MAR, model SA-MAR, is for single use.
V-STATS is an optional PC-based software which is indicated for use with the SenTec Digital Monitor (SDM) when remote monitoring and/ or trend reporting and statistical analysis of data measured by the SDM is required. V-STATS is not intended to provide diagnosis; it is intended to supplement and not to replace any part of the SDM monitoring procedures.
Caution: Federal law restricts this device to sale by or on the order of a physician.
3
X Prescription Use (Part 21 CFR 801 Subpart D)
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4
510(k) Summary
| Submitter [807.92(a)(1)]: | Address | SenTec AG
Ringstrasse 39
4106 Therwil – Switzerland |
|--------------------------------|---------|----------------------------------------------------------------------------------------------------|
| | Phone | +41 61 726 97 60 |
| | FAX | +41 61 726 97 61 |
| Contact Person [807.92(a)(1)]: | | Ms. Anke Weisbrich, Ph.D.
Quality Assurance & Regulatory Affairs Manager
weisbrich@sentec.ch |
| Date prepared [807.92(a)(1)]: | | Dec 14th, 2015 |
Date prepared [807.92(a)(1)]:
Trade, Common and Classification Name [807.92(a)(2)]:
| Trade / Proprietary Name | Common /
Usual Name | Classification
Name | Product
Code | Class | Regulation
Number |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------------------|-----------------|-------|-------------------------|
| SenTec Digital Monitoring
System (SDMS)
SenTec Digital Monitor (SDM),
sensors, accessories for sensor
application/maintenance;
V-STATS™ PC-based trend
reporting, data analysis and remote
monitoring Software for the SDM | Cutaneous Carbon
Dioxide Monitor | Monitor, Carbon-
Dioxide, Cutaneous | LKD | II | 21 CFR Part
868.2480 |
| | Cutaneous
Oxygen Monitor | Monitor, oxygen,
cutaneous, for infant
not under gas
anesthesia | KLK | II | 21 CFR Part
868.2500 |
| | Cutaneous
Oxygen Monitor | Monitor, oxygen,
cutaneous, for uses
other than for infant
not under gas
anesthesia | LPP | II | 21 CFR Part
868.2500 |
| | Pulse Oximeter | Oximeter | DQA | II | 21 CFR Part
870.2700 |
| | Pulse Oximeter | Oximeter, Ear | DPZ | II | 21 CFR Part
870.2710 |
Substantially Equivalent to [807.92(a)(3)]:
| Device | Manufacturer | Comment | |
|---|---|---|---|
| K101690 | SenTec Digital Monitoring | ||
| System | SenTec AG | This device is predicate for PCO2, SpO2, and PR | |
| monitoring for monitoring of PCO2, SpO2, and PR at | |||
| the ear lobe, forehead and cheek in adult and | |||
| pediatric patients and for PCO2 monitoring only in | |||
| adult, pediatric and neonatal patients using | |||
| conventional PCO2 measurement sites. | |||
| K093154 | TCM CombiM | Radiometer | This device is the predicate for PO2 monitoring on |
| conventional PO2 monitoring sites in adult and | |||
| through neonatal patients. | |||
| K101690 | V-STATS™ PC software | ||
| V3.00 | SenTec AG | The V-STATS™ software V3.00 (including the | |
| V-CareNeT remote monitoring package) is predicate | |||
| for trend reporting, data analysis and remote | |||
| monitoring of the SenTec Digital Monitor using the | |||
| current V-STATS V4.00, which includes the new PO2 | |||
| monitoring parameter. |
5
Reason For Submission: Additional or Expanded Indications
Description of the device [807.92(a)(4)]:
The SenTec Digital Monitoring System (SDMS) as listed under K101690 is a device consisting of a standalone monitor [SenTec Digital Monitor (SDM)], the digital sensors V-Sign™ Sensor (model VS-A/P) and its successor V-Sign™ Sensor 2 (model VS-A/P/N), connecting cables, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR) using the ear lobe, forehead or cheek as monitoring site in adult and pediatric patients. It is furthermore designed for PCO2-only monitoring in adult, pediatric and neonatal patients using conventional PCO2 measurement sites. V-STATS™ is an optional PC software application for remote monitoring and/or trend reporting and statistical analysis of the data measured with the SDMS.
The additions and expanded indications of the SenTec Digital Monitoring System (SDMS) introduced by this new 510(k) submission are summarized below:
- This new 510(k) submission expands the intended use of the SDMS by introducing non- invasive, transcutaneous oxygen (tcPO2) by measuring the oxygen partial pressure (PO2) as new monitoring parameter to the SDMS. Introducing the tcPO2 parameter includes updated firmware versions of the existing SenTec Digital Monitor (SDM) and the introduction of a new digital sensor (OxiVenT™ Sensor, see below).
- This new 510(k) submission introduces SenTec's OxiVenT™ Sensor, model OV-A/P/N. The - OxiVenT™ Sensor is a combined sensor for the continuous measurement of transcutaneous oxygen (tcPO2), as well as the previously cleared measurement of transcutaneous carbon dioxide (tcPCO2), oxygen saturation (SpO2) and pulse rate (PR).
- V-Sign™ Sensor 2 (model VS-A/P/N) has been cleared under K101690. This new 510(k) submission expands the intended use by introducing new SpO2/PR measurement sites in adult and pediatric patients: Next to the already existing measurement sites on the forehead and cheek, new the upper arm and area on the back above the shoulder blade are added.
- This new 510(k) submission expands the intended use of the Multi-Site Attachment Rings, models MAR-MI and MAR-SF, approved under K101690 and K071672. to attach the new OxiVenT™ Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninyasive carbon dioxide and/or oxygen tension monitoring is required for adult. pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the V-Sign™ Sensor 2 or the new OxiVenT™ Sensor to the forehead, cheek, as well as the new pulse oximetry (SpO2/PR) measurement sites upper arm as well as on the shoulder blade.
- This new 510(k) submission introduces the Staysite™ Adhesive pad (REF SA-MAR), an additional adhesive pad that can be used optionally if more secure attachment is required – the pad is attached on top off the Multi-Site Attachment Rings (MAR-SF/MI).
- The V-STATS™ PC software for trend data reporting and remote monitoring (cleared in K101690) has been updated to version 4.00 in order to incorporate download and display of the new PO2 parameter.
In total, the modifications, additions, and enhancements described above represent the step-wise evolution of the SenTec Digital Monitoring System (SDMS) to provide improved monitoring as well as expanded measurement and reporting capabilities. A traditional 510(k) has been selected instead of a special 510(k) because some of the changes affect the indications for use.
6
Image /page/6/Picture/0 description: The image shows the word "sentec" in black font, except for the "T" which is in orange. The word is in lowercase letters. The font is sans-serif and the letters are evenly spaced.
Indications for Use [807.92(a)(5)]:
The SenTec Digital Monitoring System (SDMS) - consisting of the SenTec Digital Monitor (SDM), sensors and accessories - is indicated for continuous, noninyasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in clinical settings such as hospitals, hospitals, hospital-type facilities, intra-hospital transport environments, clinics, ambulatory surgery centers and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only.
The V-Sign™ Sensor 2, model VS-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of V-Sign™ Sensor 2 is indicated for carbon dioxide tension monitoring only.
The OxiVenT™ Sensor, model OV-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension as well as oxygen saturation and pulse rate are required for adult and pediatric patients. In neonatal patients the use of OxiVenT™ Sensor is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
SenTec's Ear Clip, model EC-MI, is intended for use with the V-Sign™ Sensor 2 when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring and with the OxiVenT™ Sensor when continuous, noninvasive carbon dioxide and oxygen tension monitoring as well as oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single use and is indicated to attach the V-Sign™ Sensor 2 or OxiVenT™ Sensor to the earlobe of the patient. The use of the Ear Clip is contraindicated for patients whose earlobes are too small to ensure adequate sensor application.
SenTec's Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach V-Sign™ Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, noninvasive carbon dioxide tension is required for adult, pediatric, and neonatal patients. The Multi-Site Attachment Rings, model MAR-MI, are intended to attach the OxiVenT™ Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninvasive carbon dioxide and/or oxygen tension monitoring is required for adult, pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-MI, are intended to attach the V-Sign™ Sensor 2 or the OxiVenT™ Sensor to the forehead, cheek, upper arm as well as on the shoulder blade. The Multi-Site Attachment Rings, model MAR-MI, are for single use.
SenTec's Staysite™ Adhesive pad, model SA-MAR, is an optional, single use adhesive pad which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF if more secure attachment is required. The Staysite™ Adhesive pad for MAR, model SA-MAR, is for single use.
V-STATS™ is a PC-based software which is indicated for use with the SenTec Digital Monitor (SDM) when remote monitoring and/or trend reporting and statistical analysis of the data measured by the SDM is required. V-STATS™ is not intended to provide diagnosis, it is intended to supplement and not to replace any part of the SDM monitoring procedures.
Caution: Federal law restricts this device to sale by or on the order of a physician.
7
Technological Characteristics [807.92(a)(6)]:
The SenTec Digital Monitoring System (SDMS) has the same indications for use as well as the same indicated patient population as the specified combination of the predicate devices.
Compared to the SDMS confiquration cleared under K101690 the technological characteristics (hardware and software) regarding continuous, noninvasive patient monitoring of PCO2, SpO2 and PR remain unchanged are identical to the SDMS configuration listed under K101690.
In this submission the intended use of the SDMS has been extended to include additionally continuous, noninvasive monitoring of PO2. This addition required hardware (e.g. new sensor type) and software (firmware and V-STATS™ PC software) changes. All relevant patient monitoring features of the SDMS for PO2 monitoring are equivalent to those of Radiometer`s TCM CombiM when used with the tc Sensor 84 as cleared in K093154
SenTec's new OxiVenT™ Sensor (model OV-A/P/N) uses the exact same basic principles of operation and the same technology as the predicate devices. The OxiVenT™ Sensor uses a different PO2 monitoring technology than its predicate device (Radiometer `s TCM CombiM with tc Sensor 84, K093154) but with equivalent function. This does not raise additional issues regarding safety and effectiveness.
The V-Sign™ Sensor 2 (model VS-A/P/N) in this submission uses the exact same basic principles of operation and the same technology as cleared in K101690. However, additional pulse oximetry monitoring sites in adult and pediatric were added in this submission. Also, the lowest operator-selectable sensor set temperature is new 37°C instead of 39°C previously. These differences do not raise additional issues regarding safety and effectiveness.
The existing accessories (Digital Sensor Adapter Cable, Ear Clip, Multi-Site Attachment Rings, Membrane Changer, Service Gas, Contact Gel) remain unchanged but may now also be used for SenTec's new OxiVenT™ Sensor (model OV-A/P/N) (subject to this submission). The new, optional sensor application accessory, Staysite™ Adhesive pad (model SA-MAR), does not add new indications and does not raise additional issues regarding safety and effectiveness.
The latest version of the V-STATS™ PC software including the V-CareNeT™ package (this submission) remains unchanged in function as cleared in K101690 regarding remote monitoring and/or trend reporting and statistical data analysis. In this submission data download, display and statistical analysis of the new PO2 monitoring parameter has been added.
Comparison of Technological Features to Predicate Devices:
| Claim /
Attribute | Modified Device (Applicant)
SDMS with OxiVenT™ Sensor or
V-Sign™ Sensor 2 | Predicate Device
SDMS with V-Sign™ 2 Sensor | Predicate Device
TCM CombiM with tc Sensor 84 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SenTec AG | SenTec AG | Radiometer Medical ApS |
| Covered by K-
Number | To be assigned | K101690 | K093154 |
| Monitor | 'SenTec Digital Monitor' (SDM)
(SMB V08.00 and MPB V06.00) | 'SenTec Digital Monitor' (SDM)
(SMB V07.00 and MPB V05.00) | TCM CombiM monitor |
| Claim /
Attribute | Modified Device (Applicant)
SDMS with OxiVenT™ Sensor or
V-Sign™ Sensor 2 | Predicate Device
SDMS with V-Sign™ 2 Sensor | Predicate Device
TCM CombiM with tc Sensor 84 |
| Sensors
considered in
comparison | V-Sign™ Sensor 2 (VS-A/P/N):
PCO2, SpO2, PR
OxiVenT™ Sensor (OV-A/P/N):
PCO2, PO2, SpO2, PR | V-Sign™ Sensor 2 (VS-A/P/N):
PCO2, Sp02, PR | tc Sensor 84: PCO2, PO2, |
| Patient Population | Adults, Pediatrics for PCO2, PO2,
SpO2, PR monitoring.
Adults, Pediatrics, Neonates for
PCO2, PO2 monitoring. | Adults, Pediatrics for PCO2, SpO2,
PR monitoring.
Adults, Pediatrics, Neonates for
PCO2-only monitoring. | Adults, Pediatrics, Neonates for
PCO2, PO2 monitoring. |
| Intended Use
(monitoring
system) | The SenTec Digital Monitoring
System - consisting of the SenTec
Digital Monitor (SDM), sensors and
accessories - is indicated for
continuous, noninvasive patient
monitoring. | The SenTec Digital Monitoring
System - consisting of the SenTec
Digital Monitor (SDM), sensors and
accessories - is indicated for
continuous, noninvasive patient
monitoring. | The TCM CombiM monitoring system
is intended for continuous
transcutaneous monitoring of carbon
dioxide (tcpCO2) and oxygen (tcpO2)
partial pressures. |
| SpO2 range | 1 - 100% | 1 - 100% | N/A |
| SpO2 Accuracy | For all approved sites:
V-Sign™ Sensor 2: 70 - 100%: ±
2% (Arms)
OxiVenT™ Sensor: 70 - 100%: ±
2.25% (Arms)