MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS

K111888 · Masimo Corporation · DQA · Sep 23, 2011 · Cardiovascular

Device Facts

• Record ID: K111888
• Device Name: MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 23, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

Pulse oximetry sensors; utilize infrared emitters and detectors for non-invasive optical assessment of tissue oxygenation; compatible with Masimo SET and Rainbow SET instruments. Used in hospitals, mobile, and home environments; operated by clinicians or patients. Output (SpO2 and pulse rate) displayed on host instrument; assists healthcare providers in patient monitoring and clinical decision-making regarding oxygenation status.

Clinical Evidence

Bench testing only. Testing included ambient light/noise rejection, electrostatic discharge, voltage breakdown, bend/pull testing, off-patient detection, tape strip life cycle, current transfer ratio, light piping, electrocautery noise rejection, sensor skin temperature, moisture resistance, and cleaning/storage/operating condition verification.

Technological Characteristics

Pulse oximetry sensors; infrared emitters and detectors; compatible with Masimo SET and Rainbow SET instruments. Non-clinical testing verified performance against environmental and mechanical stressors (e.g., moisture, ESD, electrocautery noise).

Indications for Use

Indicated for continuous noninvasive monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients. Applicable for motion/no-motion conditions and well/poorly perfused patients in hospital, hospital-type, mobile, and home settings.

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

• LNCS/M-LNCS Oximetry Sensors (K101896)

Submission Summary (Full Text)

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## 11888

Masimo M-LNCS/LNCS/LNOP Multisite-L Sensors

Image /page/0/Picture/2 description: The image shows the Masimo Corporation logo and contact information. The logo is a stylized "M" with the word "Masimo" next to it. The text "K111888 - Additional Information" is at the top of the image. The address "Forty Parker, Irvine, CA 92618" is below the company name.

SEP 2 3 2011

## 510(k) Summary

| Submitter: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>[phone]<br>Fax: [phone] |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Collette<br>Senior Manager, Regulatory Affairs |
| Date Prepared: | August 24, 2011 |
| Trade name: | Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors |
| Classification<br>Name: | Oximeter Sensor, (21 CFR 870.2700) |
| Predicate<br>Device: | K101896, LNCS/M-LNCS Oximetry Sensors |
| Device<br>Description: | The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry<br>Sensors are pulse oximetry sensors. They measure tissue<br>oxygenation non-invasively through infrared emitters and<br>detectors. They are fully compatible for use with Masimo<br>SET and Masimo Rainbow SET instruments. |
| Indications for<br>Use: | The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry<br>Sensors are indicated for the continuous noninvasive<br>monitoring of functional oxygen saturation of arterial<br>hemoqlobin (SpO2) and pulse rate (measured by an SpO2<br>sensor) for use with adult, pediatric, infant, and neonatal<br>patients during both no motion and motion conditions, and<br>for patients who are well or poorly perfused in hospitals,<br>hospital-type facilities, mobile, and home environments. |

:

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Masimo M-LNCS/LNCS/LNOP Multisite-L Sensors

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K111888 - Additional Information

| <img alt="Masimo Logo" src=""/> | MASIMO CORPORATION<br>Forty Parker<br>Irvine, CA 92618 |
|---------------------------------|--------------------------------------------------------|
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| Comparative Analysis: | The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are substantially equivalent to the predicate device in the design, principles of operation, and performance. The subject and predicate device operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors. |
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| Functional/Safety Testing: | The following non-clinical testing was conducted to verify that the Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors met all design specifications: Ambient light rejection, noise rejection, electrostatic discharge, voltage breakdown, bend testing, off-patient detection, tape strip life cycle, current transfer ratio, light piping, electrocautery noise rejection, sensor skin temperature, moisture resistance and cleaning, drop, storage and operating conditions, bend and pull. |
| Conclusion: | The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are substantially equivalent to the predicate device. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID-20993-0002

Mr. Anil Bhalani Director. Regulatory Affairs Masimo Corporation 40 and 50 Parker Irvine, California 92618

2 3 2011

Re: K111888

Trade/Device Name: Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 24. 2011 Received: August 25, 2011

Dear Mr. Bhalaní:

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 - Mr. Bhalani

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 svstems (OS) 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 /uem115809.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/Safetv /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 /ResourcesforYou/Industry/default.htm.

Sincerely yours,

Rh 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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## Appendix 2 -- Indications for Use Statement

510(k) Number (if known):

Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors Device Name:

Indications for Use:

The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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 Schutten

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k211188

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