MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1

K101031 · Masimo Corporation · DQA · Nov 18, 2010 · Cardiovascular

Device Facts

• Record ID: K101031
• Device Name: MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Masimo Disposable Ear Oximetry Sensors (E1 Sensors) provide continuous non-invasive monitoring of arterial oxygen saturation (SpO2) and pulse rate. Device utilizes optical emitters and detectors to measure tissue oxygenation; compatible with Masimo SET and Rainbow SET technology platforms. Intended for single-patient use in hospital, mobile, and home settings. Healthcare providers use the output, displayed on compatible oximetry monitors, to assess patient oxygenation status and pulse rate, facilitating clinical decision-making for patients weighing over 30kg. Disposable design distinguishes it from reusable predicate sensors.

Clinical Evidence

Bench testing only. Performance validated against Masimo SET technology standards. Accuracy for SpO2 (70-100%) is ±3.5% and pulse rate (25-240 bpm) is ±3 bpm under both no-motion and low-perfusion conditions.

Technological Characteristics

Disposable ear-mounted oximetry sensor. Operates via non-invasive optical assessment using emitters and detectors. Compatible with Masimo SET and Rainbow SET technology platforms. Validated for patients >30kg. Complies with voluntary safety and performance standards.

Indications for Use

Indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult and pediatric patients (>30kg), including well or poorly perfused patients, in hospital, mobile, and home environments.

Regulatory Classification

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.

Predicate Devices

• Masimo Reusable Ear Sensor (K012992)
• LNCS Oximetry Sensors (K051212)

Submission Summary (Full Text)

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# 510(k) SUMMARY

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] |
|-----------------------------------|--------------------------------------------------------------------------------------------|
| 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<br>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.

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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<br>(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 [phone] or [phone] 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/ |
|----------------|---------|
|----------------|---------|