MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31

K133064 · Envitec-Wismar GmbH · DQA · May 2, 2014 · Cardiovascular

Device Facts

• Record ID: K133064
• Device Name: MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
• Applicant: Envitec-Wismar GmbH
• Product Code: DQA · Cardiovascular
• Decision Date: May 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

MySign® S is a handheld pulse oximeter with accessory sensors indicated for continuous noninvasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile transport units. For professional use only.

Device Story

Handheld pulse oximeter for continuous non-invasive monitoring of SpO2 and pulse rate; utilizes reusable/disposable sensors; illuminates arterially perfused tissue with two LED wavelengths; measures time-varying absorbance via photodiode; provides numeric SpO2/pulse rate displays, pulse bar/waveform, and audible/visual alarms; used in hospitals, clinical facilities, and mobile transport by healthcare professionals; includes PC software for retrospective data management, trend charting, and reporting; aids clinical decision-making through real-time saturation monitoring and alarm notification.

Clinical Evidence

Clinical testing performed under controlled hypoxia vs. co-oximetry reference. Results validate accuracy claims for SpO2 range of 70% to 100%. Testing conducted under institutionally approved protocol with informed consent.

Technological Characteristics

Handheld pulse oximeter; two-wavelength LED illumination and photodiode sensing; SpO2 range 1-100%; pulse rate range 0-300 BPM; audible/visual alarms (55-75 db(A)); biocompatible patient contact materials; software-based data management; compliant with IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, and IEC 60601-1-8.

Indications for Use

Indicated for continuous non-invasive monitoring of functional oxygen saturation (SpO2) and pulse rate in adult and pediatric patients (excluding neonates and infants) in hospitals, hospital-type facilities, and mobile transport units. For professional use only.

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

• Envitec OxiPen (K070193)
• Nellcor N-395 (K991823)
• Envitec MySign PC Software (K122290)

Submission Summary (Full Text)

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K133064

MAY 0 2 2014

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### 510(k) Summary in accordance with 21 CFR 807.92

Submitted by: (1) (a)

EnviteC-Wismar GmbH by Honeywell Alter Holzhafen 18 Wismar 23966 Germany Tel.: [phone] Fax: [phone] [e-mail]

Contact Person:

Position/Title:

R&D Manager

Marko Sproessel

Date of Preparation: May 2, 2014

- (2) Trade Name: EnviteC MySign® S Pulse Oximeter, Accessory SpO2 Sensors, and MySign® PC Software
Common/Classification Name: OXIMETER; EAR OXIMETER

Product Code(s):

Class:

Class II

(3) Predicate Device(s): Substantial Equivalence to:

DQA; 21 CFR §870.2700

DPZ; 21 CFR §870.2710

| K Number | Model | Manufacturer |
|----------|-----------------------------------------------------------------------------------------|---------------------------------------------|
| K070193 | Envitec OxiPen | EnviteC-Wismar GmbH, a<br>Honeywell Company |
| K991823 | Nellcor N-395 | Philips Medical Systems<br>(formerly HP) |
| K122290 | Envitec MySign PC Software<br>(listed accessory of MySign O<br>Oxygen measuring device) | EnviteC-Wismar GmbH, a<br>Honeywell Company |

Reason for Submission: New Device(s)

ನ

- Description of Device: (4)
The EnviteC MySign® S Pulse Oximeter is a handheld pulse oximeter monitor validated for use in portable applications, including out of hospital transport.

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The MySign® S Pulse Oximeter features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator or waveform for visual assessment of pulsation. The device has settable alarms and an audible pulse tone which varies with saturation level.

The MySign® S is offered with a family of Reusable and Disposable SpO2 Sensors for adult and pediatric applications.

MySign® PC Software may be used to obtain retrospective monitoring data from MySign® series monitors and to perform utility functions such as setting the institution identification.

#### (5) Intended use:

The measurement of functional oxygen saturation of arterial hemoglobin (SpO2) has been a standard of care in the USA for 20 years. Applications for oximetry include monitoring in the anesthesia, recovery, and critical care environments, as well as transport monitoring and home care.

### Indications for Use:

MySign® S is a handheld pulse oximeter with accessory sensors indicated for continuous non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile transport units. For professional use only.

#### (6) Technological Characteristics:

The EnviteC MySign® S Pulse Oximeter and Accessory SpO2 Sensors employ the same technological characteristics as the listed predicate devices to determine arterial functional oxygen saturation: arterially perfused tissue is illuminated sequentially by two wavelengths of light emitted by light emitting diodes (LED's), and the time varying absorbance of the tissue is measured from a photodiode light sensor. This method is characteristic of all pulse oximeter monitors and sensors which are the subject of this submission as well as the predicate devices.

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# Comparison of Technological Features to Predicate Device(s):

1

| | Envitec MySign® S<br>Pulse Oximeter Monitor | Envitec OxiPen Pulse<br>Oximeter | Nellcor N395 Pulse<br>Oximeter |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product/Feature | Envitec MySign® S<br>Pulse Oximeter Monitor | Envitec OxiPen Pulse<br>Oximeter | Nellcor N395 Pulse<br>Oximeter |
| Manufacturer | EnviteC-Wismar GmbH<br>by Honeywell | EnviteC-Wismar GmbH<br>by Honeywell | Nellcor, Inc<br>(now Covidien) |
| 510(k) Number | (pending this<br>submission) | K070193 | K991823 |
| Patient<br>Population | Adult through pediatric<br>(not infant or neonatal)<br>patients | Adult through pediatric<br>(not infant or neonatal)<br>patients | Adult through neonatal<br>patients |
| Indications: | MySign® S is a handheld<br>pulse oximeter with<br>accessory sensors<br>indicated for continuous<br>non-invasive monitoring<br>of the functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate for adult and<br>pediatric (excluding<br>neonatal and infant)<br>patients in hospitals,<br>hospital-type facilities,<br>mobile units, and home<br>environments. | The EnviteC OxiPen<br>Pulse Oximeter is<br>intended for noninvasive<br>spot-check measurement<br>of functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2), and<br>pulse rate (measured by<br>SpO2 sensor<br>accessories).<br>The monitor is intended<br>for use on adult and<br>pediatric patients in<br>hospitals, hospital-type<br>facilities, mobile, and<br>home environments. | The intended use of the<br>N-395 Pulse Oximeter<br>is the continuous, non-<br>invasive monitoring of<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate. For use with<br>neonatal, pediatric and<br>adult patients, in<br>hospitals, hospital-type<br>facilities and intra-<br>hospital transport<br>environments. For<br>prescription use only. |
| Use | Continuous monitoring<br>of functional oxygen<br>saturation with alarms | Spot monitoring of<br>functional oxygen<br>saturation (no alarms) | Continuous monitoring<br>of functional oxygen<br>saturation with alarms |
| Measurement<br>principle | Two wavelength pulse<br>measurement to obtain<br>functional oxygen<br>saturation | Two wavelength pulse<br>measurement to obtain<br>functional oxygen<br>saturation | Two wavelength pulse<br>measurement to obtain<br>functional oxygen<br>saturation |
| SpO2 range | 1-100% | 0-100% | 1-100% |
| SpO2 accuracy | Monitor:<br>70-100%: ARMS =<br>$\pm$ 2 % (with SoftTip<br>R3211-12 MySign)<br>Accuracy claim varies<br>slightly by sensor type | Monitor:<br>70-100%: ARMS = 2.0<br>Accuracy claim varies<br>slightly by sensor type | Monitor:<br>70-100%: $\pm$ 2 digits<br>Neonatal: $\pm$ 3 digits<br>Saturation (%SpO2 $\pm$ 1<br>SD) |
| Pulse rate range | 0-300 BPM | 20-300 BPM | 20-250 BPM |
| Pulse rate<br>accuracy | $\pm$ 3 BPM (30-250 BPM) | $\pm$ 3 BPM (20-300 BPM) | $\pm$ 3 digits (20-250) |
| Product/Feature | Envitec MySign® S<br>Pulse Oximeter Monitor | Envitec OxiPen Pulse<br>Oximeter | Nellcor N395 Pulse<br>Oximeter |
| Available<br>Oximetry<br>Sensors<br>supported by.<br>IFU's | Finger Clip; SoftTip<br>Finger Sensor(s);<br>SoftTip+; Ear Clip;<br>Disposable<br>Adult/Pediatric | Finger Clip; SoftTip<br>Finger Sensor | Full range of Nellcor<br>reusable/disposable<br>sensors including,<br>Finger Clip, Ear Clip, Y<br>Sensor, Disposable<br>Adult-Neonatal |
| Visible &<br>Auditory Alarms | Audible Alarms/Alerts<br>55-75 db(A) | Audible alerts for sensor<br>off, disconnect, power<br>off | Audible Alarms/Alerts,<br>outputs vary by priority<br>(high, medium, low) |
| IFU structure | Comprehensive user<br>manual, separate<br>accessory instructions | Comprehensive user<br>manual, separate<br>accessory instructions | Comprehensive user<br>manual, separate<br>accessory instructions |

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## Page 4 of 5

| Product/Feature | EnviteC MySign® PC Software (new<br>version to support MySign S) | EnviteC MySign® PC Software<br>(cleared version for MySign O) |
|--------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Manufacturer | EnviteC-Wismar GmbH by Honeywell | EnviteC-Wismar GmbH by Honeywell |
| 510(k) Number | (pending - this submission) | K122290 |
| Devices<br>Supported | MySign S (new)<br>MySign O (existing) | MySign O |
| PC Operating<br>System | Microsoft Windows XP or later,<br>Microsoft .NET 4.0 Framework | Microsoft Windows XP or later,<br>Microsoft .NET 3.5 or 4.0 Framework |
| Device<br>connection | USB Serial Port | USB Serial Port |
| Basic menu<br>functions | Dataset, PC Data, Patient Data,<br>Export to Excel, Save, Print (to PDF),<br>Delete, System Settings | Dataset, PC Data, Patient Data,<br>Export to Excel, Save, Print (to PDF),<br>Delete, System Settings |
| Parameters<br>Displayed | %SpO2, Pulse Rate, % O2, alarm<br>limits at time of measurement<br>(tabular or graphical view) | % O2, alarm limits at time of<br>measurement<br>(tabular or graphical view) |
| Data present-<br>ation options | Tabular (data listing)<br>Trend Chart | Tabular (data listing)<br>Trend Chart |

#### (b) (1) Non-Clinical Tests Submitted:

The EnviteC MySign® S Pulse Oximeter and Accessories were tested in accordance with current applicable standards for medical device electrical safety and electromagnetic compatibility and particular standards for pulse oximeter monitors, including the following recognized standards:

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- IEC 60601-1, Medical Electrical Equipment Part 1, General Requirements . for Safety
- IEC 60601-1-2, Medical Electrical Equipment Collateral Standard. . Electromagnetic Compatibility Requirements & Tests
- . ISO 80601-2-61, Medical Electrical Equipment - Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeters.
- . 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, Including MySign® PC, Software, 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

Sensor patient contact materials meet applicable standards for biocompatibility.

#### (2) Clinical Tests Submitted:

Clinical testing was performed to validate the performance and accuracy of the MySign® S Pulse Oximeter with SpO2 Sensors under controlled hvpoxia versus arterial oxygen saturation as determined by co-oximetry. All testing was performed under an institutionally approved protocol with subject informed consent. Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2.

#### Conclusions from Tests: (3)

As described in (b)(1) and (b)(2) above, EnviteC MySign® S Pulse Oximeter and Accessories are equivalent to predicate devices as substantiated by parameter, bench, and clinical testing. Device safety is substantiated by testing to applicable standards and by biocompatibility of patient contact materials.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G60 Silver Spring, MD 20993-0002

### May 2, 2014

EnviteC-Wismar GmbH c/o Mr. Stephen Gorski Imagenix Incorporated S65 W35739 Piper Road Eagle, WI 53119

Re: K133064

Trade/Device Name: EnviteC MySign® S Pulse Oximeter, Accessory SpO2 Sensors, and MySign® PC Software Regulation Number: 21 CFR 870.2700 Regulation Name: OXIMETER Regulatory Class: Class II Product Code: DQA, DPZ Dated: March 28, 2014 Received: April 2, 2014

### 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -
S FDA

Erin I. Keith, M.S. Acting 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): K133064

### Device Name:

MySign® S Pulse Oximeter and Accessories

### Indications for use:

MySign® S is a handheld pulse oximeter with accessory sensors indicated for continuous noninvasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile transport units. For professional use only.

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)

Neel J. Patel-S
2014.05.02 15:14:52 '04'00'

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