LNCS OXIMETRY SENSORS

K042346 · Masimo Corporation · DQA · Sep 20, 2004 · Cardiovascular

Device Facts

• Record ID: K042346
• Device Name: LNCS OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LNOP x 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, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

Disposable and reusable pulse oximetry sensors; flex-circuit based design. Inputs: optical signals via red (658 nm) and infrared (905 nm) emitters and detectors. Operation: non-invasive optical assessment of tissue oxygenation; compatible with Masimo SET pulse oximeter monitors. Output: SpO2 and pulse rate data displayed on host monitor. Used in hospitals, mobile, and home environments by clinicians or patients. Benefits: continuous monitoring of oxygenation status to support clinical decision-making in various perfusion states.

Clinical Evidence

Clinical studies conducted on healthy adult volunteers under motion and no-motion conditions during induced hypoxia. Accuracy compared against CO-Oximeter arterial blood samples. Results: SpO2 accuracy <2% for adults, pediatrics, and infants (70-100% range); <3% for neonates.

Technological Characteristics

Flex-circuit based disposable/reusable sensors. Emitters: 658 nm (Red) and 905 nm (Infrared). Patient-contacting materials identical to SPO2.COM line. Compatible with Masimo SET monitors. Non-sterile, single-patient use.

Indications for Use

Indicated for continuous noninvasive monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients, including those well or poorly perfused, 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 (K031330)
• SPO2.COM A, I, P, N, RSI Pulse Oximeter Sensors (K033298)

Submission Summary (Full Text)

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# SEP 2 0 2004 510(k) SUMMARY

K042346

Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the address "40 Parker Irvine, CA 92618". 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: | August 27, 2004 |
| Trade Name | LNOPv and LNOP x 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 SET Radical Pulse Oximeter with SatShare™ and LNOP*<br>series of Sensors and Cables<br>510(k) Number - K031330<br>SPO2.COM A, I, P, N, RSI Pulse Oximeter Sensors<br>510(k) Number - K033298 |

#### Device Description

The LNOPx and LNOP x Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The LNOP x and LNOP x disposable sensors are similar in construction to the predicate devices except that the SPO2 COM sensors are cable based while the LNOP sensors including the LNOP x sensors are flex circuit based. The emitter and detector are connected to the flex circuit. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masmo's LNOP series of disposable sensors. Two sizes of disposable LNOPy sensors are available for use with infant and neonatal patients. Two sizes of disposable LNOP x sensors are available for use with adult and pediatric patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the bandage material The patient contacting materials in the LNOP x disposable sensors are the same that is used in Masimo's SPO2.COM sensor line. The LNOP x disposable sensors are supplied non-sterile for single patient use.

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## 510(k) SUMMARY

#### Predicate Devices

| LNCS Sensor Line | Masimo Predicate LNOP Sensors<br>- in K031330, K033298 |
|----------------------------------------|--------------------------------------------------------|
| LNOP Adtx - Adult Disposable Sensor | LNOP-Adt, SPO2.COM A |
| LNOP Pdtx - Pediatric DisposableSensor | LNOP-Pdt, SPO2.COM P |
| LNOPv In - Infant Disposable Sensor | LNOP-Neo, SPO2.COM I |
| LNOP Ne - Neonatal Disposable Sensor | LNOP-Neo, SPO2.COM N |

#### Intended Use

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

#### Technology Comparison

The I.NOP and L.NOP x 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 LNOP v and LNOP x Oximetry Sensors are designed, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximeters. The LNOP x Oximetry Sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The accuracy of the I.NOP x Oximetry Sensors is equivalent to those of the predicate devices.

#### Performance Testing

#### Biocompatibility

All the patient contacting materials used in the LNOP x Oximetry Sensors are the same materials that are used in Masimo's SPO2. COM series of sensors. Test results demonstrated that the materials were non-toxic, nonirritating, and non sensitizing.

#### Environmental Testing

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

#### Clinical Testing

Clinical studies were performed using the LNOP x Oximetry Sensors on healthy adult volunteer subjects during motion and no motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the LNOP x Oximetry Sensors resulted in an accuracy of less than 2% Spon a Ris in the range of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% Apys for neonates.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

SEP 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042346

Trade/Device Name: LNOPv and LNOP x Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 27, 2004 Received: August 30, 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.

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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 (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):

LNOPv and LNOP x Oximetry Sensors Device Name:

### Indications For Use:

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poorly perfused in hospital-type facilities, mobile, and home environments.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
*Uu rihom*

| (Division Sign-Off) | |
|---------------------------------------------------------------------------------|---------|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number | K042346 |