LNOPV AD-L AND PD-L OXIMETRY SENSORS

K050068 · Masimo Corporation · DQA · Feb 9, 2005 · Cardiovascular

Device Facts

• Record ID: K050068
• Device Name: LNOPV AD-L AND PD-L OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LNOPv Ad-L and Pd-L Oximetry Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

Disposable oximetry sensors (LNOPv Ad-L for adults, Pd-L for pediatrics) designed for use with Masimo SET pulse oximeter monitors. Sensors utilize red (658 nm) and infrared (905 nm) light emitters and detectors to perform non-invasive optical assessment of tissue oxygenation. Compared to predicate LNOPv sensors, these feature a shorter tail and inverted emitter/detector positioning. Used in clinical, mobile, and home settings to provide continuous SpO2 and pulse rate data to healthcare providers or patients. Output enables real-time monitoring of patient oxygenation status, facilitating clinical decision-making regarding respiratory or circulatory support. Benefits include non-invasive, continuous tracking of patient perfusion and oxygen saturation levels.

Clinical Evidence

Clinical studies conducted on healthy adult volunteers under motion and no-motion conditions during progressive induced hypoxia. Arterial hemoglobin oxygen saturation measured by sensors compared against CO-Oximeter blood sample analysis. Results showed accuracy of <2% SpO2 ARMS in the 70%-100% SaO2 range for both adult and pediatric populations.

Technological Characteristics

Disposable optical sensors; red (658 nm) and infrared (905 nm) emitters; photodetector. Materials identical to predicate sensors; biocompatible (non-toxic, non-irritating, non-sensitizing). Non-sterile. Designed for compatibility with Masimo SET pulse oximeter monitors. Electrical, mechanical, and environmental testing performed per 1993 FDA Reviewer Guidance.

Indications for Use

Indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult and pediatric patients, including those who are well or poorly perfused, in hospital, hospital-type, 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

• LNOPv and LNOP x Oximetry Sensors (K042346)

Submission Summary (Full Text)

{0}------------------------------------------------

rEB - 9 2005 510(k) SUMMARY

K050068

Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo, the text "4 D Parker Irvine, CA 92618 Tel: [phone] Fax: [phone]" is displayed. This text provides the address and contact information for the company's Irvine, California location. The phone number is 949-297-7000 and the fax number is 949-297-7001.

| 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: | February 7, 2005 |
| Trade Name | LNOPv Ad-L and Pd-L Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices: | LNOPv and LNOP x Oximetry Sensors - K042346 |

Device Description

The LNOPv Ad L and Pd L Oximetry Sensors are fully compatible disposable sensors for use with Masino SET THE INOF PHE Hand I & H Chulse oximeter monitors. They represent a design change to the Masimo LNOPv Oximetry Sensors.

The LNOPv Ad L and Pd L disposable sensors are similar in construction to the predicate devices LNOPv In and I NO v Ne except that the LNOPv Ad L and Pd L have a shorter tail and the emitter and detector position is switched. The LNOPv Ad-Land Pd-L use the same emitters (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) as used in Masimo's LNOPv In and Ne sensors. The patient contacting materials in the wavelengal of 500 mm/ as about in hasim ore the same that is used in Masimo's LNOPv In and Ne sensors. The LNOPv Ad-L and Pd-L disposable sensors are supplied non sterile for single patient use.

The LNOPv Ad L and Pd-L disposable sensors have the same electrical, optical, and material components as the LNOPv In and Ne disposable sensors.

## Predicate Devices

| LNOPv Sensor Line | Masimo Predicate LNOP Sensors<br>- in K04236 |
|------------------------------------------|----------------------------------------------|
| LNOPv Ad-L - Adult Disposable Sensor | LNOPv Ne |
| LNOPv Pd-L - Pediatric Disposable Sensor | LNOPv In |

{1}------------------------------------------------

# 510(k) SUMMARY

# Intended Use

The LNOPv Ad-L and Pd-L Oximetry Sensors are intended for the continuous nonitorial or functions of finish I he LNOF V Ad-L and I d-L Oximory Donoso are eate (measured by an SpO2 sensor) for adult and , pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.

# Technology Comparison

The LNOPv Ad-L and Pd-L Oximetry Sensors are substantially 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 LNOPv Ad-L and Pd-L Oximetry Sensors are designed, and manufactured for full compatibility with Masino THE LINOF V AC-2 and For D Oximedy Delivers. The LNOP v Ad-L and Pd-L Oximetry Sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The accuracy of the LNOPv Ad-L and Pd-L Oximetry Sensors is equivalent to those of the predicate devices.

## Performance Testing

## Biocompatibility

All the patient contacting materials used in the LNOPv Ad-L and Pd-L Oximetry Sensors are the same materials that are All the pation on the sensors. Test results demonstrated that the materials were non-toxic, non-irritating, and non sensitizing.

#### Environmental Testing

Applicable environmetal testing per the Reviewers Guidance for Premarket Submissions - November 1993, i.e. electrical, mechanical and environmental were performed and all tests passed

# Clinical Testing

Clinical studies were performed using the LNOPv Oximetry Sensors on healthy adult volunteer subjects during motion ond no motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin and no no howith the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the LNOPv Oximetry Disposable sensors resulted in an accuracy of less than 2% SpO2 ARMS in the range of 70%-100% SaO2 for adults and pediatrics.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

FEB - 9 2005

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: K050068

Trade/Device Name: LNOPv Ad-L Oximetry Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 10, 2005 Received: January 12, 2005

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.

{3}------------------------------------------------

# 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 (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/industry/support/index.html.

Sincerely yours,

Ching-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

{4}------------------------------------------------

# Indications for Use

# 510(k) Number (if known):

LNOPv Ad-L and Pd-L Oximetry Sensors Device Name:

Indications For Use:

The LNOPv Ad-L and Pd-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional I he LNOY Ad-L allo FU-L Oxincily Schools are mailsee to: measured by an SpO2 sensor) for use with and oxygen saturation of arterial nemogrom (OPO)) this pass tate for patients who are well or poorly perfused in podiatio passital-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) 000 €

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aum Sabom

nesthesiology, Ger

involver.