MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR

K032551 · Masimo Corp. · DQA · Feb 19, 2004 · Cardiovascular

Device Facts

• Record ID: K032551
• Device Name: MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
• Applicant: Masimo Corp.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Reusable transflectance pulse oximetry sensor; utilizes two light-emitting diodes (LEDs) to measure light absorption of blood. Principle of operation based on differential light absorption of oxygenated vs. unsaturated hemoglobin to calculate SpO2 and pulse rate. Used in hospitals, mobile, and home environments; operated by clinicians or patients. Output provided to compatible pulse oximeter monitor for clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Bench testing and clinical study on adult volunteers. Accuracy (Arms) for LNOP-TF-I sensor determined to be ± 2.0% SpO2 compared to arterial blood samples analyzed on a laboratory CO-Oximeter.

Technological Characteristics

Reusable transflectance sensor; utilizes two LEDs for light emission; measures light absorption for SpO2 and pulse rate calculation. Compatible with Masimo SET pulse oximetry systems.

Indications for Use

Indicated for continuous noninvasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adults and pediatrics >30 kg 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

• Masimo SET Radical Pulse Oximeter with SatShare and LNOP series of Sensors and Cables (K000126)
• Nellcor Oximax Max-Fast Adhesive Forchcad Sensor (K021089)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the company's address, which is 2852 Kelvin Avenue, Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686. The text "K032551" is written diagonally above the logo.

# 510(k) SUMMARY

FEB 1 9 2004

| Submitted by: | Masimo Corporation<br>2852 Kelvin Ave<br>Irvine, CA 92614-5826<br>[phone]<br>FAX [phone] |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | October 2, 2003 |
| Trade Names | LNOP-TF-I Reusable Transflectance Sensor |
| Common Names | Pulse Oximetery Sensors |
| Classification Names | Oximeter (74DQA) (870.2700)<br>Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices | Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and<br>Cables 510(k) Number - K000126<br>Nellcor Oximax Max-Fast Adhesive Forchcad Sensor - 510(k) Number - K021089 |

#### Description

The Masino series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin in arterial blood. This filing includes the addition of 2 reusable sensors and a disposable sensor.

#### Intended use

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

#### Indications For Use:

The additional Masimo series of sensors are indicated for the following:

Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospital-type facilities, mobile, and home environments.

#### Comparison to Predicate Devices:

The additional Masimo series of sensors all use the same theory and principle of operation as the predicate devices.

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## 510(k) SUMMARY

#### Performance Data and Conclusions:

Performance testing was conducted on adult volunteers. The additional sensor was compared to arterial blood samples analyzed on a laboratory CO-Oximeter. Accuracy (Arms) for the LNOP-TF-I sensor is ± 2.0% SpO2.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized stripes or lines, which are meant to represent the concept of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2004

Mr. James Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Ave. Irvine, CA 92614-5826

Re: K032551

Trade/Device Name: Masimo LNOP TF-1 Reusable Transflectance Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Codc: 74 DQA Dated: February 4, 2004 Received: February 5, 2004

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.

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

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Page 2 - Mr. James Cronin

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 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/dsma/dsmamain.html.

Sincerely yours,

Chiu Lin, Ph.D.

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): K032551

Device Name: Masimo SET® Radical Pulse Oximeter with SatShare™ and the Masimo Series of Sensors and Cables

Indications For Use:

.

The following additional Masimo Sensor is indicated for the continuous noninvasive functional of arterial hemoglobin (SpO2) and pulse rate:

Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg 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 807 Subpart C) 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

ion o: Anesthesiologi Infection Control, Denta

510(k) Number: K032551