(22 days)
Not Found
No
The document describes a sensor modification for improved accuracy in oxygen saturation measurement, but there is no mention of AI, ML, or related concepts.
No
The device is indicated for continuous noninvasive monitoring of oxygen saturation and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
The device is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status, thereby aiding in diagnosis or monitoring of medical conditions.
No
The device description explicitly states it is a "single patient use device" and a "modification of the existing device," implying a physical sensor component, not solely software.
Based on the provided information, the Masimo E1 Ear Sensor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate". This is a measurement taken directly from the patient's body, not from a sample of bodily fluid or tissue that is analyzed outside the body.
- Device Description: The description focuses on a sensor that attaches to the ear to measure physiological parameters.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The Masimo E1 Ear Sensor directly measures physiological signals from the patient's ear.
N/A
Intended Use / Indications for Use
The Masimo E1 Ear Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients, (weighing > 30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
Product codes
DQA
Device Description
The Masimo El Ear Sensor is a single patient use device that is designed to be used with instruments that include or are compatible with the Masimo SET and Masimo Rainbow SET technologies. The subject device is a modification of the existing device that provides improved oxygen saturation measurement accuracy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
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 Masimo El Ear Sensor was tested in accordance with the requirements of the design control regulations and established quality assurance processes. Testing included: Design Review Process, Risk Analysis per ISO 14971, Biocompatibility per ISO 10993, Electromagnetic Compatibility per IEC 60601-1-2, Electrical Safety Testing per IEC 60601-1, Environmental Testing, Component Testing, and Clinical Performance Testing. The modified E1 Ear Sensor showed an improvement in oxygen saturation accuracy specification from ± 3.5% to ± 2.5% (ARMS) under no motion and both well- and poorly-perfused conditions.
Key Metrics
Accuracy (ARMS) for SpO2:
Existing Device - K101031: ± 3.5% (No motion/Well-perfused, No motion/poorly-perfused)
Subject Device: ± 2.5% (No motion/Well-perfused, No motion/poorly-perfused)
Accuracy for Pulse Rate:
Existing Device - K101031: 3 beats/minute (No motion/Well-perfused, No motion/poorly-perfused)
Subject Device: 3 beats/minute (No motion/Well-perfused, No motion/poorly-perfused)
Predicate Device(s)
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
JUL 2 4 2012
11/2/9/2 Section 5. 510(k) Summary
Submitter:
Masimo Corporation 40 Parker Irvine, CA 92618 Phone: (949) 297-7000 FAX: (949) 297-7592
David Collette
Class II
DQA
Contact:
Sr. Manager, Regulatory Affairs
Date Summary Prepared: June 29. 2012
Trade Name: Masimo El Ear Sensor
Regulation Name: Pulse Oximeter
Classification Regulation: 21 CFR 870.2700
Product Code:
K101031 - Masimo Disposable Oximetry Ear Sensors
Device Description
Existing Device:
The Masimo El Ear Sensor is a single patient use device that is designed to be used with instruments that include or are compatible with the Masimo SET and Masimo Rainbow SET technologies.
The subject device is a modification of the existing device that provides improved oxygen saturation measurement accuracy.
Indications for Use
The Masimo E1 Ear Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients, (weighing > 30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
1
Specifications
The modified E1 Ear Sensor in this submission has been shown in verification and clinical validation studies to provide an improvement in the oxygen saturation accuracy specification from ± 3.5% to ± 2.5% (ARMS) under no motion and both well- and poorly-perfused conditions.
| Accuracy (ARMS)/
| Conditions | Existing Device - K101031 | Subject Device |
|---|---|---|
| No motion/ | ||
| Well-perfused | SpO2: ± 3.5% | |
| Pulse Rate: 3 beats/minute | SpO2: ± 2.5% | |
| Pulse Rate: 3 beats/minute | ||
| No motion/ | ||
| poorly-perfused | SpO2: ± 3.5% | |
| Pulse Rate: 3 beats/minute | SpO2: ± 2.5% | |
| Pulse Rate: 3 beats/minute |
E1 Ear Sensor Accuracy Snecifications (Армя)
Summary of Testing
The following testing of the Masimo El Ear Sensor was performed in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence of the modified device to the cleared device:
- . Design Review Process
- . Risk Analysis per ISO 14971
- Biocompatibility per ISO 10993 .
- Electromagnetic Compatibility per IEC 60601-1-2
- . Electrical Safety Testing per IEC 60601-1
- Environmental Testing .
- Component Testing
- . Clinical Performance Testing
Conclusion
The information in this 510(k) submission demonstrates that the subject Masimo E1 Ear Sensor is substantially equivalent to the existing device with respect to safety, effectiveness, and performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 symbol resembling an eagle or bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 4 2012
Mr. David Collette Senior Manager, Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
Re: K121912
Trade/Device Name: Masimo E1 Ear Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 29, 2012 Received: July 2, 2012
Dear Mr. Collette:
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- Mr. Collette
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.
Anthony D. Watson
nthony 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
Section 4. Indications for Use
Indications for Use
510(k) Number: _ 12 12 12
Device Name: Masimo E1 Ear Sensor
Indications for Use:
The Masimo E1 Ear Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients, (weighing > 30kg), who are well or poorly perfused, in hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 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 Sigm-Off) Division of Amesthesiology, General Hospital Infection Control, Dental Devices
121912 5-10(k) Number