(273 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on non-invasive physiological monitoring using established sensor technology.
No.
The device is indicated for non-invasive patient monitoring of oxygenation and ventilation; it does not provide any therapeutic function.
Yes
The device is indicated for "non-invasive patient monitoring of oxygenation and ventilation" and for "continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR)", which are measurements used for diagnostic purposes.
No
The device description explicitly states that the system consists of "monitors, sensors, cables, accessories and disposables" in addition to PC-based software, indicating it includes significant hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The system is indicated for "non-invasive patient monitoring of oxygenation and ventilation." This involves measuring physiological parameters directly from the patient's intact skin.
- Device Description: The system monitors "cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR)." These are measurements taken from the body surface.
- Anatomical Site: The sensors are in contact with "intact skin."
- Lack of mention of biological samples: There is no mention of the device analyzing biological samples such as blood, urine, tissue, etc., which is a defining characteristic of IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device operates by non-invasively measuring parameters on the surface of the body, not by analyzing biological samples.
N/A
Intended Use / Indications for 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.
Product codes
LKD, KLK, LPP, DQA, DPZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intact skin of the patient.
Indicated Patient Age Range
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.
Intended User / Care Setting
Target User Population: professional medical personnel, e.g. nurses, physicians, and - if under clinical supervision - lay operators.
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K041548, K071672, K101690, K151329
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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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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)
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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 / | |||
| Model | tCOM+ (REF 103164) | Sentec Digital Monitor (REF SDM) | N/A |
| Description of | |||
| device | The tCOM+ is a portable, lightweight, stand-alone | ||
| monitor with a convenient carrying handle and with | |||
| an integrated calibration and storage facility for | |||
| Sentec's digital sensors. | |||
| tCOM+ provides the same features as the predicate | |||
| device Sentec Digital Monitor but has a modern user | |||
| interface which is controllable via touchscreen and | |||
| wireless communication interfaces. | Sentec's Digital Monitor (SDM) is a portable, stand- | ||
| alone monitor with an integrated calibration and | |||
| storage facility for Sentec's digital sensors. | Similar | ||
| 510(k) | K232516 | K151339 | N/A |
| Product codes | LKD, KLK, LPP | LKD, KLK, LPP | Identical |
| Regulation | |||
| numbers | 21 CFR Part 868.2480 | ||
| 21 CFR Part 868.2500 | 21 CFR Part 868.2480 | ||
| 21 CFR Part 868.2500 | Identical | ||
| Prescription | |||
| device | Yes | Yes | Identical |
| Intended | |||
| patient | |||
| population | tcPCO2 and tcPO2 monitoring is indicated in adult, | ||
| pediatric and neonatal patients. Pulse oximetry | |||
| monitoring is indicated in adult/pediatric patients | |||
| only. | tcPCO2 and tcPO2 monitoring is indicated in adult, | ||
| pediatric and neonatal patients. Pulse oximetry | |||
| monitoring is indicated in adult/pediatric patients | |||
| only. | Identical | ||
| Indication for Use | The tCOM+ is a portable stand-alone patient monitor | ||
| intended for continuous, noninvasive patient | |||
| monitoring of carbon dioxide partial pressure | |||
| (PCO2), oxygen partial pressure (PO2), functional | |||
| oxygen saturation (SpO2) and pulse rate (PR), using | |||
| either | The SDM is a portable stand-alone patient monitor | ||
| intended for continuous, noninvasive patient | |||
| monitoring of carbon dioxide partial pressure (PCO2), | |||
| oxygen partial pressure (PO2), functional oxygen | |||
| saturation (SpO2) and pulse rate (PR), using either | |||
| • single, digital sensor (V-Sign™ Sensor 2) for | |||
| PCO2, SpO2 and PR measurement, OR | Identical | ||
| • single, digital sensor (V-Sign™ Sensor 2) for | |||
| PCO2, SpO2 and PR measurement, OR | |||
| • a single, digital sensor (OxiVenT™ Sensor) for | |||
| PCO2, PO2, SpO2 and PR measurement | |||
| PO2 measurement with tCOM+ is only possible | |||
| when used in combination with an OxiVenT™ | |||
| Sensor. | • a single, digital sensor (OxiVenT™ Sensor) for | ||
| PCO2, PO2, SpO2 and PR measurement | |||
| PO2 measurement with SDM is only possible when | |||
| used in combination with an OxiVenT™ Sensor. | |||
| Environment of | |||
| use | In clinical and non-clinical settings such as hospitals, | ||
| 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 outside of the hospital. Intra-hospital | |||
| transport includes transport of a patient within the | |||
| hospital or hospital-type facilities. | In clinical and non-clinical settings such as hospitals, | ||
| 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 outside of the hospital. Intra-hospital | |||
| transport includes transport of a patient within the | |||
| hospital or hospital-type facilities. | Identical | ||
| Method of | |||
| operation | Power is applied to the monitor. | ||
| Sensor is heated, calibrated and monitor is | |||
| configured (alarms etc.). | |||
| Sensor applied to patient with Ear Clip or Multi-Site | |||
| Attachment Rings or Non-Adhesive Wrap and using | |||
| Contact Gel. | |||
| The patient's SpO2, PR, and/or PCO2 and/or PO2 are | |||
| monitored. If monitoring continues for more than | |||
| predefined time an alarm is triggered (Site Timer) | |||
| and site must be inspected. | Power is applied to the monitor. | ||
| Sensor is heated, calibrated and monitor is | |||
| configured (alarms etc.). | |||
| Sensor applied to patient with Ear Clip or Multi-Site | |||
| Attachment Rings or Non-Adhesive Wrap and using | |||
| Contact Gel. | |||
| The patient's SpO2, PR, and/or PCO2 and/or PO2 are | |||
| monitored. If monitoring continues for more than | |||
| predefined 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) typically | |||
| every 28 days. | Membrane must be prepared (exchanged) typically | ||
| every 28 days. | |||
| Physical | |||
| characteristics | The tCOM+ is portable and mountable on a standard | ||
| hospital rail. | |||
| Height = 15.4 cm | |||
| Width = 26.8 cm | |||
| Depth = 16.2 cm | |||
| Weight ~ 2.5 kg | The SDM is portable and mountable on a standard | ||
| hospital rail. | |||
| Height = 10.2 cm | |||
| Width = 27 cm | |||
| Depth = 23 cm | |||
| Weight ~ 2.5 kg | Similar | ||
| Portable | Yes, handle at the top of the monitor | Yes (flip feet serves as carrying handle) | Similar |
| Wireless | |||
| data | |||
| communication | The tCOM+ enables: | ||
| Wi-Fi communication for connection to | |||
| networks.Bluetooth communication (disabled in the | |||
| software for this version).RFID communication (disabled in the software | |||
| for this version). | The SDM offers no wireless data communication | Different, | |
| additional | |||
| communications | |||
| interface | |||
| User controls | The tCOM+ uses a touch screen to navigate | ||
| between the different menus, and the power | |||
| ON/STAND-BY switch is on the left-hand side of the | |||
| panel. | The SDM uses buttons to navigate between the | ||
| different menus, and the power ON/OFF switch is on | |||
| the rear of the panel. | Different, | ||
| update to touch | |||
| screen | |||
| User | |||
| Interface | |||
| 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 | ||
| Device | |||
| Description | Adapter cable required to connect the V-SignTM | ||
| Sensor 2 and OxiVenTTM Sensor to the tCOM+ | |||
| patient monitor. It transfers the power needed to | |||
| operate the sensor. It furthermore transmits digitized | |||
| data between the digital sensor and the tCOM+. | Adapter cable required to connect the V-SignTM | ||
| Sensor 2 and OxiVenTTM Sensor to the Sentec | |||
| Digital Monitor. It transfers the power needed to | |||
| operate the sensor. It furthermore transmits digitized | |||
| 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 |
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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 |
| Regulation | |||
| numbers | 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 Gel | ||
| Single Dose Contact Gel (REF GEL-SD) | Contact Gel | ||
| Contact Gel (REF GEL-04) | N/A | ||
| 510(k) | K232516 | K041548 | N/A |
| Description of | |||
| device | Sentec's Contact Gel ensures adequate contact | ||
| between the patient's skin and the sensor, i.e., CO2/ | |||
| O2 diffusing out of the skin will be trapped by the | |||
| contact liquid rather than diffusing to the | |||
| surroundings. | Sentec's Contact Gel ensures adequate contact | ||
| between the patient's skin and the sensor, i.e., CO2/ | |||
| O2 diffusing out of the skin will be trapped by the | |||
| contact liquid rather than diffusing to the | |||
| surroundings. | Identical | ||
| Single use | Yes | No | Difference is |
| only | |||
| the | |||
| packaging | |||
| size | |||
| Intended Use | The Contact Gel GEL-SD serves as contact gel to | ||
| achieve proper gas conduction and heat transfer | |||
| between the patients' skin and Sentec's TC sensors. | The Contact Gel GEL-04 serves as contact gel to | ||
| achieve proper gas conduction and heat transfer | |||
| between 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 | ||
| Physical | |||
| characteristics | 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 a | ||
| straight-forward replacement of Sentec's Sensor | |||
| Membranes. The bottom of the device has an anti- | |||
| slippery coating to improve usability. | The Membrane Changer allows for a straight-forward | ||
| replacement of Sentec's Sensor Membranes. The | |||
| Membrane Changer reloadable (MC-R) can be | |||
| 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 | ||
| the electrolyte and membrane of the V-SignTM Sensor | |||
| 2 and the OxiVenTTM Sensor. | The Membrane Changer serves as a tool to change | ||
| the electrolyte and membrane of the V-SignTM Sensor | |||
| 2 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 (REF | ||
| MAR-MI) | N/A | ||
| 510(k) | K232516 | K071672, K101690, K151339 | N/A |
| Device Description | Single use sensor application ring, recommended for | ||
| adult, pediatric and neonatal patients. The adhesive | |||
| used to attach the application ring to the patient's | |||
| skin is hypoallergenic, pressure sensitive and | |||
| designed for medical/surgical use. The use of MARe- | |||
| MI therefore is recommended for mature/intact skin | |||
| applications. | Single use sensor application ring, recommended for | ||
| adult, pediatric and neonatal patients. The adhesive | |||
| used to attach the application ring to the patient's | |||
| skin is hypoallergenic, pressure sensitive and | |||
| designed for medical/surgical use. The use of MAR- | |||
| MI therefore is recommended for mature/intact skin | |||
| applications. | Similar | ||
| The design of the snap ring itself has been optimized | |||
| to ensure easy insertion/removal of sensors into/from | |||
| the ring. | |||
| Intended Use | Is intended to attach the Sentec sensors to | ||
| conventional measurement sites. Recommended for | |||
| adult, pediatric, and neonatal patients with | |||
| mature/intact skin. | Is intended to attach the Sentec sensors to | ||
| conventional measurement sites. Recommended for | |||
| adult, pediatric, and neonatal patients with | |||
| mature/intact skin. | Identical | ||
| Physical | |||
| characteristics | Snap ring inner diameter = 14.65 mm | ||
| Snap ring outer diameter = 20 mm | |||
| Adhesive ring diameter = 30 mm | |||
| Snap ring color = White | |||
| Snap ring geometry = More snap joints, less wide | Snap ring inner diameter = 14.65 mm | ||
| Snap ring outer diameter = 20 mm | |||
| Adhesive ring diameter = 30 mm | |||
| Snap ring color = Grey | |||
| Snap 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 | ||
| Brand | |||
| name | |||
| Model | / 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 use | ||
| for up to 24 hours, is recommended for preterm / | |||
| neonatal patients of very low birth weight and with | |||
| sensitive/fragile skin. This applicator does not contain | |||
| any adhesives and is wrapped around the thigh. | Single use sensor application ring, recommended for | ||
| adult, pediatric and neonatal patients with | |||
| sensitive/fragile skin. The adhesive making skin | |||
| contact is a silicone gel adhesive used in skin therapy | |||
| and wound healing. The use of MAR-SF therefore is | |||
| recommended for sensitive/fragile skin applications. | Similar | ||
| Intended for Use | Is intended to be wrapped around the thigh of | ||
| neonatal patients with very sensitive/fragile skin for | |||
| subsequent attachment of Sentec's TC sensors. | Is intended to attach Sentec's TC sensors to | ||
| conventional measurement sites, recommended for | |||
| adult, pediatric and neonatal patients with | |||
| sensitive/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 | ||
| Physical | |||
| characteristics | Snap ring inner diameter = 14.65 mm | ||
| Snap ring outer diameter = 20 mm | |||
| Snap ring geometry same as MARe-MI | |||
| Wrap dimension: Length = 53 mm, Width = 11mm | Snap ring inner diameter = 14.65 mm | ||
| Snap ring outer diameter = 20 mm | |||
| Adhesive 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.