(219 days)
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.
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.
Here's a breakdown of the requested information based on the provided text, focusing on the study and acceptance criteria for the Masimo Disposable Oximetry Ear Sensors:
1. Table of Acceptance Criteria and Reported Device Performance
| Measurement | Acceptance Criteria (Accuracy Range) | Acceptance Criteria (Accuracy) | Reported Device Performance (Table states "Accuracy") |
|---|---|---|---|
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | $\pm$ 3.5% | $\pm$ 3.5% (The text states the specifications for the E1 Sensors are "as following" and then lists these values under "Accuracy". This implies these are the reported performance values that meet the criteria.) |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | $\pm$ 3.5% | $\pm$ 3.5% |
| Pulse Rate, No Motion | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance Testing" was applied to the development of the E1 Sensors and that "The E1 Sensors have been validated to the Masimo SET Technology."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document describes a sensor for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate). This is a direct measurement device and not an AI-assisted diagnostic tool that would involve "human readers" or an MRMC study in the context of improving human interpretation. Therefore, an MRMC comparative effectiveness study was not applicable and not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was done. The "Specifications" section directly lists the accuracy of the E1 Sensors for SpO2 and Pulse Rate measurements, which are inherent performance characteristics of the device itself, independent of human interpretation or intervention during measurement. The validation was against "Masimo SET Technology," implying a direct comparison to an established measurement standard rather than human-in-the-loop performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document implies the ground truth for performance validation was likely established through comparison with Masimo SET Technology, which itself would be validated against a recognized gold standard for oxygen saturation and pulse rate measurement (e.g., blood gas analysis for SpO2). However, the specific method for establishing this ground truth (e.g., clinical study with arterial blood gas draws) is not detailed in this summary.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" as this device is a sensor for direct measurement and not a machine learning algorithm that typically requires a distinct training phase. The validation stated is against "Masimo SET Technology."
9. How the Ground Truth for the Training Set was Established
As noted in point 8, the concept of a "training set" and its associated ground truth establishment is not directly applicable to this type of device based on the provided information. The device's performance is validated against an established technology (Masimo SET Technology), which would have its own validated ground truth.
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510(k) SUMMARY
| Submitted by: | Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 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. 012992LNCS 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.
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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.
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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.
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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
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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/ |
|---|---|
| ---------------- | --------- |
§ 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).