(154 days)
Not Found
No
The device description and performance studies focus on standard pulse oximetry technology and compatibility with predicate devices, with no mention of AI or ML.
No
This device is for monitoring SpO2 and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device is indicated for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are parameters measured to assess a patient's physiological state, fitting the definition of a diagnostic device.
No
The device description explicitly states the sensors are comprised of a connector, cable, and sensor housing containing LEDs and a photodetector, which are physical hardware components.
Based on the provided information, the EnviteC Reusable SpO2 Sensors are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The EnviteC Reusable SpO2 Sensors are used for continuous non-invasive monitoring of oxygen saturation and pulse rate by placing the sensor on the patient's finger or ear. This is a measurement taken on the body, not on a specimen from the body.
- Intended Use: The intended use clearly states "continuous non-invasive monitoring," which is characteristic of a physiological monitoring device, not an IVD.
Therefore, the EnviteC Reusable SpO2 Sensors fall under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
EnviteC Reusable SpO2 Sensors are indicated for continuous noninvasive monitoring of 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.
Prescription device.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DPZ
Device Description
The EnviteC Reusable SpO2 Sensors are a family of oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturers listed above.
EnviteC's Reusable SpO2 Sensors are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Three types of sensor housings are offered in this submission:
- A finger clip with rigid halves positioned by mild spring force .
- An ear clip with rigid halves positioned by mild spring force and an I ear hanger for the cable
- I A soft rubber finger sensor with unitary sealed tube type construction
A unique sensor type exists for each compatible manufacturer above, and each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (HP/Philips, Minolta).
Each sensor type includes the following features: - r Connector pin-outs specific for the manufacturer type
- Component specifications specific for the manufacture type
Each sensor clearly specifies the manufacturer type with two compatibility statements: - One printed on or attached to the sensor r
- 트 One on the instructions for use.
The EnviteC Reusable SpO2 Sensors employ the same technological characteristics as the predicate devices to determine arterial 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 sensors which are the subject of this submission as well as the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger, ear
Indicated Patient Age Range
Adult and pediatric (excluding neonatal and infant)
Intended User / Care Setting
Hospitals, hospital-type facilities, mobile units and home environments.
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
Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Submitted:
The sensors were tested in accordance with current applicable standards for medical device Electrical Safety and Electromagnetic Compatibility. The sensors (with predicate device monitors) were tested for pulse rate with a listed simulator. Sensor electro-optical parameters were measured and compared to predicate devices. The sensors passed all of the tests.
Sensor patient contact materials meet applicable standards for biocompatibility.
Clinical Tests Submitted:
Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable Sp₂ 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.
Conclusions from Tests:
As described in (b)(1) and (b)(2) above, EnviteC Reusable SpO2 Sensors are equivalent to predicate sensors as substantiated by parameter, bench, and clinical testing. Device safety is substantiated by testing to applicable standards and by biocompatibility of patient contact materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy claims for the specified range of 70% to 100% SaO2.
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).
0
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510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
Submitted by: EnviteC-Wismar GmbH by Honeywell Alter Holzhafen 18 Wismar 23966 Germany Tel.: +49-38 41 360 221 Fax: +49-38 41 360 222 Marcus.Lindenlaub@Honeywell.com Contact Person: Marcus Lindenlaub Position/Title: Managing Director
Date of Preparation:
(2) Trade Name: EnviteC Reusable SpO2 Sensors
Common/Classification Name: OXIMETER; EAR OXIMETER
Product Code(s):
DQA; 21 CFR §870.2700 DPZ; 21 CFR §870.2710
Class:
(a)
(1)
Class II
June 10, 2009
Predicate Device(s): (3)
Substantial Equivalence to:
| K Number | Model | Manufacturer |
|---|---|---|
| K062605 | Philips Reusable SpO2 Sensors, | |
| Models M1196A and M1196T | ||
| (Finger Clip Sensors) | Philips Medical Systems | |
| (formerly HP) | ||
| K030973 | Philips picoSAT II Sp02 Pulse | |
| Oximetry Module | Philips Medical Systems | |
| (formerly HP) | ||
| K053419 | PULSOX-300, 300i | Konica Minolta Sensing, Inc. |
Reason for Submission:
New Device(s)
Description of Device: (4)
The EnviteC Reusable SpO2 Sensors are a family of oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturers listed above.
1
Page 2 of 3
EnviteC's Reusable SpO2 Sensors are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Three types of sensor housings are offered in this submission:
- A finger clip with rigid halves positioned by mild spring force .
- An ear clip with rigid halves positioned by mild spring force and an I ear hanger for the cable
- I A soft rubber finger sensor with unitary sealed tube type construction
A unique sensor type exists for each compatible manufacturer above, and each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (HP/Philips, Minolta).
Each sensor type includes the following features:
- r Connector pin-outs specific for the manufacturer type
- Component specifications specific for the manufacture type
Each sensor clearly specifies the manufacturer type with two compatibility statements:
- One printed on or attached to the sensor r
- 트 One on the instructions for use.
(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:
EnviteC Reusable SpO2 Sensors are indicated for continuous noninvasive monitoring of 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.
Prescription device.
(6) Technological Characteristics:
The EnviteC Reusable SpO2 Sensors employ the same technological characteristics as the predicate devices to determine arterial oxygen saturation: arterially perfused tissue is illuminated sequentially by two wavelengths of light emitted by light emitting diodes (LED's), and the time
2
Page 3 of 3
varying absorbance of the tissue is measured from a photodiode light sensor. This method is characteristic of all pulse oximeter sensors which are the subject of this submission as well as the predicate devices.
(b) (1) Non-Clinical Tests Submitted:
The sensors were tested in accordance with current applicable standards for medical device Electrical Safety and Electromagnetic Compatibility. The sensors (with predicate device monitors) were tested for pulse rate with a listed simulator. Sensor electro-optical parameters were measured and compared to predicate devices. The sensors passed all of the tests.
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 EnviteC Reusable 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.
(3) Conclusions from Tests:
As described in (b)(1) and (b)(2) above, EnviteC Reusable SpO2 Sensors are equivalent to predicate sensors as substantiated by parameter, bench, and clinical testing. Device safety is substantiated by testing to applicable standards and by biocompatibility of patient contact materials.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EnviteC-Wismar GmbH C/O Mr. Stephen H. Gorski Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119
JUL 2 4 2009
Re: K090438
Trade/Device Name: EnviteC Reusable SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: June 23, 2009 Received: June 24, 2009
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 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.
4
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
ht
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
EnviteC Reusable SpO2 Sensors
Indications for use:
EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediation (excluding neonatal and infant) patients in hospital-type facilities, mobile units and home environments.
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)
y Schulten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090438
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