LNCS AND SPO2.COM SENSORS

K060143 · Masimo Corporation · DQA · Jun 16, 2006 · Cardiovascular

Device Facts

• Record ID: K060143
• Device Name: LNCS AND SPO2.COM SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LNCS oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments. The SPO2.COM oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

Disposable pulse oximetry sensors; utilize non-invasive optical assessment of tissue oxygenation via emitters and detectors; input signals processed by compatible pulse oximeter monitors (Masimo SET or Nellcor compatible); output provides continuous SpO2 and pulse rate data to clinicians or patients; used in hospitals, mobile, and home environments; enables real-time monitoring of patient oxygenation status; device design identical to predicates; modification limited to addition of Ethylene Oxide sterilization capability.

Clinical Evidence

Bench testing only. Performance data included Ethylene Oxide sterilization testing and in-house laboratory testing to confirm that sensors remain substantially equivalent to predicates before and after sterilization.

Technological Characteristics

Disposable optical sensors; non-invasive pulse oximetry principle using emitters and detectors; compatible with Masimo SET and Nellcor pulse oximeter monitors; sterilized via Ethylene Oxide.

Indications for Use

Indicated for continuous monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients. Applicable for well or poorly perfused patients in hospital, hospital-type, 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

• SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors (K033298)
• LNCS Oximetry Sensors (K041815)
• LNCS Oximetry Sensors (K051212)

Submission Summary (Full Text)

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## 510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K060143'. The characters are written in a handwritten style, with varying stroke thicknesses. The overall impression is that of a label or identifier.

Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the company's address, which is 40 Parker, Irvine, CA 92618. The image also includes the company's phone number, which is 949-297-7000, and fax number, which is 949-297-7001.

JUN 16 2006

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | January 17, 2006 |
| Trade Name | LNCS and SPO2.com Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices: | SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors 510(k) Number - K033298<br>LNCS Oximetry Sensors - K041815<br>LNCS Oximetry Sensors - K051212 |

#### Device Description

The LNCS Oximery Sensors are fully compatible disposable sensors for use with Masimo SET compatible pulse oximeter monitors and also with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.

The SPO2.COM Oximetry Sensors are fully compatible disposable sensors for use with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.

#### Intended Use

The LNCS oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The SPO2.COM oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

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# 510(k) SUMMARY

#### Technology Comparison

The LNCS and SPO2.COM oximetry sensors are equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.

The LNCS oximetry sensors are designed, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximeters and Nellcor compatible pulse oximeter monitors. The LNCS oximetry sensors are constructed of exact materials and components as used in the predicate devices.

The SPO2.COM oximetry sensors are designed, configured, and manufactured for full compatibility with Nellcor compatible pulse oximeter monitors. The SPO2.COM oximetry sensors are constructed of exact materials and components as used in the predicate devices.

The accuracy of the LNCS and SPO2.COM oximetry sensors is equivalent to those of the predicate devices.

#### Performance Testing

Performance data include results from Ethylene Oxide Sterilization Testing and in-house laboratory testing.

The performance data demonstrate that the LNCS and SPO2.COM sensors are substantially equivalent to the LNCS and SPO2.COM sensors before and after Ethylene Oxide Sterilization.

#### Conclusion

The results of the performance data demonstrate that the LNCS and SPO2.COM oximetry sensors are as safe and effective than the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Public Health Service

JUN 16 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 40 Parker Irvine, California 92618

Re: K060143

Trade/Device Name: LNCS and SPO2.COM Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 9, 2006 Received: June 12, 2006

Dear Mr. Cronin:

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 - Mr. Cronin

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 (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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chiu Lin, Ph.D.

. . . . . . .

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):

LNCS and SPO2.COM Sensors Device Name:

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

The SPO2.COM 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, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C) 011

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off)
ton of Anesthesiology, General Hospital,
Cion Control Dental Dovinn

AA6

Number: K066/73