LNCS OXIMETRY SENSORS

K083622 · Masimo Corporation · DQA · Apr 2, 2009 · Cardiovascular

Device Facts

• Record ID: K083622
• Device Name: LNCS OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 2, 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 disposable pulse oximetry sensors; compatible with Masimo SET and Nellcor pulse oximeter monitors. Device uses non-invasive optical assessment of tissue oxygenation via emitters and detectors to measure SpO2 and pulse rate. Sensors are applied to patients in hospital, mobile, or home settings. Output is displayed on compatible monitors for clinician or patient use to assess oxygenation status. This submission specifically covers the transition to ethylene oxide (EO) sterilization for the sensors. No changes to sensor design, performance, or principles of operation compared to predicate devices.

Clinical Evidence

Bench testing only. Performance data included results from in-house and laboratory validation testing on sensors subjected to EO sterilization to ensure safety and effectiveness equivalent to predicate devices.

Technological Characteristics

Disposable pulse oximetry sensors; non-invasive optical assessment using emitters and detectors. 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 use in hospital, mobile, and home environments, including patients with motion or poor perfusion.

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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# 510(k) SUMMARY

K083622

# APR - 2 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 5, 2008 |
| Trade Name | LNCS Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | 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 fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximetry Sensors are also compatible with Nellcor and 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 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.

### Technology Comparison

The LNCS Oximetry Sensors in this filing are substantially equivalent in design, principles of operation, materials, and performance to predicate LNCS Oximetry Sensors (K041815, K051212, and K060143) and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.

The LNCS Oximetry Sensors in this filing are designed, configured, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximeter monitors, and Nellcor and Nellcor compatible pulse oximeter monitors. The accuracy of the LNCS Oximetry Sensors is equivalent to those of the predicate devices.

### Performance Testing

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

### Conclusion

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR - 2 2009

Re: K083622

Trade/Device Name: LNCS Sensors Regulation Number: 21 CFR 870.2700 Regulation Name; Oximeter Regulatory Class: II Product Code: DQA Dated: March 5, 2009 Received: March 10, 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 such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Susan Runoe

Ginette Y. Michaud, M.D. Acting 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

K083622

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.

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 CDF of Device Evaluation (ODE)

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

510(k) Number:

Masimo Sterilized LNCS Sensors . 510(k) File Page 10 of 394