The SenTec Digital Monitor System (comprising the SenTec Digital Monitor, V-Sign™ Sensor and Accessories) is indicated for continuous noninvasive monitoring. The SenTec Digital Monitor System is indicated for use in hospital type realities, includes intra-hospital transport environments, and clinical supervision, home environments. The SenTec Digital Monitor 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 noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required for adult through pediatric patients.

SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated for patients weighing 30 kg or more, using exclusively the ear lobe as the monitoring site. The use of the SenTec Ear Clip is contraindicated for patients whose ear-lobes are very small (resulting in inadequate sensor application).

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

Device Description

The Sentec Digital Monitor 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 noninvasive measurement of cutaneous carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor).

The V-Sign™ Sensor combines within one digital sensor the technology to measure cutaneous PCO2 with the optical elements (LED, photodetector) needed for pulse oximetry. The PCO2 measurement of the V-Sign™ Sensor is based on a Stow-Severinghaus type PCO2 sensor. The V-Sign™ Sensor slightly raises the temperature at the monitoring site to achieve the cutaneous PCO2 measurement. Safe temperature is achieved using two independent measurement and control systems. The sensor is applied to the patient's ear lobe using SenTec's single patient use Ear Clip and a thin layer of Sensor Gel.

The Sentec Digital Monitor (SDM) is equipped with an integrated calibration unit, the Docking Station, allowing an automatic PCO2 sensor calibration that begins when the V-Sign™ Sensor is stored in the Docking Station. This ensures that the V-Sign™ Sensor is continuously ready to use.

The V-Sign Disposable Set provides a straight-forward preparation of the V-Sign™ Sensor - with the ease of 4 "Push-and-Turn" procedures, all necessary steps to exchange the sensor's membrane are performed.

AI/ML Overview

The Sentec Digital Monitor System (SDMS) is intended for continuous non-invasive monitoring of cutaneous partial pressure of carbon dioxide (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR).

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it indicates that the device met specified requirements based on various tests. For the purpose of this response, I infer the performance from the statements made about the device's functionality and comparison to predicate devices, and the successful completion of testing.

Metric / Test Item	Acceptance Criteria (Inferred from statements)	Reported Device Performance
Electrical, Mechanical, Environmental Safety	Compliance with applicable standards (e.g., electrical safety, EMC, shock, vibe, temp/humidity) and FDA Guidance Document: Cutaneous Carbon Dioxide	"The device passed all tests."
Biocompatibility	Compliance with ISO 10993-1.997 for contact materials	"All materials met Biocompatibility requirements."
Pulse Rate Accuracy (Bench Test)	Pulse rate values within +/- 3 digits of a laboratory pulse rate simulator (Implied standard for pulse oximeters)	"The Sentec Digital Monitor System measured pulse rate values within ±3 digits of a laboratory pulse rate simulator."
SpO2 Accuracy (Clinical Study)	Reported saturation values meet specified accuracy requirements (Specific numeric criteria not provided, but implies equivalence to predicate devices and acceptable clinical performance).	"The clinical studies show that the reported saturation values from the Sentec Digital Monitor System meet specified accuracy requirements." (The study involved "progressive induced hypoxia against arterial hemoglobin oxygen determined from and the PCO samples with a CO-Oximeter as reference.") This implies that the SpO2 measurements were compared to a gold standard (CO-Oximeter) during hypoxia, and the device performed acceptably. The precise accuracy range (e.g., +/- X%) is not explicitly stated in the summary, but the successful conclusion suggests it met predefined benchmarks.
PCO2 Performance (Clinical Study)	Support for the performance of transcutaneous PCO2 (Implied equivalence to predicate devices and acceptable clinical performance).	"The clinical study data furthermore support the performance of the PCO samples with a CO-Oximeter as reference." While less specific than SpO2, this indicates the PCO2 measurement from the device was compared against a reference (PCO samples with a CO-Oximeter as reference) and found to be performing as expected for its intended use. The specific accuracy for PCO2 is not quantified in this summary.
Overall Safety and Effectiveness	Safe, effective, and performs as intended as a combination of predicate devices	"The clinical and non-clinical testing performed demonstrates that the Sentec Digital Monitor System is safe, effective and performs as intended comparable to that of your company and the predicate devices."

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

Test Set Sample Size: The document only states "healthy adult volunteer subjects" were used for the clinical studies. No specific number is provided.
Data Provenance: The data is prospective, generated from clinical studies with healthy adult volunteers. The country of origin is not explicitly stated, but the manufacturer is Sentec Inc. located in Switzerland.

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

Not applicable. The ground truth for SpO2 and PCO2 measurements was established using objective measurement devices (CO-Oximeter and direct PCO samples), not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement from reference devices/methods, not through expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a monitor, not an AI for interpretation, so improvements in human reader performance with AI assistance are not relevant here.

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

Yes, the studies described are essentially standalone performance evaluations of the device (monitor and sensor) against reference standards. The results demonstrate the device's accuracy and performance independent of human interpretation or interaction other than operation.

7. The Type of Ground Truth Used

For SpO2 and PCO2: Objective physiological measurements using a CO-Oximeter and direct PCO samples.
For Pulse Rate: Laboratory pulse rate simulator.
For Safety: Compliance with national and international standards.

8. The Sample Size for the Training Set

Not applicable. The Sentec Digital Monitor System is a sensing device, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its underlying technology is based on established biophysical principles (2-wavelength SpO2 measurement, PCO2 electrode technology) and not on learned patterns from a large dataset. Calibration is mentioned, but this is a technical adjustment using known references, not a "training set" for an algorithm.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The device uses an integrated calibration unit (Docking Station) for daily PCO2 sensor calibration, which relies on known gas values for accurate measurements.

Summary

{0}------------------------------------------------

AUG - 9 2004 Sentec Digital Monitor System 510(k) Notification

2041548

B Statements / Certifications 510k Summary

Section B - Statements / Certifications

510(k) Summary

Submitter [807.92(a)(1)]:

Phone FAX

Address

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

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

Hayoz Josef, Ph.D. Scientific Development & Product Mananger

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

June 4, 2004

Sentec Inc.

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

Trade / Proprietary Name	Common /Usual Name	ClassificationName	ProductCode	Class	RegulationNumber
Sentec Digital Monitor SystemSentec Digital Monitor,V-SignTM Sensor & Accessories	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)]:

The Sentec Digital Monitor System combines of a pulse oximeter (sensor appled to the ear lobe) and a The Sentec Digital Monton System Combines of i) a Pulse Oximeter and ii) a Cutaneous Carbon Dioxide Clicaneous caron goxice nonitor. This it is a confidincial of 1/ a 1 also Oxincer the combination of (applicable portions of) the following devices:

	Device	Manufacturer	Comment
K991644	MicroGas 7650Transcutaneous Monitor	Linde Medical Sensors	These two devices are exactly the same devices(refer to 510k summary of K991644). Between theLinde MicroGas 7650 (K991644) and the KontronMicroGas 7650 (P 810037/S007) are only labelingdifferences.
P810037/ S007	MicroGas 7650Transcutaneous Monitor	Kontron Instruments AG,Medical Sensors	The PCO2 part of these two devices is predicateto the PCO2 part of the Sentec Digital MonitorSystem.
K972468	NPB-195 Pulse Oximeter	Nellcor Puritan Bennett Inc.	These two devices are predicate devices to thepulse oximetry part of the Sentec DigitalMonitor System.
K944760	Dura-Y OxygenTransducer, Ear Clip	Nellcor

RF-005522-_-Confidential

{1}------------------------------------------------

Reason For Submission: New Device

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

Description of the device (60.15) is a device consisting of a stand-alone moritor, a digital sensor, a The Seinter Digital Thomor "System" (18 horner and maintenance. The SDMS is designed for the continuous Connecting cable, and accessories for senser apprial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor).

The V-Sign™ Sensor combines within one digital sensor the technology to measure cutaneous PCO2 with the optical elements (LED, photodetector) needed for pulse oximely. The PCO2 measurement of the V-Sign™ Sensor is based elements (LLP, photodecector) needed tor paise Sightly raises the temperature at the monitoring site on a stow-sevelingnaus type i coz school. The v Bigh " at hor the cutaneous PCO2 measurement. Safe temperature to actieved using two independent measurement and control systems. The sensor is applied to the patient's ear lobe using SenTec's single patient use Ear Clip and a thin layer of Sensor Gel.

The Sentec Digital Monitor (SDM) is equipped with an integrated calibration unit, the Docking Station, ally The Sentec Digital Promor (SDFT) is Cualped With an an a firstored in the Docking Station the V-Sign™ Sensor is autoniatic pcoz school callibration that benus that the V-Sign™ Sensor is continuously ready to use.

The V-Sign Disposable Set provides a straight-forward preparation of the V-Sign™ Sensor- with the ease of 4 "Pushand-Turn" procedures, all necessary steps to exchange the sensor's membrane are performed.

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

ITTLEINGEd OSS [007.32(0)[1]]
The SenTec Digital Monitor System (comprising the SenTec Digital Monitor, V-Sign" Sensor and Accessories in The Serree Digital Monton System (complishing the SenTec Digital Monitor System is indicated for use in Indicated Tor Continuous normination in the best of the best of the one of clinical supervision, home environments. The SenTec Digital Monitor 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 noninvasive in The P-5gli - Serison, noder V-7 yr ; is natured for ase man the Bentee against for adult through pediatric patients.
carbon dioxide tension, oxygen saturation and pulse rate

SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon Sen rec s Lar clip, model EC TV , I s meeting are required. The Ear Clip is for single-patient use and dioxice tellsion, Uxygen Saturator and paise race rionisoning and monitoring site. The use of the indicated for patients weighing to kg of more, asing exhabitely the car issues of the inadequate sensor application).

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

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

Companison' co productions the same indications for use as a combination of the predicate devices.

The indicated patient population of the Sentec Digital Monitor System is similar to that of the family The Indicated patient population of the Schee Digital Nonter s 7650 and patients weighing more than 30 kg for the the entire population for the Population Tor the Poss person applied to the ear lobe with the Dura-Y Ear Clip.

The technological characteristics of the Sentec Digital Monitor System and the two predicate devices are essentially The technological Characters of the Sence Bigian Fronton M82 sensor and of the NPB-195 with the Dura-Y the Same. All relevant reading of the Microus 7030 with Gories of Sentec Digital Monitor System. In particular these are:

same principles of operation (2 wavelength SpO2 measurement, and PCO2 electrode technology) -
Same philipies or operatori (2 Wavelengal Spoz mussurenting (MicroGas) and Ear Clip (Nellcor)] ।
calibration unit integrated in monitor -
similar alarms and messages as predicate devices -

{2}------------------------------------------------

similar accessories for maintenance: membrane exchange tool, sensor contact gel, service gas -
all devices are portable stand-alone monitors -

The method of operation of the Sentec Digital Monitor System is the same as a combination of both predicate devices:

A. Sensor preparation

need to calibrate the PCO2 part of the sensors -
need to remembrane the sensor -
need to store the sensor in the calibration unit with the monitor switched-on ・
need to clean the sensor prior inserting it into the calibration unit

B. Monitoring

application of the sensor to a site using a specific sensor application means -
need to use a contact liquid that traps gases diffusing out of the skin -
need to use a warmed sensor
need to inspect the application site regularly (Site Timer) -

The materials used in both devices are similar. The instruments cases are formed of thermoplastic materials. The The macenals used in bour downed electronic parts (resistors, capacitors, integrated circuits, wiring, connectors, etc.).

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

Standards Testing (Electrical, Mechanical and Environmental)

The Sentec Digital Monitor System was tested to applicable standards for medical device Electrical Safety, The Schee Bigfar Tronicol - System The Noten, and Environmental Temperature and Humidity. Additionally the clectioninghede companier , Shock and Visialer, Sha annothing Guidance Document: Cutaneous Carbon Dioxide device was tested in accordance with the dass for Industry and FDA, December 13, 2002. The device passed all tests.

Biocompatibility Testing

Blocompatibility testing
Biocompatibility testing has been contact materials in compliance with ISO 10993-11.997. All materials met Biocompatibility requirements.

Bench Testing

Bench testing verified that the Sentec Digital Monitor System measured pulse rate values within ±3 digits of a laboratory pulse rate simulator.

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

Clinical studies were performed using the Sentec Digital Monitor System with healthy adult volunteer subjects who were subjected to progressive induced hypoxia against arterial hemoglobin oxygen determined from and the DCO samples with a CO-Oximeter as reference. The clinical study data furthermore support the performance of the POD Samples with a CO-Oximeer as relevelop. The clinical studies show that the reported saturation values from the Sentec Digital Monitor System meet specified accuracy requirements.

Conclusion[807.92(b)(3)]:

The results of all laboratory tests demonstrate that Sentec Digital Monitor System meets specified requirements.

The clinical and non-clinical testing performed demonstrates that the Sentec Digital Monitor System is safe, The climical and non-chilical testing performical che eno ento entore of your any and the predicate devices.

Other information [807.92(d)]:

Not applicable

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Sentec, Incorporated C/O Mr. Stephen Gorski Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119

Re: K041548

Trade/Device Name: Sentec Digital Monitor System (SDMS) Regulation Number: 21 CFR 868.2480, 870.2710 Regulation Name: Cutaneous Carbon Dioxide (PcCO2) Monitor Regulatory Class: II Product Code: LKD, DPZ Dated: June 4, 2004 Received: June 9, 2004

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.

{4}------------------------------------------------

Page 2 - Mr. Gorski

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. or the Five of arryly 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 und ilsting (2 - - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic 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), n 9se contact the Office of Compliance at (301) 594-4646. 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/dsma/dsmamain.html

Sincerely vours,

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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Sentec Digital Monitor System (SDMS) Device Name:

Indications for use:

The SenTec Digital Monitor System (comprising the SenTec Digital Monitor, V-Sign™ Sensor and The SenTec Digital Monitor System (Comprising the Sent monitoring. The SenTec Digital Monitor Accessories/ is indicated for continuous notrails intra-hospital transport environments, and System is indicated for use in nospital type realities, includes intrasses in for prescription use only.

The V-Sign™ Sensor, model VS-A/P, is indicated for use with the Sentec Digital Monitor with continuous and required for adult I he v-sign - Sellson, model v5 r47 ; is marcation and pulse rate monitoring are required for adult through pediatric patients.

SenTects Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-Schrocs Lar dip) model 2011 invasive carbon chonal callery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . for single patier. The use of the SenTec Ear Clip is contraindicated for patients whose ear-lobes are very small {resulting in inadequate sensor application}.

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

Prescription Use __ X (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)

Cury Sution

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental I

510(k) Number:

Page I of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.

(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.