ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
Device Facts
| Record ID | K122290 |
|---|---|
| Device Name | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE |
| Applicant | Envitec-Wismar GmbH |
| Product Code | CCL · Anesthesiology |
| Decision Date | Jan 23, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1720 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The oxygen measuring device MySign® O is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas. MySign® O can be used for monitoring the breathing gases dispensed by the following devices: Anaesthesia breathing systems Respiratory equipment Infant incubators Oxygen therapy systems The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home. Prescription device
Device Story
Handheld oxygen monitor; utilizes electro-galvanic oxygen sensor (OOM111) to measure inspired oxygen concentrations in breathing gas. Sensor produces electrical voltage proportional to oxygen level; microprocessor with analog-to-digital converter processes signal to calculate and display oxygen percentage. Features settable high/low alarm limits. Used in hospitals, transport, emergencies, and home settings by clinicians or patients. Optional PC software allows configuration and data transmission from device memory; software does not perform diagnostic functions or influence monitor performance. Output enables healthcare providers to monitor oxygen delivery, facilitating clinical adjustments to breathing gas supplies to ensure patient safety.
Clinical Evidence
No clinical data. Bench testing only. Device performance validated against recognized standards including IEC 60601-1, IEC 60601-1-2, ISO 21647, and IEC 60601-1-8. Testing confirmed device meets acceptance criteria for linearity, measurement accuracy, and drift.
Technological Characteristics
Electro-galvanic oxygen sensor; microprocessor-based monitor with analog-to-digital converter. Handheld form factor. Connectivity via optional PC software for data readout. Biocompatible materials per EN ISO 10993. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 21647 (respiratory gas monitors), IEC 60601-1-8 (alarms). Software developed per IEC 62304.
Indications for Use
Indicated for continuous or spot monitoring of inspired oxygen concentrations in breathing gas for patients using anesthesia breathing systems, respiratory equipment, infant incubators, or oxygen therapy systems. Suitable for hospital, transport (excluding air), emergency, and home artificial respiration settings. Prescription use only.
Regulatory Classification
Identification
An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.
Predicate Devices
- Max O2 Plus - Model OM25 ME (K040484)
- Max O2 CU (K063488)
- EnviteC Medical Oxygen Sensors (including sensor OOM111) (K082655)
Submission Summary (Full Text)
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K122790
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## 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
| (a) (1) Submitted by: | EnviteC-Wismar GmbH by Honeywell<br>Alter Holzhafen 18<br>Wismar 23966<br>Germany<br>Tel.: +49-38 41 360 221<br>Fax: +49-38 41 360 222<br>Marko.Sproessel@Honeywell.com |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marko Sproessel |
|----------------------|----------------------------------|
| Position/Title: | Research and Development Manager |
| Date of Preparation: | January 3, 2013 |
| (2) Trade Name: | EnviteC MySign® O Oxygen Measuring Device |
|-----------------------------|-------------------------------------------|
| Common/Classification Name: | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Product Code(s): | 21 CFR §868.1720; CCL |
| Class: | Class II |
| (3) Predicate Device(s): | Substantial Equivalence to: |
|--------------------------|-----------------------------|
|--------------------------|-----------------------------|
| K Number | Model | Manufacturer |
|----------|-------------------------------------------------------------|---------------------|
| K040484 | Max O2 Plus - Model OM25 ME | Maxtec, Inc. |
| K063488 | Max O2 CU | Maxtec, Inc. |
| K082655 | EnviteC Medical Oxygen Sensors<br>(including sensor OOM111) | EnviteC-Wismar GmbH |
Reason for Submission: New Device
#### Description of Device: (4)
The EnviteC MySign® O Oxygen Measuring Device is a hand held oxygen monitor which uses the established technology of the EnviteC electrogalvanic oxygen sensor type OOM111. The EnviteC OOM111 medical oxygen sensor has been previously evaluated and cleared under 510(k) K082655.
The MySign® O Oxygen Measuring Device incorporates a medical oxygen sensor placed in the inspired air path or gas supply, a sensor cable, and a
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### Page 2 of 3
monitor to display the measurements. The device is intended for continuous or spot monitoring of inspired oxygen concentrations in breathing gas and provides settable low and high alarm limits.
The optional MySign® PC Software can be used to configure MySign® devices and to transmit data from the device to the PC for the readout of measurement data which is stored in the memory of MySign® monitor. The PC software is not intended for diagnostic functions nor will it influence essential performance functions of the monitor - the MySign® O monitor will not perform measurements when PC connected.
#### (5) Intended use:
Inspired oxygen monitors have widespread use for continuous or spot monitoring of inspired oxygen concentrations in breathing gas and air supplies.
### Indications for Use:
The oxygen measuring device MySign® O is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas.
MySign® O can be used for monitoring the breathing gases dispensed by the following devices:
Anaesthesia breathing systems Respiratory equipment Infant incubators Oxygen therapy systems
The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home.
Prescription device
#### (6) Technological Characteristics:
The EnviteC MySign® O Oxygen Measuring Device utilizes the same measurement principles as the predicate devices to measure oxygen: an electro-galvanic oxygen sensor produces an electrical voltage in relation to the amount of oxygen present. The monitor utilizes a microprocessor with analog to digital converter to obtain the sensor voltage and displays the calculated oxygen percentage. This method is characteristic of the oxygen sensor and monitor which are the subject of this submission as well as of the predicate device characteristics.
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#### (b) (1) Non-Clinical Tests Submitted:
The EnviteC MySign® O Oxygen Measuring Device was tested in accordance with current applicable standards for medical device electrical safety and electromagnetic compatibility and particular standards for respiratory gas monitors, including the following recognized standards:
- . 60601-1, Medical Electrical Equipment - Part 1, General IEC Requirements for Safety
- . IEC 60601-1-2, Medical Electrical Equipment - Collateral Standard. Electromagnetic Compatibility Requirements & Tests
- . ISO 21647, Medical Electrical Equipment - Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors.
- . IEC 60601-1- 8, Medical Electrical Equipment - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Risk management and software validation was performed on the device in accordance with established development processes per the following:
- ANSI/AAMI/ISO 14971, Medical devices-Risk management-Application . of risk management to medical devices
- . IEC 62304, Medical Device Software, Software Life Cycle Processes
- FDA/ODE Guidance for the Content of Premarket Submissions for . Software Contained in Medical Devices
Accessories for placement of the oxygen sensor in the path of the inspired air or gas supply were tested to meet applicable standards for biocompatibility per EN ISO 10993, Biological evaluation of medical devices.
Device parameters were compared to the listed predicate devices, and tested for linearity, measurement accuracy, and drift. The EnviteC MySign® O Oxygen Measuring Device met test acceptance criteria established by the respiratory gas monitoring standard.
#### (2) Clinical Tests Submitted:
(None)
#### (3) Conclusions from Tests:
As described in (b)(1) and (b)(2) above, the EnviteC MySign® O Oxygen Measuring Device is equivalent to the listed predicate devices as substantiated by parameter and bench testing and evaluation. Device safety is substantiated by risk management activities, and internal and independent laboratory testing to applicable standards.
D(1) - 3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol resembling a stylized caduceus or a representation of human services.
### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
### January 23, 2013
EnviteC-Wismar GmbH C/O Mr. Stephen H. Gorski Imagenix. Incorporated S65 W35739 Piper Road EAGLE WI 53119
Re: K122290
Trade/Device Name: MySign® O Oxygen Measuring Device Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: December 20, 2012 Received: December 26, 2012
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. 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 - 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
**Kwame** Q. **Ulmer**
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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):
MySign® O Oxygen Measuring Device Device Name:
Indications For Use:
The oxygen measuring device MySign® O is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas.
MySign® O can be used for monitoring the breathing gases dispensed by the following devices:
Anaesthesia breathing systems
Respiratory equipment
Infant incubators
Oxygen therapy systems
The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home.
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)
| Albert E. | Albert E. Moyal |
|-----------|---------------------|
| | 2013.01.15 14:35:44 |
| Moyal | -05'00' |
for LS(Division Sign-Off) Division of Anesthesiology, General Hc.spital Division Control, Dental Devices
C-1 510(k) Number:
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