MASIMO LNCS/M-LNCS OXIMETRY SENSORS

K101896 · Masimo Corporation · DQA · Oct 21, 2010 · Cardiovascular

Device Facts

• Record ID: K101896
• Device Name: MASIMO LNCS/M-LNCS OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 21, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LNCS/M-LNCS Sensors are indicated for the continuous nonitoring 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 hospitals, hospital-type facilities, mobile, and home environments.

Device Story

LNCS/M-LNCS Oximetry Sensors are adhesive sensors for continuous monitoring of SpO2 and pulse rate; compatible with Masimo SET, Masimo Rainbow SET, Nellcor, and Philips FAST-SpO2 technologies. Sensors input optical signals from patient tissue; output data to compatible monitoring instruments. Used in hospitals, mobile, and home environments by clinicians or patients. Design features lower profile compared to predicates for improved fit and comfort; utilizes modified inner wrap materials and LED assembly molding. Output enables real-time physiological monitoring to assist clinical decision-making regarding patient oxygenation and heart rate status.

Clinical Evidence

Bench testing only. Testing included biocompatibility, performance testing (bench accuracy), and visual/functional validation. Results confirm sensors meet design specifications and perform equivalently to predicate devices.

Technological Characteristics

Adhesive oximetry sensors; compatible with Masimo, Nellcor, and Philips FAST-SpO2 technologies. Features lower profile design with modified inner wrap materials and LED assembly molding. SpO2 accuracy: +/- 2-3% (no motion/low perfusion); Pulse rate accuracy: +/- 3-5 bpm (range 25-300 bpm).

Indications for Use

Indicated for continuous monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients. Applicable for patients in no-motion conditions and those with good or poor perfusion in hospital, 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 Oximetry Sensors (K051212)

Submission Summary (Full Text)

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MASIMO CORPORATION
Forty Parker
Irvine, CA 92618

K101896

| Submitted by: | Masimo Corporation<br>40 Parker, Irvine, CA 92618<br>Phone: [phone], Fax: [phone] | OCT 2 1 2010 |
|-----------------------------------|---------------------------------------------------------------------------------------------|--------------|
| Company Contact: | Anil Bhalani, Director of Regulatory Affairs | |
| Date Summary Prepared: | September 17, 2010 | |
| Trade Name | LNCS/M-LNCS Oximetry Sensors | |
| Common Name | Oximeter Sensor | |
| Regulation Number: | 21 CFR 870.2700 | |
| Regulation Name/Product Code: | Oximeter/ DQA | |
| Substantially Equivalent Devices: | LNCS Oximetry Sensors, 510(k) No. K051212 | |

#### Device Description:

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

- · Masimo SET technology
- · Masimo Rainbow SET technology
- Nellcor technology
- · Philips FAST-SpO2 technology

#### Intended Use/ Indications for Use

The LNCS/M-LNCS Sensors are indicated for the continuous nonitoring 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 hospitals, hospital-type facilities, mobile, and home environments.

#### Comparison to Predicate Device

The sensors in this filing are the same indications for use, intended use, performance and principle of operations, as the respective predicate sensors (K051212).

The main difference is that the sensors in this filing have a lower profile in comparison to the predicates, for optimal fit and comfort for patients. The design is optimized or improved by the removal of excess inner wrap materials and an alternate molding compound in LED assemblies. The sensor model names in Inist was motenally and the corresponding predicate segsor model names are the same. See Table 1 below for the sensor model names and comparison descriptions.

Additionally, the upper pulse rate accuracy range for Masimo technology has been revised from 240 bpm to 300 bpm. See Table 2 below for the sensor specifications.

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Masimo Cordoration .

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Image /page/1/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a stylized letter "M" with a checkmark-like shape incorporated into it, followed by the word "MASIMO" in bold, sans-serif font. To the right of the logo, the text "MASIMO CORPORATION" is printed above the address "irvino, CA 92618".

# 510(k) SUMMARY

### Table 1: Sensor Models for LNCS and M-LNCS Oximetry Sensors

| Pending Masimo<br>LNCS and M-LNCS Oximetry Sensors | Predicate Masimo<br>LNCS/M-LNCS Oximetry Sensors<br>In K051212 | Comparison Description<br>(pending vs. predicate) |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------|
| LNCS Inf-L: Infant Adhesive Sensor | LNCS Inf-L | |
| LNCS/M-LNCS Inf : Infant Adhesive Sensor | LNCS/M-LNCS Inf | |
| LNCS/M-LNCS Inf-3: Infant Adhesive<br>Sensor | LNCS/M-LNCS Inf-3 | |
| LNCS Neo-L: Neonatal Adhesive Sensor | LNCS Neo-L | Lower profile design for |
| LNCS/M-LNCS Neo: Neonatal/Adult<br>Adhesive Sensor | LNCS/M-LNCS Neo | optimized fit and patient<br>comfort. |
| LNCS/M-LNCS Neo-3: Neonatal/Adult<br>Adhesive Sensor | LNCS/M-LNCS Neo-3 | |
| LNCS NeoPt-L: Neonatal Adhesive Sensor | LNCS NeoPt-L | Same indications for use,<br>intended use, patient |
| LNCS/M-LNCS NeoPt: Neonatal Adhesive<br>Sensor | LNCS/M-LNCS NeoPt | populations, patient weight<br>measurement sites, |
| LNCS/M-LNCS NeoPt-3: Neonatal Adhesive<br>Sensor | LNCS/M-LNCS NeoPt-3 | performance, and<br>biocompatible materials. |
| LNCS/M-LNCS NeoPt-500: Neonatal<br>Adhesive Sensor | LNCS/M-LNCS NeoPt-500 | |
| LNCS/M-LNCS Newborn Neonatal:<br>Neonatal Adhesive Sensor | LNCS/M-LNCS Newborn Neonatal | |
| LNCS/M-LNCS Newborn Infant/Pediatrics:<br>Infant/Pediatric Adhesive Sensor | LNCS/M-LNCS Newborn<br>Infant/Pediatrics | |
| | Accessories used with Masimo LNCS/M-LNCS Sensors | |
| LNCS/M-LNCS Inf Series: Replacement<br>Tapes for LNCS/M-LNCS Inf Series Sensors | LNCS/M-LNCS Inf Series<br>Replacement Tapes | |
| LNCS/M-LNCS Neo Series: Replacement<br>Tapes for LNCS/M-LNCS Neo Series<br>Sensors | LNCS/M-LNCS Neo Series<br>Replacement Tapes | |
| LNCS/M-LNCS NeoPt and Newborn Series:<br>Replacement Wraps for LNCS/M-LNCS<br>NeoPt and Newborn Neonatal Series<br>Sensors | LNCS/M-LNCS NeoPt and Newborn<br>Neonatal Series Replacement Wraps | Same as predicate. |
| Red LNC Series: Patient Cables | Red LNC Series Patient Cables | |
| LNC/M-LNC Series: Patient Cables | LNC/M-LNC Series Patient Cables | |
| LNCS/M-LNCS and LNC/M-LNC Series:<br>Adapter Cables | LNCS/M-LNCS and LNC/M-LNC<br>Series Adapter Cables | |

# Table 2: Sensor Specifications for LNCS/M-LNCS Oximetry Sensors

| | Accuracy Range | Accuracy:<br>Adult/ Pediatric/<br>Infant | Accuracy:<br>Neonatal | Predicate Device:<br>Accuracy Range/<br>Specification |
|-----------------------|----------------|------------------------------------------|-----------------------|-------------------------------------------------------|
| Masimo Technology | | | | |
| SpO2, no motion | 70-100% | $\pm$ 2% | $\pm$ 3% | Same |
| SpO2, motion | 70-100% | $\pm$ 3% | $\pm$ 3% | Same |
| SpO2, low perfusion | 70-100% | $\pm$ 2% | $\pm$ 3% | Same |
| Pulse rate, no motion | 25-300 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm | 25-240 bpm/ $\pm$ 3 bpm |

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Image /page/2/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a stylized letter 'M' followed by the word 'Masimo' in bold font. To the right of the logo, the text 'MASIMO CORPORATION' is displayed above the address 'Forty Parker, Irvine, CA 92618'.

# 510(k) SUMMARY

| | Accuracy Range | Accuracy:<br>Adult/ Pediatric/<br>Infant | Accuracy:<br>Neonatal | Predicate Device:<br>Accuracy Range/<br>Specification |
|---------------------------|----------------|------------------------------------------|-----------------------|-------------------------------------------------------|
| Masimo Technology | | | | |
| Pulse rate, motion | 25-300 bpm | $+ 5 bpm$ | $+ 5 bpm$ | 25-240 bpm/ $+ 5 bpm$ |
| Pulse rate, low perfusion | 25-300 bpm | $+ 3 bpm$ | $+ 3 bpm$ | 25-240 bpm/ $+ 3 bpm$ |
| Nellcor/Philips Fast | | | | |
| Technology | | | | |
| SpO2, no motion | 70-100% | $+ 2%$ | $+ 3%$ | Same |
| Pulse rate, no motion | 25-240 bpm | $+ 3 bpm$ | $+ 3 bpm$ | Same |

### Test Summary

The following non-clinical testing was conducted to verify that the LNCS/M-LNCS Oximetry Sensors met all design specifications: blocompatibility testing, performance testing including bench accuracy testing and visual and validated functional testing.

### Conclusion

The results demonstrated that the LNCS/M-LNCS Oximetry Sensors are as safe and effective as the legally marketed predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

OCT 2 1 2010

Re: K101896

Trade/Device Name: Masimo LNCS/M-LNCS Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 17, 2010 Received: September 22, 2010

Dear Mr. Bhalani:

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jus L. Hito

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):

### OCT 2 1 2010

Masimo LNCS/M-LNCS Oximetry Sensors Device Name:

#### Indications For Use:

The LNCS/M-LNCS Sensors are indicated for the continuous nonitoring 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.

Prescription Use 2 (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K101896

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

infection control

510(k) Number: L. Lull

510(k) Special, LNCS/M-LNCS Sensors Masimo, 7/6/2010 Page 15 of 254