LNCS OXIMETRY SENSORS

K083719 · Masimo Corporation · NLF · Jul 30, 2009 · Cardiovascular

Device Facts

• Record ID: K083719
• Device Name: LNCS OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: NLF · Cardiovascular
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 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 and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Story

LNCS Oximetry Sensors are reprocessed, disposable pulse oximetry sensors; compatible with Masimo SET and Nellcor-compatible monitors. Sensors detect light absorption to measure SpO2 and pulse rate. Used in hospital, mobile, and home settings by clinicians or patients. Reprocessing involves cleaning and ethylene oxide (EO) sterilization. Output displayed on compatible monitors to assist clinicians in assessing patient oxygenation status; facilitates clinical decision-making regarding respiratory support or intervention.

Clinical Evidence

Bench testing only. Validation testing performed on reprocessed sensors following EO sterilization to ensure performance equivalence to predicate devices.

Technological Characteristics

Disposable pulse oximetry sensors; compatible with Masimo SET and Nellcor monitors. Sterilization method: Ethylene Oxide (EO).

Indications for Use

Indicated for continuous monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients. Suitable for patients who are well or poorly perfused, under both motion and no-motion conditions, 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 LNCS Oximetry Sensors (K041815)
• Masimo LNCS Oximetry Sensors (K051212)
• Masimo LNCS Oximetry Sensors (K060143)

Submission Summary (Full Text)

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K083719510(k) SUMMARY

JUL 30 2009

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs | | | |
| Date Summary Prepared: | December 12, 2008 | | | |
| Trade Name | LNCS Oximetry Sensors | | | |
| Common Name | Oximeter Sensor | | | |
| Classification Name and Product Code: | Reprocessed, Oximeter (NLF) (870.2700)<br>Oximeter (74DQA) (870.2700)<br>Cable, Transducer and Electrode (74DSA) (870.2900) | | | |
| Substantially Equivalent Devices: | Masimo LNCS Oximetry Sensors, 510(k) No. K041815<br>Masimo LNCS Oximetry Sensors, 510(k) No. K051212<br>Masimo LNCS Oximetry Sensors, 510(k) No. K060143 | | | |

## Device Description

The LNCS Oximetry Sensors are to be reprocessed. They are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximety Sensors are also compatible with Nellcor compatible pulse oximeter monitors.

There is no change in the sensor design or performance. The only change is that the sensors are to be reprocessed and subjected to ethylene oxide (EO) sterilization, and are to be supplied as sterile sensors by Masimo.

#### Predicate Device

The predicate devices used in this filing are the LNCS Oximetry Sensors (K041815, K051212, and K060143).

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# 510(k) SUMMARY

#### Intended Use/ Indications for Use

The LNCS Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO- 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.

### Performance Testing

Performance data include results from in-house and laboratory validation testing on the sensors after they have been reprocessed and subjected to EO sterilization.

#### Conclusion

The results of the performance data demonstrate that the LNCS Oximetery Sensors, after reprocessed and sterilized are as safe and effective as the legally marketed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

JUL 300 2009

Re: K083719

Trade/Device Name: LNCS Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: July 24, 2009 Received: July 29, 2009

Dear Ms. Thomlinson:

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.

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 Eederal Register.

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## Page 2- Ms. Thomlinson

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.goy/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Ream

Susan Runner, D.D.S., M.A. Acting Division 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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# List of Models

1

:

:

and the comments of the comments of the comments of the comments of

| Masimo Corporation, Models |
|----------------------------|
| LNCS Oximetry Sensors (11) |
| Adtx |
| Adtx-3 |
| Pdtx |
| Pdtx-3 |
| Inf |
| Inf-3 |
| Neo |
| Neo-3 |
| NeoPt |
| NeoPt-3 |
| NeoPt-500 |

:

:

and the same of the same of the same of the same of the season of the season

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## Indications for Use

083719

ﺪ

510(k) Number (if known):

Device Name: LNCS Sensors

Indications For Use:

The 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 and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

L. Schult

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

510(k) Number: K083719

Prescription Use x (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)