(58 days)
Not Found
No
The device description and performance studies focus on the hardware components and clinical validation against co-oximetry, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is indicated for monitoring SpO2 and pulse rate, which are diagnostic or 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 physiological parameters used to assess a patient's condition and help guide medical decisions, thereby serving a diagnostic purpose.
No
The device description explicitly states that the device consists of hardware components: a connector, a cable, sensor housings containing an LED light source, and a photodetector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device function: The EnviteC Reusable Multi-site Y SpO2 Sensors are used for continuous non-invasive monitoring of oxygen saturation and pulse rate by being placed on the skin (finger, thumb, toe, or foot). This is a non-invasive physiological measurement, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states "continuous non-invasive monitoring," which aligns with a physiological monitoring device, not an IVD.
Therefore, this device falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Recommended for use on the ear. Prescription device.
EnviteC Reusable Multi-site Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The EnviteC Reusable Multi-site Y SpO2 Sensors are a family of oximeter THE ENTROS NOWBLOG Walidated for compatibility with the predicate oximeter manufacturers listed above.
EnviteC's Reusable Multi-site Y SpO₂ Sensors consist of a connector and a cable which divides at the distal end into two sensor housings. One a ouble white a dual LED light source, and the other contains a light sensitive photodetector. The housings may be positioned on various seristive proceded.org finger, thumb, toe, or foot, and are affixed by a medical grade tape.
A unique Y sensor exists for each manufacturer above, and each Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.).
Each sensor type includes the following unique features:
- Connector pin-outs specific for the manufacturer type .
- Component specifications specific for the manufacture type 에
Each sensor also specifies the manufacturer type with two compatibility statements:
- One printed on or attached to the sensor .
- One on the instructions for use. l
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, thumb, toe, or foot
Indicated Patient Age Range
adult, pediatric, infant, and neonatal
Intended User / Care Setting
hospitals, hospital-type facilities, mobile, 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
Not Found
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 applicable standards for medical device Electrical Safety and Electromagnetic Compatibility. The medical device monitors) were tested for pulse rate with a sensors (with prodicate dones ro-optical parameters were measured and Insted Simmator. " Conton" Store Y sensors passed all of the tests.
Sensor patient contact materials (housing and attachment tape) meet applicable standards for biocompatibility.
Clinical Tests Submitted:
Clinical testing was performed to validate the performance and accuracy Official testing was perfect Multi-site Y SpO2 Sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. Trypoxia versus arterial oxygen-can institutionally approved protocol with All testing was porrormed 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 Multi-site Y SpO2 Sensors are equivalent to predicate sensors as substantiated by Spoz Sensoro and clinical testing. Device safety is substantiated by parameter, bother, and by biocompatibility of patient contact materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K944760, K962127, K893877, K910770, K010463, K032979, K890033, K993979
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
FEB 11 2005
K043463
Page 1 of 3
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
| (1) | Submitted by: | EnviteC-Wismar GmbH
Alter Holzhafen 18
Wismar 23966
Germany
Tel.: +49-38 41 360 221
Fax: +49-38 41 360 222
E-mail: b.lindner@envitec.com | |
|-----|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| | Contact Person: | Bernd Lindner | |
| | Position/Title: | Managing Director | |
| | Date of Preparation: | November 1, 2004 | |
| (2) | Trade Name: | EnviteC Reusable Multi-site Y SpO2 Sensors | |
| | Common/Classification Name: OXIMETER | | |
| | Product Code(s): | DQA; 21 CFR §870.2700 | |
| | Class: | Class II | |
| (3) | Predicate Device(s): Substantial Equivalence to: | | |
| | K Number | Model | Manufacturer |
| | K944760 | Nellcor Dura-Y Oxygen
Transducer, Ear Clip | Nellcor Puritan Bennett, Inc. |
| | K962127 | Ohmeda 3800 Pulse Oximeter | Datex-Ohmeda, Inc. |
| | K893877 | Biochem 3100 Oximeter | BCI-Biochem International, Inc |
| | K910770 | CSI 504-US Pulse Oximeter | CSI-Criticare Systems, Inc. |
| | K010463 | Datex-Ohmeda S/5 Oxygen
Saturation Module, M-OSAT and
Accessories | Datex-Ohmeda, Inc. |
| | K032979 | Philips Reusable SpO2 Sensors | Philips Medizin Ayateme
Böeblingen GmbH (formerly HP) |
| | K890033 | Model 8700 Pulse Oximeter | Nonin Medical, Inc. |
| | K993979 | Model 2001MARSpO2 Pulse
Oximeter | Novametrix Medical Systems Inc. |
Reason for Submission: New Device(s)
1
Description of Device: (4)
The EnviteC Reusable Multi-site Y SpO2 Sensors are a family of oximeter THE ENTROS NOWBLOG Walidated for compatibility with the predicate oximeter manufacturers listed above.
EnviteC's Reusable Multi-site Y SpO₂ Sensors consist of a connector and a cable which divides at the distal end into two sensor housings. One a ouble white a dual LED light source, and the other contains a light sensitive photodetector. The housings may be positioned on various seristive proceded.org finger, thumb, toe, or foot, and are affixed by a medical grade tape.
A unique Y sensor exists for each manufacturer above, and each Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.).
Each sensor type includes the following unique features:
- Connector pin-outs specific for the manufacturer type .
- Component specifications specific for the manufacture type 에
Each sensor also specifies the manufacturer type with two compatibility statements:
- One printed on or attached to the sensor .
- One on the instructions for use. l
Intended use: (5)
The measurement of functional oxygen saturation of arterial hemoglobin (SpO2) has been a standard of care in the USA for 20 years. Applications (opez) no both de monitoring in the anesthesia, recovery, and critical care environments, as well as transport monitoring and home care.
Indications for Use:
EnviteC Reusable Multi-site Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Not recommended for use on the ear.
Prescription device.
2
Technological Characteristics: (6)
The EnviteC Reusable Multi-site Y SpO2 Sensors employ the same The "Envited" Nousable "Mail" 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 two wavelenging absorbance of the tissue is measured from a photodiode light time varying absorbands characteristic of all Y sensors which are the subject of this submission as well as the predicate devices.
Non-Clinical Tests Submitted: (1) (b)
The sensors were tested in accordance with applicable standards for medical device Electrical Safety and Electromagnetic Compatibility. The medical device monitors) were tested for pulse rate with a sensors (with prodicate dones ro-optical parameters were measured and Insted Simmator. " Conton" Store Y sensors passed all of the tests.
Sensor patient contact materials (housing and attachment tape) meet applicable standards for biocompatibility.
Clinical Tests Submitted: (2)
Clinical testing was performed to validate the performance and accuracy Official testing was perfect Multi-site Y SpO2 Sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. Trypoxia versus arterial oxygen-can institutionally approved protocol with All testing was porrormed 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 Reusable Multi-site Y SpO2 Sensors are equivalent to predicate sensors as substantiated by Spoz Sensoro and clinical testing. Device safety is substantiated by parameter, bother, 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
FEB 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Envitec-Wismar GMBH Mr. Stephen Gorski Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119
Re: K043463
Trade/Device Name: EnviteC Reusable Multi-Site Y SpO2 Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 12, 2004 Received: December 15, 2004
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 such 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
Indications for Use
510(k) Number (if known):
EnviteC Reusable Multi-site Y SpO2 Sensors Device Name:
Indications for use:
EnviteC Reusable Multi-site Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, infant, and neonatal patients in hospital-type facilities, mobile, and home environments.
Not recommended for use on the ear.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Prescription Use × (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) |
|---|
| -------------------------------------------------------- |
Cure Suleom
ion of Annsthesiology, General Hospital, Jution Control. Dental Devices
Number K043463
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