MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP

K090662 · Masimo Corporation · DQA · Aug 10, 2009 · Cardiovascular

Device Facts

• Record ID: K090662
• Device Name: MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Reusable pulse oximetry sensor; inputs optical signals via patient contact; transforms signals into SpO2 and pulse rate data for display on compatible Masimo SET, Masimo Rainbow SET, or Nellcor pulse oximeter monitors. Used in hospital, mobile, and home environments by clinicians or patients. Output provides real-time physiological data to assist healthcare providers in monitoring patient oxygenation and heart rate, facilitating clinical decision-making regarding patient respiratory and cardiovascular status.

Clinical Evidence

Clinical testing was performed to validate sensor performance. The submission states compliance with voluntary standards and includes risk analysis, design reviews, biocompatibility, performance, safety, and environmental testing. No specific numerical clinical trial results (e.g., mean bias, ARMS) are provided in the summary text, but the device is claimed to be equivalent to the predicate.

Technological Characteristics

Reusable soft oximetry sensor; compatible with Masimo SET, Rainbow SET, and Nellcor monitors. Designed for adult (>30 kg) and pediatric (10-50 kg) patients. SpO2 accuracy 70-100% ± 2%; pulse rate accuracy 25-240 ± 3 bpm. Materials and design equivalent to predicate LNCS sensors. Connectivity via standard oximetry sensor interface.

Indications for Use

Indicated for continuous noninvasive monitoring and spot-checking of SpO2 and pulse rate in adult and pediatric patients. Suitable for well or poorly perfused patients in hospital, mobile, and home settings during 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

• Masimo LNCS Oximetry Sensors (K051212)

Submission Summary (Full Text)

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AUG 10 2009

## 510(k) SUMMARY

K09 0662

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] |
|---------------------------------------|-----------------------------------------------------------------------------------------|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | March 9, 2009 |
| Trade Name | Masimo SET Reusable Soft 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 LNCS Oximetry Sensors , 510(k) No. K051212 |

### Device Description

The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) are fully compatible reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The DBI/P Sensors are also fully compatible for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-oximeter monitors. Additionally, the DBI Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.

### Predicate Device

The predicate devices used in this filing are the Masimo LNCS Oximetry Sensors (K051212).

#### Intended Use

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

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# 510(k) SUMMARY

#### Technology

:

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The DBVP Sensors are substantially equivalent in design, principles of operation, materials, and performance to predicate device LNCS Oximetry Sensors. The DBI/P Sensor performance is equivalent to those of the LNCS Oximetry Sensor.

The specifications for the DBI/P Sensors for adults (> 30 kg) and pediatrics (10-50 kg) are the following:

| FEATURES | SENSOR SPECIFICATIONS:<br>with Masimo SET and Masimo<br>Rainbow SET Technology | SENSOR SPECIFICATIONS:<br>with Nellcor and Nellcor<br>Compatible Technology |
|---------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Accuracy – SpO2<br>During No Motion<br>Conditions | Adults, Pediatrics: 70% - 100% $\pm$ 2%<br>Adults, Pediatrics: 0% - 69%<br>unspecified | Adults, Pediatrics: 70% - 100% $\pm$ 2%<br>Adults, Pediatrics: 0% - 69%<br>unspecified |
| Accuracy – SpO2<br>Low Perfusion | Adults, Pediatrics: 70% - 100% $\pm$ 2%<br>Adults, Pediatrics: 0% - 69%<br>unspecified | N/A |
| Accuracy – Pulse Rate<br>During No Motion<br>Conditions | Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm | Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm |
| Accuracy – Pulse Rate<br>Low Perfusion | Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm | N/A |

### Test Summary

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

- Risk Analysis ●
- Design Reviews .
- Biocompatibility Testing .
- Performance Testing .
- Safety Testing .
- Environmental Testing
- Clinical Testing

#### Conclusions

The information in this 510(k) submission demonstrates that the Masimo SET® Reusable Soft Oximetry Sensors are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered in the image.

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

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

AUG 10 2009

Re: K090662

Trade/Device Name: Masimo SET Reusable Soft Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: July 29, 2009 Received: August 4, 2009

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.

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. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

far

Susan Runner, D.D.S., M.A. Acting Division 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 SET Reusable Soft Sensors Device Name:

Indications For Use:

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

L. Arletta

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

-10(k) Number. 4 090662

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 Evaluation (ODE)

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