LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS

K094046 · Masimo Corporation · DQA · May 14, 2010 · Cardiovascular

Device Facts

• Record ID: K094046
• Device Name: LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: May 14, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Reprocessed LNCS 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

Reprocessed LNCS Oximetry Sensors are disposable pulse oximetry sensors; compatible with Masimo SET and Nellcor-compatible monitors. Sensors detect arterial hemoglobin oxygen saturation (SpO2) and pulse rate via noninvasive optical sensing. Used in clinical and home settings by healthcare providers or patients. Output displayed on compatible pulse oximeter monitors; assists clinicians in assessing patient oxygenation status; enables continuous monitoring to detect hypoxemia or pulse rate abnormalities. Device is a reprocessed version of single-use sensors.

Clinical Evidence

Bench testing only. Performance verified through bench accuracy testing for SpO2 and pulse rate across motion, no-motion, and low-perfusion conditions. Biocompatibility (cytotoxicity, sensitization, skin irritation), sterilization process validation, and environmental packaging validation were performed.

Technological Characteristics

Disposable optical oximetry sensors. Sensing principle: pulse oximetry (photoplethysmography). Compatible with Masimo SET and Nellcor-compatible monitors. Sterilization: validated process. Materials: biocompatible components verified via cytotoxicity, sensitization, and skin irritation testing.

Indications for Use

Indicated for continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients. Suitable for patients in no motion or motion conditions, and those with good or poor perfusion. Used in hospitals, hospital-type facilities, 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

• Reprocessed LNCS Oximetry Sensors (K083719)

Submission Summary (Full Text)

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K094046

## 510(k) SUMMARY

MAY 1 4 2010 :

| Submitted by: | Masimo Corporation<br>40 Parker, Irvine, CA 92618<br>Phone: [phone]; Fax: [phone] |
|-----------------------------------|---------------------------------------------------------------------------------------------|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | May 6, 2010 |
| Trade Name | Reprocessed LNCS Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Regulation Number: | 21 CFR 870.2700 |
| Regulation Name/ Product Code: | Oximeter/ NLF, DQA |
| Substantially Equivalent Devices: | Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719 |

### Device Description

The Reprocessed LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The Reprocessed LNCS Oximetry Sensors , are also compatible with Nellcor compatible pulse oximeter monitors.

#### Intended Use/ Indications for Use

The Reprocessed LNCS Sensors are indicated for the continuous nonitoring of functional oxygen 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 hospitals, hospital-type facilities, mobile, and home environments.

### Comparison to Predicate Device

The sensors in this filing are the same in design, performance, and principle of operations, as the respective predicate sensors (K083719). The main difference is that the predicate devices have replaceable tapes and the pending sensors do not have replaceable tapes.

The predicate sensors and the corresponding Reprocessed LNCS Oximetry Sensors in this filing are:

| Predicate Reprocessed LNCS<br>Sensors in K083719 | Reprocessed LNCS Oximetry Sensors |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Infant single-use sensor:<br>Reprocessed LNCS Inf<br>Reprocessed LNCS Inf-3 | Infant single-use sensor:<br>Reprocessed LNCS Inf-L<br>Reprocessed LNCS Inf-L-3 |
| Neonatal single-use sensor:<br>Reprocessed LNCS Neo<br>Reprocessed LNCS Neo-3 | Neonatal single-use sensor:<br>Reprocessed LNCS Neo-L<br>Reprocessed LNCS Neo-L-3 |
| Neonatal single-use sensor:<br>Reprocessed LNCS NeoPt<br>Reprocessed LNCS NeoPt-3 | Neonatal single-use sensor:<br>Reprocessed LNCS NeoPt-L<br>Reprocessed LNCS NeoPt-L-3 |

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# 510(k) SUMMARY

| Measurement | Accuracy<br>Range | Accuracy:<br>Reprocessed LNCS<br>infant sensors | Accuracy:<br>Reprocessed LNCS<br>neonatal sensors |
|--------------------------------------------------|-------------------|-------------------------------------------------|---------------------------------------------------|
| SpO2, no motion<br>(Masimo technology) | 70-100% | $\pm$ 2% | $\pm$ 3% |
| SpO2, motion<br>(Masimo technology) | 70-100% | $\pm$ 3% | $\pm$ 3% |
| SpO2, low perfusion<br>(Masimo technology) | 70-100% | $\pm$ 2% | $\pm$ 3% |
| Pulse rate, no motion<br>(Masimo technology) | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| Pulse rate, motion<br>(Masimo technology) | 25-240 bpm | $\pm$ 5 bpm | $\pm$ 5 bpm |
| Pulse rate, low perfusion<br>(Masimo technology) | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| SpO2, no motion<br>(Nellcor technology) | 70-100% | $\pm$ 2% | $\pm$ 3% |
| Pulse rate, no motion<br>(Nellcor technology) | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |

The sensors in this filing have the same specifications as the predicate devices, which are as following:

### Test Summary

The following non-clinical testing was conducted to verify that the Reprocessed LNCS Sensors met all design specifications: biocompatibility testing including cytotoxicity, sensitization, and skin irritation testing; performance testing including bench accuracy testing including process validation of the sterilization procedures, and visual and validated functional testing of all products; and environmental testing including device packaging validation.

#### Conclusion

The results demonstrated that the Reprocessed LNCS Oximetry Sensors are equivalent to the predicate devices.

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Public Health Service

MAY 1 4 2010

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

Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 and 50 Parker Irvine, California 92618

Re: K094046

Trade/Device Name: Masimo LNCS Oximetry Sensors, Masimo Reprocessed LNCS Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Il Product Code: DQA Dated: April 12, 2010 Received: April 14, 2010

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. 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. 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.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:

Nh 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

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

Masimo Reprocessed LNCS Oximetry Sensors Device Name:

Indications For Use:

The Reprocessed LNCS 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 (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)

L. Schuller

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

510(k) Number: k094046