(121 days)
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™ 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.
The provided FDA 510(k) summary describes the acceptance criteria and the study that proves the Nellcor™ USB Pulse Oximetry Monitor Interface Cable meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Measurement Range | 1% to 100% | 1% to 100% (Requirement and testing done at 0 to 100%) |
| SpO2 Accuracy (Without Motion - Adults) | 70-100% $\pm$ 2 digits | 70-100% $\pm$ 2 digits |
| SpO2 Accuracy (Without Motion - Neonates) | 70-100% $\pm$ 2 digits | 70-100% $\pm$ 2 digits |
| SpO2 Accuracy (With Motion - Adults, Neonates) | 70-100% $\pm$ 3 digits | 70-100% $\pm$ 3 digits |
| SpO2 Accuracy (Low Perfusion) | 70-100% $\pm$ 2 digits | 70-100% $\pm$ 2 digits |
| SpO2 Accuracy (LoSat) | 60-80% $\pm$ 3 digits | 60% to 80% $\pm$ 3 digits |
| Pulse Rate Measurement Range (BPM - Without Motion) | 20 to 250 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits |
| Pulse Rate Measurement Range (BPM - With Motion) | 20 to 250 BPM $\pm$ 5 digits | 20 to 250 BPM $\pm$ 5 digits |
| Pulse Rate Measurement Range (BPM - Low Perfusion) | 20 to 250 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits |
Note: The document explicitly states the subject device has the "same" performance specifications as the predicate which are detailed in the table for the Nellcor OxiMAX N-600X Pulse Oximeter.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Data from 12 healthy volunteers were included in the analysis for the controlled hypoxia blood studies.
- Data Provenance: Prospective. The study involved recruiting healthy non-smoking adult volunteers from the local population. The country of origin is not explicitly stated but implies a single location for the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention experts being used to establish the ground truth for the test set. The ground truth was established through direct physiological measurements (blood samples analyzed by CO-oximeter).
4. Adjudication Method for the Test Set
No adjudication method is described as the ground truth was established by objective measurements (CO-oximetry of drawn blood samples), not by expert opinion requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a pulse oximetry monitor interface cable, and its performance is evaluated against physiological ground truth rather than against human interpretation of medical images or data. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this type of device.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The clinical data section describes the direct comparison of the pulse oximeter SpO2 readings to SaO2 values from drawn blood samples. This evaluates the algorithm's performance independent of human interpretation for the core functions of SpO2 and pulse rate measurement.
7. The Type of Ground Truth Used
The ground truth used was physiological measurements from blood samples analyzed by a CO-oximeter (hemoximetry). This is considered highly objective and directly correlates to arterial oxygen saturation (SaO2).
8. The Sample Size for the Training Set
The document does not explicitly state a separate "training set" or its size for the Nellcor™ USB Pulse Oximetry Monitor Interface Cable in the context of machine learning. The device is a "line extension" of existing pulse oximeters, and it uses the "same oximetry software" and "same specifications as N-600X". The information shared describes the clinical validation, not necessarily a machine learning model training process.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" in the context of machine learning model development is not explicitly described. However, the device's underlying oximetry software, which would have been "trained" or designed to perform accurately, likely relied on extensive physiological data and controlled studies similar to the validation study described for this device, or those for its predicate device (N-600X Pulse Oximeter). The document states that "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." This implies that the design and performance were established through similar rigorous clinical studies using CO-oximetry as the ground truth for those prior devices.
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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
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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
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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
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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 InterfaceCable |
| 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: |
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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 on05/09/2013) |
| Applicant: | Covidien LP |
| 6135 Gunbarrel AveBoulder, 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.
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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.
| RecognitionNumber | StandardDevelopingOrganization | StandardDesignationNumber and Date | Title of Standard |
|---|---|---|---|
| 1-85 | ISO | 80601-2-61 Firstedition 2011-04-01 | Medical electrical equipment - Part 2-61:Particular requirements for basic safety andessential performance of pulse oximeterequipment |
| 2-156 | AAMI ANSI ISO | 10993-1:2009/(R)2013 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| 19-8 | IEC | 60601-1-2 Edition4.0 2014-02 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard:Electromagnetic disturbances - Requirements andtests |
| 19-4 | AAMI ANSI | ES60601-1:2005/(R)2012 andA1:2012, | C1:2009/(R)2012 and A2:2010/(R)2012(Consolidated Text) Medical electrical equipment- Part 1: General requirements for basic safety andessential performance (IEC 60601-1:2005, MOD) |
| 19-1 | IEC | 60601-1-2 Edition 3:2007-03 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard:Electromagnetic compatibility - Requirements andtests |
| 5-89 | IEC | 60601-1-6 Edition3.1 2013-10 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability |
| 5-76 | IEC | 60601-1-8 Edition2.1 2012-11 | Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements, tests and guidance for alarmsystems in medical electrical equipment andmedical electrical systems |
| 13-79 | IEC | 62304 Edition 1.12015-06 | Medical device software - Software life cycleprocesses |
| 5-40 | ISO | 14971 Secondedition 2007-03-01 | Medical devices - Application of riskmanagement to medical devices |
| 5-90 | ISO | 15223-1 SecondEdition 2012-07-01 | Medical devices - Symbols to be used withmedical device labels, labelling, and informationto be supplied - Part 1: General requirements |
| 5-116 | ISO | 7010 Second edition2011-06-01 | Graphical symbols - Safety colours and safetysigns - Registered safety signs [IncludingAMENDMENT 1 (2012) throughAMENDMENT 7 (2016)] |
Standards used for performance testing include:
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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
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The technological characteristics of the subject device compared to the predicate device that demonstrates substantial equivalence:
| Name/510(K)Number | Subject Device: Nellcor USBPulse Oximetry MonitorInterface Cable | Predicate Device: NellcorOxiMAX N-600X PulseOximeter with SPD | Impact of Differences |
|---|---|---|---|
| K172482 | K141518 | ||
| Characteristics | |||
| Web site | www.nellcor.com | www.nellcor.com | N/A |
| Indication foruse | The Nellcor™ USB PulseOximetry Monitor InterfaceCable is indicated forprescription use only for spotcheck or continuous non-invasive monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate. It is intended for usewith neonatal, pediatric, andadult patients during both nomotion and motion conditionsand for patients who are eitherwell or poorly perfused, inhospitals and hospital-typefacilities. | The Nellcor OxiMAX N-600XPulse Oximetry System isindicated for prescriptionuse only for the continuousnon-invasive monitoring offunctional oxygen saturationof arterial hemoglobin(SpO2) and pulse rate. The N-600X Pulse Oximeter isintended for use withneonatal, pediatric, and adultpatients during both nomotion and motionconditions and for patientswho are either well or poorlyperfused, in hospitals,hospital-type facilities, intrahospital transport, and homeenvironments.The N-600X with SPD featureis intended for use on adultsto detect patterns ofdesaturation that areindicative of repetitivereductions in airflowthrough the upper airwayand into the lungs. | The indication for use forthe subject device is limitedwithin the use of thepredicate device. TheNellcor™ USB PulseOximetry Monitor InterfaceCable doesn't includemobile transport (EMS) andhome environments in theindicated areas of use. |
| Environment ofUse | Hospitals, hospital-typefacilities. | Same | N/A |
| Measurementparameter | Oxygen saturation, Pulse rate | Same | N/A |
| Sensorcompatibility | Use only Nellcor-approvedsensors | Same | N/A |
| IntendedPatientPopulation | Adult, Pediatric, Neonate | Same | N/A |
| PerformanceSpecifications | |||
| SpO2Technology | Spectrophotometry andplethysmography | Same | N/A |
| SpO2 Algorithm | Comparison of red/infraredmodulation % | 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. |
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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
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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-
§ 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).