(219 days)
No
The document describes a disposable ear oximetry sensor that utilizes existing Masimo SET and Rainbow SET technologies for non-invasive monitoring. There is no mention of AI, ML, or any related concepts in the intended use, device description, performance studies, or key metrics. The focus is on the sensor's compatibility with established oximetry technologies and its performance in measuring SpO2 and pulse rate.
No.
The device is for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate), not for treatment or therapy.
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 of a patient's physiological state.
No
The device description explicitly states it is a "Disposable Ear Oximetry Sensor" and mentions "emitters and detectors," indicating a physical hardware component for optical assessment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate". This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The device is described as a "Disposable Ear Oximetry Sensor". Oximetry is a method of measuring oxygen saturation in the blood in vivo.
- Input Imaging Modality: The input is described as "Non-invasive optical assessment of tissue oxygenation using emitters and detectors". This further confirms that the measurement is being taken directly from the patient's tissue.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device directly measures a physiological parameter on the patient.
N/A
Intended Use / Indications for Use
The Masimo Disposable Ear Sensors are indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an Oximeter) for adult and pediatric patients, (weighing >30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
Product codes
DQA, DPZ, DSA
Device Description
The Masimo Disposable Ear Oximetry Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
The E1 Sensors and the predicates (K012992) Masimo Reuseable Ear Sensor (LNOP Sensor) and (K051212) the LNCS Reusable Ear Sensor (LNCS Sensor) have similar indications for use/ intended use. The main difference is that the E1 Sensors are disposable ear sensors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear (implied by "Ear Oximetry Sensors")
Indicated Patient Age Range
Adult and pediatric patients, (weighing >30kg)
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
The E1 Sensors comply with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the E1 Sensors:
- Risk Analysis .
- Design Reviews .
- Biocompatibility Testing .
- Performance Testing .
- . Safety Testing
Key Metrics
| Measurement | Accuracy Range | Accuracy |
|---|---|---|
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | $\pm$ 3.5% |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | $\pm$ 3.5% |
| Pulse Rate, No Motion | 25-240 bpm | $\pm$ 3 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | $\pm$ 3 bpm |
Predicate Device(s)
012992, K051212
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
949-297-7000
FAX 949-297-7592 |
|-----------------------------------|--------------------------------------------------------------------------------------------|
| Company Contact: | Shelly Harris, Manager of Regulatory Affairs |
| Date Summary Prepared: | November 5, 2010 |
| Trade Name: | Masimo Resposable Oximetry Sensors |
| Common Name: | Oximeter Sensor |
| Regulation Number: | 21 CFR 870.2700 |
| Regulation Name: | Oximeter |
| Regulation Class: | Class II |
| Product Code: | DQA, DPZ, DSA |
| Substantially Equivalent Devices: | Masimo Reusable Ear Sensor, 510(k) No. 012992
LNCS Oximetry Sensors, 510(k) No. K051212 |
Device Description
The Masimo Disposable Ear Oximetry Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
The E1 Sensors and the predicates (K012992) Masimo Reuseable Ear Sensor (LNOP Sensor) and (K051212) the LNCS Reusable Ear Sensor (LNCS Sensor) have similar indications for use/ intended use. The main difference is that the E1 Sensors are disposable ear sensors.
Predicate Device
The predicate devices used in this filing are:
- · Masimo Reusable Ear Sensor, 510(k) No. 012992
- · LNCS Oximetry Sensors, 510(k) No. K051212
Intended Use/ Indications for Use
The Masimo Disposable Ear Sensors are indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an monitoring of tansitional Drygol and pediatric patients, (weighing >30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
1
Technology Comparison
The E1 Sensors are substantially equivalent to the predicate sensors in the design, principles of THE LT Sensors are substantially oquralism to the predicates operate on identical principles of noninvasive optical assessment of tissue oxygenation using emitters and detectors.
Specifications
The specifications for the E1 Sensors are as following:
| Masimo SET Technology and Masimo Rainbow SET Technology
| (Adults and Pediatrics > 30kg) | ||
|---|---|---|
| Measurement | Accuracy Range | Accuracy |
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | $\pm$ 3.5% |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | $\pm$ 3.5% |
| Pulse Rate, No Motion | 25-240 bpm | $\pm$ 3 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | $\pm$ 3 bpm |
The E1 Sensors have been validated to the Masimo SET Technology.
Test Summary
The E1 Sensors comply with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the E1 Sensors:
- Risk Analysis .
- Design Reviews .
- Biocompatibility Testing .
- Performance Testing .
- . Safety Testing
Conclusions
The information in this 510(k) submission demonstrates that the E1 Sensors are substantially equivalent to the predicate devices, with respect to safety, effectiveness, and performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Shelly Harris Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
NOV 1 8 2010
Re: K101031
Trade/Device Name: Masimo Disposable Oximetry Ear Sensors Regulation Number: 21 CFR 870.2710 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ, DSA Dated: November 5, 2010 Received: November 10, 2010
Dear Ms. Harris:
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.
3
Page 2- Ms. Harris
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 vours.
Wh 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
4
Indications for Use
K101031 510(k) Number (if known):
Masimo Disposable Oximetry Ear Sensors Device Name:
NOV 1 8 2010
Indications For Use:
The Masimo Disposable Ear Sensors are indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate invaswe monitoring of functional oxygen saturen of antonation of and only of the started by and (incasured by an Opez ochool) for a bespital-type facilities, mobile, and home environments.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109 Subpart D) | (Per 21 CFR 801.109 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K10/03/ |
|---|---|
| ---------------- | --------- |