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, noninyasive 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.

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-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.

AI/ML Overview

The provided text describes the SenTec Digital Monitoring System (SDMS) and its modifications/expansions, focusing on proving its substantial equivalence to predicate devices. However, it does not explicitly
detail a randomized controlled trial (RCT) or a specific study that includes all the requested elements for acceptance criteria and device performance in a summary table format. Instead, it references various tests and studies conducted to ensure compliance with standards and demonstrates performance.

Here's an attempt to extract and synthesize the information based on your request, as much as possible from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of what you'd typically expect for a clinical study with primary and secondary endpoints. Instead, it lists technical specifications and accuracy claims, often comparing them to predicate devices. The "reported device performance" is given as meeting these specified accuracy requirements or being equivalent to predicate devices.

Metric / Parameter	Acceptance Criteria (Implicit from Predicate/Claims)	Reported Device Performance (SDMS with V-Sign™ Sensor 2 and/or OxiVenT™ Sensor)
SpO2 Accuracy	V-Sign™ Sensor 2: 70 - 100%: ± 2% (Arms) for all approved sites.OxiVenT™ Sensor: 70 - 100%: ± 2.25% (Arms) for all approved sites.< 70%: unspecified. (These are the claims, acting as acceptance criteria for the new device as they align with/are compared to the predicate's claims)	V-Sign™ Sensor 2: 70 - 100%: ± 2% (Arms).OxiVenT™ Sensor: 70 - 100%: ± 2.25% (Arms).Results from clinical studies show that "reported saturation values from the SDMS meet specified accuracy requirements." (Implies meeting the claimed ranges).
PR Accuracy	± 3 bpm (Claimed)	± 3 bpm."Bench performance testing verified that the SenTec Digital Monitoring System (SDMS) measures pulse rate values within specified accuracy claims for all supported sensor types."
PCO2 Drift	typically < 0.5%/h (Claimed, aligned with predicate)	typically < 0.5%/h
PCO2 Linearity	typically < 1.0 mmHg (0.13 kPa) (Claimed, aligned with predicate)	typically < 1.0 mmHg (0.13 kPa)
PO2 Drift	< 0.1%/h (Claimed)	< 0.1%/h
PO2 Linearity	< 1 mmHg (0.1 kPa) (Claimed)	< 1 mmHg (0.1 kPa)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document states that "Clinical studies were performed using the SenTec Digital Monitoring System (SDMS) with healthy adult volunteer subjects". However, it does not specify the exact number of subjects or cases (sample size) used in these clinical studies.
Data Provenance: The studies were conducted with "healthy adult volunteer subjects." The country of origin is not explicitly stated. The studies are described as "Clinical studies," implying prospective data collection for the purpose of this submission.
- Retrospective/Prospective: Based on the description ("Clinical studies were performed..."), the data appears to be prospectively collected for the purpose of demonstrating device performance for this regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document primarily discusses technical performance and accuracy against a reference standard rather than expert-established ground truth for a diagnostic interpretation.

For SpO2 monitoring, the ground truth was "arterial hemoglobin oxygen saturation determined from arterial blood samples with a CO-Oximeter as reference." This is a high-precision instrument-based reference, not an expert panel.
For PCO2 and PO2, comparison is made against the performance of predicate devices or established technical specifications. There's no mention of experts establishing a diagnostic ground truth.

Therefore, this section is not applicable in the traditional sense of diagnostic AI studies requiring expert interpretation.

4. Adjudication Method for the Test Set

As the ground truth for the clinical studies was established using a CO-Oximeter (a reference instrument) for SpO2 and technical specifications/predicate device performance for other parameters, there was no need for an adjudication method by expert reviewers. This section is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies described are focused on the device's accuracy against a physical reference standard, not its impact on human reader performance or diagnostic accuracy.
Effect Size: Not applicable, as no such study was performed or described.

6. Standalone Performance

Yes, a standalone performance study was done. The described "Clinical studies" and "Bench Performance testing" assess the device's accuracy and performance in measuring physiological parameters (PCO2, PO2, SpO2, PR) independently. The results (e.g., SpO2 accuracy of ± 2% for V-Sign™ Sensor 2 and ± 2.25% for OxiVenT™ Sensor for 70-100% range against CO-Oximeter, PR accuracy of ± 3 bpm, PCO2/PO2 drift and linearity) are indicative of the device's standalone performance.

7. Type of Ground Truth Used

SpO2: Arterial hemoglobin oxygen saturation determined from arterial blood samples with a CO-Oximeter as reference. This is an objective, instrument-based reference standard.
PCO2, PO2, PR: Performance claims are evaluated against technical specifications and comparison to predicate devices. While not explicitly stated as "ground truth" for each specific study, the acceptance of these metrics implies internal validation against established physical or chemical reference methods for sensor calibration and accuracy.

8. Sample Size for the Training Set

The document describes the device as a "SenTec Digital Monitoring System (SDMS)," which is a hardware-based medical device with integrated software/firmware for physiological monitoring. This is not an AI/ML device in the context of typical training sets for models. Therefore, the concept of a "training set" in the machine learning sense is not applicable to this device as described.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for an AI/ML model in the context of this traditional medical device submission, this question is not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K151329

Device Name SenTec Digital Monitoring System (SDMS)

Indications for Use (Describe)

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.

Caution: Federal law restricts this device to sale by or on the order of a physician.

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X Prescription Use (Part 21 CFR 801 Subpart D)

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510(k) Summary

Submitter [807.92(a)(1)]:	Address	SenTec AGRingstrasse 394106 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 Managerweisbrich@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	ClassificationName	ProductCode	Class	RegulationNumber
SenTec Digital MonitoringSystem (SDMS)SenTec Digital Monitor (SDM),sensors, accessories for sensorapplication/maintenance;V-STATS™ PC-based trendreporting, data analysis and remotemonitoring Software for the SDM	Cutaneous CarbonDioxide Monitor	Monitor, Carbon-Dioxide, Cutaneous	LKD	II	21 CFR Part868.2480
	CutaneousOxygen Monitor	Monitor, oxygen,cutaneous, for infantnot under gasanesthesia	KLK	II	21 CFR Part868.2500
	CutaneousOxygen Monitor	Monitor, oxygen,cutaneous, for usesother than for infantnot under gasanesthesia	LPP	II	21 CFR Part868.2500
	Pulse Oximeter	Oximeter	DQA	II	21 CFR Part870.2700
	Pulse Oximeter	Oximeter, Ear	DPZ	II	21 CFR Part870.2710

Substantially Equivalent to [807.92(a)(3)]:

	Device	Manufacturer	Comment
K101690	SenTec Digital MonitoringSystem	SenTec AG	This device is predicate for PCO2, SpO2, and PRmonitoring for monitoring of PCO2, SpO2, and PR atthe ear lobe, forehead and cheek in adult andpediatric patients and for PCO2 monitoring only inadult, pediatric and neonatal patients usingconventional PCO2 measurement sites.
K093154	TCM CombiM	Radiometer	This device is the predicate for PO2 monitoring onconventional PO2 monitoring sites in adult andthrough neonatal patients.
K101690	V-STATS™ PC softwareV3.00	SenTec AG	The V-STATS™ software V3.00 (including theV-CareNeT remote monitoring package) is predicatefor trend reporting, data analysis and remotemonitoring of the SenTec Digital Monitor using thecurrent V-STATS V4.00, which includes the new PO2monitoring parameter.

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Reason For Submission: Additional or Expanded Indications

Description of the device [807.92(a)(4)]:

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.

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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.

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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 orV-Sign™ Sensor 2	Predicate DeviceSDMS with V-Sign™ 2 Sensor	Predicate DeviceTCM 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 orV-Sign™ Sensor 2	Predicate DeviceSDMS with V-Sign™ 2 Sensor	Predicate DeviceTCM CombiM with tc Sensor 84
Sensorsconsidered incomparison	V-Sign™ Sensor 2 (VS-A/P/N):PCO2, SpO2, PROxiVenT™ 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 forPCO2, PO2 monitoring.	Adults, Pediatrics for PCO2, SpO2,PR monitoring.Adults, Pediatrics, Neonates forPCO2-only monitoring.	Adults, Pediatrics, Neonates forPCO2, PO2 monitoring.
Intended Use(monitoringsystem)	The SenTec Digital MonitoringSystem - consisting of the SenTecDigital Monitor (SDM), sensors andaccessories - is indicated forcontinuous, noninvasive patientmonitoring.	The SenTec Digital MonitoringSystem - consisting of the SenTecDigital Monitor (SDM), sensors andaccessories - is indicated forcontinuous, noninvasive patientmonitoring.	The TCM CombiM monitoring systemis intended for continuoustranscutaneous monitoring of carbondioxide (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)< 70%: unspecified	For all approved sites:V-Sign™ Sensor 2: 70 - 100%: ±2% (Arms)< 70%: unspecified	N/A
PR range	30 - 250 bpm	30 – 250 bpm	N/A
PR Accuracy	± 3 bpm	± 3 bpm	N/A
PCO2 range	0 – 200 mmHg (0 – 26.7 kPa)	0 - 200 mmHg (0 - 26.7 kPa)	5-200 mmHg (0.7-26.7 kPa)
PCO2 Drift	typically < 0.5%/h	typically < 0.5%/h	≤ 1%/h
PCO2 Responsetime	V-Sign™ Sensor 2: typically < 75 sOxiVenT™ Sensor:: typically < 80 s	V-Sign™ Sensor 2: typically < 75 s	≤ 60 sec
PCO2 Linearity	typically < 1.0 mmHg (0.13 kPa)	< 1.0 mmHg (0.13 kPa)	at 1 % CO2: better than 1 mmHg(0.13 kPa)at 10 % CO2: better than 1 mmHg(0.13 kPa)at 33 % CO2: better than 5 mmHg(0.67 kPa)
PO2 range	0 - 800 mmHg(0 - 106.7 kPa)	N/A	0 - 800 mmHg(0.0 - 99.9 kPa)
PO2 Drift	< 0.1%/h	N/A	≤ 1%/h
PO2 Responsetime	< 120 s	N/A	≤ 25 sec
Alarm System	Physiological and technical alarms.Auditory and visual alarm signals	Physiological and technical alarms.	Physiological and technical alarms.
Claim /Attribute	Modified Device (Applicant)SDMS with OxiVenT™ Sensor orV-Sign™ Sensor 2	Predicate DeviceSDMS with V-Sign™ 2 Sensor	Predicate DeviceTCM CombiM with tc Sensor 84
PO2 Linearity	< 1 mmHg (0.1 kPa)	N/A	at 0 % O2: better than 1 mmHg(0.13 kPa)at 21 % O2: better than 3 mmHg(0.4 kPa)at 50 % O2: better than 5 mmHg(0.67 kPa)at 90 % O2: better than 25 mmHg(3.33 kPa)

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Image /page/8/Picture/0 description: The image shows the word "sentec" in a stylized font. The letters "s", "e", "n", "c" are in black, while the letter "T" is in orange. The logo appears to be for a company or organization named Sentec.

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Image /page/9/Picture/0 description: The image shows the word "sentec" in a sans-serif font. The letters "s", "e", "n", "e", and "c" are black, while the "T" is orange. The logo is simple and modern.

Claim /Attribute	New Device (Applicant)V-STATS™ V4.00 (incl. V-CareNeT™ Package)	Predicate DeviceV-STATS™ V3.00 (incl. V-CareNeT™ Package)
Manufacturer	SenTec AG	SenTec AG
Covered by K-Number	(To be assigned)	K101690
Brand Name	V-STATS™ Software (incl. V-CareNeT™ Package)	V-STATS™ Software (incl. V-CareNeT™ Package)
Supported device	SDM with OxiVenT™ Sensor or SDM with V-Sign™Sensor	SDM with V-Sign™ Sensor 2
Intended Use	V-STATS™ is a PC-based software which is intended foruse with the SenTec Digital Monitor (SDM) whenremote monitoring and/ or trend reporting andstatistical analysis of the data measured by the SDM isrequired. V STATS™ is not intended to providediagnosis, it is intended to supplement and not toreplace any part of the SDM monitoring procedures.	V-STATS™ is a PC-based software which is intended foruse with the SenTec Digital Monitor (SDM) whenremote monitoring and/ or trend reporting andstatistical analysis of the data measured by the SDM isrequired. V STATS™ is not intended to providediagnosis, it is intended to supplement and not toreplace any part of the SDM monitoring procedures.
Required SystemComponents	Trend Data Download from SenTec Digital Monitor(SDM) via serial interface• PC with V-STATS 4.00• SDM with SMB-SW-V07.01 or higher• conventional serial cable to connect SDM to PC withV-STATS	Trend Data Download from SenTec Digital Monitor(SDM) via serial interface• PC with V-STATS 3.00• SDM with SMB-SW-V06.10 or newer• conventional serial cable to connect SDM to PC withV-STATS
	Trend Data Download from SDM via LAN interface(network)• PC with V-STATS 4.00, V-CareNeT Package must beactivated• SDM with SMB-SW-V07.01 or higher• local-area network (LAN) with router / switch	Trend Data Download from SDM via LAN interface(network)• PC with V-STATS 3.00, V-CareNeT Package must beactivated• SDM with SMB-SW-V07.00• local-area network (LAN) with router / switch
	Operating system:Microsoft Windows XP (32 bits), Vista (32 and 64 bits),7 (32 and 64 bits), 8 (32 and 64 bits), 8.1 (32 and 64bits)	Operating system:Microsoft Windows XP, Vista
Basic Menu functions	Data import/export, trend curve display, data analysis(e.g. event markers, set baseline, statistical analysis),create analysis report, system setting, help menu (incl.searchable online help), remote monitoring	Data import/export, trend curve display, data analysis(e.g. event markers, set baseline, statistical analysis),create analysis report, system setting, help menu,remote monitoring
Parametersdisplayed	PCO2, PO2, SpO2, PR, PI (pulsation index), HP (heatingpower)	PCO2, SpO2, PR
Data presentationoptions	Trend curves, statistical analysis, customized analysisreports for print-out or pfd	Trend curves, statistical analysis, customized analysisreports for print-out
Remote monitoringoption	V-CareNeT™ included	V-CareNeT™ included

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Non-Clinical Performance data [807.92(b)(1)]:

Standards Testing (Electrical, Mechanical and Environmental)

The SenTec Digital Monitoring System (SDMS) was tested to applicable standards for medical device Electrical Safety, Electromagnetic Compatibility, Shock and Vibration, and Environmental Temperature and Humidity. Additionally the device was tested in accordance with applicable alarm standards as well as FDA Guidance Documents and particular standards applicable for pulse oximeters and cutaneous PCO2, PO2 monitors.

Biocompatibility Testing

Biocompatibility testing has been conducted for all patient contact materials in compliance with ISO 10993-1:2009. Scope of testing addressed the new/changed materials of the V-Sign™ Sensor 2 and OxiVenT™ Sensor, as well as the new Staysite™ Adhesive pad. Testing included cytotoxicity, sensitization and irritation, consistent for the specified use with intact skin. Results of testing indicate the materials were non-cytotoxic, non-irritant, and did not elicit a sensitization response. All materials met Biocompatibility requirements.

Risk Analysis

Detailed risk, hazard, and failure analyses were performed on the SenTec Digital Monitoring System (SDMS) in consideration of the additions being introduced with this new 510(k). All hazards were mitiqated as low as possible and residual risks were determined to be acceptable.

Software Development and Testing

The SenTec Digital Monitoring System (SDMS) software was developed in accordance with FDA guidelines for MODERATE level of concern devices. The software was verified to requirements and validated to meet the specified intended use(s).

Bench Performance testing

Bench performance testing verified that the SenTec Digital Monitoring System (SDMS) measures pulse rate values within specified accuracy claims for all supported sensor types.

Clinical Performance data [807.92(b)(2)]:

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.

Conclusion [807.92(b)(3)]:

The results of all laboratory tests demonstrate that the SenTec Digital Monitoring System (SDMS) meets specified requirements.

The clinical and non-clinical testing performed demonstrates that the SenTec Digital Monitoring System (SDMS) performs as well as the predicate devices, and therefore, it is substantial equivalent to the predicate devices.

Other information [807.92(d)]:

Not applicable.

Regulation Number and Section

§ 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.