M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS

K110723 · Masimo Corporation · NLF · Jul 28, 2011 · Cardiovascular

Device Facts

• Record ID: K110723
• Device Name: M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: NLF · Cardiovascular
• Decision Date: Jul 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpQ2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxvgen saturation of arterial hemoglobin (SpQ2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Story

M-LNCS and Reprocessed M-LNCS Oximetry Sensors are disposable, non-invasive sensors; input signals derived from light absorption (SpO2/pulse rate); compatible with Masimo SET, Masimo Rainbow SET, and Nellcor pulse oximetry technologies. Sensors attach to patients; signals processed by compatible oximeter instruments to provide real-time SpO2 and pulse rate data. Used in hospitals, mobile, and home environments by clinicians or patients. Output displayed on host monitor; assists clinicians in assessing patient oxygenation status; enables continuous monitoring to detect hypoxemia or pulse rate abnormalities. Benefits include non-invasive, continuous physiological tracking.

Clinical Evidence

Bench testing only. Validation included biocompatibility testing, functional testing of sensors post-sterilization (EO) or reprocessing, and bench accuracy testing. Accuracy validated on adult volunteers; 1% added to neonatal/preterm sensors to account for fetal hemoglobin properties. Performance metrics for SpO2 (70-100%) and pulse rate (25-240 bpm) provided for motion, no-motion, and low-perfusion conditions.

Technological Characteristics

Disposable adhesive oximetry sensors; compatible with Masimo SET, Rainbow SET, and Nellcor technologies. Interfacing connector design differs from predicates. Sterilization via ethylene oxide (EO). Accuracy ranges: SpO2 ±2-3%, Pulse Rate ±3-5 bpm depending on motion/perfusion state.

Indications for Use

Indicated for continuous non-invasive monitoring of functional oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients. Applicable for patients in no-motion conditions, and those well or poorly perfused in hospital, mobile, or 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

• Masimo LNCS/M-LNCS Oximetry Sensors (K101896)
• LNCS Oximetry Sensors-Sterile (K083622)
• Reprocessed LNCS Oximetry Sensors (K083719)

Submission Summary (Full Text)

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## 510(k) SUMMARY

JUL 28 2011

| Submitted by: | Masimo Corporation<br>40 Parker, Irvine, CA 92618<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Anil Bhalani, Director of Regulatory Affairs |
| Date Summary Prepared: | May 11, 2011 |
| Trade Name | M-LNCS and Reprocessed M-LNCS Oximetry Sensors |
| Requlation Number: | 21 CFR 870.2700 |
| Regulation Class: | Class II |
| Regulation Name: | Oximeter |
| Common Name: | Oximeter Sensor |
| Product Code: | NLF, DQA, DSA |
| Substantially Equivalent Devices: | Masimo LNCS/M-LNCS Oximetry Sensors, 510(k) No. K101896<br>LNCS Oximetry Sensors-Sterile, 510(k) No. K083622<br>Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719 |

### Device Description

The M-LNCS and Reprocessed M-LNCS Oximetry Sensors are fully compatible disposable sensors for use with instruments which include or compatible with the following technologies:

- · Masimo SET technology
- · Masimo Rainbow SET technology
- · Nellcor technology

The M-LNCS series has been validated with Masimo SET Oximetry Technology and on Nellcor's N-200 Pulse Oximeter. The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for properties of fetal hemoglobin.

### Intended Use/ Indications for Use

The M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpQ2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxvgen saturation of arterial hemoglobin (SpQ2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

### Comparison to Predicate Devices

The predicate devices used in this filing are:

K110723-M-LNCS Sensors June 2011, Page 5 of 35

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# 510(k) SUMMARY

- LNCS Oximetry Sensors-Sterile, 510(k) No. K083622 .
- Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719 .

The sensors in this filing are substantially equivalent to the predicate sensors in the indication for use/intended use. In addition, they have the same performance and principle of operations, and are subjected to the same processes for sterile (ethylene oxide sterilization) and reprocessing as the respective predicate sensors in the cleared K083719 filings. The main difference is that the sensors in this filing have a different interfacing connector in comparison to the predicates.

## Predicate Devices

## Table 1 - Oximetry Sensors, Sterile

| M-LNCS Oximetry Sensors<br>(Single-Use and Sterile) | Predicate LNCS Oximetry Sensors<br>(Single-Use and Sterile) in K083622 |
|-----------------------------------------------------|------------------------------------------------------------------------|
| M-LNCS Adtx-3: Adult Adhesive Sensor | LNCS Adtx-3 |
| M-LNCS Pdtx-3: Pediatric Adhesive Sensor | LNCS Pdtx-3 |
| M-LNCS Inf-3: Infant Adhesive Sensor | LNCS Inf-3 |
| M-LNCS Neo-3: Neonatal Adhesive Sensor | LNCS Neo-3 |
| M-LNCS NeoPt-3: Neonatal Adhesive Sensor | LNCS NeoPt-3 |
| M-LNCS NeoPt-500: Neonatal Adhesive Sensor | LNCS NeoPt-500 |

## Table 2 - Oximetry Sensors, Reprocessed

| Reprocessed M-LNCS (Single-Use) Sensors | Predicate Reprocessed LNCS<br>(Single-Use) Sensors in K083719 |
|--------------------------------------------------------|---------------------------------------------------------------|
| Reprocessed M-LNCS Adtx: Adult Adhesive Sensor | Reprocessed LNCS Adtx |
| Reprocessed M-LNCS Adtx-3: Adult Adhesive Sensor | Reprocessed LNCS Adtx-3 |
| Reprocessed M-LNCS Pdtx: Pediatric Adhesive Sensor | Reprocessed LNCS Pdtx |
| Reprocessed M-LNCS Pdtx-3: Pediatric Adhesive Sensor | Reprocessed LNCS Pdtx-3 |
| Reprocessed M-LNCS Inf: Infant Adhesive Sensor | Reprocessed LNCS Inf |
| Reprocessed M-LNCS Inf-3: Infant Adhesive Sensor | Reprocessed LNCS Inf-3 |
| Reprocessed M-LNCS Neo: Neonatal Adhesive Sensor | Reprocessed LNCS Neo |
| Reprocessed M-LNCS Neo-3: Neonatal Adhesive Sensor | Reprocessed LNCS Neo-3 |
| Reprocessed M-LNCS NeoPt: Neonatal Adhesive Sensor | Reprocessed LNCS NeoPt |
| Reprocessed M-LNCS NeoPt-3: Neonatal Adhesive Sensor | Reprocessed LNCS NeoPt-3 |
| Reprocessed M-LNCS NeoPt-500: Neonatal Adhesive Sensor | Reprocessed LNCS NeoPt-500 |

## Table 3 - Sensor Specifications for Sterile and Reprocessed M-LNCS Sensors

| | Accuracy Range | Accuracy:<br>Adult/ Pediatric/ Infant | Accuracy:<br>Neonatal |
|---------------------------|----------------|---------------------------------------|-----------------------|
| Masimo Technology | | | |
| SpO2, no motion | 70-100% | $\pm$ 2% | $\pm$ 3% |
| SpO2, motion | 70-100% | $\pm$ 3% | $\pm$ 3% |
| SpO2, low perfusion | 70-100% | $\pm$ 2% | $\pm$ 3% |
| Pulse rate, no motion | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| Pulse rate, motion | 25-240 bpm | $\pm$ 5 bpm | $\pm$ 5 bpm |
| Pulse rate, low perfusion | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| Nellcor Technology | | | |
| SpO2, no motion | 70-100% | $\pm$ 2% | $\pm$ 3% |
| Pulse rate, no motion | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |

K110723-M-LNCS Sensors June 2011, Page 6 of 35

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# 510(k) SUMMARY

### Test Summary

The following non-clinical testing was conducted and verifies that the sterile and reprocessed M-LNCS Oximetry Sensors met all design specifications: biocompatibility testing, in-house and laboratory validation testing on the sensors after they have been subjected to ethylene oxide sterilization (EO) or the sensors have been reprocessed and subjected to EO sterilization, performance testing including bench accuracy testing and visual and validated functional testing.

## Conclusion

The results of the performance data demonstrate that the sterile M-LNCS and Reprocessed M-LNCS Oximetry Sensors are as safe and effective as the legally marketed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

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

JUL 2 8 2011

Re: K110723

Trade/Device Name: Masimo M-LNCS Oximetry Sensors Masimo Reprocessed M-LNCS Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF, DQA, DSA Dated: June 14, 2011 Received: June 28, 2011

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 (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/ 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/Safetv/Reporta Problem /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
Susan Ruane

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

| 510(k) Number (if known): | K110723 |
|---------------------------|---------|
|---------------------------|---------|

Masimo M-LNCS Oximetry Sensors Device Name: Masimo Reprocessed M-LNCS Oximetry Sensors

### Indications For Use:

The M-LNCS Sensors are indicated for the continuous non-invasive 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 conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive 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 (Per 21 CFR 801.109 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801.109 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

L Shutte
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sion 040

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

510(k) Number: K110723

510(k) Special, 03/11/2011 Masimo M-LNCS Sterile & Reprocessed Sensors Page 2-1