The Nellcor pulse oximetry monitor interface cable

K172482 · Covidien · DQA · Dec 15, 2017 · Cardiovascular

Device Facts

• Record ID: K172482
• Device Name: The Nellcor pulse oximetry monitor interface cable
• Applicant: Covidien
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) 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 and hospital-type facilities.

Device Story

The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is an external oximetry-in-the-cable solution that connects to a host monitor via USB 2.0. It embeds an oximetry PCBA engine within the sensor connector. The device uses spectrophotometry (red and infrared light absorption) and plethysmography to measure functional oxygen saturation (SpO2) and pulse rate. It processes pulsatile arterial blood flow to calculate SpO2, excluding non-pulsatile absorbers like tissue and venous blood. The cable is powered by the host monitor, which displays digital SpO2 values, pulse rate, and plethysmographic waveforms. Used in hospitals by clinicians, the device provides real-time monitoring data to assist in clinical decision-making regarding patient oxygenation status. It is a line extension of existing Nellcor OxiMAX technology, designed to provide oximetry reporting to compatible host systems.

Clinical Evidence

Clinical validation involved a prospective controlled hypoxia study with 12 healthy adult volunteers (ages 18-50, diverse skin pigmentations). SpO2 readings were compared against SaO2 values from arterial blood samples measured via CO-oximetry across 60-100% saturation ranges. Motion performance was validated using aperiodic rubbing/tapping movements (1-4 Hz). Results confirmed accuracy specifications met established criteria for adult, pediatric, and neonatal populations, consistent with predicate performance.

Technological Characteristics

USB-powered interface cable with embedded Oximetry PCBA. Uses red/infrared LED spectrophotometry and plethysmography. Compatible with Nellcor SpO2 sensors. Complies with ISO 80601-2-61:2011, IEC 60601-1:2005, and ISO 10993-1/5/10 for biocompatibility. Software includes OxiMAX pulse oximetry algorithms. Connectivity via USB 2.0 Full-Speed to host monitor. Biocompatibility testing (cytotoxicity, skin irritation, sensitization) performed per ISO 10993.

Indications for Use

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

• N-600X Pulse Oximeter (K141518)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is commonly used on products and materials related to food, drugs, and other regulated items in the United States.

December 15, 2017

Covidien Mia Carroll Principal Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301

Re: K172482

Trade/Device Name: Nellcor™ USB Pulse Oximetry Monitor Interface Cable Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 15, 2017 Received: August 16, 2017

Dear Mia Carroll:

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.

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

{1}------------------------------------------------

manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Tara A. Ryan -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## 005_Indications for Use

510(k) Number: K172482

Device Name: Nellcor™ USB Pulse Oximetry Monitor Interface Cable

Indications for Use:

The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) 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 and hospital-type facilities.

Prescription Use _X___________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-the Counter Use (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)

Page 1 of __1_

{3}------------------------------------------------

#### K172482

# 006_510(K) SUMMARY

| Applicant Name and Address: | Covidien LP. |
|-------------------------------------------|--------------------------------------------------------|
| | 6135 Gunbarrel Ave |
| | Boulder, CO 80301 |
| | Phone: [phone] |
| | Fax: [phone] |
| Establishment Registration Number: | 2936999 |
| Device Name(s): | Nellcor™ USB Pulse Oximetry Monitor Interface<br>Cable |
| Classification: | Class II |
| Classification Name: | Oximeter (74DQA) (per 21 CFR §870.2700) |
| Product Code: | DQA |
| Date Prepared: | 06/30/2017 |
| 510(k) Contact Person and Phone | Mia M. Carroll |
| Number: | Principal Regulatory Affairs Specialist |
| | Covidien - Respiratory and Monitoring Solutions |
| | 6135 Gunbarrel Ave. |
| | Boulder, CO 80301 |
| | Phone: [phone] |
| | Fax: [phone] |
| Name and Address of Manufacturing Site(s) | |
| Establishment Registration Number: | Registration Number: 3026961 |
| | TYCO ELECTRONICS |
| Registered Establishment Name: | 10025 S.W. Freeman Court |
| | Wilsonville , OR 97070 |
| Address: | |

{4}------------------------------------------------

#### K172482 Predicate Devices:

The predicate device(s) to which the Nellcor™ USB Pulse Oximetry Monitor Interface Cable is claiming substantial equivalence are as follows:

| Trade Name: | N-600X Pulse Oximeter |
|----------------|-----------------------------------------|
| 510(k) Number: | K141518 (cleared on<br>05/09/2013) |
| Applicant: | Covidien LP |
| | 6135 Gunbarrel Ave<br>Boulder, CO 80301 |

## Purpose of this 510(k):

This 510(k) submission is to obtain market clearance for the Nellcor™ USB Pulse Oximetry Monitor Interface Cable, a line extension of the Nellcor pulse oximeters with OxiMAX technology.

## General Description of Subject Device:

The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is a modification of the OxiMax N-600X Pulse Oximetry Systems. When connected to a qualified host display monitor, it is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate using Nellcor pulse oximetry sensors with OxiMAX technology. The cable provides digital values of SpO2 and Pulse Rate, which are displayed on the host monitor. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is connected via USB2 and is powered by the host monitor.

## Mechanism of Action for the Nellcor USB Pulse Oximetry Monitor Interface Cable

The Nellcor™ USB Pulse Oximetry Monitor Interface Cable (the "monitoring cable") is a cable with Oximetry PCBA "engine" embedded in the sensor connector to provide external Oximetry-in-the-cable solution for devices with USB connectivity. The cable uses pulse oximetry to measure functional oxygen saturation in the blood. The cable is powered by and achieves its mechanism of action through connection to a host system. To connect the monitoring cable to a host monitoring system, insert the monitoring cable's USB connector into a compatible USB port on the host system. Then connect the Nellcor SpO2 sensor to the port in the sensor connector end of the cable.

## Principle of Operation for the Nellcor USB Pulse Oximetry Monitor Interface Cable

Pulse oximetry is based on two physical principles: oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (measured using spectrophotometry), and the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (registered using plethysmography). A monitoring system determines Sp02 by passing red and infrared light into a vascular bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared lowvoltage light-emitting diodes (LED) in the sensor serve as light sources; a photo diode serves as the photo detector.

{5}------------------------------------------------

K172482 Page 3 of 7 Since oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation. The monitoring cable uses the pulsatile nature of arterial flow to identify the oxygen saturation of arterial hemoglobin. During systole, a new pulse of arterial blood enters the vascular bed, and blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The monitoring cable bases its Sp02 measurements on the difference between maximum absorption (measurements at systole and diastole). By doing so, it focuses on light absorption by pulsatile arterial blood, eliminating the effects of non-pulsatile absorbers such as tissue, bone, and venous blood.

#### Power

The cable is powered by USB connection to a compatible host monitor.

| Recognition<br>Number | Standard<br>Developing<br>Organization | Standard<br>Designation<br>Number and Date | Title of Standard |
|-----------------------|----------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1-85 | ISO | 80601-2-61 First<br>edition 2011-04-01 | Medical electrical equipment - Part 2-61:<br>Particular requirements for basic safety and<br>essential performance of pulse oximeter<br>equipment |
| 2-156 | AAMI ANSI ISO | 10993-<br>1:2009/(R)2013 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management<br>process |
| 19-8 | IEC | 60601-1-2 Edition<br>4.0 2014-02 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and<br>tests |
| 19-4 | AAMI ANSI | ES60601-<br>1:2005/(R)2012 and<br>A1:2012, | C1:2009/(R)2012 and A2:2010/(R)2012<br>(Consolidated Text) Medical electrical equipment<br>- Part 1: General requirements for basic safety and<br>essential performance (IEC 60601-1:2005, MOD) |
| 19-1 | IEC | 60601-1-2 Edition 3:<br>2007-03 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and<br>tests |
| 5-89 | IEC | 60601-1-6 Edition<br>3.1 2013-10 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Usability |
| 5-76 | IEC | 60601-1-8 Edition<br>2.1 2012-11 | Medical electrical equipment - Part 1-8: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: General<br>requirements, tests and guidance for alarm<br>systems in medical electrical equipment and<br>medical electrical systems |
| 13-79 | IEC | 62304 Edition 1.1<br>2015-06 | Medical device software - Software life cycle<br>processes |
| 5-40 | ISO | 14971 Second<br>edition 2007-03-01 | Medical devices - Application of risk<br>management to medical devices |
| 5-90 | ISO | 15223-1 Second<br>Edition 2012-07-01 | Medical devices - Symbols to be used with<br>medical device labels, labelling, and information<br>to be supplied - Part 1: General requirements |
| 5-116 | ISO | 7010 Second edition<br>2011-06-01 | Graphical symbols - Safety colours and safety<br>signs - Registered safety signs [Including<br>AMENDMENT 1 (2012) through<br>AMENDMENT 7 (2016)] |

## Standards used for performance testing include:

{6}------------------------------------------------

## Biocompatibility Testing

The Nellcor™ USB Pulse Oximetry Monitor Interface Cable could have incidental contact with the patient during monitoring. Because of this, the

following Biocompatibility testing was performed and is included in report RE00094646:

- cytotoxicity test per ISO 10993-5:2009
- Skin Irritation and Skin Sensitization Test per ISO 10993-10:2009.

#### Software and Electrical components of the subject device:

Functionally, the Nellcor USB Pulse Oximetry Monitor Interface Cable consists of the following electrical subsystems:

- USB Connector Cable to Host
- Isolation module
- Sp02 Module measures the oxygen saturation and contains pulse oximetry software.

#### Host Monitoring System Requirements:

The monitoring cable provides oximetry reporting to any host monitoring system that provides the following features:

- USB Standard A female receptacle supporting USB 2.0 Full-Speed
- Operating system compatible with the monitoring cable's Client-Side Virtual COM Port Driver
- User interface software that can update the displayed monitoring cable information

• User interface software providing a GUI to display SpO2 and pulse rate as reported by the monitoring cable

- User interface software providing a GUI that allows a user to send commands to the monitoring cable

{7}------------------------------------------------

#### The technological characteristics of the subject device compared to the predicate device that demonstrates substantial equivalence:

| Name/510(K)<br>Number | Subject Device: Nellcor USB<br>Pulse Oximetry Monitor<br>Interface Cable | Predicate Device: Nellcor<br>OxiMAX N-600X Pulse<br>Oximeter with SPD | Impact of Differences |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K172482 | K141518 | |
| Characteristics | | | |
| Web site | www.nellcor.com | www.nellcor.com | N/A |
| Indication for<br>use | The Nellcor™ USB Pulse<br>Oximetry Monitor Interface<br>Cable is indicated for<br>prescription use only for spot<br>check or continuous non-<br>invasive monitoring of<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate. It is intended for use<br>with neonatal, pediatric, and<br>adult patients during both no<br>motion and motion conditions<br>and for patients who are either<br>well or poorly perfused, in<br>hospitals and hospital-type<br>facilities. | The Nellcor OxiMAX N-600X<br>Pulse Oximetry System is<br>indicated for prescription<br>use only for the continuous<br>non-invasive monitoring of<br>functional oxygen saturation<br>of arterial hemoglobin<br>(SpO2) and pulse rate. The N-<br>600X Pulse Oximeter is<br>intended for use with<br>neonatal, pediatric, and adult<br>patients during both no<br>motion and motion<br>conditions and for patients<br>who are either well or poorly<br>perfused, in hospitals,<br>hospital-type facilities, intra<br>hospital transport, and home<br>environments.<br>The N-600X with SPD feature<br>is intended for use on adults<br>to detect patterns of<br>desaturation that are<br>indicative of repetitive<br>reductions in airflow<br>through the upper airway<br>and into the lungs. | The indication for use for<br>the subject device is limited<br>within the use of the<br>predicate device. The<br>Nellcor™ USB Pulse<br>Oximetry Monitor Interface<br>Cable doesn't include<br>mobile transport (EMS) and<br>home environments in the<br>indicated areas of use. |
| Environment of<br>Use | Hospitals, hospital-type<br>facilities. | Same | N/A |
| Measurement<br>parameter | Oxygen saturation, Pulse rate | Same | N/A |
| Sensor<br>compatibility | Use only Nellcor-approved<br>sensors | Same | N/A |
| Intended<br>Patient<br>Population | Adult, Pediatric, Neonate | Same | N/A |
| Performance<br>Specifications | | | |
| SpO2<br>Technology | Spectrophotometry and<br>plethysmography | Same | N/A |
| SpO2 Algorithm | Comparison of red/infrared<br>modulation % | Same | N/A |
| Name/510(K) Number | Subject Device: Nellcor USB Pulse Oximetry Monitor Interface Cable | Predicate Device: Nellcor OxiMAX N-600X Pulse Oximeter with SPD | Impact of Differences |
| | K172482 | K141518 | |
| Characteristics | | | |
| SpO2 measurement range (%) | 1% to 100% (Requirement and testing is done at 0 to 100%). | Same | N/A |
| SpO2 measurement accuracy specification | | | |
| • Without motion - Adults | 70-100% $\pm$ 2 digits | Same | N/A |
| • Without motion - Neonates | 70-100% $\pm$ 2 digits | Same | N/A |
| • With motion - Adults, Neonates | 70-100% $\pm$ 3 digits | Same | N/A |
| • Low Perfusion | 70-100% $\pm$ 2 digits | Same | N/A |
| • LoSat | 60% to 80% $\pm$ 3 digits | Same | N/A |
| Pulse rate measurement range(BPM) and accuracy | | | |
| • Without Motion (Adult and Neonate) | 20 to 250 BPM $\pm$ 3 digits | Same | N/A |
| • With Motion | 20 to 250 BPM $\pm$ 5 digits | Same | N/A |
| • Low Perfusion | 20 to 250 BPM $\pm$ 3 digits | Same | N/A |
| Compliance | ISO 80601-2-61:2011 | ISO9919:2005 | No impact to substantial equivalence because the ISO 80601-2-61:2011 standard has superseded ISO9919:2005 since 2011 and is the current FDA recognized pulse oximetry particular standard. |

{8}------------------------------------------------

#### Summary of Technical Characteristics

The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is a line extension of the Nellcor family of pulse oximeters. It is technologically identical to the predicate devices. It has the same oximetry software and performs within the same specifications as N-600X. The clinical performance when used with adult, pediatric and neonatal patients meets the same acceptance criteria as in the N-600X pulse oximeter clinical evaluations submitted in K060576 and K141518. The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is intended to be used with the same Nellcor SpO2 sensors that are

{9}------------------------------------------------

commercially available and used with the predicate device. Based on the results of the non-clinical validation studies, Covidien has established that the Nellcor™ USB Pulse Oximetry Monitor Interface Cable is substantially equivalent to the predicate devices.

Page 7 of 7

## 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 in low perfusion conditions, Host connectivity and performance verification, Human Factors Summative Usability validation, and testing incorporating simulated motion performed to validate the pulse rate accuracy across the measurement range during motion.

## Discussion of clinical data

Prospective Clinical data is submitted in Section 021 Performance Testing - Clinical for the Nellcor™ USB Pulse Oximetry Monitor Interface Cable. Accuracy specifications were validated using measurements of healthy non-smoking adult volunteers during controlled hypoxia blood studies spanning the 60-100% saturation ranges. Subjects were recruited from the local population and comprised both men and women ranging in age from 18-50 years old, and spanned a diverse range of skin pigmentations. Pulse oximeter Sp02 readings were compared to Sa02 values of drawn blood samples measured by hemoximetry. Data from 12 healthy volunteers were included in the analysis. Sp02 values were continuously recorded from each instrument while inspired oxygen was controlled to produce five steady state plateaus at target saturations. Arterial blood samples are periodically taken from an indwelling arterial catheter at each plateau resulting in a total of approximately 30 samples per subject. Each arterial sample is drawn while Sp02 data were simultaneously collected and marked for direct comparison to reference-standard measurements of blood SaO2 by a CO-oximeter. End tidal CO2, respiratory rate, and respiratory pattern were continuously monitored throughout the study through CO2 sampling line connected to the patient monitor.

Motion performance was validated during a controlled hypoxia blood study over an SaO2 span of 70% to 98.9%. Subjects performed rubbing and tapping movements 1-2 cm in amplitude with aperiodic intervals (randomly changing) with a random variation in frequency between 1-4 Hz. All accuracies are expressed as ±1 SD.

## Conclusions

The technological characteristics of the Nellcor™ USB Pulse Oximetry Monitor Interface Cable 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.

-End of Section 006_510(k) Summary-