NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )

K141542 · Covidien, LLC · DQA · Oct 2, 2014 · Cardiovascular

Device Facts

• Record ID: K141542
• Device Name: NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
• Applicant: Covidien, LLC
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

Portable pulse oximeter; monitors functional oxygen saturation (SpO2) and pulse rate. Inputs: optical signals from Nellcor OxiMAX sensors. Processing: OxiMAX technology PCBA; calculates SpO2 and pulse rate. Outputs: digital SpO2/pulse rate values; pulse amplitude via blip bar or plethysmographic waveform. Used in hospitals, mobile, and home environments; operated by clinicians or patients. Provides real-time physiological data to support clinical decision-making; enables non-invasive patient monitoring.

Clinical Evidence

No new clinical data; relies on clinical data previously submitted for predicates K060576 and K123581. Performance established via non-clinical bench testing, including ISO 80601-2-61:2011 and IEC 60601-1:2005 compliance, pulse oximetry performance verification, and human factors summative usability validation. Motion testing validated pulse rate accuracy (20-250 bpm) using a functional tester.

Technological Characteristics

Hand-held portable pulse oximeter. Powered by four AA batteries. Uses Nellcor OxiMAX sensors. PCBA and software identical to N-600X predicate. Complies with ISO 80601-2-61:2011 and IEC 60601-1:2005. Connectivity via sensor cable.

Indications for Use

Indicated for prescription use for spot check or continuous non-invasive monitoring of SpO2 and pulse rate in neonatal, pediatric, and adult patients. Suitable for well or poorly perfused patients under motion or no-motion conditions in hospital, mobile, or 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

• OxiMAX NPB-40 Pulse Oximeter (K051352)
• N-600X Pulse Oximeter (K123581)

Submission Summary (Full Text)

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

October 2, 2014

Covidien Ms. Mia Ware Senior Regulatory Affairs Product Specialist 6135 Gunbarrel Ave. Boulder, CO 80301

Re: K141542

Trade/Device Name: Nellcor Portable SpO2 Patient Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 28, 2014 Received: September 4, 2014

Dear Ms. Ware:

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. Ware

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name "Tejashri Purohit-Sheth, M.D." in a serif font. The name is written in black ink on a white background. The text appears to be a professional title, possibly indicating a medical doctor.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known)

### K141542

Device Name

NellcorTM Portable SpO2 Patient Monitoring System

#### Indications for Use (Describe)

The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(K) SUMMARY

| Applicant Name and Address: | Covidien LP.<br>6135 Gunbarrel Ave<br>Boulder, CO 80301<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 2936999 |
| Device Name(s): | Nellcor™ Portable SpO2 Patient Monitoring System |
| Classification: | Class II |
| Classification Name: | Oximeter (74DQA) (per 21 CFR §870.2700) |
| Product Code: | DQA |
| Date Prepared: | 06/09/2014 |
| 510(k) Contact Person and Phone Number: | Mia M. Ware<br>Sr. Regulatory Affairs Specialist<br>Covidien - Respiratory and Monitoring Solutions<br>6135 Gunbarrel Ave.<br>Boulder, CO 80301<br>Phone: [phone]<br>Fax: [phone] |
| Name and Address of Manufacturing Site(s) | |
| Establishment Registration Number: | 30003591740 |
| Registered Establishment Name: | Mediana Co. LTD |
| Address: | Wonju Medical Industry Park,<br>1650-1, Donghwa-ri, Munmak-<br>eup, Wonju-si, Gangwon-do, Korea |

## Predicate Devices:

The predicate device(s) to which the Nellcor™ Portable SpO2 Patient Monitoring System is claiming substantial equivalence are as follows:

| Trade Name: | OxiMAX NPB-40 Pulse Oximeter | N-600X Pulse Oximeter |
|----------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) Number: | K051352 (cleared on 8/11/05) | K123581 (cleared on 05/09/2013) |
| Applicant: | Nellcor Puritan Bennett, Incorporated<br>4280 Hacienda Drive<br>Pleasanton, CA 94588-8604 | Covidien LP<br>6135 Gunbarrel Ave<br>Boulder, CO 80301 |

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# Purpose of this 510(k):

This 510(k) submission is to obtain market clearance for the Nellcor Portable Sp02 Patient Monitoring System, a line extension of the Nellcor pulse oximeters with OxiMAX technology.

# General Description:

The Nellcor Portable SpO2 Patient Monitoring System is a modification of the OxiMax NPB-40 and N-600X Pulse Oximetry Systems. It is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using Nellcor pulse oximetry sensors with OxiMAX technology, and the oximetry sensor cable. The monitor displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Nellcor Portable Sp02 Patient Monitoring System is powered by four AA batteries.

# Proposed Nellcor Portable SpO2 Patient Monitoring System Indications for Use:

The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

# Summary of Technical Characteristics

The Nellcor Portable Sp02 Patient Monitoring System is a line extension of the Nell-1 family of pulse oximeters. It is technologically identical to the predicate devices. It has the same oximetry PCBA and software as N-600X and has the same hand-held portable form factor and performs within the same specifications as the NPB-40. The clinical performance when used with adult, pediatric and neonatal patients is the same as in the N-600X pulse oximeter and was established with that oximeter in K060576 and K123581. The Nellcor Portable SpO2 Patient Monitoring System is intended to be used with the same Nellcor Sp02 sensors that are commercially available and used with the predicate devices. Based on the results of the non-clinical validation studies, Covidien has established that the Nellcor Portable SpO2 Patient Monitoring System is substantially equivalent to the predicate devices.

## Non-clinical/bench-testing data

The performance testing section of this submission includes verification and validation reports for pulse oximetry performance in accordance with FDA Guidance document: "Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff". Non-clinical testing in this submission includes, but is not limited to, ISO 80601-2-61:2011 and IEC 60601-1:2005 test reports, Oximetry performance verification, Human Factors Summative Usability validation, and testing incorporating simulated motion performed to validate the pulse rate accuracy of in the range of 20 -250 beats per minute during motion using a functional tester.

## Discussion of clinical data

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Clinical data submitted in K060576, and K123581 is applicable to the Nellcor Portable SpO2 Patient Monitoring System. Because there are no changes to the performance, technology, and intended use of the device, the clinical data submitted as part of the premarket notifications for the predicate devices also applies to the Nellcor Portable SpO2 Patient Monitoring System.

## Conclusions

The technological characteristics of the Nellcor Portable SpO2 Patient Monitoring System and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices.