Sentec Digital Monitoring System (SDMS) tCOM+

K232516 · Sentec AG · LKD · May 17, 2024 · Anesthesiology

Device Facts

Record IDK232516
Device NameSentec Digital Monitoring System (SDMS) tCOM+
ApplicantSentec AG
Product CodeLKD · Anesthesiology
Decision DateMay 17, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 868.2480
Device ClassClass 2
AttributesPediatric

Intended Use

The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation. The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive. The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring. Intended patient population: tcPCO2 and tcPO2 monitoring is indicated in adult/pediatric (older than term birth plus 12 months) and neonatal (younger than term birth plus 12 months) patients. Pulse oximetry monitoring is indicated in adult/ pediatric patients only. The target user population: of the Sentec Digital Monitoring System (SDMS) is professional medical personnel, e.g. nurses, physicians, and - if under clinical supervision - lay operators. The correct and safe application of tcPCO2 and tcPCO2 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.

Device Story

Portable, stand-alone monitor (tCOM+) for continuous, non-invasive monitoring of cutaneous carbon dioxide (tcPCO2), oxygen (tcPO2), oxygen saturation (SpO2), and pulse rate (PR). Inputs: signals from V-Sign Sensor 2 or OxiVenT Sensor applied to intact skin via attachment rings/wraps and contact gel. Device heats sensor, performs periodic calibration, and monitors physiological parameters. Output: real-time data displayed on touchscreen interface. Used in hospitals, clinics, and home environments by professional medical personnel or trained lay operators under clinical supervision. Facilitates clinical decision-making regarding patient ventilation and oxygenation status. Benefits: continuous monitoring without invasive blood sampling.

Clinical Evidence

No clinical data generated. Substantial equivalence supported by bench testing, biocompatibility testing (ISO 10993-1), and human factors evaluation. Device uses identical sensors and algorithms as the predicate (K151329).

Technological Characteristics

Portable, stand-alone monitor with touchscreen. Uses transcutaneous electrochemical sensing for PCO2/PO2 and pulse oximetry for SpO2/PR. Connectivity: Wi-Fi (Bluetooth/RFID disabled). Materials: biocompatible patient-contact components (ISO 10993). Power: AC/battery. Dimensions: 15.4cm x 26.8cm x 16.2cm; weight ~2.5kg. Software: Moderate level of concern.

Indications for Use

Indicated for non-invasive monitoring of oxygenation and ventilation in adult, pediatric, and neonatal patients. tcPCO2 and tcPO2 monitoring indicated for all ages (neonatal <12 months; adult/pediatric >12 months). Pulse oximetry indicated for adult/pediatric patients only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". 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. {1}------------------------------------------------ Page 2 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232516 Device Name Sentec Digital Monitoring System (SDMS) ### Indications for Use (Describe) The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation. Note: This manual uses the term "system" to refer to any combination of the tCOM+ or SDM and sensors, cables, accessories, disposables, and software. The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive. The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring. Intended patient population: tcPCO2 and tcPO2 monitoring is indicated in adult/pediatric (older than term birth plus 12 months) and neonatal (younger than term birth plus 12 months) patients. Pulse oximetry monitoring is indicated in adult/ pediatric patients only. The target user population: of the Sentec Digital Monitoring System (SDMS) is professional medical personnel, e.g. nurses, physicians, and - if under clinical supervision - lay operators. The correct and safe application of tcPCO2 and tcPO2 measuring equipment require straining of the user (e.g. physiological restrictions, technical aspects such as membrane change, meaning of drift, calibration). Home care providers also require specific training to be allowed to install the SDMS in home environments and to instruct lay persons how to apply the sensors correctly. The lay operator 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) {4}------------------------------------------------ ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Sentec. The word "sentec" is written in a sans-serif font in gray color. To the right of the word "sentec" is a small orange circle, which appears to be part of the logo design. The logo is simple and modern. 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 {6}------------------------------------------------ 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 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 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. 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. ### 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. 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: 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ ### Table 1: Comparison of tCOM+ vs. Predicate SDM | Claim / Attribute | Subject device | Predicate Device | Comments | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------| | Brand name /<br>Model | tCOM+ (REF 103164) | Sentec Digital Monitor (REF SDM) | N/A | | Description of<br>device | The tCOM+ is a portable, lightweight, stand-alone<br>monitor with a convenient carrying handle and with<br>an integrated calibration and storage facility for<br>Sentec's digital sensors.<br>tCOM+ provides the same features as the predicate<br>device Sentec Digital Monitor but has a modern user<br>interface which is controllable via touchscreen and<br>wireless communication interfaces. | Sentec's Digital Monitor (SDM) is a portable, stand-<br>alone monitor with an integrated calibration and<br>storage facility for Sentec's digital sensors. | Similar | | 510(k) | K232516 | K151339 | N/A | | Product codes | LKD, KLK, LPP | LKD, KLK, LPP | Identical | | Regulation<br>numbers | 21 CFR Part 868.2480<br>21 CFR Part 868.2500 | 21 CFR Part 868.2480<br>21 CFR Part 868.2500 | Identical | | Prescription<br>device | Yes | Yes | Identical | | Intended<br>patient<br>population | tcPCO2 and tcPO2 monitoring is indicated in adult,<br>pediatric and neonatal patients. Pulse oximetry<br>monitoring is indicated in adult/pediatric patients<br>only. | tcPCO2 and tcPO2 monitoring is indicated in adult,<br>pediatric and neonatal patients. Pulse oximetry<br>monitoring is indicated in adult/pediatric patients<br>only. | Identical | | Indication for Use | The tCOM+ is a portable stand-alone patient monitor<br>intended for continuous, noninvasive patient<br>monitoring of carbon dioxide partial pressure<br>(PCO2), oxygen partial pressure (PO2), functional<br>oxygen saturation (SpO2) and pulse rate (PR), using<br>either | The SDM is a portable stand-alone patient monitor<br>intended for continuous, noninvasive patient<br>monitoring of carbon dioxide partial pressure (PCO2),<br>oxygen partial pressure (PO2), functional oxygen<br>saturation (SpO2) and pulse rate (PR), using either<br>• single, digital sensor (V-Sign™ Sensor 2) for<br>PCO2, SpO2 and PR measurement, OR | Identical | | | • single, digital sensor (V-Sign™ Sensor 2) for<br>PCO2, SpO2 and PR measurement, OR<br>• a single, digital sensor (OxiVenT™ Sensor) for<br>PCO2, PO2, SpO2 and PR measurement<br>PO2 measurement with tCOM+ is only possible<br>when used in combination with an OxiVenT™<br>Sensor. | • a single, digital sensor (OxiVenT™ Sensor) for<br>PCO2, PO2, SpO2 and PR measurement<br>PO2 measurement with SDM is only possible when<br>used in combination with an OxiVenT™ Sensor. | | | Environment of<br>use | In clinical and non-clinical settings such as hospitals,<br>hospital-type facilities, intra-hospital transport<br>environments, clinics, physician offices, ambulatory<br>surgery centers and - if under clinical supervision -<br>home environments. Hospital use typically covers<br>areas such as general care floors, operating rooms,<br>special procedure areas, intensive and critical care<br>areas. Hospital type facilities typically cover facilities<br>such as surgical centers, special nursing facilities<br>and sleep labs outside of the hospital. Intra-hospital<br>transport includes transport of a patient within the<br>hospital or hospital-type facilities. | In clinical and non-clinical settings such as hospitals,<br>hospital-type facilities, intra-hospital transport<br>environments, clinics, physician offices, ambulatory<br>surgery centers and - if under clinical supervision -<br>home environments. Hospital use typically covers<br>areas such as general care floors, operating rooms,<br>special procedure areas, intensive and critical care<br>areas. Hospital type facilities typically cover facilities<br>such as surgical centers, special nursing facilities<br>and sleep labs outside of the hospital. Intra-hospital<br>transport includes transport of a patient within the<br>hospital or hospital-type facilities. | Identical | | Method of<br>operation | Power is applied to the monitor.<br>Sensor is heated, calibrated and monitor is<br>configured (alarms etc.).<br>Sensor applied to patient with Ear Clip or Multi-Site<br>Attachment Rings or Non-Adhesive Wrap and using<br>Contact Gel.<br>The patient's SpO2, PR, and/or PCO2 and/or PO2 are<br>monitored. If monitoring continues for more than<br>predefined time an alarm is triggered (Site Timer)<br>and site must be inspected. | Power is applied to the monitor.<br>Sensor is heated, calibrated and monitor is<br>configured (alarms etc.).<br>Sensor applied to patient with Ear Clip or Multi-Site<br>Attachment Rings or Non-Adhesive Wrap and using<br>Contact Gel.<br>The patient's SpO2, PR, and/or PCO2 and/or PO2 are<br>monitored. If monitoring continues for more than<br>predefined time an alarm is triggered (Site Timer)<br>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) typically<br>every 28 days. | Membrane must be prepared (exchanged) typically<br>every 28 days. | | | Physical<br>characteristics | The tCOM+ is portable and mountable on a standard<br>hospital rail.<br>Height = 15.4 cm<br>Width = 26.8 cm<br>Depth = 16.2 cm<br>Weight ~ 2.5 kg | The SDM is portable and mountable on a standard<br>hospital rail.<br>Height = 10.2 cm<br>Width = 27 cm<br>Depth = 23 cm<br>Weight ~ 2.5 kg | Similar | | Portable | Yes, handle at the top of the monitor | Yes (flip feet serves as carrying handle) | Similar | | Wireless<br>data<br>communication | The tCOM+ enables:<br>Wi-Fi communication for connection to<br>networks.Bluetooth communication (disabled in the<br>software for this version).RFID communication (disabled in the software<br>for this version). | The SDM offers no wireless data communication | Different,<br>additional<br>communications<br>interface | | User controls | The tCOM+ uses a touch screen to navigate<br>between the different menus, and the power<br>ON/STAND-BY switch is on the left-hand side of the<br>panel. | The SDM uses buttons to navigate between the<br>different menus, and the power ON/OFF switch is on<br>the rear of the panel. | Different,<br>update to touch<br>screen<br>User<br>Interface | | | Sensor Adapter Cable (for tCOM+) | Digital Sensor Adapter Cable (for SDM) | | | Brand name /<br>Model | Sensor Adapter Cable Regular (REF 103420), Long<br>(REF 103421) and Extra Long (REF 103422) | Digital Sensor Adapter Cable 150 cm (REF AC-150),<br>250 cm (REF AC-250) and 750 cm (AC-750) | N/A | | Device<br>Description | Adapter cable required to connect the V-SignTM<br>Sensor 2 and OxiVenTTM Sensor to the tCOM+<br>patient monitor. It transfers the power needed to<br>operate the sensor. It furthermore transmits digitized<br>data between the digital sensor and the tCOM+. | Adapter cable required to connect the V-SignTM<br>Sensor 2 and OxiVenTTM Sensor to the Sentec<br>Digital Monitor. It transfers the power needed to<br>operate the sensor. It furthermore transmits digitized<br>data 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 | {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ### 510(k) Summary K232516 {12}------------------------------------------------ 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 | | Regulation<br>numbers | 21 CFR Part 868.2480, 21 CFR Part 868.2500,<br>21 CFR Part 870.2700, 21 CFR Part 870.2710 | 21 CFR Part 868.2480, 21 CFR Part 868.2500,<br>21 CFR Part 870.2700, 21 CFR Part 870.2710 | Identical | | Brand name /<br>Model | Single Dose Contact Gel<br>Single Dose Contact Gel (REF GEL-SD) | Contact Gel<br>Contact Gel (REF GEL-04) | N/A | | 510(k) | K232516 | K041548 | N/A | | Description of<br>device | Sentec's Contact Gel ensures adequate contact<br>between the patient's skin and the sensor, i.e., CO2/<br>O2 diffusing out of the skin will be trapped by the<br>contact liquid rather than diffusing to the<br>surroundings. | Sentec's Contact Gel ensures adequate contact<br>between the patient's skin and the sensor, i.e., CO2/<br>O2 diffusing out of the skin will be trapped by the<br>contact liquid rather than diffusing to the<br>surroundings. | Identical | | Single use | Yes | No | Difference is<br>only<br>the<br>packaging<br>size | | Intended Use | The Contact Gel GEL-SD serves as contact gel to<br>achieve proper gas conduction and heat transfer<br>between the patients' skin and Sentec's TC sensors. | The Contact Gel GEL-04 serves as contact gel to<br>achieve proper gas conduction and heat transfer<br>between the patients' skin and Sentec's TC sensors. | Identical | | Gel Composition | (>90%)<br>Glycerol<br>●<br>1, 2 Propanediol<br>● | (>90%)<br>Glycerol<br>●<br>1, 2 Propanediol<br>● | Identical | | | Polyvinylpyrrolidone (PVP) low concentration Deionized Water | Polyvinylpyrrolidone (PVP) low concentration Deionized Water | | | Physical<br>characteristics | Vial of 0.3 g | Bottle of 5ml | Different | | Biocompatibility | Prolonged intact skin contact, compliant with ISO-<br>10993-5 and ISO 10993-10 | Prolonged intact skin contact, compliant with ISO-<br>10993-5 and ISO 10993-10 | Identical | | | Membrane Changer single use | Membrane Changer | | | Brand name /<br>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 a<br>straight-forward replacement of Sentec's Sensor<br>Membranes. The bottom of the device has an anti-<br>slippery coating to improve usability. | The Membrane Changer allows for a straight-forward<br>replacement of Sentec's Sensor Membranes. The<br>Membrane Changer reloadable (MC-R) can be<br>reused by replacing its insert (MC-I). | Similar | | Single use | Yes | No | Different | | Indication for Use | The Membrane Changer serves as a tool to change<br>the electrolyte and membrane of the V-SignTM Sensor<br>2 and the OxiVenTTM Sensor. | The Membrane Changer serves as a tool to change<br>the electrolyte and membrane of the V-SignTM Sensor<br>2 and the OxiVenTTM Sensor. | Identical | | | MARe-MI | MAR-MI | | | Brand name /<br>Model | Multi-Site Attachment Ring "Easy" Mature/Intact<br>(REF MARe-MI) | Multi-Site Attachment Ring Mature/Intact (REF<br>MAR-MI) | N/A | | 510(k) | K232516 | K071672, K101690, K151339 | N/A | | Device Description | Single use sensor application ring, recommended for<br>adult, pediatric and neonatal patients. The adhesive<br>used to attach the application ring to the patient's<br>skin is hypoallergenic, pressure sensitive and<br>designed for medical/surgical use. The use of MARe-<br>MI therefore is recommended for mature/intact skin<br>applications. | Single use sensor application ring, recommended for<br>adult, pediatric and neonatal patients. The adhesive<br>used to attach the application ring to the patient's<br>skin is hypoallergenic, pressure sensitive and<br>designed for medical/surgical use. The use of MAR-<br>MI therefore is recommended for mature/intact skin<br>applications. | Similar | | | The design of the snap ring itself has been optimized<br>to ensure easy insertion/removal of sensors into/from<br>the ring. | | | | Intended Use | Is intended to attach the Sentec sensors to<br>conventional measurement sites. Recommended for<br>adult, pediatric, and neonatal patients with<br>mature/intact skin. | Is intended to attach the Sentec sensors to<br>conventional measurement sites. Recommended for<br>adult, pediatric, and neonatal patients with<br>mature/intact skin. | Identical | | Physical<br>characteristics | Snap ring inner diameter = 14.65 mm<br>Snap ring outer diameter = 20 mm<br>Adhesive ring diameter = 30 mm<br>Snap ring color = White<br>Snap ring geometry = More snap joints, less wide | Snap ring inner diameter = 14.65 mm<br>Snap ring outer diameter = 20 mm<br>Adhesive ring diameter = 30 mm<br>Snap ring color = Grey<br>Snap ring geometry = Fewer snap joints, wider | Similar | | Biocompatibility | Prolonged intact skin contact, compliant with ISO-<br>10993-5 and ISO 10993-10 | Prolonged intact skin contact, compliant with ISO-<br>10993-5 and ISO 10993-10 | Identical | | | Non-Adhesive Wrap…
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