(185 days)
Not Found
No
The device description and performance studies focus on standard oximetry technology and compatibility with existing monitors, with no mention of AI or ML.
No.
The device is an oximeter sensor, which is used for monitoring physiological parameters (SpO2 and pulse rate), not for providing therapy or treatment.
Yes.
The device is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are diagnostic measurements.
No
The device description clearly details physical hardware components, including plastic shells, silicone pads, optical components, cables, and connectors, which are integral to the device's function as an oximeter sensor.
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 Envisen Oximeter Sensors are used for continuous non-invasive monitoring of oxygen saturation and pulse rate. This is done by placing the sensor on the patient's finger (or other body part for disposable versions) and measuring light absorption through the tissue.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly measures physiological parameters through the skin.
Therefore, since the device does not perform tests on samples taken from the body, it falls outside the definition of an In Vitro Diagnostic. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
"Envisen Disposable and Reusable Oximeter Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for patients in hospitals, hospital-type facilities, mobile, and home environments."
Product codes (comma separated list FDA assigned to the subject device)
DQA, 21 CFR §870.2700
Device Description
"The Envisen Disposable and Reusable SpO2 Sensors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors.
Envisen Reusable Oximeter Sensors are finger clip type sensors with specifications validated to meet the requirements for compatibility with each specified manufacturer series. Each finger clip is comprised of a plastic shell with silicone pads which position the optical components to measure throught he finger, and a cable with manufacturer specific connector.
Envisen Disposable Oximeter Sensors consist of adhesive medical tape assemblies which are provided in three different configurations for application on adult, pediatric, and infant patients. Each sensor uses a cable with manufacturer specific connector.
sensors are labeled for compatibility for a specific All manufacturer/monitor series and includes the following elements:
- Optical and electronic specifications specific to the monitor type
- Connector configuration specific for the monitor type
Sensor labeling clearly specifies the manufacturer/monitor type with two compatibility statements:
- Compatibility label attached to the sensor cable
- Compatibility information provided on the instructions for use.
Both reusable and disposable sensors utilize configurations (finger clip, adhesive tapes) which have wide industry and clinical acceptance."
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, pediatric, and infant patients
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
"Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Envisen Disposable and Reusable Oximeter Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests: "All sensors have been tested to meet current applicable standards for pulse oximeter sensors, including device electrical and thermal safety and EMC (electromagnetic compatibility). All sensors were tested for pulse rate with a listed SpO2 simulator. The devices passed all of the tests. Patient contact materials meet requirements for biocompatibility."
Clinical Tests: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Envisen Disposable and Reusable Oximeter Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range."
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.
K993637, K052186, K093853, K080255, K062605, K083705, K910770, K962127, K010463
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
KIO3588
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
JUN 1 0 2011
- Submitted by: Envisen Inc. Block 1, Zone A, Jian Long Industrial Complex Henggang, Longgang District Shenzhen 518115 China Tel +86 755 8882 7227 Fax +86 755 2865 1415 E-mail: feilu@envisen.com Dr. Fei Lu, Ph.D Contact Person: Position/Title: General Manager Date of Preparation: November 1, 2010 Trade Name: Envisen Disposable and Reusable Oximeter Sensors
| Common/Classification Name: | Oximeter |
|---|---|
| Product Code: | DQA, 21 CFR §870.2700 |
| Class: | Class II |
(3) Predicate Device(s):
(a) (1)
| 510(k) | Device | Manufacturer |
|---|---|---|
| K993637 | N-395 Pulse Oximeter | Nellcor Puritan Bennett, Inc. |
| K052186 | Nellcor Oximax pulse oximetery | |
| sensors | Nellcor Puritan Bennett, Inc. | |
| K093853 | Single-patient use disposable | |
| sensor series | Nonin Medical, Inc. | |
| K080255 | MODEL 7500A Palmsat Pulse | |
| Oximeter | Nonin Medical, Inc. | |
| K062605 | Philips SpO2 Reusable Sensor, | |
| Model M1196A and M1196T | Philips Medical Systems | |
| K083705 | BCI WW1020 SPECTRO2 Pulse | |
| Oximeter | Smiths Medical PM, Inc. | |
| (formerly SIMS BCI) | ||
| K910770 | CSI 504-US Pulse Oximeter | Criticare Systems, Inc. |
| K962127 | Ohmeda 3800 Pulse Oximeter | GE Healthcare Finland Oy |
| (formerly Ohmeda Medical) | ||
| K010463 | Datex-Ohmeda Oxygen | |
| Saturation Module, M-OSAT and | ||
| Accessories | GE Healthcare Finland Oy | |
| (formerly Datex-Ohmeda, | ||
| Inc.) |
1
Reason for Submission:
New Device(s)
Description of Device: (4)
The Envisen Disposable and Reusable SpO2 Sens ors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors.
Envisen Reusable Oximeter Sensors ar e finger clip type sensors with specifications validated to meet the requirements for compatibility with each specified manufacturer ser ies. Ea ch finger clip is comprised of a plastic shell with silic one pads which position the optical components to measure throught he finger, and a cable with manufacturer specific connector.
Envisen Disposable Oximeter Sensors consist of adhesive medical tape assemblies which are provide d in three different configurations for application on a dult, pediatric, and infant patients. Each sensor uses a cable with manufacturer specific connector.
sensors are labeled for c ompatibility for a specific All manufacturer/monitor series and includes the following elements:
- 트 Optical and electronic specifications specific to the monitor type
- Connector configuration specific for the monitor type 트
Sensor labeling clearly specifies the manufacturer/monitor type with two compatibility statements:
- . Compatibility label attached to the sensor cable
- Compatibility information provided on the instructions for use. .
Both reusable and dispos able sensors utilize configurations (finger clip, adhesive tapes) which have wide industry and clinical acceptance.
(5) Intended use:
SpO2 monitoring applications include anesthesia/intra-operative, recovery, ICU/critical care, day surgery, home/chronic care, and transport.
2
Device Indications for Use:
Envisen Disposable and Reusable Oximeter Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for patients in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Device
(6) Technological Characteristics:
The EnviteC Disposable and Reusable SpO2 Sensors utilize the same measurement principles as the listed predicate devices: two wavelengths of light (red, infrared) from light emitting diodes (LED's) illuminate the patient's arterial tissue; and the light transmission through the tissue is measured using a photodiode light detector. The transmission properties vary with the patient's arterial blood saturation and pulse rate.
This method is fundamental to all pulse oximeter sensors and monitors for the non-invasive measurement of functional oxygen saturation (SpO2).
(b) (1) Non-Clinical Tests Submitted:
All sensors have been tested to meet current applicable standards for pulse oximeter sensors, including device electrical and thermal safety and EMC (electromagnetic compatibility). All sensors were tested for pulse rate with a listed SpO2 simulator. The devices passed all of the tests.
Patient contact materials meet requirements for biocompatibility.
(2) Clinical Tests Submitted:
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Envisen Disposable and Reusable Oximeter Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
(3) Conclusions from Tests:
As described in (b)(1) and (b)(2), testing above demonstrates that the Envisen Disposable and Reusable Oximeter Sensors are equivalent to predicate sensors as substantiated by laboratory and clinical testing.
Device safety is supported by compliance testing and by use of biocompatible patient contact materials.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 0 2011
Shenzhen Envisen Industry Company Limited C/O Mr. Stephen H. Gorski President Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119
Re: K103584
Trade/Device Name: Envisen Disposable and Reusable Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 20, 2011 Received: May 31, 2011
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.
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/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,
for
Anthony D. Watson, B.S., M.S., M.B.A. 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):
Envisen Disposable and Reusable Oximeter Sensors Device Name:
Indications for use:
Envisen Disposable and Reusable Oximeter Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate for patients in hospitals, hospital-type facilities, mobile, 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)
L. Schultze
(Division Sign-Otf) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103584
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