(217 days)
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.
The EnviteC MySign® S Pulse Oximeter is a handheld pulse oximeter monitor validated for use in portable applications, including out of hospital transport. 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.
The EnviteC MySign® S Pulse Oximeter, Accessory SpO2 Sensors, and MySign® PC Software are evaluated based on their performance in measuring functional oxygen saturation (SpO2) and pulse rate.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | ARMS = $\pm$ 2 % (70-100% saturation) | ARMS = $\pm$ 2 % (70-100% SpO2) (with SoftTip R3211-12 MySign); varies slightly by sensor type |
| SpO2 Range | 1-100% | 1-100% |
| Pulse Rate Accuracy | $\pm$ 3 BPM (30-250 BPM) | $\pm$ 3 BPM (30-250 BPM) |
| Pulse Rate Range | 0-300 BPM | 0-300 BPM |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the number of subjects (the sample size) used in the clinical test. It mentions that "All testing was performed under an institutionally approved protocol with subject informed consent."
- Data Provenance: The clinical testing was performed to validate performance "under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." This implies a prospective study design where subjects were intentionally desaturated. The country of origin of the data is not specified, but the submission is from a German company (EnviteC-Wismar GmbH by Honeywell).
3. Number of Experts and their Qualifications for Ground Truth
- The document implies that the ground truth for SpO2 was established by co-oximetry readings from arterial blood samples. This is a standard and highly accurate method for determining arterial oxygen saturation.
- The document does not mention the use of human experts to establish ground truth for the device's primary measurements (SpO2 and pulse rate). The gold standard for SpO2 measurement in these types of studies is the direct measurement of arterial blood gases using a co-oximeter, not expert consensus on visual assessment. Therefore, the concept of "number of experts" is not directly applicable in the context of establishing ground truth for SpO2 accuracy.
4. Adjudication Method for the Test Set
- There is no mention of an adjudication method in the context of the clinical accuracy testing. The ground truth was established by co-oximetry, which is a direct measurement, and thus expert adjudication would not be typical for this type of quantitative assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This device is a pulse oximeter, and its performance is assessed against a gold standard (co-oximetry), not by comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was done for the algorithm (the pulse oximeter device itself). The clinical testing described directly assesses the accuracy of the EnviteC MySign® S Pulse Oximeter with its sensors in measuring SpO2 against co-oximetry, and pulse rate against what is presumed to be the co-oximeter's pulse rate measurement or an ECG/reference monitor. This is a standalone performance assessment of the device.
7. Type of Ground Truth Used
- The ground truth for SpO2 accuracy was established by arterial oxygen saturation as determined by co-oximetry. This is considered a highly accurate and direct measure for oxygen saturation.
8. Sample Size for the Training Set
- The document does not provide information regarding a "training set" or its sample size. Pulse oximeters typically rely on established physiological principles and spectrophotometric measurements. While their algorithms are developed and refined, the concept of a distinct "training set" for a machine learning model, as seen in AI/ML medical devices, is not explicitly detailed or a standard regulatory requirement for conventional pulse oximeters. The development process would involve calibration and internal testing, but not typically a labeled "training set" as understood in current AI contexts.
9. How the Ground Truth for the Training Set Was Established
- Since a "training set" is not explicitly mentioned or described, there is no information on how its ground truth was established.
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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.: +49-38 41 360 221 Fax: +49-38 41 360 222 Marko.Sproessel@Honeywell.com
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, aHoneywell Company |
| K991823 | Nellcor N-395 | Philips Medical Systems(formerly HP) |
| K122290 | Envitec MySign PC Software(listed accessory of MySign OOxygen measuring device) | EnviteC-Wismar GmbH, aHoneywell 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® SPulse Oximeter Monitor | Envitec OxiPen PulseOximeter | Nellcor N395 PulseOximeter | |
|---|---|---|---|
| Product/Feature | Envitec MySign® SPulse Oximeter Monitor | Envitec OxiPen PulseOximeter | Nellcor N395 PulseOximeter |
| Manufacturer | EnviteC-Wismar GmbHby Honeywell | EnviteC-Wismar GmbHby Honeywell | Nellcor, Inc(now Covidien) |
| 510(k) Number | (pending thissubmission) | K070193 | K991823 |
| PatientPopulation | Adult through pediatric(not infant or neonatal)patients | Adult through pediatric(not infant or neonatal)patients | Adult through neonatalpatients |
| Indications: | MySign® S is a handheldpulse oximeter withaccessory sensorsindicated for continuousnon-invasive monitoringof the functional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate for adult andpediatric (excludingneonatal and infant)patients in hospitals,hospital-type facilities,mobile units, and homeenvironments. | The EnviteC OxiPenPulse Oximeter isintended for noninvasivespot-check measurementof functional oxygensaturation of arterialhemoglobin (SpO2), andpulse rate (measured bySpO2 sensoraccessories).The monitor is intendedfor use on adult andpediatric patients inhospitals, hospital-typefacilities, mobile, andhome environments. | The intended use of theN-395 Pulse Oximeteris the continuous, non-invasive monitoring offunctional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate. For use withneonatal, pediatric andadult patients, inhospitals, hospital-typefacilities and intra-hospital transportenvironments. Forprescription use only. |
| Use | Continuous monitoringof functional oxygensaturation with alarms | Spot monitoring offunctional oxygensaturation (no alarms) | Continuous monitoringof functional oxygensaturation with alarms |
| Measurementprinciple | Two wavelength pulsemeasurement to obtainfunctional oxygensaturation | Two wavelength pulsemeasurement to obtainfunctional oxygensaturation | Two wavelength pulsemeasurement to obtainfunctional oxygensaturation |
| SpO2 range | 1-100% | 0-100% | 1-100% |
| SpO2 accuracy | Monitor:70-100%: ARMS =$\pm$ 2 % (with SoftTipR3211-12 MySign)Accuracy claim variesslightly by sensor type | Monitor:70-100%: ARMS = 2.0Accuracy claim variesslightly by sensor type | Monitor:70-100%: $\pm$ 2 digitsNeonatal: $\pm$ 3 digitsSaturation (%SpO2 $\pm$ 1SD) |
| Pulse rate range | 0-300 BPM | 20-300 BPM | 20-250 BPM |
| Pulse rateaccuracy | $\pm$ 3 BPM (30-250 BPM) | $\pm$ 3 BPM (20-300 BPM) | $\pm$ 3 digits (20-250) |
| Product/Feature | Envitec MySign® SPulse Oximeter Monitor | Envitec OxiPen PulseOximeter | Nellcor N395 PulseOximeter |
| AvailableOximetrySensorssupported by.IFU's | Finger Clip; SoftTipFinger Sensor(s);SoftTip+; Ear Clip;DisposableAdult/Pediatric | Finger Clip; SoftTipFinger Sensor | Full range of Nellcorreusable/disposablesensors including,Finger Clip, Ear Clip, YSensor, DisposableAdult-Neonatal |
| Visible &Auditory Alarms | Audible Alarms/Alerts55-75 db(A) | Audible alerts for sensoroff, disconnect, poweroff | Audible Alarms/Alerts,outputs vary by priority(high, medium, low) |
| IFU structure | Comprehensive usermanual, separateaccessory instructions | Comprehensive usermanual, separateaccessory instructions | Comprehensive usermanual, separateaccessory instructions |
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| Product/Feature | EnviteC MySign® PC Software (newversion to support MySign S) | EnviteC MySign® PC Software(cleared version for MySign O) |
|---|---|---|
| Manufacturer | EnviteC-Wismar GmbH by Honeywell | EnviteC-Wismar GmbH by Honeywell |
| 510(k) Number | (pending - this submission) | K122290 |
| DevicesSupported | MySign S (new)MySign O (existing) | MySign O |
| PC OperatingSystem | Microsoft Windows XP or later,Microsoft .NET 4.0 Framework | Microsoft Windows XP or later,Microsoft .NET 3.5 or 4.0 Framework |
| Deviceconnection | USB Serial Port | USB Serial Port |
| Basic menufunctions | Dataset, PC Data, Patient Data,Export to Excel, Save, Print (to PDF),Delete, System Settings | Dataset, PC Data, Patient Data,Export to Excel, Save, Print (to PDF),Delete, System Settings |
| ParametersDisplayed | %SpO2, Pulse Rate, % O2, alarmlimits at time of measurement(tabular or graphical view) | % O2, alarm limits at time ofmeasurement(tabular or graphical view) |
| Data present-ation options | Tabular (data listing)Trend Chart | Tabular (data listing)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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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'
Page 1 of __
§ 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).