SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS

K033298 · Masimo Corp. · DQA · Dec 12, 2003 · Cardiovascular

Device Facts

• Record ID: K033298
• Device Name: SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS
• Applicant: Masimo Corp.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The SPO2.COM oximetry sensors and cables are intended for the continuous nominvasive monitoring of functional oxygen saturation of arterial hermoglobin (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

SPO2.COM Oximetry Sensors and cables are disposable or reusable sensors designed for compatibility with Nellcor 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. Reusable sensors feature a molded clothespin-style housing; disposable sensors use adhesive bandages for attachment to fingers or toes. Devices are used in hospitals, mobile, and home environments by clinicians or patients. Output consists of raw optical signals processed by the host oximeter monitor to calculate SpO2 and pulse rate. This data assists healthcare providers in continuous patient monitoring, enabling timely clinical intervention for hypoxia or abnormal pulse rates.

Clinical Evidence

Clinical studies conducted on healthy adult volunteers using induced hypoxia. Arterial hemoglobin saturation measured by SPO2.COM sensors compared against CO-Oximeter blood sample analysis. Results: Accuracy <2% SpO2 for 70-100% range in adults, pediatrics, and infants; <3% SpO2 for neonates.

Technological Characteristics

Non-invasive optical sensor; red (658 nm) and infrared (905 nm) emitters; photodetector. Form factors: reusable clothespin-style and disposable adhesive bandage sensors. Materials identical to Masimo LNOP line; biocompatible, non-toxic, non-irritating. Non-sterile (disposable) and reusable configurations. Connectivity: wired interface to Nellcor-compatible pulse oximeter monitors.

Indications for Use

Indicated for continuous non-invasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients 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)
• Nellcor N-395 Pulse Oximeter (K991823)
• Nellcor N-200 Pulse Oximeter (K863784)

Submission Summary (Full Text)

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DEC 1 2 2003

510(k) SUMMARY

Image /page/0/Picture/2 description: The image shows the logo and contact information for Masimo, a company located at 2852 Kelvin Avenue in Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686. The logo features the company name in a stylized font.

| 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 11, 2003 |
| Trade Name | SPO2.COM 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 ^® series of Sensors and<br>Cables<br>510(k) Number - K031330<br>Nellcor N-395 Pulse Oximeter - K991823<br>Nellcor N-200 Pulse Oximeter - K863784 |

Device Description

The SPO2.COM Oximetry Sensors are fully compatible disposable replacement sensors for use with Nellon and Nelloor compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The SPO2.COM RSI reusable sensor is essentially identical to Masimo LNOP-DCI sensor except for the end of the cable which interfaces with the Neller. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the SPO2.COM RSI and LNOP-DCI sensors. The patient contacting materials in the SPO2.COM RSI and LNOP-DCI sensors are the same. The SPO2.COM RSI sensors are supplied non-sterile.

The SPO2.COM disposable sensors are similar in construction to the predicate devices. The emitter and detector are connected to the cable assembly. 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 Masimo's LNOP series of stime that that tour sizes of disposable SPO2.COM sensors are available for use with adult, pediatric, infant and neonatal cuspount our sensors are cssentially identical except for the emitter and detector spacing and size and orientation of the bandage material. The patient contacting materials in the SPO2.COM disposable schsors are the same that is used in Masimo's LNOP sensor line. The SPO2.COM disposable sensors are supplied non-sterile for single patient use.

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# 510(k) SUMMARY

The SPO2.COM patient cables are similar in construction to the predicate device enabling the SPO2.COM Oximetry Sensors to be connected to Nellcor and Nellcor compatible pulse oximeter monitors.

### Predicate Devices

:

| SPO2.COM Sensor Line | Masimo Predicate LNOP Sensors<br>- in K031330 | Nellcor Predicate Sensors found in<br>K863784 and K991823 |
|------------------------------------------|-----------------------------------------------|-----------------------------------------------------------|
| SPO2.COM RSI - Reusable Adult Sensor | LNOP-DCI | DS-100A |
| SPO2.COM A – Adult Disposable Sensor | LNOP-Adt | D-25 |
| SPO2.COM P - Pediatric DisposableSensor | LNOP- Pdt | D-20 |
| SPO2.COM I - Infant Disposable Sensor | LNOP-Neo | I-25 |
| SPO2.COM N -- Neonatal Disposable Sensor | LNOP-Neo | N-25 |
| SPO2.COM 200 - Patient Cable | PC Patient Cable | N/A |
| SPO2.COM 395 - Patient Cable | PC Patient Cable | N/A |

#### Intended Use

The SPO2.COM oximetry sensors and cables are intended for the continuous nominvasive monitoring of functional oxygen saturation of arterial hermoglobin (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.

#### Technology Comparison

The SPO2.COM 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 SPO2.COM oximetry sensors are designed, configured, and manufactured for full compatibility with Nellcor and Nellcor The or oz. Out oximeters. The SPO2. COM oximetry sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

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

#### Performance Testing

#### Biocompatibility

All the patient contacting materials used in the SPO2.COM sensors are the same materials that are used in Masimo's LNOP series of 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 SPO2.COM Adult and Reusable oximetry sensors on healthy adult volunteer enhined studios nore perfective 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 SPO2.COM Adult and Reusable schsors resulted in an accuracy of less than 2% SpO2 Aranievel of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% AsMs for neonates.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is composed of three thick, curved lines, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

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

Re: K033298

Trade/Device Name: SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: December 5, 2003 Received: December 8, 2003

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. James J. 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,

Carls

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): K033298

SPO2.COM Sensors and Cables Device Name:

Indications For Use:

The SPO2.COM Sensors and Cables 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 _____________________________________________________________________________________________________________________________________________________________ (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)

6. ANN Antoshina

510(k) Numbe