(121 days)
Not Found
No
The document describes a pulse oximetry cable and its functionality, focusing on signal processing and data transmission. There is no mention of AI, ML, or related concepts in the description, performance studies, or key metrics.
No
This device is a monitor or interface cable that provides data (oxygen saturation and pulse rate) through connection to a host system. It does not provide any treatment or therapy itself.
Yes
The device is designed for "monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states it is a "cable with Oximetry PCBA 'engine' embedded in the sensor connector" and includes electrical subsystems like a USB Connector Cable and an Isolation module, indicating it is a hardware device with embedded software.
Based on the provided information, the Nellcor™ USB Pulse Oximetry Monitor Interface Cable is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Device Function: The Nellcor™ USB Pulse Oximetry Monitor Interface Cable measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate non-invasively by using a sensor placed on the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes monitoring physiological parameters directly from the patient, not analyzing biological samples.
Therefore, the device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes
DQA
Device Description
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric, and adult patients
Intended User / Care Setting
hospitals and hospital-type facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
SpO2 measurement accuracy specification:
• Without motion - Adults: 70-100% ± 2 digits
• Without motion - Neonates: 70-100% ± 2 digits
• With motion - Adults, Neonates: 70-100% ± 3 digits
• Low Perfusion: 70-100% ± 2 digits
• LoSat: 60% to 80% ± 3 digits
Pulse rate measurement range(BPM) and accuracy:
• Without Motion (Adult and Neonate): 20 to 250 BPM ± 3 digits
• With Motion: 20 to 250 BPM ± 5 digits
• Low Perfusion: 20 to 250 BPM ± 3 digits
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (303) 305-2750 | |
| Fax: (303) 305-2212 | |
| Establishment Registration Number: | 2936999 |
| Device Name(s): | Nellcor™ USB Pulse Oximetry Monitor Interface |
| 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: (303)305-2750 | |
| Fax: (303) 305-2212 | |
| 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 |
| 05/09/2013) | |
| Applicant: | Covidien LP |
| 6135 Gunbarrel Ave | |
| 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
Number | Standard
Developing
Organization | Standard
Designation
Number and Date | Title of Standard |
|-----------------------|----------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1-85 | ISO | 80601-2-61 First
edition 2011-04-01 | Medical electrical equipment - Part 2-61:
Particular requirements for basic safety and
essential performance of pulse oximeter
equipment |
| 2-156 | AAMI ANSI ISO | 10993-
1:2009/(R)2013 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process |
| 19-8 | IEC | 60601-1-2 Edition
4.0 2014-02 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard:
Electromagnetic disturbances - Requirements and
tests |
| 19-4 | AAMI ANSI | ES60601-
1:2005/(R)2012 and
A1:2012, | C1:2009/(R)2012 and A2:2010/(R)2012
(Consolidated Text) Medical electrical equipment
- Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005, MOD) |
| 19-1 | IEC | 60601-1-2 Edition 3:
2007-03 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard:
Electromagnetic compatibility - Requirements and
tests |
| 5-89 | IEC | 60601-1-6 Edition
3.1 2013-10 | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability |
| 5-76 | IEC | 60601-1-8 Edition
2.1 2012-11 | Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential
performance - Collateral Standard: General
requirements, tests and guidance for alarm
systems in medical electrical equipment and
medical electrical systems |
| 13-79 | IEC | 62304 Edition 1.1
2015-06 | Medical device software - Software life cycle
processes |
| 5-40 | ISO | 14971 Second
edition 2007-03-01 | Medical devices - Application of risk
management to medical devices |
| 5-90 | ISO | 15223-1 Second
Edition 2012-07-01 | Medical devices - Symbols to be used with
medical device labels, labelling, and information
to be supplied - Part 1: General requirements |
| 5-116 | ISO | 7010 Second edition
2011-06-01 | Graphical symbols - Safety colours and safety
signs - Registered safety signs [Including
AMENDMENT 1 (2012) through
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)
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 | | | |
| Web site | www.nellcor.com | www.nellcor.com | N/A |
| Indication 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. | The Nellcor OxiMAX N-600X
Pulse Oximetry System is
indicated for prescription
use only for the continuous
non-invasive monitoring of
functional oxygen saturation
of arterial hemoglobin
(SpO2) and pulse rate. The N-
600X Pulse Oximeter 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, intra
hospital transport, and home
environments.
The N-600X with SPD feature
is intended for use on adults
to detect patterns of
desaturation that are
indicative of repetitive
reductions in airflow
through the upper airway
and into the lungs. | The indication for use for
the subject device is limited
within the use of the
predicate device. The
Nellcor™ USB Pulse
Oximetry Monitor Interface
Cable doesn't include
mobile transport (EMS) and
home environments in the
indicated areas of use. |
| Environment of
Use | Hospitals, hospital-type
facilities. | Same | N/A |
| Measurement
parameter | Oxygen saturation, Pulse rate | Same | N/A |
| Sensor
compatibility | Use only Nellcor-approved
sensors | Same | N/A |
| Intended
Patient
Population | Adult, Pediatric, Neonate | Same | N/A |
| Performance
Specifications | | | |
| SpO2
Technology | Spectrophotometry and
plethysmography | Same | N/A |
| SpO2 Algorithm | Comparison of red/infrared
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-