(85 days)
Not Found
No
The summary describes a system for continuous, non-invasive monitoring of physiological parameters (PCO2, SpO2, PR) using a sensor and monitor. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the hardware components and their application.
No
The device is indicated for monitoring of physiological parameters like carbon dioxide tension, oxygen saturation, and pulse rate, not for directly treating a disease or condition.
Yes
The device is indicated for continuous, non-invasive monitoring of physiological parameters such as carbon dioxide tension, oxygen saturation, and pulse rate, which are used by clinicians to assess a patient's condition and help diagnose medical issues.
No
The device description explicitly states it consists of a stand-alone monitor, a digital sensor, a connecting cable, and accessories, indicating it is a hardware-based system, not software-only.
Based on the provided information, 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 derived from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- SenTec System Function: The SenTec Digital Monitoring System is described as a device for continuous, non-invasive patient monitoring. It measures physiological parameters (carbon dioxide tension, oxygen saturation, and pulse rate) directly from the patient's body (ear lobe or other conventional sites) without requiring the collection and analysis of a biological specimen.
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), the V-Sign™ Sensor and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only.
The V-Sign™ Sensor, model VS-A/P, is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of the V-Sign™ Sensor is indicated for carbon dioxide tension monitoring only.
SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clíp is for single-patient use and is indicated to attach the V-Sign™ Sensor to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose ear-lobes are too small to ensure adequate sensor application.
SenTec's Multi-Site Attachment Ring, model MAR-A/P/N, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult pediatric, and neonatal patients. The Multi-Site Attachment Ring, model MAR-A/P/N, is for single use and is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.
SenTec's Multi-Site Attachment Ring, model MAR-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult and pediatric patients. The Multi-Site Attachment Ring, model MAR-A/P, is for single use and is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.
Product codes (comma separated list FDA assigned to the subject device)
73 LKD, 74 DQA, 74 DPZ
Device Description
The SenTec Digital Monitoring System (SDMS) is a device consisting of a stand-alone monitor, a digital sensor, a connecting cable, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dloxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor) applied to the ear lobe with the SenTec Ear Clip.
This new 510(k) adds two new Multi-Site Attachment Rings for PCQ2 monitoring only, applied to a conventional PCO2 measurement site:
- MAR-A/P/N for adult, pediatric and neonatal patients .
- MAR-A/P for adult and pediatric patients
The monitoring features of the SDMS are unchanged
The Multi-Site Attachment Rings consists of a round adhesive pad integrated with a snap ring. The adhesive pad attaches to the patient's skin at the measurement site and the snap ring captures the V-Sign™ Sensor while permitting rotation and removal/reinsertion of the ring is prepared for application by removing an adhesive liner film.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear lobe, conventional measurement sites for carbon dioxide tension monitoring
Indicated Patient Age Range
adult, pediatric, neonatal
Intended User / Care Setting
hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments.
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)
Biocompatibility testing has been conducted for all patient contact materials in compliance with ISO 10993-1:2003. All materials met Biocompatibility requirements.
Detailed risk, hazard, and failure analyses were performed on the SDMS in consideration of the Multi-Site Attachment Rings. All hazards were mitigated to ALARP levels (as low as reasonably possible) and residual risks were determined to be acceptable.
Application tests performed with the V-Sign Sensor and Multi-Site Attachment Rings confirmed that the sensor was properly positioned for measurement of PCO2.
In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Single Sensor Monitorir
SenTec Digital Monitoring System 510(k) Notification
Section 5
SEP | 2007
Summary of Safety & Effectiveness
Section 5 - Summary of Safety & Effectiveness
510(k) Summary
Submitter [807.92(a)(1)]:
Address
Phone FAX
SenTec AG Ringstrasse 39 4106 Therwil - Switzerland +41 61 726 97 60 +41 61 726 97 61
Contact Person [807.92(a)(1)]:
Ms. Sabine Nieba, Ph.D. Quality & Regulatory Affairs Manager nieba@sentec.ch
Date prepared [807.92(a)(1)]:
August 18, 2007
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
SenTec Digital Monitor,
V-SignTM Sensor & Accessories for
sensor application/maintenance;
new Multi-Site Attachment Rings | Cutaneous Carbon
Dioxide Monitor | Monitor, Carbon-
Dioxide, Cutaneous | 73 LKD | II | 21 CFR Part
868.2480 |
| | Pulse Oximeter | Oximeter | 74 DQA | II | 21 CFR Part
870.2700 |
| | Pulse Oximeter | Oximeter, Ear | 74 DPZ | II | 21 CFR Part
870.2710 |
Substantially Equivalent to [807.92(a)(3)]:
| Device | Manufacturer | Comment | |
|---|---|---|---|
| K041548 | SenTec Digital Monitoring | ||
| System | SenTec AG | This device is predicate for PCO2, SpO2, and PR | |
| monitoring using the ear lobe as monitoring site in | |||
| adult and pediatric patients. | |||
| K063434 | TOSCA 500 tcPCO2, SpO2 | ||
| and PR monitoring system | Radiometer Basel AG | These devices are predicate for PCO2 only | |
| monitoring using the new Multi-Site Attachment Ring | |||
| to attach the V-Sign Sensor to the patient. | |||
| The "TOSCA Fixation Ring 32 mm" cleared in | |||
| K063434 is predicate for the usage of the Multi-Site | |||
| Attachment Ring in adult and pediatric patients. | |||
| K991644 | MicroGas 7650 | ||
| Transcutaneous Monitor | Linde Medical Sensors | The "Adhesive Ring 32 mm" cleared in K991644 is | |
| predicate for the usage of the Multi-Site Attachment | |||
| Ring in neonates. |
Reason For Submission: Additional or Expanded Indications
1
Description of the device [807.92(a)(4)]:
The SenTec Digital Monitoring System (SDMS) is a device consisting of a stand-alone monitor, a digital sensor, a connecting cable, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dloxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor) applied to the ear lobe with the SenTec Ear Clip.
This new 510(k) adds two new Multi-Site Attachment Rings for PCQ2 monitoring only, applied to a conventional PCO2 measurement site:
- MAR-A/P/N for adult, pediatric and neonatal patients .
- MAR-A/P for adult and pediatric patients
The monitoring features of the SDMS are unchanged
The Multi-Site Attachment Rings consists of a round adhesive pad integrated with a snap ring. The adhesive pad attaches to the patient's skin at the measurement site and the snap ring captures the V-Sign™ Sensor while permitting rotation and removal/reinsertion of the ring is prepared for application by removing an adhesive liner film.
Intended Use [807.92(a)(5)]:
The SenTec Digital Monitoring System - consisting of the SenTec Digital Monitor (SDM), the V-Sign™ Sensor and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only.
The V-Sign™ Sensor, model VS-A/P, is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of the V-Sign™ Sensor is indicated for carbon dioxide tension monitoring only.
SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, noninvasive carbon dioxide tension, 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 to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose ear-lobes are too small to ensure adequate sensor application.
SenTec's Multi-Site Attachment Ring, model MAR-A/P/N, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult pediatric, and neonatal patients. The Multi-Site Attachment Ring, model MAR-A/P/N, is for single use and is indicated to attach the V-Sign™ Sensorto conventional measurement sites for carbon dioxide tension monitoring,
SenTec's Multi-Site Attachment Ring, model MAR-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult and pediatric patients. The Multi-Site Attachment Ring, model MAR-A/P, is for single use and is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.
Comparison to predicate device [807.92(a)(6)]:
Confidential
2
The SenTec Digital Monitoring System has the same indications for use as well as the same indicated patient population as a combination of the predicate devices.
The new Multi-Site Attachment Rings are to be used only for PCO2 measurements. All relevant features of the SenTec Digital Monitoring System are equivalent to the TOSCA 500 as well as to the PCO2-part of the Microgas 7650. The key features are:
- same principles of operation (2 wavelength SpO2 measurement, and PCO2 electrode technology) -
- sensors heated to typically 42 °C (note SDMS uses 41°C for neonatal applications) ।
- equivalent or similar means to control sensor temperature and application time at the site -
- equivalent or similar sensor application means [adhesive Ear Clip and adhesive attachment rings]
- equivalent or similar sensor calibration unit integrated in monitor -
- equivalent or similar alarms, messages and menu structure as predicate devices -
- equivalent or similar accessories for maintenance: membrane exchange tool, sensor contact gel, service gas
The method of operation is equivalent to that of the SenTec Digital Monitoring System listed under K041548, in particular for sensor preparation and monitoring.
Non-Clinical Performance data [807.92(b)(1)]:
Biocompatibility testing has been conducted for all patient contact materials in compliance with ISO 10993-1:2003. All materials met Biocompatibility requirements.
Detailed risk, hazard, and failure analyses were performed on the SDMS in consideration of the Multi-Site Attachment Rings. All hazards were mitigated to ALARP levels (as low as reasonably possible) and residual risks were determined to be acceptable.
Application tests performed with the V-Sign Sensor and Multi-Site Attachment Rings confirmed that the sensor was properly positioned for measurement of PCO2.
Clinical Performance data [807.92(b)(2)]:
In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed.
Conclusion [807.92(b)(3)]:
The results of all laboratory and performance tests demonstrate that the SenTec Digital Monitoring System meets specified requirements.
As described above, the SenTec Digital Monitoring System with Multi-Site Attachment Rings performs in a manner equivalent to the predicate devices. Device safety is substantiated by risk analyses and biocompatibility of patient contact materials.
Other information [807.92(d)]:
Not applicable.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
SEP 12 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SenTec AG C/O Mr. Stephen H. Gorski Submission Correspondent for SenTec AG Imagenix, Incorporated S65 West 35739 Piper Road Eagle, Wisconsin 53119
Re: K071672
Trade/Device Name: SenTec Digital Monitoring System (SDMS) Regulation Number: 21 CFR 868.2480 Regulation Name: Cutaneous Carbon Dioxide (PcCO2 ) Monitor Regulatory Class: II Product Code: LKD Dated: May 21, 2007 Received: June 19, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 -Mr. Gorski
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
SenTec Digital Monitoring System (SDMS) Device Name:
Indications for use:
The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), the V-Sign™ Sensor and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only.
The V-Sign™ Sensor, model VS-A/P, is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of the V-Sign™ Sensor is indicated for carbon dioxide tension monitoring only.
SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clíp is for single-patient use and is indicated to attach the V-Sign™ Sensor to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose ear-lobes are too small to ensure adequate sensor application.
SenTec's Multi-Site Attachment Ring, model MAR-A/P/N, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult pediatric, and neonatal patients. The Multi-Site Attachment Ring, model MAR-A/P/N, is for single use and is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.
SenTec's Multi-Site Attachment Ring, model MAR-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult and pediatric patients, Continuous, fion Invasive corbon unside tenaily in the morning to cand is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.
X Prescription Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | 9/10/07 |
| Infection Control, Dental Devices | |
| Page 1 of 1 |
510(k) Number: K071672