BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE

K121806 · Covidien · DQA · Sep 28, 2012 · Cardiovascular

Device Facts

• Record ID: K121806
• Device Name: BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
• Applicant: Covidien
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 28, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO₂) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. The Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Device Story

Portable pulse oximeter; monitors SpO2, pulse rate, and respiration rate. Inputs: photoplethysmography (PPG) signals from compatible Nellcor OxiMax sensors. Operation: processes PPG data to calculate SpO2, pulse, and respiration rate; displays digital values and plethysmographic waveforms. Used in hospitals/clinical settings by healthcare providers. Output: real-time respiratory and oxygenation metrics; aids clinicians in identifying desaturation patterns and respiratory distress. Benefits: continuous, non-invasive patient monitoring; facilitates early detection of respiratory events.

Clinical Evidence

Bench testing only. Verification and validation confirmed system mechanical and software features met requirements. Performance testing included 20-point COPs (Clinical Oximetry Protocols) and Low Perfusion Pulse Rate and Saturation Accuracy tests. Usability evaluated via formative and summative studies in simulated operating environments. No clinical or animal data required.

Technological Characteristics

Portable pulse oximeter; internal AC power (80-264VAC) or 7.2V, 83W/hr rechargeable lithium-ion battery. Uses Nellcor OxiMax oxygen transducers/respiratory sensors. Features internal printed circuit board assembly. Software-based calculation of respiration rate from photoplethysmography data. Connectivity via standard electrical utility receptacle.

Indications for Use

Indicated for continuous non-invasive monitoring of SpO2, pulse rate, and respiration rate in adult, pediatric, and neonatal patients (respiration rate for adults only) in hospitals, hospital-type facilities, and during intra-hospital transport. Includes patients who are well or poorly perfused. SPD Alert feature indicated for adult facility-use to detect desaturation patterns indicative of repetitive airflow reductions.

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

• N-600x Pulse Oximeter with Oximax SPD Alert (K083325)
• Covidien Respiration Rate Software (K111933)

Reference Devices

• K060576

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word COVIDIEN next to a black square with a white cross in the middle. The word COVIDIEN is in all caps and is in a bold, sans-serif font. The black square is to the left of the word COVIDIEN. The white cross is in the center of the black square.

# K 121806 510(k) Summary

Date summary prepared: 31-Aug-2012

# 510(k) Submitter/Holder

Covidien IIc 6135 Gunbarrel Avenue Boulder, CO 80301

# Contact

Elizabeth Malo Sr. Regulatory Affairs Specialist Office 303.305.2763 Mobile [phone] Fax: [phone] Email: [e-mail]

#### Name of Device

| Trade Name: | Bedside Respiratory Patient Monitoring System |
|----------------------|-----------------------------------------------------------------|
| Catalog Numbers: | GR101704, GR101704-RR |
| Common Name: | Pulse oximeter |
| Classification Name: | oximeter (21 CFR § 870.2700, class II, DQA) |
| | monitor, breathing frequency (21 CFR § 868.2375, class II, BZQ) |

#### Purpose of Submission

The purpose of this submission is to introduce the Covidien Nellcor Bedside Respiratory Patient Monitoring System which effectively integrates Respiration Rate software parameter into a pulse oximetry monitor whose design is fundamentally similar to the proposed predicate. The intended use of the Bedside Respiratory Patient Monitoring System is the same as that of the predicate with the addition of the continuous noninvasive monitoring of respiration rate in adult patients.

This submission followed the "Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, 2005," the "Guidance for Industry on General / Specific Intended Use, 1998," and the "Draft Guidance for Industry and FDA Staff: Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review, 2011."

#### Predicate Devices

Bedside Respiratory Patient Monitoring System was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:

| Trade Name: | N-600x Pulse Oximeter with Oximax SPD Alert |
|---------------------|-----------------------------------------------------------|
| Device Common Name: | Oximeter |
| 510(k) Number: | K083325 (cleared 3/2009) |
| Manufacturer: | Covidien, formerly Nellcor, a division of Tyco Healthcare |
| Trade Name: | Covidien Respiration Rate Software |
| Device Common Name: | Monitor, breathing frequency |
| 510(k) Number: | K111933 (cleared 3/2012) |
| Manufacturer: | Covidien, formerly Nellcor, a division of Tyco Healthcare |

SEP 2 8 2012

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# Device Description

The Covidien Nellcor Bedside Respiratory Patient Monitoring System is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of a range of compatible Nellcor OxiMax oxygen transducers (sensors). The Bedside Respiratory Patient Monitoring System displays digital values of SpO2 and pulse and respiratory rate. Pulse amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (from 80VAC to 264VAC) or alternatively by an integral sealed 7.2V, 83W/hr rechargeable lithium-ion battery. The Nellcor OxiMax Bedside Respiratory Patient Monitoring System is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, and intra-hospital transport.

# Intended Use

The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO₂) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

# Technological and Performance Characteristics

The Bedside Respiratory Patient Monitoring System features the same performance characteristics as the predicate K083325, N-600x Pulse Oximeter with Oximax SPD Alert. There are no significant changes to the function of the device other than the addition of the respiration rate software as an optional parameter for use on the finished device.

#### Performance Data

The design of the Bedside Respiratory Patient Monitoring System features the same internal printed circuit board assembly as the predicate device thus performance data to demonstrate saturation and pulse rate accuracy, and SPD are unchanged and the associated information provided in K060576 and K083325 are applicable to the device subject of this submission. Integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate based upon oximetry ohotoplethysmography data, therefore performance data to respiration rate are unchanged and the associated information provided in K111933 are applicable to the device subject of this submission

Bench Testing: Design verification and validation testing was performed to confirm the system mechanical and software features met specified requirements. Performance testing included verification of the stated operating range and validation of accuracy claims through 20-point COPs and Low Perfusion Pulse Rate and Saturation Accuracy tests. All verification and validation activities met product requirements.

Animal Testing: Animal testing was not required to demonstrate that the proposed device met its design requirements and therefore there are no animal data associated with this device.

#### Usability / Human Factors

Usability was evaluated with users in simulated operating environments. These studies consisted of formative and Summative studies, which demonstrate the device provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator.

#### Substantial Equivalence

In establishing substantial equivalence of the Bedside Respiratory Patient Monitoring System to the predicate in establishing Subtainer oquindines o events, and instrument risk profiles. The use of the Bedside Respiratory Patient Monitoring System in patient events, and finstranient her promotive with a more withpes of safety and effectiveness compared with the predicate devices currently in use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 2 8 2012

Covidien Ms. Elizabeth Malo Senior Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301

Re: K121806

Trade/Device Name: Covidien Nellcor™ Bedside Respiratory Patient Monitoring System and the Covidien Nellcor 114 Bedside Respiratory Patient Monitoring System with Respiration Rate Software

Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, BZQ Dated: August 31, 2012 Received: September 4, 2012

Dear Ms. Malo:

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 1 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. Malo

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 Statement 4.1

. 510(k) Number (if known): 121806

Device Name: Covidien Nelloor™ Bedside Respiratory Patient Monitoring System and the Covidien Nellcor™ Bedside Respiratory Patient Monitoring System Respiration Rate Software

Indications for Use:

For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software:

The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for The None - Butly as a continuous non-invasive monitor of arterial oxygen saturation (SpO₂) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. montoning of com is intenced only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Use Prescription (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter (21 CFR 801 Subpart C)

Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulthe

Division of Anestheslology, General Ho Infection Control, Dental

510(k) Number: k121806