(217 days)
Not Found
No
The provided text describes a standard pulse oximeter and its associated software. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on basic physiological monitoring and data retrieval.
No.
The device is indicated for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate), which is a diagnostic or monitoring function, not a therapeutic one. It does not actively treat or prevent a disease or condition.
Yes
The device is a pulse oximeter that non-invasively monitors functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The "Intended Use" explicitly states it's for "monitoring," which is a form of diagnosis to assess physiological conditions. The "Summary of Performance Studies" also mentions "accuracy claims" and clinical testing to "validate the performance and accuracy" of the device in monitoring physiological parameters related to oxygen saturation, which is used for diagnostic purposes.
No
The device description explicitly states it is a "handheld pulse oximeter monitor" and mentions "accessory sensors," indicating it is a hardware device with accompanying software.
Based on the provided information, the MySign® S Pulse Oximeter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MySign® S Function: The MySign® S is a pulse oximeter that measures oxygen saturation and pulse rate non-invasively by placing a sensor on the patient's skin (arterially perfused tissue). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "continuous non-invasive monitoring."
Therefore, the MySign® S falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DPZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric (excluding neonatal and infant)
Intended User / Care Setting
professional use only; hospitals, hospital-type facilities, and mobile transport units.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing was performed to validate the performance and accuracy of the MySign® S Pulse Oximeter with SpO2 Sensors under controlled hypoxia 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: Monitor: 70-100%: ARMS = +/- 2 % (with SoftTip R3211-12 MySign); Accuracy claim varies slightly by sensor type.
Pulse rate accuracy: +/- 3 BPM (30-250 BPM)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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MAY 0 2 2014
Page 1 of 5
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, a |
| Honeywell Company | ||
| K991823 | Nellcor N-395 | Philips Medical Systems |
| (formerly HP) | ||
| K122290 | Envitec MySign PC Software | |
| (listed accessory of MySign O | ||
| Oxygen measuring device) | EnviteC-Wismar GmbH, a | |
| 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.
1
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.
2
Comparison of Technological Features to Predicate Device(s):
1
| | Envitec MySign® S
Pulse Oximeter Monitor | Envitec OxiPen Pulse
Oximeter | Nellcor N395 Pulse
Oximeter |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product/Feature | Envitec MySign® S
Pulse Oximeter Monitor | Envitec OxiPen Pulse
Oximeter | Nellcor N395 Pulse
Oximeter |
| Manufacturer | EnviteC-Wismar GmbH
by Honeywell | EnviteC-Wismar GmbH
by Honeywell | Nellcor, Inc
(now Covidien) |
| 510(k) Number | (pending this
submission) | K070193 | K991823 |
| Patient
Population | Adult through pediatric
(not infant or neonatal)
patients | Adult through pediatric
(not infant or neonatal)
patients | Adult through neonatal
patients |
| Indications: | 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,
mobile units, and home
environments. | The EnviteC OxiPen
Pulse Oximeter is
intended for noninvasive
spot-check measurement
of functional oxygen
saturation of arterial
hemoglobin (SpO2), and
pulse rate (measured by
SpO2 sensor
accessories).
The monitor is intended
for use on adult and
pediatric patients in
hospitals, hospital-type
facilities, mobile, and
home environments. | The intended use of the
N-395 Pulse Oximeter
is the continuous, non-
invasive monitoring of
functional oxygen
saturation of arterial
hemoglobin (SpO2) and
pulse rate. For use with
neonatal, pediatric and
adult patients, in
hospitals, hospital-type
facilities and intra-
hospital transport
environments. For
prescription use only. |
| Use | Continuous monitoring
of functional oxygen
saturation with alarms | Spot monitoring of
functional oxygen
saturation (no alarms) | Continuous monitoring
of functional oxygen
saturation with alarms |
| Measurement
principle | Two wavelength pulse
measurement to obtain
functional oxygen
saturation | Two wavelength pulse
measurement to obtain
functional oxygen
saturation | Two wavelength pulse
measurement to obtain
functional oxygen
saturation |
| SpO2 range | 1-100% | 0-100% | 1-100% |
| SpO2 accuracy | Monitor:
70-100%: ARMS =
$\pm$ 2 % (with SoftTip
R3211-12 MySign)
Accuracy claim varies
slightly by sensor type | Monitor:
70-100%: ARMS = 2.0
Accuracy claim varies
slightly by sensor type | Monitor:
70-100%: $\pm$ 2 digits
Neonatal: $\pm$ 3 digits
Saturation (%SpO2 $\pm$ 1
SD) |
| Pulse rate range | 0-300 BPM | 20-300 BPM | 20-250 BPM |
| Pulse rate
accuracy | $\pm$ 3 BPM (30-250 BPM) | $\pm$ 3 BPM (20-300 BPM) | $\pm$ 3 digits (20-250) |
| Product/Feature | Envitec MySign® S
Pulse Oximeter Monitor | Envitec OxiPen Pulse
Oximeter | Nellcor N395 Pulse
Oximeter |
| Available
Oximetry
Sensors
supported by.
IFU's | Finger Clip; SoftTip
Finger Sensor(s);
SoftTip+; Ear Clip;
Disposable
Adult/Pediatric | Finger Clip; SoftTip
Finger Sensor | Full range of Nellcor
reusable/disposable
sensors including,
Finger Clip, Ear Clip, Y
Sensor, Disposable
Adult-Neonatal |
| Visible &
Auditory Alarms | Audible Alarms/Alerts
55-75 db(A) | Audible alerts for sensor
off, disconnect, power
off | Audible Alarms/Alerts,
outputs vary by priority
(high, medium, low) |
| IFU structure | Comprehensive user
manual, separate
accessory instructions | Comprehensive user
manual, separate
accessory instructions | Comprehensive user
manual, separate
accessory instructions |
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| Product/Feature | EnviteC MySign® PC Software (new
version 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 |
| Devices
Supported | MySign S (new)
MySign O (existing) | MySign O |
| PC Operating
System | Microsoft Windows XP or later,
Microsoft .NET 4.0 Framework | Microsoft Windows XP or later,
Microsoft .NET 3.5 or 4.0 Framework |
| Device
connection | USB Serial Port | USB Serial Port |
| Basic menu
functions | 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 |
| Parameters
Displayed | %SpO2, Pulse Rate, % O2, alarm
limits at time of measurement
(tabular or graphical view) | % O2, alarm limits at time of
measurement
(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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Page 5 of 5
- 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.
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus symbol.
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.
6
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
7
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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