MASIMO SET USPO2 PULSE OXIMETRY CABLE

K121914 · Masimo Corporation · DQA · Sep 7, 2012 · Cardiovascular

Device Facts

• Record ID: K121914
• Device Name: MASIMO SET USPO2 PULSE OXIMETRY CABLE
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

Device Story

In-line cable interface; connects Masimo LNCS-compatible SpO2 sensors to GE ApexPro Telemetry System. Utilizes Masimo SET (Signal Extraction Technology) to process pulse oximetry signals; provides continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate. Used in hospital/hospital-type facilities; operated by clinicians. Output displayed on host telemetry system; assists clinicians in patient physiological status assessment; enables continuous monitoring of oxygenation and heart rate.

Clinical Evidence

Bench testing only. Included design review, risk analysis (ISO 14971), software verification/validation, electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1), environmental testing, and system compatibility testing with the GE ApexPro Telemetry System.

Technological Characteristics

In-line cable with distal 9-pin sensor connector; compatible with Masimo LNCS and LNOP (via adapter) sensors. Utilizes Masimo SET signal processing technology. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for continuous noninvasive monitoring of SpO2 and pulse rate in adult, pediatric, and neonatal patients. Suitable for use during motion and no-motion conditions, and for patients with good or poor perfusion in hospital 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® IntelliVue Pulse Oximeter Module (K040259)

Reference Devices

• GE ApexPro Telemetry System (K080251)

Submission Summary (Full Text)

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| 510(k) Summary | K121914 | SEP 7 2012 |
|----------------------------|-----------------------------------------------------------------------------------------------------|------------|
| Submitter: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] | |
| Contact: | David Collette<br>Sr. Manager, Regulatory Affairs | |
| Date Summary Prepared: | September 6, 2012 | |
| Trade Name: | Masimo SET® uSpO2™ Pulse Oximetry Cable | |
| Regulation Name: | Pulse Oximeter | |
| Classification Regulation: | 21 CFR 870.2700<br>Class II | |
| Product Code: | DQA | |
| Existing Device: | K040259 - Masimo SET® IntelliVue Pulse Oximeter Module | |

## Device Description

The Masimo SET® uSpO2™ Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when installed in a compatible OEM host system.

In this submission, the uSpO2 Pulse Oximetry Cable incorporates a distal integrated LNCScompatible 9-pin sensor connector with a length of cable used to interface to the host device, the GE ApexPro Telemetry System (K080251). The proximal end of the cable incorporates a connector that is compatible with the host device.

#### Indications for Use

The Masimo SET uSpO2 Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET uSpO2 Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

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## Predicate Device Comparison

| Characteristic | Masimo SET® IntelliVue<br>Pulse Oximeter Module<br>K040259 | Masimo SET® uSpO2™ Pulse<br>Oximetry Cable<br>K121912 |
|----------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Host system | Philips IntelliVue | GE ApexPro Telemetry<br>System |
| Physical configuration | Plug-in module<br>Direct connect to host<br>system. | Plug-in module with in-line<br>cable to connect to host<br>system. |
| Pulse oximetry technology | Masimo SET Technology | Masimo SET Technology |
| Communication protocol | IntelliVue host-system<br>specific | GE ApexPro host-system<br>specific |
| Compatible sensors and<br>cables | Masimo LNOP and LNCS<br>oximetry sensors<br>Masimo LNC patient cables | Masimo LNCS oximetry<br>sensors<br>Masimo LNOP oximetry<br>sensors (with adapter)<br>(patient cables not required) |

## Summary of Testing

The following testing of the uSpO2 Pulse Oximetry Cable was performed in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence of the modified device to the cleared device:

- . Design Review Process
- Risk Analysis per ISO 14971 .
- Software Verification and Validation per FDA Guidance Documents .
- Electromagnetic Compatibility per IEC 60601-1-2 t
- . Electrical Safety Testing per IEC 60601-1
- Environmental Testing (Operating Temperature, Humidity, Fluid Ingress) .
- . Component and System Testing
- System Compatibility Testing (GE ApexPro Telemetry System) .

#### Conclusion

The information in this 510(k) submission demonstrates that the subject Masimo SET uSpO2 Pulse Oximetry Cable is substantially equivalent to the existing device with respect to safety, effectiveness, and performance.

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

SEP 7 2012

Masimo Corporation Mr. David Collette Senior Manager, Regulatory Affairs 40 Parker Irvine, California 92618

Re: K121914

Trade/Device Name: Masimo Set® uSpO2™ Pulse Oximetry Cable Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 8, 2012 Received: August 9, 2012

Dear Mr. Collette:

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- Mr. Collette

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 yours,

for

B. Sheth

B. Sheth m.D.

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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# Section 4. Indications for Use

# Indications for Use

510(k) Number: K12|914

Device Name: Masimo SET® uSpO2™ Pulse Oximetry Cable

Indications for Use:

The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® uSpO2" Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

Prescription Use, X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultk

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

510(k) Number: K121914