MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D

K100617 · Masimo Corporation · DQA · May 28, 2010 · Cardiovascular

Device Facts

• Record ID: K100617
• Device Name: MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: May 28, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo Resposable Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients, during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Story

Masimo Resposable Oximetry Sensors (S2 Sensors) are noninvasive optical sensors; input consists of light absorption data from tissue; device transforms optical signals into SpO2 and pulse rate measurements; compatible with Masimo SET, Masimo Rainbow SET, Nellcor, and Philips FAST-SpO2 technologies; used in hospital, mobile, and home environments; operated by clinicians or patients; output displayed on compatible monitoring instruments; assists healthcare providers in assessing patient oxygenation status; benefits include continuous, real-time monitoring of vital signs.

Clinical Evidence

Bench testing only. Performance validated through risk analysis, design reviews, biocompatibility testing, and performance testing. Accuracy for SpO2 (70-100%) is ±2% (no motion/low perfusion) and ±3% (motion). Pulse rate accuracy is ±3 bpm (no motion/low perfusion) and ±5 bpm (motion).

Technological Characteristics

Noninvasive optical sensor; emitters and detectors; compatible with Masimo SET, Rainbow SET, Nellcor, and Philips FAST-SpO2 technologies. Designed for adults (>30kg) and pediatrics (10-50kg).

Indications for Use

Indicated for continuous noninvasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult and pediatric patients. Applicable for well or poorly perfused patients under motion or no-motion conditions in hospital, 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

• LNCS Oximetry Sensors (K051212)
• Masimo Rainbow Resposable Sensors (K090165)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K100617

| Submitted by: | Masimo Corporation | MAY 2 8 2010 |
|-----------------------------------|-------------------------------------------------------|--------------|
| | 40 Parker | |
| | Irvine, CA 92618 | |
| | 949-297-7000 | |
| | FAX [phone] | |
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs | |
| Date Summary Prepared: | March 2, 2010 | |
| Trade Name: | Masimo Resposable Oximetry Sensors | |
| Common Name: | Oximeter Sensor | |
| Regulation Number: | 21 CFR 870.2700 | |
| Regulation Name: | Oximeter | |
| Regulation Class: | Class II | |
| Product Code: | DQA, DSA | |
| Substantially Equivalent Devices: | LNCS Oximetry Sensors, 510k) No. K051212 | |
| | Masimo Rainbow Resposable Sensors, 510(k) No. K090165 | |

#### Device Description

The Masimo Resposable Oximetry Sensors (S2 Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:

- · Masimo SET technology
- · Masimo Rainbow SET technology
- · Nellcor technology
- · Philips FAST-SpO2 technology

The S2 Sensors and the predicates (K051212), the LNCS Oximetry Sensors (LNCS Sensors), have the same indications for use/ intended use. The S2 Sensors also have the same sensor design as the predicates (K090165), the Masimo Rainbow Resposable Sensor (R2 Sensors). The reason for this filing is to modify the LNCS Sensor design.

#### Predicate Device

The predicate devices used in this filing are:

- · The LNCS Oximetry Sensors (LNCS Sensors), 510(k) No. K051212
- · The Masimo Rainbow Resposable Sensors (R2 Sensors), 510(k) No. K090165.

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# 510(k) SUMMARY

#### Intended Use/ Indications for Use

The Masimo Resposable Oximetry Sensors 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 and pediatric patients, during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

#### Technology Comparison

The S2 Sensors are substantially equivalent to the predicate sensors in the design, principles of operation, and performance. The S2 Sensors and the predicates operate on identical principles of noninvasive optical assessment of tissue oxygenation using emitters and detectors.

#### Specifications

The specifications for the S2 Sensors are as following:

| Masimo SEI Technology and Masimo Rainbow SEI Technology/<br>(Adults > 30kg, Pediatrics 10-50kg) | | |
|-------------------------------------------------------------------------------------------------|----------------|----------|
| Measurement | Accuracy Range | Accuracy |
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | + 2% |
| Arterial Oxygen Saturation (SpO2), Motion | 70-100% | + 3% |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | + 2% |
| Pulse Rate, No Motion | 25-240 bpm | + 3 bpm |
| Pulse Rate, Motion | 25-240 bpm | + 5 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | + 3 bpm |
| Nellcor Technology and Philips FAST SpO2 Technology/<br>(Adults > 30kg, Pediatrics 10-50kg) | | |
| Measurement | Accuracy Range | Accuracy |
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | + 2% |
| Pulse Rate, No Motion | 25-240 bpm | + 3 bpm |

#### Test Summary

The S2 Sensors comply with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the S2 Sensors:

- Risk Analysis .
- Design Reviews .
- Biocompatibility Testing .
- Performance Testing �
- Safety Testing .

. .

#### Conclusions

The information in this 510(k) submission demonstrates that the S2 Sensors are substantially equivalent to the predicate devices, with respect to safety, effectiveness, and performance.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which consists of a staff with a snake entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

## MAY 2 8 2010

Re: K100617

Trade/Device Name: Masimo Resposable Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 26, 2010 Received: April 29, 2010

Dear Ms. Thomlinson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Marguerite Thomlinson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Masimo Resposable Oximetry Sensors Device Name:

Indications For Use:

The Masimo Resposable Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Prescription Use × (Per 21 CFR 801.109 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801.109 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluations (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Special, 3/2/2010 Resposable SpO2 Sensors Page 14 of 152

510(k) Number: