Sentec Digital Monitoring System (SDMS) tCOM+ by Sentec AG

The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.

The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.

The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.

Device Description

Sentec's Digital Monitoring System is intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR) in adult and pediatric patients as well as for PCO2 and PO2 monitoring in neonatal patients.

The tCOM+ (REF 103164) is a portable, lightweight, stand-alone monitor with a convenient carrying handle and with an integrated calibration and storage facility for the V-Sign™ Sensor 2 or OxiVenT™ Sensor, respectively. It provides continuous and noninvasive PCO2, SpO2 and PR monitoring if used with a V-Sign™ Sensor 2 or PCO2, PO2, SpO2 and PR monitoring if used with a OxiVenT™ Sensor.

AI/ML Overview

Acceptance Criteria and Study for Sentec Digital Monitoring System (SDMS) tCOM+

The Sentec Digital Monitoring System (SDMS) tCOM+ is a transcutaneous blood gas monitoring system intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PO2), oxygen saturation (SpO2), and pulse rate (PR). The tCOM+ is an updated version of the previously cleared Sentec Digital Monitor (SDM), with technological upgrades such as a touchscreen user interface and wireless communication capabilities.

The submission focuses on demonstrating substantial equivalence to its predicate device, the SDM, and updated disposables. The core performance of the device, particularly its measurement modalities, is considered unchanged from the predicate. Therefore, the acceptance criteria and supporting studies primarily revolve around verifying the safety and effectiveness of the new monitor features and updated accessories, and demonstrating that the clinical performance remains consistent with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (Summary from Submission)
Electrical Safety	Compliance with AAMI ANSI ES 60601-1: 2005 + A1: 2012 + A2: 2021 (General requirements for basic safety and essential performance).	Device was tested to applicable standards and all specified requirements were met.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2: 2014 + A1:2020 (Electromagnetic disturbances - Requirements and tests) and IEC TR 60601-4-2 (Guidance and interpretation --Electromagnetic immunity).	Device was tested to applicable standards and all specified requirements were met.
Home Healthcare Environment Use	Compliance with IEC 60601-1-11:2015 + A1:2020 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment).	Device was tested to applicable standards and all specified requirements were met.
Particular Requirements (TC Partial Pressure Monitoring)	Compliance with IEC 60601-2-23:2011 (Particular requirements for the basic safety and essential performance of TC partial pressure monitoring).	Device was tested to applicable standards and all specified requirements were met.
Particular Requirements (Pulse Oximeter)	Compliance with ISO 80601-2-61:2017 (Particular requirements for basic safety and essential performance of pulse oximeter equipment).	Device was tested to applicable standards and all specified requirements were met.
Wireless Coexistence	Compliance with AAMI TIR69:2017 (Risk management of radio-frequency wireless coexistence) and ANSI C63.27-2017 (Evaluation of Wireless Coexistence).	Device was tested to applicable standards and all specified requirements were met.
Usability	Compliance with IEC 60601-1-6:2020 (Usability) and successful Human Factors Evaluation testing according to FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 2016).	A Human Factor Evaluation testing was performed following the FDA Guidance and the results demonstrate that the device meets specified requirements.
Alarm Systems	Compliance with IEC 60601-1-8:2020 (General requirements, tests and guidance for alarm systems).	Device was tested to applicable standards and all specified requirements were met.
Bench Performance	All specified requirements for mechanical strength, ingress of liquids, and electronic performance.	Bench tests were conducted, and all specified requirements were met.
Biocompatibility	Compliance with ISO 10993-1:2018 for all patient contact materials (e.g., Contact Gel, Multi-Site Attachment Ring, Non-Adhesive Wrap).	Biocompatibility testing was conducted for all patient contact materials in compliance with ISO 10993-1:2018, and all materials met Biocompatibility requirements.
Risk Management	All hazards mitigated as far as possible, and residual risks determined to be acceptable.	Detailed risk, hazard, and failure analyses were performed, all hazards were mitigated, and residual risks were determined to be acceptable.
Software Development	Development in accordance with FDA guidelines for MODERATE level of concern devices; software verified to requirements and validated to meet specified intended use(s).	The software was developed in accordance with FDA guidelines for MODERATE level of concern devices, verified to requirements, and validated to meet the specified intended use(s).
Clinical Performance	No degradation in clinical functionality or performance compared to the predicate device (SDM) for tcPCO2, tcPO2, SpO2, and PR monitoring. This includes the performance of the updated disposables.	No new clinical performance data were generated as the tCOM+ uses the same sensors without software changes impacting algorithm or clinical performance. The updated disposables (Calibration Gas, MARe-MI, Non-Adhesive Wrap, Contact Gel, Membrane Changer) do not affect the clinical functionality or performance.

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

The provided documentation does not specify sample sizes for test sets in the context of clinical performance data. The submission explicitly states:

"No clinical performance data were generated on the tCOM+, because compared to its predicate device, the Sentec Digital Monitor (SDM), it uses the same sensors without software changes impacting algorithm or clinical performance."
"The introduction of the updated disposables...do not affect the clinical functionality or performance of Sentec's Digital Monitoring System. No further clinical data was required to support safety and performance."

Therefore, there isn't a "test set" of patient data for clinical performance in the context of the tCOM+ submission. The testing done involved non-clinical performance (bench testing, biocompatibility, risk management, software validation, human factors) and compliance with various recognized standards.

For the Human Factors Evaluation testing, while a sample size for participants is typically part of such studies, the document does not disclose this information or the data provenance.

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

Given that "no clinical performance data were generated" for the tCOM+ as the clinical functionality and performance are considered unchanged from the predicate, no experts were used to establish ground truth for a new clinical test set for this submission. The ground truth for the predicate device's performance would have been established during its initial clearance, but that information is not part of this 510(k) summary.

4. Adjudication Method for the Test Set

Since no new clinical test set was generated for the tCOM+, there was no adjudication method employed for clinical data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that no clinical performance data were generated for the tCOM+, as the device's core measurement technology and algorithms are identical to its predicate. Therefore, there is no effect size reported for human readers with or without AI assistance, as AI assistance is not described as a new feature requiring such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The submission does not specifically describe a standalone (algorithm only) performance study in the context of new clinical data. The device is a monitoring system that interacts with a human user (professional medical personnel or trained lay operators). The core measurement algorithms for PCO2, PO2, SpO2, and PR are stated to be "unchanged" and "identical" to the predicate. The software development and testing focused on verification to requirements and validation to meet specified intended uses, implying the algorithm's performance inherited from the predicate was considered sufficient.

7. The Type of Ground Truth Used

For the non-clinical aspects:

Mechanical, Electrical, EMC, Safety Standards: Compliance with industry-recognized standards (e.g., IEC 60601 series, ISO 80601-2-61). The "ground truth" here is adherence to the technical specifications and test methodologies defined by these standards.
Biocompatibility: Compliance with ISO 10993-1:2018. The "ground truth" is established by laboratory testing results against the criteria within this standard.
Risk Management: Identification and mitigation of hazards, with acceptable residual risks. The "ground truth" is the thoroughness of the risk analysis and the documented resolution of identified risks.
Software Development: Verification to requirements and validation to intended use. The "ground truth" is the functional correctness and reliability of the software against its specifications.
Human Factors: Conformance to usability engineering principles as per FDA guidance. The "ground truth" is successful completion of human factors testing.

For clinical performance, the ground truth is assumed to be equivalent to the predicate device's established clinical ground truth, as the core measurement technology, sensors, and algorithms remain unchanged. The original predicate device's clearance would have relied on appropriate clinical data (e.g., comparison to arterial blood gas measurements for PCO2/PO2, or co-oximetry for SpO2), but this is not detailed in the current submission.

8. The Sample Size for the Training Set

The submission does not mention a training set in the context of new algorithm development or machine learning. Since the software changes primarily relate to the user interface and connectivity, and the measurement algorithms are "identical to the configuration listed under K151329" (the predicate), there was no new training required for clinical algorithms.

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

As no new training set for algorithms was used in this submission, this question is not applicable.

Summary

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May 17, 2024

Sentec AG % Paul Dryden Consultant ProMedic Consulting LLC 131 Bav Point Dr NE Saint Petersburg, Florida 33704

Re: K232516

Trade/Device Name: Sentec Digital Monitoring System (SDMS) tCOM+ Regulation Number: 21 CFR 868.2480 Regulation Name: Cutaneous Carbon Dioxide (Pcco2) Monitor Regulatory Class: Class II Product Code: LKD, KLK, LPP, DQA, DPZ Dated: April 16, 2024 Received: April 17, 2024

Dear Paul Dryden:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.

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See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232516

Device Name Sentec Digital Monitoring System (SDMS)

Indications for Use (Describe)

Note: This manual uses the term "system" to refer to any combination of the tCOM+ or SDM and sensors, cables, accessories, disposables, and software.

The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.

Intended patient population: tcPCO2 and tcPO2 monitoring is indicated in adult/pediatric (older than term birth plus 12 months) and neonatal (younger than term birth plus 12 months) patients. Pulse oximetry monitoring is indicated in adult/ pediatric patients only.

The target user population: of the Sentec Digital Monitoring System (SDMS) is professional medical personnel, e.g. nurses, physicians, and - if under clinical supervision - lay operators. The correct and safe application of tcPCO2 and tcPO2 measuring equipment require straining of the user (e.g. physiological restrictions, technical aspects such as membrane change, meaning of drift, calibration). Home care providers also require specific training to be allowed to install the SDMS in home environments and to instruct lay persons how to apply the sensors correctly. The lay operator can-not modify the tCOM+ configuration by means of its menu.

Training: Professional medical personnel and instructed home care personnel are trained by Sentec or a qualified and authorized distributor. The instructed home care personnel provide the lay user manual and explains attachment and detachment of the sensor. The instructed home care personnel also define the for the attachment of the sensor.

Environment of 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. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas. Hospital type facilities typically cover facilities such as surgical centers, special nursing facilities and sleep labs out-side of the hospital transport includes transport of a patient within the hospital or hospital-type facilities.

The SDMS fulfills the requirements of a non-transit operable device to be used in home environments.

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared:

17-May-2024

510(k) Summary

1 Sponsor

Sentec AG Ringstrasse 39 4106 Therwil, Switzerland Tel: +41 61 726 97 60

Sponsor Contact:

Caroline Möller, Ph.D., Global Head of Regulatory Affairs and Quality Assurance

Submission Contact: Paul Dryden, ProMedic Consulting LLC

2 Device

Proprietary or Trade name Sentec Digital Monitoring System (SDMS) with tCOM+

Common/Usual Name

Transcutaneous blood gas monitoring system

Classification CFR

21 CFR §868.2480 21 CFR §868.2500 21 CFR §868.2700 21 CFR §868.2710

Product codes

LKD - Monitor, Carbon-Dioxide, Cutaneous KLK - Monitor, oxygen, cutaneous, for infant not under gas anesthesia LPP - Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia DQA - Oximeter DPZ- Oximeter, Ear

Predicate 510(k)s:

Sentec Digital Monitoring System (SDMS) with SDM K041548, K071672, K101690, K151329.

Reason for Submission: Introduction of the new patient monitor tCOM+ and its accessories for the previously cleared Sentec Digital Monitoring System. The tCOM+ is the successor monitor of Sentec's

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Digital Monitor (SDM). The tCOM+ monitor comprises the same features as the predicate monitor SDM but has an updated user interface controllable via touchscreen and wireless communication interfaces.

3 Device Description

The introduction of the new patient monitor tCOM+ as part of Sentec's Digital Monitoring System does not change the indications for use nor the intended patient population.

Compared to Sentec's Digital Monitoring System configuration cleared under K151329, the technological characteristics (hardware and software) regarding continuous, noninvasive patient monitoring of PCO2, PQ2, SpO2 and PR remain unchanged and are identical to the configuration listed under K151329.

ব Indications for Use

The Sentec Digital Monitoring System (SDMS) - consisting of a patient monitor, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.

The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and noninvasive.

The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor, the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.

The target user population: The Sentec Digital Monitoring System (SDMS) is professional medical personnel, e.g. nurses, physicians, and - if under clinical supervision - lay operators. The correct and safe application of tcPC02 and tcP02 measuring equipment requires training of the user (e.g.

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physiological restrictions, technical aspects such as membrane change, meaning of drift calibration). Home care providers also require specific training to be allowed to install the SDMS in home Environments and to instruct lay persons how to apply the sensors correctly. The lay operator cannot modify the tCOM+ configuration by means of its menu.

Training: Professional medical personnel and instructed home care personnel are trained by Sentec or a qualified and authorized distributor. The instructed home care personnel provide the lay user with the lay user manual and explain attachment of the sensor. The instructed home care personnel also define the application site for the attachment of the sensor.

Environment of use: In clinical and non-clinical settings such as hospital-type facilities, intrahospital transport environments, clinics, physician offices, ambulatory surgery centers and – if under clinical supervision - home environments. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas. Hospital type facilities typically cover facilities such as surgical centers, special nursing facilities and sleep labs outside of the hospital Intra-hospital transport includes transport of a patient within hospitals or hospital-type facilities.

The SDMS fulfils the requirements of a non-transit operable and portable device to be used in home environments.

Technological Characteristics 5

Sentec´s new patient monitor tCOM+ uses the same basic principles of operation and similar technology as the predicate device SDM. The tCOM+ introduces technological upgrades such as an updated monitor graphical user interface controllable via touchscreen and wireless connectivity. The tCOM+ is as safe and effective as its predicate device SDM.

Some of the already cleared disposables have been updated (Membrane Changer single-use, Multi-Site Attachments Rings "easy", Contact Gel single-use and Non-Adhesive Wrap).

The latest version of the V-STATS™ PC remains unchanged as cleared in K151329 regarding remote monitoring and/or trend reporting and statistical data analysis.

6 Comparison of Technological Characteristics and Performance with the Predicate

Table 1 compares the tCOM+ with the predicate Sentec Digital Monitor.

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Table 1: Comparison of tCOM+ vs. Predicate SDM

Claim / Attribute	Subject device	Predicate Device	Comments
Brand name /Model	tCOM+ (REF 103164)	Sentec Digital Monitor (REF SDM)	N/A
Description ofdevice	The tCOM+ is a portable, lightweight, stand-alonemonitor with a convenient carrying handle and withan integrated calibration and storage facility forSentec's digital sensors.tCOM+ provides the same features as the predicatedevice Sentec Digital Monitor but has a modern userinterface which is controllable via touchscreen andwireless communication interfaces.	Sentec's Digital Monitor (SDM) is a portable, stand-alone monitor with an integrated calibration andstorage facility for Sentec's digital sensors.	Similar
510(k)	K232516	K151339	N/A
Product codes	LKD, KLK, LPP	LKD, KLK, LPP	Identical
Regulationnumbers	21 CFR Part 868.248021 CFR Part 868.2500	21 CFR Part 868.248021 CFR Part 868.2500	Identical
Prescriptiondevice	Yes	Yes	Identical
Intendedpatientpopulation	tcPCO2 and tcPO2 monitoring is indicated in adult,pediatric and neonatal patients. Pulse oximetrymonitoring is indicated in adult/pediatric patientsonly.	tcPCO2 and tcPO2 monitoring is indicated in adult,pediatric and neonatal patients. Pulse oximetrymonitoring is indicated in adult/pediatric patientsonly.	Identical
Indication for Use	The tCOM+ is a portable stand-alone patient monitorintended for continuous, noninvasive patientmonitoring of carbon dioxide partial pressure(PCO2), oxygen partial pressure (PO2), functionaloxygen saturation (SpO2) and pulse rate (PR), usingeither	The SDM is a portable stand-alone patient monitorintended for continuous, noninvasive patientmonitoring of carbon dioxide partial pressure (PCO2),oxygen partial pressure (PO2), functional oxygensaturation (SpO2) and pulse rate (PR), using either• single, digital sensor (V-Sign™ Sensor 2) forPCO2, SpO2 and PR measurement, OR	Identical
	• single, digital sensor (V-Sign™ Sensor 2) forPCO2, SpO2 and PR measurement, OR• a single, digital sensor (OxiVenT™ Sensor) forPCO2, PO2, SpO2 and PR measurementPO2 measurement with tCOM+ is only possiblewhen used in combination with an OxiVenT™Sensor.	• a single, digital sensor (OxiVenT™ Sensor) forPCO2, PO2, SpO2 and PR measurementPO2 measurement with SDM is only possible whenused in combination with an OxiVenT™ Sensor.
Environment ofuse	In clinical and non-clinical settings such as hospitals,hospital-type facilities, intra-hospital transportenvironments, clinics, physician offices, ambulatorysurgery centers and - if under clinical supervision -home environments. Hospital use typically coversareas such as general care floors, operating rooms,special procedure areas, intensive and critical careareas. Hospital type facilities typically cover facilitiessuch as surgical centers, special nursing facilitiesand sleep labs outside of the hospital. Intra-hospitaltransport includes transport of a patient within thehospital or hospital-type facilities.	In clinical and non-clinical settings such as hospitals,hospital-type facilities, intra-hospital transportenvironments, clinics, physician offices, ambulatorysurgery centers and - if under clinical supervision -home environments. Hospital use typically coversareas such as general care floors, operating rooms,special procedure areas, intensive and critical careareas. Hospital type facilities typically cover facilitiessuch as surgical centers, special nursing facilitiesand sleep labs outside of the hospital. Intra-hospitaltransport includes transport of a patient within thehospital or hospital-type facilities.	Identical
Method ofoperation	Power is applied to the monitor.Sensor is heated, calibrated and monitor isconfigured (alarms etc.).Sensor applied to patient with Ear Clip or Multi-SiteAttachment Rings or Non-Adhesive Wrap and usingContact Gel.The patient's SpO2, PR, and/or PCO2 and/or PO2 aremonitored. If monitoring continues for more thanpredefined time an alarm is triggered (Site Timer)and site must be inspected.	Power is applied to the monitor.Sensor is heated, calibrated and monitor isconfigured (alarms etc.).Sensor applied to patient with Ear Clip or Multi-SiteAttachment Rings or Non-Adhesive Wrap and usingContact Gel.The patient's SpO2, PR, and/or PCO2 and/or PO2 aremonitored. If monitoring continues for more thanpredefined time an alarm is triggered (Site Timer)and site must be inspected.	Identical
	At every 8 - 12 hours, the sensor must be calibrated.	At every 8 -12 hours, the sensor must be calibrated.
	Membrane must be prepared (exchanged) typicallyevery 28 days.	Membrane must be prepared (exchanged) typicallyevery 28 days.
Physicalcharacteristics	The tCOM+ is portable and mountable on a standardhospital rail.Height = 15.4 cmWidth = 26.8 cmDepth = 16.2 cmWeight ~ 2.5 kg	The SDM is portable and mountable on a standardhospital rail.Height = 10.2 cmWidth = 27 cmDepth = 23 cmWeight ~ 2.5 kg	Similar
Portable	Yes, handle at the top of the monitor	Yes (flip feet serves as carrying handle)	Similar
Wirelessdatacommunication	The tCOM+ enables:Wi-Fi communication for connection tonetworks.Bluetooth communication (disabled in thesoftware for this version).RFID communication (disabled in the softwarefor this version).	The SDM offers no wireless data communication	Different,additionalcommunicationsinterface
User controls	The tCOM+ uses a touch screen to navigatebetween the different menus, and the powerON/STAND-BY switch is on the left-hand side of thepanel.	The SDM uses buttons to navigate between thedifferent menus, and the power ON/OFF switch is onthe rear of the panel.	Different,update to touchscreenUserInterface
	Sensor Adapter Cable (for tCOM+)	Digital Sensor Adapter Cable (for SDM)
Brand name /Model	Sensor Adapter Cable Regular (REF 103420), Long(REF 103421) and Extra Long (REF 103422)	Digital Sensor Adapter Cable 150 cm (REF AC-150),250 cm (REF AC-250) and 750 cm (AC-750)	N/A
DeviceDescription	Adapter cable required to connect the V-SignTMSensor 2 and OxiVenTTM Sensor to the tCOM+patient monitor. It transfers the power needed tooperate the sensor. It furthermore transmits digitizeddata between the digital sensor and the tCOM+.	Adapter cable required to connect the V-SignTMSensor 2 and OxiVenTTM Sensor to the SentecDigital Monitor. It transfers the power needed tooperate the sensor. It furthermore transmits digitizeddata between the digital sensor and the SDM.	Identical
Intended Use	Intended to connect digital Sentec sensors (V-SignTM Sensor 2, OxiVentTM Sensor) to the new patient monitor tCOM+.	Intended to connect digital Sentec sensors (V-SignTM Sensor 2, OxiVentTM Sensor) to the Sentec Digital Monitor.	Identical
	Calibration Gas (for tCOM+)	Service Gas (for SDM)
Brand name / Model	Calibration Gas (REF 103149) for tCOM+	Service Gas (REF GAS-0812) for SDM	N/A
Device Description	Calibration gas for docking station, cylinder of 0.21 l at 9.5 bar. The calibration gas is needed for the periodic calibration of the V-SignTM Sensor 2 and the OxiVentTM Sensor.	Calibration gas for docking station, cylinder of 0.56 l at 9.5 bar. The calibration gas is needed for the periodic calibration of the V-SignTM Sensor 2 and the OxiVentTM Sensor.	Similar
Intended Use	The Calibration Gas serves as calibration gas for Sentec's sensors that monitor tcPCO2 and/or tcPO2 (V-SignTM Sensor 2 and OxiVentTM Sensor). The Calibration Gas is intended for use only with the docking station integrated in the tCOM+.	The Service Gas serves as calibration gas for Sentec's sensors that monitor tcPCO2 and/or tcPO2 (V-SignTM Sensor 2 and OxiVentTM Sensor). The Service Gas, is intended for use only with the docking station integrated in the Sentec Digital Monitor.	Similar
Gas composition	8-vol% CO2, 12-vol% O2, 80-vol% N2 mixture	8-vol% CO2, 12-vol% O2, 80-vol% N2 mixture	Identical
Container characteristics	Gas bottle of 0.21 l at a pressure of 9.5 bar (2,05 l at 1 bar, 21°C). Compliant with TRG 300; 75/324/EWG; 94/1/EG; D.O.T.-2Q; Aerosol UN 1950 or Compressed Gas UN 1956, Non- flammable gas	Gas bottle of 0.56 l at a pressure of 9.5 bar (5.7 l at 1 bar, 21 °C). Compliant with TRG 300; 75/324/EWG; 94/1/EG; D.O.T.-2Q; Aerosol UN 1950 or Compressed Gas UN 1956, Non- flammable gas.	Similar

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510(k) Summary K232516

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Image /page/12/Picture/0 description: The image shows the word "sentec" in a sans-serif font. The word is gray, except for a small orange circle that replaces the period at the end of the word. The font is a rounded sans-serif, and the letters are closely spaced together.

The Table 2 hereafter compares the updated disposables with their predicates.

Table 2: New versions of Sentec's Digital Monitoring System Disposables in comparison with their Predicates

Claim / Attribute	Subject device	Predicate Device	Comments
Product codes	LKD, KLK, LPP, DQA	LKD, KLK, LPP, DQA	Identical
Regulationnumbers	21 CFR Part 868.2480, 21 CFR Part 868.2500,21 CFR Part 870.2700, 21 CFR Part 870.2710	21 CFR Part 868.2480, 21 CFR Part 868.2500,21 CFR Part 870.2700, 21 CFR Part 870.2710	Identical
Brand name /Model	Single Dose Contact GelSingle Dose Contact Gel (REF GEL-SD)	Contact GelContact Gel (REF GEL-04)	N/A
510(k)	K232516	K041548	N/A
Description ofdevice	Sentec's Contact Gel ensures adequate contactbetween the patient's skin and the sensor, i.e., CO2/O2 diffusing out of the skin will be trapped by thecontact liquid rather than diffusing to thesurroundings.	Sentec's Contact Gel ensures adequate contactbetween the patient's skin and the sensor, i.e., CO2/O2 diffusing out of the skin will be trapped by thecontact liquid rather than diffusing to thesurroundings.	Identical
Single use	Yes	No	Difference isonlythepackagingsize
Intended Use	The Contact Gel GEL-SD serves as contact gel toachieve proper gas conduction and heat transferbetween the patients' skin and Sentec's TC sensors.	The Contact Gel GEL-04 serves as contact gel toachieve proper gas conduction and heat transferbetween the patients' skin and Sentec's TC sensors.	Identical
Gel Composition	(>90%)Glycerol●1, 2 Propanediol●	(>90%)Glycerol●1, 2 Propanediol●	Identical
	Polyvinylpyrrolidone (PVP) low concentration Deionized Water	Polyvinylpyrrolidone (PVP) low concentration Deionized Water
Physicalcharacteristics	Vial of 0.3 g	Bottle of 5ml	Different
Biocompatibility	Prolonged intact skin contact, compliant with ISO-10993-5 and ISO 10993-10	Prolonged intact skin contact, compliant with ISO-10993-5 and ISO 10993-10	Identical
	Membrane Changer single use	Membrane Changer
Brand name /Model	Membrane changer (REF MC)	Membrane changer (REF MC-R, MC-I)	N/A
510(k)	K232516	K101690, K151339	N/A
Device Description	The Membrane Changer single-use allows for astraight-forward replacement of Sentec's SensorMembranes. The bottom of the device has an anti-slippery coating to improve usability.	The Membrane Changer allows for a straight-forwardreplacement of Sentec's Sensor Membranes. TheMembrane Changer reloadable (MC-R) can bereused by replacing its insert (MC-I).	Similar
Single use	Yes	No	Different
Indication for Use	The Membrane Changer serves as a tool to changethe electrolyte and membrane of the V-SignTM Sensor2 and the OxiVenTTM Sensor.	The Membrane Changer serves as a tool to changethe electrolyte and membrane of the V-SignTM Sensor2 and the OxiVenTTM Sensor.	Identical
	MARe-MI	MAR-MI
Brand name /Model	Multi-Site Attachment Ring "Easy" Mature/Intact(REF MARe-MI)	Multi-Site Attachment Ring Mature/Intact (REFMAR-MI)	N/A
510(k)	K232516	K071672, K101690, K151339	N/A
Device Description	Single use sensor application ring, recommended foradult, pediatric and neonatal patients. The adhesiveused to attach the application ring to the patient'sskin is hypoallergenic, pressure sensitive anddesigned for medical/surgical use. The use of MARe-MI therefore is recommended for mature/intact skinapplications.	Single use sensor application ring, recommended foradult, pediatric and neonatal patients. The adhesiveused to attach the application ring to the patient'sskin is hypoallergenic, pressure sensitive anddesigned for medical/surgical use. The use of MAR-MI therefore is recommended for mature/intact skinapplications.	Similar
	The design of the snap ring itself has been optimizedto ensure easy insertion/removal of sensors into/fromthe ring.
Intended Use	Is intended to attach the Sentec sensors toconventional measurement sites. Recommended foradult, pediatric, and neonatal patients withmature/intact skin.	Is intended to attach the Sentec sensors toconventional measurement sites. Recommended foradult, pediatric, and neonatal patients withmature/intact skin.	Identical
Physicalcharacteristics	Snap ring inner diameter = 14.65 mmSnap ring outer diameter = 20 mmAdhesive ring diameter = 30 mmSnap ring color = WhiteSnap ring geometry = More snap joints, less wide	Snap ring inner diameter = 14.65 mmSnap ring outer diameter = 20 mmAdhesive ring diameter = 30 mmSnap ring color = GreySnap ring geometry = Fewer snap joints, wider	Similar
Biocompatibility	Prolonged intact skin contact, compliant with ISO-10993-5 and ISO 10993-10	Prolonged intact skin contact, compliant with ISO-10993-5 and ISO 10993-10	Identical
	Non-Adhesive Wrap	MAR-SF
BrandnameModel	/ Non-Adhesive Wrap (REF 103520)	Multi-Site Attachment Ring Sensitive/Fragile(REF MAR-SF)	N/A
510(k)	K232516	K071672, K101690, K151339	N/A
Device Description	The non-adhesive application ring, single-patient usefor up to 24 hours, is recommended for preterm /neonatal patients of very low birth weight and withsensitive/fragile skin. This applicator does not containany adhesives and is wrapped around the thigh.	Single use sensor application ring, recommended foradult, pediatric and neonatal patients withsensitive/fragile skin. The adhesive making skincontact is a silicone gel adhesive used in skin therapyand wound healing. The use of MAR-SF therefore isrecommended for sensitive/fragile skin applications.	Similar
Intended for Use	Is intended to be wrapped around the thigh ofneonatal patients with very sensitive/fragile skin forsubsequent attachment of Sentec's TC sensors.	Is intended to attach Sentec's TC sensors toconventional measurement sites, recommended foradult, pediatric and neonatal patients withsensitive/fragile skin.	Similar
Biocompatibility	Prolonged intact skin contact, compliant with ISO-10993-5 and ISO 10993-10	Prolonged intact skin contact, compliant with ISO-10993-5 and ISO 10993-10	Identical
Physicalcharacteristics	Snap ring inner diameter = 14.65 mmSnap ring outer diameter = 20 mmSnap ring geometry same as MARe-MIWrap dimension: Length = 53 mm, Width = 11mm	Snap ring inner diameter = 14.65 mmSnap ring outer diameter = 20 mmAdhesive ring diameter = 30 mm	Different

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510(k) Summary K232516

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7 Non-Clinical Performance data

Standards Testing

The tCOM+ was tested to applicable standards for medical devices:

AAMI ANSI ES 60601-1: 2005 + A1: 2012 + A2: 2021 Medical electrical equipment Part 1: -General requirements for basic safety and essential performance;
-IEC 60601-1-2: 2014 + A1:2020 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;
IEC 60601-1-11:2015 + A1:2020, Part 1-11 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment:
-IEC 60601-2-23:2011 - Particular requirements for the basic safety and essential performance of TC partial pressure monitoring;
-ISO 80601-2-61:2017 Particular requirements for basic safety and essential performance of pulse oximeter equipment;
IEC TR 60601-4-2 Medical electrical equipment Part 4-2: Guidance and interpretation --Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems;
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
-AAMI ES60601-1:2005, ES60601-1:2005/AMD1 1:2012, ES60601-1:2005/AMD2:2021 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
-IEC 60601-1-11:2015 + A1:2020, Part 1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment;
-IEC 60601-1-6:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability;
-IEC 60601-1-8:2020 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems;

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AAMI TIR69:2017 - Risk management of radio-frequency wireless coexistence for medical devices and systems;
-ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.

Bench Performance Testing

Bench tests were conducted on the tCOM+ in complicable standards for medical devices, and for mechanical strength, ingress of liquids and electronic performance. All specified requirements were met.

Biocompatibility Testing

Biocompatibility testing was conducted for all patient contact materials in compliance with ISO 10993-1:2018. All materials met Biocompatibility requirements.

Risk Management

Detailed risk, hazard, and failure analyses were performed on Sentec's Digital Monitoring System in consideration of the additions and modifications being introduced by the tCOM+ patient monitor and its accessories. All hazards were mitigated as far 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).

Human Factor Evaluation Testing

A Human Factor Evaluation testing was performed following the FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" from February 2016.

8 Clinical Performance data

No clinical performance data were generated on the tCOM+, because compared to its predicate device, the Sentec Digital Monitor (SDM), it uses the same sensors without software changes impacting algorithm or clinical performance.

The introduction of the updated disposables, the Calibration Gas for tCOM+ (103149), Multi-Site Attachment Ring "Easy" Mature/Intact (REF MARe-MI), the Non-Adhesive Wrap (REF 103520), the Contact Gel (REF GEL-SD) and the Membrane Changer single-use (REF MC), do not affect the clinical functionality or performance of Sentec's Digital Monitoring System. No further clinical data was required to support safety and performance.

The use of the devices (user interface/patient interface), use environment and indications for use remain unchanged.

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ഗ Conclusion

The tCOM+ and its accessories are determined to be substantially equivalent to the predicate devices of the previously cleared Sentec Digital Monitoring System.

Identical Indications for Use to the predicate devices. -
No change to patient populations. -
No change to environments of use. -
No changes to measurement modalities and related technology -

The results of the laboratory tests and the Human Factors Evaluation studies demonstrate that Sentec's Digital Monitoring System with tCOM+ patient monitor, and the updated disposables meet the specified requirements.

Non-clinical testing further demonstrates that the tCOM+ patient monitor, and associated disposables are safe, effective, and substantially equivalent to the predicate Sentec Digital Monitoring System components.

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.