MODIFICATION TO LNCS OXIMETRY SENSORS

K051212 · Masimo Corporation · DQA · Jul 12, 2005 · Cardiovascular

Device Facts

• Record ID: K051212
• Device Name: MODIFICATION TO LNCS OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LNCS oximetry sensors are interest of the continuous of inctional oxygen saturation of arterial The LNCS oximetry sensors are miended tot the commonly of themseling of the more of the more of the mater patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

LNCS Oximetry Sensors are disposable and reusable sensors designed for non-invasive optical assessment of tissue oxygenation; they utilize emitters and detectors to measure functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate. The sensors are compatible with Masimo SET and Nellcor pulse oximeter monitors. Used in hospitals, hospital-type facilities, mobile, and home environments, the sensors provide data to the host monitor, which processes the signals to display SpO2 and pulse rate. This information assists clinicians in patient monitoring and clinical decision-making regarding oxygenation status. The sensors benefit patients by providing continuous, real-time monitoring of vital signs.

Clinical Evidence

Clinical studies were conducted on healthy adult volunteers using LNCS disposable sensors with Nellcor N-200 instruments. Subjects underwent progressive induced hypoxia under no-motion conditions. Arterial blood samples were measured via CO-Oximeter as the reference. Results demonstrated an accuracy of <2% SpO2 ARMS in the 70%-100% SaO2 range for adults, pediatrics, and infants, and <3% ARMS for neonates.

Technological Characteristics

Non-invasive optical sensor using emitters and detectors. Materials are identical to Masimo's LNOP sensors (non-toxic, non-irritating, non-sensitizing). Compatible with Masimo SET and Nellcor pulse oximeter monitors. Environmental testing performed per November 1993 Reviewers Guidance (electrical, mechanical).

Indications for Use

Indicated for continuous monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in adult, pediatric, and neonatal patients in hospital, hospital-type, mobile, and home environments, including patients who are well or poorly perfused, under both motion and no-motion conditions.

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

• LNCS Oximetry Sensors (K041815)
• SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors (K0332)
• Nellcor N-395 Pulse Oximeter (K991823)
• Nellcor N-200 Pulse Oximeter (K863784)

Submission Summary (Full Text)

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K05/2/2

010

# JUL 122005 510(k) SUMMARY

Image /page/0/Picture/2 description: The image shows the logo and contact information for Masimo. The logo is a stylized wordmark with the company name in bold, sans-serif font. Below the logo is the address: 40 Parker, Irvine, CA 92618. The telephone 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: | May 10, 2005 |
| 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)<br>Oximeter, Ear (74DPZ) (870.2710) |
| Substantially Equivalent Devices: | LNCS Oximetry Sensors<br>510(k) Number – K041815<br>SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors 510(k) Number -- K0332<br>Nellcor N-395 Pulse Oximeter – K991823<br>Nellcor N-200 Pulse Oximeter - K863784 |

# Device Description

The LNCS Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo SET and Masimo SET The LNCS Oximetry Sensors are tuly computible disposed and the use oximeter montiors. There is no
compatible pulse oximeter monitors and that the sate and that the eased with compatible pulse oximeter montors and Nellor and Neticor composible pass and also be used with Nellcor and change in acciginal pulse oximeter monitors.

# Intended Use

The LNCS oximetry sensors are interest of the continuous of inctional oxygen saturation of arterial The LNCS oximetry sensors are miended tot the commonly of themseling of the more of the more of the mater patients in hospitals, hospital-type facilities, mobile, and home environments.

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# 510(k) SUMMARY

### Technology Comparison

The LNCS oximetry sensors are equivalent in intended use, design, principles of operation, materials, and performance to I he LNCS oximery sensors an 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 Masims . I lie LNCS oximenty and Nellcor and Nellcor compatible pulse oximeter monitors. The LNCS oximetry SET companition pulse of exact materials and components as used in the predicate devices.

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

#### Performance Testing

#### Biocompatibility

All the patient contacting materials used in the LNCS sensors are the same materials that are used in Masimo's LNOP All the patient comacing materials used in 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 LNCS Disposable oximetry sensors with Nellcor N-200 instruments on healthy adult volunteer subjects during no motion conditions who were subjected to a progressive induced Instruitents on nealthy addit volunt value with the instruments against the arterial hemoglobin ifyposal and neasuring the arterial blood samples with a CO-Oximeter. Clinical testing of the LNCS Disposable and Uxygun dolor in an accuracy of less than 2% SpO2 AxMs in the range of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% ARMS for neonates.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three parallel lines.

JUL 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4

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

Re: K051212

K051212
Trade/Device Name: Modification to LCN Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Sensor Regulatory Class: Class II Product Code: DQA Dated: June 30, 2005 Received: July 1, 2005

Dear Mr. Cronin:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section >><<<<>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manatise producal Device Amendments, or to commerce prior to May 26, 1770, the chasiness and of the Federal Food. Drug, devices that have been reclassince in accerdance was a proval approval approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a premarket approva and Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, therefore, market the do received be requirements for annual registration, listing of general controls provisions of the Fiel 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 If your device is classified (Scc above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controlls. Entroling and to 898. In addition, FDA may be found in the Ood of Poussal Sincerning 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 Please be advised that I Dri- s issuation or our device complies with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must of any Federal statutes and regulations anninesses of 3 mot limited to: registration and listing (21 Comply with an the Act 3 requirements, n.c.i.e.s.
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decleils over of Sectibed in your Section 510(k) I his letter will andw you to oegin manceing your antial equivalence of your device to a legally premarket nothication. The PDA miding of basification 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 If you desire specific advice for your ac [phone]. Also, please note the regulation entitled, Colliact the Office of Complians in (21CFR Part 807.97). You may obtain "Misorallumig by relevel to premaritoritive under the Act from the Division of Small other gelleral Information on your response Assistance at its toll-free number (800) 638-204 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Auyxubeom for
Chin Lin, Ph.D.

Chin 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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# 510(k) Number (if known):

#### LNCS Sensors Device Name:

# Indications For Use:

The LNCS Sensors are indicated for the continuous nonitoring of functional-oxygen saturation of arterial The LNCS Sensors are indicated tor the communes with and with recident of the t, and neouatal hemoglobin (SpO), and pulse rate (measured by an SpO-sellson for ass who box 7 man 7
patients during both no motion conditions, and for patients who are well or poorly perfus patients during oour no 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auy Salom

Division Sign-Off) islon of Angethesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

009