The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), the V-Sign™ Sensor and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only.

The V-Sign™ Sensor, model VS-A/P, is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of the V-Sign™ Sensor is indicated for carbon dioxide tension monitoring only.

SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach the V-Sign™ Sensor to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose ear-lobes are too small to ensure adequate sensor application.

SenTec's Multi-Site Attachment Ring, model MAR-A/P/N, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult pediatric, and neonatal patients. The Multi-Site Attachment Ring, model MAR-A/P/N, is for single use and is indicated to attach the V-Sign™ Sensorto conventional measurement sites for carbon dioxide tension monitoring,

SenTec's Multi-Site Attachment Ring, model MAR-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult and pediatric patients. The Multi-Site Attachment Ring, model MAR-A/P, is for single use and is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.

Device Description

The SenTec Digital Monitoring System (SDMS) is a device consisting of a stand-alone monitor, a digital sensor, a connecting cable, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dloxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor) applied to the ear lobe with the SenTec Ear Clip.

This new 510(k) adds two new Multi-Site Attachment Rings for PCQ2 monitoring only, applied to a conventional PCO2 measurement site:

MAR-A/P/N for adult, pediatric and neonatal patients .
MAR-A/P for adult and pediatric patients

The monitoring features of the SDMS are unchanged

The Multi-Site Attachment Rings consists of a round adhesive pad integrated with a snap ring. The adhesive pad attaches to the patient's skin at the measurement site and the snap ring captures the V-Sign™ Sensor while permitting rotation and removal/reinsertion of the ring is prepared for application by removing an adhesive liner film.

AI/ML Overview

The provided document describes the SenTec Digital Monitoring System (SDMS) and its 510(k) submission for new multi-site attachment rings. However, the document does not contain specific acceptance criteria or details of a clinical study that proves the device meets such criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. It states:

"In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed."
"The results of all laboratory and performance tests demonstrate that the SenTec Digital Monitoring System meets specified requirements." (However, these "specified requirements" are not detailed or quantified in the provided text).
"As described above, the SenTec Digital Monitoring System with Multi-Site Attachment Rings performs in a manner equivalent to the predicate devices. Device safety is substantiated by risk analyses and biocompatibility of patient contact materials."

Therefore, based on the provided text, I cannot complete many of the requested sections as the information is not present. The device's "performance" is primarily described as being "equivalent" to predicate devices, and the document explicitly states that no additional clinical studies were performed.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be created. The document does not provide a table of acceptance criteria or quantified performance metrics for the SenTec Digital Monitoring System with the new multi-site attachment rings. It only states that "laboratory and performance tests demonstrate that the SenTec Digital Monitoring System meets specified requirements" and performs "in a manner equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance

Not applicable for clinical studies. The document explicitly states: "In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed."
For non-clinical tests: "Application tests performed with the V-Sign Sensor and Multi-Site Attachment Rings confirmed that the sensor was properly positioned for measurement of PCO2." The sample size, data provenance, and specific results of these application tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set or ground truth established by experts is described, as no clinical studies were performed for this specific submission.

4. Adjudication method for the test set

Not applicable. No clinical test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a medical device for monitoring physiological parameters (PCO2, SpO2, PR), not an AI-powered diagnostic tool involving human readers. Therefore, an MRMC study or AI assistance is not relevant or mentioned.

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

Not applicable in the context of an AI algorithm. This device is a monitoring system and its performance is assessed based on its ability to accurately measure physiological parameters, not an algorithm's classification performance. The "clinical performance data" section states no additional clinical studies were required or performed.

7. The type of ground truth used

Not explicitly stated for the "specified requirements" or equivalence claim. For the initial predicate device (K041548), one would infer that the ground truth for PCO2 and SpO2 measurements would have been established using reference methods (e.g., arterial blood gas analysis for PCO2/SpO2, and ECG for pulse rate). However, for this specific submission, no new ground truth is described as no new clinical studies were performed. The "equivalence" relies on the ground truth established for the predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI algorithm that requires a training set.

Summary of available information regarding performance:

Non-Clinical Performance:
- Biocompatibility testing: "All materials met Biocompatibility requirements" per ISO 10993-1:2003.
- Risk/Hazard Analysis: "All hazards were mitigated to ALARP levels... and residual risks were determined to be acceptable."
- Application tests: "confirmed that the sensor was properly positioned for measurement of PCO2." (No further details on sample size or specific results provided).
Clinical Performance:
- "no additional Clinical studies were required and none were performed."
- The device is deemed to perform "in a manner equivalent to the predicate devices."

In essence, the 510(k) submission for the new multi-site attachment rings for the SenTec Digital Monitoring System relies on showing substantial equivalence to existing legally marketed predicate devices, rather than presenting new clinical study data with specific acceptance criteria.

Summary

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Single Sensor Monitorir

SenTec Digital Monitoring System 510(k) Notification

Section 5

SEP | 2007

Summary of Safety & Effectiveness

Section 5 - Summary of Safety & Effectiveness

510(k) Summary

Submitter [807.92(a)(1)]:

Address

Phone FAX

SenTec AG Ringstrasse 39 4106 Therwil - Switzerland +41 61 726 97 60 +41 61 726 97 61

Contact Person [807.92(a)(1)]:

Ms. Sabine Nieba, Ph.D. Quality & Regulatory Affairs Manager nieba@sentec.ch

Date prepared [807.92(a)(1)]:

August 18, 2007

Trade, Common and Classification Name [807.92(a)(2)]:

Trade / Proprietary Name	Common /Usual Name	ClassificationName	ProductCode	Class	RegulationNumber
SenTec Digital MonitoringSystemSenTec Digital Monitor,V-SignTM Sensor & Accessories forsensor application/maintenance;new Multi-Site Attachment Rings	Cutaneous CarbonDioxide Monitor	Monitor, Carbon-Dioxide, Cutaneous	73 LKD	II	21 CFR Part868.2480
	Pulse Oximeter	Oximeter	74 DQA	II	21 CFR Part870.2700
	Pulse Oximeter	Oximeter, Ear	74 DPZ	II	21 CFR Part870.2710

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

	Device	Manufacturer	Comment
K041548	SenTec Digital MonitoringSystem	SenTec AG	This device is predicate for PCO2, SpO2, and PRmonitoring using the ear lobe as monitoring site inadult and pediatric patients.
K063434	TOSCA 500 tcPCO2, SpO2and PR monitoring system	Radiometer Basel AG	These devices are predicate for PCO2 onlymonitoring using the new Multi-Site Attachment Ringto attach the V-Sign Sensor to the patient.The "TOSCA Fixation Ring 32 mm" cleared inK063434 is predicate for the usage of the Multi-SiteAttachment Ring in adult and pediatric patients.
K991644	MicroGas 7650Transcutaneous Monitor	Linde Medical Sensors	The "Adhesive Ring 32 mm" cleared in K991644 ispredicate for the usage of the Multi-Site AttachmentRing in neonates.

Reason For Submission: Additional or Expanded Indications

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

This new 510(k) adds two new Multi-Site Attachment Rings for PCQ2 monitoring only, applied to a conventional PCO2 measurement site:

MAR-A/P/N for adult, pediatric and neonatal patients .
MAR-A/P for adult and pediatric patients

The monitoring features of the SDMS are unchanged

Intended Use [807.92(a)(5)]:

The SenTec Digital Monitoring System - consisting of the SenTec Digital Monitor (SDM), the V-Sign™ Sensor and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only.

Comparison to predicate device [807.92(a)(6)]:

Confidential

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The SenTec Digital Monitoring System has the same indications for use as well as the same indicated patient population as a combination of the predicate devices.

The new Multi-Site Attachment Rings are to be used only for PCO2 measurements. All relevant features of the SenTec Digital Monitoring System are equivalent to the TOSCA 500 as well as to the PCO2-part of the Microgas 7650. The key features are:

same principles of operation (2 wavelength SpO2 measurement, and PCO2 electrode technology) -
sensors heated to typically 42 °C (note SDMS uses 41°C for neonatal applications) ।
equivalent or similar means to control sensor temperature and application time at the site -
equivalent or similar sensor application means [adhesive Ear Clip and adhesive attachment rings]
equivalent or similar sensor calibration unit integrated in monitor -
equivalent or similar alarms, messages and menu structure as predicate devices -
equivalent or similar accessories for maintenance: membrane exchange tool, sensor contact gel, service gas

The method of operation is equivalent to that of the SenTec Digital Monitoring System listed under K041548, in particular for sensor preparation and monitoring.

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

Biocompatibility testing has been conducted for all patient contact materials in compliance with ISO 10993-1:2003. All materials met Biocompatibility requirements.

Detailed risk, hazard, and failure analyses were performed on the SDMS in consideration of the Multi-Site Attachment Rings. All hazards were mitigated to ALARP levels (as low as reasonably possible) and residual risks were determined to be acceptable.

Application tests performed with the V-Sign Sensor and Multi-Site Attachment Rings confirmed that the sensor was properly positioned for measurement of PCO2.

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

In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed.

Conclusion [807.92(b)(3)]:

The results of all laboratory and performance tests demonstrate that the SenTec Digital Monitoring System meets specified requirements.

As described above, the SenTec Digital Monitoring System with Multi-Site Attachment Rings performs in a manner equivalent to the predicate devices. Device safety is substantiated by risk analyses and biocompatibility of patient contact materials.

Other information [807.92(d)]:

Not applicable.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

SEP 12 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SenTec AG C/O Mr. Stephen H. Gorski Submission Correspondent for SenTec AG Imagenix, Incorporated S65 West 35739 Piper Road Eagle, Wisconsin 53119

Re: K071672

Trade/Device Name: SenTec Digital Monitoring System (SDMS) Regulation Number: 21 CFR 868.2480 Regulation Name: Cutaneous Carbon Dioxide (PcCO2 ) Monitor Regulatory Class: II Product Code: LKD Dated: May 21, 2007 Received: June 19, 2007

Dear Mr. Gorski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Gorski

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

SenTec Digital Monitoring System (SDMS) Device Name:

Indications for use:

SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clíp is for single-patient use and is indicated to attach the V-Sign™ Sensor to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose ear-lobes are too small to ensure adequate sensor application.

SenTec's Multi-Site Attachment Ring, model MAR-A/P/N, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult pediatric, and neonatal patients. The Multi-Site Attachment Ring, model MAR-A/P/N, is for single use and is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.

SenTec's Multi-Site Attachment Ring, model MAR-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult and pediatric patients, Continuous, fion Invasive corbon unside tenaily in the morning to cand is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.

X Prescription Use (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital	9/10/07
Infection Control, Dental Devices
	Page 1 of 1

510(k) Number: K071672

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).