SENTEC DIGITAL MONITORING SYSTEM

K071672 · Sentec AG · DQA · Sep 12, 2007 · Cardiovascular

Device Facts

• Record ID: K071672
• Device Name: SENTEC DIGITAL MONITORING SYSTEM
• Applicant: Sentec AG
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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™ 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. 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 Story

System monitors PCO2, SpO2, and pulse rate using V-Sign digital sensor. Sensor uses 2-wavelength optical measurement for SpO2 and electrode technology for PCO2. Sensor heated to 41-42°C to ensure perfusion. New Multi-Site Attachment Rings allow sensor placement on conventional skin sites (non-ear lobe) for PCO2 monitoring. Used in hospitals, transport, and supervised home settings. Clinicians use real-time monitor output for patient status assessment. System includes monitor, sensor, cable, and attachment accessories. Benefits include continuous, non-invasive physiological data for clinical decision-making.

Clinical Evidence

No clinical studies performed. Substantial equivalence supported by bench testing, biocompatibility testing per ISO 10993-1:2003, and risk/hazard analysis.

Technological Characteristics

Transcutaneous PCO2 electrode and 2-wavelength pulse oximetry sensor. Heated sensor (41-42°C). Connectivity via digital cable to monitor. Single-use adhesive attachment rings and ear clips. Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for continuous, non-invasive monitoring of PCO2, SpO2, and pulse rate in adult and pediatric patients; PCO2 monitoring only in neonates. Contraindicated for patients with ear lobes too small for the ear clip.

Regulatory Classification

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.

Predicate Devices

• SenTec Digital Monitoring System (K041548)
• TOSCA 500 tcPCO2, SpO2 and PR monitoring system (K063434)
• MicroGas 7650 Transcutaneous Monitor (K991644)

Submission Summary (Full Text)

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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 [phone] [phone]

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

Ms. Sabine Nieba, Ph.D. Quality & Regulatory Affairs Manager [e-mail]

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

August 18, 2007

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

| Trade / Proprietary Name | Common /<br>Usual Name | Classification<br>Name | Product<br>Code | Class | Regulation<br>Number |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------|-----------------|-------|-------------------------|
| SenTec Digital Monitoring<br>System<br>SenTec Digital Monitor,<br>V-SignTM Sensor & Accessories for<br>sensor application/maintenance;<br>new Multi-Site Attachment Rings | Cutaneous Carbon<br>Dioxide Monitor | Monitor, Carbon-<br>Dioxide, Cutaneous | 73 LKD | II | 21 CFR Part<br>868.2480 |
| | Pulse Oximeter | Oximeter | 74 DQA | II | 21 CFR Part<br>870.2700 |
| | Pulse Oximeter | Oximeter, Ear | 74 DPZ | II | 21 CFR Part<br>870.2710 |

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

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

### Reason For Submission: Additional or Expanded Indications

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

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.

#### 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.

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.

#### 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 [phone]. 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 [phone] or [phone] 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:

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 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